Clinical Trials/NCT00546637

NCT00546637CompletedPhase 3

A Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of Fesoterodine As An "Add-On" Therapy In Men With Persistent Overactive Bladder Symptoms Under Monotherapy Of Alpha Blocker For Lower Urinary Tract Symptoms.

Pfizer1 site in 1 country947 target enrollmentStarted: November 2007Last updated: February 18, 2011

Conditions

Interventions

Drugs

Trial Snapshot

Phase: Phase 3
Status: Completed
Sponsor: Pfizer
Enrollment: 947
Locations: 1
Primary Endpoint: Numerical Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 12

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

To evaluate the efficacy and safety of fesoterodine on overactive bladder symptom improvement when added to ongoing alpha blocker treatment.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages: 40 Years to — (Adult, Older Adult)
Sex: Male
Accepts Healthy Volunteers: No

Inclusion Criteria

•Men aged 40 years and above.
•On a stable and well-tolerated dose of an alpha-blocker prescribed for LUTS for at least 6 weeks prior to screening (Visit 1).
•Persistent symptoms of OAB with urinary frequency >=8 times/24 hours and micturition-related urgency episodes >=3 episode/24 hours.

Exclusion Criteria

•Contraindication to fesoterodine (antimuscarinics).
•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.

Arms & Interventions

Fesoterodine 4mg or 8mg

Experimental

Intervention: Fesoterodine (Drug)

Placebo

Placebo Comparator

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

Numerical Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 12

Time Frame: Baseline, Week 12

The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS Scale \>= 3 divided by the total number of days that diary data was collected at that visit. USS total range 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.

Secondary Outcomes

Numerical Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 4(Baseline, Week 4)
Percentage Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12(Baseline, Week 4 and 12)
Numerical Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12(Baseline, Week 4 and 12)
Percentage Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12(Baseline, Week 4 and 12)
Numerical Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12(Baseline, Week 4 and 12)
Percentage Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12(Baseline, Week 4 and 12)
Numerical Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12(Baseline, Week 4 and Week 12)
Percentage Change From Baseline in UUI Episodes Per 24 Hours at Week 4 and 12(Baseline, Week 4 and 12)
Numerical Change From Baseline in Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12(Baseline, Week 4 and 12)
Percentage Change From Baseline in Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12(Baseline, Week 4 and 12)
Numerical Change From Baseline in Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12(Baseline, Week 4 and 12)
Percentage Change From Baseline in Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12(Baseline, Week 4 and 12)
Numerical Change From Baseline in Urinary Sensation Scale (USS) Sum Rating Per 24 Hours at Week 4 and 12(Baseline, Week 4 and 12)
Change From Baseline in International Prostate Symptom Score (IPSS) Total Score (Sum Question 1 [Q1] to Q7) Per 24 Hours at Week 4 and 12(Baseline, Week 4 and 12)
Change From Baseline in IPSS Storage Domain (Sum Q2, Q4, and Q7) Per 24 Hours at Week 4 and 12(Baseline, Week 4 and 12)
Change From Baseline in IPSS Voiding Domain (Sum Q1, Q3, Q5, and Q6) Per 24 Hours at Week 4 and 12(Baseline, Week 4 and 12)
Change From Baseline in IPSS Quality of Life (QoL) Score (Q8) Per 24 Hours at Week 4 and 12(Baseline, Week 4 and 12)
Change From Baseline in IPSS Individual Item Scores (Q1, Q2, Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 4(Baseline, Week 4)
Change From Baseline in IPSS Individual Item Scores (Q1, Q2,Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 12(Baseline, Week 12)
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) Per 24 Hours at Week 4(Baseline, Week 4)
Number of Participants With Change From Baseline in PPBC Per 24 Hours at Week 12(Baseline, Week 12)
Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) Per 24 Hours at Week 4(Baseline, Week 4)
Number of Participants With Change From Baseline in Change From Baseline in UPS Per 24 Hours at Week 12.(Baseline, Week 12)
Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Per 24 Hours at Week 4 and 12(Baseline, Week 4 and 12)
Change From Baseline in Total Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12(Baseline, Week 4 and 12)
Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Concern Domain)(Baseline, Week 4 and 12)
Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Coping Domain)(Baseline, Week 4 and Week 12)
Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Sleep Domain)(Baseline, Week 4 and Week 12)
Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Social Interaction Domain)(Baseline, Week 4 and Week 12)
Change From Baseline in Post Void Residual (PVR) Urine Volume Per 24 Hours at Week 4, 8 and 12(Baseline, Week 4, 8 and 12)
Change From Baseline in Maximum Urinary Flow Rate (QMAX) Per 24 Hours at Week 12(Baseline, Week 12)
Number of Participants Reporting Urinary Retention Requiring Catheterization (All Causalities)(Baseline, Week 12)
Number of Participants Experiencing Adverse Events Related to Increased Voiding Difficulty (All Causalities)(Baseline, Week 12)

Investigators

Sponsor

Pfizer

Sponsor Class

Industry

Study Sites (1)

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