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Anticholinergic vs. Botox Comparison Study
NCT01166438 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 249 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NICHD Pelvic Floor Disorders Network, which has 38 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01166438 reports 11 study locations spanning 9 distinct geographic areas — top geographies include California, Michigan, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01166438?
This trial is sponsored by NICHD Pelvic Floor Disorders Network, which has 38 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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