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

NCT07416227 | Recruiting DMC

• 1 other identifier: FMASU MD295/2025
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the effectiveness of Rezum therapy versus Prostatic Artery Embolization in managing moderate-to-severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH), with the primary endpoint being the improvement in the International Prostate Symptom Score (IPSS) over a 6-month follow-up period. Secondary endpoints include changes in post-void residual urine (PVR), maximum urinary flow rate (Qmax), patient-reported quality of life (QoL), and the preservation of ejaculatory and overall sexual function as assessed by validated questionnaires. This study aims to provide evidence-based guidance for optimizing treatment strategies for men with BPH, particularly those seeking alternatives to pharmacological therapy.

Conditions

Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms

Keywords

Comparison between Water Vapor Thermal Therapy and Prostatic Artery Embolization in treatment of Benign Prostatic Hyperplasia; Rezum vs Prostatic artery embolization in the treatment of Benign prostatic hyperplasia with lower urinary tract symptoms

Outcome Measures

Primary Outcomes (1)

• Improvement in the International Prostate Symptom Score (IPSS) over a 6-month follow-up period.

  Changes in a International Prostate Symptom Score (IPSS) will be measured to assess the degree of improvement after each procedure. Reduction of the score more than that it was before the procedure means better results and vice versa. (0-7) means mild symptoms , (8-19) means moderate symptoms and (20-35) means severe symptoms. The Unit of measure is a score .

  6 months follow up for each patient following the procedure

Secondary Outcomes (1)

• 1-Changes in post-voiding residual urine (PVR) assed by pelviabdomenal ultrasound in (mL) 2-Maximum urinary flow rate (Qmax) assessed by Uroflowmetry in (mL/s) 3-The preservation of ejaculatory function assessed by a validated questionnaire (MSHQ-EJD).

  6 months follow up for each patient following the procedure

Study Arms (2)

Arm A - Water Vapor Thermal Therapy (Rezum) group

EXPERIMENTAL

procedures will be performed with only sedation or under general anathesia according to the patient preference and anathesiologist recommendations in a lithotomy position. A single-use transurethral delivery device with an 18-gauge retractable needle is used to inject steam into the targeted area. The procedure is visualized using an integrated cystoscope with a standard 4 mm 30° lens. Saline irrigation is used to improve visualization and to cool down the urethral surface during the procedure. Injection starts 1 cm distal to the bladder neck at 3 and 9 o'clock positions. Each injection deploys 0.5 ml of steam over 9 s at 103 °C raising the tissue temperature to 70 °C and it is recommended to wait for a couple of seconds postinjection to avoid loss of vapor through the puncture site. After each injection, the needle is retracted and reinserted 1 cm distal to the previous injection until the proximal edge of the verumontanum creating tissue ablation along the prostatic urethra.

Procedure: Rezum

Arm B - Prostatic Artery Embolization (PAE)

ACTIVE COMPARATOR

Patients will undergo the procedure under local anathesia. The Patients will lie in supine position and sterilization of the groin will be done then puncture of the right femoral and/or left femoral artery will be done using puncture set after local anathesia. 6F vascular sheath, then a 5F cobra head catheter will be introduced in right and/or left femoral artery to catheterize one of the internal iliac artery then catheterizing its anterior division. An ipsilateral oblique view (30-40 degrees) and/or cranio-caudal view (10 degrees) will be obtained for differentiation of prostatic artery from other branches of anterior division \& for identification of prostatic artery origin. Selective catheterization of prostatic artery with suitable type of micro catheter and adjusted microwire angle. Embolizing material (400-500 micron microspheres) will be injected slowly and cautiously to avoid reflux under fluoroscopy guidance.

Procedure: Prostatic Artery Embolization

Interventions

Rezum PROCEDURE

A single-use transurethral delivery device with an 18-gauge retractable needle is used to inject steam into the targeted area with a fixed depth of 10.25 mm via 12 emitter holes spaced at the needle tip with an angle of 120°. The procedure is visualized using an integrated cystoscope with a standard 4 mm 30° lens. Saline irrigation is used to improve visualization and to cool down the urethral surface during the procedure. Injection starts 1 cm distal to the bladder neck at 3 and 9 o'clock positions. Each injection deploys 0.5 ml of steam over 9 s at 103 °C raising the tissue temperature to 70 °C and it is recommended to wait for a couple of seconds postinjection to avoid loss of vapor through the puncture site. After each injection, the needle is retracted and reinserted 1 cm distal to the previous injection until the proximal edge of the verumontanum creating tissue ablation along the prostatic urethra.

Arm A - Water Vapor Thermal Therapy (Rezum) group

Prostatic Artery Embolization PROCEDURE

Sterilization of the groin will be done then puncture of the right femoral and/or left femoral artery will be done using puncture set after local anathesia. 6F vascular sheath, then a 5F cobra head catheter will be introduced in right and/or left femoral artery to catheterize one of the internal iliac artery then catheterizing its anterior division. An ipsilateral oblique view (30-40 degrees) and/or cranio-caudal view (10 degrees) will be obtained for differentiation of prostatic artery from other branches of anterior division \& for identification of prostatic artery origin. Selective catheterization of prostatic artery with suitable type of micro catheter and adjusted microwire angle. Embolizing material (400-500 micron microspheres) will be injected slowly and cautiously to avoid reflux under fluoroscopy guidance.

Arm B - Prostatic Artery Embolization (PAE)

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: Only males are eligible to participate as the study is directed to assess the improvement of lower urinary tract symptoms due to Benign prostatic hyperplasia which is a male accessory sexual gland.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥50 years.
• IPSS ≥13.
• Prostate volume between 30-80 mL.
• Maximum urinary flow rate (Qmax) ≤15 mL/sec in patients with voiding LUTs.
• Patients not responding to medical treatment.

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Abbassia, 00202, Egypt

RECRUITING

Central Study Contacts

Seif AbdElmomen Yosef, MBBCh, MSc Faculty of Medicine

CONTACT

01093390291; siefabdelmomen@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Comparison between Water Vapor Thermal Therapy and Prostatic Artery Embolization in treatment of Benign Prostatic Hyperplasia

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: February 18, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

EG (1)