Comparing Water Vapour Thermal Therapy (Rezūm) and TURP

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05762198
• Other study ID #: CRE-2022.537-T
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: January 2024
• Source: Chinese University of Hong Kong
• Contact: Peter Ka-Fung CHIU, FRCS, PhD
• Phone: 35051663
• Email: peterchiu[@]surgery.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: June 30, 2026
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital, Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (13)

Barry MJ, Williford WO, Chang Y, Machi M, Jones KM, Walker-Corkery E, Lepor H. Benign prostatic hyperplasia specific health status measures in clinical research: how much change in the American Urological Association symptom index and the benign prostatic hyperplasia impact index is perceptible to patients? J Urol. 1995 Nov;154(5):1770-4. doi: 10.1016/s0022-5347(01)66780-6. — View Citation

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. — View Citation

McVary KT, El-Arabi A, Roehrborn C. Preservation of Sexual Function 5 Years After Water Vapor Thermal Therapy for Benign Prostatic Hyperplasia. Sex Med. 2021 Dec;9(6):100454. doi: 10.1016/j.esxm.2021.100454. Epub 2021 Oct 30. — View Citation

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 Hyperplasia. J Urol. 2016 May;195(5):1529-1538. doi: 10.1016/j.juro.2015.10.181. Epub 2015 Nov 22. — View Citation

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 Hyperplasia. J Urol. 2021 Sep;206(3):715-724. doi: 10.1097/JU.0000000000001778. Epub 2021 Apr 19. — View Citation

McVary KT, Holland B, Beahrs JR. Water vapor thermal therapy to alleviate catheter-dependent urinary retention secondary to benign prostatic hyperplasia. Prostate Cancer Prostatic Dis. 2020 Jun;23(2):303-308. doi: 10.1038/s41391-019-0187-5. Epub 2019 Nov 18. — View Citation

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. — View Citation

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 6. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Yu SCH, Cho C, Hung E, Wang D, Chiu P, Yee CH, Ng A. Case-Control Study of Intra-arterial Verapamil for Intraprostatic Anastomoses to Extraprostatic Arteries in Prostatic Artery Embolization for Benign Prostatic Hypertrophy. J Vasc Interv Radiol. 2017 Aug;28(8):1167-1176. doi: 10.1016/j.jvir.2017.04.004. Epub 2017 May 13. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in International Prostate Symptom Score (IPSS) at 12 months after treatment	IPSS score ranging from 0-35 (the higher the worse)	Baseline, 3 months, 6 months and 12 months after intervention
Secondary	Successful trial without catheter (TWOC) within 3 months	Percentage of patients successfully TWOC	At 3 months
Secondary	Complication rate	Assessed by Clavien-Dindo classification	30 days after intervention
Secondary	Post-op quality of life score	Change in quality of life assessed by change in International Prostate QOL score (ranges from 0 to 6, the higher the worse)	Baseline, 3 months, 6 months and 12 months after intervention
Secondary	Change in voiding function in uroflowmetry	It is assessed by maximum flow rate and post void volume in uroflowmetry	Baseline, 3 months, 6 months and 12 months after intervention
Secondary	Post-op International Index of Erectile function score	Score 1-5 (the lower the worse)	Baseline, 3 months, 6 months and 12 months after intervention
Secondary	Hospital stays of procedure	Measure the hours of in-patient hospitalisation	On Discharge
Secondary	Unplanned readmission rate after operation in 30 days	Percentage of patients with unplanned readmission	30 days after intervention