Safety and Effectiveness Study of the Zenflow Spring System - A Minimally Invasive Treatment for LUTS Associated With BPH
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 279
- 试验地点
- 14
- 主要终点
- Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH) as compared to Sham
研究概览
简要总结
Evaluate the safety and effectiveness of the Zenflow Spring System in relieving LUTS associated with BPH.
详细描述
Prospective, multi-center, multinational, 2:1 randomized, single-blinded, controlled clinical trial of the Zenflow Spring System.
Patients randomized to the treatment group will undergo Zenflow Spring placement.
Patients randomized to the control group will undergo a Sham procedure. Patients and site personnel administering follow-up assessments will be blinded to the randomized treatment through completion of the 3-month follow-up visit. Once a patient has completed their 3-month follow-up assessments, they will be unblinded. Following unblinding, patients who received a Sham procedure may elect to receive treatment with the Zenflow Spring System or alternatively they may exit the study.
The duration of study participation is 60 months for patients who receive a Spring Implant and 3 months for subjects in the Control Arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The patient and site personnel administering follow-up assessments to 3 months will be blinded to the study assignment. Unblinding will occur at 3 months post procedure after follow-up assessments are completed.
All patients will be asked post-treatment if they believe they are in the Treatment Arm, Control Arm, or do not know. The blinding questionnaire will be administered at discharge and at the 1-month and 3-month follow-up assessments.
Control Arm patients can receive treatment with the Zenflow Spring System within 30 days after their 3-month follow-up assessments are completed, and their symptoms warrant treatment and enrollment criteria are met.
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subject is able and willing to comply with all the assessments of the study,
- •Subject or subject's legal representative has been informed of the nature of the study, agrees to participate and has signed the informed consent form,
- •≥ 45 years of age,
- •Baseline IPSS score ≥ 13; ≥ 1 in the IPSS voiding to storage sub-score ratio (IPSS-V/S),
- •Prostate volume 25 - 80 cc by transrectal ultrasound (TRUS), measured within 120 days post study consent,
- •Prostatic urethral length between 25 and 45 mm, as measured by cystoscopic pull-back,
- •Failed, intolerant, or subject choice to not take a medication regimen for the treatment of LUTS.
排除标准
- •Obstructive intravesical median prostatic lobe as determined by ultrasound (i.e., more than 10 mm intravesical prostatic protrusion on sagittal mid-prostate plane via abdominal ultrasound),
- •High bladder neck with the absence of lateral lobe encroachment indicating a high likelihood of primary bladder neck obstruction as determined by the Investigator,
- •Urethral stricture, meatal stenosis, or bladder neck stricture - either current or recurrent,
- •Anatomical anomalies that will not accommodate the Implant, as determined by cystoscopy (e.g., prostatic urethral length to height geometry),
- •Requires indwelling catheter or intermittent catheterization to void,
- •Baseline PSA > 10 ng/mL or confirmed or suspected prostate cancer (Subjects with a PSA level above 2.5 ng/mL, or age specific, or local reference ranges should have prostate cancer excluded to the Investigator's satisfaction),
- •One of the following baseline test results, taken from a single uroflowmetry reading:
- •Urinary volume void ≤ 125mL (pre-bladder urinary volume of ≥ 150 mL required),
- •Peak urinary flow rate (Qmax) of ≤ 5 ml/second or > 15 mL/second,
- •Post- void residual volume (PVR) > 250 mL
- •History of other diseases causing voiding dysfunction including urinary retention (e.g., uncontrolled diabetes, diagnosis of neurogenic bladder, Parkinson's disease, multiple sclerosis, etc.),
- •Subjects with overactive bladder in the absence of benign prostatic obstruction,
- •Acute urinary tract infection (UTI) or finding of asymptomatic bacteriuria (Note: subject can be enrolled if the UTI is treated and followed with a negative urine test result), or subjects with history of recurrent UTIs (defined as > 3 UTIs in the past 12 months),
- •Concomitant bladder stones,
- •Previous pelvic irradiation or radical pelvic surgery,
- •Previous prostate surgery, including: enucleation, resection, vaporization, thermotherapy, ablation, stenting or prostatic urethral lift,
- •Chronic prostatitis, recurrent prostatitis, chronic pelvic pain syndrome (CPPS), or painful bladder syndrome within the past 12 months
- •Known allergy to nickel,
- •Life expectancy less than 60 months,
- •Use of concomitant medications (e.g., anticholinergics, antispasmodics or tricyclic antidepressants) affecting bladder function,
- •Inability to stop taking anticoagulants and/or antiplatelets for at least 3 days prior to the procedure or coumadin for at least 5 days prior to the procedure (Note: low dose aspirin therapy (81 mg) is permitted),
- •Taking 5-alpha-reductase inhibitors within 3 months of baseline evaluation,
- •Taking one of the following within 2 weeks of baseline evaluation:
- •alpha-blockers,
- •imipramine,
- •anticholinergics,
- •cholinergic gonadotropin releasing hormonal analogues,
- •Phosphodiesterase-5 Enzyme Inhibitors (Tadalafil) in doses for BPH,
- •Beta-3 adrenergic receptor agonist (Mirabegron),
- •Taking androgens, unless eugonadal state for at least 3 months or greater as documented by the Investigator,
- •Taking one of the following within 24 hours of pre-treatment (baseline) evaluation:
- •phenylephrine, or,
- •pseudoephedrine,
- •Future fertility concerns, or,
- •In the Investigator's opinion, the subject has a physical, psychological, or medical impairment that might prevent study completion or would confound study results (including subject questionnaires).
结局指标
主要结局
Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH) as compared to Sham
时间窗: Procedure to 3 months
The Treatment Arm will be considered superior to the Control Arm (Sham) when the mean 3-month improvement from baseline score for the IPSS symptom questionnaire demonstrates a minimum statistical margin of 25% compared to mean improvement from baseline for the Control Arm (Sham) alone.
Effectiveness- Symptoms Improvement
时间窗: Procedure to 12 months
The mean percent change in IPSS in the treatment arm is at least 30% improvement over the Patient's pre-treatment baseline score.
Safety - Adverse Events
时间窗: Procedure through 12 months
The rate of device or procedure related serious adverse events in both the Treatment Arm and the Sham Arm.
Safety - The need for urinary catheterization
时间窗: Greater than 7 days after procedure
The rate of extended post-operative urinary catheterization (\> 7 days from treatment) for inability to void among patients treated with the Zenflow Spring System.
次要结局
- Safety - Sexual Health Questionnaire 1(3 months post procedure through 24 months post procedure)
- Safety - Adverse Events(Procedure through 60 months)
- Effectiveness - long term symptom improvement 2(Procedure through 60 months)
- Effectiveness - flow metrics(1 month post procedure through 60 months)
- Safety - Device Removal(Procedure through 60 months)
- Safety - Pain Assessment Questionnaire(Procedure through 3 months)
- Safety - Sexual Health Questionnaire 2(3 months post procedure through 24 months post procedure)
- Effectiveness - long term symptom improvement 1(Procedure through 12 months)
- Safety - Classification of Adverse Events(Procedure through 3 months)
- Effectiveness - Re-intervention (device)(Procedure through 60 months)
- Effectiveness - Re-intervention (drug)(Procedure through 60 months)