To Evaluate The Efficacy of Electrical Stimulation and Biofeedback Treatment for Pelvic Floor Disorder Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- 1-Hour Pad test of urine leakage amount (gm)
研究概览
简要总结
Female pelvic floor disorders (PFDs) include urinary incontinence,pelvic organ prolapse (POP), and fecal incontinence-which often occur together.
Pelvic floor disorders impair multiple aspects of the life quality, including the sexual function of women.
Surgery became the first choice of treatment, however, and not until 1980s was the renewed interest in conservative therapies.
This may be because of higher awareness among women and cost of and morbidity after surgery.
The conservative treatment included pelvic floor muscle training, electrical stimulation, vaginal cones, and biofeedback.
The outcome was up to 35~70 % improved rate as the literature before. Current guidelines recommended conservative management as a first-line therapy. However, there was no consistent consensus on this issue due to variations in stimulation parameters、adjuvant concurrent modality or duration of treatment course, and insufficient result about large and long term follow up of randomized- controlled studies.
Therefore, the investigators try to conduct one randomized-controlled trial to evaluate the efficacy of conservative treatment for Pelvic floor disorder (Pelvic organ prolapse, urinary incontinence, chronic pelvic pain etc.).
At the aspect of Quality of life, our studies tried to focus on the different domains of pelvic disorder and sexual quality by means of validated questionnaire more objectively.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients suffering from pelvic organ prolapse and/or urinary incontinence and/or fecal incontinence.
排除标准
- •Patient is pregnant The patient had any major medical or psychiatric disease The patient with Metabolic medical device
结局指标
主要结局
1-Hour Pad test of urine leakage amount (gm)
时间窗: Total 18 times of treatment, for 3 months
A pad test is a tool to used to measure urine leakage amount . Pad testing can be done over a period of time to one hour. A sanitary napkin is weighed and then worn for sixty minutes, during which time the individual is asked to perform certain activities which may include: * Walking briskly for three minutes * Sitting and then standing ten to twenty times * Walking up and down stairs for one to two minutes * Picking up objects from the floor five to ten times * Coughing twelve times (at various strengths; may be repeated) * Running in place for one minute (may be repeated) The pad is then removed and weighed again to calculate the amount of urine voided.
次要结局
- Quality of life (score)(Total 18 times of treatment, for 3 months)
研究者
Tsung-Hsien Su
Mackay Memorial Hospital
Mackay Memorial Hospital