Benign Prostatic Hyperplasia
Conditions
Keywords
Benign Prostatic Hyperplasia
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.
Interventions
PROCEDURETargeted Microwave Ablation
3D ultrasound-guided focal thermal ablation of the prostate transition zone
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Targeted Microwave Ablation
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Need for postoperative bladder catheterization | 1 month | — |
| Duration of postoperative bladder catheterization | 1 month | — |
| 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). |
| Length of hospital stay | 1 month | — |
| IPSS score | 1, 3 and 12 months | to assess urinary tract symptoms - 0-7 Mildly symptomatic 8-19 Moderately symptomatic 20-35 Severely symptomatic |
| Urinary Symptom Profile (USP) | 1, 3 and 12 months | to assess urinary tract symptoms |
| 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 |
| 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). |
Countries
France
Contacts
Primary ContactNicolas BARRY DELONGCHAMPS, MD, PHD
Backup ContactKarima MESBAHI
Outcome results
None listed