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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
3D ultrasound-guided focal thermal ablation of the prostate transition zone
Hôpital Cochin
Paris, France
RECRUITINGDifference between IPSS score at baseline and at 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.
Time frame: 3 months
Length of hospital stay
Time frame: 1 month
Need for postoperative bladder catheterization
Time frame: 1 month
Duration of postoperative bladder catheterization
Time frame: 1 month
Postoperative pain
Visual analogue scale (1 to 10)
Time frame: two hours after surgery
Dimensions of transitional zone tissue ablation
Measurement on prostatic mpMRI performed at day 7
Time frame: 7 days
Male Sexual Health Questionnaire-ejaculatory dysfunction Short Form (MSHQ-EjD-SF)
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).
Time frame: 1, 3 and 12 months
International Index of Erectile Function (IIEF-15)
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).
Time frame: 1, 3 and 12 months
IPSS score
to assess urinary tract symptoms - 0-7 Mildly symptomatic 8-19 Moderately symptomatic 20-35 Severely symptomatic
Time frame: 1, 3 and 12 months
Urinary Symptom Profile (USP)
to assess urinary tract symptoms
Time frame: 1, 3 and 12 months
Qmax
to assess urinary tract symptoms
Time frame: 1, 3 and 12 months
Patients perspectives and treatment preferences
Characterization of patient motivation to undergo TMA at baseline, as assessed by the patient perspective questionnaire
Time frame: Baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.