Long Term Follow up of Water Vapor Thermal Therapy (Rezum) for Benign Prostatic Hyperplasia (BPH)

June 24, 2025 updated by: Mahmoud Mohammed Elsaid Ali Elshahawy, Helwan University

Long Term Post-operative Effectiveness and Morbidity of Rezum Therapy for Benign Prostatic Hyperplasia

This study aims to assess the effectiveness and morbidity of water vapor thermal therapy (Rezūm therapy) for benign prostatic hyperplasia (BPH). Data will be collected and analyzed from patients treated by Rezūm and followed up for 4 years prior to evaluating clinical outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators will conduct a retrospective study evaluating patients treated with water vapor thermal therapy (Rezūm therapy) for BPH and followed up for4 years. The primary objectives are to assess the long-term effectiveness and morbidity rates associated with the procedure. Data collected will include urinary symptom scores, sexual function, and any treatment-related complications.

Study Type

Interventional

Enrollment (Actual)

86

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
    • Cairo
      • Helwan, Cairo, Egypt, 11795
        • Faculty of Medicine Helwan University

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:

  • patients underwent rezum procedure for benign prostatic hyperplasia from 2 to 4 years

Exclusion Criteria:

  • previous prostatic intervention
  • concurrent urological morbidity like urethral stricture
  • neurological disease like parkinson's disease

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: patient treated by rezum procedure
patients had benign prostatic hyperplasia and treated by rezum procedure from 2 to 4 years included in the study
Procedure: water vapor thermal therapy (Rezum) for prostate
all patients underwent rezum therapy for bph are evaluated for its effectiveness for long period
Other Names:
  • Prostate steam treatment (Rezum) for benign prostatic hyperplasia (BPH)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in prostate volume
Time Frame: 4 years
Prostate volume will be measured via transrectal ultrasound.
4 years
hange in International Prostate Symptom Score (IPSS)
Time Frame: 4 years
IPSS is a questionnaire evaluating urinary symptoms. Scores ranging from 0 to 7 indicate mild symptoms, from 8 to 19 moderate symptoms, and from 20 to 35 severe symptoms.
4 years
international index of erectile function (IIEF)
Time Frame: 4 years
IIEF is a questionnaire evaluating sexual function. Scores ranging from 5 to 7 indicate severe symptoms, 8 to 11 moderate symptoms, 12 to 16 mild to moderate symptoms, 17 to 21 mild symptoms, and 22 to 25 no erectile dysfunction
4 years
Change in Post-Void Residual Urine
Time Frame: 4 years
Residual urine volume measured after urination using pelvic ultrasound.
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retreatment Rate Following Rezūm Therapy
Time Frame: 4 years
Number of participants requiring additional treatment for BPH after Rezūm therapy.
4 years
complication rate
Time Frame: 4 years
incidence of complications post procedure during follow-up
4 years

Collaborators and Investigators

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

Sponsor

Helwan University

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)

March 1, 2021

Primary Completion (Actual)

March 1, 2025

Study Completion (Actual)

May 1, 2025

Study Registration Dates

First Submitted

July 24, 2023

First Submitted That Met QC Criteria

August 1, 2023

First Posted (Actual)

August 8, 2023

Study Record Updates

Last Update Posted (Actual)

June 27, 2025

Last Update Submitted That Met QC Criteria

June 24, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 30-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Patients are not permitted to post any of their personal information

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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