A Study Comparing the Efficacy and Safety of OROS® Oxybutynin to That of Ditropan® (Immediate-release Oxybutynin) for the Treatment of Patients With Urge or Mixed Urinary Incontinence.

NCT00269750 | Completed Phase 3

• 1 other identifier: CR005968
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare the efficacy and safety of OROS® oxybutynin to that of Ditropan® (immediate-release oxybutynin) for the treatment of patients with urge or mixed urinary incontinence. Oxybutynin is an antispasmodic, anticholinergic medication for the treatment of the symptoms of overactive bladder.

Conditions

Urge Incontinence

Keywords

Ditropan®; OROS®; urge; oxybutynin; mixed urinary incontinence

Outcome Measures

Primary Outcomes (1)

• Change from baseline in: the number of urge urinary incontinence episodes per week; total number of urinary incontinence episodes; total void frequency (normal and incontinent)

Secondary Outcomes (1)

• Incidence of adverse events

Interventions

OROS® oxybutynin or Ditropan® DRUG

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with urge or mixed urinary incontinence, provided that stress urinary incontinence is not the predominant manifestation of mixed urinary incontinence
• Patients who are currently taking immediate release oxybutynin (Ditropan®) hyoscyamine (Levsin®) or propantheline (Pro-banthine®), or who have taken Ditropan in the past for urge or mixed UI. (Patients who have taken Ditropan for urge or mixed urinary incontinence, but who have discontinued the medication should have discontinued due to anticholinergic effects and not due to failure of efficacy)
• 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, who have at least six urge urinary incontinence episodes per week recorded on the Run-in Diary after washout of anticholinergic medications, and who demonstrate that the number of urge incontinent episodes per week is greater than the number of incontinent episodes not associated with urgency per week
• Patients who are in good general health prior to study participation, having normal blood pressure with or without hypertension medication
• 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

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 glaucoma or untreated narrow anterior chamber angles, obstructive bowel disease or severe narrowing of the gastrointestinal tract, obstructive uropathy, or myasthenia gravis
• Patients with known allergy or hypersensitivity to oxybutynin or clinically significant medical problems or other organ abnormality or pathology for whom, administration of oxybutynin would present undue risk
• Male patients with a PSA \> 10 ng/mL or a PSA between 4 ng/mL and 10 ng/mL who in the opinion of the investigator require further evaluation or treatment for prostate cancer, or male patients who have had prostate surgery less than nine months before study enrollment. (Prostate pathology from surgery must be benign)
• Patients whose estimated creatinine clearance is less than 50 mL/min or a have hemoglobin level less than 10 g/dL

Sponsors & Collaborators

• Alza Corporation, DE, USA: lead

Related Publications (1)

• Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.

  PMID: 37160401 DERIVED

Related Links

• The maximum tolerated dose and minimum effective dose of OROS® oxybutynin compared to Ditropan® in the treatment of patients with urge or mixed urinary incontinence (UI)

MeSH Terms

Conditions

Urinary Incontinence, Urge

Interventions

oxybutynin

Condition Hierarchy (Ancestors)

Urinary Incontinence; 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: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 22, 2005
• First Posted: December 26, 2005
• Study Start: July 1, 1996
• Study Completion: February 1, 1997
• Last Updated: May 19, 2011

Record last verified: 2010-04