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

Purpose

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).

Condition	Intervention	Phase
Urinary Incontinence	Drug: Tolterodine ER 4 mg QD Drug: Tamsulosin 0.4 mg QD	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Tamsulosin Tamsulosin hydrochloride Tolterodine Tolterodine tartrate

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Patient Perception of Treatment Benefit at Week 12:
Treatment benefit, treatment satisfaction, and willingness to continue treatment questions at week 12

Secondary Outcome Measures:

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


Estimated Enrollment:	830
Study Start Date:	November 2004
Study Completion Date:	May 2006

Eligibility


Ages Eligible for Study:	40 Years and older (Adult, Senior)
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00147654

Show 95 Study Locations

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


ClinicalTrials.gov Identifier:	NCT00147654 History of Changes
Other Study ID Numbers:	A6121120
Study First Received:	September 2, 2005
Last Updated:	June 7, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Urinary Incontinence Enuresis Urinary Bladder Neck Obstruction Urination Disorders Urologic Diseases Lower Urinary Tract Symptoms Urological Manifestations Signs and Symptoms Behavioral Symptoms Elimination Disorders Mental Disorders Urethral Obstruction Urethral Diseases Urinary Bladder Diseases	Tamsulosin Tolterodine Tartrate Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Urological Agents Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents

ClinicalTrials.gov processed this record on September 30, 2016