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NCT05250908 · ClinicalTrials.gov registry record · NA
INTIBIA Pivotal Study
A NA study of Lower Urinary Tract Symptoms and Urologic Diseases, sponsored by Coloplast A/S.
- Active
- Registry status
- NA
- Development phase
- 208
- Enrollment target
- 20
- Study locations
NCT05250908: Active NA study of Lower Urinary Tract Symptoms and Urologic Diseases, sponsored by Coloplast A/S.
NCT05250908 is a NA study of Lower Urinary Tract Symptoms and Urologic Diseases that is active but no longer recruiting, run by Coloplast A/S. The registered enrollment target is 208 participants, below the 741-participant average among 21 other Lower Urinary Tract Symptoms trials with a reported enrollment target (72% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05250908, a NA study of Lower Urinary Tract Symptoms and Urologic Diseases, is active but no longer recruiting, sponsored by Coloplast A/S.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 208 participants
- Enrollment target
- 20
- Study locations
Study Summary
Prospective, randomized, double-blind, multicenter study to evaluate the safety and efficacy of an implantable tibial nerve stimulator in subjects with urgency urinary incontinence (UUI).
Primary Outcome
≥50% reduction in UUI episodes between INTIBIA therapeutic and INTIBIA non-therapeutic
Conditions Studied
Interventions
- DEVICE INTIBIA Therapeutic
- DEVICE INTIBIA Non-Therapeutic
Study Locations (20)
Pennsylvania
- The Institute for Female Pelvic Medicine and Reconstructive Surgery- Axia Womens Health - Allentown
- MidLantic Urology - Bala-Cynwyd
- The Female Pelvic Health Center - Newtown
- Thomas Jefferson University - Philadelphia
California
- Cedars-Sinai Medical Group - Beverly Hills
- Urology Group of Southern California - Los Angeles
Michigan
- University of Michigan - Ann Arbor
- Advanced Urogynecology of Michigan - Dearborn
Ohio
- The Urology Group - Cincinnati
- MetroHealth System - Cleveland
District of Columbia
- MedStar Washington Hospital Center - Washington D.C.
Florida
- Advanced Urology Associates - Daytona Beach
Georgia
- Southeastern Urogynecology & Pelvic Surgery - Moultrie
Idaho
- Rosemark WomenCare Specialists - Idaho Falls
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 208 participants |
| Start Date | 2022-03-07 |
| Est. Completion | 2026-06-27 |
| Phase | NA |
What the registry record for NCT05250908 still lists
NCT05250908 is an interventional study that assigns participants to a tested intervention. The registered 208 participants enrollment target is mid-sized for trials with a published cap, below the 741-participant average among 21 other Lower Urinary Tract Symptoms trials with a reported enrollment target (72% lower).
The record links to 6 conditions, with Lower Urinary Tract Symptoms appearing as the primary indexed condition, and to 2 interventions - of which INTIBIA Therapeutic is the first listed.
NCT05250908 names 20 study sites across 14 states, led by Pennsylvania, California, Michigan.
Frequently Asked Questions
What is clinical trial NCT05250908 about?
NCT05250908 is a clinical study titled "INTIBIA Pivotal Study". Prospective, randomized, double-blind, multicenter study to evaluate the safety and efficacy of an implantable tibial nerve stimulator in subjects with urgency urinary incontinence (UUI).
What is the current status of trial NCT05250908?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 208 participants. The study started on 2022-03-07. Estimated completion is 2026-06-27.
What conditions does trial NCT05250908 study?
This clinical trial studies the following conditions: Lower Urinary Tract Symptoms, Urologic Diseases, Urinary Incontinence, Urge, Urinary Bladder, Overactive, Urinary Bladder Diseases.
What interventions are being tested in trial NCT05250908?
The interventions under investigation include: INTIBIA Therapeutic (DEVICE), INTIBIA Non-Therapeutic (DEVICE).
Who is sponsoring clinical trial NCT05250908?
This trial is sponsored by Coloplast A/S, which has 21 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05250908 being conducted?
This trial has 20 study locations across California, District of Columbia, Florida, Georgia, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05250908's enrollment target sits among peer trials
208 7th of 21 higher than 15 of 21 other Lower Urinary Tract Symptoms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lower Urinary Tract Symptoms 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.
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