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CompletedNCT05982444Updated Jun 27, 2025

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

An interventional study of water vapor thermal therapy (Rezum) for prostate in Benign Prostatic Hyperplasia and Lower Urinary Track Symptoms, sponsored by Helwan University. Completed at 1 site in Egypt. Open to male participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-06-27.

Sponsored by Helwan University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 4 months after the study started (first participant enrolled Mar 2021, registered Jul 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
86
Allocation
Not applicable
Ages
40 Years to 80 Years
Sex
Male
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Study summary

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.

Read the 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.

02

Conditions studied

  • Benign Prostatic Hyperplasia
  • Lower Urinary Track Symptoms

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Keywords

  • water vapor thermal therapy
03

In context

Prostatic Hyperplasia

783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.

This study's enrollment of 86 is below the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.

Browse Prostatic Hyperplasia studies →

Lead sponsor

Helwan University is the lead sponsor of 69 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
86 participants (actual)

Study arms

  • 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

Interventions

  • Procedurewater vapor thermal therapy (Rezum) for prostate

    all patients underwent rezum therapy for bph are evaluated for its effectiveness for long period

    Also known as: Prostate steam treatment (Rezum) for benign prostatic hyperplasia (BPH)

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What researchers measure

Primary outcomes

  1. change in prostate volume

    Prostate volume will be measured via transrectal ultrasound.

    Time frame: 4 years

  2. hange in International Prostate Symptom Score (IPSS)

    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.

    Time frame: 4 years

  3. international index of erectile function (IIEF)

    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

    Time frame: 4 years

  4. Change in Post-Void Residual Urine

    Residual urine volume measured after urination using pelvic ultrasound.

    Time frame: 4 years

Secondary outcomes

  1. Retreatment Rate Following Rezūm Therapy

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

    Time frame: 4 years

  2. complication rate

    incidence of complications post procedure during follow-up

    Time frame: 4 years

07

Study locations

1 site
  • Faculty of Medicine Helwan University
    Helwan, Cairo Governorate 11795, Egypt
08

References and documents

Individual participant data

Plan to share: No — Patients are not permitted to post any of their personal information

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05982444
Lead sponsor
Helwan University
Responsible party
Mahmoud Mohammed Elsaid Ali Elshahawy (Principal Investigator, Faculty of medicine, Helwan University) — Principal investigator
First posted
Aug 8, 2023
Start date
Mar 1, 2021
Primary completion
Mar 1, 2025
Completion
May 1, 2025
Last update
Jun 27, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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