Actively Recruiting

Phase Not Applicable
Age: 50Years +
MALE
ID07416227

Comparison Between Water Vapor Thermal Therapy and Prostatic Artery Embolization in Treatment of Benign Prostatic Hyperplasia

Led by Ain Shams University · Updated on 2026-02-18

30

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating two procedures, Rezum therapy and Prostatic Artery Embolization, for men aged 50 and older with moderate-to-severe lower urinary tract symptoms caused by benign prostatic hyperplasia (BPH). The study seeks to compare how well these treatments improve symptoms using the International Prostate Symptom Score (IPSS) over six months. It also looks at urine retention, urine flow rate, quality of life, and sexual function to guide treatment choices for men wanting alternatives to medication. Participants are randomly assigned to one of two groups. The Rezum group receives steam injections into the prostate using a special device under sedation or general anesthesia to heat and shrink prostate tissue. The Prostatic Artery Embolization group undergoes a minimally invasive procedure under local anesthesia where small particles are injected into arteries supplying the prostate to reduce its size. Both procedures involve specific catheter or needle techniques and imaging guidance. During the study, participants have a full medical evaluation including imaging and lab tests before treatment. Follow-up visits occur at 1, 3, and 6 months after treatment to assess symptoms and quality of life through questionnaires, urine flow tests, and ultrasound scans. Researchers monitor treatment effects, safety, and patient well-being throughout the study lasting at least six months per participant. Data on operative and post-operative outcomes will be analyzed to compare these two treatment methods.

CONDITIONS

Brief Title

Comparison Between Water Vapor Thermal Therapy and Prostatic Artery Embolization in Treatment of Benign Prostatic Hyperplasia

Who Can Participate

Age: 50Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 50 years or older
  • International Prostate Symptom Score (IPSS) of 13 or higher
  • Prostate volume between 30 and 80 milliliters
  • Maximum urinary flow rate (Qmax) of 15 mL/sec or less in patients with voiding lower urinary tract symptoms
  • Patients not responding to medical treatment
Not Eligible

You will not qualify if you...

  • History or suspicion of prostate cancer
  • Previous prostate surgery or minimally invasive BPH intervention
  • Neurological bladder dysfunction
  • Active urinary tract infection

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single treatment procedure

Participants receive either water vapor thermal therapy (Rezum) under sedation or general anesthesia, or prostatic artery embolization under local anesthesia to treat benign prostatic hyperplasia.

1 treatment visit (in-person)

Follow-up

Duration - 6 months

Participants are monitored to assess symptom improvement and treatment effects through questionnaires, uroflowmetry, and pelvic ultrasound.

Visits at 1, 3, and 6 months post-treatment

Trial Site Locations

Total: 1 location

1

Ain Shams University

Cairo, Abbassia, Egypt, 00202

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Research Team

S

Seif AbdElmomen Yosef, MBBCh, MSc Faculty of Medicine

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Frequently Asked Questions

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