A Comparison of a New Drug to Treat Overactive Bladder vs. Placebo

Overview

A new drug for overactive bladder is compared to placebo to determine if it is safe and effective. The study lasts approximately 12 weeks.

Full Title of Study: “Multi-Center, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Daily Dosing With Oxybutynin Topical Gel to Treat the Symptoms of Overactive Bladder With a 14-Week Open-Label Safety Extension”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 2007

Interventions

  • Drug: Oxybutynin topical gel
    • 1 application daily to skin for 12 weeks
  • Other: Placebo topical gel
    • 1 application daily to skin for 12 weeks

Arms, Groups and Cohorts

  • Experimental: Oxybutynin topical gel
    • Oxybutynin topical gel
  • Placebo Comparator: Placebo topical gel
    • placebo topical gel

Clinical Trial Outcome Measures

Primary Measures

  • Baseline Average Number of Daily Incontinence Episodes
    • Time Frame: Baseline
    • Average number of daily incontinence episodes at baseline
  • Change From Baseline in Average Daily Number of Incontinence Episodes
    • Time Frame: Baseline to Week 12
    • Change from Baseline to Week 12 in average daily number of incontinence episodes

Secondary Measures

  • Baseline Average Daily Urinary Frequency
    • Time Frame: Baseline
    • Number of daily urinary voids
  • Change From Baseline in Average Daily Urinary Frequency
    • Time Frame: Baseline to 12 weeks
    • Change from baseline in average daily urinary frequency
  • Baseline Average Urine Void Volume
    • Time Frame: Baseline
    • Baseline average urine void volume
  • Change From Baseline in Average Urine Void Volume
    • Time Frame: Change from Baseline to Week 12
    • Change from baseline to Week 12 in average urine void volume

Participating in This Clinical Trial

Inclusion Criteria

  • Females and males, 18 years of older with overactive bladder symptoms

Exclusion Criteria

  • Treatable conditions that may cause urinary incontinence
  • Medical conditions in which it would be unsafe to use an anti-cholinergic agent.
  • The use of concomitant drugs that would confound the efficacy evaluation.
  • The use of concomitant drugs that would be unsafe with an anti-cholinergic agent.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Watson Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Gary Hoel PhD, Executive Director, Watson
  • Overall Official(s)
    • Kim Caramelli, MS, Study Director, Watson Pharmaceuticals

Citations Reporting on Results

Staskin DR, Dmochowski RR, Sand PK, Macdiarmid SA, Caramelli KE, Thomas H, Hoel G. Efficacy and safety of oxybutynin chloride topical gel for overactive bladder: a randomized, double-blind, placebo controlled, multicenter study. J Urol. 2009 Apr;181(4):1764-72. doi: 10.1016/j.juro.2008.11.125. Epub 2009 Feb 23.

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