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Completed

NCT Number: NCT00147654

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

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).

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

40 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tolterodine ER 4 mg QD

Drug

Tamsulosin 0.4 mg QD

Drug

Primary outcomes

  1. Patient Perception of Treatment Benefit at Week 12:

  2. Treatment benefit, treatment satisfaction, and willingness to continue treatment questions at week 12

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2004
Study completion
2006
First posted
Sep 7, 2005
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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