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

• Status: Completed
• Trial end date: 1997-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alza Corporation, DE, USA
• Treatments: Mandelic Acids; Oxybutynin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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