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

Phase 2

Not yet recruiting

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.

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. 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
patients with BPH	Targeted Microwave Ablation	Targeted Microwave Ablation

Primary Outcome Measures

Name	Time	Method
Difference between IPSS score at baseline and at 3 months	3 months	The International Prostate Symptom Score IPSS is a self-questionnaire - It contains seven questions about symptoms related to BPH and one question about the patient's perceived quality of life. The seven questions are scored from 0 to 5. The sum of the 7 items gives the International Prostate Symptom Score in terms of severity (out of 35): 0-7 Mildly symptomatic - 8-19 Moderately symptomatic - 20-35 Severely symptomatic - Efficacy of the intervention with a decrease of at least 6 points on IPSS score between 3 months and baseline.

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay	1 month
Need for postoperative bladder catheterization	1 month
Qmax	1, 3 and 12 months	to assess urinary tract symptoms
Patients perspectives and treatment preferences	Baseline	Characterization of patient motivation to undergo TMA at baseline, as assessed by the patient perspective questionnaire
Duration of postoperative bladder catheterization	1 month
Urinary Symptom Profile (USP)	1, 3 and 12 months	to assess urinary tract symptoms
Postoperative pain	two hours after surgery	Visual analogue scale (1 to 10)
Dimensions of transitional zone tissue ablation	7 days	Measurement on prostatic mpMRI performed at day 7
Male Sexual Health Questionnaire-ejaculatory dysfunction Short Form (MSHQ-EjD-SF)	1, 3 and 12 months	4 items to assess ejaculatory functions This score is based on 3 questions concerning symptoms (score from 1 to 15) and one question about discomfort (score from 0 to 5).
International Index of Erectile Function (IIEF-15)	1, 3 and 12 months	15 items to assess ejaculatory functions and global sexual life - This score is based on 3 questions concerning symptoms (score from 1 to 15) and one question about discomfort (score from 0 to 5).
IPSS score	1, 3 and 12 months	to assess urinary tract symptoms - 0-7 Mildly symptomatic 8-19 Moderately symptomatic 20-35 Severely symptomatic