A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder (0000-107)
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: tolterodine tartrate; Comparator: Placebo to tolterodine tartrate
Intervention description: Part I: tolterodine tartrate 4 mg capsule once a day (qd) for 7 days
Part IIa: tolterodine tartrate 4 mg capsule qd for 7 days
Part IIb: single dose tolterodine tartrate 4 mg capsule; Part I: placebo to tolterodine tartrate 4 mg capsule once a day (qd) for 7 days
Part IIa: placebo to tolterodine tartrate 4 mg capsule qd for 7 days
Part IIb: single dose placebo to tolterodine tartrate 4 mg capsule
Intervention MeSH terms: Tolterodine Tartrate
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 20.0
Sex: Female
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No

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.
    

Eligibility 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