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Compares treatment options for Benign Prostatic Hyperplasia
Official title Water Vapor Thermal Therapy Versus Ejaculation-Preserving HoLEP for Benign Prostatic Hyperplasia
ClinicalTrials.gov ID: NCT07648875
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older, men only
You may be able to join if
- 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.
You likely can't join if
- Suspected or confirmed prostate cancer.
- Abnormal prostate-specific antigen or digital rectal examination suspicious for malignancy unless prostate cancer has been excluded according to...
- Previous prostate surgery.
- Previous urethral surgery likely to affect instrumentation or study outcomes.
- Urethral stricture disease.
- Neurogenic bladder dysfunction.
See the full eligibility 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 informed consent.
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Banī Suwayf, Beni Suweif Governorate, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Banī Suwayf, Beni Suweif Governorate, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.