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

Overview

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

Full Title of Study: “A Phase 2, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Crossover Study Of The Efficacy Of Fesoterodine In Increasing Urethral Pressure In Stress Urinary Incontinence Patients.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: July 2010

Interventions

  • Drug: Fesoterodine
    • Fesoterodine 4 mg and 8 mg and placebo – each dosed for 7 days with 7 day washout between dosing periods

Arms, Groups and Cohorts

  • Experimental: Arm 1

Clinical Trial Outcome Measures

Primary Measures

  • Change From Baseline in Opening Urethral Pressure (OUP) at Day 7
    • Time Frame: Baseline, Day 7 of each period
    • OUP measured by urethral reflectometry calculated as the mean of all of the OUP 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.

Secondary Measures

  • Change From Baseline in Closing Urethral Pressure at Day 7
    • Time Frame: Baseline, Day 7 of each period
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pfizer
  • Provider of Information About this Clinical Study
    • Director, Clinical Trial Disclosure Group, Pfizer, Inc.
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

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