A Prospective Randomized Efficacy Study Comparing a Pelvic Digital Health System Home Program of Pelvic Floor Muscle Exercise to Kegel Exercises in the Treatment of Stress-Predominant Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 试验地点
- 14
- 主要终点
- PGI-I
研究概览
简要总结
A randomized controlled trial for patients with stress urinary incontinence or stress-dominant mixed incontinence. Subjects will be randomized to 8-weeks of home kegel exercises or 8 weeks of pelvic floor muscle exercises using the leva digital pelvic health system that includes visual biofeedback via smartphone.
详细描述
A randomized controlled trial for patients with stress urinary incontinence or stress-dominant mixed incontinence.Subjects will be randomized to 8-weeks of home kegel exercises or 8 weeks of pelvic floor muscle exercises using the leva digital pelvic health system that includes visual biofeedback via smartphone. Leva subjects will perform guided pelvic floor muscle exercises for 2 1/2 minutes twice daily. Home kegel subjects will perform kegel exercises three times daily. Following 8-weeks of training, subjects will be permitted to continue the exercises or pursue additional therapies as indicated. Subjects randomized to the leva digital health system will be further randomized to receive automated reminders for the remainder of one year, or no additional reminders.
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 (Outcomes Assessor)
盲法说明
Assessments of pelvic floor muscle function accomplished by testing at baseline, 4-weeks (mid-study) and 8-weeks will be performed by blinded assessor
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Capable of giving informed consent.
- •Self-reported stress-type UI symptoms of >= three months duration
- •Diagnosis of stress predominant urinary incontinence based on MESA stress symptom score greater than MESA urge symptom score (percent of total possible urge score).
- •UDI-6 score >/= 25
- •Willing to participate in the 8-week study with follow up at 6-and 12-months, refraining from the pursuit of treatment for Stress Urinary Incontinence using other modalities (i.e. will not wear a pessary, participate in pelvic floor PT or surgery) during the first 8- weeks.
排除标准
- •Absence of a vagina.
- •Age <18 years.
- •Stage 3-4 pelvic organ prolapse (as determined by POP-Q).
- •Diagnosis of any neuromuscular disease.
- •Non-ambulatory.
- •Currently pregnant or <12 months post-partum.
- •</= 3 months after failed surgery for stress urinary incontinence.
- •Previous pelvic floor muscle training (PFMT) within the last 12 months under a supervised therapeutic plan of care.
- •Currently taking, or has taken within the last 2 months, medication to treat urinary incontinence.
- •Prior augmentation cystoplasty or artificial sphincter.
- •Implanted nerve stimulator for urinary symptoms.
- •Participation in another clinical study within 30 days of screening.
- •Impaired cognitive function.
- •Contraindication to the use of a vaginal probe.
- •Unable to understand instructions on the use of the leva® Plus Pelvic Digital Health System.
- •Unable to actively recruit the pelvic floor muscles to any degree for attempted volitional contraction.
结局指标
主要结局
PGI-I
时间窗: 8 weeks after randomization
PGI-I, Patient Global Impression of Improvement, is a five-point scale that ranges from "not at all" to "very much better."
UDI-6
时间窗: 8 weeks after randomization
Urogenital Distress Inventory is a six question validated questionnaire evaluating incontinence symptoms. It is scored from 0-100, with higher scores indicating more severely bothersome symptoms
次要结局
- 3-day voiding diary(8 weeks after randomization)