Outpatient Biofeedback in Addition to Home Pelvic Floor Muscle Training for Stress Urinary Incontinence: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 主要终点
- Change in pad test
研究概览
简要总结
To test whether biofeedback (BF) added to pelvic floor muscle training (PFMT) promotes additional benefits over PFMT alone in the stress urinary incontinence (SUI) treatment.
详细描述
Introduction
The aim of this study was to test the hypothesis that outpatient BF added to home PFMT results in increased frequency of home exercises sets per month performed by the patients and objective cure rate after 3 months of supervised training. Secondarily, to investigate other subjective and objective clinical parameters in the groups that received or not BF together with PFMT after 3 months of supervised training, and in a longer term of 9-month follow-up.
Method: 72 incontinent women were randomized to the: BF Group (outpatient BF + home PFMT) or PFMT Group (outpatient PFMT + home PFMT).
Assessments: baseline after 3 months of supervised treatment and at 9-month follow-up (after 6 additional months of home PFMT without supervision).
Primary outcomes: adherence - monthly exercises sets performed (exercise diary) and objective cure of SUI (pad test) after 3 months.
Secondary outcomes: urinary symptoms, muscle function, quality of life, adhesion and subject cure at the two time-points.
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
- 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
- •SUI and mixed urinary incontinence with predominant symptoms of SUI with ≥ 2 g of leakage measured by pad test
排除标准
- •younger than 18 years old
- •chronic degenerative diseases
- •pelvic organ prolapse greater than stage I by POP-Q
- •neurologic or psychiatric diseases
- •previously undergone pelvic floor re-education programs and/or previous pelvic floor surgeries
结局指标
主要结局
Change in pad test
时间窗: Baseline, after 3 months of supervised treatment and at 9-month follow-up
To quantify the severity of SUI and as the tool to estimate objective cure rate
次要结局
- Change in pelvic floor muscle function (Peritron manometer)(Baseline, after 3 months of supervised treatment and at 9-month follow-up)
- Frequency of the outpatient sessions(After 3 months of supervised treatment)
- Change in 7-Day Voiding Diary(Baseline, after 3 months of supervised treatment and at 9-month follow-up)
- Change in pelvic floor muscle function (Oxford Grading Scale)(Baseline, after 3 months of supervised treatment and at 9-month follow-up)
- Change in Incontinence Quality-of-Life Questionnaire (I-QoL)(Baseline, after 3 months of supervised treatment and at 9-month follow-up)
- Subjective cure of SUI ("satisfied" or "dissatisfied")(After 3 months of supervised treatment and at 9-month follow-up)
- Frequency and adhesion to the home exercises(After 3 months of supervised treatment and at 9-month follow-up)
研究者
Fatima Fitz
Physical Therapist
Federal University of São Paulo