The effect of the ethanol injection in prostate tissue versus no injection for treatment of benign prostatic hyperplasia

The effect of the ethanol injection in prostate tissue versus no injection for treatment of benign prostatic hyperplasia: a before after clinical trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT201407049014N39

Enrollment

Registered

2014-07-04

Start date

2014-07-23

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Benign Prostate Hyperplasia. Hyperplasia of prostate

Interventions

Intervention 1: injection of 10 to 20 ml alcohol 98% into prostatic tissue in 4 to 10 location. Intervention 2: comparison with situation before intervention.

Treatment - Drugs

injection of 10 to 20 ml alcohol 98% into prostatic tissue in 4 to 10 location

comparison with situation before intervention

Eligibility

Sex/Gender

Male

Age

40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
Measuring the injection induced pain. Timepoint: immediately after injection. Method of measurement: using visual analog scale (VAS).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Mohammad Reza Mojallali

Shahid Beheshti Hospital

rezamojallal@yahoo.com+98 81 3264 0021

Outcome results

None listed

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