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NCT06754046 · ClinicalTrials.gov registry record · NA
BELIEVE Trial: Bulking vErsus sLing for Treating Stress Urinary IncontinEnce at the Time of Vaginal prolapsE Repair (BELIEVE)
A NA study of Stress Urinary Incontinence and Vaginal Prolapse, sponsored by University Hospitals Cleveland Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 476
- Enrollment target
- 1
- Study location
NCT06754046 is a NA study of Stress Urinary Incontinence and Vaginal Prolapse that is actively recruiting participants, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 476 participants, above the 149-participant average among 35 other Stress Urinary Incontinence trials with a reported enrollment target (219% higher). The trial reports 1 study location across 1 state.
The verdict
NCT06754046, a NA study of Stress Urinary Incontinence and Vaginal Prolapse, is actively recruiting participants, sponsored by University Hospitals Cleveland Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 476 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to learn if retropubic midurethral sling (RP-MUS) or bulkamide injection (PAHG) at the time of pelvic organ prolapse repair is better from the patient's perspective. The main questions it aims to answer are: What is the average difference in the urogenital distress inventory (UDI) long form score 24 months after surgery for each procedure? Which procedure has the fewest complications and lowest short- and long-term morbidity profile? Participants will: Be blinded and randomized to one of two procedures for the duration of the study, 24 months. Complete 6 total visits for the clinical trial including validated questionnaires. Few participants will be selected to complete a qualitative interview at 3 timepoints over 24 month duration of the study.
Conditions Studied
Interventions
- DEVICE RP-MUS
- PROCEDURE PAHG
Study Locations (1)
Ohio
- University Hospitals Cleveland Medical Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 476 participants |
| Start Date | 2025-05-01 |
| Est. Completion | 2029-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06754046
The ClinicalTrials.gov registry entry for NCT06754046 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 476 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 149-participant average among 35 other Stress Urinary Incontinence trials with a reported enrollment target (219% higher). The listed sponsor is University Hospitals Cleveland Medical Center, which has 230 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Stress Urinary Incontinence appearing as the primary indexed condition, and to 2 interventions - of which RP-MUS is the first listed.
NCT06754046 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT06754046 about?
NCT06754046 is a clinical study titled "BELIEVE Trial: Bulking vErsus sLing for Treating Stress Urinary IncontinEnce at the Time of Vaginal prolapsE Repair (BELIEVE)". The goal of this clinical trial is to learn if retropubic midurethral sling (RP-MUS) or bulkamide injection (PAHG) at the time of pelvic organ prolapse repair is better from the patient's perspective. The main questions it aims to answer are: What is the average difference in the urogenital distres...
What is the current status of trial NCT06754046?
This trial is currently recruiting. It is a NA study. The enrollment target is 476 participants. The study started on 2025-05-01. Estimated completion is 2029-04.
What conditions does trial NCT06754046 study?
This clinical trial studies the following conditions: Stress Urinary Incontinence, Vaginal Prolapse.
What interventions are being tested in trial NCT06754046?
The interventions under investigation include: RP-MUS (DEVICE), PAHG (PROCEDURE).
Who is sponsoring clinical trial NCT06754046?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06754046 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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