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A 14 Week Randomized Parallel Group Placebo-Controlled Double-Blind Multicentre Study Of Fesoterodine 8 Mg In Overactive Bladder Patients With Sub-Optimal Response To Tolterodine 4 Mg Extended Release (ER).

Phase 4
18 Years
Not Enrolling
Urinary Bladder, Overactive

Thank you

Trial Information

A 14 Week Randomized Parallel Group Placebo-Controlled Double-Blind Multicentre Study Of Fesoterodine 8 Mg In Overactive Bladder Patients With Sub-Optimal Response To Tolterodine 4 Mg Extended Release (ER).

Inclusion Criteria:

- Diagnosis of overactive bladder with symptoms for at least 6 months.

- Moderate to severe incontinence episode frequency and subsequent sub-optimal response
to tolterodine

- Women of child-bearing potential must not intend to become pregnant, be pregnant or
producing breast milk at the time of study entry, and must use contraception

Exclusion Criteria:

- Conditions or prior treatment that may also affect bladder function

- Clinically significant urinary tract infection (UTI)

- Ongoing treatment with overactive bladder medications (these can be stopped at the
first visit to allow entry into the study).

Type of Study:


Study Design:

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

Outcome Measure:

Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours

Outcome Description:

UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.

Outcome Time Frame:

Baseline, Week 12

Safety Issue:


Principal Investigator

Pfizer Call Center

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

May 2011

Completion Date:

May 2012

Related Keywords:

  • Urinary Bladder, Overactive
  • Bladder Overactive
  • Overactive urinary bladder
  • Overactive Bladder
  • Urinary Bladder, Overactive



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