Convective Radio-frequency Water Vapor Energy Verses Trans-urethral Enucleation of Prostate for Management of Benign Prostatic Hyperplasia
Prospective Study Comparing Convective Radio-frequency Water Vapor Energy With Trans-urethral Enucleation of Prostate for Management of Benign Prostatic Hyperplasia
1 other identifier
interventional
70
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedFirst Submitted
Initial submission to the registry
May 8, 2026
CompletedFirst Posted
Study publicly available on registry
May 14, 2026
CompletedMay 19, 2026
May 1, 2026
1 year
May 8, 2026
May 15, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
International Prostate Symptom Score (IPSS)
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.
1, 6, 12 months
Secondary Outcomes (4)
International Index of Erectile Function (IIEF-EF)
1, 6, 12 months
four-item version of Male Sexual Health Questionnaire (MSHQ-EjD Short Form)
1, 6, 12 months
Qmax maximum urinary flow rate
1, 6, 12 months
Post Void Residual volume (PVR)
1, 6, 12 months
Study Arms (2)
Convective RF water vapor energy (Rezum)
ACTIVE COMPARATORTransurethral enucleation of prostate (TUEP)
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of medicine Beni Suef University
Banī Suwayf, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
May 8, 2026
First Posted
May 14, 2026
Study Start
March 1, 2025
Primary Completion
March 1, 2026
Study Completion
May 1, 2026
Last Updated
May 19, 2026
Record last verified: 2026-05