RecruitingPhase 2NCT06212453

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

22 participants

Start Date

Apr 24, 2024

Study Type

INTERVENTIONAL

Conditions

Benign Prostatic Hyperplasia

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

Sex: MALEMin Age: 40 Years

Inclusion Criteria10

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 Criteria11

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.

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Interventions

PROCEDURETargeted Microwave Ablation

3D ultrasound-guided focal thermal ablation of the prostate transition zone

Locations(1)

Hôpital Cochin

Paris, France

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