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 (BETTANY)

Assistance Publique - Hôpitaux de Paris

Status and phase

Enrolling

Phase 2

Conditions

Benign Prostatic Hyperplasia

Treatments

Procedure: Targeted Microwave Ablation

Study type

Interventional

Funder types

Other

Identifiers

NCT06212453

APHP230759

2023-A02267-38 (Other Identifier)

Details and patient eligibility

About

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.

Full 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. However, these treatments are burdened by their invasiveness, intra and post-operative morbidity, and long-term complications, including ejaculatory dysfunction (70%), urethral strictures (7%), urinary incontinence (2%), and bleeding. Laser-based surgical strategies have only partially overcome these drawbacks.

To provide a personalized therapy for the treatment of BPH related-symptoms, several minimally invasive surgical therapies (MISTs) were developed with the aim of achieving outcomes comparable to the gold standard invasive procedures while minimizing SD and other complications. Urolift implants and Rezum system have demonstrated less complication rate and hospitalization time than standard surgeries.

Recently, 3D ultrasound-guided transperineal focal microwave ablation (TMA) was developed as a focal treatment for localized prostate cancer. Ultrasound-MRI image fusion was performed with organ-based tracking-registration using KOELIS Trinity™ (Koelis, Meylan, France). Microwave thermal ablation was provided by the TATO generator (Biomedical Srl, Firenze, Italy) using a single 17G needle inserted transperineally. This treatment was reported to be safe, precise, and feasible in an outpatient setting.

Enrollment

22 estimated patients

Sex

Male

Ages

40+ years old

Volunteers

No Healthy Volunteers

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 clinical study involving an investigational product within 1 month before study entry.