A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder (0000-107)

• Status: Completed
• Trial end date: 2009-01-19
• Target enrollment: 0
• Participant gender: Female

Summary

This study will design an alternative urodynamic platform to better evaluate treatment effects of medications for overactive bladder. Part II is dependent on results of Part I and may not be conducted.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Tolterodine Tartrate

Criteria

Inclusion Criteria:

• Patient is a postmenopausal female 40 to 75 years of age

• Patient has a Body Mass Index (BMI) less than or equal to 35 kg/m2

• Patient has a documented history of overactive bladder for at least 6 months prior to screening

Exclusion Criteria:

• Patient has stress or mixed incontinence

• Patient has a history of interstitial cystitis, painful bladder syndrome, or chronic pelvic pain

• Patient has a history of stroke, seizures, or major neurological disorders

• Patient has a history of fecal incontinence

• Patient has a history of continual urine leakage

• Patient has had surgery to correct stress urinary incontinence or pelvic organ prolapse within 6 months of study start

• Patient received bladder training of electrostimulation within 2 weeks of study start

• Patient requires a catheter

• Patient is taking medications that cannot be stopped for the duration of the trial including certain anticholinergics or smooth muscle relaxants

• Patient began taking tricyclic antidepressants, serotonin/norepinephrine reuptake inhibitors, calcium channel blockers, ephedrine/pseudoephedrine, or diuretic therapy less than 8 weeks before study start

• Patient has been on hormone replacement therapy for less than 12 weeks at study start

• Patient must take medication for arrhythmia

• Patient consumes more than 2 alcoholic beverages per day

• Patient consumes more than 3 servings of caffeinated beverages per day (1 serving = 120 mg caffeine)

• Patient has multiple and/or severe allergies to foods and drugs

• Patient regularly uses any illegal drugs