NCT05250908 is a NA clinical trial of INTIBIA Therapeutic in Urinary Incontinence, Urge, sponsored by Coloplast A/S.

Who is sponsoring NCT05250908?

NCT05250908 is sponsored by Coloplast A/S.

What drugs are being tested in NCT05250908?

Interventions in NCT05250908: INTIBIA Therapeutic, INTIBIA Non-Therapeutic.

What condition does NCT05250908 study?

NCT05250908 studies Urinary Incontinence, Urge, Urinary Bladder, Overactive, Urinary Bladder Diseases, Urologic Diseases, Lower Urinary Tract Symptoms, Urological Manifestations.

Is NCT05250908 still recruiting?

NCT05250908 is currently active, enrolled. Last updated 2 March 2026.

Last reviewed 2026-03-02 · How we verify

NCT05250908

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

INTIBIA Pivotal Study

Active, enrolled NA Last updated 2 March 2026

What this trial tests

NA trial testing INTIBIA Therapeutic in Urinary Incontinence, Urge in 208 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

7 March 2022

Primary endpoint
12 May 2025

27 June 2026

Quick facts

Lead sponsor	Coloplast A/S
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	208
Start date	7 March 2022
Primary completion	12 May 2025
Estimated completion	27 June 2026
Sites	22 locations across Netherlands, United States

Drugs / interventions tested

INTIBIA Therapeutic
INTIBIA Non-Therapeutic

Conditions studied

Urinary Incontinence, Urge — all drugs for Urinary Incontinence, Urge →
Urinary Bladder, Overactive — all drugs for Urinary Bladder, Overactive →
Urinary Bladder Diseases — all drugs for Urinary Bladder Diseases →
Urologic Diseases — all drugs for Urologic Diseases →

Sponsor

Coloplast A/S — full company profile →

Who can join

Adults 22 to 80, any sex, with Urinary Incontinence, Urge or Urinary Bladder, Overactive. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Rationale and design of an implant procedure and pivotal study to evaluate safety and effectiveness of Medtronic's tibial neuromodulation device.
Lee UJ, Xavier K, Benson K, Burgess K, et al · · 2023 · cited 3× · PMID 37691849 · DOI 10.1016/j.conctc.2023.101198
Emerging Implantable Tibial Nerve Stimulation Devices for Overactive Bladder.
Nyan TH, Park E. · · 2025 · PMID 41077787 · DOI 10.5213/inj.2550162.081

Verify or expand the search:

Other recruiting trials for Urinary Incontinence, Urge

Currently open trials in the same condition.

NCT06201013 — Vitamin D Treat-to-Target Strategy for Children With Overactive Bladder-Wet · NA · recruiting
NCT06754189 — Safety and Performance of UCon Patch Electrode · NA · recruiting
NCT06091566 — Safety and Performance of UCon Bar Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD) · NA · recruiting
NCT05874375 — UCon Treatment of Overactive Bladder (OAB) in Males · NA · recruiting
NCT05362292 — TReating Incontinence for Underlying Mental and Physical Health · Phase 4 · recruiting

Other Coloplast A/S trials

Trials by the same sponsor.

NCT07475468 — CP382 - Intermittent Catheter (IC) PRO Panel Plan · not yet recruiting
NCT07384559 — Exploratory Study Investigating the Urinary Bladder During Intermittent Catheterization in Healthy and Spinal Cord Injur · NA · not yet recruiting
NCT07376421 — Clinical Investigation Exploring a Newly Developed Ostomy Baseplate · NA · recruiting
NCT07126327 — Peristeen Light Explorative Clinical Investigation · NA · recruiting
NCT07316530 — Clinical Investigation Exploring a Newly Developed Ostomy Baseplate. · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05250908 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Coloplast A/S
Last refreshed: 2 March 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05250908.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing