# 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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