A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder

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.

• Drug: tolterodine tartrate
  Part I: tolterodine tartrate 4mg capsule qd for 7 days Part IIa: tolterodine tartrate 4mg capsule qd for 7 days Part IIb: single dose tolterodine tartrate 4mg capsule
• Drug: Comparator: Placebo to tolterodine tartrate
  Part I: placebo to tolterodine tartrate 4mg capsule qd for 7 days Part IIa: placebo to tolterodine tartrate 4mg capsule qd for 7 days Part IIb: single dose placebo to tolterodine tartrate 4mg capsule

• Experimental: 1
  Part I, Sequence 1: tolterodine tartrate crossing over to matching placebo
  Interventions:

  • Drug: tolterodine tartrate
  • Drug: Comparator: Placebo to tolterodine tartrate
• Experimental: 2
  Part I, Sequence 2: placebo crossing over to study drug 4mg qd
  Interventions:

  • Drug: tolterodine tartrate
  • Drug: Comparator: Placebo to tolterodine tartrate
• Experimental: 3
  Part II, Sequence 1: study drug crossing over to placebo
  Interventions:

  • Drug: tolterodine tartrate
  • Drug: Comparator: Placebo to tolterodine tartrate
• Experimental: 4
  Part II, Sequence 2: placebo crossing over to study drug
  Interventions:

  • Drug: tolterodine tartrate
  • Drug: Comparator: Placebo to tolterodine tartrate

Inclusion Criteria:

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