Prospective Post Market Clinical Trial for the Zenflow Spring System - A Minimally Invasive Treatment for LUTS Associated With BPH
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 110
- 主要终点
- International Prostate Symptom Score (IPSS) Total Score
研究概览
简要总结
This is a prospective, randomized, open-label, parallel-group post-market clinical trial (PMCT). The overall objective of this PMCT is to compare the effectiveness, durability, and patient-centered outcomes of the Zenflow Spring System versus Tamsulosin in men who are not on active therapy with moderate to severe LUTS/BPH. Patients randomized to the Tamsulosin therapy arm will be allowed to crossover to receive treatment with the Zenflow Spring System after 1) their 3-month follow-up assessments are completed, 2) the patient's symptoms are confirmed to continue to warrant treatment; and 3) the patient continues to meet the study enrollment criteria.
详细描述
The purpose of this post-market clinical trial (PMCT) is to compare the Zenflow Spring System with Tamsulosin in men with moderate to severe BPH symptoms who are not currently receiving treatment.
The study will look at how well each treatment works, how long the results last, how quickly patients return to normal activities, how satisfied they are with their treatment, and any side effects. Patients will be followed at 1, 3, 6, and 12 months. The study will also track any implant removals or additional procedures, as well as any changes to or stopping of Tamsulosin.
Patients who qualify for the study will be randomly assigned, with an equal chance, to receive either the Zenflow Spring System or Tamsulosin.
Patients randomized to the Tamsulosin therapy arm will be allowed to crossover to receive treatment with the Zenflow Spring System after 1) their 3-month follow-up assessments are completed, 2) the patient's symptoms are confirmed to continue to warrant treatment; and 3) the patient continues to meet the study enrollment criteria. No crossover will be permitted beyond 30 days after completion of the 12-month follow-up. Patients who elect crossover and have a successful placement of the Spring Implant will be followed for 1 additional month and then will exit the study.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •The Spring® Implant and Delivery System is indicated for the treatment of obstructive lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH) in men with prostatic urethral lengths between 25mm and 45mm and prostate sizes between 25cc and 80cc.
- •In addition to the above labeling requirements, patients must also meet all the following criteria to be eligible for enrollment in this study:
- •Moderate to severe LUTS, defined as an International Prostate Symptom Score (IPSS ≥ 8)
- •Not actively taking any medication indicated for BPH, defined as current use of:
- •Alpha-adrenergic antagonists (Alpha Blockers) within 2 weeks of baseline IPSS assessment
- •5-alpha reductase inhibitors (5ARI) within 6 months of baseline IPSS assessment
- •PDE5 daily use (on demand use is permitted)
- •Ability to provide informed consent and comply with study procedures and follow-up schedule
排除标准
- •Known, previous adverse reaction to use of alpha-adrenergic antagonists (e.g., Tamsulosin)
- •Neurologic conditions affecting bladder function, including but not limited to:
- •Multiple sclerosis
- •Parkinson's disease
- •Neurogenic bladder or other conditions causing non-obstructive voiding dysfunction
研究组 & 干预措施
Zenflow Arm: Zenflow Spring System Treatment
Zenflow Arm: Patients randomized to the Zenflow Spring System arm will undergo the procedure according to manufacturer specifications and standardized procedural protocols.
干预措施: Zenflow Arm: Zenflow Spring System implant procedure (Device)
Tamsulosin Treatment
Medical Therapy Arm: Patients randomized to the medical therapy arm will receive Tamsulosin 0.4 mg once daily. Subjects will be encouraged to remain on this medical therapy through at least 3 months of treatment, unless significant adverse health reaction occurs.
干预措施: Medical Therapy Tamsulosin (Drug)
结局指标
主要结局
International Prostate Symptom Score (IPSS) Total Score
时间窗: Baseline (Day 1) to 3 months
Mean change in IPSS Total Score from baseline at 3 months. This is a 7-question patient questionnaire used to measure the severity of lower urinary tract symptoms associated with BPH. Each of the 7 symptom questions is scored from 0 to 5, giving a total possible score of 0-35. Lower scores are better.
Observed rate of device-related or Tamsulosin-related serious adverse events (SAEs).
时间窗: Baseline through study completion, an average of 1 year (Duration of study)
Observed rate of device-related or Tamsulosin-related serious adverse events (SAEs).
次要结局
- Mean change in International Prostate Symptom Score (IPSS) Total Score from baseline at 1, 6, and 12 months(Baseline at 1, 6, and 12 months)
- Mean change in International Prostate Symptom Score (IPSS) Quality of Life (QoL) from baseline 1, 3, 6 and 12 months(Baseline 1, 3, 6 and 12 months)
- Adherence to assigned treatment (Spring Implant arm or Medical Therapy Arm) and reasons for any discontinuations(Baseline through study completion, an average of 1 year (Study duration))
- The observed rates of device related AEs or Tamsulosin-related adverse events(Baseline through study completion, an average of 1 year (Duration of study))