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

The Efficacy and side effects of different doses of finastride/ dutastride accompanying with tamsulosin for Benign prostate hyperplasia in Iranian men

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20120516009772N2

Enrollment

175

Registered

2021-01-18

Start date

2019-09-22

Completion date

Unknown

Last updated

2021-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

medical treatment of benign prostate hyperplasia. Benign neoplasm of prostate

Interventions

Intervention 1: Control group: patients with benign prostate hyperplasia take tamsulosin 0.4 mg (made by tasnim company)and placebo(made by tasnim company) daily for six months. Intervention 2: Interv

Eligibility

Sex/Gender

Male

Age

55 Years to 75 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

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

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmir Reza Abedi

Shahid Beheshti University of Medical Sciences

amirezabedi@gmail.com+98 21 2271 8014

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026