An interventional study of Water Vapor Thermal Therapy and Ejaculation-Preserving Holmium Laser Enucleation of the Prostate in Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, 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
Among 11 studies in Prostatic Hyperplasia by Beni-Suef University — 5 open to participants now, 5 under way, none of them phase 3. Prostatic Hyperplasia · Beni-Suef University.
Among the 11 studies in Prostatic Hyperplasia by Beni-Suef University, this one is the 6th largest by planned enrollment, is one of 4 that started in 2026, is one of 6 with no phase, and was the 7th registered.
828 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.
Browse Prostatic Hyperplasia studies →5 of the 11 studies in Prostatic Hyperplasia by Beni-Suef University are open now, in 1 country. Recruiting first, the newest first:
Beni-Suef University · Sites in Egypt
Ages 50+ · Men only
Beni-Suef University · Sites in Egypt
Ages 50+ · Men only
Beni-Suef University · Sites in Egypt
Ages 50+ · Men only
Beni-Suef University · Sites in Egypt
Ages 50+ · Men only
By country, each count listing its studies:
Of the 102 Prostatic Hyperplasia studies recruiting now, 70 (69%) set no upper age limit and 4 (4%) stop at 75 or younger; 7 take children under 18; 7 take healthy volunteers.
This study: 50 Years and older · male · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
First in 2015; this study’s year is marked. 4 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 120 is above the median of 92 across 627 interventional studies indexed under Prostatic Hyperplasia.
Median enrollment 120 across the 11 interventional studies. Of the 6 that completed or were terminated, 0 (0%) have results posted.
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Beni-Suef University is the lead sponsor of 349 studies on the registry; 123 are open to participants now.
4 of the studies in Prostatic Hyperplasia by Beni-Suef University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07650968Beni-Suef UniversityTamsulosin Dose Escalation or Silodosin Switch Before Trial Without Catheter in BPH-Related Acute Urinary Retention | 2027-05 |
| NCT07654413Beni-Suef UniversityTamsulosin With or Without Tadalafil for Trial Without Catheter After Acute Urinary Retention Due to Benign Prostatic Hyperplasia | 2027-11 |
| NCT07648875Beni-Suef UniversityWater Vapor Thermal Therapy Versus Ejaculation-Preserving HoLEP for Benign Prostatic Hyperplasia | 2027-11 |
| NCT07648888Beni-Suef UniversityWater Vapor Thermal Therapy Versus Ejaculation-Sparing Bipolar Transurethral Enucleation for Benign Prostatic Hyperplasia | 2027-11 |
Add all 4 to your calendar (.ics) → With an account.
Among the 11 studies in Prostatic Hyperplasia by Beni-Suef University, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Benign prostatic hyperplasia is a common cause of male lower urinary tract symptoms. Treatment selection depends on symptom severity, prostate volume, degree of obstruction, comorbidities, patient preference, expected durability, perioperative morbidity, and the patient's wish to preserve sexual and ejaculatory function.
Water Vapor Thermal Therapy, commercially known as Rezum, is a minimally invasive transurethral therapy that uses convective radiofrequency-generated water vapor to ablate obstructing prostatic tissue. It is commonly used for men with moderate-to-severe lower urinary tract symptoms due to benign prostatic hyperplasia and is considered attractive for patients wishing to preserve sexual and ejaculatory function.
Holmium Laser Enucleation of the Prostate is an effective endoscopic anatomical enucleation procedure for benign prostatic obstruction. Conventional HoLEP provides strong de-obstructive efficacy but may be associated with ejaculatory dysfunction. Ejaculation-preserving HoLEP uses technical modifications aiming to preserve antegrade ejaculation while maintaining adequate relief of obstruction.
This study is a prospective, controlled, non-randomized comparative clinical study conducted at the Department of Urology, Beni-Suef University Hospital, Egypt. Sexually active men aged 50 years or older with symptomatic benign prostatic hyperplasia, prostate volume 30-80 mL, International Prostate Symptom Score of 13 or higher, maximum urinary flow rate of 15 mL/s or less, preserved antegrade ejaculation at baseline, and desire to preserve ejaculation will be eligible.
Patients will not be randomly allocated. Each eligible patient will receive standardized counseling about both treatment options, including the mechanism of action, anesthesia, expected urinary improvement, potential effect on ejaculation and erectile function, catheterization duration, hospital stay, possible complications, retreatment risk, and alternative management options. The final treatment decision will be made through shared decision-making between the patient and treating physician.
Patients selecting Water Vapor Thermal Therapy will undergo transurethral convective water vapor treatment using the Rezum system according to standard procedural principles. Vapor injections will be delivered into 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.
Patients selecting ejaculation-preserving HoLEP will undergo Holmium Laser Enucleation of the Prostate using a standardized ejaculation-sparing modification. 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 adenoma. A standardized operative checklist will document whether the ejaculation-preserving steps were fully, partially, or not successfully achieved.
Baseline assessment will include medical and urological history, sexual history, digital rectal examination, urinalysis, urine culture when indicated, complete blood count, serum creatinine, coagulation profile, serum prostate-specific antigen, pelvi-abdominal ultrasound, transrectal ultrasound assessment of prostate volume, uroflowmetry, post-void residual urine volume, International Prostate Symptom Score, IPSS quality-of-life score, International Index of Erectile Function-5, and Male Sexual Health Questionnaire-Ejaculatory Dysfunction-Short Form.
Participants will be followed at 1, 3, 6, and 12 months after the procedure. Follow-up assessment will include urinary symptoms, quality of life, maximum urinary flow rate, post-void residual urine volume, erectile function, ejaculatory function, antegrade ejaculation status, adverse events, complications, restart of benign prostatic hyperplasia medication, and any retreatment or reintervention.
The primary outcome is the change in the MSHQ-EjD-SF Function domain score from baseline to 12 months. Secondary outcomes include change in MSHQ-EjD-SF Bother score, change in International Index of Erectile Function-5 score, proportion of patients preserving antegrade ejaculation, change in International Prostate Symptom Score, change in IPSS 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 within 12 months.
Because this is a non-randomized comparative study, baseline differences between groups will be assessed. Adjusted analyses using multivariable regression and propensity-score methods may be performed to reduce allocation bias.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 group will undergo transurethral convective radiofrequency water vapor thermal therapy using the Rezum system for symptomatic benign prostatic hyperplasia. 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.
Procedure: Water Vapor Thermal Therapy
Patients in this group will undergo Holmium Laser Enucleation of the Prostate using an ejaculation-preserving modification. 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.
Procedure: Ejaculation-Preserving Holmium Laser Enucleation of the Prostate
Transurethral 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.
Holmium 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.
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 procedure
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 procedure
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 procedure
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 procedure
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 procedure
Change in Post-Void Residual Urine Volume
Change from baseline in post-void residual urine volume (PVR), measured by ultrasound and reported in mL. Lower values indicate better bladder emptying.
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months after the procedure
Plan to share: No — Individual participant data will not be publicly shared. Study results will be reported in aggregate form only. Participant data will be coded and kept confidential according to institutional ethics requirements and written informed consent.
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Nov 2027, 17 months after the start.
Of 153 non-industry interventional studies with no phase under Prostatic Hyperplasia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 48. This study's planned 17 months is below that.
Counting every sponsor, half of 205 studies reached it within 26 months; a quarter within 15 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
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