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NCT05806164 · ClinicalTrials.gov registry record · Phase 4
Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence
A Phase 4 study of Urgency Urinary Incontinence, sponsored by Women and Infants Hospital of Rhode Island.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 432
- Enrollment target
- 5
- Study locations
NCT05806164 is a Phase 4 study of Urgency Urinary Incontinence that is actively recruiting participants, run by Women and Infants Hospital of Rhode Island. The registered enrollment target is 432 participants, above the 190-participant average among 4 other Urgency Urinary Incontinence trials with a reported enrollment target (127% higher). The trial reports 5 study locations across 5 states.
The verdict
NCT05806164, a Phase 4 study of Urgency Urinary Incontinence, is actively recruiting participants, sponsored by Women and Infants Hospital of Rhode Island.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 432 participants
- Enrollment target
- 5
- Study locations
Study Summary
The goal of this clinical trial is to compare treatment outcomes between an oral medication (beta agonist) versus onabotulinumtoxinA injections in women with urgency urinary incontinence (UUI). Participants will be randomly selected to receive one of the two treatments. The primary outcome measure will be at 3 months, and women will be followed for a total of 12 months. Based on patient expert input, there are 2 primary outcomes: Treatment satisfaction and urinary symptom severity. The study will also have a long-term follow-up component (prospective cohort) including 346 participants from the parent trial to describe treatment continuation, treatment efficacy, patient direct costs and other secondary outcomes up to 5 years after treatment.
Conditions Studied
Interventions
- DRUG OnabotulinumtoxinA 100 UNT [Botox]
- DRUG Beta3-Agonists, Adrenergic [Mirabegron/Vibegron]
Study Locations (5)
Alabama
- University of Alabama at Birmingham - Birmingham
California
- University of California, San Diego - San Diego
District of Columbia
- Howard University - Washington D.C.
New Mexico
- University of New Mexico - Albuquerque
Rhode Island
- Women & Infants Hospital of Rhode Island - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 432 participants |
| Start Date | 2023-06-06 |
| Est. Completion | 2030-08-01 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05806164
The ClinicalTrials.gov registry entry for NCT05806164 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 432 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 190-participant average among 4 other Urgency Urinary Incontinence trials with a reported enrollment target (127% higher). The listed sponsor is Women and Infants Hospital of Rhode Island, which has 65 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Urgency Urinary Incontinence appearing as the primary indexed condition, and to 2 interventions - of which OnabotulinumtoxinA 100 UNT [Botox] is the first listed.
NCT05806164 reports 5 study locations spanning 5 distinct geographic areas - top geographies include Alabama, California, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT05806164 about?
NCT05806164 is a clinical study titled "Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence". The goal of this clinical trial is to compare treatment outcomes between an oral medication (beta agonist) versus onabotulinumtoxinA injections in women with urgency urinary incontinence (UUI). Participants will be randomly selected to receive one of the two treatments. The primary outcome measure ...
What is the current status of trial NCT05806164?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 432 participants. The study started on 2023-06-06. Estimated completion is 2030-08-01.
What conditions does trial NCT05806164 study?
This clinical trial studies the following conditions: Urgency Urinary Incontinence.
What interventions are being tested in trial NCT05806164?
The interventions under investigation include: OnabotulinumtoxinA 100 UNT [Botox] (DRUG), Beta3-Agonists, Adrenergic [Mirabegron/Vibegron] (DRUG).
Who is sponsoring clinical trial NCT05806164?
This trial is sponsored by Women and Infants Hospital of Rhode Island, which has 65 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05806164 being conducted?
This trial has 5 study locations across Alabama, California, District of Columbia, New Mexico, Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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