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NCT03767595 · ClinicalTrials.gov registry record · NA
ProACT Post-Approval Study
A NA study of Stress Urinary Incontinence, sponsored by Uromedica.
- Recruiting
- Registry status
- NA
- Development phase
- 145
- Enrollment target
- 6
- Study locations
NCT03767595: Recruiting NA study of Stress Urinary Incontinence, sponsored by Uromedica.
NCT03767595 is a NA study of Stress Urinary Incontinence that is actively recruiting participants, run by Uromedica. The registered enrollment target is 145 participants, roughly in line with the 159-participant average among 35 other Stress Urinary Incontinence trials with a reported enrollment target. The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03767595, a NA study of Stress Urinary Incontinence, is actively recruiting participants, sponsored by Uromedica.
- RECRUITING
- Registry status
- NA
- Development phase
- 145 participants
- Enrollment target
- 6
- Study locations
Study Summary
The ProACT Post Approval Study is a 5-year prospective, open-label, multi-center study designed to evaluate the long-term incidence of urethral stricture and device erosion after ProACT implantation. In addition, the study will evaluate whether treatment with ProACT affects clinical outcomes after subsequent SUI therapies.
Primary Outcome
Cumulative incidence of ProACT-related clinically relevant urethral strictures over 5 years of follow up.
Conditions Studied
Interventions
- DEVICE ProACT Adjustable Continence Therapy for Men
Study Locations (6)
Colorado
- University of Colorado - Denver
Florida
- University of Florida - Gainesville
Georgia
- Emory University - Atlanta
Kansas
- University of Kansas Medical Center - Kansas City
Michigan
- University of Michigan - Ann Arbor
Minnesota
- CentraCare- St. Cloud - Saint Cloud
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 145 participants |
| Start Date | 2019-02-19 |
| Est. Completion | 2030-09-01 |
| Phase | NA |
What NCT03767595 shows while recruiting
NCT03767595 is an interventional study that assigns participants to a tested intervention. The registered 145 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 159-participant average among 35 other Stress Urinary Incontinence trials with a reported enrollment target.
The record links to 1 condition, with Stress Urinary Incontinence appearing as the primary indexed condition, and to 1 intervention - of which ProACT Adjustable Continence Therapy for Men is the first listed.
NCT03767595 lists 6 locations in 6 states (Colorado, Florida, Georgia).
Frequently Asked Questions
What is clinical trial NCT03767595 about?
NCT03767595 is a clinical study titled "ProACT Post-Approval Study". The ProACT Post Approval Study is a 5-year prospective, open-label, multi-center study designed to evaluate the long-term incidence of urethral stricture and device erosion after ProACT implantation. In addition, the study will evaluate whether treatment with ProACT affects clinical outcomes after s...
What is the current status of trial NCT03767595?
This trial is currently recruiting. It is a NA study. The enrollment target is 145 participants. The study started on 2019-02-19. Estimated completion is 2030-09-01.
What conditions does trial NCT03767595 study?
This clinical trial studies the following conditions: Stress Urinary Incontinence.
What interventions are being tested in trial NCT03767595?
The interventions under investigation include: ProACT Adjustable Continence Therapy for Men (DEVICE).
Who is sponsoring clinical trial NCT03767595?
This trial is sponsored by Uromedica, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03767595 being conducted?
This trial has 6 study locations across Colorado, Florida, Georgia, Kansas, Michigan. 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 NCT03767595's enrollment target sits among peer trials
145 12th of 35 higher than 24 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
-
Trial of Transurethral Bulking Agent Injection Versus Single-Incision Sling for Stress Urinary Incontinence
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