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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 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.

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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).

Conditions Studied

Lower Urinary Tract Symptoms Urologic Diseases Urinary Incontinence, Urge Urinary Bladder, Overactive Urinary Bladder Diseases Urological Manifestations

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

FieldValue
Enrollment Target 208 participants
Start Date 2022-03-07
Est. Completion 2026-06-27
Phase NA

Sponsor

Coloplast A/S

21 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05250908

The ClinicalTrials.gov registry entry for NCT05250908 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 208 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 741-participant average among 21 other Lower Urinary Tract Symptoms trials with a reported enrollment target (72% lower). The listed sponsor is Coloplast A/S, which has 21 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.