INTIBIA Pivotal Study
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Phase
Not applicable
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
208actual
Sites
22
Countries
Netherlands, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-03-07 | actual | When the study began enrolling |
| Primary completion | 2025-05-12 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-06-27 | estimated | The whole study's end, after follow-up |
| First posted | 2022-02-22 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-02 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Urinary Incontinence, Urge
- Urinary Bladder, Overactive
- Urinary Bladder Diseases
- Urologic Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
Interventions
- Device: INTIBIA Therapeutic
- Device: INTIBIA Non-Therapeutic
Primary outcomes
what the primary-completion date above is the date OFResponse Rate
measured 3 Months
Response Rate
measured 12 Months
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