Office for Research on Women's Health (ORWH): Specialized Centers of Research (SCOR) on Sex and Gender Factors Affecting Women's Health. Project 3: Selection Criteria For Muscle Therapy in SUI
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- The short-term outcome of "positive response" is defined as able to reduce leakage during coughing to under 2 ml or 50% decrease from baseline (whichever is more stringent). This will be evaluated immediately at 1 month.
研究概览
简要总结
The IRIS project stands for Incontinence Research Intervention Study. The purpose of this research project is to develop an effective behavioral therapy for urinary incontinence and specifically to test Knack therapy, a self-help treatment. The Knack therapy involves learning the skill of performing a pelvic muscle contraction simultaneously with an event known to trigger leakage, in order to stop that leakage.
详细描述
This proposal aims to develop and test, in a general population of women with stress urinary incontinence (SUI), a model for predicting who will succeed in overcoming incontinence long-term (1-year) by simply using Knack therapy (thus avoiding invasive and costly surgery and time consuming Kegel's exercises). Specific Aims are to:
- develop a logistic regression model to predict success with the Knack;
- validate the model by determining the proportion of people who succeed according to who is predicted to succeed; and
- develop long-term effectiveness of the Knack (1-year).
The project will be implemented in three phases: model development (n=160 women), model validation (n~160), and long-term follow-up of women who demonstrate response. This will be evaluated immediately and at 1 month and at 3-months and 1-year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 否
入选标准
- •Women who are incontinent
- •Women who experience leakage with coughing, sneezing or exercising
- •Women who are generally healthy
- •Women who are over the age of eighteen
- •Women who are not pregnant nor expecting to become pregnant within a year
排除标准
- •No urine leakage when coughing, sneezing, or exercising
- •Under the age of eighteen
- •Pregnant or expecting to become pregnant
- •Untreated urinary tract infection
- •Pronounced pain or discomfort with pelvic exams
- •History of neurologic conditions
结局指标
主要结局
The short-term outcome of "positive response" is defined as able to reduce leakage during coughing to under 2 ml or 50% decrease from baseline (whichever is more stringent). This will be evaluated immediately at 1 month.
次要结局
- Long-term success (3-months and 1-year) is defined both by the paper towel test criteria and by documentation of at least 50% reduction of leakage in diary to reflect success at home.