Clinical trial · Interventional
Comparing Water Vapour Thermal Therapy (Rezūm) and TURP
A Randomized Controlled Trial Comparing Water Vapour Thermal Therapy (Rezūm) and TURP in Men With Benign Prostatic Hyperplasia in Refractory Urinary Retention
NCT05762198CI-TRIAL-00089392completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 9, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260909-000002
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rezūm | Device | — | UNRESOLVED |
| TURP | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Rezūm
- interventionNames
- Device: Rezūm
- type
- ACTIVE_COMPARATOR
- label
- TURP
- interventionNames
- Device: TURP
Primary outcomes (1)
- measure
- Changes in International Prostate Symptom Score (IPSS) at 12 months after treatment
- timeFrame
- Baseline, 3 months, 6 months and 12 months after intervention
- description
- IPSS score ranging from 0-35 (the higher the worse)
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
References
Publications (13)
- BACKGROUNDNg 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
- BACKGROUNDYee 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
- BACKGROUNDYee 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
- BACKGROUNDYip 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
- BACKGROUNDTeo 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
- BACKGROUNDMcVary 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 Hyperplasia. J Urol. 2016 May;195(5):1529-1538. doi: 10.1016/j.juro.2015.10.181. Epub 2015 Nov 22.