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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
3	tolterodine tartrate	Part II, Sequence 1: study drug crossing over to placebo
1	tolterodine tartrate	Part I, Sequence 1: tolterodine tartrate crossing over to matching placebo
4	tolterodine tartrate	Part II, Sequence 2: placebo crossing over to study drug
2	tolterodine tartrate	Part I, Sequence 2: placebo crossing over to study drug 4 mg once a Day (qd)

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 7 on Tolterodine 4 mg and Placebo	4 hours post dose 7	Change from baseline in maximum cystometric capacity at 4 hours post dose 7 on tolterodine 4 mg and placebo (analysis on natural log transformed data)

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 1 on Tolterodine 4 mg and Placebo	4 hours post dose 1	Change from baseline in maximum cystometric capacity at 4 hours post dose 1 on tolterodine 4 mg and placebo (analysis on natural log transformed data)