The Zenflow Spring System EU Safety and Performance Study
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 10
- 主要终点
- Need for urinary catheterization
研究概览
简要总结
The objectives of the trial are to demonstrate the safety and performance of the Zenflow Spring System in relieving the symptoms of obstructive Benign Prostatic Hyperplasia (BPH).
详细描述
A multi-center, prospective, single arm safety and performance trial. Subjects will be treated either in the Investigator's out-patient treatment room or in the OR, with local anaesthesia only. All subjects will be followed for the entire duration of the study until exit after the 60 month follow-up visit.
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
- 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
- •Patient is able and willing to comply with all the assessments of the study
- •Patient or patient'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, and a baseline Quality of Life (QoL) question score > 3
- •Prostate volume 25 - 80 cc by Trans Rectal Ultrasound (TRUS) or abdominal ultrasound, measured within past 90 days and prostatic urethral length between 2.5- 4.5 cm
- •Failed, intolerant, or patient choice to not take a medication regimen for the treatment of LUTS
- •Patient must meet ONE of the following criteria:
- •Baseline PSA <= 2.5ng/mL
- •Baseline PSA >2.5 ng/mL and <=10 ng/mL AND free PSA >=25% of total PSA (no biopsy required or negative biopsy)
- •Baseline PSA >10ng/mL AND negative prostate biopsy1 result within 12 months
- •Negative prostate biopsy1 within 12 months if abnormal digital rectal examination
- •3 Tesla MRI of the prostate, with normal findings, within 12 months prior to the baseline visit
排除标准
- •Obstructive intravesical median prostatic lobe which, in the opinion of the Investigator, would not benefit from treatment
- •Urethral stricture, meatal stenosis, or bladder neck obstruction - either current, or recurrent requiring 2 or more dilations as reported in the patient's history
- •Requiring self-catheterization to void
- •Baseline PSA > 10 ng/mL or confirmed or suspected prostate cancer
- •Any of the following, taken from a single uroflowmetry reading:
- •Peak urinary flow rate > 12 ml/second
- •Post-void residual (PVR) > 250 ml
- •Peak Urinary flow rate of > 15 ml/second
- •< 125ml urinary volume voided at baseline (pre-bladder urinary volume of ≥ 150 ml required)
- •Other condition or disease that might cause urinary retention
- •History of other diseases causing voiding dysfunction
- •Concomitant Urinary Tract Infection (UTI) (subject can be enrolled following successful treatment of UTI and a clean urine test), or a history of recurrent or chronic UTIs (defined as 2 or more UTIs in the past 12 months)
- •Concomitant bladder stones
- •Previous pelvic irradiation or radical pelvic surgery
- •Previous prostate surgery, stent implantations, laser prostatectomy, hyperthermia or another invasive treatment to the prostate
- •Chronic prostatitis, or recurring prostatitis within the past 12 months
- •Known allergy to nickel
- •Life expectancy less than 24 months
- •Use of concomitant medications (e.g., anticholinergics, antispasmodics or 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 (low dose aspirin therapy not prohibited)
- •Taking 5-alpha reductase inhibitors within 3 months of pre-treatment (baseline) evaluation unless evidence of same drug dose for at least 6 months with a stable voiding pattern (the drug dose should not be altered or discontinued throughout the study)
- •Taking one of the following within 2 weeks of pre-treatment (baseline) evaluation:
- •alpha-blockers,
- •anticholinergics, or
- •cholinergic medication gonadotropin releasing hormonal analogs
- •Taking one of the following within 24 hours of pre-treatment (baseline) evaluation:
- •phenylephrine, or
- •pseudoephedrine
- •Future fertility concerns
- •Any severe illness that might prevent study completion or would confound study results
结局指标
主要结局
Need for urinary catheterization
时间窗: 7 days after the procedure
Rate of extended post-operative urinary catheterization
Successful placement of the Zenflow Spring Implant
时间窗: Day of discharge up to 7 days following device placement
Successful deployment and procedural success for the Zenflow System to implant the Spring device in the operating room or an out-patient clinical setting.
Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH) using the International Prostate Symptom Score and Quality of Life Score (IPSS+QoL)
时间窗: Baseline and 3 months
The patient is asked to respond to 7 questions related to his urinary health using a rating scale of 0 to 5 where zero is excellent and 5 is the worst possible. The responses to the 7 questions are tallied for a total score. In addition the patient is asked 1 question related to his Quality of Life. The possible responses range from 0 to 6 where 0 is the best and 6 is the worst.
次要结局
- Incidence of procedure or device related serious adverse events(Up to 30 days)
- Assessment of Sexual Health Assessment: Change in sexual health measured by change in the Sexual Health Inventory for Men (SHIM) questionnaire score(Baseline, 3, 6, 12, & 24 months)
- Assessment of Sexual Health Assessment: Change in sexual health measured by change in ability to ejaculate using the Male Sexual Health Questionnaire - Ejaculatory domain (MSHQ-EjD)(Baseline, 3, 6, 12, & 24 months)
- Assessment of Pain, evaluated using a Visual Analog Score (VAS) of 1 to 10(Baseline, 2 weeks, 1 month and 3 months)
- Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH)(Up to 2 years)
- Assessment of Adverse Events(Up to 2 years)