Assessment of the Effectiveness of a Pelvic Exercise Device in Strengthening Pelvic Floor Muscles and Treating Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 93
- 试验地点
- 2
- 主要终点
- Change in pelvic floor strength
研究概览
简要总结
This study will assess the effectiveness of a new pelvic floor exercise device in strengthening pelvic floor muscles and treating urinary incontinence among women who are experiencing symptoms of pelvic floor weakness. The study will be conducted over 12 weeks and results will be collected through self-assessment questionnaires and clinical pelvic examination. Effectiveness outcomes will be tracked over the duration of the trial and measured against historical symptoms.
详细描述
The objective of the study is to test the device with women who are experiencing symptoms of pelvic floor weakness, namely urinary incontinence, vaginal laxity and sexual sensation problems, to assess the changes in pelvic floor muscle strength, before and after the intervention.
The study device is a pelvic floor exercise device that provides biofeedback and exercise guidance.
Women who meet the inclusion criteria will be recruited from the regular patients at the investigation site and given the device to use at home daily for 12 weeks. Subjects will submit information regarding their experience with the device and self-assessed improvements in their symptoms. A pelvic examination will be conducted at the start and conclusion of the study to measure a pelvic floor muscle strength reading.
The research hypothesis is that strength level, subjective assessment of vaginal tightness and sexual sensations will be greater at the end of the study than at the baseline and the mean value of frequency and volume of bladder leaks will be less than at the baseline.
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
- 20 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject provides written informed consent and HIPAA authorization before any study procedures are conducted;
- •Experience urinary incontinence and/or vaginal laxity and/or decreased sexual sensation for a period of 6 weeks or more.
排除标准
- •Subject has any condition or exhibits behavior that indicates to the Principal Investigator that the Subject is unlikely to be compliant with study procedures and visits
- •Has had prior surgery for incontinence, prolapse or vaginal tightening
- •Has been diagnosed with pelvic organ prolapse more severe than grade 2
- •Suffers from vaginal penetration difficulties
- •Has had more than 3 urinary tract infections in the past 12 months
- •Has any conditions of the bladder that effect continence
- •Suffer from vaginal/vulvar/pelvic pain
- •Is currently taking any medication for incontinence
- •Is pregnant or trying to become pregnant
- •Has given birth less than 6 weeks prior to enrollment
- •Has been diagnosed obese - BMI > 30
- •Is a heavy smoker - > 20 cigarettes per day
- •Has a history of neurological conditions - Parkinson's, multiple sclerosis and other
- •Suffers from chronic constipation
研究组 & 干预措施
Pelvic floor exercise
Pelvic floor exerciser, daily use
干预措施: Pelvic floor exerciser (Device)
结局指标
主要结局
Change in pelvic floor strength
时间窗: 12 weeks
Pelvic floor strength measured by a clinical perineometer in cm H2O. A baseline measurement of resting and peak muscle contraction values will be recorded at the start before the intervention and after the 12 weeks of treatment.
次要结局
- Frequency of bladder leaks.(12 weeks)
- Volume of bladder leaks(12 weeks)