European Registry for Transperineal Laser Ablation of Prostate (TPLA) for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Obstruction (BPO)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- Rate of partecipants needing for other surgery
研究概览
简要总结
The goal of this observational study is to assess mid- and long-term effectiveness of Transperineal Laser Ablation of Prostate (TPLA) for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic obstruction measured by need and/or time until surgical retreatment.
Data regarding patient-reported outcomes measures (PROMs), flowmetry parameters and safety about consecutive patients undergoing TPLA will be collected in a dedicated platform.
Secondary objectives of the study are:
- To assess functional and safety outcomes in patients treated with transperineal laser ablation for LUTS due to benign prostatic obstruction;
- To identify possible differences in characteristics of patients treated with transperineal laser ablation among the centers and possible relations between treatment application and outcomes, in order to explore the optimal indications and possible limitations of TPLA for LUTS.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years;
- •Prostate volume ≥ 30 mL;
- •Moderate-to-severe LUTS according to International Prostatic Symptoms Score (IPSS ≥8)
- •Consent to participate;
排除标准
- •Absence of consent;
- •Subsequent withdrawal of consent;
- •Diagnosis or suspicion of prostate cancer at multiparametric magnetic resonance
- •Documented bladder impaired contractility
- •Urethral stenosis
- •Previous prostate surgery
结局指标
主要结局
Rate of partecipants needing for other surgery
时间窗: 5 years
Mid- and long-term effectiveness of TPLA measured by need and/or time until surgical retreatment for BPO (e.g. Transurethral resection of prostate (TURP), endoscopic enucleation, simple prostatectomy)
次要结局
- Number of Participants with Treatment-Related Adverse Events according to Clavien-Dindo Scale(6 months)
- Change from Baseline in the Male Sexual Health Questionnaire bother (MSHQ bother)(5 years)
- Change from Baseline in the International Prostatic Symptoms Score (IPSS)(5 years)
- Change from Baseline in the International Index of Erectile Function (IIEF-5)(5 years)
- Change from Baseline in the IPSS - Quality of Life score(5 years)
- Change from Baseline in maximum flow rate (ml/s)(5 years)
- Number of Participants with Treatment-Related Adverse Events according to Comprehensive Complication Index(6 months)
- Change from Baseline in the Male Sexual Health Questionnaire 3-items (MSHQ 3-items)(5 years)
- Change from Baseline in post void residual volume (ml)(5 years)
研究者
Francesco Sessa
Principal Investigator
University of Florence