Prospective Study Comparing Convective Radio-frequency Water Vapor Energy With Trans-urethral Enucleation of Prostate for Management of Benign Prostatic Hyperplasia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Beni-Suef University
- Enrollment
- 70
- Locations
- 1
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Investigators
Hany Fathy Badawy, MD
Associate professor
Beni-Suef University