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NCT Number: NCT05982444

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

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.

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Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Lower Urinary Track Symptoms Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

40 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine Helwan University

Helwan, Cairo Governorate, 11795, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

water vapor thermal therapy (Rezum) for prostate

Procedure

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)

Primary outcomes

  1. change in prostate volume

    Time frame: 4 years

    Prostate volume will be measured via transrectal ultrasound.

  2. 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.

  3. 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. Change in Post-Void Residual Urine

    Time frame: 4 years

    Residual urine volume measured after urination using pelvic ultrasound.

Secondary outcomes

  1. Retreatment Rate Following Rezūm Therapy

    Time frame: 4 years

    Number of participants requiring additional treatment for BPH after Rezūm therapy.

  2. complication rate

    Time frame: 4 years

    incidence of complications post procedure during follow-up

Sponsors and collaborators

Lead sponsor

Helwan University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Aug 8, 2023
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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