Water Vapor Thermal Therapy Versus Ejaculation-Preserving HoLEP for Benign Prostatic Hyperplasia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age50+
SponsorBeni-Suef University
About this trial
This prospective comparative study will evaluate Water Vapor Thermal Therapy (Rezum) versus ejaculation-preserving Holmium Laser Enucleation of the Prostate (EP-HoLEP) in sexually active men with symptomatic benign prostatic hyperplasia and prostate volume 30-80 mL.
Eligible patients will not be randomized. The treatment option will be selected through shared decision-making between the patient and treating physician after standardized counseling about the expected benefits, risks, recovery, catheter duration, urinary outcomes, durability, and potential effects on ejaculation and sexual function.
The main objective is to compare the change in ejaculatory function from baseline to 12 months using the Male Sexual Health Questionnaire-Ejaculatory Dysfunction-Short Form (MSHQ-EjD-SF) Function domain. Secondary outcomes will include urinary symptom improvement, quality of life, maximum urinary flow rate, post-void residual urine volume, erectile function, antegrade ejaculation preservation, catheterization duration, hospital stay, complications, restart of benign prostatic hyperplasia medication, and retreatment or reintervention within 12 months.
Eligibility criteria
Qualifiers
Male patients aged 50 years or older.
Symptomatic benign prostatic hyperplasia with moderate-to-severe lower urinary tract symptoms.
International Prostate Symptom Score (IPSS) of 13 or higher.
Prostate volume 30 to 80 mL measured by transrectal ultrasound.
Disqualifiers
Suspected or confirmed prostate cancer.
Abnormal prostate-specific antigen or digital rectal examination suspicious for malignancy unless prostate cancer has been excluded according to standard clinical practice.
Previous prostate surgery.
Previous urethral surgery likely to affect instrumentation or study outcomes.
Trial design
Treatments tested in this trial
- Water Vapor Thermal Therapy
- Ejaculation-Preserving Holmium Laser Enucleation of the Prostate
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov