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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Difference between IPSS score at baseline and at 3 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
patients with BPH
Targeted Microwave Ablation
干预措施: Targeted Microwave Ablation (Procedure)
结局指标
主要结局
Difference between IPSS score at baseline and at 3 months
时间窗: 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.
次要结局
- Length of hospital stay(1 month)
- Need for postoperative bladder catheterization(1 month)
- Qmax(1, 3 and 12 months)
- Patients perspectives and treatment preferences(Baseline)
- Duration of postoperative bladder catheterization(1 month)
- Urinary Symptom Profile (USP)(1, 3 and 12 months)
- Postoperative pain(two hours after surgery)
- Dimensions of transitional zone tissue ablation(7 days)
- Male Sexual Health Questionnaire-ejaculatory dysfunction Short Form (MSHQ-EjD-SF)(1, 3 and 12 months)
- International Index of Erectile Function (IIEF-15)(1, 3 and 12 months)
- IPSS score(1, 3 and 12 months)