NCT04757116招募中不适用
A Post-Market, Prospective, Randomized, Controlled, Multicenter International Study to Assess the Safety of the Temporarily Implanted Nitinol Device (iTind) Compared to the UroLift® System in Subjects With Symptomatic Benign Prostatic Hyperplasia (BPH)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 256
- 试验地点
- 37
- 主要终点
- Incidence of all intraoperative and post-operative complications
研究概览
简要总结
The study objective is to evaluate the efficacy and safety of the iTind device compared to UroLift.
详细描述
Both iTind and UroLift are minimally invasive treatment options for relieving lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). The iTind device is a temporary, self-expanding nitinol implant that remains in place for 5 to 7 days to reshape the prostatic urethra through localized ischemic pressure and tissue remodeling. In contrast, the UroLift system involves the permanent placement of transprostatic implants that retract the enlarged lateral lobes of the prostate to widen the urethral lumen.
This study is designed to directly compare the safety and effectiveness of the iTind device versus the UroLift system in treating LUTS due to BPH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of lower urinary tract symptoms presumed to be secondary to benign prostatic enlargement causing bladder outlet obstruction for which treatment is recommended
- •Willing and able to provide informed consent
- •Males ≥ 50 years of age or older
- •PSA < 4 ng/ml or if the PSA is 4 - 10 ng/ml, prostate cancer must be ruled out to the satisfaction of the Principal Investigator (PI) by local standard of care methods within prior 6 months
- •Prostate volume up to 75 cc (inclusive) documented by cross-sectional imaging (TRUS, MRI, etc.). Results from standard of care imaging may be accepted up to 6 months prior to Screening
- •International Prostate Symptom Score (IPSS) for urinary symptoms ≥ 13
- •Maximum urinary flow rate (Qmax) of ≤ 15 mL/sec and ≥ 5 mL/sec (voided volume must be ≥ 125 mL)
- •Willing and able to complete all study visits including questionnaires at baseline and at follow-up visits
排除标准
- •History of prostate cancer or suspected, should be ruled out to the satisfaction of the PI by local standard of care methods within prior 6 months
- •Confirmed bladder cancer within the last 2 years or currently suspected bladder cancer
- •History of acute bacterial prostatitis within the last 2 years
- •Median lobe obstruction of the prostate as confirmed by cross-sectional imaging
- •PSA value > 10 ng/ml
- •Contraindicated for iTind or UroLift as determined by the PI
- •Neurogenic bladder and/or sphincter abnormalities due to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes or other neurological disorders that affect bladder function
- •Clinically significant bladder diverticulum
- •Diagnosed with urethral stricture, meatal stenosis, bladder neck contracture, rectal disease, artificial urinary sphincter, incompetent sphincter, urinary incontinence due to incompetent sphincter
- •Prior rectal surgery (other than hemorrhoidectomy) or history of rectal disease treatment if the therapy may potentially cause injury to site (e.g., if a transrectal probe is used), pelvic radiotherapy or radical pelvic surgery, urinary diversion surgery, prostate surgery, balloon dilation, urethral stent implantation, laser prostatectomy, or any other invasive treatment to the prostate, or penile prosthesis if it may prevent insertion of the iTind or UroLift device
- •An active urinary tract infection during randomization
- •Clinically significant hematuria within the last 3 months or ongoing cystolithiasis
- •Prostate volume > 75 cc
- •Post-void residual volume (PVR) > 250 mL
- •Actively using catheterization or unable to void naturally
- •Unable to complete a 2-week washout period for alpha blockers prior to procedure or unable to discontinue 5ARIs or daily use of PDE5 inhibitors by the time of procedure
- •Taking anti-platelet or anticoagulants (except low dose aspirin - 81 mg - 100 mg) within the last 7 days prior to procedure
- •Known or suspected allergy to nickel, titanium or polyester/polypropylene
研究组 & 干预措施
iTind arm
Experimental
The iTind is a minimally invasive temporary implant
干预措施: iTind (Device)
UroLift
Active Comparator
The UroLift is a minimally invasive permanent implant
干预措施: UroLift (Procedure)
结局指标
主要结局
Incidence of all intraoperative and post-operative complications
时间窗: 3 months
Incidence of all intraoperative and post-operative complications (i.e., related to procedure and/or device) at 3 months
Difference in change of IPSS from baseline between iTind and UroLift groups at 3 months
时间窗: 3 months
Difference in change of IPSS from baseline between iTind and UroLift groups at 3 months
次要结局
- Difference in change from baseline between iTind and UroLift groups in International Prostate Symptom Score (IPSS)(1, 3, 6, 12, 24, 36, 48, and 60 months)
- Difference in change of IPSS from baseline between iTind and UroLift groups at 12 months(12 month)
- Incidence of all intraoperative and post-operative adverse events (AEs) (i.e., related to procedure and/or device) through 3 months post-procedure.(3 month)
- Difference in change of IPSS from baseline between iTind and UroLift groups at 1, 6, 24, and 36 months(1, 6, 24, and 36 months)
- Difference in change of QoL scores (SHIM, MSHQ-EjD, SF-6D) from baseline between iTind and UroLift at 1, 3, 6, 12, 24, and 36 months(1, 3, 6, 12, 24, and 36 months)
- Difference in rate of re-intervention between iTind and UroLift groups at 1, 3, 6, 12, 18, 24, and 36 months(1, 3, 6, 12, 18, 24, and 36 months)
- Difference in reporting between iTind and UroLift groups at 1, 6, 12, 18, 24, and 36, months •Overall incidence of procedure and/or device related adverse events(1, 6, 12, 18, 24, and 36, months)
- Difference in change from baseline between iTind and UroLift groups in International Prostate Symptom Score (IPSS)(1, 3, 6, 12, 24, 36, 48, and 60 months)
- Difference in change of QoL scores from baseline between iTind and UroLift(1, 3, 6, 12, 24, 36, 48, and 60 months)
- Difference in rate of re-intervention(1, 3, 6, 12, 18, 24, 36, 48, and 60 months)
- Difference in reporting between iTind and UroLift groups(1, 3, 6, 12, 18, 24, 36, 48, and 60 months)
研究者
研究点 (37)
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