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Water vapor or surgery? new study aims to protect ejaculation in prostate treatment

NCT ID NCT07648888

Symptom relief Sponsor: Beni-Suef University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two minimally invasive procedures for men with an enlarged prostate: water vapor thermal therapy (Rezum) and ejaculation-sparing surgery. It includes 120 sexually active men aged 50 or older who have moderate-to-severe urinary symptoms. The goal is to see which treatment better preserves ejaculation while improving urine flow over 12 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Water vapor thermal therapy (Rezum) and ejaculation-sparing bipolar transurethral enucleation of the prostate (ES-B-TUEP)
What this could lead to
If successful, this could help doctors choose which procedure better preserves ejaculation while relieving urinary symptoms in men with an enlarged prostate.
What could go wrong
This is a small, non-randomized study, so results may not apply to all men. Both procedures carry risks like infection, bleeding, or urinary problems.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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) 13 or higher. * Prostate volume 30 to 80 mL measured by transrectal ultrasound. * Maximum urinary flow rate (Qmax) 15 mL/s or less with voided volume 150 mL or more. * Post-void residual urine volume 250 mL or less. * Failed, intolerant, or unwilling 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 informed consent. Exclusion Criteria: * 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. * 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. * Recurrent urinary retention or 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.

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Conditions

The condition(s) this trial relates to.

benign prostatic hyperplasia Ejaculatory Dysfunction Lower Urinary Tract Symptoms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Benign prostatic hyperplasia Ejaculatory dysfunction Lower urinary tract symptoms

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Urology- Beni-Suef University Hospitals

    RECRUITING

    Banī Suwayf, Beni Suweif Governorate, 02456, Egypt

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