Water Vapor Therapy vs Ejaculation-Sparing Enucleation for Benign Prostatic Hyperplasia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, non-randomized study compares two procedural treatments for men over 50 with moderate-to-severe lower urinary tract symptoms due to BPH who wish to preserve ejaculation. Participants choose between Water Vapor Thermal Therapy and an ejaculation-sparing bipolar enucleation after counseling. Outcomes include urinary symptom relief, urinary flow, residual urine, erectile function, perioperative data, complications, catheterization duration, hospital stay, need for medications, and retreatment over follow-up. The trial is not randomized and uses shared decision-making to assign treatment within two cohorts. The primary outcome focuses on the rate of treatment success or improvement in relevant clinical endpoints.

Why it matters

Who can join: the full rules

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.

Where it's running

• Department of Urology- Beni-Suef University Hospitals
  Banī Suwayf, Beni Suweif Governorate, Egypt Recruiting

Study contacts

• Principal investigator: Hany F Badawy, MD — Faculty of Medicine, Beni-Suef University hospital
• Study coordinator: Hany F Badawy, MD
• Email: HANYFATHY86@GMAIL.COM
• Phone: +201149525028

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Tamsulosin alone vs. tamsulosin with tadalafil for troublesome urinary symptoms from enlarged prostate

  This study tests whether adding tadalafil to tamsulosin helps men with BPH see better urinary symptoms and quality of life, using two tadalafil doses over 12 weeks.

  Recruiting Ain Shams University · Cairo, Cairo Governorate · NCT07722884

• Water Vapor Therapy versus Ejaculation-Preserving HoLEP for Benign Prostatic Hyperplasia

  This study compares Rezum water vapor therapy to ejaculation-preserving HoLEP in sexually active men with moderate-to-severe symptoms from BPH to see which preserves ejaculation better while easing urinary symptoms.

  Recruiting Beni-Suef University · Banī Suwayf, Beni Suweif Governorate · NCT07648875

• Ejaculation-Preserving Bipolar Prostate Enucleation for BPH

  This randomized trial tests whether a modified ejaculation-preserving bipolar TUEP can maintain ejaculation while still relieving urinary symptoms in sexually active men with BPH who didn’t improve with meds.

  Recruiting Beni-Suef University · Banī Suwayf, Beni Suweif Governorate · NCT07629479

• Global registry for benign prostatic hyperplasia treatments

  This study is collecting information from men with benign prostatic hyperplasia to see how different treatments work and to help improve future care.

  Recruiting at 22 sites Société Internationale d'Urologie · Los Angeles, California and 29 other locations · NCT05543200

• Registry for assessing treatments of benign prostatic hyperplasia

  This study is collecting information to see how well different treatments for enlarged prostate symptoms work, comparing new options with traditional ones for men aged 18 and older.

  Recruiting Cantonal Hospital of St. Gallen · Sankt Gallen, Canton of St. Gallen · NCT03521648

• Sonablate HIFU Registry for Prostate Cancer and BPH

  This registry collects real-world data from men treated with Sonablate HIFU to see how well it works and how it affects urinary and sexual function over the long term.

  Recruiting Sonablate · Indianapolis, Indiana · NCT07757490

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.