A Feasibility, Short-term Study With a Novel, Dynamic, and Disposable Over the Counter Device for Stress Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Gynamics LTD
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Continuous percent change in urine leakage
研究概览
简要总结
This study was designed as an open label, feasibility, single-center, cross-over prospective study in women with stress urinary incontinence. Subjects served as their own control.
详细描述
The primary objectives of this feasibility study were to evaluate the short-term efficacy of the Nolix device by measuring a reduction of SUI following a modified 1-hour PWG test and to measure the safety of the Nolix device based on adverse events that were reported by subjects during the study. The secondary objective was to assess usability and patient satisfaction using the Nolix device.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females aged 21 and above
- •Suffering from Stress Urinary Incontinence
- •Women who can understand the nature of the study, are physically able to perform all required tasks and consent to it by signing a written Informed Consent Form prior to participation in the study
排除标准
- •Age ≤ 21 years
- •Pregnant or planning to become pregnant during the study.
- •Vaginal birth or Cesarean section for the last 3 months prior to entering the study.
- •Severely atrophic vagina.
- •A history of Toxic Shock Syndrome (TSS).
- •Active urinary tract or vaginal infection.
- •Patients prone to recurrent vaginal or urinary tract infections (i.e. more than 3 times in the past year).
- •Has experienced unusual or unexpected vaginal bleeding within the last 6 months.
- •Vaginal surgery within the last 3 months prior to entering the study.
- •Has experienced difficulties with the use of intra-vaginal devices, including tampons.
- •Presence of any condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- •Average daily PWG as measured in the baseline pad period is less than 4 grams /12 hours.
结局指标
主要结局
Continuous percent change in urine leakage
时间窗: Pads were measured before and immediately after the 1 hour PWG test
Continuous percent change in urine leakage is defined as: 100%\*(PWG without Nolix - PWG with Nolix)/PWG without Nolix.
Dichotomous change in urine leakage
时间窗: Pads were measured before and immediately after the 1 hour PWG
In accordance with FDA recommendations, the clinically meaningful level of improvement in PWG is at least 50%. Therefore, the dichotomous change is defined for each patient as follows: Success ("1"), if continuous percent change in PWG \> 50% or Failure ("0"), if continuous percent change in PWG \< 50%
Change in the dryness of the pad
时间窗: Pads were measured before and immediately after the 1 hour PWG
Success ("1") if following the 1-hour PWG test, the pad weight increases by no more than 1 gram or Failure ("0") if following the 1-hour test, the pad weight increased by more than 1 gram.
次要结局
- Comfort during Nolix use(1 Day)
- Overall satisfaction: Nolix Satisfaction Questionnaire(1 Day)