Rinovum Subsidiary 2, LLC: Disposable Stress Urinary Incontinence Pessary Device Efficacy and Safety Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 6
- 主要终点
- Percentage Reduction of Mean Pad Weight Gain (g/hr) During Treatment Phase as Compared to Baseline Phase.
研究概览
简要总结
This study is an interventional, single arm, multi-center study. It will be conducted at sites in the northeastern United States. The protocol will be approved by Chesapeake IRB or applicable local IRBs. The sample size will consist of approximately 50 participants. Participants will undergo an initial control period in which preweighed pads will be worn for 7 consecutive days for 12 hours. This will be followed by device usage for 14 consecutive days where participants will wear both device and preweighed pads simultaneously. for 12 hours.
详细描述
The purpose of this study is to evaluate the efficacy and safety of an over-the-counter (OTC) disposable stress urinary incontinence (SUI) pessary device. Specifically, this study will evaluate the effectiveness of the pessary device by assessing reduction in urine leakage in approximately 50 women with Stress Urinary Incontinence (SUI). Efficacy will be assessed by mean pad weight gain per hour, reduction of stress urinary incontinence events per day, and a quality of life questionnaire. The safety of the OTC SUI pessary device will be evaluated by assessing all 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
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •• Provision of signed and dated informed consent form
- •Literacy must be in English (able to read and understand Informed Consent)
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Female, aged >18
- •Be in generally good heath as determined by the Investigator
- •Have a physician diagnosis of SUI that occurred prior to or during the screening visit of this study
- •Have a > 3-month history of experiencing > 3 episodes of SUI per week
- •Be willing to use the investigational pessary device for the control of urinary incontinence
- •Have experience with wearing a tampon
- •The most recent Pap smear is normal within 36 months.
排除标准
- •• Is pregnant, or planning to become pregnant during the study
- •Has been physician diagnosed with urge urinary incontinence or mixed urinary incontinence prior to or during the screening visit for this study
- •Is post-partum within 3 months
- •Has had an intrauterine device (IUD) placement of less than 6 months
- •Has self-reported difficulty emptying her bladder;
- •Has a history of Toxic Shock Syndrome (TSS) or symptoms consistent with TSS;
- •Has experienced difficulty inserting or wearing an intra-vaginal device, including a tampon;
- •Has had vaginal surgery, perineal surgery, uterine surgery, or abortion (spontaneous or induced) within the past 3 months;
- •Has any Screening laboratory value outside the laboratory reference range considered clinically significant by the Investigator which could impact the safety of the participant or the outcome of the study
- •Has an active urinary tract infection or vaginal infection requiring treatment
- •If for any reason, the Investigator decides that the participant should not participate in the study.
- •Class III Obesity (BMI> 40.0 kg/m2)
- •Advanced prolapse
- •Fit assessment is not successful during screening visit
研究组 & 干预措施
RS-2 SUI Device
Comparing use of device to non-treatment phase
干预措施: SUI Device (Device)
结局指标
主要结局
Percentage Reduction of Mean Pad Weight Gain (g/hr) During Treatment Phase as Compared to Baseline Phase.
时间窗: 7 days of the baseline phase and 7 days of treatment phase
Pad weight gain (PWG) was measured by weighing used pads returned by participants and subtracting the pre-weight of that pad to obtain the total weight of leakage. The total weight of leakage was then divided by the number of hours the pad was worn by the participant to calculate the PWG/hr. The average PWG/hr for baseline was calculated by averaging the PWG/hr for the entire 7 days of the baseline phase. The average treatment PWG/hr for treatment phase was calculated by averaging the PWG/hr of the last 7 days of treatment phase. The percent change from baseline to treatment phase was then calculated. The objective was to show that PWG/hr is reduced by \>50% during treatment phase. Thus, the null hypothesis is that the mean weight gain reduction per hour is \<=50%, and the alternative is that it is \>50%, from the control period (no device) to the treatment period (women wearing the device).
次要结局
- Change in Mean SUI Episodes During Treatment Phase as Compared to Baseline Phase(7 days of baseline period and last 7 days of treatment phase)
- Change in Quality of Life From Before Treatment Phase to After Treatment Phase(Before Treatment Phase and After Treatment Phase is complete)
- Adverse Events and Labs Evaluation to Determine Safety of the Device(21 days)