Back to resultsEvaluation Of The Ability Of Fesoterodine To Increase Urethral Pressure In Stress Urinary Incontinence Patients
Primary Purpose
Stress Urinary Incontinence
Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Fesoterodine
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring Phase 2 stress urinary incontinence Fesoterodine
Eligibility Criteria
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
Sites / Locations
- Glostrup Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01042236
Brief Title
Evaluation Of The Ability Of Fesoterodine To Increase Urethral Pressure In Stress Urinary Incontinence Patients
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The hypothesis under evaluation is that fesotorodine may provide clinical benefit in the treatment of the condition of stress urinary incontinence
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
Phase 2 stress urinary incontinence Fesoterodine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Fesoterodine
Other Intervention Name(s)
Toviaz
Intervention Description
Fesoterodine 4 mg and 8 mg and placebo - each dosed for 7 days with 7 day washout between dosing periods
Primary Outcome Measure Information:
Title
Change From Baseline in Opening Urethral Pressure (OUP) at Day 7
Description
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.
Time Frame
Baseline, Day 7 of each period
Secondary Outcome Measure Information:
Title
Change From Baseline in Closing Urethral Pressure at Day 7
Description
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.
Time Frame
Baseline, Day 7 of each period
Title
Change From Baseline in Opening Urethral Elastance at Day 7
Description
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.
Time Frame
Baseline, Day 7 of each period
Title
Change From Baseline in Closing Urethral Elastance at Day 7
Description
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.
Time Frame
Baseline, Day 7 of each period
Title
Incontinence Episode Frequency Per 24 Hours
Description
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.
Time Frame
Baseline, Day 7 of each period
Title
Percent Change From Baseline in Incontinence Episode Frequency Per 24 Hours
Description
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.
Time Frame
Baseline, Day 7 of each period
Title
Stress Incontinence Episode Frequency Per 24 Hours
Description
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.
Time Frame
Baseline, Day 7 of each period
Title
Percent Change From Baseline in Stress Incontinence Episode Frequency Per 24 Hours
Description
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.
Time Frame
Baseline, Day 7 of each period
Title
Urgency Urinary Incontinence Episode Frequency Per 24 Hours
Description
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.
Time Frame
Baseline, Day 7 of each period
Title
Percent Change From Baseline in Urgency Urinary Incontinence Episode Frequency Per 24 Hours
Description
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.
Time Frame
Baseline, Day 7 of each period
Title
Plasma 5-hydroxymethyl Tolterodine (5- HMT) Concentration
Description
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.
Time Frame
Baseline, Day 7 of each period
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Glostrup Hospital
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
24258099
Citation
Klarskov N, Darekar A, Scholfield D, Whelan L, Lose G. Effect of fesoterodine on urethral closure function in women with stress urinary incontinence assessed by urethral pressure reflectometry. Int Urogynecol J. 2014 Jun;25(6):755-60. doi: 10.1007/s00192-013-2269-6. Epub 2013 Nov 21.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0221064&StudyName=Evaluation%20Of%20The%20Ability%20Of%20Fesoterodine%20To%20Increase%20Urethral%20Pressure%20In%20Stress%20Urinary%20Incontinence%20Patients
Description
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Evaluation Of The Ability Of Fesoterodine To Increase Urethral Pressure In Stress Urinary Incontinence Patients
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