ESTEEM: Combined Treatment for Mixed Incontinence

• Sponsor: NICHD Pelvic Floor Disorders Network (Other)
• Overall Status: Completed
• CT.gov ID: NCT01959347
• Collaborator: Women and Infants Hospital of Rhode Island (Other), The Cleveland Clinic (Other), Duke University (Other), University of Alabama at Birmingham (Other), University of New Mexico (Other), University of Pennsylvania (Other), University of Pittsburgh (Other), University of California, San Diego (Other), Kaiser Permanente (Other), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH), RTI International (Other)
• Enrollment: 480
• Locations: 10
• Arms: 2
• Duration (Months): 47
• Patients Per Site: 48
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

The overarching goal of this randomized trial is to estimate the effect of combined midurethral sling (MUS) and peri-operative behavioral/pelvic floor therapy (BPTx) compared to MUS alone on successful treatment of MUI symptoms in 472 women. Secondary objectives include estimating the effect of combined treatment compared to MUS on improving overactive bladder (OAB) and stress urinary incontinence (SUI) outcomes separately, need for additional treatment, time to failure and identifying predictors of poor outcomes in this MUI population.

A supplemental study, The Human Microbiome Study of ESTEEM, will evaluate the urinary and vaginal microbiome as it relates to women with MUI, their treatment and unaffected controls.

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence, Stress; Urinary Incontinence, Urge	Procedure: Miduretheral Sling; Other: Miduretheral Sling with behavioral/pelvic floor therapy	Phase 3

Detailed Description

ESTEEM is a multi-center randomized trial of 472 women with MUI who have elected to undergo surgical treatment for SUI. Participants will be randomized to a peri-operative BPTx program+MUS versus MUS alone. The purpose is to compare combined MUS+BPTx versus MUS alone (control) on improving MUI symptoms at 1 year.

Patients will be assigned to one of the two treatment groups. Randomization will be stratified by clinical site and by UUI "severity," which will be defined by the number of urgency urinary IEs on diary.

The primary outcome for this study is the mean change from baseline in UDI-total score at 1 year postoperative. The UDI is a validated, disease-specific, patient-reported outcome (PRO) measure.

Secondary outcomes UUI/OAB outcomes will be measured using the UDI-irritative subscale that measures symptom burden, impact, and changes related to OAB. It is highly responsive to treatment-related change and is able to discriminate among levels of change in all bladder diary variables (urinary urgency, frequency and urge incontinence) and patient ratings of treatment benefit that will characterize how MUS may affect all OAB symptoms individually and as a whole. SUI symptom outcomes will be measured using the UDI-stress subscale to compare SUI outcomes between women randomized to MUS + BPTx versus MUS alone.

Other UUI/OAB outcomes that will be compared between groups include 1) the change in IE frequency and type, number of urgency episodes, urgency severity with voids, number of diurnal voids, and number of nocturnal voids using a bladder diary; 2) patient satisfaction with treatment using the OAB-SAT-q; 3) bother and heal related quality of life using the OAB-q subscale

For analyzing time to failure, "failure" will be defined as initiation of any additional treatment for either SUI or UUI/OAB symptoms during the follow-up period. Subjects lost to follow up will be censored at the time of their last visit.

Quality of life/global impression will be assessed be compared between treatment groups using the a) Incontinence Impact Questionnaire (IIQ), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ), c) European Quality of Life-5 Dimensions (EQ-5D), d) Adaptation Index and e) Patient Global Impression of Improvement (PGI-I) and Patient Global Impression of Severity (PGI-S).

Safety/additional treatments will be characterized as a) additional re-treatments for SUI or UUI within 12 months of treatment, and type of re-treatment and b) return to OR for sling revision due to worsened OAB symptoms.

To evaluate the association between PFM strength and improvements in UI symptoms, we will objectively assess PFM strength changes using the Peritron Perineometer, and instrument specifically designed for pelvic floor assessment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 480 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Care Provider)
• Primary Purpose: Treatment
• Official Title: Effects of Surgical Treatment Enhanced With Exercise for Mixed Urinary Incontinence (ESTEEM)
• Study Start Date: Oct 28, 2013
• Actual Primary Completion Date: Aug 9, 2017
• Actual Study Completion Date: Sep 29, 2017

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: Miduretheral Sling (Control) Miduretheral Sling (Control)	Procedure: Miduretheral Sling; MUS can include the TVT™ (mechanical cut mesh only, Gynecare, ETHICON Women's Health & Urology, Somerville, NJ), TVT-O™ (mechanical cut mesh only, Gynecare), or Monarc™ (American Medical Systems, Minnetonka, MN).; Other Names: MUS
Experimental: MUS+BPTx Miduretheral Sling with behavioral/pelvic floor therapy	Other: Miduretheral Sling with behavioral/pelvic floor therapy; MUS is combined with components of behavioral therapy (designed to change behaviors to encourage continence), and pelvic floor muscle therapy (designed to strengthen the pelvic floor muscles, enhance the physiological closure of the bladder neck, and improve coordination). This is done prior to MUS (1 visit) and after MUS for 5 visits at 2, 4, 6, 8 weeks and 6 months.; Other Names: MUS + BPTx

Outcome Measures

Primary Outcome Measures

1. Change From Baseline UDI Total Score [3, 6, and 12 Months]

   The Urogenital Distress Inventory (UDI) is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI scale has a range from 0 to 300 with higher scores indicating greater distress. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Secondary Outcome Measures

1. Change From Baseline UDI Stress Score [3, 6, and 12 Months]

   The Urogenital Distress Inventory is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI Stress subscale has a range from 0 to 100 with higher scores indicating greater distress. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

2. Change From Baseline UDI Irritative Score [3, 6, and 12 Months]

   The Urogenital Distress Inventory is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI Irritative subscale has a range from 0 to 100 with higher scores indicating greater distress. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

3. Change From Baseline UDI Obstructive Score [3, 6, and 12 Months]

   The Urogenital Distress Inventory is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI Obstructive subscale has a range from 0 to 100 with higher scores indicating greater distress. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

Other Outcome Measures

1. Change From Baseline Number of Stress Incontinence Episodes [2 weeks and 2, 6, and 12 Months]

   Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in number of stress incontinence episodes at 2 weeks, 2, 6, or 12 months and the number of stress incontinence episodes at baseline.

2. Change From Baseline Number of Urge Incontinence Episodes [2 weeks and 2, 6, and 12 Months]

   Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in number of urge incontinence episodes at 2 weeks, 2, 6, or 12 months and the number of urge incontinence episodes at baseline.

3. Change From Baseline Number of Unknown Incontinence Episodes [2 weeks and 2, 6, and 12 Months]

   Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in number of unknown incontinence episodes at 2 weeks, 2, 6, or 12 months and the number of unknown incontinence episodes at baseline.

4. Change From Baseline Total Number of Incontinence Episodes [2 weeks and 2, 6, and 12 Months]

   Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in total number of incontinence episodes at 2 weeks, 2, 6, or 12 months and the total number of incontinence episodes at baseline.

5. Change From Baseline Number of Wet Pads Per Day [2 weeks and 2, 6, and 12 Months]

   Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in number of wet pads per day at 2 weeks, 2, 6, or 12 months and the number of wet pads per day at baseline.

6. Change From Baseline Number of Pads Per Day [2 weeks and 2, 6, and 12 Months]

   Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in total number of pads per day at 2 weeks, 2, 6, or 12 months and the total number of pads per day at baseline.

7. Change From Baseline Number of Daytime Voids [2 weeks and 2, 6, and 12 Months]

   Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in number of daytime voids at 2 weeks, 2, 6, or 12 months and the number of daytime voids at baseline.

8. Change From Baseline Number of Nighttime Voids [2 weeks and 2, 6, and 12 Months]

   Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in number of nighttime voids at 2 weeks, 2, 6, or 12 months and the number of nighttime voids at baseline.

9. Change From Baseline Number of Urgency Voids Without Incontinence [2 weeks and 2, 6, and 12 Months]

   Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in number of urgency voids without incontinence at 2 weeks, 2, 6, or 12 months and the number of urgency voids without incontinence at baseline.

10. Number of Participants With <8 Voids After Baseline (Normalization of Voiding Frequency) [2 weeks and 2, 6, and 12 Months]

    Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, for participants with >8 voids at baseline, the outcome is calculated as Yes=no more than 8 voids noted at the time point, No=Otherwise

11. Number of Participants With 50% Reduction in Voids Relative to Baseline (Improved Voiding Frequency) [2 weeks and 2, 6, and 12 Months]

    Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome is calculated as Yes=at least 50% reduction in the number of voids between 2 weeks, 2, 6, and 12 months and baseline, No=Otherwise

12. Number of Participants With Greater Number of Voids Relative to Baseline or >8 Voids (Worsening Voiding Frequency) [2 weeks and 2, 6, and 12 Months]

    Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome is calculated as Yes=greater than baseline number of voids at the time point or with greater than 8 voids at the time point, No=Otherwise

13. Change From Baseline PISQ-IR NSAPR Score [3, 6, and 12 Months]

    The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Not Partner Related subscale (NSA-PR) ranges from 0 to 100 with higher scores indicating worse function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

14. Change From Baseline PISQ-IR NSACS Score [3, 6, and 12 Months]

    The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Not Sexually Active-Condition Specific subscale (NSA-CS) ranges from 0 to 100 with worse scores indicating better function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

15. Change From Baseline PISQ-IR NSAGQR Score [3, 6, and 12 Months]

    The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Not Sexually Active-Global Quality Rating subscale (NSA-GQR) ranges from 0 to 100 with higher scores indicating worse function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

16. Change From Baseline PISQ-IR NSACI Score [3, 6, and 12 Months]

    The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Not Sexually Active-Condition Impact subscale (NSA-CI) ranges from 0 to 100 with higher scores indicating worse function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

17. Change From Baseline PISQ-IR SAAO Score [3, 6, and 12 Months]

    The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Sexually Active-Arousal, Orgasm subscale (SA-AO) ranges from 0 to 100 with higher scores indicating worse function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

18. Change From Baseline PISQ-IR SAPR Score [3, 6, and 12 Months]

    The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Sexually Active-Partner Related subscale (SA-PR) ranges from 0 to 100 with higher scores indicating better function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

19. Change From Baseline PISQ-IR SACS Score [3, 6, and 12 Months]

    The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Sexually Active-Condition Specific subscale (SA-CS) ranges from 0 to 100 with higher scores indicating better function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

20. Change From Baseline PISQ-IR SAGQR Score [3, 6, and 12 Months]

    The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Sexually Active-Global Quality Rating subscale (SA-GQR) ranges from 0 to 100 with higher scores indicating better function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

21. Change From Baseline PISQ-IR SACI Score [3, 6, and 12 Months]

    The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Sexually Active-Condition Impact subscale (SA-CI) ranges from 0 to 100 with higher scores indicating better function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

22. Change From Baseline PISQ-IR SAD Score [3, 6, and 12 Months]

    The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Sexually Active-Desire subscale (SA-D) ranges from 0 to 100 with higher scores indicating better function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

23. Change From Baseline EQ-5D Index Score [3, 6, and 12 Months]

    EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life. The index score ranges from 0 to 1 with higher scores indicating a better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

24. Change From Baseline EQ-5D Visual Analog Scale Score [3, 6, and 12 Months]

    EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life. The visual analog scale (VAS) score ranges from 0 to 100 with higher scores indicating a better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

25. Change From Baseline OABq-LF Symptom Severity Score [3, 6, and 12 Months]

    The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Symptom Severity score ranges from 0 to 100 with higher score indicating worse quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

26. Change From Baseline OABq-LF Coping Score [3, 6, and 12 Months]

    The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Coping score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

27. Change From Baseline OABq-LF Concern Score [3, 6, and 12 Months]

    The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Concern score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

28. Change From Baseline OABq-LF Sleep Score [3, 6, and 12 Months]

    The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Sleep score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

29. Change From Baseline OABq-LF Social Score [3, 6, and 12 Months]

    The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Social score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

30. Change From Baseline OABq-LF HRQL Total Score [3, 6, and 12 Months]

    The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF HRQL score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

31. OAB-SATq Satisfaction Score [3, 6, and 12 Months]

    The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The OAB-SATq Satisfaction score ranges from 0 to 100 with higher scores indicating higher satisfaction.

32. OAB-SATq Side Effect Score [3, 6, and 12 Months]

    The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The OAB-SATq Side Effect score ranges from 0 to 100 with higher scores indicating fewer side effects.

33. OAB-SATq Endorsement Score [3, 6, and 12 Months]

    The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The OAB-SATq Endorsement score ranges from 0 to 100 with higher scores indicating greater endorsement.

34. OAB-SATq Convenience Score [3, 6, and 12 Months]

    The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The OAB-SATq Convenience score ranges from 0 to 100 with higher scores indicating greater convenience.

35. OAB-SATq Preference Score [3, 6, and 12 Months]

    The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The preference score is a binary [yes/no] indicator as to whether a subject indicated slight or definite preference for the treatment among women that have had previous treatment for overactive bladder. The outcome is the percentage of participants that prefer the current treatment to previous treatments.

36. Change From Baseline IIq-LF Physical Activity Score [3, 6, and 12 Months]

    The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Physical Activity score ranges from 0 to 100 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

37. Change From Baseline IIq-LF Travel Score [3, 6, and 12 Months]

    The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Travel score ranges from 0 to 100 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

38. Change From Baseline IIq-LF Social Relationship Score [3, 6, and 12 Months]

    The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Social Relationship score ranges from 0 to 100 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

39. Change From Baseline IIq-LF Emotional Health Score [3, 6, and 12 Months]

    The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Emotional Health score ranges from 0 to 100 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

40. Change From Baseline IIq-LF Total Score [3, 6, and 12 Months]

    The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Total score ranges from 0 to 400 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

41. Change From Baseline ADI Hygiene Score [3, 6, and 12 Months]

    The Adaptation Index is a standardized measure of health-related quality of life. The ADI Hygiene score ranges from 0 to 100 with higher score indicating worse severity in adaptive behaviors. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

42. Change From Baseline ADI Avoidance Score [3, 6, and 12 Months]

    The Adaptation Index is a standardized measure of health-related quality of life. The ADI Avoidance score ranges from 0 to 100 with higher score indicating worse severity in adaptive behaviors. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.

43. Change From Baseline Brink Score [2 weeks and 2 and 12 Months]

    The Brink scale considers three pelvic floor muscle contraction variables: vaginal pressure or muscle force, elevation or vertical displacement of the examiner fingers, and duration of contraction. The score ranges from 3 to 12 with higher scores indicating greater PFM function. The change from baseline outcome is calculated as the difference in score at 3 or 12 months and the score at baseline.

44. Change From Average Peak Muscle Contraction Pressure (cm H2O) [2 weeks and 2 and 12 Months]

    The average peak muscle contraction is measured during a physical exam. The outcome is calculated as the difference in measured value at 3 or 12 months and the score at baseline.

45. PGI-I [3, 6, and 12 Months]

    The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse). Included here are participants who had improvement as indicated by a rating of 1 (very much better), 2 (much better).

46. PGI-S [Baseline 3, 6, and 12 Months]

    The Patient Global Impression of Severity (PGI-S) is a patient-reported measure of perceived severity of condition, as assessed on a scale of 1 (Normal) to 4 (Severe). Included here are participants who reported Normal or Mild severity as indicated by a rating of 1 or 2.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Presence of both SUI and UUI on bladder diary; and > 2 IEs/3 days

2. 1 Stress IE/3 day diary

3. 1 Urge IE/3 day diary

4. Reporting at least "moderate bother" from UUI item on the UDI "Do you usually experience urine leakage associated with a feeling of urgency, that is a strong sensation of needing to go to the bathroom?"

5. Reporting at least "moderate bother" from SUI item on UDI "Do you usually experience urine leakage related to coughing, sneezing, or laughing"

6. Diagnosis of SUI defined by a positive cough stress test (CST) or urodynamic evaluation within the past 18 months

7. Desires surgical treatment for SUI symptoms

8. Urinary symptoms >3 months

9. Subjects understand that BPTx is a treatment option for MUI outside of ESTEEM study protocol

10. Urodynamics within past 18 months

Exclusion Criteria:

1. Anterior or apical compartment prolapse at or beyond the hymen (>0 on POPQ), regardless if patient is symptomatic

a)Women with anterior or apical prolapse above the hymen (<0) who do not report vaginal bulge symptoms will be eligible

1. Planned concomitant surgery for anterior vaginal wall or apical prolapse > 0

a)Women undergoing only rectocele repair are eligible

1. Women undergoing hysterectomy for any indication will be excluded

2. Active pelvic organ malignancy

3. Age <21 years

4. Pregnant or plans for future pregnancy in next 12 months, or within 12 months post-partum

5. Post-void residual >150 cc on 2 occasions, or current catheter use

6. Participation in other trial that may influence results of this study

7. Unevaluated hematuria

8. Prior sling, synthetic mesh for prolapse, implanted nerve stimulator for incontinence

9. Spinal cord injury or advanced/severe neurologic conditions including Multiple Sclerosis, Parkinsons

10. Women on anti-muscarinic therapy will be eligible after 3 week wash-out period

11. Non-ambulatory

12. History of serious adverse reaction to synthetic mesh

13. Not able to complete study assessments per clinician judgment, or not available for 12 month follow-up

14. Women who only report "other IE" on bladder diary, and do not report at minimum 1 stress and 1 urge IE/3 days

15. Diagnosis of and/or history of bladder pain or chronic pelvic pain

16. Women who had intravesical Botox injection within the past 12 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham, Department of Obstetrics and Gynecology	Birmingham	Alabama	United States	35249-7333
2	Kaiser Permanente -- Downey	Downey	California	United States	90242
3	University of California at San Diego, UCSD Women's Pelvic Medicine Center	La Jolla	California	United States	92037-0974
4	Kaiser Permanente -- San Diego	San Diego	California	United States	92110
5	University of New Mexico Health Sciences Center, Department of Obstetrics and Gynecology	Albuquerque	New Mexico	United States	87131-0001
6	Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery	Durham	North Carolina	United States	27707
7	Cleveland Clinic, Department OB/GYN	Cleveland	Ohio	United States	44195
8	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
9	Magee-Womens Hospital, Department of Obstetrics and Gynecology	Pittsburgh	Pennsylvania	United States	15213
10	Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery	Providence	Rhode Island	United States	02903

Sponsors and Collaborators

• NICHD Pelvic Floor Disorders Network
• Women and Infants Hospital of Rhode Island
• The Cleveland Clinic
• Duke University
• University of Alabama at Birmingham
• University of New Mexico
• University of Pennsylvania
• University of Pittsburgh
• University of California, San Diego
• Kaiser Permanente
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• RTI International

Investigators

• Principal Investigator: Vivian W. Sung, Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery
• Principal Investigator: Dennis Wallace, RTI International

Study Documents (Full-Text)

• Study Protocol - Feb 12, 2014
• Statistical Analysis Plan - Sep 12, 2018

More Information

Publications

None provided.

• Responsible Party: NICHD Pelvic Floor Disorders Network
• ClinicalTrials.gov Identifier: NCT01959347
• Other Study ID Numbers: PFDN-26P01; U10HD041261; U10HD069013; U10HD054215; U10HD041267; U10HD054214; U10HD069025; U10HD069010; U10HD041263; U01HD069031
• First Posted: Oct 10, 2013
• Last Update Posted: May 14, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by NICHD Pelvic Floor Disorders Network: urinary incontinence; midurethral sling; pelvic floor therapy
• Additional relevant MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress; Urinary Incontinence, Urge

Study Results

Participant Flow

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Period Title: Overall Study
STARTED	238	242
COMPLETED	229	235
NOT COMPLETED	9	7

Baseline Characteristics

Arm/Group Title	MUS Only	MUS+BPTx	Total
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy	Total of all reporting groups
Overall Participants	229	235	464
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.6 (10.4)	54.3 (11)	54 (10.7)
Sex/Gender, Customized (Count of Participants)
Female	229 100%	235 100%	464 100%
Race/Ethnicity, Customized (Count of Participants)
American Indian/Alaskan Native	3 1.3%	7 3%	10 2.2%
Asian	1 0.4%	2 0.9%	3 0.6%
Black/African American	19 8.3%	22 9.4%	41 8.8%
More than one race	1 0.4%	2 0.9%	3 0.6%
Other	23 10%	19 8.1%	42 9.1%
Unknown/Not Reported	1 0.4%	2 0.9%	3 0.6%
White	181 79%	181 77%	362 78%
Race/Ethnicity, Customized (Count of Participants)
Hispanic/Latina	56 24.5%	49 20.9%	105 22.6%
Not Hispanic/Not Latina	169 73.8%	184 78.3%	353 76.1%
Unknown/Not Reported	4 1.7%	2 0.9%	6 1.3%
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	32.3 (7)	31.7 (7)	32 (7)
Current Smoker (Count of Participants)
No	200 87.3%	203 86.4%	403 86.9%
Yes	28 12.2%	32 13.6%	60 12.9%
Unknown or Not Reported	1 0.4%	0 0%	1 0.2%
Ever Pregnant (Count of Participants)
No	10 4.4%	15 6.4%	25 5.4%
Yes	218 95.2%	220 93.6%	438 94.4%
Unknown or Not Reported	1 0.4%	0 0%	1 0.2%
Number of Vaginal Deliveries (Number of deliveries) [Median (Full Range) ]
Median (Full Range) [Number of deliveries]	2	2	2
Number of Cesarean Deliveries (Number of deliveries) [Median (Full Range) ]
Median (Full Range) [Number of deliveries]	0	0	0
Menstrual Status (Count of Participants)
not sure	28 12.2%	32 13.6%	60 12.9%
post-menopausal	124 54.1%	138 58.7%	262 56.5%
pre-menopausal	76 33.2%	65 27.7%	141 30.4%
Unknown or Not Reported	1 0.4%	0 0%	1 0.2%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline UDI Total Score
Description	The Urogenital Distress Inventory (UDI) is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI scale has a range from 0 to 300 with higher scores indicating greater distress. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time Frame	3, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
3 Months	-138.8	-142.7
6 Months	-137	-147.4
12 Months	-137.9	-147.7

2. Secondary Outcome

Title	Change From Baseline UDI Stress Score
Description	The Urogenital Distress Inventory is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI Stress subscale has a range from 0 to 100 with higher scores indicating greater distress. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time Frame	3, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
3 Months	-70.6	-72.5
6 Months	-69.5	-72.8
12 Months	-69.3	-73.8

3. Secondary Outcome

Title	Change From Baseline UDI Irritative Score
Description	The Urogenital Distress Inventory is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI Irritative subscale has a range from 0 to 100 with higher scores indicating greater distress. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time Frame	3, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
3 Months	-49.7	-50.1
6 Months	-49.5	-53.5
12 Months	-50	-53.5

4. Secondary Outcome

Title	Change From Baseline UDI Obstructive Score
Description	The Urogenital Distress Inventory is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI Obstructive subscale has a range from 0 to 100 with higher scores indicating greater distress. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time Frame	3, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
3 Months	-18.5	-20.2
6 Months	-18	-21.1
12 Months	-18.5	-20.3

5. Other Pre-specified Outcome

Title	Change From Baseline Number of Stress Incontinence Episodes
Description	Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in number of stress incontinence episodes at 2 weeks, 2, 6, or 12 months and the number of stress incontinence episodes at baseline.
Time Frame	2 weeks and 2, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
0.5 Months	-2.2	-2.2
2 Months	-2.3	-2.4
6 Months	-2.3	-2.3
12 Months	-2.2	-2.2

6. Other Pre-specified Outcome

Title	Change From Baseline Number of Urge Incontinence Episodes
Description	Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in number of urge incontinence episodes at 2 weeks, 2, 6, or 12 months and the number of urge incontinence episodes at baseline.
Time Frame	2 weeks and 2, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
0.5 Months	-1.8	-1.7
2 Months	-2	-2
6 Months	-2	-2
12 Months	-1.9	-2.2

7. Other Pre-specified Outcome

Title	Change From Baseline Number of Unknown Incontinence Episodes
Description	Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in number of unknown incontinence episodes at 2 weeks, 2, 6, or 12 months and the number of unknown incontinence episodes at baseline.
Time Frame	2 weeks and 2, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
0.5 Months	-0.2	-0.4
2 Months	-0.3	-0.4
6 Months	-0.3	-0.4
12 Months	-0.3	-0.4

8. Other Pre-specified Outcome

Title	Change From Baseline Total Number of Incontinence Episodes
Description	Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in total number of incontinence episodes at 2 weeks, 2, 6, or 12 months and the total number of incontinence episodes at baseline.
Time Frame	2 weeks and 2, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
0.5 Months	-4.2	-4.3
2 Months	-4.7	-4.8
6 Months	-4.6	-4.7
12 Months	-4.4	-4.8

9. Other Pre-specified Outcome

Title	Change From Baseline Number of Wet Pads Per Day
Description	Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in number of wet pads per day at 2 weeks, 2, 6, or 12 months and the number of wet pads per day at baseline.
Time Frame	2 weeks and 2, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
0.5 Months	-2	-2.2
2 Months	-2.4	-2.7
6 Months	-2.2	-2.7
12 Months	-2.2	-2.7

10. Other Pre-specified Outcome

Title	Change From Baseline Number of Pads Per Day
Description	Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in total number of pads per day at 2 weeks, 2, 6, or 12 months and the total number of pads per day at baseline.
Time Frame	2 weeks and 2, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
0.5 Months	-1.6	-1.9
2 Months	-2.2	-2.7
6 Months	-2.2	-2.8
12 Months	-2.3	-2.7

11. Other Pre-specified Outcome

Title	Change From Baseline Number of Daytime Voids
Description	Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in number of daytime voids at 2 weeks, 2, 6, or 12 months and the number of daytime voids at baseline.
Time Frame	2 weeks and 2, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
0.5 Months	-0.6	-0.8
2 Months	-0.7	-1.6
6 Months	-1.1	-2.2
12 Months	-1.2	-2

12. Other Pre-specified Outcome

Title	Change From Baseline Number of Nighttime Voids
Description	Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in number of nighttime voids at 2 weeks, 2, 6, or 12 months and the number of nighttime voids at baseline.
Time Frame	2 weeks and 2, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
0.5 Months	-0.2	-0.4
2 Months	-0.4	-0.7
6 Months	-0.5	-0.8
12 Months	-0.4	-0.8

13. Other Pre-specified Outcome

Title	Change From Baseline Number of Urgency Voids Without Incontinence
Description	Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome variable is computed as the difference in number of urgency voids without incontinence at 2 weeks, 2, 6, or 12 months and the number of urgency voids without incontinence at baseline.
Time Frame	2 weeks and 2, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
0.5 Months	-1.1	-0.8
2 Months	-1.6	-4.3
6 Months	-3.5	-4.8
12 Months	-3.9	-5.1

14. Other Pre-specified Outcome

Title	Number of Participants With <8 Voids After Baseline (Normalization of Voiding Frequency)
Description	Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, for participants with >8 voids at baseline, the outcome is calculated as Yes=no more than 8 voids noted at the time point, No=Otherwise
Time Frame	2 weeks and 2, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
Yes	48 21%	59 25.1%
No	82 35.8%	68 28.9%
Yes	49 21.4%	81 34.5%
No	76 33.2%	43 18.3%
Yes	46 20.1%	79 33.6%
No	56 24.5%	33 14%
Yes	48 21%	80 34%
No	57 24.9%	29 12.3%

15. Other Pre-specified Outcome

Title	Number of Participants With 50% Reduction in Voids Relative to Baseline (Improved Voiding Frequency)
Description	Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome is calculated as Yes=at least 50% reduction in the number of voids between 2 weeks, 2, 6, and 12 months and baseline, No=Otherwise
Time Frame	2 weeks and 2, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
Yes	1 0.4%	8 3.4%
No	198 86.5%	190 80.9%
Yes	2 0.9%	13 5.5%
No	189 82.5%	177 75.3%
Yes	6 2.6%	15 6.4%
No	152 66.4%	155 66%
Yes	8 3.5%	15 6.4%
No	153 66.8%	150 63.8%

16. Other Pre-specified Outcome

Title	Number of Participants With Greater Number of Voids Relative to Baseline or >8 Voids (Worsening Voiding Frequency)
Description	Based on data collected from participant-completed diaries at baseline, 2 weeks, and 2, 6, and 12 months, the outcome is calculated as Yes=greater than baseline number of voids at the time point or with greater than 8 voids at the time point, No=Otherwise
Time Frame	2 weeks and 2, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
Yes	124 54.1%	104 44.3%
No	75 32.8%	94 40%
Yes	111 48.5%	68 28.9%
No	80 34.9%	122 51.9%
Yes	81 35.4%	43 18.3%
No	77 33.6%	127 54%
Yes	79 34.5%	43 18.3%
No	82 35.8%	122 51.9%

17. Other Pre-specified Outcome

Title	Change From Baseline PISQ-IR NSAPR Score
Description	The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Not Partner Related subscale (NSA-PR) ranges from 0 to 100 with higher scores indicating worse function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time Frame	3, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
3 Months	7.1	-8.8
6 Months	5.5	2.5
12 Months	3.3	2.3

18. Other Pre-specified Outcome

Title	Change From Baseline PISQ-IR NSACS Score
Description	The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Not Sexually Active-Condition Specific subscale (NSA-CS) ranges from 0 to 100 with worse scores indicating better function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time Frame	3, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
3 Months	-16.8	-20.3
6 Months	-18.9	-16.4
12 Months	-13.5	-9.9

19. Other Pre-specified Outcome

Title	Change From Baseline PISQ-IR NSAGQR Score
Description	The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Not Sexually Active-Global Quality Rating subscale (NSA-GQR) ranges from 0 to 100 with higher scores indicating worse function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time Frame	3, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
3 Months	-10	-14.8
6 Months	-9.8	-15.3
12 Months	-9.1	-16.5

20. Other Pre-specified Outcome

Title	Change From Baseline PISQ-IR NSACI Score
Description	The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Not Sexually Active-Condition Impact subscale (NSA-CI) ranges from 0 to 100 with higher scores indicating worse function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time Frame	3, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
3 Months	-25.2	-27.9
6 Months	-32.1	-23.8
12 Months	-28.8	-33

21. Other Pre-specified Outcome

Title	Change From Baseline PISQ-IR SAAO Score
Description	The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Sexually Active-Arousal, Orgasm subscale (SA-AO) ranges from 0 to 100 with higher scores indicating worse function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time Frame	3, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
3 Months	6.8	10.8
6 Months	6.5	12.1
12 Months	9.2	9.6

22. Other Pre-specified Outcome

Title	Change From Baseline PISQ-IR SAPR Score
Description	The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Sexually Active-Partner Related subscale (SA-PR) ranges from 0 to 100 with higher scores indicating better function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time Frame	3, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
3 Months	5.2	7
6 Months	4.9	6.3
12 Months	2.3	4.6

23. Other Pre-specified Outcome

Title	Change From Baseline PISQ-IR SACS Score
Description	The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Sexually Active-Condition Specific subscale (SA-CS) ranges from 0 to 100 with higher scores indicating better function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time Frame	3, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
3 Months	21.1	28.2
6 Months	20	28.9
12 Months	24.2	26.3

24. Other Pre-specified Outcome

Title	Change From Baseline PISQ-IR SAGQR Score
Description	The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Sexually Active-Global Quality Rating subscale (SA-GQR) ranges from 0 to 100 with higher scores indicating better function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time Frame	3, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
3 Months	13.5	18.3
6 Months	12.1	19
12 Months	19	13.5

25. Other Pre-specified Outcome

Title	Change From Baseline PISQ-IR SACI Score
Description	The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Sexually Active-Condition Impact subscale (SA-CI) ranges from 0 to 100 with higher scores indicating better function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time Frame	3, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
3 Months	28.4	33.6
6 Months	28.9	35.3
12 Months	31.7	35.5

26. Other Pre-specified Outcome

Title	Change From Baseline PISQ-IR SAD Score
Description	The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. Using the Rockwood scoring, the PISQ-IR Sexually Active-Desire subscale (SA-D) ranges from 0 to 100 with higher scores indicating better function/satisfaction. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time Frame	3, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
3 Months	3.8	7.1
6 Months	0.4	5.4
12 Months	2.7	2.5

27. Other Pre-specified Outcome

Title	Change From Baseline EQ-5D Index Score
Description	EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life. The index score ranges from 0 to 1 with higher scores indicating a better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time Frame	3, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
3 Months	0	0
6 Months	0	0
12 Months	0	0

28. Other Pre-specified Outcome

Title	Change From Baseline EQ-5D Visual Analog Scale Score
Description	EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life. The visual analog scale (VAS) score ranges from 0 to 100 with higher scores indicating a better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time Frame	3, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
3 Months	0.3	4
6 Months	2.5	3.1
12 Months	1.2	4.8

29. Other Pre-specified Outcome

Title	Change From Baseline OABq-LF Symptom Severity Score
Description	The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Symptom Severity score ranges from 0 to 100 with higher score indicating worse quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time Frame	3, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
3 Months	-45.3	-46.9
6 Months	-45.4	-47.2
12 Months	-45.7	-48.5

30. Other Pre-specified Outcome

Title	Change From Baseline OABq-LF Coping Score
Description	The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Coping score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time Frame	3, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
3 Months	43.1	48.2
6 Months	43.3	48.4
12 Months	43.9	47.9

31. Other Pre-specified Outcome

Title	Change From Baseline OABq-LF Concern Score
Description	The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Concern score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time Frame	3, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
3 Months	47.6	51.2
6 Months	47	51.1
12 Months	46.9	50.4

32. Other Pre-specified Outcome

Title	Change From Baseline OABq-LF Sleep Score
Description	The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Sleep score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time Frame	3, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
3 Months	31.7	31.6
6 Months	31.3	31.9
12 Months	31.8	32.7

33. Other Pre-specified Outcome

Title	Change From Baseline OABq-LF Social Score
Description	The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF Social score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time Frame	3, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
3 Months	25.6	26.5
6 Months	23.5	26.1
12 Months	24.1	25.8

34. Other Pre-specified Outcome

Title	Change From Baseline OABq-LF HRQL Total Score
Description	The Overactive Bladder Questionnaire-Long Form is a standardized a measure of overactive bladder symptoms and health-related quality of life. The OABq-LF HRQL score ranges from 0 to 100 with higher score indicating better quality of life. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time Frame	3, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
3 Months	38.6	41.4
6 Months	38	41.4
12 Months	38.6	41.1

35. Other Pre-specified Outcome

Title	OAB-SATq Satisfaction Score
Description	The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The OAB-SATq Satisfaction score ranges from 0 to 100 with higher scores indicating higher satisfaction.
Time Frame	3, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
3 Months	19.3	18.2
6 Months	19.8	18.7
12 Months	18.1	17.3

36. Other Pre-specified Outcome

Title	OAB-SATq Side Effect Score
Description	The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The OAB-SATq Side Effect score ranges from 0 to 100 with higher scores indicating fewer side effects.
Time Frame	3, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
3 Months	76	84.3
6 Months	79.7	87.2
12 Months	81	86.3

37. Other Pre-specified Outcome

Title	OAB-SATq Endorsement Score
Description	The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The OAB-SATq Endorsement score ranges from 0 to 100 with higher scores indicating greater endorsement.
Time Frame	3, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
3 Months	10.6	8.8
6 Months	11.2	6.6
12 Months	10.7	8.9

38. Other Pre-specified Outcome

Title	OAB-SATq Convenience Score
Description	The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The OAB-SATq Convenience score ranges from 0 to 100 with higher scores indicating greater convenience.
Time Frame	3, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
3 Months	18.8	25.8
6 Months	19.1	26.2
12 Months	19.7	21.3

39. Other Pre-specified Outcome

Title	OAB-SATq Preference Score
Description	The Overactive Bladder Satisfaction with Treatment Questionnaire is a standardized a measure of satisfaction with treatment for overactive bladder symptoms. The preference score is a binary [yes/no] indicator as to whether a subject indicated slight or definite preference for the treatment among women that have had previous treatment for overactive bladder. The outcome is the percentage of participants that prefer the current treatment to previous treatments.
Time Frame	3, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
Yes	111 48.5%	109 46.4%
No	12 5.2%	9 3.8%
Yes	101 44.1%	112 47.7%
No	3 1.3%	5 2.1%
Yes	98 42.8%	107 45.5%
No	11 4.8%	9 3.8%

40. Other Pre-specified Outcome

Title	Change From Baseline IIq-LF Physical Activity Score
Description	The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Physical Activity score ranges from 0 to 100 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time Frame	3, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
3 Months	-39.2	-40.9
6 Months	-39.1	-42.1
12 Months	-42.3	-42.5

41. Other Pre-specified Outcome

Title	Change From Baseline IIq-LF Travel Score
Description	The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Travel score ranges from 0 to 100 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time Frame	3, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
3 Months	-33.9	-38.9
6 Months	-33.4	-40.9
12 Months	-35.4	-40.8

42. Other Pre-specified Outcome

Title	Change From Baseline IIq-LF Social Relationship Score
Description	The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Social Relationship score ranges from 0 to 100 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time Frame	3, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
3 Months	-28.9	-32.8
6 Months	-28.6	-33.7
12 Months	-30	-34.1

43. Other Pre-specified Outcome

Title	Change From Baseline IIq-LF Emotional Health Score
Description	The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Emotional Health score ranges from 0 to 100 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time Frame	3, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
3 Months	-38.4	-40.7
6 Months	-38.6	-41.5
12 Months	-38.3	-42.8

44. Other Pre-specified Outcome

Title	Change From Baseline IIq-LF Total Score
Description	The Incontinence Impact Questionnaire-Long Form is a standardized a measure of health-related quality of life. The IIq-LF Total score ranges from 0 to 400 with higher scores indicating worse impact. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time Frame	3, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
3 Months	-140.4	-153.3
6 Months	-139.8	-158.2
12 Months	-146	-160.1

45. Other Pre-specified Outcome

Title	Change From Baseline ADI Hygiene Score
Description	The Adaptation Index is a standardized measure of health-related quality of life. The ADI Hygiene score ranges from 0 to 100 with higher score indicating worse severity in adaptive behaviors. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time Frame	3, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
3 Months	-32.1	-36.7
6 Months	-34.6	-37.6
12 Months	-35.5	-38.8

46. Other Pre-specified Outcome

Title	Change From Baseline ADI Avoidance Score
Description	The Adaptation Index is a standardized measure of health-related quality of life. The ADI Avoidance score ranges from 0 to 100 with higher score indicating worse severity in adaptive behaviors. The change from baseline outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time Frame	3, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
3 Months	-31.3	-33.8
6 Months	-32.5	-34.5
12 Months	-33	-35.7

47. Other Pre-specified Outcome

Title	Change From Baseline Brink Score
Description	The Brink scale considers three pelvic floor muscle contraction variables: vaginal pressure or muscle force, elevation or vertical displacement of the examiner fingers, and duration of contraction. The score ranges from 3 to 12 with higher scores indicating greater PFM function. The change from baseline outcome is calculated as the difference in score at 3 or 12 months and the score at baseline.
Time Frame	2 weeks and 2 and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
0.5 Months	0.5	0.2
2 Months	0.5	0.6
12 Months	0.6	0.6

48. Other Pre-specified Outcome

Title	Change From Average Peak Muscle Contraction Pressure (cm H2O)
Description	The average peak muscle contraction is measured during a physical exam. The outcome is calculated as the difference in measured value at 3 or 12 months and the score at baseline.
Time Frame	2 weeks and 2 and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
0.5 Months	3.7	0.7
2 Months	5	4.6
12 Months	4	4.4

49. Other Pre-specified Outcome

Title	PGI-I
Description	The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse). Included here are participants who had improvement as indicated by a rating of 1 (very much better), 2 (much better).
Time Frame	3, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
Improved	179 78.2%	178 75.7%
No Improvement/Worsened	18 7.9%	19 8.1%
Improved	156 68.1%	168 71.5%
No Improvement/Worsened	19 8.3%	13 5.5%
Improved	147 64.2%	159 67.7%
No Improvement/Worsened	27 11.8%	22 9.4%

50. Other Pre-specified Outcome

Title	PGI-S
Description	The Patient Global Impression of Severity (PGI-S) is a patient-reported measure of perceived severity of condition, as assessed on a scale of 1 (Normal) to 4 (Severe). Included here are participants who reported Normal or Mild severity as indicated by a rating of 1 or 2.
Time Frame	Baseline 3, 6, and 12 Months

Outcome Measure Data

Analysis Population Description

An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and who provided outcome data after baseline was performed. Data that was collected after a participant was retreated for urinary incontinence was excluded from the analysis.

Arm/Group Title	MUS Only	MUS+BPTx
Arm/Group Description	Midurethral sling alone	Midurethral sling and behavioral/pelvic floor therapy
Measure Participants	229	235
Normal/Mild	41 17.9%	48 20.4%
Moderate/Severe	188 82.1%	187 79.6%
Normal/Mild	171 74.7%	174 74%
Moderate/Severe	26 11.4%	24 10.2%
Normal/Mild	155 67.7%	166 70.6%
Moderate/Severe	21 9.2%	16 6.8%
Normal/Mild	155 67.7%	164 69.8%
Moderate/Severe	19 8.3%	16 6.8%

Adverse Events

Time Frame	12 Months
Arm/Group Title	MUS Only		MUS+BPTx
Arm/Group Description	Midurethral sling alone		Midurethral sling and behavioral/pelvic floor therapy
All Cause Mortality
	MUS Only		MUS+BPTx
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/238 (0%)		0/242 (0%)
Serious Adverse Events
	MUS Only		MUS+BPTx
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	28/238 (11.8%)		21/242 (8.7%)
Cardiac disorders
Acute myocardial infarction	1/238 (0.4%)	1	0/242 (0%)	0
Angina unstable	1/238 (0.4%)	1	0/242 (0%)	0
Atrial fibrillation	1/238 (0.4%)	1	0/242 (0%)	0
Atrial flutter	0/238 (0%)	0	1/242 (0.4%)	1
Palpitations	0/238 (0%)	0	1/242 (0.4%)	1
Pericardial effusion	0/238 (0%)	0	1/242 (0.4%)	1
Gastrointestinal disorders
Gastritis	2/238 (0.8%)	2	0/242 (0%)	0
Large intestinal obstruction	1/238 (0.4%)	1	0/242 (0%)	0
Pancreatitis acute	3/238 (1.3%)	3	0/242 (0%)	0
Umbilical hernia	0/238 (0%)	0	1/242 (0.4%)	1
Vomiting	0/238 (0%)	0	1/242 (0.4%)	1
General disorders
Chest pain	1/238 (0.4%)	1	1/242 (0.4%)	1
Non-cardiac chest pain	1/238 (0.4%)	1	0/242 (0%)	0
Hepatobiliary disorders
Bile duct stone	1/238 (0.4%)	1	0/242 (0%)	0
Biliary colic	0/238 (0%)	0	1/242 (0.4%)	1
Infections and infestations
Appendicitis	1/238 (0.4%)	1	0/242 (0%)	0
Atypical pneumonia	0/238 (0%)	0	1/242 (0.4%)	1
Cellulitis	0/238 (0%)	0	2/242 (0.8%)	2
Diverticulitis	1/238 (0.4%)	1	0/242 (0%)	0
Gastroenteritis	1/238 (0.4%)	1	1/242 (0.4%)	1
Pneumonia	0/238 (0%)	0	1/242 (0.4%)	1
Pyelonephritis	2/238 (0.8%)	2	1/242 (0.4%)	1
Urinary tract infection	1/238 (0.4%)	1	0/242 (0%)	0
Wound infection	1/238 (0.4%)	1	0/242 (0%)	0
Injury, poisoning and procedural complications
Procedural nausea	0/238 (0%)	0	1/242 (0.4%)	1
Procedural vomiting	0/238 (0%)	0	1/242 (0.4%)	1
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion	0/238 (0%)	0	1/242 (0.4%)	1
Osteoarthritis	0/238 (0%)	0	1/242 (0.4%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage IV	1/238 (0.4%)	1	0/242 (0%)	0
Malignant melanoma	1/238 (0.4%)	1	0/242 (0%)	0
Uterine leiomyoma	1/238 (0.4%)	1	0/242 (0%)	0
Nervous system disorders
Central nervous system lesion	0/238 (0%)	0	1/242 (0.4%)	1
Cerebrovascular accident	1/238 (0.4%)	1	0/242 (0%)	0
Loss of consciousness	0/238 (0%)	0	1/242 (0.4%)	1
Multiple sclerosis	1/238 (0.4%)	1	0/242 (0%)	0
Somnolence	0/238 (0%)	0	1/242 (0.4%)	1
Spondylitic myelopathy	1/238 (0.4%)	1	0/242 (0%)	0
Syncope	1/238 (0.4%)	1	0/242 (0%)	0
Psychiatric disorders
Anxiety	1/238 (0.4%)	1	0/242 (0%)	0
Mental status changes	0/238 (0%)	0	1/242 (0.4%)	1
Renal and urinary disorders
Chronic kidney disease	1/238 (0.4%)	1	0/242 (0%)	0
Prerenal failure	1/238 (0.4%)	1	0/242 (0%)	0
Urinary retention	1/238 (0.4%)	1	0/242 (0%)	0
Respiratory, thoracic and mediastinal disorders
Asthma	0/238 (0%)	0	2/242 (0.8%)	3
Hypoxia	1/238 (0.4%)	1	0/242 (0%)	0
Pulmonary embolism	0/238 (0%)	0	1/242 (0.4%)	1
Pulmonary sarcoidosis	0/238 (0%)	0	1/242 (0.4%)	1
Surgical and medical procedures
Bladder neck suspension	2/238 (0.8%)	2	0/242 (0%)	0
Gastrectomy	0/238 (0%)	0	1/242 (0.4%)	1
Gastric bypass	1/238 (0.4%)	1	0/242 (0%)	0
High frequency ablation	0/238 (0%)	0	1/242 (0.4%)	1
Inguinal hernia repair	0/238 (0%)	0	1/242 (0.4%)	1
Tendon operation	1/238 (0.4%)	1	0/242 (0%)	0
Vascular disorders
Haematoma	1/238 (0.4%)	1	0/242 (0%)	0
Other (Not Including Serious) Adverse Events
	MUS Only		MUS+BPTx
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	163/238 (68.5%)		172/242 (71.1%)
Blood and lymphatic system disorders
Anaemia	3/238 (1.3%)	3	2/242 (0.8%)	2
Cardiac disorders
Arrhythmia supraventricular	0/238 (0%)	0	1/242 (0.4%)	1
Atrial fibrillation	2/238 (0.8%)	2	0/242 (0%)	0
Palpitations	1/238 (0.4%)	1	2/242 (0.8%)	2
Sinus tachycardia	1/238 (0.4%)	1	0/242 (0%)	0
Congenital, familial and genetic disorders
Argininosuccinate lyase deficiency	1/238 (0.4%)	1	0/242 (0%)	0
Ear and labyrinth disorders
Ear pain	3/238 (1.3%)	3	1/242 (0.4%)	1
Eustachian tube dysfunction	0/238 (0%)	0	1/242 (0.4%)	1
Tinnitus	2/238 (0.8%)	2	0/242 (0%)	0
Vertigo	2/238 (0.8%)	2	0/242 (0%)	0
Vertigo positional	0/238 (0%)	0	1/242 (0.4%)	1
Endocrine disorders
Hypothyroidism	1/238 (0.4%)	1	0/242 (0%)	0
Eye disorders
Blepharitis	2/238 (0.8%)	2	0/242 (0%)	0
Blepharochalasis	0/238 (0%)	0	1/242 (0.4%)	1
Conjunctival haemorrhage	1/238 (0.4%)	1	0/242 (0%)	0
Conjunctivitis allergic	0/238 (0%)	0	1/242 (0.4%)	1
Dry eye	2/238 (0.8%)	2	1/242 (0.4%)	1
Eyelid ptosis	0/238 (0%)	0	1/242 (0.4%)	1
Glaucoma	0/238 (0%)	0	1/242 (0.4%)	1
Periorbital oedema	0/238 (0%)	0	1/242 (0.4%)	1
Pinguecula	0/238 (0%)	0	1/242 (0.4%)	1
Pterygium	0/238 (0%)	0	1/242 (0.4%)	1
Retinal detachment	0/238 (0%)	0	1/242 (0.4%)	1
Vision blurred	1/238 (0.4%)	1	0/242 (0%)	0
Gastrointestinal disorders
Abdominal distension	2/238 (0.8%)	2	0/242 (0%)	0
Abdominal pain	11/238 (4.6%)	13	11/242 (4.5%)	13
Abdominal pain lower	5/238 (2.1%)	5	4/242 (1.7%)	4
Abdominal pain upper	3/238 (1.3%)	3	2/242 (0.8%)	2
Cheilitis	0/238 (0%)	0	1/242 (0.4%)	1
Colitis microscopic	1/238 (0.4%)	1	0/242 (0%)	0
Constipation	9/238 (3.8%)	9	14/242 (5.8%)	16
Diarrhoea	6/238 (2.5%)	6	7/242 (2.9%)	7
Diverticulum intestinal	0/238 (0%)	0	1/242 (0.4%)	1
Dyspepsia	1/238 (0.4%)	1	4/242 (1.7%)	4
Faecal incontinence	1/238 (0.4%)	1	2/242 (0.8%)	2
Functional gastrointestinal disorder	1/238 (0.4%)	1	0/242 (0%)	0
Gastritis	0/238 (0%)	0	1/242 (0.4%)	1
Gastrooesophageal reflux disease	2/238 (0.8%)	2	1/242 (0.4%)	1
Gingival swelling	1/238 (0.4%)	1	0/242 (0%)	0
Haemorrhoids	4/238 (1.7%)	4	1/242 (0.4%)	1
Irritable bowel syndrome	2/238 (0.8%)	2	1/242 (0.4%)	1
Levator syndrome	2/238 (0.8%)	2	3/242 (1.2%)	3
Nausea	8/238 (3.4%)	8	4/242 (1.7%)	5
Proctalgia	0/238 (0%)	0	1/242 (0.4%)	1
Rectal haemorrhage	0/238 (0%)	0	1/242 (0.4%)	1
Retroperitoneal haematoma	0/238 (0%)	0	1/242 (0.4%)	1
Stomatitis	0/238 (0%)	0	1/242 (0.4%)	1
Toothache	0/238 (0%)	0	1/242 (0.4%)	1
Vomiting	4/238 (1.7%)	5	2/242 (0.8%)	2
General disorders
Adverse drug reaction	0/238 (0%)	0	1/242 (0.4%)	1
Asthenia	1/238 (0.4%)	1	0/242 (0%)	0
Catheter site pain	0/238 (0%)	0	1/242 (0.4%)	1
Chest discomfort	2/238 (0.8%)	2	0/242 (0%)	0
Chest pain	5/238 (2.1%)	5	4/242 (1.7%)	4
Chills	1/238 (0.4%)	1	0/242 (0%)	0
Discomfort	0/238 (0%)	0	1/242 (0.4%)	1
Facial pain	0/238 (0%)	0	1/242 (0.4%)	1
Fatigue	0/238 (0%)	0	2/242 (0.8%)	2
Hernia pain	1/238 (0.4%)	1	0/242 (0%)	0
Inflammation	1/238 (0.4%)	1	0/242 (0%)	0
Local swelling	2/238 (0.8%)	2	0/242 (0%)	0
Malaise	1/238 (0.4%)	1	0/242 (0%)	0
Medical device site reaction	2/238 (0.8%)	2	4/242 (1.7%)	4
Oedema peripheral	3/238 (1.3%)	3	2/242 (0.8%)	2
Pain	0/238 (0%)	0	2/242 (0.8%)	2
Polyp	0/238 (0%)	0	1/242 (0.4%)	1
Pyrexia	1/238 (0.4%)	1	1/242 (0.4%)	1
Suprapubic pain	0/238 (0%)	0	6/242 (2.5%)	6
Hepatobiliary disorders
Cholecystitis	0/238 (0%)	0	1/242 (0.4%)	1
Cholelithiasis	0/238 (0%)	0	2/242 (0.8%)	2
Hyperplastic cholecystopathy	1/238 (0.4%)	1	0/242 (0%)	0
Immune system disorders
Allergic oedema	1/238 (0.4%)	1	0/242 (0%)	0
Drug hypersensitivity	0/238 (0%)	0	1/242 (0.4%)	1
Food allergy	1/238 (0.4%)	1	0/242 (0%)	0
Hypersensitivity	0/238 (0%)	0	4/242 (1.7%)	4
Seasonal allergy	1/238 (0.4%)	1	0/242 (0%)	0
Infections and infestations
Abscess limb	0/238 (0%)	0	1/242 (0.4%)	1
Acute sinusitis	1/238 (0.4%)	1	3/242 (1.2%)	3
Atypical pneumonia	0/238 (0%)	0	1/242 (0.4%)	1
Bacterial vaginosis	0/238 (0%)	0	4/242 (1.7%)	4
Balanitis candida	0/238 (0%)	0	1/242 (0.4%)	1
Body tinea	2/238 (0.8%)	2	0/242 (0%)	0
Bronchitis	4/238 (1.7%)	4	3/242 (1.2%)	3
Bronchitis bacterial	0/238 (0%)	0	1/242 (0.4%)	1
Bronchitis viral	1/238 (0.4%)	1	0/242 (0%)	0
Candida infection	2/238 (0.8%)	2	0/242 (0%)	0
Cellulitis	1/238 (0.4%)	1	2/242 (0.8%)	2
Cervicitis	0/238 (0%)	0	1/242 (0.4%)	1
Chronic sinusitis	0/238 (0%)	0	1/242 (0.4%)	1
Clostridium difficile colitis	0/238 (0%)	0	1/242 (0.4%)	1
Conjunctivitis	4/238 (1.7%)	4	1/242 (0.4%)	1
Diarrhoea infectious	0/238 (0%)	0	1/242 (0.4%)	1
Ear infection	2/238 (0.8%)	2	0/242 (0%)	0
Eye infection	0/238 (0%)	0	1/242 (0.4%)	1
Folliculitis	1/238 (0.4%)	1	0/242 (0%)	0
Fungal infection	8/238 (3.4%)	9	1/242 (0.4%)	2
Furuncle	2/238 (0.8%)	2	2/242 (0.8%)	2
Gastroenteritis	2/238 (0.8%)	3	3/242 (1.2%)	3
Gastroenteritis viral	1/238 (0.4%)	1	0/242 (0%)	0
Helicobacter infection	0/238 (0%)	0	2/242 (0.8%)	2
Herpes simplex	0/238 (0%)	0	1/242 (0.4%)	1
Herpes zoster	0/238 (0%)	0	2/242 (0.8%)	2
Impetigo	1/238 (0.4%)	1	0/242 (0%)	0
Incision site infection	1/238 (0.4%)	1	1/242 (0.4%)	1
Infected bunion	0/238 (0%)	0	1/242 (0.4%)	1
Influenza	3/238 (1.3%)	3	4/242 (1.7%)	4
Nail bed infection fungal	0/238 (0%)	0	1/242 (0.4%)	1
Nasopharyngitis	2/238 (0.8%)	3	1/242 (0.4%)	1
Onychomycosis	0/238 (0%)	0	3/242 (1.2%)	3
Otitis externa	2/238 (0.8%)	3	0/242 (0%)	0
Otitis media	1/238 (0.4%)	1	1/242 (0.4%)	1
Pharyngitis streptococcal	0/238 (0%)	0	1/242 (0.4%)	1
Pneumonia	3/238 (1.3%)	3	0/242 (0%)	0
Pyelonephritis acute	0/238 (0%)	0	1/242 (0.4%)	1
Rhinitis	0/238 (0%)	0	1/242 (0.4%)	1
Sinusitis	8/238 (3.4%)	9	8/242 (3.3%)	8
Sinusitis bacterial	1/238 (0.4%)	1	0/242 (0%)	0
Skin candida	1/238 (0.4%)	1	0/242 (0%)	0
Skin infection	0/238 (0%)	0	1/242 (0.4%)	1
Tooth infection	0/238 (0%)	0	1/242 (0.4%)	1
Upper respiratory tract infection	11/238 (4.6%)	12	7/242 (2.9%)	7
Urinary tract infection	60/238 (25.2%)	75	58/242 (24%)	74
Vaginal infection	1/238 (0.4%)	1	5/242 (2.1%)	5
Vaginitis bacterial	1/238 (0.4%)	1	0/242 (0%)	0
Vestibular neuronitis	0/238 (0%)	0	1/242 (0.4%)	1
Viral infection	0/238 (0%)	0	1/242 (0.4%)	1
Viral upper respiratory tract infection	1/238 (0.4%)	1	1/242 (0.4%)	1
Vulvitis	0/238 (0%)	0	1/242 (0.4%)	1
Vulvovaginal candidiasis	2/238 (0.8%)	2	2/242 (0.8%)	3
Vulvovaginal mycotic infection	2/238 (0.8%)	2	3/242 (1.2%)	3
Wound infection	0/238 (0%)	0	1/242 (0.4%)	1
Injury, poisoning and procedural complications
Animal bite	2/238 (0.8%)	2	0/242 (0%)	0
Ankle fracture	0/238 (0%)	0	1/242 (0.4%)	1
Back injury	1/238 (0.4%)	1	0/242 (0%)	0
Bladder injury	1/238 (0.4%)	1	0/242 (0%)	0
Contusion	1/238 (0.4%)	1	2/242 (0.8%)	2
Epicondylitis	0/238 (0%)	0	1/242 (0.4%)	1
Exposure to allergen	0/238 (0%)	0	1/242 (0.4%)	1
Facial bones fracture	0/238 (0%)	0	1/242 (0.4%)	1
Fall	4/238 (1.7%)	4	3/242 (1.2%)	3
Foot fracture	2/238 (0.8%)	2	0/242 (0%)	0
Foreign body	0/238 (0%)	0	1/242 (0.4%)	1
Hand fracture	0/238 (0%)	0	1/242 (0.4%)	1
Humerus fracture	1/238 (0.4%)	1	0/242 (0%)	0
Iliotibial band syndrome	0/238 (0%)	0	1/242 (0.4%)	1
Incision site complication	1/238 (0.4%)	1	0/242 (0%)	0
Incision site haemorrhage	0/238 (0%)	0	1/242 (0.4%)	1
Incision site pain	0/238 (0%)	0	2/242 (0.8%)	2
Joint injury	1/238 (0.4%)	1	0/242 (0%)	0
Laceration	1/238 (0.4%)	1	0/242 (0%)	0
Ligament sprain	1/238 (0.4%)	1	2/242 (0.8%)	2
Limb injury	1/238 (0.4%)	1	1/242 (0.4%)	1
Muscle strain	1/238 (0.4%)	1	3/242 (1.2%)	3
Post procedural haemorrhage	1/238 (0.4%)	1	0/242 (0%)	0
Procedural pain	1/238 (0.4%)	1	4/242 (1.7%)	4
Road traffic accident	0/238 (0%)	0	1/242 (0.4%)	1
Suture related complication	0/238 (0%)	0	1/242 (0.4%)	1
Thermal burn	1/238 (0.4%)	1	0/242 (0%)	0
Vulvovaginal injury	0/238 (0%)	0	1/242 (0.4%)	1
Wound dehiscence	0/238 (0%)	0	1/242 (0.4%)	1
Wrist fracture	0/238 (0%)	0	1/242 (0.4%)	1
Investigations
Anti-thyroid antibody	1/238 (0.4%)	1	0/242 (0%)	0
Blood cholesterol increased	2/238 (0.8%)	2	1/242 (0.4%)	1
Blood pressure increased	1/238 (0.4%)	1	2/242 (0.8%)	2
Blood thyroid stimulating hormone increas	1/238 (0.4%)	1	0/242 (0%)	0
C-reactive protein increased	0/238 (0%)	0	1/242 (0.4%)	1
Cardiovascular function test abnormal	0/238 (0%)	0	1/242 (0.4%)	1
Erythrocytes sedimentation rate increased	0/238 (0%)	0	1/242 (0.4%)	1
Glycosylated haemoglobin increased	2/238 (0.8%)	2	0/242 (0%)	0
Helicobacter test positive	0/238 (0%)	0	2/242 (0.8%)	2
Prealbumin abnormal	0/238 (0%)	0	1/242 (0.4%)	1
Vitamin D decreased	1/238 (0.4%)	1	0/242 (0%)	0
Metabolism and nutrition disorders
Dehydration	0/238 (0%)	0	1/242 (0.4%)	1
Diabetes mellitus inadequate control	1/238 (0.4%)	1	0/242 (0%)	0
Electrolyte imbalance	1/238 (0.4%)	1	0/242 (0%)	0
Glucose tolerance impaired	1/238 (0.4%)	1	1/242 (0.4%)	1
Hypercholesterolaemia	0/238 (0%)	0	1/242 (0.4%)	1
Hypokalaemia	0/238 (0%)	0	1/242 (0.4%)	1
Vitamin D deficiency	1/238 (0.4%)	1	0/242 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	6/238 (2.5%)	8	18/242 (7.4%)	24
Arthritis	1/238 (0.4%)	1	1/242 (0.4%)	1
Back pain	12/238 (5%)	12	18/242 (7.4%)	20
Bursitis	1/238 (0.4%)	1	1/242 (0.4%)	1
Costochondritis	1/238 (0.4%)	1	1/242 (0.4%)	1
Diastasis recti abdominis	0/238 (0%)	0	1/242 (0.4%)	1
Fibromyalgia	1/238 (0.4%)	1	5/242 (2.1%)	5
Flank pain	1/238 (0.4%)	1	1/242 (0.4%)	1
Groin pain	1/238 (0.4%)	1	2/242 (0.8%)	2
Intervertebral disc annular tear	1/238 (0.4%)	1	0/242 (0%)	0
Intervertebral disc degeneration	1/238 (0.4%)	1	1/242 (0.4%)	1
Joint range of motion decreased	0/238 (0%)	0	1/242 (0.4%)	1
Joint swelling	2/238 (0.8%)	3	1/242 (0.4%)	1
Muscle spasms	1/238 (0.4%)	1	4/242 (1.7%)	5
Muscle tightness	1/238 (0.4%)	1	0/242 (0%)	0
Muscular weakness	0/238 (0%)	0	1/242 (0.4%)	1
Musculoskeletal discomfort	0/238 (0%)	0	1/242 (0.4%)	1
Musculoskeletal pain	4/238 (1.7%)	4	1/242 (0.4%)	1
Myalgia	0/238 (0%)	0	1/242 (0.4%)	1
Myofascial pain syndrome	1/238 (0.4%)	1	0/242 (0%)	0
Neck pain	2/238 (0.8%)	2	4/242 (1.7%)	5
Osteoarthritis	7/238 (2.9%)	8	5/242 (2.1%)	6
Osteoporosis	0/238 (0%)	0	1/242 (0.4%)	1
Pain in extremity	11/238 (4.6%)	11	8/242 (3.3%)	9
Plantar fasciitis	1/238 (0.4%)	1	4/242 (1.7%)	4
Pubic pain	0/238 (0%)	0	1/242 (0.4%)	1
Rheumatoid arthritis	2/238 (0.8%)	2	0/242 (0%)	0
Rotator cuff syndrome	0/238 (0%)	0	4/242 (1.7%)	4
Spinal osteoarthritis	0/238 (0%)	0	1/242 (0.4%)	1
Synovial cyst	2/238 (0.8%)	2	1/242 (0.4%)	1
Systemic lupus erythematosus	1/238 (0.4%)	1	0/242 (0%)	0
Tendonitis	1/238 (0.4%)	1	1/242 (0.4%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma	0/238 (0%)	0	1/242 (0.4%)	1
Benign breast neoplasm	0/238 (0%)	0	1/242 (0.4%)	1
Breast cancer	0/238 (0%)	0	1/242 (0.4%)	1
Colon adenoma	0/238 (0%)	0	1/242 (0.4%)	1
Lip squamous cell carcinoma	0/238 (0%)	0	1/242 (0.4%)	1
Melanocytic naevus	1/238 (0.4%)	1	1/242 (0.4%)	1
Ovarian fibroma	1/238 (0.4%)	1	0/242 (0%)	0
Seborrhoeic keratosis	1/238 (0.4%)	1	1/242 (0.4%)	1
Uterine leiomyoma	1/238 (0.4%)	1	2/242 (0.8%)	2
Nervous system disorders
Amnesia	1/238 (0.4%)	1	1/242 (0.4%)	1
Balance disorder	1/238 (0.4%)	1	0/242 (0%)	0
Burning sensation	0/238 (0%)	0	1/242 (0.4%)	1
Carpal tunnel syndrome	2/238 (0.8%)	2	1/242 (0.4%)	1
Cerebral small vessel ischaemic disease	1/238 (0.4%)	1	0/242 (0%)	0
Cervical radiculopathy	0/238 (0%)	0	1/242 (0.4%)	1
Dizziness	4/238 (1.7%)	4	3/242 (1.2%)	3
Femoral nerve palsy	1/238 (0.4%)	1	0/242 (0%)	0
Headache	6/238 (2.5%)	6	9/242 (3.7%)	10
Hypertensive encephalopathy	1/238 (0.4%)	1	0/242 (0%)	0
Hypoaesthesia	3/238 (1.3%)	4	1/242 (0.4%)	1
Lumbar radiculopathy	1/238 (0.4%)	1	0/242 (0%)	0
Meralgia paraesthetica	0/238 (0%)	0	1/242 (0.4%)	1
Migraine	4/238 (1.7%)	4	3/242 (1.2%)	4
Morton's neuralgia	0/238 (0%)	0	1/242 (0.4%)	1
Neuralgia	1/238 (0.4%)	1	0/242 (0%)	0
Paraesthesia	1/238 (0.4%)	1	0/242 (0%)	0
Piriformis syndrome	0/238 (0%)	0	1/242 (0.4%)	1
Radicular pain	0/238 (0%)	0	1/242 (0.4%)	1
Radiculitis	1/238 (0.4%)	1	0/242 (0%)	0
Radiculopathy	1/238 (0.4%)	1	1/242 (0.4%)	1
Resting tremor	0/238 (0%)	0	1/242 (0.4%)	1
Sciatica	1/238 (0.4%)	1	6/242 (2.5%)	6
Sinus headache	0/238 (0%)	0	1/242 (0.4%)	1
Syncope	0/238 (0%)	0	1/242 (0.4%)	1
Tension headache	1/238 (0.4%)	1	0/242 (0%)	0
Visual field defect	0/238 (0%)	0	1/242 (0.4%)	1
Psychiatric disorders
Anxiety	5/238 (2.1%)	5	1/242 (0.4%)	1
Anxiety disorder	0/238 (0%)	0	1/242 (0.4%)	1
Bipolar I disorder	0/238 (0%)	0	1/242 (0.4%)	1
Depression	5/238 (2.1%)	5	0/242 (0%)	0
Grief reaction	1/238 (0.4%)	1	0/242 (0%)	0
Insomnia	0/238 (0%)	0	2/242 (0.8%)	2
Libido decreased	1/238 (0.4%)	1	0/242 (0%)	0
Panic attack	0/238 (0%)	0	1/242 (0.4%)	1
Renal and urinary disorders
Bladder pain	2/238 (0.8%)	2	0/242 (0%)	0
Bladder perforation	1/238 (0.4%)	1	1/242 (0.4%)	1
Cystitis haemorrhagic	0/238 (0%)	0	1/242 (0.4%)	1
Dysuria	3/238 (1.3%)	3	7/242 (2.9%)	7
Haematuria	1/238 (0.4%)	1	2/242 (0.8%)	2
Micturition urgency	3/238 (1.3%)	3	2/242 (0.8%)	2
Nephrolithiasis	5/238 (2.1%)	5	0/242 (0%)	0
Pollakiuria	1/238 (0.4%)	2	1/242 (0.4%)	1
Proteinuria	1/238 (0.4%)	1	0/242 (0%)	0
Stress urinary incontinence	0/238 (0%)	0	1/242 (0.4%)	1
Urethral discharge	1/238 (0.4%)	1	0/242 (0%)	0
Urge incontinence	2/238 (0.8%)	2	0/242 (0%)	0
Urinary retention	16/238 (6.7%)	16	17/242 (7%)	18
Reproductive system and breast disorders
Adnexa uteri mass	0/238 (0%)	0	1/242 (0.4%)	1
Atrophic vulvovaginitis	2/238 (0.8%)	2	3/242 (1.2%)	3
Bartholin's cyst	2/238 (0.8%)	2	0/242 (0%)	0
Breast discharge	0/238 (0%)	0	1/242 (0.4%)	1
Breast mass	0/238 (0%)	0	2/242 (0.8%)	2
Breast pain	1/238 (0.4%)	1	0/242 (0%)	0
Dyspareunia	13/238 (5.5%)	13	11/242 (4.5%)	11
Genital pain	15/238 (6.3%)	15	4/242 (1.7%)	4
Labia enlarged	0/238 (0%)	0	1/242 (0.4%)	1
Menometrorrhagia	1/238 (0.4%)	1	0/242 (0%)	0
Menorrhagia	0/238 (0%)	0	1/242 (0.4%)	1
Metrorrhagia	1/238 (0.4%)	1	0/242 (0%)	0
Ovarian cyst	0/238 (0%)	0	3/242 (1.2%)	3
Ovarian cyst ruptured	0/238 (0%)	0	1/242 (0.4%)	1
Ovulation pain	1/238 (0.4%)	1	0/242 (0%)	0
Pelvic floor muscle weakness	1/238 (0.4%)	1	0/242 (0%)	0
Pelvic haematoma	0/238 (0%)	0	1/242 (0.4%)	1
Pelvic pain	4/238 (1.7%)	4	6/242 (2.5%)	7
Perineal pain	1/238 (0.4%)	1	1/242 (0.4%)	1
Postmenopausal haemorrhage	0/238 (0%)	0	1/242 (0.4%)	1
Pruritus genital	1/238 (0.4%)	1	0/242 (0%)	0
Vaginal cyst	0/238 (0%)	0	1/242 (0.4%)	1
Vaginal discharge	1/238 (0.4%)	1	2/242 (0.8%)	2
Vaginal enlargement	1/238 (0.4%)	1	0/242 (0%)	0
Vaginal haemorrhage	6/238 (2.5%)	6	8/242 (3.3%)	8
Vaginal prolapse	0/238 (0%)	0	1/242 (0.4%)	1
Vulva cyst	0/238 (0%)	0	1/242 (0.4%)	1
Vulvovaginal burning sensation	0/238 (0%)	0	1/242 (0.4%)	1
Vulvovaginal discomfort	2/238 (0.8%)	2	1/242 (0.4%)	1
Vulvovaginal erythema	1/238 (0.4%)	1	0/242 (0%)	0
Vulvovaginal pain	1/238 (0.4%)	1	5/242 (2.1%)	5
Vulvovaginal pruritus	4/238 (1.7%)	4	3/242 (1.2%)	3
Respiratory, thoracic and mediastinal disorders
Asthma	5/238 (2.1%)	6	5/242 (2.1%)	6
Bronchial hyperreactivity	1/238 (0.4%)	1	0/242 (0%)	0
Bronchospasm	0/238 (0%)	0	1/242 (0.4%)	1
Choking	1/238 (0.4%)	1	0/242 (0%)	0
Chronic obstructive pulmonary disease	1/238 (0.4%)	1	1/242 (0.4%)	1
Cough	7/238 (2.9%)	7	9/242 (3.7%)	10
Dyspnoea	2/238 (0.8%)	2	2/242 (0.8%)	2
Hypoxia	0/238 (0%)	0	1/242 (0.4%)	1
Nasal congestion	0/238 (0%)	0	1/242 (0.4%)	1
Oropharyngeal pain	2/238 (0.8%)	2	1/242 (0.4%)	1
Pleurisy	0/238 (0%)	0	1/242 (0.4%)	1
Pulmonary mass	1/238 (0.4%)	1	0/242 (0%)	0
Rhinitis allergic	2/238 (0.8%)	2	1/242 (0.4%)	1
Sleep apnoea syndrome	1/238 (0.4%)	1	0/242 (0%)	0
Tonsillar hypertrophy	1/238 (0.4%)	1	0/242 (0%)	0
Tonsillolith	0/238 (0%)	0	1/242 (0.4%)	1
Upper respiratory tract congestion	0/238 (0%)	0	1/242 (0.4%)	1
Wheezing	0/238 (0%)	0	1/242 (0.4%)	1
Skin and subcutaneous tissue disorders
Actinic keratosis	1/238 (0.4%)	1	3/242 (1.2%)	3
Alopecia	0/238 (0%)	0	1/242 (0.4%)	1
Dermatitis	1/238 (0.4%)	1	3/242 (1.2%)	3
Dermatitis allergic	0/238 (0%)	0	1/242 (0.4%)	1
Ecchymosis	0/238 (0%)	0	2/242 (0.8%)	2
Excessive granulation tissue	1/238 (0.4%)	1	0/242 (0%)	0
Hand dermatitis	1/238 (0.4%)	1	0/242 (0%)	0
Hyperhidrosis	1/238 (0.4%)	1	0/242 (0%)	0
Hyperkeratosis	0/238 (0%)	0	1/242 (0.4%)	1
Ingrowing nail	1/238 (0.4%)	1	0/242 (0%)	0
Intertrigo	0/238 (0%)	0	1/242 (0.4%)	1
Night sweats	0/238 (0%)	0	1/242 (0.4%)	1
Pruritus	2/238 (0.8%)	2	2/242 (0.8%)	2
Psoriasis	0/238 (0%)	0	1/242 (0.4%)	1
Rash	1/238 (0.4%)	1	1/242 (0.4%)	1
Skin lesion	1/238 (0.4%)	1	1/242 (0.4%)	1
Urticaria	2/238 (0.8%)	2	1/242 (0.4%)	1
Surgical and medical procedures
Bartholin's cyst removal	1/238 (0.4%)	1	0/242 (0%)	0
Bladder operation	0/238 (0%)	0	1/242 (0.4%)	1
Cataract operation	0/238 (0%)	0	1/242 (0.4%)	1
Endodontic procedure	1/238 (0.4%)	1	1/242 (0.4%)	1
Foot operation	1/238 (0.4%)	1	0/242 (0%)	0
Gastric bypass	0/238 (0%)	0	1/242 (0.4%)	1
Incisional drainage	0/238 (0%)	0	1/242 (0.4%)	1
Knee arthroplasty	0/238 (0%)	0	1/242 (0.4%)	1
Knee operation	0/238 (0%)	0	1/242 (0.4%)	1
Mastectomy	0/238 (0%)	0	1/242 (0.4%)	1
Medical device implantation	1/238 (0.4%)	1	0/242 (0%)	0
Tooth extraction	1/238 (0.4%)	1	1/242 (0.4%)	1
Tympanoplasty	0/238 (0%)	0	1/242 (0.4%)	1
Umbilical hernia repair	1/238 (0.4%)	1	0/242 (0%)	0
Vaginectomy	0/238 (0%)	0	1/242 (0.4%)	1
Vascular disorders
Haematoma	0/238 (0%)	0	2/242 (0.8%)	2
Haemorrhage	1/238 (0.4%)	1	0/242 (0%)	0
Hot flush	2/238 (0.8%)	2	0/242 (0%)	0
Hypertension	3/238 (1.3%)	3	1/242 (0.4%)	1
Varicose vein	0/238 (0%)	0	1/242 (0.4%)	1

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.