Evaluation Of The Ability Of Fesoterodine To Increase Urethral Pressure In Stress Urinary Incontinence Patients

• Change From Baseline in Closing Urethral Pressure at Day 7 [ Time Frame: Baseline, Day 7 of each period ] [ Designated as safety issue: No ]
  Closing urethral pressure measured by urethral reflectometry calculated as the mean of each of the closing urethral pressure measurements obtained in triplicate at each time point for each participant. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately.
• Change From Baseline in Opening Urethral Elastance at Day 7 [ Time Frame: Baseline, Day 7 of each period ] [ Designated as safety issue: No ]
  Opening urethral elastance measured by urethral reflectometry calculated as the mean of each of the opening urethral pressure measurements obtained in triplicate at each time point for each participant. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately.
• Change From Baseline in Closing Urethral Elastance at Day 7 [ Time Frame: Baseline, Day 7 of each period ] [ Designated as safety issue: No ]
  Closing urethral elastance measured by urethral reflectometry calculated as the mean of each of the closing urethral pressure measurements obtained in triplicate at each time point for each participant. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately.
• Incontinence Episode Frequency Per 24 Hours [ Time Frame: Baseline, Day 7 of each period ] [ Designated as safety issue: No ]
  Incontinence Episode Frequency (IEF) calculated as the average daily total incontinence episodes (stress or urgency) that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.
• Percent Change From Baseline in Incontinence Episode Frequency Per 24 Hours [ Time Frame: Baseline, Day 7 of each period ] [ Designated as safety issue: No ]
  Incontinence Episode Frequency (IEF) calculated as the average daily total incontinence episodes (stress or urgency) that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.
• Stress Incontinence Episode Frequency Per 24 Hours [ Time Frame: Baseline, Day 7 of each period ] [ Designated as safety issue: No ]
  Stress Incontinence Component of the daily IEF calculated as the average daily number of stress leakage episodes that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.
• Percent Change From Baseline in Stress Incontinence Episode Frequency Per 24 Hours [ Time Frame: Baseline, Day 7 of each period ] [ Designated as safety issue: No ]
  Stress Incontinence Component of the daily IEF calculated as the average daily number of stress leakage episodes that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.
• Urgency Urinary Incontinence Episode Frequency Per 24 Hours [ Time Frame: Baseline, Day 7 of each period ] [ Designated as safety issue: No ]
  Urgency Urinary Incontinence Component of the daily IEF calculated as the average daily number of urgency leakage episodes that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.
• Percent Change From Baseline in Urgency Urinary Incontinence Episode Frequency Per 24 Hours [ Time Frame: Baseline, Day 7 of each period ] [ Designated as safety issue: No ]
  Urgency Urinary Incontinence Component of the daily IEF calculated as the average daily number of urgency leakage episodes that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.
• Plasma 5-hydroxymethyl Tolterodine (5- HMT) Concentration [ Time Frame: Baseline, Day 7 of each period ] [ Designated as safety issue: No ]
  Plasma 5-HMT concentration data pre and post reflectometry following multiple doses of fesoterodine 4 mg OD and fesoterodine 8 mg OD. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately. Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.02 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.

• Urethral closure pressure [ Time Frame: 35 days ] [ Designated as safety issue: No ]
• Urethral elastance [ Time Frame: 35 days ] [ Designated as safety issue: No ]
• Incontinence episode frequency [ Time Frame: 35 days ] [ Designated as safety issue: No ]
• Stress incontinence episode frequency [ Time Frame: 35 days ] [ Designated as safety issue: No ]
• Urgency incontinence episode frequency [ Time Frame: 35 days ] [ Designated as safety issue: No ]
• Plasma exposure [ Time Frame: 35 days ] [ Designated as safety issue: No ]

The hypothesis under evaluation is that fesotorodine may provide clinical benefit in the treatment of the condition of stress urinary incontinence

Inclusion Criteria:

• Female, 18 - 65 years
• SUI symptoms for longer than 3 months
• Subjects must be non-pregnant and not breastfeeding

Exclusion Criteria:

• Disease or medical condition affecting the bladder or urinary tract (other tan stress urinary incontinence)
• Subjects taking medication with effects on the bladder or urinary tract
• Subejcts with medical conditions which could be adversely affected by administration of fesoterodine - gastrointestinal tract disease, glaucoma, hepatic impairment