A Clinical Trial Comparing Laser TURP With and Without Dutasteride.
The purpose of this research study is to determine if the study drug Dutasteride taken before and after Laser TURP(Transurethral Resection of the Prostate), can provide effective and safe, long term improvement of lower urinary tract symptoms.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Primary Purpose: Treatment
|Official Title:||A Randomized, Placebo-Controlled, Double-Masked Clinical Trial Comparing Laser TURP With and Without Neo-Adjuvant Dutasteride|
- Primary Outcome Measure will be the mean change in AUA Symptom Index at one year.
- Secondary Outcome Measures will be changes in AUA Symptom Index; Urinary Symptoms, Problems Due to Urinary Symptoms, Quality of Life Due to Urinary Problems, Qmax, prostate size (transitional zone) and total prostate volume.
|Study Start Date:||October 2006|
|Study Completion Date:||April 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00431626
|Principal Investigator:||Kevin T. McVary, MD||Northwestern University|