Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05982444
Enrollment
86
Registered
2023-08-08
Start date
2021-03-01
Completion date
2025-05-01
Last updated
2025-06-27

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

Conditions

Benign Prostatic Hyperplasia, Lower Urinary Track Symptoms

Keywords

water vapor thermal therapy

Brief 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.

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.

Interventions

PROCEDUREwater vapor thermal therapy (Rezum) for prostate

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

Sponsors

Helwan University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
40 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
change in prostate volume4 yearsProstate volume will be measured via transrectal ultrasound.
hange in International Prostate Symptom Score (IPSS)4 yearsIPSS 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.
international index of erectile function (IIEF)4 yearsIIEF 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
Change in Post-Void Residual Urine4 yearsResidual urine volume measured after urination using pelvic ultrasound.

Secondary

MeasureTime frameDescription
Retreatment Rate Following Rezūm Therapy4 yearsNumber of participants requiring additional treatment for BPH after Rezūm therapy.
complication rate4 yearsincidence of complications post procedure during follow-up

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026