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Dutasteride With Tolterodine ER or Placebo to Treat Lower Urinary Tract Symptoms (LUTS) (LUTS)

This study has been completed.
Sponsor:
Collaborators:
GlaxoSmithKline
Pfizer
Information provided by (Responsible Party):
Paul F. Siami, MD, Siami, Paul F., M.D.
ClinicalTrials.gov Identifier:
NCT00939120
First received: June 12, 2009
Last updated: April 15, 2015
Last verified: April 2015
Results First Received: March 16, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Benign Prostatic Hyperplasia (BPH)
Interventions: Drug: Tolterodine ER 4mg
Drug: Placebo
Drug: Pre-randomization Dutasteride

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Tolterodine ER 4mg + Dutasteride 0.5mg Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
Placebo + Dutasteride 0.5mg Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.

Participant Flow:   Overall Study
    Tolterodine ER 4mg + Dutasteride 0.5mg   Placebo + Dutasteride 0.5mg
STARTED   23   23 
COMPLETED   15   18 
NOT COMPLETED   8   5 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Number of patients randomized into control or experimental groups.

Reporting Groups
  Description
Tolterodine ER 4mg + Dutasteride 0.5mg Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
Placebo + Dutasteride 0.5mg Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
Total Total of all reporting groups

Baseline Measures
   Tolterodine ER 4mg + Dutasteride 0.5mg   Placebo + Dutasteride 0.5mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 23   23   46 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 68.6  (9.5)   67.7  (7.4)   68.2  (8.4) 
[1] Age of patient at enrollment
Gender [1] 
[Units: Participants]
     
Female   0   0   0 
Male   23   23   46 
[1] Gender of participant.
Race (NIH/OMB) [1] 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   0   1   1 
White   23   22   45 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
[1] Race of the participant.
Region of Enrollment [1] 
[Units: Participants]
     
United States   23   23   46 
[1] Region in which participant was enrolled.
Prostate volume [1] 
[Units: mL]
Mean (Standard Deviation)
 43.9  (15.8)   43.1  (16.0)   43.5  (15.7) 
[1] Prostate volume measured by transrectal ultrasound, age-adjusted for this study.
Prostate specific antigen [1] 
[Units: ng/mL]
Mean (Standard Deviation)
 4.0  (2.1)   5.3  (8.8)   4.6  (6.4) 
[1] Prostate specific antigen measured via blood test.
Voided volume [1] 
[Units: mL]
Mean (Standard Deviation)
 202.5  (96.5)   273.7  (189.9)   238.1  (153.2) 
[1] Voided urinary volume via uroflowmetry.
Maximum flow rate [1] 
[Units: mL/sec]
Mean (Standard Deviation)
 11.1  (3.5)   12.4  (4.8)   11.7  (4.2) 
[1] Maximum urine flow rate (Qmax) measured via uroflowmetry.
Post-void residual volume [1] 
[Units: mL]
Mean (Standard Deviation)
 93.0  (69.2)   81.6  (60.7)   87.3  (64.6) 
[1] Post-voiding residual volume (PVR) measured in each participant via ultrasound.
Overactive bladder questionnaire [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 86.4  (22.3)   86.1  (29.9)   86.3  (26.1) 
[1] The Overactive Bladder Questionnaire score is based on the answers to 33 questions concerning bladder symptoms. Each question is assigned points from 1 to 6 indicating increasing severity of the particular symptom. The total score can therefore range from 33 to 198 (asymptomatic to very symptomatic).
Patient's perception of bladder condition [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 3.7  (0.9)   3.7  (1.0)   3.7  (0.9) 
[1] Patient-reported scores on a scale of 1-6 indicating how their bladder condition affects them. Scores are as follows: 1 = Does not cause me any problems at all; 2 = Causes me some very minor problems; 3 = Causes me some minor problems; 4 = Causes me (some) moderate problems; 5 = Causes me severe problems; 6 = Causes me many severe problems.
International prostate symptoms score, total [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 18.0  (6.2)   17.7  (4.5)   17.9  (5.4) 
[1] The IPSS is based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).
International prostate symptoms score, voiding subscore [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 9.1  (4.3)   9.0  (3.8)   9.1  (4.0) 
[1]

The IPSS is based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).

Voiding sub-component is 4/7 questions, thus ranging from 0-20.

International prostate symptoms score, storage subscore [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 8.9  (2.7)   8.7  (2.2)   8.8  (2.4) 
[1]

The IPSS is based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).

Storage sub-component is 3/7 questions, thus ranging from 0-15.

Urinary urgency [1] 
[Units: Urgency episodes]
Mean (Standard Deviation)
 6.7  (3.5)   8.6  (3.5)   7.7  (3.6) 
[1] Patient reported number of urgency episodes during a 24-hour period.
Urinary frequency [1] 
[Units: Frequency episodes]
Mean (Standard Deviation)
 11.3  (2.2)   11.4  (2.2)   11.3  (2.2) 
[1] Participant reported urinary frequency episodes during a 24-hour period.


  Outcome Measures
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1.  Primary:   Post-void Residual (PVR) Volume   [ Time Frame: 12 months ]

2.  Primary:   Maximum Urine Flow Rate (Qmax).   [ Time Frame: 12 months ]

3.  Primary:   Urine Voided Volume (Voiding)   [ Time Frame: 12 months ]

4.  Primary:   Acute Urinary Retention (AUR)   [ Time Frame: 12 months ]

5.  Secondary:   Overactive Bladder Questionnaire (OABq)   [ Time Frame: 12 months ]

6.  Secondary:   Patient Perception of Bladder Condition (PPBC)   [ Time Frame: 12 months ]

7.  Secondary:   International Prostate Symptoms Score (IPSS), Total   [ Time Frame: 12 months ]

8.  Secondary:   International Prostate Symptoms Score, Voiding Subscore   [ Time Frame: 12 months ]

9.  Secondary:   International Prostate Symptoms Score (IPSS), Storage Subscore   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Paul Siami
Organization: Research institute at Deaconess Clinic
phone: 812-426-9548
e-mail: paul.siami@deaconess.com



Responsible Party: Paul F. Siami, MD, Siami, Paul F., M.D.
ClinicalTrials.gov Identifier: NCT00939120     History of Changes
Other Study ID Numbers: 110983
Study First Received: June 12, 2009
Results First Received: March 16, 2015
Last Updated: April 15, 2015
Health Authority: United States: Food and Drug Administration