Refractory Overactive Bladder: Sacral NEuromodulation v. BoTulinum Toxin Assessment (ROSETTA)

• Sponsor: NICHD Pelvic Floor Disorders Network (Other)
• Overall Status: Completed
• CT.gov ID: NCT01502956
• Collaborator: Duke University (Other), University of Alabama at Birmingham (Other), University of California, San Diego (Other), The Cleveland Clinic (Other), Brown University (Other), University of New Mexico (Other), University of Pennsylvania (Other), University of Pittsburgh (Other), Oregon Health and Science University (Other), RTI International (Other), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
• Enrollment: 386
• Locations: 9
• Arms: 2
• Duration (Months): 53
• Patients Per Site: 42.9
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

The purpose of this randomized, open-label, active-control trial is to compare the effectiveness of intra-detrusor botulinum toxin A (Botox A®, Allergan) versus sacral neuromodulation (InterStim®, Medtronic) for the treatment of refractory urge urinary incontinence. In addition, the study will evaluate select technical attributes of the interventions as well as the effect of these two interventions on other lower urinary tract and pelvic floor symptoms.

Hypothesis: InterStim® therapy will result in a greater reduction in daily urge urinary incontinence episodes over the 6-month follow-up period as compared to Botox A® injection.

A supplemental study investigates whether biological markers including those related to inflammation and connective tissue remodeling change following treatments with Botox A® and Interstim®.

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence, Urge	Device: InterStim® device; Drug: Botox® injection	Phase 3

Detailed Description

Primary Aim:

To compare the change from baseline in the number of urge urinary incontinence episodes (UUIE) over 6 the six month follow-up period in women randomized to sacral neuromodulation (InterStim®) therapy, versus those randomized to intra-detrusor injection with 200 units of botulinum toxin A (Botox A®).

Secondary Aims:

• Long Term Efficacy: To compare the long-term (12 and 24 month) efficacy outcomes in women randomized to sacral neuromodulation(InterStim®) therapy, versus those randomized to intra-detrusor injection with 200 units of botulinum toxin A (Botox A®). Secondary efficacy outcomes, collected at 12 and 24 months as well as 6 months,include adequate control of their urge urinary incontinence, change in bothersome symptoms of urinary urge incontinence (UUI), severity of urge incontinence, urinary frequency, nocturia, subject satisfaction with therapy, quality of life measures and bowel and sexual function.

• Cost Effectiveness: To compare utilization of medical resources for cost effectiveness analysis and cost-utility between treatment groups.

• Treatment Safety and Burden: To assess safety profile and treatment burden of both interventions by comparing adverse event incidence between treatment arms, and also by obtaining estimates of incidence of treatment-specific safety and burden outcomes. Safety and burden outcomes for Botox A® injections include receipt of additional injections and intermittent catheterization due to voiding dysfunction/partial urinary retention. Safety and burden outcomes for InterStim® device include infection, pain, lead migration, reprogramming (and reasons for) and surgical revision (and reasons for).

Study Design

• Study Type: Interventional
• Actual Enrollment: 386 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Refractory Overactive Bladder: Sacral NEuromodulation v. BoTulinum Toxin Assessment (ROSETTA)
• Study Start Date: Feb 1, 2012
• Actual Primary Completion Date: Jul 1, 2016
• Actual Study Completion Date: Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: InterStim® device The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.	Device: InterStim® device; Eligible subjects will complete baseline assessments, be randomized and scheduled for first stage lead placement (FSLP) InterStim®. The criterion for an initial clinical response to InterStim® therapy will be defined as a ≥50% improvement in the mean number of UUIE/day on a minimum 3 day bladder diary, completed during the 7-14 days following the first stage lead placement (FSLP). Subjects with a ≥ 50% improvement mean number of UUIE/day will be eligible to proceed with implantation of the implantable pulse generator (IPG). Subjects will then be followed monthly to determine the response to therapy.
Active Comparator: Botox® injection Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.	Drug: Botox® injection; Eligible subjects will complete baseline assessments, be randomized and scheduled for Botox A® injection visit. Subjects who received a Botox A® injection will be assessed for a clinical response, at 1 month from injection, using the same clinical criterion (≥50% improvement in the mean number of UUIE/day on a 3 day bladder diary completed prior to the 1 month visit). Those subjects that experience a clinical response, at one month, will be eligible for a repeat Botox A® injection after 6 months, if they experience degradation of clinical effect, using the PGSC.; Other Names: Botox

Outcome Measures

Primary Outcome Measures

1. Number of Urge Urinary Incontinence (UUI) Episodes [6 Months]

   The primary outcome is the change from baseline in mean number of UUI episodes over the first 6-month visit period (1, 2, 3, 4, 5 and 6 month assessments); and is measured using 3-day bladder diaries administered monthly for the first 6 month visit period.

Secondary Outcome Measures

1. Number of Participants With Improvement of Bladder Function and Urinary Leakage [6 Months]

   Proportion of subjects who report adequate improvement of their bladder function and urinary leakage with the Patient Global Impression of Improvement Questionnaire (PGI-I) at 6 months. Adequate improvement is defined as a rating of 1, 2, or 3 (better) on the patient-reported measure of perceived improvement with treatment on a scale of 1 (very much better) to 7 (very much worse).

2. Change in Overactive Bladder [6 Months]

   Change in mean Overactive Bladder Questionnaire Short Form (OABq-SF) score throughout baseline to the first 6-month visit (1, 2, 3, 4, 5, and 6-month assessments). Values range from 0 to 100 with higher scores on the symptom scale indicating greater severity of symptoms and higher scores on the quality of life scale indicating a better quality of life.

3. Urinary Frequency and Nocturia [6 Months]

   Change in mean number of urinary incontinence episodes (any type) and nocturia episodes from baseline over the first 6-month visit period (1, 2, 3, 4, 5, and 6-month assessments) as measured by the 3 day bladder diary.

4. Severity of Urge Incontinence Symptoms [6 Months]

   Severity of urge incontinence symptoms at 6 month visit period as measured by the Sandvik questionnaire. The Sandvik score is a patient-reported measure of incontinence severity as assessed on a scale of slight (1-2), moderate (3-6), severe (8-9), very severe (12) to severe (10-12) using a standard scoring algorithm.

5. Treatment Satisfaction (OAB-SATq Treatment Satisfaction, Adverse Effects, Treatment Endorsement, and Convenience) [6 months]

   Treatment satisfaction as measured by the mean Overactive Bladder Satisfaction of Treatment Questionnaire (OAB-SATq) score at 6 months (6 month assessment). The OAB-SATq score ranges from 0 to 100 and includes 5 subscales: treatment satisfaction, side effects, treatment endorsement, convenience, and treatment preference, with higher scores reflecting better satisfaction.

6. Treatment Satisfaction (OAB-SATq Treatment Preference) [6 Months]

   Treatment preference as measured by the Overactive Bladder Satisfaction of Treatment Questionnaire (OAB-SATq) at 6 months (6 month assessment).OAB-SATq treatment preference is a binary outcome that is classified as yes if a participant answers either "Slight preference for the treatment I am receiving now" or "Definitely prefer the treatment I am receiving now" to the question "Do you prefer the treatment that you received since entering this study to the treatment you received before the study?"

7. Quality of Life (UDI-SF) [6 Months]

   Change from baseline in quality of life measures over the first 6 month visit period (6 month assessment) as measured by the change in mean Urinary Distress Inventory Short Form (UDI-SF) score. The UDI-SF scale has a range from 0 to 100 with higher scores indicating greater distress.

8. Quality of Life (IIQ-SF) [6 Months]

   Change from baseline in quality of life measures over the first 6 month visit period (6 month assessment) as measured by the change in the mean Incontinence Impact Questionnaire short form (IIQ-SF) score. The IIQ-SF scale has a range from 0 to 100 with higher scores indicating a worse quality of life.

9. Quality of Life (HUI-3) [6 Months]

   Change from baseline in quality of life measures over the first 6 month visit period (6 month assessment) as measured by the Health Utility Index, Version 3 (HUI-3). The HUI 3 scale has a range from 0 to 1 with higher scores representing better health.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Non-pregnant adult female at least 21 years old, with no plans to become pregnant during the course of the trial) and if of child-bearing potential, with a negative pregnancy test, and if sexually active, must be using medically acceptable contraception.

• 6 urge urinary incontinence episodes on a 3-day baseline bladder diary, with these urge incontinence episodes representing greater than 50% of the total incontinent episodes recorded.

• Willing and able to complete all study related items and interviews.

• Refractory urinary urge urinary incontinence: defined as (1) Persistent symptoms despite at least one or more conservative treatments (e.g. supervised behavioral therapy, supervised physical therapy); and (2)Persistent symptoms despite the use of a minimum of two anticholinergics, or unable to tolerate medication due to side effects, or has a contraindication to taking anticholinergic medication.

• Currently not on an anticholinergic or antimuscarinic medication (e.g. oxybutynin, tolterodine, and/or fesoterodine) or be willing to stop medication for 3 weeks prior to completing baseline bladder diary and expected to remain off medications through duration of study.

• Demonstrates ability (or have caregiver demonstrate ability) to perform clean intermittent self-catheterization.

• Grossly neurologically normal on exam and no gross systemic neurologic conditions believed to affect urinary function.

• Urodynamic assessment within the previous 18 months prior to enrollment or done after enrollment, prior to randomization.

Exclusion Criteria:

• Neurologic diseases such as multiple sclerosis, Parkinson Disease, CVA within 6 months prior to enrollment, myasthenia gravis, Charcot-Marie-Tooth disease, clinically significant peripheral neuropathy, and complete spinal cord injury.

• Untreated urinary tract infection (UTI).

• Any prior use of either study therapy for treatment of urinary urge incontinence (Botox A® or Interstim®).

• Current participation in any other conflicting interventional research study.

• PVR >150 ml on 2 occasions within 6 months prior to enrollment (If the PVR value was obtained by ultrasound and was ≥150 ml, the PVR will be confirmed by catheterization which will be the gold standard)

• Subjects with knowledge of planned MRIs or diathermy, except those allowable per Medtronic guidelines.

• Current or prior bladder malignancy.

• Surgically altered detrusor muscle, such as augmentation cystoplasty.

• Subjects taking aminoglycosides.

• Currently pregnant or lactating.

• Subjects who are on ambulatory anticoagulant therapy, including aspirin, who are unable to discontinue treatment for 24 hours prior to bladder injection and staged InterStim® procedure.

• Serum creatinine level greater than twice the upper limit of normal within the previous year prior to enrollment.

• Surgical treatment for stress incontinence (sling, Burch or urethral injection) or pelvic organ prolapse recommended or planned at enrollment by study investigator(s).

• Prior stress incontinence or prolapsed surgery within the last 6 months prior to enrollment.

• Allergy to lidocaine or bupivacaine.

• Prior pelvic radiation.

• Uninvestigated hematuria.

• Greater than or equal to Stage III vaginal prolapse.

• Known allergy to Botox A®.

• Use of a vaginal pessary.

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	University of California, San Diego, Women's Pelvic Medicine Center	La Jolla	California	United States	92037
3	University of New Mexico Health Sciences Center	Albuquerque	New Mexico	United States	87131-0001
4	Duke Division of Urogynecology and Reconstructive Pelvic Surgery	Durham	North Carolina	United States	277707
5	Cleveland Clinic, Obstretric and Gynecology and Women Health Institute	Cleveland	Ohio	United States	44194
6	Oregon Health and Science University, Kohler Pavilion	Portland	Oregon	United States	97239
7	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
8	Univesity of Pittsburgh, Magee-Womens Hospital	Pittsburgh	Pennsylvania	United States	15213
9	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
• Duke University
• University of Alabama at Birmingham
• University of California, San Diego
• The Cleveland Clinic
• Brown University
• University of New Mexico
• University of Pennsylvania
• University of Pittsburgh
• Oregon Health and Science University
• RTI International
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

• Study Chair: Cindy Amundsen, MD, Duke University
• Principal Investigator: Holly Richter, PhD, MD, University of Alabama at Birmingham
• Principal Investigator: Shawn A. Menefee, MD, Kaiser Permanente, San Diego, CA
• Principal Investigator: Sandip Vasada, MD, The Cleveland Clinic
• Principal Investigator: Deborah L. Myers, MD, Brown/Women and Infants Hospital of Rhode Island
• Principal Investigator: Yoko Kumesu, MD, University of New Mexico
• Principal Investigator: Lily Arya, MD, University of Pennsylvania
• Principal Investigator: Jerry Lowder, MD, University of Pittsburgh
• Principal Investigator: W. Thomas Gregory, MD, Oregon Health and Science University
• Principal Investigator: Dennis Wallace, PhD, RTI International
• Principal Investigator: Susan Meikle, MD, MSPH, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NICHD Pelvic Floor Disorders Network
• ClinicalTrials.gov Identifier: NCT01502956
• Other Study ID Numbers: PFDN 20; U01HD069031
• First Posted: Jan 2, 2012
• Last Update Posted: May 2, 2018
• Last Verified: Apr 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by NICHD Pelvic Floor Disorders Network: Refractory Urinary Urge Incontinence; Botox A®; Interstim® Device
• Additional relevant MeSH terms: Urinary Incontinence; Urinary Bladder, Overactive; Urinary Incontinence, Urge; Botulinum Toxins, Type A

Study Results

Participant Flow

Recruitment Details	Women who have persistent severe UUI symptoms, defined as ≥6 UUI episodes on a 3-day bladder diary are recruited from urology and urogynecology subspecialty clinics as well as by other marketing methods.

Arm/Group Title	InterStim® Device	Botox® Injection
Arm/Group Description	The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed. InterStim® device: Eligible subjects will complete baseline assessments, be randomized and scheduled for first stage lead placement (FSLP) InterStim®. The criterion for an initial clinical response to InterStim® therapy will be d	Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months. Botox® injection: Eligible subjects will complete baseline assessments, be randomized and scheduled for Botox A® injection visit. Subjects who received a Botox A® injection will be assessed for a clinical response, at 1 month from injection, using the same clinical criterion (≥50% improvement in the mean number of UUIE/day on a 3 day bladder diary completed prior to the 1 month visit). Those subjects that experience a clinical response, at one month, will be eligible for a repeat Botox A® injection after 6 months, if they experience degradation of clinical effect, using the PGSC.
Period Title: Overall Study
STARTED	192	194
COMPLETED	168	168
NOT COMPLETED	24	26

Baseline Characteristics

Arm/Group Title	InterStim® Device	Botox® Injection	Total
Arm/Group Description	The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 1st stage is lead placement into the S3 foramen with best response to stimulation.The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.	Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.	Total of all reporting groups
Overall Participants	174	190	364
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.1 (11.8)	62.9 (11.5)	63.0 (11.6)
Age, Customized (Count of Participants)
Age <65 years	91 52.3%	100 52.6%	191 52.5%
Age => 65 years	83 47.7%	90 47.4%	173 47.5%
Sex/Gender, Customized (Count of Participants)
Female	174 100%	190 100%	364 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	10 5.7%	18 9.5%	28 7.7%
Not Hispanic or Latino	160 92%	167 87.9%	327 89.8%
Unknown or Not Reported	4 2.3%	5 2.6%	9 2.5%
Race/Ethnicity, Customized (Count of Participants)
White	149 85.6%	154 81.1%	303 83.2%
Black	16 9.2%	22 11.6%	38 10.4%
American Indian/Alaska Native	1 0.6%	4 2.1%	5 1.4%
Asian	1 0.6%	1 0.5%	2 0.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Other	7 4%	9 4.7%	16 4.4%
Menopausal Status (Count of Participants)
Pre-menopausal	18 10.3%	20 10.5%	38 10.4%
Post-menopausal	149 85.6%	162 85.3%	311 85.4%
Not sure	7 4%	8 4.2%	15 4.1%
History of Recurrent UTIs (Count of Participants)
No history of recurrent UTIs	149 85.6%	166 87.4%	315 86.5%
History of recurrent UTIs	25 14.4%	24 12.6%	49 13.5%
Urinary Incontinence Episodes Per Day (Episodes per day) [Mean (Standard Deviation) ]
Total incontinence episodes per day	5.8 (3.0)	6.0 (3.0)	5.9 (3.0)
Urge incontinence episodes per day	5.2 (2.7)	5.4 (2.7)	5.3 (2.7)
Nocturia (number of night voids per day) (Voids per day) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Voids per day]	1.7 (1.4)	1.7 (1.2)	1.7 (1.3)
Overactive Bladder Questionnaire - Short Form (OABq-SF) (units on a scale) [Mean (Standard Deviation) ]
OABq-SF Symptom Bother	76.1 (16.8)	74.6 (19.5)	75.3 (18.3)
OABq-SF Quality of Life	36.8 (21.6)	38.2 (23.0)	37.5 (22.3)
Urinary Frequency and Nocturia - Sandvik Questionnaire (Count of Participants)
Slight	1 0.6%	2 1.1%	3 0.8%
Moderate	25 14.4%	27 14.2%	52 14.3%
Severe	38 21.8%	52 27.4%	90 24.7%
Very Severe	105 60.3%	103 54.2%	208 57.1%
Urinary Distress Inventory Short Form (UDI-SF) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	59.2 (16.9)	60.9 (18.3)	60.1 (17.7)
Incontinence Impact Questionnaire Short Form (IIQ-SF) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	52.5 (25.8)	52.7 (27.6)	52.6 (26.7)
Health Utilities Index Mark 3 (HUI-3) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	0.74 (0.28)	0.71 (0.30)	0.73 (0.29)

Outcome Measures

1. Primary Outcome

Title	Number of Urge Urinary Incontinence (UUI) Episodes
Description	The primary outcome is the change from baseline in mean number of UUI episodes over the first 6-month visit period (1, 2, 3, 4, 5 and 6 month assessments); and is measured using 3-day bladder diaries administered monthly for the first 6 month visit period.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

All eligible participants who provided at least 1 post-baseline diary assessment.

Arm/Group Title	InterStim® Device	Botox® Injection
Arm/Group Description	The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 1st stage is lead placement into the S3 foramen with best response to stimulation.The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.	Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.
Measure Participants	174	190
Mean (95% Confidence Interval) [UUI episodes]	-3.25	-3.89

2. Secondary Outcome

Title	Number of Participants With Improvement of Bladder Function and Urinary Leakage
Description	Proportion of subjects who report adequate improvement of their bladder function and urinary leakage with the Patient Global Impression of Improvement Questionnaire (PGI-I) at 6 months. Adequate improvement is defined as a rating of 1, 2, or 3 (better) on the patient-reported measure of perceived improvement with treatment on a scale of 1 (very much better) to 7 (very much worse).
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

All eligible participants who provided at least 1 postbaseline diary assessment.

Arm/Group Title	InterStim® Device	Botox® Injection
Arm/Group Description	The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 1st stage is lead placement into the S3 foramen with best response to stimulation.The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.	Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.
Measure Participants	174	190
Urinary leakage	91 52.3%	101 53.2%
Bladder function	92 52.9%	100 52.6%

3. Secondary Outcome

Title	Change in Overactive Bladder
Description	Change in mean Overactive Bladder Questionnaire Short Form (OABq-SF) score throughout baseline to the first 6-month visit (1, 2, 3, 4, 5, and 6-month assessments). Values range from 0 to 100 with higher scores on the symptom scale indicating greater severity of symptoms and higher scores on the quality of life scale indicating a better quality of life.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

All eligible participants who provided at least 1 post-baseline diary assessment.

Arm/Group Title	InterStim® Device	Botox® Injection
Arm/Group Description	The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 1st stage is lead placement into the S3 foramen with best response to stimulation.The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.	Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.
Measure Participants	174	190
OABq-SF Symptom Bother	-38.6	-46.7
OABq-SF Quality of Life	38.1	41.6

4. Secondary Outcome

Title	Urinary Frequency and Nocturia
Description	Change in mean number of urinary incontinence episodes (any type) and nocturia episodes from baseline over the first 6-month visit period (1, 2, 3, 4, 5, and 6-month assessments) as measured by the 3 day bladder diary.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

All eligible participants who provided at least 1 post-baseline diary assessment.

Arm/Group Title	InterStim® Device	Botox® Injection
Arm/Group Description	The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 1st stage is lead placement into the S3 foramen with best response to stimulation.The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.	Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.
Measure Participants	174	190
Incontinence episodes (any)	-3.50	-4.02
Nocturia episodes	-0.26	-0.40

5. Secondary Outcome

Title	Severity of Urge Incontinence Symptoms
Description	Severity of urge incontinence symptoms at 6 month visit period as measured by the Sandvik questionnaire. The Sandvik score is a patient-reported measure of incontinence severity as assessed on a scale of slight (1-2), moderate (3-6), severe (8-9), very severe (12) to severe (10-12) using a standard scoring algorithm.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

All eligible participants who provided at least 1 post-baseline diary assessment.

Arm/Group Title	InterStim® Device	Botox® Injection
Arm/Group Description	The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 1st stage is lead placement into the S3 foramen with best response to stimulation.The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.	Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.
Measure Participants	174	190
Sandvik Slight	23 13.2%	29 15.3%
Sandvik Moderate	33 19%	33 17.4%
Sandvik Severe	24 13.8%	28 14.7%
Sandvik Very Severe	44 25.3%	36 18.9%

6. Secondary Outcome

Title	Treatment Satisfaction (OAB-SATq Treatment Satisfaction, Adverse Effects, Treatment Endorsement, and Convenience)
Description	Treatment satisfaction as measured by the mean Overactive Bladder Satisfaction of Treatment Questionnaire (OAB-SATq) score at 6 months (6 month assessment). The OAB-SATq score ranges from 0 to 100 and includes 5 subscales: treatment satisfaction, side effects, treatment endorsement, convenience, and treatment preference, with higher scores reflecting better satisfaction.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

All eligible participants who provided at least 1 post-baseline diary assessment.

Arm/Group Title	InterStim® Device	Botox® Injection
Arm/Group Description	The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 1st stage is lead placement into the S3 foramen with best response to stimulation.The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.	Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.
Measure Participants	174	190
OAB-SATq Treatment Satisfaction	59.8	67.7
OAB-SATq Adverse Effects	85.1	88.4
OAB-SATq Endorsement	67.6	78.1
OAB-SATq Convenience	70.2	67.6

7. Secondary Outcome

Title	Treatment Satisfaction (OAB-SATq Treatment Preference)
Description	Treatment preference as measured by the Overactive Bladder Satisfaction of Treatment Questionnaire (OAB-SATq) at 6 months (6 month assessment).OAB-SATq treatment preference is a binary outcome that is classified as yes if a participant answers either "Slight preference for the treatment I am receiving now" or "Definitely prefer the treatment I am receiving now" to the question "Do you prefer the treatment that you received since entering this study to the treatment you received before the study?"
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

All eligible participants who provided at least 1 postbaseline diary assessment.

Arm/Group Title	InterStim® Device	Botox® Injection
Arm/Group Description	The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 1st stage is lead placement into the S3 foramen with best response to stimulation.The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.	Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.
Measure Participants	174	190
Count of Participants [Participants]	89 51.1%	113 59.5%

8. Secondary Outcome

Title	Quality of Life (UDI-SF)
Description	Change from baseline in quality of life measures over the first 6 month visit period (6 month assessment) as measured by the change in mean Urinary Distress Inventory Short Form (UDI-SF) score. The UDI-SF scale has a range from 0 to 100 with higher scores indicating greater distress.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

All eligible participants who provided at least 1 post-baseline diary assessment.

Arm/Group Title	InterStim® Device	Botox® Injection
Arm/Group Description	The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 1st stage is lead placement into the S3 foramen with best response to stimulation.The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.	Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.
Measure Participants	174	190
Mean (95% Confidence Interval) [units on a scale]	-8.6	-10.0

9. Secondary Outcome

Title	Quality of Life (IIQ-SF)
Description	Change from baseline in quality of life measures over the first 6 month visit period (6 month assessment) as measured by the change in the mean Incontinence Impact Questionnaire short form (IIQ-SF) score. The IIQ-SF scale has a range from 0 to 100 with higher scores indicating a worse quality of life.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

All eligible participants who provided at least 1 post-baseline diary assessment.

Arm/Group Title	InterStim® Device	Botox® Injection
Arm/Group Description	The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 1st stage is lead placement into the S3 foramen with best response to stimulation.The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.	Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.
Measure Participants	174	190
Mean (95% Confidence Interval) [units on a scale]	-10.4	-12.4

10. Secondary Outcome

Title	Quality of Life (HUI-3)
Description	Change from baseline in quality of life measures over the first 6 month visit period (6 month assessment) as measured by the Health Utility Index, Version 3 (HUI-3). The HUI 3 scale has a range from 0 to 1 with higher scores representing better health.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

All eligible participants who provided at least 1 post-baseline diary assessment.

Arm/Group Title	InterStim® Device	Botox® Injection
Arm/Group Description	The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 1st stage is lead placement into the S3 foramen with best response to stimulation.The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.	Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.
Measure Participants	174	190
Mean (95% Confidence Interval) [units on a scale]	-0.006	-0.011

Adverse Events

Time Frame	Reported Adverse Events (AEs) include events starting on or after day 0 and on or before 6-month visit.
Adverse Event Reporting Description	If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE.
Arm/Group Title	InterStim® Device		Botox® Injection
Arm/Group Description	The FSLP InterStim® device is to be done within 3 months of enrolling/consenting. The 1st stage is lead placement into the S3 foramen with best response to stimulation. The 1st stage is lead placement into the S3 foramen with best response to stimulation.The 4 electrodes will be tested and set to an amplitude that achieves comfortable stimulation in the vaginal, perineal, or rectal sensation. If =/>50% improvement, participant will then have the 2nd stage IPG implantation, 8-18 days after last FSLP. If there is a technical problem with lead on 1st FSLP, then the participant can have a 2nd FSLP and may go on to have IPG implantation with lead replacement. The 2nd FSLP must be initiated no longer than 1 month since the initiation of the 1st FSLP. If the participant is a non-responder and there is no technical problem, then the lead is removed.		Total of 200 units of Botox A will be dissolved into 10mL of saline and injected into the bladder within 3 months of enrolling/consenting. Participants determined to have a clinical response at the 1 month visit (post 1st injection) may receive additional injections between 6-24 months.
All Cause Mortality
	InterStim® Device		Botox® Injection
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	InterStim® Device		Botox® Injection
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	58/178 (32.6%)		58/191 (30.4%)
Blood and lymphatic system disorders
Anaemia	1/178 (0.6%)	1	0/191 (0%)	0
Cardiac disorders
Acute myocardial infarction	0/178 (0%)	0	1/191 (0.5%)	1
Angina pectoris	1/178 (0.6%)	1	0/191 (0%)	0
Atrial fibrillation	3/178 (1.7%)	5	2/191 (1%)	3
Bradycardia	1/178 (0.6%)	1	0/191 (0%)	0
Cardiac arrest	1/178 (0.6%)	1	0/191 (0%)	0
Cardiac failure congestive	0/178 (0%)	0	1/191 (0.5%)	1
Coronary artery disease	0/178 (0%)	0	2/191 (1%)	2
Myocardial infarction	1/178 (0.6%)	1	0/191 (0%)	0
Pericardial effusion	0/178 (0%)	0	1/191 (0.5%)	1
Supraventricular tachycardia	1/178 (0.6%)	1	0/191 (0%)	0
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy	0/178 (0%)	0	1/191 (0.5%)	1
Gastrointestinal disorders
Abdominal hernia	0/178 (0%)	0	1/191 (0.5%)	1
Colitis ischaemic	0/178 (0%)	0	1/191 (0.5%)	1
Constipation	0/178 (0%)	0	1/191 (0.5%)	1
Diarrhea	0/178 (0%)	0	1/191 (0.5%)	1
Gastroesophageal reflux disease	1/178 (0.6%)	1	0/191 (0%)	0
Ileus	1/178 (0.6%)	1	0/191 (0%)	0
Inflammatory bowel disease	1/178 (0.6%)	1	0/191 (0%)	0
Intestinal cyst	0/178 (0%)	0	1/191 (0.5%)	1
Oesophageal mass	0/178 (0%)	0	1/191 (0.5%)	1
Pancreatitis	0/178 (0%)	0	1/191 (0.5%)	1
Rectal haemorrhage	1/178 (0.6%)	1	0/191 (0%)	0
Salivary gland calculus	1/178 (0.6%)	1	0/191 (0%)	0
Small intestinal obstruction	1/178 (0.6%)	1	0/191 (0%)	0
General disorders
Chest pain	2/178 (1.1%)	2	2/191 (1%)	2
Device deployment issue	1/178 (0.6%)	1	0/191 (0%)	0
Device dislocation	3/178 (1.7%)	3	0/191 (0%)	0
Hernia	1/178 (0.6%)	1	1/191 (0.5%)	1
Medical device site pain	1/178 (0.6%)	1	0/191 (0%)	0
Hepatobiliary disorders
Cholelithiasis	1/178 (0.6%)	1	0/191 (0%)	0
Hepatic steatosis	0/178 (0%)	0	1/191 (0.5%)	1
Infections and infestations
Abscess	1/178 (0.6%)	1	1/191 (0.5%)	1
Bronchitis	0/178 (0%)	0	1/191 (0.5%)	1
Cellulitis	3/178 (1.7%)	3	1/191 (0.5%)	1
Clostridium difficile infection	2/178 (1.1%)	4	0/191 (0%)	0
Clostridium difficile sepsis	0/178 (0%)	0	1/191 (0.5%)	1
Device related infection	1/178 (0.6%)	1	0/191 (0%)	0
Diverticulitis	0/178 (0%)	0	1/191 (0.5%)	1
Epiglottitis	1/178 (0.6%)	1	0/191 (0%)	0
Incision site infection	1/178 (0.6%)	1	0/191 (0%)	0
Infectious colitis	0/178 (0%)	0	1/191 (0.5%)	1
Influenza	1/178 (0.6%)	1	2/191 (1%)	2
Lymphangitis	0/178 (0%)	0	1/191 (0.5%)	1
Meningitis viral	1/178 (0.6%)	1	0/191 (0%)	0
Osteomyelitis	0/178 (0%)	0	1/191 (0.5%)	1
Parotitis	1/178 (0.6%)	1	0/191 (0%)	0
Pneumonia	3/178 (1.7%)	3	0/191 (0%)	0
Post procedural infection	1/178 (0.6%)	1	0/191 (0%)	0
Pyelonephritis	0/178 (0%)	0	1/191 (0.5%)	1
Sepsis	0/178 (0%)	0	4/191 (2.1%)	4
Subcutaneous abscess	1/178 (0.6%)	1	0/191 (0%)	0
Urinary tract infection	0/178 (0%)	0	1/191 (0.5%)	1
Wound infection	1/178 (0.6%)	1	1/191 (0.5%)	2
Wound infection staphylococcal	0/178 (0%)	0	1/191 (0.5%)	1
Injury, poisoning and procedural complications
Anastomotic ulcer	1/178 (0.6%)	1	0/191 (0%)	0
Ankle fracture	1/178 (0.6%)	1	1/191 (0.5%)	1
Carotid artery restenosis	0/178 (0%)	0	1/191 (0.5%)	1
Cervical vertebral fracture	1/178 (0.6%)	1	0/191 (0%)	0
Contusion	1/178 (0.6%)	1	0/191 (0%)	0
Facial bones fracture	1/178 (0.6%)	1	0/191 (0%)	0
Fall	1/178 (0.6%)	1	2/191 (1%)	2
Femoral neck fracture	0/178 (0%)	0	1/191 (0.5%)	1
Foot fracture	0/178 (0%)	0	2/191 (1%)	2
Hip fracture	0/178 (0%)	0	1/191 (0.5%)	1
Incision site pain	1/178 (0.6%)	1	0/191 (0%)	0
Lower limb fracture	1/178 (0.6%)	1	0/191 (0%)	0
Overdose	0/178 (0%)	0	1/191 (0.5%)	1
Road traffic accident	1/178 (0.6%)	1	0/191 (0%)	0
Seroma	0/178 (0%)	0	1/191 (0.5%)	1
Subdural haematoma	0/178 (0%)	0	1/191 (0.5%)	1
Tongue injury	1/178 (0.6%)	1	0/191 (0%)	0
Upper limb fracture	0/178 (0%)	0	3/191 (1.6%)	3
Investigations
Cyst aspiration	1/178 (0.6%)	1	0/191 (0%)	0
Metabolism and nutrition disorders
Dehydration	0/178 (0%)	0	1/191 (0.5%)	1
Hyponatremia	0/178 (0%)	0	1/191 (0.5%)	1
Lactic acidosis	0/178 (0%)	0	1/191 (0.5%)	1
Obesity	1/178 (0.6%)	1	0/191 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	1/178 (0.6%)	1	1/191 (0.5%)	2
Arthritis	1/178 (0.6%)	1	0/191 (0%)	0
Back pain	1/178 (0.6%)	1	0/191 (0%)	0
Intervertebral disc degeneration	1/178 (0.6%)	1	0/191 (0%)	0
Musculoskeletal pain	1/178 (0.6%)	1	0/191 (0%)	0
Osteoarthritis	4/178 (2.2%)	5	3/191 (1.6%)	3
Rotator cuff syndrome	1/178 (0.6%)	1	0/191 (0%)	0
Spinal column stenosis	0/178 (0%)	0	1/191 (0.5%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma	1/178 (0.6%)	1	0/191 (0%)	0
Breast cancer	0/178 (0%)	0	4/191 (2.1%)	4
Diffuse large B-cell lymphoma	0/178 (0%)	0	1/191 (0.5%)	1
Endometrial adenocarcinoma	0/178 (0%)	0	1/191 (0.5%)	1
Uterine leiomyoma	0/178 (0%)	0	1/191 (0.5%)	1
Nervous system disorders
Cauda equina syndrome	1/178 (0.6%)	1	0/191 (0%)	0
Cerebral haemorrhage	0/178 (0%)	0	1/191 (0.5%)	1
Cerebrovascular accident	1/178 (0.6%)	1	0/191 (0%)	0
Dementia	1/178 (0.6%)	1	0/191 (0%)	0
Dizziness	0/178 (0%)	0	2/191 (1%)	2
Intracranial aneurysm	1/178 (0.6%)	1	0/191 (0%)	0
Loss of consciousness	1/178 (0.6%)	1	0/191 (0%)	0
Radiculopathy	1/178 (0.6%)	1	0/191 (0%)	0
Seizure	2/178 (1.1%)	2	1/191 (0.5%)	1
Syncope	0/178 (0%)	0	2/191 (1%)	2
Toxic encephalopathy	1/178 (0.6%)	1	0/191 (0%)	0
Transient ischaemic attack	2/178 (1.1%)	2	1/191 (0.5%)	1
Psychiatric disorders
Agitation	1/178 (0.6%)	1	0/191 (0%)	0
Confusional state	0/178 (0%)	0	1/191 (0.5%)	1
Depression	0/178 (0%)	0	1/191 (0.5%)	1
Depression suicidal	0/178 (0%)	0	1/191 (0.5%)	1
Mental status changes	1/178 (0.6%)	1	0/191 (0%)	0
Renal and urinary disorders
Acute kidney injury	0/178 (0%)	0	1/191 (0.5%)	1
Nephrolithiasis	1/178 (0.6%)	1	0/191 (0%)	0
Renal failure	1/178 (0.6%)	1	0/191 (0%)	0
Urinary retention	1/178 (0.6%)	1	0/191 (0%)	0
Reproductive system and breast disorders
Ovarian cyst	1/178 (0.6%)	1	0/191 (0%)	0
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	0/178 (0%)	0	1/191 (0.5%)	1
Asthma	0/178 (0%)	0	1/191 (0.5%)	1
Chronic obstructive pulmonary disease	1/178 (0.6%)	1	1/191 (0.5%)	1
Dyspnoea	1/178 (0.6%)	1	0/191 (0%)	0
Obliterative bronchiolitis	0/178 (0%)	0	1/191 (0.5%)	1
Pneumonia aspiration	0/178 (0%)	0	1/191 (0.5%)	1
Pulmonary embolism	0/178 (0%)	0	1/191 (0.5%)	1
Social circumstances
Sexual abuse	1/178 (0.6%)	1	0/191 (0%)	0
Surgical and medical procedures
Abdominal hernia repair	1/178 (0.6%)	1	0/191 (0%)	0
Anal sphincterotomy	1/178 (0.6%)	1	0/191 (0%)	0
Appendicectomy	1/178 (0.6%)	1	0/191 (0%)	0
Cardiac operation	0/178 (0%)	0	1/191 (0.5%)	1
Endotracheal intubation	0/178 (0%)	0	1/191 (0.5%)	1
Gastrectomy	1/178 (0.6%)	1	1/191 (0.5%)	1
Gastric bypass	1/178 (0.6%)	1	0/191 (0%)	0
Hernia hiatus repair	1/178 (0.6%)	1	0/191 (0%)	0
Hip arthroplasty	0/178 (0%)	0	1/191 (0.5%)	1
Hysterectomy	1/178 (0.6%)	1	1/191 (0.5%)	1
Intestinal resection	1/178 (0.6%)	1	0/191 (0%)	0
Knee arthroplasty	1/178 (0.6%)	1	2/191 (1%)	2
Knee operation	1/178 (0.6%)	1	0/191 (0%)	0
Mammoplasty	0/178 (0%)	0	1/191 (0.5%)	1
Medical device change	2/178 (1.1%)	2	0/191 (0%)	0
Medical device removal	3/178 (1.7%)	3	0/191 (0%)	0
Skin graft	0/178 (0%)	0	1/191 (0.5%)	1
Spinal laminectomy	0/178 (0%)	0	1/191 (0.5%)	1
Tenotomy	0/178 (0%)	0	1/191 (0.5%)	1
Thyroidectomy	1/178 (0.6%)	1	0/191 (0%)	0
Vascular disorders
Lymphoedema	1/178 (0.6%)	1	0/191 (0%)	0
Other (Not Including Serious) Adverse Events
	InterStim® Device		Botox® Injection
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	20/178 (11.2%)		66/191 (34.6%)
Infections and infestations
Urinary Tract Infection	20/178 (11.2%)	28	66/191 (34.6%)	107

Limitations/Caveats

[Not Specified]

More Information

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.