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โ† Trials
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Water Vapor Thermal Therapy Versus Ejaculation-Preserving HoLEP for Benign Prostatic Hyperplasia

RecruitingNAAges 50 Years - anyMaleBeni-Suef University
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In plain words

What the trial is, and whether it could suit you

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 urin

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 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. * 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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What it tests

  • Water Vapor Thermal Therapy
  • Ejaculation-Preserving Holmium Laser Enucleation of the Prostate
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Where

1 site
Department of Urology- Beni-Suef University Hospitals
Banฤซ Suwayf, Egypt
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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