NCT03978741已完成不适用
Randomized, Comparator-controlled, Single Blinded, Multi-center Study Evaluating the Efficacy and Safety of Yoni.Fit in Women With Stress Urinary Incontinence
Watkins Conti Products. Inc.5 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年1月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 5
- 主要终点
- Responder rate at Day 21
研究概览
简要总结
Study to evaluate the safety and effectiveness of Yoni.Fit for the temporary management of stress urinary incontinence (SUI) in women.
详细描述
Randomized, comparator-controlled, single blinded, multicenter study to demonstrate the effectiveness, user acceptance, safety and tolerability of Yoni.Fit in the temporary management of stress urinary incontinence (SUI) in women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants must be female,
- •Must be 18 years of age or older at the time of signing the informed consent
- •With BMI < 35
- •Must meet the following 2 criteria for diagnosis of stress urinary incontinence (SUI) :
- •SUI clinical diagnosis via the cough supine test, AND
- •≥ 3 month history of experiencing Stress Urinary Incontinence (SUI) symptoms per the patient
- •Women of childbearing potential not intending to become pregnant for the duration of study participation. Subject must agree for the duration of the study to use one of the following forms of contraception
- •Systemic hormonal treatment including oral pills, patches and injections OR
- •"Single-barrier" contraception (condom, diaphragm and spermicide are each considered a barrier) OR
- •Essure® procedure done at least three month prior to screening
- •Willing to comply with study requirements, including capable of performing the activities required for the pad weight test and return for follow-up visits.
- •Must be able to speak, understand and read English and sign study specific Informed Consent Form
排除标准
- •Women having predominantly urge or mixed incontinence as defined by:
- •QUID Urge score >6, OR
- •MESA percentage Urge Score > MESA percentage Stress Score Note: the questionnaires above will be self-administered and results interpreted by the subjects as per instructions in the questionnaires.
- •Current pregnancy, lactation or planning for pregnancy in the next 6 months
- •Women at postpartum for 3 months or less prior to screening
- •Women currently have an intrauterine device (IUD) as a contraception method placement less than 6 months or have an IUD over 6 month but may replace it next 14 weeks
- •Women currently use, have used an intra-vaginal device as contraception method for the past 6 months
- •Women currently using a pessary or treated previously with any device for UI
- •Women who have been treated with pharmacologic medications for UI within the past 4 months prior to screening, including any antidiuretic or diuretic medications (both over the counter and prescription medications)
- •Women who have been previously treated with any surgical or electrical interventions for UI
- •Women who have been previously treated with pelvic floor muscle training (PFMT) for UI within the past 4 months prior to screening
- •Women who have difficulty inserting or wearing an intra-vaginal device, including a tampon
- •Women who participated in a clinical trial within the 12 months prior to screening
- •Any of the following known conditions deemed prohibitory:
- •Abnormal kidney function, including kidney stone
- •Abnormal post void residual (e.g. greater than 150cc) or self-reported difficulty emptying bladder
- •Allergy to silicon products and materials
- •Acute febrile illness of any cause in the 14 days prior to screening
- •Bladder stones or Bladder tumors
- •Chronic pelvic pain within the past 4 months prior to screening
- •Coagulation abnormalities
- •Experience pain or burning sensation during sexual intercourse or urination
- •Infections of the vagina, bladder and/or urethra within previous 3 months such as urinary tract infection (UTI)
- •Interstitial cystitis
- •Neurological disorders such as multiple sclerosis, spina bifida, Parkinson's disease which may interfere with nerve function of the bladder.
- •Toxic shock syndrome (TSS) history or symptoms consistent with TSS
- •Uncontrolled diabetes
- •Undiagnosed vaginal bleeding or hematuria
- •Vaginal discharge with a strong odor and irritation within previous 3 months
- •Vaginal soreness or pain or fibromyalgia or paravaginal defect
- •Any other medical reason that the Investigator determines that the subject should not participate in the study
- •Known history of previous pelvic organ prolapse greater than the POP-Q Stage 2 as defined by the international continence society (ICS).
结局指标
主要结局
Responder rate at Day 21
时间窗: 21 Days
Responder rate at Day 21, where responder is defined as a subject who has at least 50% reduction in mean 12-hour pad weight test through assessment period of treatment phase (the last 7 days of 14-day device usage period), when compared to the mean pad weight test during the 7-day baseline phase
次要结局
- Percent Change in mean pad weight(7 Days, 14 Days)
- Percent change in the frequency of SUI events per the patient diary(7 Days, 14 Days)
- Responder rate for frequency of SUI events per the patient diary at Day 21,(21 Days)
- Percent change in Incontinence Impact Questionnaire (IIQ-7) score(21 Days)
- Percent change in Patient Global Impression of Change (PGIC) score(21 Days)
- Percent change in Incontinence-Quality of Life (I-QOL) Assessment Questionnaire(21 Days)
- Ease of use per the USE Questionnaire: Usefulness, Satisfaction, and Ease of Use(21 Days)
- Ease of use per the USE Questionnaire: Satisfaction(21 Days)
- Ease of use per the USE Questionnaire:Ease of Use(21 Days)
研究者
研究点 (5)
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