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NCT Number: NCT05762198

Comparing Water Vapour Thermal Therapy (Rezūm) and TURP

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

50 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Prince of Wales Hospital, Chinese University of Hong Kong

Hong Kong

Location status: Recruiting

Location contact

Peter Ka-Fung CHIU, FRCS, PhD

CONTACT

[email protected]

852-3505-2625

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Rezūm

Device

In the REZUM arm, water vapour treatment is performed for all subjects under local anaesthesia.

TURP

Device

In the TURP arm, all men will receive TURP operation under general or spinal anaesthesia

Primary outcomes

  1. Changes in International Prostate Symptom Score (IPSS) at 12 months after treatment

    Time frame: Baseline, 3 months, 6 months and 12 months after intervention

    IPSS score ranging from 0-35 (the higher the worse)

Secondary outcomes

  1. Successful trial without catheter (TWOC) within 3 months

    Time frame: At 3 months

    Percentage of patients successfully TWOC

  2. Complication rate

    Time frame: 30 days after intervention

    Assessed by Clavien-Dindo classification

  3. Post-op quality of life score

    Time frame: Baseline, 3 months, 6 months and 12 months after intervention

    Change in quality of life assessed by change in International Prostate QOL score (ranges from 0 to 6, the higher the worse)

  4. Change in voiding function in uroflowmetry

    Time frame: Baseline, 3 months, 6 months and 12 months after intervention

    It is assessed by maximum flow rate and post void volume in uroflowmetry

  5. Post-op International Index of Erectile function score

    Time frame: Baseline, 3 months, 6 months and 12 months after intervention

    Score 1-5 (the lower the worse)

  6. Hospital stays of procedure

    Time frame: On Discharge

    Measure the hours of in-patient hospitalisation

  7. Unplanned readmission rate after operation in 30 days

    Time frame: 30 days after intervention

    Percentage of patients with unplanned readmission

Study contacts

Contact information is provided by the study sponsor or research team.

Peter Ka-Fung CHIU, FRCS, PhD

CONTACT

[email protected]

35051663

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 9, 2023
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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