Comparative Study Between Rezum and Tamsulosin

September 10, 2025 updated by: khaled Abdelsattar Gad Ibrahim

Comparison Between Convective Radiofrequency Water Vapor Thermal Ablation (REZUM) Versus Tamsulosin in Management of Lower Urinary Tract Symptoms in Patients With Benign Prostatic Enlargement

the investigators aimed to compare the efficacy and safety of Rezūm therapy for the management of benign prostatic hyperplasia (BPH) with Tamsulosin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

So far, data from available studies point towards good clinical outcomes with a short-term risk of self-limiting minor complications. Its application has demonstrated clinical effectiveness and possesses specific benefits that distinguish it among other treatments. It is applicable to outpatient setting, is effective in preserving sexual function and is versatile in its ability to treat a variety of prostate gland morphology.

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Nozha
      • Cairo, Nozha, Egypt, 4470351
        • The Armed Forces College of Medicine (AFCM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. with prostate volumes of 30- 80 mL,
  2. mild to mod LUTS
  3. (maximum urinary flow rate [Q max] of <15 mL/s
  4. International Prostate Symptom Score [IPSS] of >13)
  5. PVR urine < 250 ml

Exclusion Criteria:

  1. prostate cancer,
  2. neurogenic bladder
  3. urethral stricture,
  4. urinary bladder stone
  5. previous prostatic surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Rezum group
47 patient underwent Rezum therapy
Device: Rezum
Rezum procedure in Rezum group
Active Comparator: tamsulosin group
47 patients were given Tamsulosin medical treatment
Drug: Tamsulosin
Tamsulosin were given to Tamsulosin group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The International Prostate Symptom score (IPSS)
Time Frame: Time Frame: for each case in both groups the investigator assess IPSS at 3, 6, 12 after procedures through study completion, an average of 1 year
Measurement of The International Prostate Symptom score (IPSS) in both groups After 3, 6, 12 months of operation, the questioner is performed. Minimum :0 / Maximum : 35 Total score: 0-7 Mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic
Time Frame: for each case in both groups the investigator assess IPSS at 3, 6, 12 after procedures through study completion, an average of 1 year
The Maximum Urinary flow rate (Qmax)
Time Frame: Time Frame: for each case in both groups the investigator assess Qmax at 3, 6, 12 months after procedures through study completion, an average of 1year
Measurement of The Maximum Urinary flow rate (Qmax) in both groups After 3, 6, 12 months of operation, the procedure is performed. Qmax is measured by (ml/sec) Normal values are described as a Qmax above 15 ml/sec and below 10 ml/sec is considered abnormal
Time Frame: for each case in both groups the investigator assess Qmax at 3, 6, 12 months after procedures through study completion, an average of 1year
The Quality of Life (QoL)
Time Frame: [Time Frame: for each case in both groups the investigator assess QoL at 3, 6, 12 months after procedures through study completion, an average of 1 year
Measurement of The Quality of Life (QoL) in both groups After 3, 6, 12 months of operation, the questioner is performed. Minimum :0 means delighted / Maximum : 5 means unhappy
[Time Frame: for each case in both groups the investigator assess QoL at 3, 6, 12 months after procedures through study completion, an average of 1 year
The Prostate size
Time Frame: Time Frame: for each case in both groups the investigator assess prostate size at 3, 6, 12 months after procedures through study completion, an average of 1 year.
the prostate size was measured by grams by Trans-rectal ultra sound
Time Frame: for each case in both groups the investigator assess prostate size at 3, 6, 12 months after procedures through study completion, an average of 1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of complications
Time Frame: through 1 year
For each case in both groups the investigator assess the safety using incidence of complications by The Clavien-Dindo system. It uses a 5-grade scale (I-V), to classify complications from minor issues not requiring intervention (Grade I) to death (Grade V).
through 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

khaled Abdelsattar Gad Ibrahim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Actual)

May 1, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

September 4, 2025

First Submitted That Met QC Criteria

September 10, 2025

First Posted (Estimated)

September 12, 2025

Study Record Updates

Last Update Posted (Estimated)

September 12, 2025

Last Update Submitted That Met QC Criteria

September 10, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rezum procedure for BPH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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