Preliminary Performance Study of the New TIPI Device in the Prevention of Stress Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Mean Percentage of Pad Weight Gain (PWG) Change
研究概览
简要总结
Stress urinary incontinence (SUI) is most prevalent among women. SUI is characterized by loss of urine from increased abdominal pressures caused by coughing, laughing, sneezing, running, lifting or walking. SUI cause women to avoid routine physical activities, thus detracting significantly from their quality of life.
The purpose of this study is to evaluate the performance of new designs of the TIPI device, a conservative, disposable, treatment for temporary management of SUI.
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
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females aged 18 to 60 years
- •Had ≥ 1 deliveries
- •Suffering from genuine stress urinary incontinence confirmed by urodynamic testing (Urodynamic stress urinary incontinence) and normal voiding without abnormal residual urine
- •Baseline PWG (no usage of TIPI device) ≥ 6gr/8hrs
- •Average reduction of urinary incontinence of at least 70% following 3 days usage of the cleared TIPI G3 device
- •The patient has the ability to understand the nature of the study and give her consent by signing a written informed consent form.
- •Successful experience with the use of vaginal tampons
- •Willing to undergo urodynamic investigation
- •Normal pap smear within past 24 months
- •Patient is able and agrees to arrive to the study site area for a period of about 4-6 hours during 6-12 non consequent study days.
排除标准
- •Patient is pregnant, or suspected to be pregnant or is planning to be pregnant during the course of the study
- •Patients with present or suspected urinary infection
- •Patients with present or suspected vaginal infection
- •Severely atrophic vagina
- •Women who did not manage to insert a vaginal tampon, for any reason, in the past
- •Abnormal vaginal bleeding
- •Patient is currently participating in another clinical study that may directly or indirectly affect the results of this study
- •Was/is being treated for urinary incontinence by other means such as medications, surgical intervention etc. that might influence study results
- •Vaginal wall prolapse of any type reaching the level of the introitus (grade 2)
- •Co-morbid condition(s) that could limit the patient's ability to participate in the study, or impact the scientific integrity of the study
结局指标
主要结局
Mean Percentage of Pad Weight Gain (PWG) Change
时间窗: up to 8 hours of use
All eligible subjects underwent a 3-day Pad period to establish baseline Average PWG. During this period, pre-weighed pads were worn for 8 hours a day and subjects were asked to perform predefined physical activities and drink a certain amount of liquid, daily. Pads were collected and weighed in the clinic to determine baseline urine leakage. Subjects then used SMDs or the cleared TIPI (G3) with pads for up to 8 hours. The average PWG tests results with the TIPI devices were compared to the average PWG 8 hrs test without the device and were presented as percentages. The efficacy endpoint for the study was mean percent change of PWG using a certain device compared to the values obtained at the baseline period, as calculated by the following formula: % Reduction = 1-(Device/Baseline )\*100 Where, Device = the average pad weight gain (PWG) during device usage. Baseline = the average pad weight gain (PWG) during the days of baseline period.
次要结局
未报告次要终点