A Real-word, Clinical Study to Evaluate the Performance of the Optilume® BPH Catheter System in Men With Symptomatic Benign Prostatic Hyperplasia (BPH)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Efficacy: Responder Rate at 12 months
研究概览
简要总结
A post-marketing study using Optilume Catheter System for benign prostatic hyperplasia.
详细描述
This is a post-marketing study for using Optilume Catheter System, which is a Dilation Drug Coated Balloon (DCB) Catheter, to treat benign prostatic hyperplasia. Participants will go through screening process which include uroflow test (measure the strength of urine flow), post-void residual volume by bladder scan, questionnaires and transrectal ultrasound (TRUS) to determine the eligibility to the study. Participants will be followed up for 1 year after Optilume treatment procedure.
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
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male subject with symptomatic BPH NOTE: Symptomatic BPH is defined as an International Prostate Symptom Score (IPSS) ≥ 13 and peak urinary flow rate (Qmax) of ≤15 mL/sec
- •Prostate dimensions suitable for treatment with the Optilume BPH Catheter System in accordance with the approved Instructions for Use NOTE: Prostate volume between 20 to 80 gm and prostatic urethral length between 32 mm and 55 mm as determined by TRUS
- •Able to complete the study protocol in the opinion of the investigator
排除标准
- •Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with follow-up requirements
- •Unwilling to abstain from sexual intercourse or use a condom for 30 days post-procedure and a highly effective contraceptive for at least 6 months post-procedure
- •Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate
- •Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave, Rezūm, UroLift) or surgical intervention of the prostate
- •Confirmed or suspected malignancy of prostate or bladder
- •Active urinary tract infection (UTI) confirmed by culture
- •History of overt urinary incontinence requiring use of pads NOTE: Pad usage for post-micturition dribble is acceptable
- •Presence of confounding diagnoses impacting lower urinary tract symptoms or bladder function (e.g. urethral strictures, bladder neck contracture, neurogenic bladder, detrusor instability, bladder stones, etc.)
- •History of chronic urinary retention (e.g. PVR ≥300mL on two separate occasions, or catheter dependent drainage)
- •Anatomy (e.g. presence of false passage or size of meatus) is not suitable for treatment with the Optilume BPH Catheter System
- •Significant obstruction from median lobe in the opinion of the investigator
- •Disease or other health condition that is not suitable for this study
研究组 & 干预措施
Treatment
Optilume Catheter System
干预措施: Optilume Catheter System (Device)
结局指标
主要结局
Efficacy: Responder Rate at 12 months
时间窗: 12 months post treatment
≥30% improvement in International Prostate Symptom Score (IPSS) score without the need of an additional surgical or minimally invasive procedure. IPSS score ranges from 0-35 (higher score means worse symptoms)
Safety (adverse events)
时间窗: Within 12 months post treatment
Frequency and severity of treatment related adverse events will be reported using the Clavien-Dindo severity grading system.
次要结局
- Change in sexual function (International Index of Erectile Function, IIEF questionnaire)(12 months post treatment)
- Change in IPSS & IPSS QoL (questionnaire)(12 months post treatment)
- Change in Qmax (maximum flow rate)(12 months post treatment)
- Change in PVR (post-void residual)(12 months post treatment)
- Change in sexual function (Male Sexual Health Questionnaire ejaculatory dysfunction, MSHQ-EjD questionnaire)(12 months post treatment)
- Quality of Recovery (QoR) Visual Analogue Scale (VAS) score at 30 days.(30 days post treatment)
- Rate of repeat surgical intervention(12 months post treatment)
- Health care usage(30 days post treatment)
研究者
Dean Elterman
Lead Principal Investigator
Can-Am HIFU Inc.