Phase 3 N=947 Randomized Quadruple-blind Treatment

Fesoterodine "add-on" Male Overactive Bladder Study

Overactive Bladder Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT00546637 ↗

Enrolled (actual)

947

Serious AEs

2.3%

Results posted

Nov 2010

Primary outcome: Primary: Numerical Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 12 — -3.2; -2.9 number of episodes — p=0.1959

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Fesoterodine (Drug); Placebo (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: Male
Sponsor: Pfizer
Primary completion: Feb 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Numerical Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 12	-3.2; -2.9	0.1959
SECONDARY Numerical Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 4	-2.3; -1.9	0.0621
SECONDARY Percentage Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12	-30.8; -20.7; -43.8; -35.7	—
SECONDARY Numerical Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12	-1.3; -0.8; -1.9; -1.5	0.0056 sig
SECONDARY Percentage Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12	-12.0; -7.3; -14.9; -12.5	0.0012 sig
SECONDARY Numerical Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12	-0.4; -0.3; -0.6; -0.5	0.1112
SECONDARY Percentage Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12	-16.7; -11.1; -25.0; -16.7	—
SECONDARY Numerical Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12	-0.3; -0.7; -0.7; -0.7	0.3847
SECONDARY Percentage Change From Baseline in UUI Episodes Per 24 Hours at Week 4 and 12	-100.0; -100.0; -100.0; -100.0	—
SECONDARY Numerical Change From Baseline in Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12	-1.0; -1.0; -1.3; -1.0	0.0062 sig
SECONDARY Percentage Change From Baseline in Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12	-78.6; -60.0; -100.0; -88.4	0.0025 sig
SECONDARY Numerical Change From Baseline in Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12	-0.7; -0.6; -0.9; -0.9	0.1748
SECONDARY Percentage Change From Baseline in Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12	-33.3; -25.0; -50.0; -40.0	—
SECONDARY Numerical Change From Baseline in Urinary Sensation Scale (USS) Sum Rating Per 24 Hours at Week 4 and 12	-6.4; -4.7; -8.9; -7.8	0.0051 sig
SECONDARY 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	-3.4; -3.1; -4.4; -4.4	0.3579
SECONDARY Change From Baseline in IPSS Storage Domain (Sum Q2, Q4, and Q7) Per 24 Hours at Week 4 and 12	-1.8; -1.4; -2.4; -2.1	0.0223 sig
SECONDARY Change From Baseline in IPSS Voiding Domain (Sum Q1, Q3, Q5, and Q6) Per 24 Hours at Week 4 and 12	-1.6; -1.7; -2.1; -2.3	0.7564
SECONDARY Change From Baseline in IPSS Quality of Life (QoL) Score (Q8) Per 24 Hours at Week 4 and 12	-0.6; -0.5; -1.0; -1.0	0.1472
SECONDARY Change From Baseline in IPSS Individual Item Scores (Q1, Q2, Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 4	-0.6; -0.6; -0.8; -0.5; -0.4; -0.4	0.6621
SECONDARY Change From Baseline in IPSS Individual Item Scores (Q1, Q2,Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 12	-0.7; -0.8; -0.9; -0.8; -0.5; -0.6	0.1595
SECONDARY Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) Per 24 Hours at Week 4	83; 63; 171; 160; 180; 212	0.1136
SECONDARY Number of Participants With Change From Baseline in PPBC Per 24 Hours at Week 12	124; 130; 166; 138; 148; 170	0.5775
SECONDARY Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) Per 24 Hours at Week 4	111; 98; 306; 326; 41; 34	0.7433
SECONDARY Number of Participants With Change From Baseline in Change From Baseline in UPS Per 24 Hours at Week 12.	132; 129; 290; 299; 37; 31	0.9402
SECONDARY Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Per 24 Hours at Week 4 and 12	-11.6; -8.9; -15.2; -12.4	0.0040 sig
SECONDARY Change From Baseline in Total Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12	8.7; 6.9; 11.5; 10.0	0.0412 sig
SECONDARY 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)	9.7; 8.0; 12.4; 11.1	0.0941
SECONDARY 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)	9.6; 7.5; 12.5; 10.6	0.0507
SECONDARY 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)	9.6; 7.6; 13.8; 11.5	0.0845
SECONDARY 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)	5.2; 3.7; 6.3; 6.0	0.1085
SECONDARY Change From Baseline in Post Void Residual (PVR) Urine Volume Per 24 Hours at Week 4, 8 and 12	0.0; 0.0; 0.0; 0.0; 3.5; 0.0	0.0005 sig
SECONDARY Change From Baseline in Maximum Urinary Flow Rate (QMAX) Per 24 Hours at Week 12	0.0; 0.0	0.2251
SECONDARY Number of Participants Reporting Urinary Retention Requiring Catheterization (All Causalities)	1; 1	—
SECONDARY Number of Participants Experiencing Adverse Events Related to Increased Voiding Difficulty (All Causalities)	16; 4; 11; 2; 4; 0	—

Summary

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

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00546637). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.