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

Stress Urinary Incontinence Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01042236
• Other study ID #: A0221064
• Status: Completed
• Phase: Phase 2
• First received: January 4, 2010
• Last updated: July 20, 2011
• Start date: January 2009
• Est. completion date: July 2010

Study information

• Verified date: July 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medical Authority
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

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

Locations

Country	Name	City	State
Denmark	Glostrup Hospital	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Opening Urethral Pressure (OUP) at Day 7	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.	Baseline, Day 7 of each period	No
Secondary	Change From Baseline in Closing Urethral Pressure at Day 7	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.	Baseline, Day 7 of each period	No
Secondary	Change From Baseline in Opening Urethral Elastance at Day 7	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.	Baseline, Day 7 of each period	No
Secondary	Change From Baseline in Closing Urethral Elastance at Day 7	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.	Baseline, Day 7 of each period	No
Secondary	Incontinence Episode Frequency Per 24 Hours	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.	Baseline, Day 7 of each period	No
Secondary	Percent Change From Baseline in Incontinence Episode Frequency Per 24 Hours	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.	Baseline, Day 7 of each period	No
Secondary	Stress Incontinence Episode Frequency Per 24 Hours	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.	Baseline, Day 7 of each period	No
Secondary	Percent Change From Baseline in Stress Incontinence Episode Frequency Per 24 Hours	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.	Baseline, Day 7 of each period	No
Secondary	Urgency Urinary Incontinence Episode Frequency Per 24 Hours	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.	Baseline, Day 7 of each period	No
Secondary	Percent Change From Baseline in Urgency Urinary Incontinence Episode Frequency Per 24 Hours	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.	Baseline, Day 7 of each period	No
Secondary	Plasma 5-hydroxymethyl Tolterodine (5- HMT) Concentration	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.	Baseline, Day 7 of each period	No

External Links

•   To obtain contact information for a study center near you, click here.