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

Phase 2

Completed

• Conditions: Stress Urinary Incontinence
• Interventions: Drug: Fesoterodine

• Registration Number: NCT01042236
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2010-01-04
• Study First Submitted QC: 2010-01-04
• Study First Posted: 2010-01-05
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Results First Submitted: 2011-06-08
• Results First Submitted QC: 2011-06-08
• Status Verified: 2011-07
• Results First Posted: 2011-07-01
• Last Update Submitted: 2011-07-20
• Last Update Posted: 2011-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1	Fesoterodine	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Opening Urethral Pressure (OUP) at Day 7	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 Outcome Measures

Name	Time	Method
Change From Baseline in Closing Urethral Pressure at Day 7	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	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	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	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	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	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	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	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	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	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.

Trial Locations

Locations (1)

Glostrup Hospital; 🇩🇰 Glostrup, Denmark