Effect of finastride/ dutastride accompanying with tamsulosin in treatment of Benign prostate hyperplasia

Phase 3

Recruiting

Conditions: medical treatment of benign prostate hyperplasia.
Benign neoplasm of prostate
D29.1

Registration Number: IRCT20120516009772N2

Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Male

Target Recruitment: 175

Inclusion Criteria

prostate size larger than 30 gram
moderate to sever symptom (ipss>13)
older than 55 years old
Qmax of 4–15 mL/s from a pre-void bladder volume =150 and =550 mL (minimum voided volume 125 mL)
with >6 months history of BPH-LUTS

Exclusion Criteria

no surgical indication(bladder stone,uremia,urinary retention,gross hematuria,recurrent infection)
no previous prostate surgery
no urethral stricture
PSA>4
history of severe renal or hepatic insuf?ciency
History of bladder cancer or prostate cancer

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The comparison of the maximum flow rate (qmax) before , 3 and 6 moths after treatment in each group and among 5 groups under this study. Timepoint: before treatment and 3 ,6 months after treatment. Method of measurement: uroflowmetry.;The comparison of international prostate symptom score before, 3 and 6 months of treatment in each group and among 5 groups under treatment. Timepoint: before treatment ,3 and 6 months after tretment. Method of measurement: questionnaire.;The comparison of IIEF15 before ,3 and 6 months after treatment in each group among 5 groups under study. Timepoint: before treatment, 3 and 6 months after treatment. Method of measurement: IIEF15 Questionnaire.

Secondary Outcome Measures

Name	Time	Method
The comparison of complication after treatment among five groups under study. Timepoint: 3 and 6 months after treatment. Method of measurement: questionnaire.