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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 is a NA study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 280 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03520114
The ClinicalTrials.gov registry entry for NCT03520114 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 280 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which RP sling placement is the first listed.
NCT03520114 reports 0 study locations.
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.
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