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NCT01945489 · ClinicalTrials.gov registry record · Phase 4
OnabotulinumtoxinA (BOTOX®) Treatment for Urinary Incontinence in Patients With Overactive Bladder
A Phase 4 study of Overactive Bladder, sponsored by Allergan.
- Completed
- Registry status
- Phase 4
- Development phase
- 254
- Enrollment target
- 20
- Study locations
NCT01945489: Completed Phase 4 study of Overactive Bladder, sponsored by Allergan.
NCT01945489 is a Phase 4 study of Overactive Bladder that has completed, run by Allergan. The registered enrollment target is 254 participants, above the 202-participant average among 46 other Overactive Bladder trials with a reported enrollment target (26% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01945489, a Phase 4 study of Overactive Bladder, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 254 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a study to evaluate the efficacy and safety of onabotulinumtoxinA (BOTOX®) compared with placebo, in achieving a 100% reduction in urinary incontinence in patients with overactive bladder (OAB) not properly managed with an anticholinergic.
Primary Outcome
Urinary incontinence is defined as involuntary loss of urine as recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes were averaged daily during this period and compared to baseline to determine 100% reduction in episodes.
Conditions Studied
Interventions
- DRUG Normal saline
- BIOLOGICAL onabotulinumtoxinA
Study Locations (20)
Florida
- Sunrise Medical Research - Lauderdale Lakes
- Bladder and Prostate Health Investigations, LLC - Miramar
- Renstar Medical Research - Ocala
- Urology Health Team, PLLC - Ocala
- Southeastern Research Group, Inc. - Tallahassee
Indiana
- Northeast Indiana - Fort Wayne
- Urogynecology Associates - Indianapolis
- Deaconess Clinic, Inc. - Newburgh
- Urology of Indiana, LLC - Noblesville
California
- South Orange County Medical Research Center - Laguna Hills
- University of Southern California - Los Angeles
- Genesis Research LLC - San Diego
Colorado
- U. Colorado, School of Med. - Aurora
- Genitourinary Surgical Consultants - Denver
Alabama
- Urologic Clinics of North Alabama - Huntsville
Alaska
- Alaska Urological Institute dba Alaska Clinical Research Center - Anchorage
Connecticut
- Urology Associates of Norwalk - Norwalk
Georgia
- Atlanta Medical Research Institute - Alpharetta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 254 participants |
| Start Date | 2013-10-28 |
| Est. Completion | 2017-01-05 |
| Phase | Phase 4 |
What the finished NCT01945489 record still lists
NCT01945489 is an interventional study that assigns participants to a tested intervention. The registered 254 participants enrollment target is mid-sized for trials with a published cap, above the 202-participant average among 46 other Overactive Bladder trials with a reported enrollment target (26% higher).
The record links to 1 condition, with Overactive Bladder appearing as the primary indexed condition, and to 2 interventions - of which Normal saline is the first listed.
NCT01945489 names 20 study sites across 10 states, led by Florida, Indiana, California.
Frequently Asked Questions
What is clinical trial NCT01945489 about?
NCT01945489 is a clinical study titled "OnabotulinumtoxinA (BOTOX®) Treatment for Urinary Incontinence in Patients With Overactive Bladder". This is a study to evaluate the efficacy and safety of onabotulinumtoxinA (BOTOX®) compared with placebo, in achieving a 100% reduction in urinary incontinence in patients with overactive bladder (OAB) not properly managed with an anticholinergic.
What is the current status of trial NCT01945489?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 254 participants. The study started on 2013-10-28. Estimated completion is 2017-01-05.
What conditions does trial NCT01945489 study?
This clinical trial studies the following conditions: Overactive Bladder.
What interventions are being tested in trial NCT01945489?
The interventions under investigation include: Normal saline (DRUG), onabotulinumtoxinA (BIOLOGICAL).
Who is sponsoring clinical trial NCT01945489?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01945489 being conducted?
This trial has 20 study locations across Alabama, Alaska, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Overactive Bladder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01945489's enrollment target sits among peer trials
254 9th of 46 higher than 38 of 46 other Overactive Bladder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Overactive Bladder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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