Status:
RECRUITING
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
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Benign Prostatic Hyperplasia
Eligibility:
MALE
40+ years
Phase:
PHASE2
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 ...
Detailed Description
Transurethral resection of the prostate, laser vaporization or enucleation, and simple open prostatectomy represent the current gold standard surgical interventions for BPH-related obstruction. Howeve...
Eligibility Criteria
Inclusion
- 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
- 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 clinical study involving an investigational product within 1 month before study entry.
Key Trial Info
Start Date :
April 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT06212453
Start Date
April 24 2024
End Date
August 1 2026
Last Update
January 20 2025
Active Locations (1)
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1
Hôpital Cochin
Paris, France, 75014