An interventional study of Water Vapor Thermal Therapy and Ejaculation-Sparing Bipolar Transurethral Enucleation of the Prostate in Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms and Ejaculatory Dysfunction, sponsored by Beni-Suef University. Recruiting at 1 site in Egypt. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by Beni-Suef University · Not applicable, Interventional, and Treatment
This prospective comparative study will evaluate Water Vapor Thermal Therapy (WVTT/Rezum) versus Ejaculation-Sparing Bipolar Transurethral Enucleation of the Prostate (ES-B-TUEP) in sexually active men with symptomatic benign prostatic hyperplasia.
Eligible patients will have moderate-to-severe lower urinary tract symptoms, preserved antegrade ejaculation at baseline, and will be candidates for procedural treatment after failure, intolerance, or unwillingness to continue medical therapy. This is not a randomized study. Treatment selection will be based on shared decision-making between the patient and the treating surgeon after standardized counseling about both procedures.
The study will compare ejaculatory function, urinary symptom improvement, urinary flow, post-void residual urine, erectile function, perioperative outcomes, complications, catheterization duration, hospital stay, medication restart, and retreatment or reintervention during follow-up. The primary outcome will be the change in the Male Sexual Health Questionnaire-Ejaculatory Dysfunction Short Form Function domain score from baseline to 12 months.
Benign prostatic hyperplasia is a common cause of male lower urinary tract symptoms and may affect quality of life, sleep, daily activity, and sexual health. In sexually active men, preservation of antegrade ejaculation is an important factor in treatment selection and postoperative satisfaction.
Water Vapor Thermal Therapy, commercially known as Rezum, is a minimally invasive transurethral treatment that delivers radiofrequency-generated water vapor into hyperplastic prostatic tissue. It aims to improve bladder outlet obstruction while minimizing sexual adverse effects. Ejaculation-Sparing Bipolar Transurethral Enucleation of the Prostate is an anatomical endoscopic enucleation technique modified to preserve peri-montanal, supra-montanal, ejaculatory hood, and bladder-neck related structures in an attempt to preserve antegrade ejaculation while achieving effective de-obstruction.
This study is designed as a prospective, controlled, non-randomized comparative clinical study. Eligible patients will be enrolled into one of two treatment cohorts: Water Vapor Thermal Therapy/Rezum or Ejaculation-Sparing Bipolar Transurethral Enucleation of the Prostate. Treatment allocation will not be randomized. The final treatment decision will be made through shared decision-making between the patient and treating surgeon after standardized counseling regarding the expected benefits, limitations, anesthesia requirements, catheterization, recovery, possible complications, urinary outcomes, sexual outcomes, and retreatment risk of both procedures.
Baseline assessment will include medical and urological history, sexual history, physical examination, digital rectal examination, urinalysis, urine culture when indicated, complete blood count, serum creatinine, coagulation profile, prostate-specific antigen, pelvic-abdominal ultrasound, transrectal ultrasound for prostate volume, uroflowmetry, post-void residual urine measurement, International Prostate Symptom Score, International Index of Erectile Function-5, and Male Sexual Health Questionnaire-Ejaculatory Dysfunction Short Form.
Patients will be followed after treatment at 1 month, 3 months, 6 months, and 12 months. Follow-up assessments will include urinary symptom scores, quality-of-life score, maximum urinary flow rate, post-void residual urine volume, erectile function, ejaculatory function, antegrade ejaculation status, complications, restart of benign prostatic hyperplasia medication, and any retreatment or reintervention.
The primary outcome will be the change in the Male Sexual Health Questionnaire-Ejaculatory Dysfunction Short Form Function domain score from baseline to 12 months. Secondary outcomes will include change in ejaculation bother, preservation of antegrade ejaculation, change in erectile function, change in International Prostate Symptom Score, change in quality-of-life score, change in maximum urinary flow rate, change in post-void residual urine volume, operative time, catheterization duration, hospital stay, hemoglobin drop, postoperative urinary retention, hematuria or clot retention, urinary tract infection, dysuria, urgency or urge urinary incontinence, stress urinary incontinence, urethral stricture, bladder neck contracture, overall complications graded by the Clavien-Dindo classification, restart of benign prostatic hyperplasia medication, and retreatment or reintervention during 12-month follow-up.
Because this is a non-randomized comparative study, baseline differences between the two cohorts will be addressed using multivariable regression and propensity-score-based analysis where appropriate.
827 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.
This study's planned enrollment of 120 is above the median of 92 across 626 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →Beni-Suef University is the lead sponsor of 349 studies on the registry; 125 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in this arm will undergo transurethral convective radiofrequency water vapor thermal therapy using the Rezum system for symptomatic benign prostatic hyperplasia. Treatment will be performed according to standard procedural principles, including cystoscopic assessment, delivery of water vapor injections into the obstructing prostatic tissue, treatment of the median lobe when present and technically suitable, and Foley catheter placement at the end of the procedure.
Procedure: Water Vapor Thermal Therapy
Patients in this arm will undergo ejaculation-sparing bipolar transurethral enucleation of the prostate for symptomatic benign prostatic hyperplasia. The procedure will be performed using a standardized anatomy-adapted technique aiming to remove the obstructing adenoma while preserving peri-montanal, supra-montanal, ejaculatory hood, and bladder-neck related structures whenever technically feasible, followed by Foley catheter placement at the end of the procedure.
Procedure: Ejaculation-Sparing Bipolar Transurethral Enucleation of the Prostate
Transurethral convective radiofrequency water vapor thermal therapy will be performed for symptomatic benign prostatic hyperplasia. The procedure includes cystoscopic assessment and delivery of water vapor injections into the obstructing prostatic tissue, including median lobe treatment when present and technically suitable. A Foley catheter will be inserted at the end of the procedure.
Ejaculation-sparing bipolar transurethral enucleation of the prostate will be performed for symptomatic benign prostatic hyperplasia using an anatomy-adapted endoscopic technique. The procedure aims to remove the obstructing adenoma while preserving peri-montanal, supra-montanal, ejaculatory hood, and bladder-neck related structures whenever technically feasible. A Foley catheter will be inserted at the end of the procedure.
Change in MSHQ-EjD-SF Function Domain Score
Change from baseline to 12 months in the Male Sexual Health Questionnaire-Ejaculatory Dysfunction Short Form (MSHQ-EjD-SF) Function domain score. The Function domain is calculated as the sum of questions 1-3 assessing ejaculation frequency, ejaculation force, and ejaculation volume. The score ranges from 1 to 15, with higher scores indicating better ejaculatory function. The outcome will compare the change score between the Water Vapor Thermal Therapy/Rezum group and the Ejaculation-Sparing Bipolar Transurethral Enucleation group.
Time frame: Baseline and 12 months after intervention
Change in MSHQ-EjD-SF Bother Item Score
Change from baseline to 12 months in the Male Sexual Health Questionnaire-Ejaculatory Dysfunction Short Form (MSHQ-EjD-SF) Bother item score. The bother item assesses the degree of bother related to ejaculation difficulties. The score ranges from 0 to 5, with higher scores indicating greater ejaculation-related bother. The outcome will compare the change score between the Water Vapor Thermal Therapy/Rezum group and the Ejaculation-Sparing Bipolar Transurethral Enucleation group.
Time frame: Baseline and 12 months after intervention
Preservation of Antegrade Ejaculation
Proportion of patients who report preserved antegrade ejaculation at 12 months after intervention. Antegrade ejaculation will be assessed by direct patient report during follow-up and compared between the Water Vapor Thermal Therapy/Rezum group and the Ejaculation-Sparing Bipolar Transurethral Enucleation group.
Time frame: 12 months after intervention
Change in IIEF-5 Score
Change from baseline to 12 months in the International Index of Erectile Function-5 (IIEF-5) score. The IIEF-5 score ranges from 5 to 25, with higher scores indicating better erectile function. The outcome will compare the change score between the Water Vapor Thermal Therapy/Rezum group and the Ejaculation-Sparing Bipolar Transurethral Enucleation group.
Time frame: Baseline and 12 months after intervention
Change in International Prostate Symptom Score
Change from baseline in the International Prostate Symptom Score (IPSS). The IPSS ranges from 0 to 35, with higher scores indicating more severe lower urinary tract symptoms. The outcome will compare symptom improvement between the Water Vapor Thermal Therapy/Rezum group and the Ejaculation-Sparing Bipolar Transurethral Enucleation group.
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months after intervention
Change in Maximum Urinary Flow Rate
Change from baseline in maximum urinary flow rate (Qmax), measured in milliliters per second by uroflowmetry. Higher Qmax values indicate better urinary flow. The outcome will compare urinary flow improvement between the Water Vapor Thermal Therapy/Rezum group and the Ejaculation-Sparing Bipolar Transurethral Enucleation group.
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months after intervention
Change in Post-Void Residual Urine Volume
Change from baseline in post-void residual urine volume (PVR), measured in milliliters by ultrasound. Lower PVR values indicate better bladder emptying. The outcome will compare change in residual urine volume between the Water Vapor Thermal Therapy/Rezum group and the Ejaculation-Sparing Bipolar Transurethral Enucleation group.
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months after intervention
Plan to share: No — Individual participant data will not be shared because the study includes sensitive urological and sexual-function data, and no specific ethics-approved data sharing agreement is planned. De-identified aggregate results may be published in scientific meetings or peer-reviewed journals.
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