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

Recruiting now · Phase 2

Conditions studied: Benign Prostatic Hyperplasia

In brief

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.

Key facts

Study ID

NCT06212453

Run by

Assistance Publique - Hôpitaux de Paris

People needed

22

Starts

2024-04-24

Expected to finish

2026-08-01

Last updated by the study team

2025-01-20

Who can join

Age: 40 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Hôpital Cochin — Paris, France (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.