In-Office Transperineal Laser Ablation (TPLA) as a Salvage Treatment for Obstructive Benign Prostatic Hyperplasia (BPH) After Minimally Invasive Surgical Therapies (MIST)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Evaluate the impact of in-office TPLA on voiding function in patients with recurrent BPH after prior MIST procedures
研究概览
简要总结
Benign prostatic hyperplasia (BPH) is a common condition affecting aging men, often leading to lower urinary tract symptoms (LUTS). While Minimally Invasive Surgical Therapies (MIST) procedures offer less invasive alternatives to traditional surgery, some patients experience symptom recurrence or require further intervention due to lack of adequate relief of obstruction. Treatment of persistent obstruction after MIST therapy (BPH salvage therapy) typically requires surgical intervention like transurethral resection of prostate (TURP). This study proposes to evaluate the effectiveness of in-office transperineal laser ablation (TPLA) using the Echolaser system as a minimally invasive treatment option for these patients, potentially avoiding more invasive surgical procedures. The Cleveland Clinic sees a high volume of BPH salvage patients, making this an ideal setting for this research.
详细描述
TPLA of the prostate represents a promising minimally invasive treatment modality for men experiencing LUTS secondary to BPH. This technique offers a potentially attractive alternative to traditional surgical interventions, particularly given the growing interest in less invasive procedures. The current literature focuses on evaluating the effectiveness of TPLA in improving urodynamic parameters (specifically maximum urinary flow rate (Qmax) and post-void residual volume (PVR), alleviating LUTS, and preserving sexual and ejaculatory function, as well as surgical complications.
In a recent systematic review, which included 6 studies, studies consistently reported statistically significant improvements from baseline in Qmax, PVR, and IPSS scores (International Prostate Symptom Score) at all measured time points. Furthermore, three of the studies demonstrated that TPLA did not negatively impact sexual function, showing no significant changes in IIEF-6 scores (International Index of Erectile Function) and, in some cases, statistically significant improvements in MSHQ-EjD scores (Male Sexual Health Questionnaire) at various follow-up intervals, Low complication rates were observed across all studies. Pooled analysis of the available data revealed clinically meaningful improvements in both voiding and sexual function outcomes at 1-, 3-, and 6-, and 12-months post-treatment, when compared to baseline values.
While the preliminary findings from these pilot studies suggest that TPLA may be a valuable treatment option for BPH, further research is warranted. Specifically, there is a lack of data demonstrating the efficacy of TPLA as a salvage option, where other MIST options failed.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men > 40 years old
- •History of Minimally invasive BPH procedure within the last 5 years.
- •IPSS >= 12
- •Prostate Volume 30 - 80 gr as assessed by CT, MRI or TRUS.
- •PSA <4 or for patients with PSA 4-10 evaluation has been performed to rule out prostate cancer using biopsy, MRI, biomarker, or surgeon judgement. Labs within 1 year of study initiation
- •PVR > 150cc or reduced flow on uroflow likely due to obstruction based on clinical judgement
- •IIEF-6>or =10 without medication
排除标准
- •Indwelling catheter or intermittent catheterization
- •History of urethral strictures
- •Previous diagnosis of Prostate cancer
- •Active UTI or prostatitis
- •Hypoactive detrusor function
- •Neurogenic bladder (secondary to stroke, Multiple Sclerosis, Parkinson's disease, Spinal cord injury)
- •Ejaculatory dysfunction (retrograde ejaculation, anorgasmia or anejaculation)
- •Prior traditional BPH surgery (TURP, PVP, Aquablation, HOLEP, SP)
- •Presence of obstructive median lobe
- •Moderate to severe or severe ED based on IIEF-6/SHIM (SHIM of 10)
- •Peyronie's disease
研究组 & 干预措施
Transperineal Laser Ablation (TPLA)
Patients with recurrent Benign Prostatic Hyperplasia (BPH) after Minimally Invasive Surgical Therapies previous (MIST)
干预措施: Transperineal Laser Ablation (TPLA) (Procedure)
结局指标
主要结局
Evaluate the impact of in-office TPLA on voiding function in patients with recurrent BPH after prior MIST procedures
时间窗: baseline, and then 1-, 3-, 6- and 12-months post-treatment with laser ablation
Change in Urinary Function as measured with IPSS score, Uroflow variables (Qmax) and Post void residue (PVR)
次要结局
- Evaluate the effect of TPLA on erectile function & ejaculatory functions in this patient population(baseline, and then 1-, 3-, 6- and 12-months post-treatment with laser ablation)