Study of Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence
Information source: Allergan
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Overactive Bladder
Intervention: botulinum toxin Type A (Biological); Placebo/botulinum toxin Type A (Biological)
Phase: Phase 3
Status: Recruiting
Sponsored by: Allergan Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan
Overall contact:
Allergan Inc, Email: clinicaltrials@allergan.com
Summary
The purpose of this study is to assess the safety and effectiveness of botulinum toxin type
A in treating patients with idiopathic overactive bladder with urinary incontinence.
Clinical Details
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Primary outcome: Number of Episodes of Urinary Incontinence
Secondary outcome: Number of micturition episodesVolume Voided per micturition Treatment Benefit Scale Urinary Incontinence-Specific Quality of Life Instrument (I-QOL) King's Health Questionnaire Number of Urgency episodes
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Symptoms of OAB (frequency/urgency) with urinary incontinence for at least 6 months
- Inadequate response or limiting side effects with anticholinergics for the treatment
of OAB
Exclusion Criteria:
- Overactive Bladder caused by neurological condition
- Patient has predominance of stress incontinence
- History or evidence of pelvic or urological abnormality
Locations and Contacts
Allergan Inc, Email: clinicaltrials@allergan.com
Victoria, British Columbia, Canada; Recruiting
Newport Beach, California, United States; Recruiting
Additional Information
Starting date: September 2009
Ending date: January 2012
Last updated: October 15, 2009
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