A Study to Evaluate the Safety and Efficacy of OROS® Oxybutynin Chloride for the Treatment of Urge Urinary Incontinence

NCT00269724 | Completed Phase 3

• 1 other identifier: CR005971
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to is to evaluate the safety and efficacy of OROS® oxybutynin chloride in patients being treated for urge urinary incontinence. Oxybutynin is an antispasmodic, anticholinergic medication for the treatment of the symptoms of overactive bladder.

Conditions

Urinary Incontinence

Keywords

urinary incontinence; oxybutynin; OROS®

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events; Results from Physician's Anticholinergic Effects Assessment (P-ACEA)

Secondary Outcomes (1)

• Change from Week 1 to Week 12 of Maintenance Period in: Urge urinary incontinence episodes per week; Urinary incontinence episodes per week; Void frequency per week

Interventions

OROS® oxybutynin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with non-neurogenic urge urinary incontinence, neurogenic urge urinary incontinence, or mixed urge urinary incontinence with a clinically significant urge component
• Patients currently taking medications for urge urinary incontinence (that are listed in the protocol) including immediate-release oxybutynin chloride, or patients not currently taking medication for urge urinary incontinence who have had at least 6 urge urinary incontinence episodes during the 1-week Run-in Period
• Patients who are able to differentiate incontinent episodes associated with urgency from incontinent episodes not associated with urgency when recording incontinent episodes in the diary
• Patients who are in good general health prior to study participation, without significant bacteria or fewer than 10 WBC/hpf on urinalysis, or a negative urine culture
• Patients agreeing that a medically acceptable and effective birth control method will be used by the patient and partner throughout the study and for one week following the end of the study-drug treatment

You may not qualify if:

• Patients with known treatable genitourinary conditions that may cause incontinence (e.g., urinary tract infection, prostatitis, urinary tract obstruction, bladder tumor, bladder stone, prostate cancer)
• Patients with narrow-angle glaucoma or untreated narrow anterior chamber angles obstructive uropathy, partial or complete obstruction or narrowing of the gastrointestinal tract, paralytic ileus, intestinal atony, colitis or myasthenia gravis
• Patients with known allergy or hypersensitivity to oxybutynin chloride, or with clinically significant medical problems or other organ abnormality or pathology for whom, administration of oxybutynin chloride would present undue risk
• Male patients who have had prostate surgery less than six months before study enrollment or any history of prostate cancer
• Patients who have been treated with anticholinergic medications for urge urinary incontinence and have been found to be not responsive to these treatments, and patients who are at significant risk of developing complete urinary retention if placed on an anticholinergic medication

Sponsors & Collaborators

• Alza Corporation, DE, USA: lead

Related Links

• Open-label safety and dose conversion/determination study of OROS® (oxybutynin chloride) for urge urinary incontinence

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alza Corporation Clinical Trial

  Alza Corporation, DE, USA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 22, 2005
• First Posted: December 26, 2005
• Study Start: March 1, 1997
• Study Completion: September 1, 1997
• Last Updated: May 19, 2011

Record last verified: 2010-04