Single-incision Versus Retropubic Mid-Urethral Sling (Solyx) for SUI During Minimally Invasive Sacrocolpopexy

Study Overview
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Brief Summary
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SASS (Single-incision Versus Retropubic Mid-Urethral Sling (Solyx) for SUI During Minimally Invasive Sacrocolpopexy) will be a multicenter, prospective, randomized, single-blind non-inferiority trial.

Detailed Description
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SASS aims to compare the efficacy of a single-incision (SIS) versus a retropubic mid-urethral sling (RP) placed at the time of minimally invasive sacrocolpopexy in women with pelvic organ prolapse and objectively confirmed stress urinary incontinence (SUI).

Official Title
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SASS: Randomized Trial of Single-incision Versus Retropubic Mid-Urethral Sling (Solyx) for Concomitant Management of Stress Urinary Incontinence During Minimally Invasive Sacrocolpopexy

Conditions
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Stress Urinary Incontinence, Pelvic Floor Disorders

Intervention / Treatment
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* Device: RP Sling
* Device: SIS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 21 years of age Vaginal bulge symptoms as indicated by an affirmative response of >1 to question 3 of the PFDI-SF20 POP ≥ stage II according to the pelvic organ prolapse quantification (POP-Q) system45, with evidence of apical descent Women being considered for minimally invasive sacrocolpopexy (with or without concomitant hysterectomy) Objective SUI: positive standardized cough stress test on clinical examination or on urodynamic study with reduced prolapse Understanding and acceptance of the need to return for all scheduled follow-up visits and willing to complete study questionnaires Able to give informed consent Exclusion Criteria: Prior surgery for stress urinary incontinence including mid-urethral sling; Burch/MMK; fascial pubovaginal sling (autologous, xenograft or allograft); and urethral bulking injection Any serious disease, or chronic condition, that could interfere with the study compliance Unwilling to have a synthetic sling Untreated and unresolved urinary tract infection Poorly-controlled diabetes mellitus (HgbA1c > 9 within 3 months of surgery date) Neurogenic bladder/ pre-operative self-catheterization Elevated post-void residual/PVR (>150 ml) that does not resolve with prolapse reduction testing (pessary, prolapse reduced uroflow or micturition study) Prior pelvic radiation Inflammatory bowel disease Current genitourinary fistula or urethral diverticulum Planned concomitant bowel related surgery including sphincteroplasty and perineal rectal prolapse surgery, rectovaginal fistula repair, hemorrhoidectomy Pregnant or Planning to Conceive Incarcerated

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RP Sling Group<br>Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure | Device: RP Sling<br>* Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure.<br>* Other names: Advantage RP Sling;|
| Experimental: SIS Group<br>Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure | Device: SIS<br>* Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure.<br>* Other names: Solyx SIS System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with subjectively bothersome stress incontinence | Measured by a positive response of > 1 to Question 17 on Pelvic Floor Distress Inventory short form-20 (PFDI-20). Response scale from 0 to 4. Symptoms Not Present = NO 0 = not present Symptoms Present = YES, scale of bother: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = quite a bit | 6 weeks after surgery | 
| Number of participants with subjectively bothersome stress incontinence | Measured by a positive response of > 1 to Question 17 on Pelvic Floor Distress Inventory short form-20 (PFDI-20). Response scale from 0 to 4. Symptoms Not Present = NO 0 = not present Symptoms Present = YES, scale of bother: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = quite a bit | 1 year after surgery | 
| Number of participants with subjectively bothersome stress incontinence | Measured by a positive response of > 1 to Question 17 on Pelvic Floor Distress Inventory short form-20 (PFDI-20). Response scale from 0 to 4. Symptoms Not Present = NO 0 = not present Symptoms Present = YES, scale of bother: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = quite a bit | 3 years after surgery | 
| Number of participants with subjectively bothersome stress incontinence | Measured by a positive response of > 1 to Question 17 on Pelvic Floor Distress Inventory short form-20 (PFDI-20). Response scale from 0 to 4. Symptoms Not Present = NO 0 = not present Symptoms Present = YES, scale of bother: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = quite a bit | 5 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS (Visual Analogue Scale Surgeon ease of Use) | This will be assessed using the numeric rating scale (NRS). The score is 0-10, with higher scores denoting a greater degree of satisfaction. | Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5 | 
| Pelvic Organ Prolapse/Urinary Incontinence Sexual Functioning Short Form (PISQ-IR) | Questionnaire consists of 20 questions regarding sexual functioning. PISQ-IR consists of two parts. Part 1, for not Sexually Active (NSA) women, and par 2 for SA women. Response value varies from 1 to 5. Part 1, for not SA (NSA) women, where higher scores indicate a greater impact of the condition on sexual inactivity. Part 2, for SA women, with higher scores indicating better sexual function. | Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5 | 
| Pelvic Floor Impact (PFIQ-SF7) | Consists of 3 scales with each 7 questions and will be used to assess quality of life regarding pelvic floor related quality of life. The total score is the sum of the three scale score with a range of 0-300. Higher values indicate a greater degree of bother | Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5 | 
| Patient Global Impression of Improvement (PGI-I) | 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative baseline - lower scores denote improvement - 1= Very much better to 7 = Very much worse | Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5 | 
| Assessment of post-void residual (PVR) volume | Post Void Residual/PVR measurement - (collected via bladder scan or CIC) (Clean Intermittent Catheterization). PVR can be as minimum as 0ml of an average bladder capacity of 400ml | Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5 | 
| Number of Participants needing Retreatment | Surgical intervention for urinary retention (sling lysis) at any time point after surgery | 6 month up to 5 year post-surgery | 
| Number of Participants needing bladder drainage | Requirement of urinary catheter due to incontinence or retention | beyond 6 weeks post-surgery | 
| Pelvic Floor Distress Inventory (PFDI-SF20) | The PFDI-20 has a total of 20 questions and 3 scales (Urinary Distress Inventory, Pelvic Organ Prolapse Distress Inventory, and Colorectal-Anal Distress Inventory). The outcomes of this questionnaire will be evaluated stratified by compartment. Each item produces a response of 0 to 4, the average response in each scale is multiplied by 25 to obtain the scale score (range 0 to 100). The total score is the sum of the three scale score with a range of 0-300. Higher values indicate a greater degree of bother. | Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Retropubic Sling, Single-Incision Sling, Sacrocolpopexy