A Feasibility Efficacy and Safety Study of the Nolix Vaginal Device for the Temporary Management of Stress Urinary Incontinence in Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Gynamics LTD
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Device-related adverse events
研究概览
简要总结
This study is an open label, prospective, feasibility study with the Nolix device used for temporary treatment of Stress Urinary Incontinence (SUI) in subjects, serving as their own controls.
详细描述
This is an open label, prospective, feasibility study with the Nolix device used in subjects with SUI, serving as their own controls. The objective of this study is to evaluate the effectiveness (both objective and subjective) and safety of the Nolix device when used for the temporary management of SUI in women. In addition, the study is aimed to evaluate changes in the quality of life (QoL) and comfort during use of the Nolix device. The primary effectiveness endpoint is the percent change in the mean Pad Weight Gain (%PWG) between the device (during the last 7 days of the 14-days Nolix use period) and control periods , with the success criterion defined as at least >-50% of the mean %PWG change during the last 7 days of the treatment phase as compared to the control phase. Additional effectiveness endpoints include the number of self-reported SUI episodes per week, the percentage of subjects who experience a greater than -50% change in the number of self-reported daily incontinence episodes, as well as the changes in the QoL, leak scores and overall satisfaction levels. The safety of the Nolix device is also evaluated by assessing the adverse events, including the results of urinalysis, vaginal swab, and vaginal examination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 22 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
Device-related adverse events
时间窗: 21 days
Discomfort / pain, vaginal irritation or itching, vaginal spotting, vaginal or urinary tract infections
Mean pad weight gain (PWG) change of >50% when comparing the PWG control phase as compared to the Nolix device phase.
时间窗: 21 days
The primary effectiveness endpoint is the percent change in the mean Pad Weight Gain (%PWG) between the device (during the last 7 days of the 14-days Nolix use period) and control periods , with the success criterion defined as at least \>50% of the mean %PWG reduction during the last 7 days of the treatment phase as compared to the control phase.
次要结局
- Changes in Quality of Life (QoL).(21 days)
- Comfort during Nolix device use.(21 days)
- Change in number of self-reported incontinence episodes.(21 days)
- More than 50% reduction in the number of self-reported daily incontinence episodes.(21 days)
- Changes in Leak Score.(21 days)
- Overall perception of improvement.(21 days)
- Overall satisfaction: Patient Satisfaction Question (PSQ)(21 days)
- PWG measured continuously.(21 days)