Comparative Outcomes of Rezūm Versus EchoLaser for Treatment of Benign Prostatic Hyperplasia With Enlarged Median Lobe.

Официальное название

Comparative Outcomes of Rezūm (Water Vapor Therapy) Versus EchoLaser (Transperineal Laser Ablation) for Treatment of Benign Prostatic Hyperplasia With Enlarged Median Lobe. A Prospective Randomized Comparative Study.

Обзор

This study evaluates and compares two minimally invasive surgical therapies for treating men with benign prostatic hyperplasia (BPH) who specifically have an enlarged median lobe. The two treatments being compared are Rezūm (water vapor thermal therapy) and EchoLaser (transperineal laser ablation). Participants will be randomized into two equal groups to receive either the Rezūm treatment or the EchoLaser treatment. The primary goal of the study is to evaluate the change in urinary symptoms over a 6-month period using the International Prostate Symptom Score (IPSS). The study will also assess how well each treatment improves urine flow, reduces the size of the prostate, preserves sexual function, and minimizes complications.

Подробное описание

This is a single-center, prospective, randomized, active-controlled trial aiming to compare the clinical efficacy, safety profile, and functional outcomes of Rezūm water vapor thermal therapy versus EchoLaser transperineal laser ablation (TPLA). The trial focuses on symptomatic benign prostatic hyperplasia patients with a prostate volume between 30 mL and 80 mL and a confirmed enlarged intravesical median lobe. Eighty eligible male patients will be randomized 1:1 into two interventional groups: Group 1 (Rezūm Group): 40 patients will receive transurethral water vapor thermal therapy. The procedure involves targeted 9-second steam injections into the transition zone, alongside mandatory injections directed explicitly into the intravesical protruding median lobe to induce coagulative necrosis. Group 2 (EchoLaser TPLA Group): 40 patients will receive Transperineal Laser Ablation. Under real-time transrectal ultrasound (TRUS) guidance, optical fibers will deliver continuous-wave diode laser energy (1064 nm) directly to the adenoma and the obstructing median lobe. Patients will undergo clinical, functional, and safety assessments at 1, 3, and 6 months post-operatively. Follow-up evaluations include uroflowmetry (peak urinary flow rate and post-void residual volume), symptom assessment via IPSS, and sexual health evaluation using IIEF-5 and MSHQ-EjD questionnaires. Morphological changes, specifically the reduction in Total Prostate Volume (TPV) and median lobe volume, will be confirmed using TRUS or mpMRI at the 6-month follow-up. Postoperative complications will be monitored and systematically graded using the Clavien-Dindo classification system.

Вмешательства

• Устройство Rezūm Water Vapor Thermal Therapy
  Conducted via a transurethral approach. Standard 9-second thermal water vapor injections will be delivered into the transition zone, alongside mandatory, specifically angled injections directed explicitly into the intravesical protruding median lobe to induce targeted coagulative necrosis.
• Устройство EchoLaser Transperineal Laser Ablation (TPLA)
  Conducted via a transperineal approach. Under real-time transrectal ultrasound (TRUS) guidance, 21G introducer needles are placed, and optical fibers (300 µm) deliver continuous-wave diode laser energy (1064 nm) directly to the adenoma and the obstructing median lobe.

Первичные конечные точки

• Change in International Prostate Symptom Score (IPSS) [Срок оценки: Baseline to 6 months]

Вторичные конечные точки (2)

• Change in Peak Urinary Flow Rate (Qmax) [Срок оценки: Baseline, 1 month, 3 months, and 6 months]
• Change in Post-Void Residual Volume (PVR) [Срок оценки: Baseline, 1 month, 3 months, and 6 months]

Критерии участия

Критерии включения

Критерии включения

Male patients aged 50 years or older.

Diagnosis of symptomatic BPH with moderate-to-severe lower urinary tract symptoms, defined as an IPSS ≥ 12.

Total prostate volume between 30 mL and 80 mL, confirmed via Transrectal Ultrasound (TRUS) or mpMRI.

Presence of an enlarged, obstructing intravesical median lobe visualized via imaging or baseline cystoscopy.

Peak urinary flow rate (Qmax) between 5 and 15 mL/s with a minimum voided volume of ≥ 125 mL.

Критерии исключения

Confirmed or suspected prostate cancer (e.g., PSA > 4.0 ng/mL without a subsequent negative prostate biopsy or MRI).

History of prior surgical interventions for BPH (e.g., TURP, HOLEP, or other MISTs).

Presence of urethral strictures, bladder neck contracture, or established neurogenic bladder dysfunction.

Active urinary tract infection (UTI) or an episode of acute urinary retention requiring an indwelling catheter at the time of screening.

Previous pelvic radiation therapy or severe pelvic trauma.

Inability to safely pause anticoagulant/antiplatelet therapy per standard hospital perioperative protocols, if applicable.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07578428 · MS5/1/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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