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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00147654
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : June 8, 2011
Sponsor:
Information provided by:
Pfizer

Study Description
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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
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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

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Arms and Interventions
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Outcome Measures
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00147654


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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

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ClinicalTrials.gov Identifier: NCT00147654    
Other Study ID Numbers: A6121120
First Posted: September 7, 2005    Key Record Dates
Last Update Posted: June 8, 2011
Last Verified: June 2011
Additional relevant MeSH terms:
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Urinary Incontinence
Urinary Bladder Neck Obstruction
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
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