The effect of the ethanol injection in prostate tissue versus no injection for treatment of benign prostatic hyperplasia
Phase 2
- Conditions
- Benign Prostate Hyperplasia.Hyperplasia of prostate
- Registration Number
- IRCT201407049014N39
- Lead Sponsor
- Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 31
Inclusion Criteria
(a) patients with benign prostatic hyperplasia; (b) age of 40 years or older; (c) contraindication for prostatic surgery; (d) Unable to tolerate adverse effect of prostatic drug treatment; (e) prostatic surgery refusal.
Exclusion criteria: (a) history of prostatic surgery; (b) having prostatic cancer.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of urinary problem. Timepoint: before surgery and 3 and 6 months later. Method of measurement: using International Prostatic Symptoms Scale-IPSS.;Evaluation of maximum urine flow. Timepoint: before surgery and 3 and 6 months later. Method of measurement: using Peak Flow Rate.;Measuring the prostatic volume. Timepoint: before surgery and 3 and 6 months later. Method of measurement: using ultrasonography.;Measuring the remained urine volume. Timepoint: before surgery and 3 and 6 months later. Method of measurement: using ultrasonography.;Measuring the prostatic specific antigen (PSA). Timepoint: before surgery and 3 and 6 months later. Method of measurement: through blood sampling.
- Secondary Outcome Measures
Name Time Method Measuring the injection induced pain. Timepoint: immediately after injection. Method of measurement: using visual analog scale (VAS).