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ACTIVE NOT RECRUITING NA

INTIBIA Pivotal Study

NCT05250908 · View on ClinicalTrials.gov ↗

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).

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

7 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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 208 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Coloplast A/S, which has 7 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05250908 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Pennsylvania, California, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05250908?

The interventions under investigation include: INTIBIA Therapeutic (DEVICE), INTIBIA Non-Therapeutic (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05250908?

This trial is sponsored by Coloplast A/S, which has 7 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial