A Clinical Trial To Assess Fesoterodine On Treatment Satisfaction And Symptom Improvement In Overactive Bladder Patients

A 12-Week, Multicenter, Open-Label, Single-Arm Study To Evaluate The Effects Of Fesoterodine On Treatment Satisfaction And Symptom Relief In Overactive Bladder Patients.

To evaluate the effect of fesoterodine on patient satisfaction and overactive bladder (OAB) symptom relief in OAB patients who were dissatisfied with their prior therapy with tolterodine.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Drug: fesoterodine fumarate

• Study Type: Interventional
• Enrollment (Actual): 516
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium, B-1200
    • Pfizer Investigational Site
  • Edegem, Belgium, B-2650
    • Pfizer Investigational Site
  • Gent, Belgium, B-9000
    • Pfizer Investigational Site
  • Jette, Belgium, B-1090
    • Pfizer Investigational Site
  • Turnhout, Belgium, B-2300
    • Pfizer Investigational Site
• Costa Rica
  • San Jose, Costa Rica
    • Pfizer Investigational Site
  • Alajuela
    • Alajuela Centro, Alajuela, Costa Rica
      • Pfizer Investigational Site
• Czechia
  • Brno-Bohunice, Czechia, 625 00
    • Pfizer Investigational Site
  • Hradec Kralove, Czechia, 500 05
    • Pfizer Investigational Site
  • Praha 2, Czechia, 128 08
    • Pfizer Investigational Site
  • Praha 5, Czechia, 152 00
    • Pfizer Investigational Site
• Germany
  • Alzey, Germany, 55232
    • Pfizer Investigational Site
  • Berlin, Germany, 13347
    • Pfizer Investigational Site
  • Duisburg, Germany, 47179
    • Pfizer Investigational Site
  • Frankfurt, Germany, 65929
    • Pfizer Investigational Site
  • Marburg, Germany, 35039
    • Pfizer Investigational Site
  • Muelheim A.d. Ruhr, Germany, 45468
    • Pfizer Investigational Site
  • Muenchen, Germany, 81925
    • Pfizer Investigational Site
• Korea, Republic of
  • Busan, Korea, Republic of, 602-739
    • Pfizer Investigational Site
  • Daejeon, Korea, Republic of, 301-721
    • Pfizer Investigational Site
  • Jeonnam, Korea, Republic of, 519-809
    • Pfizer Investigational Site
  • Seoul, Korea, Republic of, 138-736
    • Pfizer Investigational Site
  • Seoul, Korea, Republic of, 135-710
    • Pfizer Investigational Site
  • Gyunggi-do
    • Bucheon-si, Gyunggi-do, Korea, Republic of, 420-767
      • Pfizer Investigational Site
• Poland
  • Lodz, Poland, 93-316
    • Pfizer Investigational Site
  • Myslowice, Poland, 41-400
    • Pfizer Investigational Site
• Slovakia
  • Bratislava, Slovakia, 833 05
    • Pfizer Investigational Site
  • Malacky, Slovakia, 901 01
    • Pfizer Investigational Site
  • Piestany, Slovakia, 921 01
    • Pfizer Investigational Site
  • Presov, Slovakia, 080 01
    • Pfizer Investigational Site
  • Skalica, Slovakia, 909 82
    • Pfizer Investigational Site
• Ukraine
  • Chernivtsi, Ukraine, 58002
    • Pfizer Investigational Site
  • Dnipropetrovsk, Ukraine, 49005
    • Pfizer Investigational Site
  • Kharkiv, Ukraine, 61037
    • Pfizer Investigational Site
  • Odessa, Ukraine, 65000
    • Pfizer Investigational Site
  • Zaporizhzhia, Ukraine, 69000
    • Pfizer Investigational Site
• United States
  • Alabama
    • Homewood, Alabama, United States, 35209
      • Pfizer Investigational Site
    • Huntsville, Alabama, United States, 35801
      • Pfizer Investigational Site
  • California
    • La Mesa, California, United States, 91942
      • Pfizer Investigational Site
    • Orangevale, California, United States, 95662
      • Pfizer Investigational Site
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Pfizer Investigational Site
  • Florida
    • West Palm Beach, Florida, United States, 33407
      • Pfizer Investigational Site
  • Illinois
    • Aurora, Illinois, United States, 60504
      • Pfizer Investigational Site
  • Kansas
    • Pratt, Kansas, United States, 67124
      • Pfizer Investigational Site
  • Louisiana
    • Shreveport, Louisiana, United States, 71106
      • Pfizer Investigational Site
  • Massachusetts
    • Milford, Massachusetts, United States, 01757
      • Pfizer Investigational Site
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Pfizer Investigational Site
  • New Jersey
    • Westampton, New Jersey, United States, 08060
      • Pfizer Investigational Site
  • New York
    • Kingston, New York, United States, 12401
      • Pfizer Investigational Site
    • New York, New York, United States, 10016
      • Pfizer Investigational Site
    • Poughkeepsie, New York, United States, 12601
      • Pfizer Investigational Site
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Pfizer Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • Pfizer Investigational Site
  • Oklahoma
    • Bethany, Oklahoma, United States, 73008
      • Pfizer Investigational Site
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Pfizer Investigational Site
  • Pennsylvania
    • Sellersville, Pennsylvania, United States, 18960
      • Pfizer Investigational Site
  • Texas
    • Houston, Texas, United States, 77024
      • Pfizer Investigational Site
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Pfizer Investigational Site
    • Salt Lake City, Utah, United States, 84107
      • Pfizer Investigational Site
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53209
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• OAB patients who present with OAB symptoms(≥8 micturitions and ≥3 urgency episodes per 24 h documented in the baseline bladder diary)
• OAB patients dissatisfied with their prior therapy with tolterodine

Exclusion Criteria:

• Patients with any contraindication to fesoterodine usage, e.g., urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, or known hypersensitivity to the drug or its ingredients.
• Patients with significant hepatic and renal disease or other significant unstable diseases.
• OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Open Label-fesoterodine; Single treatment study arm.	Drug: fesoterodine fumarate; 12 weeks of study treatment: Subjects received fesoterodine tablets 4 mg once daily for 4 weeks; thereafter, daily dosage was maintained at 4 mg or increased to 8 mg based on subject's and physician's subjective assessment of efficacy and tolerability.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Number of Micturition Episodes Per 24 Hours	The mean number of micturitions per 24 hours is calculated as the total number of micturitions divided by the total number of diary days collected at that visit.	Baseline and Week 12
Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours	The mean number of UUI episodes per 24 hours is calculated as the total number of micturitions with Bladder Sensation Scale (BSS) = 5 divided by the total number of diary days collected at that visit. BSS: 5 point scale measuring need to urinate from 1=no urgency to 5=unable to hold; leak urine.	Baseline and Week 12
Mean Number of Urgency Episodes Per 24 Hours	The mean number of urgency episodes per 24 hours is calculated as the total number of micturitions with Bladder Sensation Scale (BSS) >= 3 divided by the total number of diary days collected at that visit. BSS: 5 point scale measuring need to urinate from 1=no urgency to 5=unable to hold; leak urine.	Baseline and Week 12
Number of Participants Reporting Satisfaction With Current Overactive Bladder (OAB) Treatment	Number of Participants who responded satisfied = (very satisfied or somewhat satisfied) and dissatisfied = (somewhat dissatisfied or very dissatisfied) to the treatment satisfaction question.	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nocturnal Micturitions Per 24 Hours	Nocturnal micturitions (synonymous with the term "nighttime micturitions") were those recorded in the bedtime section of the bladder diary.	Baseline and Week 12
Severe Urgency Episodes Per 24 Hours	Severe urgency episodes defined as Urinary Sensation Scale (USS) rating ≥4. Subjects rated the feeling of urgency associated with each micturition episode using USS provided in the bladder diary. Scale ranges from 1=no feeling of urgency to 5=unable to hold; leak urine; decrease indicates an improvement with respect to urgency symptoms.	Baseline and Week 12
Mean Rating on the Urinary Sensation Scale	The mean rating was calculated as the sum of rating scores on the Urinary Sensation Scale divided by the total number of micturitions with non-missing rating at that visit. The scale ranges from 1 "no feeling of urgency" to 5 "unable to hold; leak urine."	Baseline and Week 12
Patient Perception of Bladder Condition (PPBC) Score	The PPBC score ranges from 1 "no problems at all" to 6 "many severe problems."	Baseline and Week 12
Patient Perception of Bladder Condition (PPBC) Score at Week 12 Relative to Baseline (Categorical Change)	Improvement: negative score change; No change: score change=0; Deterioration: positive score change	Baseline and Week 12
Urgency Perception Scale (UPS)	UPS scores range from 0 ("I am usually not able to hold urine") to 2 ("I am usually able to finish what I am doing before going to the toilet [without leaking]").	Baseline and Week 12
Urgency Perception Scale (UPS) at Week 12 Relative to Baseline (Categorical Change)	Improvement: positive score change; No improvement: zero or negative score change	Baseline and Week 12
Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Concern Domain	Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.	Baseline and Week 12
Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Coping Domain	Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.	Baseline and Week 12
Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Sleep Domain	Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.	Baseline and Week 12
Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Social Interaction Domain	Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.	Baseline and Week 12
Overactive Bladder Questionnaire (OAB-q) - Total Health Related Quality of Life (HRQL) Scale	Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.	Baseline and Week 12
Overactive Bladder Questionnaire (OAB-q) - Symptom Bother Scale	Each item rated by subject on a Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent less favorable outcome.	Baseline and Week 12
"Satisfaction With OAB Control" Module of Overactive Bladder (OAB) Treatment Satisfaction Questionnaire (TSQ) (OAB-S)	Module coded on scale (1-very satisfied to 5-very dissatisfied). Coding reversed algorithmically & results transformed: total score range 0-100. Higher final response value associated with better satisfaction. Satisfied on TSQ = very or somewhat satisfied; Not satisfied on TSQ =very or somewhat dissatisfied or neither dissatisfied nor satisfied.	Week 12
Sum Rating on the Urinary Sensation Scale	The sum rating per 24 hours was calculated as the mean rating score on the Urinary Sensation Scale multiplied by the mean number of micturitions per 24 hours at that visit. The scale ranges from 1 "no feeling of urgency" to 5 "unable to hold; leak urine."	Baseline and Week 12
Treated Subjects Reporting Satisfaction With Their Current OAB Treatment (Supportive Analysis)	Number of participants who responded satisfied = (very satisfied or somewhat satisfied) or dissatisfied = (somewhat dissatisfied or very dissatisfied) to the treatment satisfaction question at Week 12 in the safety set.	Week 12

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• Wyndaele JJ, Goldfischer ER, Morrow JD, Gong J, Tseng LJ, Guan Z, Choo MS. Effects of flexible-dose fesoterodine on overactive bladder symptoms and treatment satisfaction: an open-label study. Int J Clin Pract. 2009 Apr;63(4):560-7. doi: 10.1111/j.1742-1241.2009.02035.x.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): October 1, 2007
• Study Completion (Actual): October 1, 2007

Study Registration Dates

• First Submitted: January 19, 2007
• First Submitted That Met QC Criteria: January 19, 2007
• First Posted (Estimate): January 22, 2007

Study Record Updates

• Last Update Posted (Actual): December 5, 2018
• Last Update Submitted That Met QC Criteria: November 7, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Fesoterodine
• Other Study ID Numbers: A0221007