Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01166438 · ClinicalTrials.gov registry record · Phase 3
Anticholinergic vs. Botox Comparison Study
A Phase 3 study of Overactive Bladder and Urge Urinary Incontinence, sponsored by NICHD Pelvic Floor Disorders Network.
- Completed
- Registry status
- Phase 3
- Development phase
- 249
- Enrollment target
- 11
- Study locations
NCT01166438 is a Phase 3 study of Overactive Bladder and Urge Urinary Incontinence that has completed, run by NICHD Pelvic Floor Disorders Network. The registered enrollment target is 249 participants, above the 206-participant average among 45 other Overactive Bladder trials with a reported enrollment target (21% higher). The trial reports 11 study locations across 9 states.
The verdict
NCT01166438, a Phase 3 study of Overactive Bladder and Urge Urinary Incontinence, has completed, sponsored by NICHD Pelvic Floor Disorders Network.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 249 participants
- Enrollment target
- 11
- Study locations
Study Summary
Urinary incontinence is a prevalent condition that markedly impacts quality of life and disproportionately affects women. Overactive Bladder syndrome (OAB) is defined as symptoms of urgency and frequency with urge urinary incontinence (OAB-wet) and without urge incontinence (OAB-dry). Conservative first line treatments for urge incontinence combined with other OAB symptoms (OAB-wet) include behavioral therapy, pelvic floor training +/- biofeedback, or the use of anticholinergic medications. These treatment modalities may not result in total continence and often drug therapy is discontinued because of lack of efficacy, side effects and cost or because of not wanting to take a pill. Behavioral therapy and pelvic muscle exercises require consistent, active intervention by the patient which is often not sustained. Thus, the objective of the Anticholinergic vs Botox Comparison Study (ABC) is to determine whether a single intra-detrusor injection of botulinum toxin A (Botox A®) is more effective than a standardized regimen of oral anticholinergics in reducing urge urinary incontinence. The null hypothesis is that there is no difference in the change from baseline in average number of urge urinary incontinence episodes over 6 months between groups.
Conditions Studied
Interventions
- DRUG Botulinum toxin A (Botox A®)
- DRUG Solifenacin 5mg
- DRUG Solifenacin 10mg
- DRUG Trospium chloride
Study Locations (11)
California
- USCD Medical Center - La Jolla
- Kaiser Permanente - San Diego
Michigan
- Oakwood Hospital - Dearborn
- Beaumont Hospital - Royal Oak
Alabama
- The University of Alabama at Birmingham - Birmingham
Illinois
- Loyola University Medical Center - Maywood
North Carolina
- Duke University - Durham
Ohio
- Cleveland Clinic - Cleveland
Pennsylvania
- Magee-Women's Hospital - Pittsburgh
Texas
- University of Texas Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 249 participants |
| Start Date | 2010-03 |
| Est. Completion | 2012-05 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01166438
The ClinicalTrials.gov registry entry for NCT01166438 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 249 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 206-participant average among 45 other Overactive Bladder trials with a reported enrollment target (21% higher). The listed sponsor is NICHD Pelvic Floor Disorders Network, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Overactive Bladder appearing as the primary indexed condition, and to 4 interventions - of which Botulinum toxin A (Botox A®) is the first listed.
NCT01166438 reports 11 study locations spanning 9 distinct geographic areas - top geographies include California, Michigan, Alabama.
Frequently Asked Questions
What is clinical trial NCT01166438 about?
NCT01166438 is a clinical study titled "Anticholinergic vs. Botox Comparison Study". Urinary incontinence is a prevalent condition that markedly impacts quality of life and disproportionately affects women. Overactive Bladder syndrome (OAB) is defined as symptoms of urgency and frequency with urge urinary incontinence (OAB-wet) and without urge incontinence (OAB-dry). Conservative f...
What is the current status of trial NCT01166438?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 249 participants. The study started on 2010-03. Estimated completion is 2012-05.
What conditions does trial NCT01166438 study?
This clinical trial studies the following conditions: Overactive Bladder, Urge Urinary Incontinence.
What interventions are being tested in trial NCT01166438?
The interventions under investigation include: Botulinum toxin A (Botox A®) (DRUG), Solifenacin 5mg (DRUG), Solifenacin 10mg (DRUG), Trospium chloride (DRUG).
Who is sponsoring clinical trial NCT01166438?
This trial is sponsored by NICHD Pelvic Floor Disorders Network, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01166438 being conducted?
This trial has 11 study locations across Alabama, California, Illinois, Michigan, North Carolina. 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.
-
Study of Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence
COMPLETED · Phase 3
-
Behavioral or Solifenacin Therapy for Urinary Symptoms in Parkinson Disease
COMPLETED · Phase 3
-
Home Versus Office Removal of Percutaneous Nerve Evaluation (PNE) Lead
RECRUITING · NA
-
Bladder Botox UTI Antibiotic Prophylaxis
RECRUITING · Phase 4
-
Percutaneous Nerve Evaluation Trial Time
RECRUITING · NA
-
Noninvasive Ultrasound Assessment of Detrusor Dysfunction
RECRUITING
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.