Efficacy of Ultrasound Guided Percutaneous Transperineal Laser Ablation in Benign Prostatic Hypertrophy Patients: Non-Pharmacological Interventional Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Clinical symptoms at 1-yr follow-up evaluated with usual objective and subjective parameters
研究概览
简要总结
Efficacy of Ultrasound Guided Percutaneous Transperineal Laser Ablation in Benign Prostatic Hypertrophy Patients: Non-Pharmacological Interventional Study
详细描述
Efficacy of Ultrasound Guided Percutaneous Transperineal Laser Ablation in Benign Prostatic Hypertrophy Patients: Non-Pharmacological Interventional Study
The aim of this pilot study is to evaluate the efficacy of TPLA under US-guidance and the safety and the reproducibility in acute and follow-up.
Objective of the study: Evaluate the efficacy of percutaneous ablative treatment with neodymium laser; the complete profile of safety and tolerability in acute and in the follow-up in patients with Benign Prostatic Hypertrophy by using multiparametric prostate MRI that allows us to evaluate the prostate acutely after treatment and in follow-up. All of the imaging data is correlated with clinical and laboratory data.
Design of the study: Non-pharmacological interventional study. The clinical evaluation will be carried out at three different times:
Time 1: eligibility assessment, signing of informed consent Time 2: admission, laser ablation and control with multiparametric MRI of the post-procedural prostate (T0).
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
- 51 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Over 50 years old
- •BPH confirmed by mpMRI
- •Uroflowmetry indicating obstructive pathology
- •Surgical risk moderate-elevated
- •Symptomatology of obstructive pathology (voiding hesitation, intermittent mitt, urinary flow reduction, incomplete emptying of the bladder, post-urination incontinence and irritative symptoms such as urinary frequency, dysuria, nocturia - quantified with IPSS)
- •Signature of the information sheet and of the informed consent to the treatment, at the execution of the multiparametric MRI and the administration of the paramagnetic contrast medium.
排除标准
- •MRI signs of malignancy confirmed by biopsy investigation
- •Urethral stenosis
- •Serious coagulation disorders
- •Inadequate compliance
- •Ischemic pathology in the previous six months
- •Presence of pacemakers
- •Active phase inflammatory pathology
- •Presence of III dominant prostate lobe
- •Contraindications to the execution of MRI (claustrophobia, auricular implants, metal prostheses and other contraindications included in the specific informed consent)
- •Paramagnetic contrast medium allergy.
- •Acute and / or chronic renal failure (GFR <50 mL / min and serum creatinine> 1.5 mg / d)
- •Not adequate understanding of the information sheet
研究组 & 干预措施
ECHOLASER X4 Socratelite
Optic fiber of 300um will be inserted at a distance of 8-10mm from the urethra. Each ablation lasts 6 minutes. Each fiber ablates at an energy of 1800J with a power of 2-3W. Treatment lasts for about 30 minutes.
干预措施: Transperineal Focal Laser Ablation (TPLA) (Procedure)
结局指标
主要结局
Clinical symptoms at 1-yr follow-up evaluated with usual objective and subjective parameters
时间窗: 12 months
Improvement of obstructive symptomatology correlated to BPH. The evaluation will be based on urodynamic studies of Qmax, post void and residual volume.
Rate of complication needing re-hospitalisation or reintervention
时间窗: procedure date to 12 months
Evaluation of complications post TPLA treatment by MRI.
次要结局
- Reproducibility of Multi-parametric MRI(12 months.)
- Total and post-operative costs during follow-up compared to transurethral resection of the prostate(12 months)
- Evaluation of Quality of Life by International Prostate Symptom Score(12 months)
- Evaluation of Quality of Life by International Index of Erectile Function(12 months)
研究者
Guglielmo Manenti
Principal Investigator
University of Rome Tor Vergata