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Fesoterodine Flexible Dose Study

Phase 3
Completed
Conditions
Overactive Bladder
Interventions
Drug: Placebo
Registration Number
NCT00536484
Lead Sponsor
Pfizer
Brief Summary

This Phase 3B study is designed to test if a fesoterodine flexible dose regimen is more effective than placebo in reducing micturition frequency and other overactive bladder (OAB) symptoms, e.g., urgency, urgency incontinence episodes in patients with overactive bladder and if the fesoterodine regimen is safe and well tolerated.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
896
Inclusion Criteria
  • Overactive bladder symptoms for greater than or equal to 3 months.
  • Mean urinary frequency of greater than or equal to 8 micturitions per 24 hours in bladder diary.
  • Mean number of Urgency episodes greater than or equal to 3 per 24 hours in bladder diary.
Exclusion Criteria
  • Contraindication to fesoterodine (antimuscarinics).
  • Known etiology of OAB (e.g., neurogenic, local urinary tract pathology).
  • Previous history of acute urinary retention requiring catheterization or severe voiding difficulties in the judgment of the investigator, prior to baseline.
  • Unable to follow the study procedures, including completion of self-administered bladder diary and patient reported outcome questionnaires.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Placebo (Double-Blind)Placebo-
Fesoterodine (Double-Blind)Fesoterodine-
Primary Outcome Measures
NameTimeMethod
Change in Mean Number of Micturition Episodes Per 24 Hours at Week 12 Relative to Baseline.Baseline and Week 12

The number of micturitions per 24 hours was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit.

Change: mean at Week 12 minus mean at Baseline

Secondary Outcome Measures
NameTimeMethod
Change in Mean Number of Micturition Episodes Per 24 Hours Relative to BaselineBaseline, Week 2 and Week 6

The number of micturitions per 24 hours was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit.

Change: mean at observation minus mean at baseline

Change in Number of Urgency Episodes Per 24 Hours Relative to BaselineBaseline, Week 2, Week 6 and Week 12

Change in number of urgency episodes (urinary sensation scale \[USS\] rating of 3 or more) recorded in the bladder diary. Scale: 0=no feeling of urgency to 5=unable to hold; leak urine. The number of urgency episodes per 24 hours was calculated as the sum of all urgency episodes divided by the total number of diary days collected at that visit.

Change in Number of Severe Urgency Episodes Per 24 Hours Relative to BaselineBaseline, Week 2, Week 6 and Week 12

Change in number of severe urgency episodes (urinary sensation scale \[USS\] rating of 4 or more) recorded in the bladder diary. Scale: 0=no feeling of urgency to 5=unable to hold; leak urine. Number of severe urgency episodes per 24 hours calculated as sum of all severe urgency episodes divided by total number of diary days collected at that visit.

Change in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours Relative to BaselineBaseline, Week 2, Week 6 and Week 12

Change in number of UUI episodes (urinary sensation scale \[USS\] rating of 5) recorded in the bladder diary. Scale: 0=no feeling of urgency to 5=unable to hold; leak urine

Change in Nocturnal Micturition Episodes Per 24 Hours Relative to BaselineBaseline, Week 2, Week 6 and Week 12

Change in number of nocturnal micturitions (NM) recorded in the bladder diary. NM were defined as micturitions that occurred between the time the subject went to bed and the time he or she arose to start the next day. The number of NM per 24 hours was calculated as the sum of all NM divided by the total number of diary days collected at that visit.

Change in Number of Nocturnal Urgency Episodes Per 24 Hours Relative to BaselineBaseline, Week 2, Week 6 and Week 12

Change in number of nocturnal urgency episodes (NUE) recorded in bladder diary. NUE had urinary sensation scale (USS) rating of 3 or more that occurred between time subject went to bed and time he or she arose to start next day. Number of NUE per 24 hours was calculated as sum of all NUE divided by total number of diary days collected at that visit

Change in Frequency-urgency Sum Per 24 Hours Relative to BaselineBaseline, Week 2, Week 6 and Week 12

Change in frequency urgency sum is total urinary sensation scale (USS) ratings recorded for all micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold:leak urine. Numerical decrease indicates improvement

Change in Overactive Bladder Questionnaire (OAB-q) at Week 12 Relative to Baseline - Symptom Bother ScaleBaseline and Week 12

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 a negative change indicates improvement.

Change: mean at Week 12 minus mean at baseline

Change in Overactive Bladder Questionnaire (OAB-q) at Week 12 Relative to Baseline - Health Related Quality of Life (HRQL) SubscalesBaseline and Week 12

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 a positive change indicates improvement.

Change: mean at Week 12 minus mean at baseline.

Categorical Change in Patient Perception of Bladder Condition (PPBC) Score Relative to BaselineBaseline, Week 2, Week 6 and Week 12

PPBC scale range: 1='does not cause me any problems at all' to 6='causes me many severe problems'. Major improvement=negative score change of 2 or more from baseline; minor improvement=negative score change of 1 or more from baseline; no change=0 score change from baseline; Deterioration=positive score change from baseline

Categorical Change in Urgency Perception Scale (UPS) Relative to BaselineBaseline, Week 2, Week 6 and Week 12

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 \[without leaking\]"). Improvement: positive score change; No change: score change=0; Deterioration: negative score change

Change in Urgency Severity Visual Analog Scale (VAS) Relative to BaselineBaseline, Week 2, Week 6 and Week 12

The urgency severity VAS Scale records the subject's assessment of the severity of urgency. VAS scale ranges from 1 'Very Mild' to 10 'Very Severe'. Negative change indicated improvement.

Change: mean at observation minus mean at baseline.

Trial Locations

Locations (1)

Pfizer Investigational Site

🇺🇸

Spokane, Washington, United States

Pfizer Investigational Site
🇺🇸Spokane, Washington, United States

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