Registry of Transperineal Laser Ablation for Treatment of Lower Urinary Tract Symptoms With Use of the Echolaser® Device: A Multicentre, International Registry to Evaluate the Treatment of LUTS in Terms of Long-term Efficacy, Functional Outcomes and Safety
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 主要终点
- Long-term treatment efficacy measured by the time until surgical retreatment.
研究概览
简要总结
Rationale: The treatment of lower urinary tract symptoms (LUTS) due to benign prostatic enlargement in men with transperineal laser ablation (TPLA) may offer advantages in functional outcomes and safety over current standard therapies. As the technique is relatively new, indications and outcomes for this treatment are subject of investigation. However, the technique is already applied outside clinical studies. Clinical information from these treatments can be useful for future research. The aim of this study is to collect data on patients treated with transperineal laser ablation of the prostate outside clinical trials and to provide data on safety and functional outcomes in these patients in order to improve treatment.
Objective: To assess long-term efficacy of transperineal laser ablation for lower urinary tract symptoms, to assess functional outcomes, to assess safety, to determine baseline patient characteristics, to collect information on possible differences between centres applying treatment of transperineal laser ablation and to explore the optimal treatment indications and possible limitations.
Study design: This is an international prospective observational study in which data is recorded of patients who are treated with transperineal laser ablation for lower urinary tract symptoms.
Study population: Male patients treated with transperineal laser ablation for lower urinary tract symptoms due to benign prostatic enlargement.
Main study parameters/endpoints: The primary endpoint of this study is long-term efficacy of transperineal laser ablation for lower urinary tract symptoms measured by the time until surgical retreatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Presenting with lower urinary tract symptoms
- •Indication for transperineal laser ablation
- •Signed informed consent form
排除标准
- •Age < 18 years
- •Previous or active treatment for prostate cancer (active surveillance is not seen as active treatment)
结局指标
主要结局
Long-term treatment efficacy measured by the time until surgical retreatment.
时间窗: 5 years following TPLA treatment
The treatment effectiveness is measured by the time until the need for surgical retreatment. This is measured by the time between the TPLA treatment and retreatment indicated due to new micturion problems. The time is expressed in years.
次要结局
- Experienced functional efficacy measured by change in International Prostate Symptom Score(12 months following TPLA treatment)
- Objectified functional efficacy measured by change of maximum flow by uroflowmetry.(12 months following TPLA treatment)
- Long-term treatment efficacy measured by the time until restart of urological medication.(5 years following TPLA treatment)
- Procedural safety measuered by the incidence of TPLA procedure related adverse events, reported by the CTCAE v5.0..(1 day following TPLA treatment)
- Treatment safety measured by adverse event incidence at 30 days, reported by the CTCAE v5.0(30 days following TPLA treatment)
研究者
Dr. T.M. de Reijke
Principal Investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)