Operations and Pelvic Muscle Training in the Management of Apical Support Loss: The OPTIMAL Trial

• Sponsor: NICHD Pelvic Floor Disorders Network (Other)
• Overall Status: Completed
• CT.gov ID: NCT00597935
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
• Enrollment: 374
• Locations: 9
• Arms: 4
• Duration (Months): 65
• Patients Per Site: 41.6
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

Pelvic organ prolapse is common among women with a prevalence that has been estimated to be as high as 30%. Pelvic organ prolapse often involves a combination of support defects involving the anterior, posterior and/or apical vaginal segments. While the anterior vaginal wall is the segment most likely to demonstrate recurrent prolapse after reconstructive surgery, reoperations are highest among those who require apical suspension procedures with or without repair of other vaginal segments (12%-33%). Despite the substantial health impact, there is a paucity of high quality evidence to support different practices in the management of prolapse, particularly surgery. Thus, the objectives of the Operations and Pelvic Muscle

Training in the Management of Apical Support Loss (OPTIMAL) Trial are:

1. to compare sacrospinous ligament fixation (SSLF) to uterosacral vaginal vault ligament suspension (ULS); and

2. to assess the role of perioperative behavioral therapy/pelvic muscle training (PMT) in women undergoing vaginal surgery for apical or uterine prolapse and stress urinary incontinence.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse (POP)	Procedure: SSLF; Procedure: ULS; Behavioral: PMT	N/A

Detailed Description

Many women develop pelvic organ prolapse over the course of their lives. Pelvic organ prolapse is the downward descent of the pelvic organs (which include the uterus, bladder and bowel) into the vagina. Researchers estimate that between 7-10% of women will require surgery for prolapse sometime in their lifetime. Many will have more than one operation for the prolapse. Because this is such a common problem, the investigators in the Pelvic Floor Disorders Network strive to offer women the best treatment options. However, there were not enough carefully designed and conducted research studies to help guide them in this direction.

Women who are planning surgery for apical vaginal prolapse often experience bladder and bowel symptoms, as well as pressure and a bulge. These symptoms might include urinary leakage (urinary incontinence), urinary urgency (a sudden strong desire to urinate with fear that leakage may occur) or frequent urination, difficulty starting to urinate or perhaps a slow weak urinary stream, as well as accidental bowel leakage (fecal incontinence). After surgery, bladder and bowel symptoms may get better, get worse, or stay the same as before surgery. Sometimes new symptoms can start after surgery even if they weren't present before surgery.

The OPTIMAL study was designed to compare two commonly performed vaginal surgeries for pelvic organ prolapse. One is the sacrospinous ligament fixation, called SSLF for short. The other is the uterosacral ligament suspension, called ULS. Both surgeries involve attaching the top of the vagina, which has fallen down, to internal ligaments in the pelvis in order to resuspend the vagina and correct the prolapse.

The investigators were also interested in studying how the surgeries altered bladder and bowel symptoms. They had seen in other studies that behavioral and pelvic floor muscle therapy (PMT) is an effective therapy for stress and urge urinary incontinence, fecal incontinence, and other pelvic floor disorders. It is relatively easy to perform, and has rare side effects. They wondered if PMT around the time of surgery might further improve these symptoms.

The OPTIMAL study has two main purposes:

1. To find out which type of surgery, SSLF or ULS, has better results when used to repair prolapse of the top of the vagina,

2. To find out whether or not doing pelvic muscle exercises and behavioral changes around the time of surgery will affect both bladder and bowel symptoms after surgery, and the success of the prolapse repair.

Four Hundred women were enrolled into the OPTIMAL study, from January 2008 to May 2011. These women were randomly assigned to receive either the SSLF or the ULS surgery. They were randomly assigned to either receive the PMT training with a therapist before and after surgery or to not receive this therapy. So women fell into one of four groups:

1. SSLF plus PMT

2. ULS plus PMT

3. SSLF without PMT

4. ULS without PMT

Women in this study were followed closely at regular intervals for two years after surgery.

Study Design

• Study Type: Interventional
• Actual Enrollment: 374 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Operations and Pelvic Muscle Training in the Management of Apical Support Loss: The OPTIMAL Trial: A Randomized Trial of Sacrospinous Ligament Fixation (SSLF) Versus Uterosacral Ligament Suspension (ULS) With and Without Perioperative Behavioral Therapy/Pelvic Muscle Training
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: Jul 1, 2013
• Actual Study Completion Date: Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SSLF and PMT Sacrospinous Ligament Fixation (SSLF) and Pelvic Muscle Training & Exercises (PMT)	Procedure: SSLF; sacrospinous ligament fixation (SSLF); Behavioral: PMT; Pelvic muscle training and exercises (PMT)
Experimental: ULS and PMT Uterosacral Vaginal Vault Ligament Suspension (ULS) and Pelvic Muscle Training & Exercises (PMT)	Procedure: ULS; uterosacral vaginal vault ligament suspension (ULS); Behavioral: PMT; Pelvic muscle training and exercises (PMT)
Experimental: SSLF without PMT Sacrospinous Ligament Fixation (SSLF) without Pelvic Muscle Training & Exercises (PMT)	Procedure: SSLF; sacrospinous ligament fixation (SSLF)
Experimental: ULS without PMT Uterosacral Vaginal Vault Ligament Suspension (ULS) without Pelvic Muscle Training & Exercises (PMT)	Procedure: ULS; uterosacral vaginal vault ligament suspension (ULS)

Outcome Measures

Primary Outcome Measures

1. Surgical Success [24 months]

   The absence of the following: (1) descent of the vaginal apex more than one-third into the vaginal canal; (2) anterior or posterior vaginal wall descent beyond the hymen; (3) bothersome vaginal bulge symptoms as indicated by an affirmative response to either 'Do you usually have a sensation of bulging or protrusion from the vaginal area?' or 'Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?' in the Pelvic Floor Distress Inventory and any response other than 'not at all' to the question 'How much does this bother you?'; or (4) re-treatment for prolapse by either surgery or pessary.

2. Anatomic Failure [24 months]

   Anatomic failure is defined by one of the following: descent of the vaginal apex more than one-third into the vaginal canal, anterior or posterior vaginal wall descent beyond the hymen, or re-treatment for prolapse.

3. Urinary Distress Inventory at 6 Months [6 months]

   The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (POPDI, with 3 subscales), 2. Colorectal Anal Distress Inventory (CRADI, with 4 subscales), and 3. Urinary Distress Inventory (UDI, with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of responses for the UDI is: 0-300 with 0 (least distress) to 300 (most distress). Lower scores indicate better function / fewer symptoms.

Secondary Outcome Measures

1. Change From Baseline: Urinary Distress Inventory [Baseline and 24 months]

   The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (POPDI, with 3 subscales), 2. Colorectal Anal Distress Inventory (CRADI, with 4 subscales), and 3. Urinary Distress Inventory (UDI, with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of responses for the UDI is: 0-300 with 0 (least distress) to 300 (most distress). Change = (24 Month Score - Baseline Score). Lower scores indicate better function / fewer symptoms.

2. Change From Baseline: Pelvic Organ Prolapse Distress Inventory [Baseline and 24 months]

   The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (POPDI, with 3 subscales), 2. Colorectal Anal Distress Inventory (CRADI, with 4 subscales), and 3. Urinary Distress Inventory (UDI, with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of responses for the POPDI is: 0-300 with 0 (least distress) to 300 (most distress). Change = (24 Month Score - Baseline Score). Lower scores indicate better function / fewer symptoms.

3. Change From Baseline: Colorectal Anal Distress Inventory [Baseline and 24 months]

   The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (POPDI, with 3 subscales), 2. Colorectal Anal Distress Inventory (CRADI, with 4 subscales), and 3. Urinary Distress Inventory (UDI, with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of responses for the CRADI is: 0-400 with 0 (least distress) to 400 (most distress). Change = (24 Month Score - Baseline Score). Lower scores indicate better function / fewer symptoms.

4. Urinary Impact Questionnaire Change From Baseline to 24 Months [Baseline and 24 months]

   The Pelvic Floor Impact Questionnaire measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales: the Urinary Impact Questionnaire (UIQ; 4 subscales, range 0-400), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; 4 subscales, range 0-400), and the Colorectal-Anal Impact Questionnaire (CRAIQ; 4 subscales, range 0-400). Scores are calculated by multiplying the mean value of all answered questions for a subscale by 100 divided by 3. The subscales are then added together. The range of responses is: 0-400 with 0 (least negative impact) to 400 (most negative impact). Change = (24 Month Score - Baseline Score). Lower scores indicate better function / fewer symptoms.

5. Pelvic Organ Prolapse Impact Questionnaire Change From Baseline to 24 Months [Baseline and 24 months]

   The Pelvic Floor Impact Questionnaire measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales: the Urinary Impact Questionnaire (UIQ; 4 subscales, range 0-400), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; 4 subscales, range 0-400), and the Colorectal-Anal Impact Questionnaire (CRAIQ; 4 subscales, range 0-400). Scores are calculated by multiplying the mean value of all answered questions for a subscale by 100 divided by 3. The subscales are then added together. The range of responses is: 0-400 with 0 (least negative impact) to 400 (most negative impact). Change = (Year 2 Score - Baseline Score). Lower scores indicate better function / fewer symptoms.

6. Colorectal-Anal Impact Questionnaire Change From Baseline to 24 Months [Baseline and 24 months]

   The Pelvic Floor Impact Questionnaire measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales: the Urinary Impact Questionnaire (UIQ; 4 subscales, range 0-400), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; 4 subscales, range 0-400), and the Colorectal-Anal Impact Questionnaire (CRAIQ; 4 subscales, range 0-400). Scores are calculated by multiplying the mean value of all answered questions for a subscale by 100 divided by 3. The subscales are then added together. The range of responses is: 0-400 with 0 (least negative impact) to 400 (most negative impact). Change = (Year 2 Score - Baseline Score). Lower scores indicate better function / fewer symptoms.

7. Sexual Function 36 - Physical Health Component Score Change From Baseline to 24 Months [Baseline and 24 months]

   Sexual Function 36 (SF36) - Physical Health Component Score is the physical health component of the Sexual Function 36 survey with scores ranging from 0 to 100 with higher scores meaning a better health state. Scales are scored according to the algorithm that describes the handling of the various types of questions included in the questionnaire. Several steps are involved in the scoring process: recoding items that require it; summing over items; and transforming raw scale scores to a 0 to 100 scale. This physical health component is a function of several constructs measured under the SF36: physical functioning, physical role, bodily pain, general health, and vitality.

8. Sexual Function 36 - Mental Health Component Score Change From Baseline to 24 Months [Baseline and 24 months]

   Sexual Function 36 (SF36) - Mental Health Component Score is the mental health component of the Sexual Function 36 survey with scores ranging from 0 to 100 with higher scores meaning a better health state. Scales are scored according to the algorithm that describes the handling of the various types of questions included in the questionnaire. Several steps are involved in the scoring process: recoding items that require it; summing over items; and transforming raw scale scores to a 0 to 100 scale.

9. Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire Change From Baseline to 24 Months [Baseline and 24 months]

   Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ) is a survey of sexual functioning with scores ranging from 0 to 48 with higher scores meaning better sexual functioning. Patients were asked to answer 31 questions about their sexuality in the past 6 months.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Stage 2 to 4 prolapse

• Prolapse of the vaginal apex or cervix to at least half way into the vaginal canal (POPQ Point C > -TVL/2) [TVL stands for total vaginal length]

• Vaginal bulge symptoms as indicated by an affirmative response to either questions on the Pelvic Floor Distress Inventory (PFDI)

• Vaginal surgery for prolapse is planned, including a vaginal apical suspension procedure.

• Stress incontinence symptoms as indicated by an affirmative response to the PFDI Stress incontinence subscale

• Documentation of transurethral stress leakage on an office stress test or urodynamics with or without prolapse reduction within the previous 12 months

• A tension free vaginal tape (TVT) is planned to treat stress urinary incontinence.

• A pelvic muscle training (PMT) visit can be performed at least 2 weeks and not more than 4 weeks before surgery.

• Available for 24-months of follow-up.

• Able to complete study assessments, per clinician judgment

• Able and willing to provide written informed consent

Exclusion Criteria:

• Contraindication to sacrospinous ligament fixation (SSLF), uterosacral vaginal vault ligament suspension (ULS), or TVT in the opinion of the treating surgeon.

• History of previous surgery that included a SSLF or ULS. (Previous vaginal vault suspensions using other techniques or in which the previous technique is unknown are eligible.)

• Pelvic pain or dyspareunia due to levator ani spasm that would preclude a PMT program.

• History of previous synthetic sling procedure for stress incontinence.

• Previous adverse reaction to synthetic mesh.

• Urethral diverticulum, current or previous (i.e., repaired)

• History of femoral to femoral bypass.

• Current cytotoxic chemotherapy or current or history of pelvic radiation therapy.

• History of two inpatient hospitalizations for medical comorbidities in the previous 12 months.

• Subject wishes to retain her uterus. [Both ULS and SLS include removal of the uterus, if not previously removed]

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Alabama at Birmingham	Birmingham	Alabama	United States	35233-7333
2	Kaiser Permanente Bellflower	Bellflower	California	United States	90706
3	University of California, San Diego Medical Center	La Jolla	California	United States	92037
4	Kaiser Permanente	San Diego	California	United States	92120
5	Loyola University Medical Center	Maywood	Illinois	United States	60153
6	Duke University	Durham	North Carolina	United States	27710
7	Cleveland Clinic	Cleveland	Ohio	United States	44195
8	University of Texas Southwestern	Dallas	Texas	United States	75390
9	University of Utah	Salt Lake City	Utah	United States	84132

Sponsors and Collaborators

• NICHD Pelvic Floor Disorders Network
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

• Principal Investigator: Matthew Barber, MD, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Pelvic Floor Disorders Network website

Publications

• Barber MD, Brubaker L, Menefee S, Norton P, Borello-France D, Varner E, Schaffer J, Weidner A, Xu X, Spino C, Weber A; Pelvic Floor Disorders Network. Operations and pelvic muscle training in the management of apical support loss (OPTIMAL) trial: design and methods. Contemp Clin Trials. 2009 Mar;30(2):178-89. doi: 10.1016/j.cct.2008.12.001. Epub 2008 Dec 16.

• Responsible Party: NICHD Pelvic Floor Disorders Network
• ClinicalTrials.gov Identifier: NCT00597935
• Other Study ID Numbers: 16P01; 2U01HD041249; 2U10HD041250; 2U10HD041261; 2U10HD041267; 1U10HD054136; 1U10HD054214; 1U10HD054215; 1U10HD054241
• First Posted: Jan 18, 2008
• Last Update Posted: Oct 22, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by NICHD Pelvic Floor Disorders Network: prolapse; urinary incontinence; uterosacral vaginal vault ligament suspension; sacrospinous ligament fixation; behavioral therapy; pelvic muscle training
• Additional relevant MeSH terms: Prolapse; Pelvic Organ Prolapse

Study Results

Participant Flow

Arm/Group Title	SSLF+BPMT	SSLF+USUAL	ULS+BPMT	ULS+USUAL
Arm/Group Description	Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training	Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training	Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
Period Title: Randomized to Surgical and BPMT Arms
STARTED	95	91	91	97
COMPLETED	95	91	91	97
NOT COMPLETED	0	0	0	0
Period Title: Randomized to Surgical and BPMT Arms
STARTED	95	91	91	97
COMPLETED	93	87	87	93
NOT COMPLETED	2	4	4	4
Period Title: Randomized to Surgical and BPMT Arms
STARTED	93	87	87	93
COMPLETED	76	79	77	85
NOT COMPLETED	17	8	10	8

Baseline Characteristics

Arm/Group Title	SSLF+BPMT	SSLF+USUAL	ULS+BPMT	ULS+USUAL	Total
Arm/Group Description	Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training	Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training	Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	Total of all reporting groups
Overall Participants	95	91	91	97	374
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.3 (11.2)	58.1 (10.7)	58.7 (10.5)	55.8 (11)	57.2 (10.9)
Sex/Gender, Customized (Count of Participants)
Female	95 100%	91 100%	91 100%	97 100%	374 100%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaska Native	1 1.1%	1 1.1%	0 0%	0 0%	2 0.5%
Asian	1 1.1%	3 3.3%	0 0%	0 0%	4 1.1%
Black or African American	7 7.4%	3 3.3%	8 8.8%	4 4.1%	22 5.9%
Other	6 6.3%	7 7.7%	9 9.9%	9 9.3%	31 8.3%
White	80 84.2%	77 84.6%	74 81.3%	84 86.6%	315 84.2%
Race/Ethnicity, Customized (Count of Participants)
Hispanic/Latina	19 20%	15 16.5%	19 20.9%	22 22.7%	75 20.1%
Not Hispanic/Latina	76 80%	76 83.5%	72 79.1%	75 77.3%	299 79.9%
Insurance: Private/HMO (Count of Participants)
No	33 34.7%	30 33%	28 30.8%	32 33%	123 32.9%
Yes	62 65.3%	61 67%	63 69.2%	65 67%	251 67.1%
Insurance: Medicare or Medicaid (Count of Participants)
No	68 71.6%	65 71.4%	62 68.1%	70 72.2%	265 70.9%
Yes	27 28.4%	26 28.6%	29 31.9%	27 27.8%	109 29.1%
Insurance: Self-pay (Count of Participants)
No	93 97.9%	90 98.9%	90 98.9%	95 97.9%	368 98.4%
Yes	2 2.1%	1 1.1%	1 1.1%	2 2.1%	6 1.6%
Insurance: Other (Count of Participants)
No	77 81.1%	74 81.3%	76 83.5%	75 77.3%	302 80.7%
Yes	18 18.9%	17 18.7%	15 16.5%	22 22.7%	72 19.3%
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	30 (6.2)	28 (5.1)	28.6 (4.9)	28.8 (5.5)	28.8 (5.5)
Current Smoker (Count of Participants)
No	84 88.4%	83 91.2%	83 91.2%	91 93.8%	341 91.2%
Yes	11 11.6%	8 8.8%	8 8.8%	6 6.2%	33 8.8%
Diabetes (Count of Participants)
.	5 5.3%	2 2.2%	0 0%	1 1%	8 2.1%
No	78 82.1%	81 89%	76 83.5%	87 89.7%	322 86.1%
Yes	12 12.6%	8 8.8%	15 16.5%	9 9.3%	44 11.8%
Connective tissue disease (Count of Participants)
.	1 1.1%	1 1.1%	0 0%	3 3.1%	5 1.3%
No	93 97.9%	90 98.9%	90 98.9%	91 93.8%	364 97.3%
Yes	1 1.1%	0 0%	1 1.1%	3 3.1%	5 1.3%
Number of Vaginal Deliveries (Number of deliveries) [Median (Full Range) ]
Median (Full Range) [Number of deliveries]	3	2	3	3	3
Number of Cesarean Deliveries (Number of deliveries) [Median (Full Range) ]
Median (Full Range) [Number of deliveries]	0	0	0	0	0
Estrogen Use: Oral or patch (Count of Participants)
No	84 88.4%	76 83.5%	80 87.9%	88 90.7%	328 87.7%
Yes	11 11.6%	15 16.5%	11 12.1%	9 9.3%	46 12.3%
Estrogen Use: Vaginal (Count of Participants)
No	77 81.1%	70 76.9%	67 73.6%	72 74.2%	286 76.5%
Yes	18 18.9%	21 23.1%	24 26.4%	25 25.8%	88 23.5%
Menstrual Status (Count of Participants)
Not sure	7 7.4%	4 4.4%	6 6.6%	5 5.2%	22 5.9%
Postmenopausal	59 62.1%	64 70.3%	64 70.3%	59 60.8%	246 65.8%
Premenopausal	29 30.5%	23 25.3%	21 23.1%	33 34%	106 28.3%
Hysterectomy (Count of Participants)
No	73 76.8%	61 67%	68 74.7%	72 74.2%	274 73.3%
Yes	22 23.2%	30 33%	23 25.3%	25 25.8%	100 26.7%
Prior Stress Urinary Incontinence Surgery (Count of Participants)
No	93 97.9%	87 95.6%	87 95.6%	94 96.9%	361 96.5%
Yes	2 2.1%	4 4.4%	4 4.4%	3 3.1%	13 3.5%
Prior Pelvic Organ Prolapse Surgery (Count of Participants)
No	89 93.7%	80 87.9%	88 96.7%	91 93.8%	348 93%
Yes	6 6.3%	11 12.1%	3 3.3%	6 6.2%	26 7%
Pelvic Organ Prolapse-Q stage (Count of Participants)
2	37 38.9%	36 39.6%	35 38.5%	36 37.1%	144 38.5%
3	54 56.8%	48 52.7%	51 56%	59 60.8%	212 56.7%
4	4 4.2%	7 7.7%	5 5.5%	2 2.1%	18 4.8%

Outcome Measures

1. Primary Outcome

Title	Surgical Success
Description	The absence of the following: (1) descent of the vaginal apex more than one-third into the vaginal canal; (2) anterior or posterior vaginal wall descent beyond the hymen; (3) bothersome vaginal bulge symptoms as indicated by an affirmative response to either 'Do you usually have a sensation of bulging or protrusion from the vaginal area?' or 'Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?' in the Pelvic Floor Distress Inventory and any response other than 'not at all' to the question 'How much does this bother you?'; or (4) re-treatment for prolapse by either surgery or pessary.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

This outcome is analyzed in participants randomized to both surgical and behavioral interventions who had non-missing data for this 24-month outcome. There are minor differences between the Number of Participants Analyzed and the 24-month numbers in the Participant Flow module because of missing data.

Arm/Group Title	SSLF+BPMT	SSLF+USUAL	ULS+BPMT	ULS+USUAL
Arm/Group Description	Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training	Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training	Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
Measure Participants	72	77	73	82
Failure	25 26.3%	30 33%	28 30.8%	27 27.8%
Success	47 49.5%	47 51.6%	45 49.5%	55 56.7%

2. Primary Outcome

Title	Anatomic Failure
Description	Anatomic failure is defined by one of the following: descent of the vaginal apex more than one-third into the vaginal canal, anterior or posterior vaginal wall descent beyond the hymen, or re-treatment for prolapse.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

This outcome is analyzed in participants randomized to both surgical and behavioral interventions and who were in the study at 24 months.

Arm/Group Title	SSLF+BPMT	SSLF+USUAL	ULS+BPMT	ULS+USUAL
Arm/Group Description	Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training	Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training	Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
Measure Participants	76	79	77	85
Failure	18 18.9%	23 25.3%	19 20.9%	19 19.6%
Non-failure	58 61.1%	56 61.5%	58 63.7%	66 68%

3. Primary Outcome

Title	Urinary Distress Inventory at 6 Months
Description	The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (POPDI, with 3 subscales), 2. Colorectal Anal Distress Inventory (CRADI, with 4 subscales), and 3. Urinary Distress Inventory (UDI, with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of responses for the UDI is: 0-300 with 0 (least distress) to 300 (most distress). Lower scores indicate better function / fewer symptoms.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

This outcome is analyzed in participants randomized to both surgical and behavioral interventions who had non-missing data for this 6-month outcome. There are minor differences between the Number of Participants Analyzed and the 6-month numbers in the Participant Flow module because of missing data.

Arm/Group Title	SSLF+BPMT	SSLF+USUAL	ULS+BPMT	ULS+USUAL
Arm/Group Description	Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training	Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training	Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
Measure Participants	87	83	83	88
Mean (95% Confidence Interval) [units on a scale]	30.6	37.9	27.4	29.7

4. Secondary Outcome

Title	Change From Baseline: Urinary Distress Inventory
Description	The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (POPDI, with 3 subscales), 2. Colorectal Anal Distress Inventory (CRADI, with 4 subscales), and 3. Urinary Distress Inventory (UDI, with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of responses for the UDI is: 0-300 with 0 (least distress) to 300 (most distress). Change = (24 Month Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Time Frame	Baseline and 24 months

Outcome Measure Data

Analysis Population Description

This outcome is analyzed in participants randomized to both surgical and behavioral interventions who had non-missing data for this 24-month outcome. There are differences between the Number of Participants Analyzed and the 24-month numbers in the Participant Flow module because of missing data.

Arm/Group Title	SSLF+BPMT	SSLF+USUAL	ULS+BPMT	ULS+USUAL
Arm/Group Description	Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training	Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training	Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
Measure Participants	76	72	70	74
Mean (95% Confidence Interval) [units on a scale]	-88.1	-84.9	-82.5	-82.9

5. Secondary Outcome

Title	Change From Baseline: Pelvic Organ Prolapse Distress Inventory
Description	The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (POPDI, with 3 subscales), 2. Colorectal Anal Distress Inventory (CRADI, with 4 subscales), and 3. Urinary Distress Inventory (UDI, with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of responses for the POPDI is: 0-300 with 0 (least distress) to 300 (most distress). Change = (24 Month Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Time Frame	Baseline and 24 months

Outcome Measure Data

Analysis Population Description

This outcome is analyzed in participants randomized to both surgical and behavioral interventions who had non-missing data for this 24-month outcome. There are differences between the Number of Participants Analyzed and the 24-month numbers in the Participant Flow module because of missing data.

Arm/Group Title	SSLF+BPMT	SSLF+USUAL	ULS+BPMT	ULS+USUAL
Arm/Group Description	Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training	Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training	Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
Measure Participants	76	72	70	74
Mean (95% Confidence Interval) [units on a scale]	-77.4	-70.6	-79.3	-66.4

6. Secondary Outcome

Title	Change From Baseline: Colorectal Anal Distress Inventory
Description	The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (POPDI, with 3 subscales), 2. Colorectal Anal Distress Inventory (CRADI, with 4 subscales), and 3. Urinary Distress Inventory (UDI, with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of responses for the CRADI is: 0-400 with 0 (least distress) to 400 (most distress). Change = (24 Month Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Time Frame	Baseline and 24 months

Outcome Measure Data

Analysis Population Description

This outcome is analyzed in participants randomized to both surgical and behavioral interventions who had non-missing data for this 24-month outcome. There are differences between the Number of Participants Analyzed and the 24-month numbers in the Participant Flow module because of missing data.

Arm/Group Title	SSLF+BPMT	SSLF+USUAL	ULS+BPMT	ULS+USUAL
Arm/Group Description	Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training	Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training	Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
Measure Participants	76	72	70	74
Mean (95% Confidence Interval) [units on a scale]	-48.6	-46.5	-61.4	-52.4

7. Secondary Outcome

Title	Urinary Impact Questionnaire Change From Baseline to 24 Months
Description	The Pelvic Floor Impact Questionnaire measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales: the Urinary Impact Questionnaire (UIQ; 4 subscales, range 0-400), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; 4 subscales, range 0-400), and the Colorectal-Anal Impact Questionnaire (CRAIQ; 4 subscales, range 0-400). Scores are calculated by multiplying the mean value of all answered questions for a subscale by 100 divided by 3. The subscales are then added together. The range of responses is: 0-400 with 0 (least negative impact) to 400 (most negative impact). Change = (24 Month Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Time Frame	Baseline and 24 months

Outcome Measure Data

Analysis Population Description

This outcome is analyzed in participants randomized to both surgical and behavioral interventions who had non-missing data for this 24-month outcome. There are differences between the Number of Participants Analyzed and the 24-month numbers in the Participant Flow module because of missing data.

Arm/Group Title	SSLF+BPMT	SSLF+USUAL	ULS+BPMT	ULS+USUAL
Arm/Group Description	Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training	Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training	Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
Measure Participants	76	72	70	74
Mean (95% Confidence Interval) [units on a scale]	-84	-72.6	-79	-97.6

8. Secondary Outcome

Title	Pelvic Organ Prolapse Impact Questionnaire Change From Baseline to 24 Months
Description	The Pelvic Floor Impact Questionnaire measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales: the Urinary Impact Questionnaire (UIQ; 4 subscales, range 0-400), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; 4 subscales, range 0-400), and the Colorectal-Anal Impact Questionnaire (CRAIQ; 4 subscales, range 0-400). Scores are calculated by multiplying the mean value of all answered questions for a subscale by 100 divided by 3. The subscales are then added together. The range of responses is: 0-400 with 0 (least negative impact) to 400 (most negative impact). Change = (Year 2 Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Time Frame	Baseline and 24 months

Outcome Measure Data

Analysis Population Description

This outcome is analyzed in participants randomized to both surgical and behavioral interventions who had non-missing data for this 24-month outcome. There are differences between the Number of Participants Analyzed and the 24-month numbers in the Participant Flow module because of missing data.

Arm/Group Title	SSLF+BPMT	SSLF+USUAL	ULS+BPMT	ULS+USUAL
Arm/Group Description	Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training	Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training	Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
Measure Participants	76	73	70	76
Mean (95% Confidence Interval) [units on a scale]	-67.5	-49.1	-59.4	-82.2

9. Secondary Outcome

Title	Colorectal-Anal Impact Questionnaire Change From Baseline to 24 Months
Description	The Pelvic Floor Impact Questionnaire measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales: the Urinary Impact Questionnaire (UIQ; 4 subscales, range 0-400), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; 4 subscales, range 0-400), and the Colorectal-Anal Impact Questionnaire (CRAIQ; 4 subscales, range 0-400). Scores are calculated by multiplying the mean value of all answered questions for a subscale by 100 divided by 3. The subscales are then added together. The range of responses is: 0-400 with 0 (least negative impact) to 400 (most negative impact). Change = (Year 2 Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Time Frame	Baseline and 24 months

Outcome Measure Data

Analysis Population Description

This outcome is analyzed in participants randomized to both surgical and behavioral interventions who had non-missing data for this 24-month outcome. There are differences between the Number of Participants Analyzed and the 24-month numbers in the Participant Flow module because of missing data.

Arm/Group Title	SSLF+BPMT	SSLF+USUAL	ULS+BPMT	ULS+USUAL
Arm/Group Description	Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training	Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training	Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
Measure Participants	76	73	70	76
Mean (95% Confidence Interval) [units on a scale]	-40.9	-21.6	-29.2	-42.5

10. Secondary Outcome

Title	Sexual Function 36 - Physical Health Component Score Change From Baseline to 24 Months
Description	Sexual Function 36 (SF36) - Physical Health Component Score is the physical health component of the Sexual Function 36 survey with scores ranging from 0 to 100 with higher scores meaning a better health state. Scales are scored according to the algorithm that describes the handling of the various types of questions included in the questionnaire. Several steps are involved in the scoring process: recoding items that require it; summing over items; and transforming raw scale scores to a 0 to 100 scale. This physical health component is a function of several constructs measured under the SF36: physical functioning, physical role, bodily pain, general health, and vitality.
Time Frame	Baseline and 24 months

Outcome Measure Data

Analysis Population Description

This outcome is analyzed in participants randomized to both surgical and behavioral interventions who had non-missing data for this 24-month outcome. There are differences between the Number of Participants Analyzed and the 24-month numbers in the Participant Flow module because of missing data.

Arm/Group Title	SSLF+BPMT	SSLF+USUAL	ULS+BPMT	ULS+USUAL
Arm/Group Description	Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training	Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training	Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
Measure Participants	75	71	71	75
Mean (95% Confidence Interval) [units on a scale]	7.9	4.8	4.8	6

11. Secondary Outcome

Title	Sexual Function 36 - Mental Health Component Score Change From Baseline to 24 Months
Description	Sexual Function 36 (SF36) - Mental Health Component Score is the mental health component of the Sexual Function 36 survey with scores ranging from 0 to 100 with higher scores meaning a better health state. Scales are scored according to the algorithm that describes the handling of the various types of questions included in the questionnaire. Several steps are involved in the scoring process: recoding items that require it; summing over items; and transforming raw scale scores to a 0 to 100 scale.
Time Frame	Baseline and 24 months

Outcome Measure Data

Analysis Population Description

This outcome is analyzed in participants randomized to both surgical and behavioral interventions who had non-missing data for this 24-month outcome. There are differences between the Number of Participants Analyzed and the 24-month numbers in the Participant Flow module because of missing data.

Arm/Group Title	SSLF+BPMT	SSLF+USUAL	ULS+BPMT	ULS+USUAL
Arm/Group Description	Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training	Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training	Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
Measure Participants	75	71	71	75
Mean (95% Confidence Interval) [units on a scale]	0.6	2	2.5	1.1

12. Secondary Outcome

Title	Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire Change From Baseline to 24 Months
Description	Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ) is a survey of sexual functioning with scores ranging from 0 to 48 with higher scores meaning better sexual functioning. Patients were asked to answer 31 questions about their sexuality in the past 6 months.
Time Frame	Baseline and 24 months

Outcome Measure Data

Analysis Population Description

This outcome is analyzed in participants randomized to both surgical and behavioral interventions who had non-missing data for this 24-month outcome. There are differences between the Number of Participants Analyzed and the 24-month numbers in the Participant Flow module because of missing data.

Arm/Group Title	SSLF+BPMT	SSLF+USUAL	ULS+BPMT	ULS+USUAL
Arm/Group Description	Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training	Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training	Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training	Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
Measure Participants	35	25	27	37
Mean (95% Confidence Interval) [units on a scale]	5.6	4.6	3.8	6.6

Adverse Events

Time Frame	24 Months
Arm/Group Title	ULS+BPMT		SSLF+BPMT		ULS+USUAL		SSLF+USUAL
Arm/Group Description	Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training		Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training		Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training		Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training
All Cause Mortality
	ULS+BPMT		SSLF+BPMT		ULS+USUAL		SSLF+USUAL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	ULS+BPMT		SSLF+BPMT		ULS+USUAL		SSLF+USUAL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	15/91 (16.5%)		15/95 (15.8%)		16/97 (16.5%)		16/91 (17.6%)
Cardiac disorders
Acute Myocardial Infarction	0/91 (0%)	0	0/95 (0%)	0	1/97 (1%)	1	0/91 (0%)	0
Angina pectoris	0/91 (0%)	0	0/95 (0%)	0	0/97 (0%)	0	1/91 (1.1%)	1
Angina unstable	1/91 (1.1%)	1	0/95 (0%)	0	0/97 (0%)	0	0/91 (0%)	0
Arrhythmia	0/91 (0%)	0	0/95 (0%)	0	1/97 (1%)	1	0/91 (0%)	0
Atrial fibrillation	0/91 (0%)	0	1/95 (1.1%)	1	0/97 (0%)	0	0/91 (0%)	0
Pericardial effusion	0/91 (0%)	0	0/95 (0%)	0	1/97 (1%)	2	0/91 (0%)	0
Gastrointestinal disorders
Faecaloma	1/91 (1.1%)	1	0/95 (0%)	0	0/97 (0%)	0	0/91 (0%)	0
Gastric haemorrhage	0/91 (0%)	0	0/95 (0%)	0	1/97 (1%)	1	0/91 (0%)	0
Hiatal Hernia	0/91 (0%)	0	0/95 (0%)	0	0/97 (0%)	0	1/91 (1.1%)	1
Oesophageal achalasia	0/91 (0%)	0	0/95 (0%)	0	0/97 (0%)	0	1/91 (1.1%)	1
Vomiting	1/91 (1.1%)	1	0/95 (0%)	0	0/97 (0%)	0	0/91 (0%)	0
General disorders
Chest Pain	0/91 (0%)	0	0/95 (0%)	0	1/97 (1%)	1	0/91 (0%)	0
Fever	1/91 (1.1%)	1	0/95 (0%)	0	0/97 (0%)	0	0/91 (0%)	0
Gastrointestinal haemorrhage	0/91 (0%)	0	0/95 (0%)	0	1/97 (1%)	1	0/91 (0%)	0
Suprapubic pain	0/91 (0%)	0	0/95 (0%)	0	0/97 (0%)	0	1/91 (1.1%)	1
Unable to determine Preferred Term	1/91 (1.1%)	1	1/95 (1.1%)	1	0/97 (0%)	0	0/91 (0%)	0
Hepatobiliary disorders
Biliary cholic	1/91 (1.1%)	1	0/95 (0%)	0	0/97 (0%)	0	0/91 (0%)	0
CHOLELITHIASIS	0/91 (0%)	0	0/95 (0%)	0	0/97 (0%)	0	1/91 (1.1%)	1
Cholelithiasis	0/91 (0%)	0	0/95 (0%)	0	1/97 (1%)	1	0/91 (0%)	0
Non-alcoholic steatohepatitis	0/91 (0%)	0	0/95 (0%)	0	1/97 (1%)	2	0/91 (0%)	0
Immune system disorders
Allergic Reaction	0/91 (0%)	0	0/95 (0%)	0	0/97 (0%)	0	1/91 (1.1%)	1
Infections and infestations
Cholecystitis infective	1/91 (1.1%)	1	0/95 (0%)	0	0/97 (0%)	0	0/91 (0%)	0
DIVERTICULITIS	1/91 (1.1%)	1	0/95 (0%)	0	1/97 (1%)	2	0/91 (0%)	0
Pelvic abscess	0/91 (0%)	0	1/95 (1.1%)	1	0/97 (0%)	0	0/91 (0%)	0
Pneumonia	1/91 (1.1%)	1	0/95 (0%)	0	1/97 (1%)	1	0/91 (0%)	0
Pyelonephritis	0/91 (0%)	0	1/95 (1.1%)	1	0/97 (0%)	0	1/91 (1.1%)	1
Unable to determine Preferred Term	0/91 (0%)	0	0/95 (0%)	0	0/97 (0%)	0	1/91 (1.1%)	1
Urinary Tract Infection	0/91 (0%)	0	0/95 (0%)	0	0/97 (0%)	0	1/91 (1.1%)	1
Vaginal Abscess	0/91 (0%)	0	0/95 (0%)	0	0/97 (0%)	0	1/91 (1.1%)	1
Injury, poisoning and procedural complications
Anaemia postoperative	0/91 (0%)	0	0/95 (0%)	0	0/97 (0%)	0	1/91 (1.1%)	1
Bladder injury	0/91 (0%)	0	0/95 (0%)	0	1/97 (1%)	1	0/91 (0%)	0
Fall	0/91 (0%)	0	0/95 (0%)	0	0/97 (0%)	0	1/91 (1.1%)	1
Foot fracture	0/91 (0%)	0	0/95 (0%)	0	0/97 (0%)	0	1/91 (1.1%)	1
Procedural haemorrhage	0/91 (0%)	0	0/95 (0%)	0	1/97 (1%)	1	0/91 (0%)	0
Procedural pain	0/91 (0%)	0	0/95 (0%)	0	0/97 (0%)	0	1/91 (1.1%)	1
Investigations
Oxygen saturation decreased	0/91 (0%)	0	0/95 (0%)	0	0/97 (0%)	0	1/91 (1.1%)	1
PO2 decreased	0/91 (0%)	0	0/95 (0%)	0	0/97 (0%)	0	1/91 (1.1%)	1
Metabolism and nutrition disorders
Hypovolaemia	0/91 (0%)	0	0/95 (0%)	0	1/97 (1%)	2	0/91 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	0/91 (0%)	0	0/95 (0%)	0	1/97 (1%)	1	0/91 (0%)	0
Lumbar spinal stenosis	0/91 (0%)	0	0/95 (0%)	0	0/97 (0%)	0	1/91 (1.1%)	1
Musculoskeletal Pain	0/91 (0%)	0	0/95 (0%)	0	0/97 (0%)	0	1/91 (1.1%)	1
Osteoarthritis	0/91 (0%)	0	1/95 (1.1%)	3	0/97 (0%)	0	0/91 (0%)	0
Pain in Leg	0/91 (0%)	0	0/95 (0%)	0	0/97 (0%)	0	1/91 (1.1%)	1
Pathological fracture	0/91 (0%)	0	0/95 (0%)	0	0/97 (0%)	0	1/91 (1.1%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer	1/91 (1.1%)	1	0/95 (0%)	0	0/97 (0%)	0	0/91 (0%)	0
Endometrial cancer stage II	1/91 (1.1%)	2	0/95 (0%)	0	0/97 (0%)	0	0/91 (0%)	0
Transitonal cell carcinoma	1/91 (1.1%)	1	0/95 (0%)	0	0/97 (0%)	0	0/91 (0%)	0
Nervous system disorders
Facial paralysis	0/91 (0%)	0	1/95 (1.1%)	1	0/97 (0%)	0	0/91 (0%)	0
Pudenal canal syndrome	0/91 (0%)	0	1/95 (1.1%)	1	0/97 (0%)	0	0/91 (0%)	0
Sciatic nerve neuropathy	0/91 (0%)	0	1/95 (1.1%)	1	0/97 (0%)	0	0/91 (0%)	0
Syncope	0/91 (0%)	0	1/95 (1.1%)	1	0/97 (0%)	0	0/91 (0%)	0
Psychiatric disorders
Completed suicide	1/91 (1.1%)	1	0/95 (0%)	0	0/97 (0%)	0	0/91 (0%)	0
Depression Suicidal	0/91 (0%)	0	0/95 (0%)	0	1/97 (1%)	1	0/91 (0%)	0
Mental status changes	0/91 (0%)	0	1/95 (1.1%)	1	0/97 (0%)	0	0/91 (0%)	0
Renal and urinary disorders
Hydronephrosis	1/91 (1.1%)	1	1/95 (1.1%)	1	0/97 (0%)	0	0/91 (0%)	0
Renal failure	0/91 (0%)	0	1/95 (1.1%)	1	0/97 (0%)	0	0/91 (0%)	0
Reproductive system and breast disorders
Breast enlargement	0/91 (0%)	0	0/95 (0%)	0	0/97 (0%)	0	1/91 (1.1%)	1
Haemorrhage	0/91 (0%)	0	0/95 (0%)	0	0/97 (0%)	0	1/91 (1.1%)	1
Ovarian cyst	0/91 (0%)	0	0/95 (0%)	0	1/97 (1%)	1	0/91 (0%)	0
Ovarian vein thrombosis	0/91 (0%)	0	0/95 (0%)	0	0/97 (0%)	0	1/91 (1.1%)	2
Pelvic prolapse	1/91 (1.1%)	1	0/95 (0%)	0	0/97 (0%)	0	0/91 (0%)	0
Vaginal haemorrhage	0/91 (0%)	0	0/95 (0%)	0	1/97 (1%)	1	0/91 (0%)	0
Vulvovaginal Pain	0/91 (0%)	0	0/95 (0%)	0	0/97 (0%)	0	1/91 (1.1%)	2
Respiratory, thoracic and mediastinal disorders
Asthma	0/91 (0%)	0	1/95 (1.1%)	1	0/97 (0%)	0	0/91 (0%)	0
Pulmonary embolism	1/91 (1.1%)	1	1/95 (1.1%)	1	0/97 (0%)	0	0/91 (0%)	0
Surgical and medical procedures
Hiatus hernia	0/91 (0%)	0	1/95 (1.1%)	1	0/97 (0%)	0	0/91 (0%)	0
Knee arthroplasty	0/91 (0%)	0	0/95 (0%)	0	1/97 (1%)	3	0/91 (0%)	0
Nephrectomy	0/91 (0%)	0	1/95 (1.1%)	1	0/97 (0%)	0	0/91 (0%)	0
Prolapse repair	0/91 (0%)	0	1/95 (1.1%)	1	0/97 (0%)	0	0/91 (0%)	0
Other (Not Including Serious) Adverse Events
	ULS+BPMT		SSLF+BPMT		ULS+USUAL		SSLF+USUAL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	62/91 (68.1%)		69/95 (72.6%)		73/97 (75.3%)		62/91 (68.1%)
General disorders
OTHER ADVERSE EVENTS	19/91 (20.9%)	19	21/95 (22.1%)	21	22/97 (22.7%)	22	25/91 (27.5%)	25
MESH EROSION/EXPOSURE AT 4 WEEKS TO 24 MONTHS	2/91 (2.2%)	2	1/95 (1.1%)	1	1/97 (1%)	1	0/91 (0%)	0
SUTURE EXPOSURE AT 6 TO 24 MONTHS	10/91 (11%)	10	18/95 (18.9%)	18	19/97 (19.6%)	19	14/91 (15.4%)	14
Injury, poisoning and procedural complications
BLADDER INJURY	11/91 (12.1%)	11	10/95 (10.5%)	10	11/97 (11.3%)	11	8/91 (8.8%)	8
BLOOD TRANSFUSION	2/91 (2.2%)	2	1/95 (1.1%)	1	5/97 (5.2%)	5	3/91 (3.3%)	3
INTRAOPERTIVE URETERAL INJURY	2/91 (2.2%)	2	0/95 (0%)	0	4/97 (4.1%)	4	0/91 (0%)	0
RECTAL INJURY	0/91 (0%)	0	0/95 (0%)	0	0/97 (0%)	0	1/91 (1.1%)	1
TREATMENT - STENT PLACEMENT	0/91 (0%)	0	0/95 (0%)	0	1/97 (1%)	1	0/91 (0%)	0
TREATMENT - SUTURE REMOVED INTRAOPERATIVELY	2/91 (2.2%)	2	0/95 (0%)	0	3/97 (3.1%)	3	0/91 (0%)	0
URETERAL INJURY - DELAYED RECOGNITION	1/91 (1.1%)	1	0/95 (0%)	0	0/97 (0%)	0	0/91 (0%)	0
Nervous system disorders
NEUROLOGIC PAIN REQUIRING TREATMENT	8/91 (8.8%)	8	12/95 (12.6%)	12	5/97 (5.2%)	5	11/91 (12.1%)	11
Skin and subcutaneous tissue disorders
VAGINAL GRANULATION TISSUE AT 6 TO 24 MONTHS	20/91 (22%)	20	17/95 (17.9%)	17	16/97 (16.5%)	16	9/91 (9.9%)	9

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.