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Recruiting Phase 2 NCT06212453

Evaluation of the Functional Outcomes After Bilateral, 3D Ultrasound-guided Focal Thermal Ablation of the Prostate Transition Zone, in Patients with Benign Prostatic Hyperplasia-related Obstruction

Trial Parameters

Condition Benign Prostatic Hyperplasia
Sponsor Assistance Publique - Hôpitaux de Paris
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 22
Sex MALE
Min Age 40 Years
Max Age N/A
Start Date 2024-04-24
Completion 2025-04
Interventions
Targeted Microwave Ablation

Brief Summary

The aim of the current study is to evaluate the efficacy of transperineal focal microwave ablation (TMA) of the prostate transition zone as a new treatment for lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) within a prospective single-institutional pilot study.

Eligibility Criteria

Inclusion Criteria: * Man over 40 years old * Indication of surgical management for BPH * Prostate volume ≥30 cc and ≤100 cc as evaluated by ultrasonography * IPSS score ≥15 * Qmax ≤12 ml/s * Affiliated to the French national social security system * Patient suitable for IV sedation or general anesthesia and focal microwave ablation * Wish and able to comply with planned visits * Able to express his consent * Signed informed consent form Exclusion Criteria: * Unwillingness to accept the treatment * Neurological pathology responsible for micturition disorders * History of prostatic surgery * History of prostatic arterial embolization * Prostate protrusion Index of grade 2 (\>5 mm) or more as evaluated by ultrasonography. * Stenosis of the urethra * History of prostate cancer * History of radiotherapy or pelvic surgery * Life expectancy \<2 years * Inability to understand the informed consent document, to give consent voluntarily or to complete the study tasks. * Participation in another

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