Effect and Safety Of Detrol LA In Men With Overactive Bladder Symptoms With Or Without Bladder Outlet Obstruction

Tracking Information
First Submitted Date ICMJE	September 2, 2005
First Posted Date ICMJE	September 7, 2005
Last Update Posted Date	June 8, 2011
Study Start Date ICMJE	November 2004
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: September 2, 2005)	Patient Perception of Treatment Benefit at Week 12:; Treatment benefit, treatment satisfaction, and willingness to continue treatment questions at week 12
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00147654 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: October 21, 2010)	Micturition Diary- Change in number of urge incontinence episodes per 24 hours at week 1, week 6 and 12 relative to baseline.; Change in number of urge episodes per 24 hours at week 1, week 6 and 12 relative to baseline.; Change in number of micturitions per 24 hours at week 1, week 6 and 12 relative to baseline.; Change in number of daytime micturitions per 24 hours at week 1, week 6 and 12 relative to baseline; Change in number of nighttime micturitions per 24 hours at week 1, week 6 and 12 relative to baseline; Change in the average severity of the Urinary Sensation Scale at week 1, week 6, and week 12 relative to baseline; 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; 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; 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; 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; 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; 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; International Prostate Symptom Score (I-PSS):; Change in I-PSS total score at weeks 1, 6 and 12 relative to baseline; Change in I-PSS individual item scores (Q1, Q2, Q3, Q4, Q5, Q6, and Q7) at weeks 1, 6 and 12 relative to baseline; Change in I-PSS irritative domain (Sum of Q2, Q4, and Q7) at weeks 1, 6 and 12 relative to baseline; Change in I-PSS obstructive domain (Sum of Q1, Q3, Q5, and Q6) at weeks 1, 6 and 12 relative to baseline; Change in I-PSS index score (Sum Q1 to Q7) at weeks 1, 6 and 12 relative to baseline; Change in I-PSS QoL score (Q8) at weeks 1, 6 and 12 relative to baseline; Patient perception of urgency:; Change in the Perception of Urgency Scale (3 point scale) at week 1, week 6 and week 12 relative to baseline; Change in Patient's Perception of Bladder Condition at week 1, week 6 and week 12 relative to baseline; Patient Perception of Treatment benefit at week 1 and week 6; Treatment benefit and treatment satisfaction questions will be completed at week 1 and week 6; 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; 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; 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
Original Secondary Outcome Measures ICMJE; (submitted: September 2, 2005)	Information was omitted due to their commercial sensitivity, and will be revealed at a later date; Micturition Diary:; Change in number of urge incontinence episodes per 24 hours at week 1, week 6 and 12 relative to baseline
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Effect and Safety Of Detrol LA In Men With Overactive Bladder Symptoms With Or Without Bladder Outlet Obstruction
Official Title ICMJE	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
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).
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
Condition ICMJE	Urinary Incontinence
Intervention ICMJE	Drug: Tolterodine ER 4 mg QD; Drug: Tamsulosin 0.4 mg QD
Study Arms	Not Provided
Publications *	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. Erratum in: JAMA. 2007 Mar 21:297(11):1195. JAMA. 2007 Oct 24;298(16):1864.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Enrollment ICMJE; (submitted: September 2, 2005)	830
Original Enrollment ICMJE	Same as current
Actual Study Completion Date	May 2006
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: Male
Ages	40 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00147654
Other Study ID Numbers ICMJE	A6121120
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	Pfizer
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account	Pfizer
Verification Date	June 2011
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP