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

Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00147654
Collaborator
(none)
830
95
17.9
8.7
0.5

Study Details

Study Description

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
  • Drug: Tolterodine ER 4 mg QD
  • Drug: Tamsulosin 0.4 mg QD
Phase 4

Study Design

Study Type:
Interventional
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 :
Nov 1, 2004
Actual Study Completion Date :
May 1, 2006

Outcome Measures

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

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site Birmingham Alabama United States
2 Pfizer Investigational Site Homewood Alabama United States
3 Pfizer Investigational Site Tucson Arizona United States
4 Pfizer Investigational Site Anaheim California United States
5 Pfizer Investigational Site Culver City California United States
6 Pfizer Investigational Site Fresno California United States
7 Pfizer Investigational Site La Mesa California United States
8 Pfizer Investigational Site Long Beach California United States
9 Pfizer Investigational Site Los Angeles California United States
10 Pfizer Investigational Site Murrieta California United States
11 Pfizer Investigational Site Poway California United States
12 Pfizer Investigational Site San Bernardino California United States
13 Pfizer Investigational Site Santa Monica California United States
14 Pfizer Investigational Site Aurora Colorado United States
15 Pfizer Investigational Site Boulder Colorado United States
16 Pfizer Investigational Site Denver Colorado United States
17 Pfizer Investigational Site New Britain Connecticut United States
18 Pfizer Investigational Site Waterbury Connecticut United States
19 Pfizer Investigational Site Melbourne Florida United States
20 Pfizer Investigational Site Ocala Florida United States
21 Pfizer Investigational Site Pembroke Pines Florida United States
22 Pfizer Investigational Site Tallahassee Florida United States
23 Pfizer Investigational Site Wellington Florida United States
24 Pfizer Investigational Site Atlanta Georgia United States
25 Pfizer Investigational Site Columbus Georgia United States
26 Pfizer Investigational Site Roswell Georgia United States
27 Pfizer Investigational Site Melrose Park Illinois United States
28 Pfizer Investigational Site Evansville Indiana United States
29 Pfizer Investigational Site Jeffersonville Indiana United States
30 Pfizer Investigational Site Iowa City Iowa United States
31 Pfizer Investigational Site Overland Park Kansas United States
32 Pfizer Investigational Site Shreveport Louisiana United States
33 Pfizer Investigational Site Boston Massachusetts United States
34 Pfizer Investigational Site Brighton Massachusetts United States
35 Pfizer Investigational Site Watertown Massachusetts United States
36 Pfizer Investigational Site Columbia Missouri United States
37 Pfizer Investigational Site O'Fallon Missouri United States
38 Pfizer Investigational Site Saint Louis Missouri United States
39 Pfizer Investigational Site Missoula Montana United States
40 Pfizer Investigational Site Henderson Nevada United States
41 Pfizer Investigational Site Las Vegas Nevada United States
42 Pfizer Investigational Site Cherry Hill New Jersey United States
43 Pfizer Investigational Site Edison New Jersey United States
44 Pfizer Investigational Site Hamilton New Jersey United States
45 Pfizer Investigational Site Lawrenceville New Jersey United States
46 Pfizer Investigational Site Marlton New Jersey United States
47 Pfizer Investigational Site Mount Laurel New Jersey United States
48 Pfizer Investigational Site Sewell New Jersey United States
49 Pfizer Investigational Site Voorhees New Jersey United States
50 Pfizer Investigational Site Westhampton New Jersey United States
51 Pfizer Investigational Site Woodbury New Jersey United States
52 Pfizer Investigational Site Albuquerque New Mexico United States
53 Pfizer Investigational Site Albany New York United States
54 Pfizer Investigational Site Bay Shore New York United States
55 Pfizer Investigational Site Carmel New York United States
56 Pfizer Investigational Site Cortlandt Manor New York United States
57 Pfizer Investigational Site Garden City New York United States
58 Pfizer Investigational Site Manhasset New York United States
59 Pfizer Investigational Site New York New York United States
60 Pfizer Investigational Site Orchard Park New York United States
61 Pfizer Investigational Site Poughkeepsie New York United States
62 Pfizer Investigational Site Staten Island New York United States
63 Pfizer Investigational Site Syracuse New York United States
64 Pfizer Investigational Site Cincinnati Ohio United States
65 Pfizer Investigational Site Cleveland Ohio United States
66 Pfizer Investigational Site Columbus Ohio United States
67 Pfizer Investigational Site Oklahoma City Oklahoma United States
68 Pfizer Investigational Site Portland Oregon United States
69 Pfizer Investigational Site Allentown Pennsylvania United States
70 Pfizer Investigational Site Bala-Cynwyd Pennsylvania United States
71 Pfizer Investigational Site Bryn Mawr Pennsylvania United States
72 Pfizer Investigational Site Philadelphia Pennsylvania United States
73 Pfizer Investigational Site State College Pennsylvania United States
74 Pfizer Investigational Site Wynnewood Pennsylvania United States
75 Pfizer Investigational Site Providence Rhode Island United States
76 Pfizer Investigational Site Charleston South Carolina United States
77 Pfizer Investigational Site Greenwood South Carolina United States
78 Pfizer Investigational Site Greer South Carolina United States
79 Pfizer Investigational Site Prosperity South Carolina United States
80 Pfizer Investigational Site Saluda South Carolina United States
81 Pfizer Investigational Site Germantown Tennessee United States
82 Pfizer Investigational Site Milan Tennessee United States
83 Pfizer Investigational Site Arlington Texas United States
84 Pfizer Investigational Site Austin Texas United States
85 Pfizer Investigational Site Houston Texas United States
86 Pfizer Investigational Site San Antonio Texas United States
87 Pfizer Investigational Site Provo Utah United States
88 Pfizer Investigational Site Alexandria Virginia United States
89 Pfizer Investigational Site Arlington Virginia United States
90 Pfizer Investigational Site Charlottesville Virginia United States
91 Pfizer Investigational Site Fairfax Virginia United States
92 Pfizer Investigational Site Virginia Beach Virginia United States
93 Pfizer Investigational Site Spokane Washington United States
94 Pfizer Investigational Site Tacoma Washington United States
95 Pfizer Investigational Site Cheyenne Wyoming United States

Sponsors and Collaborators

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

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00147654
Other Study ID Numbers:
  • A6121120
First Posted:
Sep 7, 2005
Last Update Posted:
Jan 27, 2021
Last Verified:
Jan 1, 2021

Study Results

No Results Posted as of Jan 27, 2021