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Completed

NCT Number: NCT01042236

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

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

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Key information

Conditions

Stress Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Glostrup Hospital

Glostrup Municipality, 2600, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fesoterodine

Drug

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

Other names: Toviaz

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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.

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 5, 2010
Registry last updated
Jul 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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