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NCT Number: NCT06820606

Comparing Rezum and Urolift

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.

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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 and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong

Location status: Recruiting

Location contact

Peter Ka-Fung CHIU

CONTACT

[email protected]

852 3505 3933

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Rezum

Device

In the REZUM arm, water vapour treatment will be preformed.

Urolift

Device

In the UroLift arm, prostatic urethral lift treatment will be performed.

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. Hospital stays of procedure

    Time frame: From the time patient is hospitalised until the time he discharges

    Measure the hours of in-patient hospitalisation

  2. Number of days on Foley's catheter or self-catheterization after operation

    Time frame: 30 days after intervention

  3. Complication rate

    Time frame: 30 days after intervention

    Assessed by Clavien-Dindo classification

  4. Post-op quality of life score (International Prostate QOL 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; 0 being the best while 6 being the worst)

  5. Post-op quality of life score (EQ5D-5L questionnaire)

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

    Change in quality of life assessed by Quality of life: EQ5D-5L questionnaire

  6. Change in voiding function in uroflowmetry (Maximum flow rate)

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

    It is assessed by maximum flow rate (ml/s) in uroflowmetry

  7. Change in voiding function in uroflowmetry (Post void volume)

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

    It is assessed by post void volume (ml) in uroflowmetry

  8. Post-op erectile function (IIEF-EF)

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

    Assessed by Erectile function and Ejaculatory function using International Index of Erectile Function Questionnaire - Erectile function domain (IIEF-EF)

  9. Post-op erectile function (MSHQ-EjD-SF)

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

    Assessed by Erectile function and Ejaculatory function using Male Sexual Health Questionnaire - ejaculatory dysfunction (EjD) Short Form (MSHQ-EjD-SF)

  10. Unplanned readmission rate after operation in 30 days

    Time frame: 30 days after intervention

    Percentage of patients with unplanned readmission

  11. Cost of procedure and related hospitalization

    Time frame: At 12 months after treatment

Study contacts

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

Peter Ka-Fung CHIU

CONTACT

[email protected]

+852 3505 3933

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 11, 2025
Registry last updated
Feb 14, 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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