Comparing Water Vapour Thermal Therapy (Rezūm) and TURP

Официальное название

A Randomized Controlled Trial Comparing Water Vapour Thermal Therapy (Rezūm) and TURP in Men With Benign Prostatic Hyperplasia in Refractory Urinary Retention

Обзор

This is a randomized controlled trial using a non-inferiority design with the subjects randomized 1:1 to either water vapour thermal treatment (REZUM) arm or transurethral resection of prostate (TURP) arm.

Вмешательства

• Устройство Rezūm
  In the REZUM arm, water vapour treatment is performed for all subjects under local anaesthesia.
• Устройство TURP
  In the TURP arm, all men will receive TURP operation under general or spinal anaesthesia

Первичные конечные точки

• Changes in International Prostate Symptom Score (IPSS) at 12 months after treatment [Срок оценки: Baseline, 3 months, 6 months and 12 months after intervention]

Вторичные конечные точки (7)

• Successful trial without catheter (TWOC) within 3 months [Срок оценки: At 3 months]
• Complication rate [Срок оценки: 30 days after intervention]
• Post-op quality of life score [Срок оценки: Baseline, 3 months, 6 months and 12 months after intervention]
• Change in voiding function in uroflowmetry [Срок оценки: Baseline, 3 months, 6 months and 12 months after intervention]
• Post-op International Index of Erectile function score [Срок оценки: Baseline, 3 months, 6 months and 12 months after intervention]
• Hospital stays of procedure [Срок оценки: On Discharge]
• Unplanned readmission rate after operation in 30 days [Срок оценки: 30 days after intervention]

Критерии участия

Критерии включения

• Men 50-80 years
• Refractory urinary retention related to benign prostatic hyperplasia (BPH)
• On urethral Foley's catheter before treatment
• Prostate size 30-80ml on ultrasound

Критерии исключения

• Prior prostate operation
• Past or current history of prostate cancer
• Strong suspicion of prostate cancer (e.g. Elevated PSA before urinary retention or abnormal prostate on DRE without workup for prostate cancer)
• Known Urethral stricture / Bladder stone / Hypocontractile bladder
• Known neurological diseases which may affect bladder function (e.g. Parkinsonism, stroke)
• Contraindicated to undergo TURP or REZUM (e.g. not fit for GA/SA, active urinary tract infection, fail to be placed in lithotomy position, uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped)

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

Гонконг · 1 центр

• Prince of Wales Hospital, Chinese University of Hong Kong — Гонконг

Публикации

• Ng CF, Yee CH, Chan CK, Wong HM, Chiu PK, Tsu JH, Teoh JY, Ho KL. Bipolar transurethral vapourisation versus monopolar transurethral resection of prostate: a randomised controlled trial. Hong Kong Med J. 2017 Jun;23 Suppl 2(3):32-34. No abstract available. PMID 29938669
• Yee CH, Wong JH, Chiu PK, Teoh JY, Chan CK, Chan ES, Hou SM, Ng CF. Secondary hemorrhage after bipolar transurethral resection and vaporization of prostate. Urol Ann. 2016 Oct-Dec;8(4):458-463. doi: 10.4103/0974-7796.192110. PMID 28057992
• Yee CH, Wong JH, Chiu PK, Chan CK, Lee WM, Tsu JH, Teoh JY, Ng CF. Short-stay transurethral prostate surgery: A randomized controlled trial comparing transurethral resection in saline bipolar transurethral vaporization of the prostate with monopolar transurethral resection. Asian J Endosc Surg. 2015 Aug;8(3):316-22. doi: 10.1111/ases.12197. Epub 2015 Jun 3. PMID 26042336
• Yip SK, Chan NH, Chiu P, Lee KW, Ng CF. A randomized controlled trial comparing the efficacy of hybrid bipolar transurethral vaporization and resection of the prostate with bipolar transurethral resection of the prostate. J Endourol. 2011 Dec;25(12):1889-94. doi: 10.1089/end.2011.0269. Epub 2011 Sep 16. PMID 21923418
• Teo JS, Lee YM, Ho HSS. An update on transurethral surgery for benign prostatic obstruction. Asian J Urol. 2017 Jul;4(3):195-198. doi: 10.1016/j.ajur.2017.06.006. Epub 2017 Jun 15. PMID 29264231
• McVary KT, Gange SN, Gittelman MC, Goldberg KA, Patel K, Shore ND, Levin RM, Rousseau M, Beahrs JR, Kaminetsky J, Cowan BE, Cantrill CH, Mynderse LA, Ulchaker JC, Larson TR, Dixon CM, Roehrborn CG. Minimally Invasive Prostate Convective Water Vapor Energy Ablation: A Multicenter, Randomized, Controlled Study for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasi PMID 26614889
• Cantrill CH, Zorn KC, Elterman DS, Gonzalez RR. The Rezum system - a minimally invasive water vapor thermal therapy for obstructive benign prostatic hyperplasia. Can J Urol. 2019 Jun;26(3):9787-9793. PMID 31180311
• McVary KT, Gittelman MC, Goldberg KA, Patel K, Shore ND, Levin RM, Pliskin M, Beahrs JR, Prall D, Kaminetsky J, Cowan BE, Cantrill CH, Mynderse LA, Ulchaker JC, Tadros NN, Gange SN, Roehrborn CG. Final 5-Year Outcomes of the Multicenter Randomized Sham-Controlled Trial of a Water Vapor Thermal Therapy for Treatment of Moderate to Severe Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hy PMID 33872051

Идентификаторы

NCT: NCT05762198 · CRE-2022.537-T

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗