Clinical trial NCT00147654: Effect and Safety Of Detrol LA In Men With Overactive Bladder Symptoms With Or Without Bladder Outlet Obstruction
Official title: A Randomized, Double Blind, Placebo Controlled, Four Arm (Placebo, Tolterodine ER, Tamsulosin, and Tolterodine ER Plus Tamsulosin) Study To Evaluate The Clinical Efficacy And Safety Of Tolterodine ER 4 mg In Men Who Have Frequency and Urgency, With Or Without Urinary Urge Incontinence, With Or Without Bladder Outlet Obstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Incontinence
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-07
Enrollment: 830
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the trial is to evaluate the effect of tolterodine ER plus tamsulosin versus placebo on patient perception of overall treatment benefit in men who have frequency and urgency, with or without urinary urge incontinence (UUI), with or without bladder outlet obstruction (BOO).


Eligibility criteria: Inclusion Criteria:

* Male 40 years of age
* Clinical signs and symptoms of frequency and urgency, with or without UUI, with or without BOO, for at least three months
* Mean urinary frequency of 8 micturitions/24h verified by the Screening micturition diary

Exclusion Criteria:

* Post-void residual urine volume (PVR) of \> 200 ml as measured by an ultrasound
* Maximum urinary flow rate (Qmax) of \< 5 ml/second as measured by a flowmeter; a voided volume of 75 ml is required in order to accurately record the Qmax
* Prescribed and administered an antimuscarinic or antispasmodic within 1 month
* Prescribed and administered an a-1-adrenergic antagonist within 2 weeks

Primary outcomes:
measure: Patient Perception of Treatment Benefit at Week 12:
measure: Treatment benefit, treatment satisfaction, and willingness to continue treatment questions at week 12
Secondary outcomes:
measure: Micturition Diary- Change in number of urge incontinence episodes per 24 hours at week 1, week 6 and 12 relative to baseline.
measure: Change in number of urge episodes per 24 hours at week 1, week 6 and 12 relative to baseline.
measure: Change in number of micturitions per 24 hours at week 1, week 6 and 12 relative to baseline.
measure: Change in number of daytime micturitions per 24 hours at week 1, week 6 and 12 relative to baseline
measure: Change in number of nighttime micturitions per 24 hours at week 1, week 6 and 12 relative to baseline
measure: Change in the average severity of the Urinary Sensation Scale at week 1, week 6, and week 12 relative to baseline
measure: Change in number of OAB micturition episodes per 24 hours (OAB micturition is defined as micturition episodes associated with Urinary Sensation Scale score 3) at week 1, week 6 and week 12 relative to baseline
measure: Change in number of daytime OAB micturition episodes per 24 hours (OAB micturition is defined as micturition episodes associated with Urinary Sensation Scale score 3) at week 1, week 6 and week 12 relative to baseline
measure: Change in number of nighttime OAB micturition episodes per 24 hours. (severe OAB micturition is defined as micturition episodes associated with Urinary Sensation Scale score 4) at week 1, week 6 and week 12 relative to baseline
measure: Change in number of severe OAB micturition episodes per 24 hours (severe OAB micturition is defined as micturition episodes associated with Urinary Sensation Scale score 4) at week 1, week 6 and week 12 relative to baseline
measure: Change in number of daytime severe OAB micturition episodes per 24 hours (severe OAB micturition is defined as micturition episodes associated with Urinary Sensation Scale score 4) at week 1, week 6 and week 12 relative to baseline
measure: Change in number of nighttime severe OAB micturition episodes per 24 hours (severe OAB micturition is defined as micturition episodes associated with Urinary Sensation Scale score 4) at week 1, week 6 and week 12 relative to baseline
measure: International Prostate Symptom Score (I-PSS):
measure: Change in I-PSS total score at weeks 1, 6 and 12 relative to baseline
measure: Change in I-PSS individual item scores (Q1, Q2, Q3, Q4, Q5, Q6, and Q7) at weeks 1, 6 and 12 relative to baseline
measure: Change in I-PSS irritative domain (Sum of Q2, Q4, and Q7) at weeks 1, 6 and 12 relative to baseline
measure: Change in I-PSS obstructive domain (Sum of Q1, Q3, Q5, and Q6) at weeks 1, 6 and 12 relative to baseline
measure: Change in I-PSS index score (Sum Q1 to Q7) at weeks 1, 6 and 12 relative to baseline
measure: Change in I-PSS QoL score (Q8) at weeks 1, 6 and 12 relative to baseline
measure: Patient perception of urgency:
measure: Change in the Perception of Urgency Scale (3 point scale) at week 1, week 6 and week 12 relative to baseline
measure: Change in Patient's Perception of Bladder Condition at week 1, week 6 and week 12 relative to baseline
measure: Patient Perception of Treatment benefit at week 1 and week 6
measure: Treatment benefit and treatment satisfaction questions will be completed at week 1 and week 6
measure: Change in International Continence Society Male (ICSmaleLF) Questionnaire (long form modified) individual item scores at Week 1, Week 6 and Week 12 relative to baseline
measure: Change in the total score of Overactive Bladder Questionnaire (OABq) and change in total scores for each domain of OABq at week 6 and week 12 relative to baseline
measure: Change in the total score of International Index of Erectile Function (IIEF) and change in total scores for each domain of IIEF Questionnaire at week 6 and week 12 relative to baseline
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Homewood
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Anaheim
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facility: Pfizer Investigational Site
state: California
city: Culver City
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facility: Pfizer Investigational Site
state: California
city: Fresno
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facility: Pfizer Investigational Site
state: California
city: La Mesa
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facility: Pfizer Investigational Site
state: California
city: Long Beach
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facility: Pfizer Investigational Site
state: California
city: Los Angeles
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facility: Pfizer Investigational Site
state: California
city: Murrieta
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city: Poway
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city: San Bernardino
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city: Santa Monica
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city: Aurora
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state: Colorado
city: Boulder
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city: Denver
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city: New Britain
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state: Connecticut
city: Waterbury
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city: Melbourne
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city: Ocala
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city: Pembroke Pines
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city: Tallahassee
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city: Wellington
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city: Atlanta
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city: Cherry Hill
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city: Sewell
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city: Poughkeepsie
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city: Staten Island
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city: Syracuse
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city: Cincinnati
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city: Portland
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state: Oregon
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facility: Pfizer Investigational Site
state: Pennsylvania
city: Bala-Cynwyd
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Bryn Mawr
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: State College
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city: Wynnewood
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state: Pennsylvania
city: Providence
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state: Rhode Island
city: Charleston
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state: South Carolina
city: Greenwood
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state: South Carolina
city: Greer
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state: South Carolina
city: Prosperity
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state: South Carolina
city: Saluda
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state: South Carolina
city: Germantown
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state: Tennessee
city: Milan
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state: Tennessee
city: Arlington
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city: Austin
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facility: Pfizer Investigational Site
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city: Houston
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city: San Antonio
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state: Texas
city: Provo
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state: Utah
city: Alexandria
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Arlington
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Charlottesville
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Fairfax
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Virginia Beach
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Spokane
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Tacoma
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Cheyenne
country: United States
facility: Pfizer Investigational Site
state: Wyoming
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Kaplan SA, Roehrborn CG, Rovner ES, Carlsson M, Bavendam T, Guan Z. Tolterodine and tamsulosin for treatment of men with lower urinary tract symptoms and overactive bladder: a randomized controlled trial. JAMA. 2006 Nov 15;296(19):2319-28. doi: 10.1001/jama.296.19.2319.