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

Study Description

Go to 

Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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).

Condition or disease	Intervention/treatment	Phase
Urinary Incontinence	Drug: Tolterodine ER 4 mg QD; Drug: Tamsulosin 0.4 mg QD	Phase 4

Study Design

Go to 

Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Enrollment :	830 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
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
Study Start Date :	November 2004
Actual Study Completion Date :	May 2006

Arms and Interventions

Go to 

Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

Go to 

Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Micturition Diary- Change in number of urge incontinence episodes per 24 hours at week 1, week 6 and 12 relative to baseline.
2. Change in number of urge episodes per 24 hours at week 1, week 6 and 12 relative to baseline.
3. Change in number of micturitions per 24 hours at week 1, week 6 and 12 relative to baseline.
4. Change in number of daytime micturitions per 24 hours at week 1, week 6 and 12 relative to baseline
5. Change in number of nighttime micturitions per 24 hours at week 1, week 6 and 12 relative to baseline
6. Change in the average severity of the Urinary Sensation Scale at week 1, week 6, and week 12 relative to baseline
7. 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
8. 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
9. 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
10. 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
11. 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
12. 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
13. International Prostate Symptom Score (I-PSS):
14. Change in I-PSS total score at weeks 1, 6 and 12 relative to baseline
15. Change in I-PSS individual item scores (Q1, Q2, Q3, Q4, Q5, Q6, and Q7) at weeks 1, 6 and 12 relative to baseline
16. Change in I-PSS irritative domain (Sum of Q2, Q4, and Q7) at weeks 1, 6 and 12 relative to baseline
17. Change in I-PSS obstructive domain (Sum of Q1, Q3, Q5, and Q6) at weeks 1, 6 and 12 relative to baseline
18. Change in I-PSS index score (Sum Q1 to Q7) at weeks 1, 6 and 12 relative to baseline
19. Change in I-PSS QoL score (Q8) at weeks 1, 6 and 12 relative to baseline
20. Patient perception of urgency:
21. Change in the Perception of Urgency Scale (3 point scale) at week 1, week 6 and week 12 relative to baseline
22. Change in Patient's Perception of Bladder Condition at week 1, week 6 and week 12 relative to baseline
23. Patient Perception of Treatment benefit at week 1 and week 6
24. Treatment benefit and treatment satisfaction questions will be completed at week 1 and week 6
25. 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
26. 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
27. 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

Eligibility Criteria

Go to 

Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	40 Years and older (Adult, Older Adult)
Sexes 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

Go to 

Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 95 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

Go to 

Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

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
First Posted:	September 7, 2005
Last Update Posted:	June 8, 2011
Last Verified:	June 2011

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