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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Water Vapor Thermal Therapy
Procedure/SurgeryTransurethral convective radiofrequency water vapor thermal therapy for symptomatic benign prostatic hyperplasia. Water vapor injections will be delivered into the obstructing prostatic tissue according to prostate configuration and prostatic urethral length. Median lobe treatment will be performed when present and technically suitable. A Foley catheter will be inserted at the end of the procedure.
Ejaculation-Preserving Holmium Laser Enucleation of the Prostate
Procedure/SurgeryHolmium Laser Enucleation of the Prostate using an ejaculation-preserving modification for symptomatic benign prostatic hyperplasia. The technique will aim to preserve supramontanal and perimontanal tissue near the verumontanum and preserve bladder-neck fibers when technically feasible, while performing anatomical enucleation of the obstructing prostatic adenoma. A Foley catheter will be inserted at the end of the procedure.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Water Vapor Thermal TherapyActive comparator 1 intervention
Group B: Ejaculation-Preserving Holmium Laser Enucleation of the ProstateActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Male Sexual Health Questionnaire-Ejaculatory Dysfunction-Short Form Function Domain Score
Change from baseline to 12 months in the Function domain score of the Male Sexual Health Questionnaire-Ejaculatory Dysfunction-Short Form (MSHQ-EjD-SF). The Function domain consists of three items assessing ejaculation frequency, ejaculation force, and ejaculation volume. The score ranges from 1 to 15, with higher scores indicating better ejaculatory function.
Time frame
Baseline and 12 months after the procedureSecondary outcomes
1
Change in Male Sexual Health Questionnaire-Ejaculatory Dysfunction-Short Form Bother Item Score
Change from baseline to 12 months in the Bother item score of the Male Sexual Health Questionnaire-Ejaculatory Dysfunction-Short Form (MSHQ-EjD-SF). The Bother item assesses the degree of bother related to ejaculatory dysfunction and will be scored according to the validated questionnaire scoring system used in the study.
Time frame
Baseline and 12 months after the procedure2
Change in International Index of Erectile Function-5 Score
Change from baseline to 12 months in the International Index of Erectile Function-5 (IIEF-5) score. The IIEF-5 assesses erectile function. The total score ranges from 5 to 25, with higher scores indicating better erectile function.
Time frame
Baseline and 12 months after the procedure3
Change in International Prostate Symptom Score
Change from baseline in the International Prostate Symptom Score (IPSS). The IPSS assesses lower urinary tract symptom severity. The total score ranges from 0 to 35, with higher scores indicating worse urinary symptoms.
Time frame
Baseline, 1 month, 3 months, 6 months, and 12 months after the procedure4
Change in Maximum Urinary Flow Rate
Change from baseline in maximum urinary flow rate (Qmax), measured by uroflowmetry and reported in mL/s. Higher values indicate better urinary flow.
Time frame
Baseline, 1 month, 3 months, 6 months, and 12 months after the procedureSponsors and contacts
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Source ClinicalTrials.gov