ClinicalTrials.gg
RecruitingNCT07648875Updated Jun 15, 2026

Water Vapor Thermal Therapy Versus Ejaculation-Preserving HoLEP for Benign Prostatic Hyperplasia

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

From the registry’s dates

  • Started Jun 2026; still recruiting 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Non-randomized
Ages
50 Years and older
Sex
Male
01

Where this study stands

Counted across the records on this site · 2026-11-12

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.

Planned enrollment
6th of 11
120 · median 120
Started
2026
with 3 others
No phase
6 of 11
3 open now
Registered
7th of 11
by date

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.

Prostatic Hyperplasia

828 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.

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Open to participants now

5 of the 11 studies in Prostatic Hyperplasia by Beni-Suef University are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

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Where they have run

Who these studies take

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.

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02

Study summary

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.

Read the detailed description

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.

03

Conditions studied

  • Benign Prostatic Hyperplasia
  • Lower Urinary Tract Symptoms

Keywords

  • Water Vapor Thermal Therapy
  • Rezum
  • Ejaculation-Preserving HoLEP
  • Male Sexual Health Questionnaire
04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

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.

Inclusion criteria

  • 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.
  • Maximum urinary flow rate (Qmax) of 15 mL/s or less with voided volume of at least 150 mL.
  • Post-void residual urine volume of 250 mL or less.
  • Failure, intolerance, or unwillingness to continue medical therapy for benign prostatic hyperplasia.
  • Sexually active within the previous 3 months.
  • Preserved antegrade ejaculation at baseline.
  • Patient wishes to preserve ejaculation.
  • Ability to complete the International Prostate Symptom Score (IPSS), International Index of Erectile Function-5 (IIEF-5), and Male Sexual Health Questionnaire-Ejaculatory Dysfunction-Short Form (MSHQ-EjD-SF).
  • Written .

Exclusion criteria

Exclusion Criteria:

  • Suspected or confirmed prostate cancer.
  • Abnormal prostate-specific antigen or digital rectal examination suspicious for unless prostate cancer has been excluded according to standard clinical practice.
  • Previous prostate surgery.
  • Previous urethral surgery likely to affect instrumentation or study outcomes.
  • Urethral stricture disease.
  • Neurogenic bladder dysfunction.
  • Active urinary tract infection until adequately treated.
  • Bladder stones requiring concomitant surgery.
  • Prostate volume less than 30 mL or more than 80 mL.
  • Baseline anejaculation or severe ejaculatory dysfunction.
  • No sexual activity during the previous 3 months.
  • Chronic indwelling urethral or suprapubic catheter.
  • Suspected detrusor underactivity requiring urodynamic clarification.
  • Post-void residual urine volume more than 250 mL.
  • Uncontrolled coagulopathy.
  • Anticoagulation or antiplatelet therapy that cannot be safely managed perioperatively.
  • Unfitness for anesthesia or intervention.
  • Inability or unwillingness to comply with follow-up.
Terms in these criteria, in plain language(2)

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.

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • Active comparator
    Water Vapor Thermal Therapy

    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

  • Active comparator
    Ejaculation-Preserving Holmium Laser Enucleation of the Prostate

    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

Interventions

  • ProcedureWater Vapor Thermal Therapy

    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.

  • ProcedureEjaculation-Preserving Holmium Laser Enucleation of the Prostate

    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.

06

What researchers measure

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 procedure

Secondary 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 procedure

  2. 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

  3. 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

  4. 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

  5. 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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

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.

Registered
Jun 10, 2026
First posted
Jun 15, 2026
StartActual
Jun 8, 2026
Primary completionEst.
Nov 2027
CompletionEst.
Dec 2027
Last update
Jun 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07648875
Responsible party
Hany Fathy Badawy, MD (Lecturer of Urology, Faculty of Medicine, Beni-Suef University, Beni-Suef University) — Principal investigator
First posted
Jun 15, 2026
Start date
Jun 8, 2026
Primary completion
Nov 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jun 15, 2026

Study contacts

Hany F Badawy, MD
Contact
HANYFATHY86@GMAIL.COM
+201149525028

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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