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NCT04586166 · ClinicalTrials.gov registry record · NA
Single-incision Versus Retropubic Mid-Urethral Sling (Solyx) for SUI During Minimally Invasive Sacrocolpopexy
A NA study of Stress Urinary Incontinence and Pelvic Floor Disorders, sponsored by Wake Forest University Health Sciences.
- Recruiting
- Registry status
- NA
- Development phase
- 180
- Enrollment target
- 7
- Study locations
NCT04586166: Recruiting NA study of Stress Urinary Incontinence and Pelvic Floor Disorders, sponsored by Wake Forest University Health Sciences.
NCT04586166 is a NA study of Stress Urinary Incontinence and Pelvic Floor Disorders that is actively recruiting participants, run by Wake Forest University Health Sciences. The registered enrollment target is 180 participants, above the 158-participant average among 35 other Stress Urinary Incontinence trials with a reported enrollment target (14% higher). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04586166, a NA study of Stress Urinary Incontinence and Pelvic Floor Disorders, is actively recruiting participants, sponsored by Wake Forest University Health Sciences.
- RECRUITING
- Registry status
- NA
- Development phase
- 180 participants
- Enrollment target
- 7
- Study locations
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- DEVICE RP Sling
- DEVICE SIS
Study Locations (7)
Illinois
- Northwestern Medicine - Chicago
- University of Chicago - Chicago
Florida
- Florida Robotic and Minimally Invasive Urogynecology - Coconut Creek
Georgia
- Augusta University - Augusta
Massachusetts
- Boston Urogynecology Associates - Cambridge
North Carolina
- Wake Forest Baptist Medical Center - Winston-Salem
Other
- Pelvic Floor Foundation of South Africa, University of Cape Town - Cape Town
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2020-12-23 |
| Est. Completion | 2032-12 |
| Phase | NA |
What NCT04586166 shows while recruiting
NCT04586166 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, above the 158-participant average among 35 other Stress Urinary Incontinence trials with a reported enrollment target (14% higher).
The record links to 2 conditions, with Stress Urinary Incontinence appearing as the primary indexed condition, and to 2 interventions - of which RP Sling is the first listed.
NCT04586166 lists 7 locations in 6 states (Illinois, Florida, Georgia).
Frequently Asked Questions
What is clinical trial NCT04586166 about?
NCT04586166 is a clinical study titled "Single-incision Versus Retropubic Mid-Urethral Sling (Solyx) for SUI During Minimally Invasive Sacrocolpopexy". 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.
What is the current status of trial NCT04586166?
This trial is currently recruiting. It is a NA study. The enrollment target is 180 participants. The study started on 2020-12-23. Estimated completion is 2032-12.
What conditions does trial NCT04586166 study?
This clinical trial studies the following conditions: Stress Urinary Incontinence, Pelvic Floor Disorders.
What interventions are being tested in trial NCT04586166?
The interventions under investigation include: RP Sling (DEVICE), SIS (DEVICE).
Who is sponsoring clinical trial NCT04586166?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04586166 being conducted?
This trial has 7 study locations across Florida, Georgia, Illinois, Massachusetts, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stress Urinary Incontinence
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04586166's enrollment target sits among peer trials
180 9th of 35 higher than 27 of 35 other Stress Urinary Incontinence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stress Urinary Incontinence trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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BELIEVE Trial: Bulking vErsus sLing for Treating Stress Urinary IncontinEnce at the Time of Vaginal prolapsE Repair (BELIEVE)
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