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NCT03520114 · ClinicalTrials.gov registry record · NA
Retropubic vs. Single-Incision Mid-Urethral Sling for Stress Urinary Incontinence
A NA study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- NA
- Development phase
- 280
- Enrollment target
NCT03520114: Completed NA study, sponsored by Wake Forest University Health Sciences.
NCT03520114 is a NA study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 280 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03520114, a NA study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- NA
- Development phase
- 280 participants
- Enrollment target
Study Summary
One in five women will undergo prolapse surgery in their lifetime, and there is a strong correlation between prolapse and urinary incontinence. Pelvic floor surgeons aspire to improve relevant quality of life outcomes for women with pelvic floor disorders while minimizing complications and unnecessary procedures. There has been an experience of disappointment and frustration when a patient returns following POP repair with new symptoms of Stress Urinary Incontinence (SUI) that she ranks as a greater disruption to her quality of life than her original vaginal bulge. While retropubic (RP) slings are considered to be the "gold-standard" referent for other slings with long-term outcomes data, they are associated with the highest risks of intra- and post-operative complications including bladder injury, bleeding, and post-operative voiding dysfunction. Single-incision slings (SIS) are the latest iteration in sling development that build upon the benefits of slings but avoid passage through the muscles of the inner thigh. The hypothesis for this study is that single-incision slings (Altis) are non-inferior to Retropubic mid-urethral slings when placed at the time of native tissue vaginal repair.
Primary Outcome
Dichotomous outcome (Yes/No), 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
Interventions
- DEVICE RP sling placement
- DEVICE SIS placement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 280 participants |
| Start Date | 2018-12-12 |
| Est. Completion | 2024-01-02 |
| Phase | NA |
What the finished NCT03520114 record still lists
NCT03520114 is an interventional study that assigns participants to a tested intervention. The registered 280 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which RP sling placement is the first listed.
NCT03520114 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03520114 about?
NCT03520114 is a clinical study titled "Retropubic vs. Single-Incision Mid-Urethral Sling for Stress Urinary Incontinence". One in five women will undergo prolapse surgery in their lifetime, and there is a strong correlation between prolapse and urinary incontinence. Pelvic floor surgeons aspire to improve relevant quality of life outcomes for women with pelvic floor disorders while minimizing complications and unnecessa...
What is the current status of trial NCT03520114?
This trial is currently completed. It is a NA study. The enrollment target is 280 participants. The study started on 2018-12-12. Estimated completion is 2024-01-02.
What interventions are being tested in trial NCT03520114?
The interventions under investigation include: RP sling placement (DEVICE), SIS placement (DEVICE).
Who is sponsoring clinical trial NCT03520114?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03520114's enrollment target sits among peer trials
280 380th of 2000 higher than 1,620 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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