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

Not Applicable

Recruiting

• Conditions: Stress Urinary Incontinence; Pelvic Floor Disorders
• Interventions: Device: SIS; Device: RP Sling

• Registration Number: NCT04586166
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-10-07
• Study First Submitted QC: 2020-10-13
• Study First Posted: 2020-10-14
• Study Start: 2020-12-23
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-29
• Primary Completion: 2031-12
• Study Completion: 2032-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 180

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SIS Group	SIS	Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure
RP Sling Group	RP Sling	Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure

Primary Outcome Measures

Name	Time	Method
Number of participants with subjectively bothersome stress incontinence	5 years after surgery	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

Secondary Outcome Measures

Name	Time	Method
Pelvic Organ Prolapse/Urinary Incontinence Sexual Functioning Short Form (PISQ-IR)	Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5	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.
Pelvic Floor Impact (PFIQ-SF7)	Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5	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
Assessment of post-void residual (PVR) volume	Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5	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
Number of Participants needing Retreatment	6 month up to 5 year post-surgery	Surgical intervention for urinary retention (sling lysis) at any time point after surgery
Number of Participants needing bladder drainage	beyond 6 weeks post-surgery	Requirement of urinary catheter due to incontinence or retention
VAS (Visual Analogue Scale Surgeon ease of Use)	Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5	This will be assessed using the numeric rating scale (NRS). The score is 0-10, with higher scores denoting a greater degree of satisfaction.
Patient Global Impression of Improvement (PGI-I)	Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5	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
Pelvic Floor Distress Inventory (PFDI-SF20)	Baseline, Surgery, Post Op: week 2, week 6, year 1, year 2, year 3, and year 5	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.

Trial Locations

Locations (7)

Florida Robotic and Minimally Invasive Urogynecology; 🇺🇸 Coconut Creek, Florida, United States

Augusta University; 🇺🇸 Augusta, Georgia, United States

Northwestern Medicine; 🇺🇸 Chicago, Illinois, United States

Boston Urogynecology Associates; 🇺🇸 Cambridge, Massachusetts, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Wake Forest Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States

Pelvic Floor Foundation of South Africa, University of Cape Town; 🇿🇦 Cape Town, South Africa