Comparing Rezum and Urolift

Официальное название

A Randomized Controlled Trial Comparing Efficacy and Cost Effectiveness of Water Vapour Thermal Therapy (Rezum) and Prostatic Urethral Lift (UroLift) in Men With Benign Prostatic Hyperplasia

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 prostatic urethral lift (UroLift) arm.

Вмешательства

• Устройство Rezum
  In the REZUM arm, water vapour treatment will be preformed.
• Устройство UroLift
  In the UroLift arm, prostatic urethral lift treatment will be performed.

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 (11)

• Hospital stays of procedure [Срок оценки: From the time patient is hospitalised until the time he discharges]
• Number of days on Foley's catheter or self-catheterization after operation [Срок оценки: 30 days after intervention]
• Complication rate [Срок оценки: 30 days after intervention]
• Post-op quality of life score (International Prostate QOL score) [Срок оценки: Baseline, 3 months, 6 months and 12 months after intervention]
• Post-op quality of life score (EQ5D-5L questionnaire) [Срок оценки: Baseline, 3 months, 6 months and 12 months after intervention]
• Change in voiding function in uroflowmetry (Maximum flow rate) [Срок оценки: Baseline, 3 months, 6 months and 12 months after intervention]
• Change in voiding function in uroflowmetry (Post void volume) [Срок оценки: Baseline, 3 months, 6 months and 12 months after intervention]
• Post-op erectile function (IIEF-EF) [Срок оценки: Baseline, 3 months, 6 months and 12 months after intervention]
• Post-op erectile function (MSHQ-EjD-SF) [Срок оценки: Baseline, 3 months, 6 months and 12 months after intervention]
• Unplanned readmission rate after operation in 30 days [Срок оценки: 30 days after intervention]
• Cost of procedure and related hospitalization [Срок оценки: At 12 months after treatment]

Критерии участия

Критерии включения

• Male ≥ 50 years Symptomatic BPH International prostate symptom score (IPSS) ≥13 Prostate volume 30-80ml

Критерии исключения

• History or high suspicion of prostate cancer
• Current urinary tract infection
• Refractory urinary retention or post-void residual (PVR) ≥250 mL
• Intravesical prostatic protrusion (IPP)>10mm
• Prior prostate surgery
• Known or suspected allergy to nickel, titanium, or polyester/polypropylene
• Urethral stricture, meatal stenosis, bladder neck contracture
• Neurogenic bladder and/or sphincter abnormalities

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, The Chinese University of Hong Kong — Гонконг

Публикации

• Ray AF, Powell J, Speakman MJ, Longford NT, DasGupta R, Bryant T, Modi S, Dyer J, Harris M, Carolan-Rees G, Hacking N. Efficacy and safety of prostate artery embolization for benign prostatic hyperplasia: an observational study and propensity-matched comparison with transurethral resection of the prostate (the UK-ROPE study). BJU Int. 2018 Aug;122(2):270-282. doi: 10.1111/bju.14249. Epub 2018 May PMID 29645352
• Lyauk YK, Jonker DM, Lund TM, Hooker AC, Karlsson MO. Item Response Theory Modeling of the International Prostate Symptom Score in Patients with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia. AAPS J. 2020 Aug 27;22(5):115. doi: 10.1208/s12248-020-00500-w. PMID 32856168
• Elterman D, Shepherd S, Saadat SH, Alshak MN, Bhojani N, Zorn KC, Rijo E, Misrai V, Lajkosz K, Chughtai B. Prostatic urethral lift (UroLift) versus convective water vapor ablation (Rezum) for minimally invasive treatment of BPH: a comparison of improvements and durability in 3-year clinical outcomes. Can J Urol. 2021 Oct;28(5):10824-10833. PMID 34657655
• Roehrborn CG, Barkin J, Gange SN, Shore ND, Giddens JL, Bolton DM, Cowan BE, Cantwell AL, McVary KT, Te AE, Gholami SS, Moseley WG, Chin PT, Dowling WT, Freedman SJ, Incze PF, Coffield KS, Herron S, Rashid P, Rukstalis DB. Five year results of the prospective randomized controlled prostatic urethral L.I.F.T. study. Can J Urol. 2017 Jun;24(3):8802-8813. PMID 28646935
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT06820606 · CRE-2024.349-T

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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