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NCT Number: NCT07587333

Convective Radio-frequency Water Vapor Energy Verses Trans-urethral Enucleation of Prostate for Management of Benign Prostatic Hyperplasia

Convective RF water vapor energy was introduced as a minimally invasive, radio-frequency thermal energy-based treatment, designed to convectively deliver sterile water vapor, or steam for targeted ablation limited to the transition and central zones in men with clinical BPH. Thus. the aim of the study is to compare Convective RF water vapor energy (Rezum) with trans-urethral enucleation of the prostate (TUEP) regarding efficacy in terms of lower urinary tract symptoms (LUTS) improvement, international prostatic symptoms score (IPSS), improving of the maximum flow rate (Qmax), worsening of erectile and ejaculatory function, and safety regarding post operative complications & hospital stay.

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Key information

Conditions

BPH (Benign Prostatic Hyperplasia) Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine Beni Suef University

Banī Suwayf, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male aged > 50 yrs.
  • International Prostate Symptom Score (IPSS) >12
  • Maximum flow rate ( Qmax ) < 15 ml/s for 125ml voided volume
  • Post-void residual volume <350 ml
  • Prostate volume 80-120 g

Exclusion criteria

  • Active urinary tract infection at time of treatment.
  • Prostate-specific antigen (PSA) more than 10 ng/l.
  • history of prostate or bladder cancer.
  • Anticoagulants within 3d of the index procedure

Treatment and study plan

Rezum

Procedure

Convective RF water vapor energy (Rezum)

TUEP

Procedure

transurethral enucleation of prostate (TUEP)

Primary outcomes

  1. International Prostate Symptom Score (IPSS)

    Time frame: 1, 6, 12 months

    The total score ranges from 0 to 35, where 0 indicates no symptoms and 35 indicates the most severe symptoms. Higher scores represent worse urinary symptoms and poorer clinical status.

Secondary outcomes

  1. International Index of Erectile Function (IIEF-EF)

    Time frame: 1, 6, 12 months

    The erectile function domain score ranges from 1 to 30, where lower scores indicate more severe erectile dysfunction and higher scores indicate better erectile function. Higher scores represent better clinical outcomes.

  2. four-item version of Male Sexual Health Questionnaire (MSHQ-EjD Short Form)

    Time frame: 1, 6, 12 months

    The total score ranges from 1 to 15 for the ejaculatory function domain, with higher scores indicating better ejaculatory function. In the bother item, scores range from 0 to 5, where higher scores indicate greater bother or distress related to ejaculatory dysfunction.

  3. Qmax maximum urinary flow rate

    Time frame: 1, 6, 12 months

    Maximum urinary flow rate (Qmax) will be assessed using uroflowmetry, a non-invasive urodynamic test that measures the maximum flow rate of urine during voiding. Qmax is reported in milliliters per second (mL/s). Higher values indicate better urinary flow and improved urinary function.

  4. Post Void Residual volume (PVR)

    Time frame: 1, 6, 12 months

    Post-Void Residual urine volume (PVR) will be assessed using bladder ultrasound immediately after voiding to determine the amount of urine remaining in the bladder. PVR is reported in milliliters (mL). Higher values indicate worse bladder emptying and poorer urinary function.

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

Prospective Study Comparing Convective Radio-frequency Water Vapor Energy With Trans-urethral Enucleation of Prostate for Management of Benign Prostatic Hyperplasia

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 14, 2026
Registry last updated
May 19, 2026

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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