Efficacy and Tolerability of DITROPAN XL (Oxybutynin Chloride) Versus DETROL LA (Tolterodine Tartrate) in Treatment of Overactive Bladder

NCT00293839 | Completed Phase 3

• 1 other identifier: CR004570
• Study Type: interventional
• Target: 790
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare the efficacy of DITROPAN® XL (oxybutynin chloride) Extended-Release Tablets and DETROL® LA (tolterodine tartrate extended-release capsules) in the reduction of urge urinary incontinence episodes during a 12-week treatment period in patients with overactive bladder. The secondary objective is to compare the tolerability of DITROPAN® XL (oxybutynin chloride) and DETROL® LA (tolterodine tartrate) during a 12-week treatment period.

Conditions

Urinary Incontinence

Keywords

bladder; overactive

Outcome Measures

Primary Outcomes (1)

• The number of weekly urge urinary incontinence (Urge-UI) episodes at week 12, adjusted for the baseline value

Secondary Outcomes (1)

• The number of total urinary incontinence (Total-UI) episodes at week 12; Void frequency at week 12; Urge-UI ,Total-UI, and Void frequence at weeks 2, 4, and 8; tolerability of the treatments during the 12-week treatment phase.

Interventions

oxybutynin chloride DRUG

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who are able to differentiate urinary incontinence episodes associated with urgency from urinary incontinence episodes not associated with urgency
• during the 7 day baseline period have 21 to 60 urge urinary incontinence (Urge-UI) episodes, a greater number of Urge-UI episodes than urinary incontinence not associated with urge, and an average of 10 or more voids per 24 hours
• are in good general health as determined by medical history, physical examination (general, genital, pelvic, and rectal), laboratory tests and urinalysis
• if taking antihypertension medication, must be on a stable dose
• and if of child-bearing potential, practicing an acceptable method of birth control, and must have a negative pregnancy test at Visit 2 and Visit 3

You may not qualify if:

• Participants with known, treatable genitourinary conditions (identified on history or on examination) that may cause incontinence (e.g., urinary tract infection, interstitial cystitis, urinary tract obstruction, urethral diverticulum, bladder tumor, bladder stone)
• have given birth or have had pelvic, vaginal or bladder surgery less than 6 months before study enrollment
• with a second post-void residual urine volume \> 150 mL at the time of screening (determined by abdominal ultrasound)
• with significant medical problems or other organ abnormality that places them at risk from participating in the study or at a significant risk of developing complete urinary retention
• with significant impairment of the liver or kidneys as determined by laboratory assessments or hematuria (red blood cells in microscopic urinalysis)

Sponsors & Collaborators

• Alza Corporation, DE, USA: lead

Related Publications (1)

• Diokno AC, Appell RA, Sand PK, Dmochowski RR, Gburek BM, Klimberg IW, Kell SH; OPERA Study Group. Prospective, randomized, double-blind study of the efficacy and tolerability of the extended-release formulations of oxybutynin and tolterodine for overactive bladder: results of the OPERA trial. Mayo Clin Proc. 2003 Jun;78(6):687-95. doi: 10.4065/78.6.687.

  PMID: 12934777 RESULT

MeSH Terms

Conditions

Urinary Incontinence

Interventions

oxybutynin

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

  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: February 16, 2006
• First Posted: February 20, 2006
• Study Completion: December 1, 2002
• Last Updated: February 3, 2025

Record last verified: 2025-01