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Benign Prostatic HyperplasiaNCT07648875

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

A study testing Water Vapor Thermal Therapy and Ejaculation-Preserving Holmium Laser Enucleation of the Prostate in people with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by Beni-Suef University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older, men only
What is being tested?
Water Vapor Thermal Therapy and Ejaculation-Preserving Holmium Laser Enucleation of the Prostate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteEgypt
Study dates
8 Jun 2026to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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 informed consent.

Who cannot join

  • 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.
Show all 18Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hany F Badawy, MD contact

+201149525028

HANYFATHY86@GMAIL.COM

Egypt1 site, 1 recruiting
  • Department of Urology- Beni-Suef University Hospitals

    Banī Suwayf, Beni Suweif Governorate, 02456

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

    HANYFATHY86@GMAIL.COM

    Recruiting

Other trials in Egypt

About this study

Official title: Water Vapor Thermal Therapy Versus Ejaculation-Preserving Holmium Laser Enucleation of the Prostate for Benign Prostatic Hyperplasia: A Prospective Comparative Study

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.

Being tested
Water Vapor Thermal Therapy, Ejaculation-Preserving Holmium Laser Enucleation of the Prostate
Keywords
Water Vapor Thermal Therapy, Rezum, Ejaculation-Preserving HoLEP, Male Sexual Health Questionnaire
Medical subject headings
Prostatic Hyperplasia, Lower Urinary Tract Symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Water Vapor Thermal TherapyProcedure or surgery

    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.

  • Ejaculation-Preserving Holmium Laser Enucleation of the ProstateProcedure or surgery

    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.

Study groups in NCT07648875
Study groupRoleWhat they receive
Water Vapor Thermal TherapyActive comparatorPatients 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.
Receives: Procedure: Water Vapor Thermal Therapy
Ejaculation-Preserving Holmium Laser Enucleation of the ProstateActive comparatorPatients 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.
Receives: Procedure: Ejaculation-Preserving Holmium Laser Enucleation of the Prostate

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and 12 months after the procedure

Secondary outcomes (5)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Baseline, 1 month, 3 months, 6 months, and 12 months after the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2026
  2. Study start8 Jun 2026
  3. Primary completionNov 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Prospective, non-randomized, parallel-group comparative study. Eligible patients with symptomatic benign prostatic hyperplasia will choose either Water Vapor Thermal Therapy (Rezum) or ejaculation-preserving Holmium Laser Enucleation of the Prostate after standardized counseling and shared decision-making with the treating physician. Outcomes will be compared between the two treatment groups during 12 months of follow-up.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07648875
Sponsor's protocol ID
BSU-REZUM-EJPHOLEP-2026
Status last verified
Jun 2026
First submitted
10 Jun 2026
Last updated
15 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A study testing Water Vapor Thermal Therapy and Ejaculation-Preserving Holmium Laser Enucleation of the Prostate in people with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by Beni-Suef University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hany F Badawy, MD (+201149525028, HANYFATHY86@GMAIL.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Male Sexual Health Questionnaire-Ejaculatory Dysfunction-Short Form Function Domain Score (time frame: Baseline and 12 months after the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.

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