A Multi-center, Open-label, Prospective, Feasibility Study Evaluating the ParaPatch System for the Treatment of Urinary Incontinence and Overactive Bladder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Number of Participants Who Used the ParaPatch System With Adverse Events Through the Completion of the Study
研究概览
简要总结
A multi-center, open-label, prospective, feasibility study evaluating the ParaPatch System for the treatment of urinary incontinence and overactive bladder.
详细描述
- Baseline Period
o The baseline period will allow for washout of any medication affecting bladder function and to allow subject to begin her voiding diary.
- Prospective data collection will take place in the form voiding diary. Leak frequency, and other relevant parameters will be collected.
- Inclusion/exclusion criteria will be rechecked at end of baseline.
- Qol questionnaires will be completed in the office at the end of baseline period.
- Evaluation Period
o During the evaluation period, the subjects will use the ParaPatch System.
- No medications affecting bladder function will be allowed during the evaluation period.
- Subjects will complete voiding diaries, during the evaluation period. Data capture to include: adverse events, medication use, leak frequency and other relevant parameters.
- Qol questionnaires will be completed in the office at the end of evaluation period.
- Follow-up Period
o Subjects will be followed for after the evaluation period to check for residual Adverse Events.
- No medications affecting bladder function will be allowed during the follow-up period.
- Subjects will be called by the clinical coordinator at the end of the Follow-up period and asked about potential Adverse Events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged from >18 to < 75 years old.
- •Subject has the ability to read and comprehend English, and to reliably record information as required by the Protocol, including the proper completion of the questionnaires.
- •Subject is able to provide written informed consent prior to participation in the study.
- •Diagnosed with either of the following: a) overactive bladder, or b) urinary stress incontinence.
排除标准
- •Are currently participating or have participated within the past 30 days in any clinical investigation involving or impacting urinary or renal function.
- •Subject has demonstrated or is believed to be at risk of non-compliance with study procedures (e.g., for completing the diary or returning for required follow-up visits).
- •Subject has undergone onabotulinumtoxin-A injections of the bladder in the last twelve (12) months.
- •Subject is not suitable for the study for any reason (including overall health, pre-existing conditions or medications) in the judgment of the investigator.
- •Have an untreated recurrent urinary tract infection (> 2 times within the past 6 months).
- •Have neurogenic disorders such as Multiple Sclerosis, ALS, or Parkinson s Disease.
- •Patients with a diagnosis of painful bladder syndrome, other pelvic pain or interstitial cystitis.
研究组 & 干预措施
1) Stress urinary incontinence
Stress urinary incontinence. Diagnosed with urinary stress incontinence and treated with the ParaPatch System
干预措施: ParaPatch (Device)
2) Overactive bladder
Overactive bladder. Diagnosed with overactive bladder syndrome and treated with the ParaPatch System
干预措施: ParaPatch (Device)
结局指标
主要结局
Number of Participants Who Used the ParaPatch System With Adverse Events Through the Completion of the Study
时间窗: up to 3 weeks
Documentation, follow-up and characterization of all adverse events in all subjects who use the ParaPatch System, through the completion of the study.
次要结局
- Stress Incontinence Arm(up to 3 weeks)
- Overactive Bladder Arm(up to 3 weeks)