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

Condition(s) studied

Investigational drug(s) / intervention(s)

Rezum: 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.

Prostatic Artery Embolization: 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.

Study 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.

Eligibility

Primary outcome measure(s)

• Improvement in the International Prostate Symptom Score (IPSS) over a 6-month follow-up period. — 6 months follow up for each patient following the procedure
  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 .

Trial sites (1)

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