Pelvic Floor Muscle Training With the Leva® System for Treatment of Urge Predominant Urinary Incontinence: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Urogenital Distress Inventory
研究概览
简要总结
This is a pilot non-comparative study to assess the effectiveness of pelvic floor muscle training guided by the leva® system for improving change in subject-reported incontinence-related quality of life and urgency urinary incontinence (UUI) episode frequency based on voiding diaries in women at 8 weeks.
详细描述
Our study aims to investigate a new alternative to formal pelvic floor physical therapy that may provide subjects with a more accessible, private method of undergoing pelvic floor muscle training (PFMT) with real-time biofeedback on performance. The leva® Pelvic Digital Health System by Renovia Inc is a novel tool for subjects with urinary incontinence to train and strengthen pelvic floor muscles via directional mechano-transductive feedback on performance in the privacy of their own homes. We hypothesize that women using the leva® System will experience significant improvements in subjective urge-related incontinence symptoms. In addition, changes in incontinence-related quality of life and UUI episode frequency will be determined.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18-85 years old
- •Urinary incontinence for ≥ 3 months
- •Reporting at least "moderate bother" on Item 2 on the UDI-6, "Do you experience urine leakage in related to the feeling of urgency" (on new patient paperwork)
- •If mixed urinary incontinence, Medical Epidemiologic Social Aspect of Aging Urinary Incontinence Questionnaire (MESA) score indicating urge-predominant MUI (Urge subscale % > Stress subscale %)
- •Presence of ≥ 1 UUI episode on 3-d bladder diary (see Appendix 2)
- •Is the baseline bladder diary consistent with the patient's typical habits?
- •Not currently taking anti-muscarinic or beta3 agonist therapy (after at least 2 week wash-out period)
- •Brink Score > 3 (see below)
- •Access to smartphone technology, including iOS or Android™
排除标准
- •Non-English speakers
- •Severely impaired mobility or cognition
- •Spinal cord injury or advanced/severe neurologic condition including Multiple Sclerosis, Parkinson's Disease
- •Concomitant prolapse beyond the hymen or repair of prolapse in the previous 6 months
- •Received intravesical botulinum injection within the previous 12 months
- •History of implanted nerve stimulator for incontinence
- •History of prior sling or vaginal mesh placement
- •Previous diagnosis of Interstitial cystitis
- •Active pelvic organ malignancy
- •History of pelvic radiation
- •Urethral obstruction
- •Urinary retention or prolonged catheter use
- •Less than 12 months post-partum are currently pregnant, or plan to become pregnant in the following 12 months
- •Untreated symptomatic urinary tract infection
- •Unevaluated hematuria
- •Medical instability
- •Not available for follow-up in 6 months
- •Participation in other research trials that could influence results of this study
结局指标
主要结局
Urogenital Distress Inventory
时间窗: Change from Baseline UDI score to 8 weeks and 6 months post-intervention
The Urogenital Distress Inventory (UDI) is a 19-item questionnaire assessing subjective symptoms of pelvic floor disorders including incontinence. The 19 items fall into one of three subscales (Irritative symptoms, Obstructive symptoms, and Stress Symptoms). . The subject responds to each item by choosing from one of four answer options from 0 to 3 with higher scores indicating a greater severity of symptom. For scoring, first each subscale score is calculated by finding the mean score of items within the subscale section, subtracting 1, and multiplying that by 100/3. Next, the subscale scores are summed to determine the overall UDI score with possible scores ranging from 0-300. High scores indicate greater symptoms severity.
次要结局
- Incontinence Impact Questionnaire Short Form (IIQ-7)(Change from Baseline IIQ-7 score to 8 weeks and 6 months post-intervention)
- Urge Urinary Incontinence Episode Frequency on a Three-Day Voiding Diary(Change from Baseline urge urinary incontinence episode frequency to 8 weeks and 6 months post-intervention)
研究者
Anne Stachowicz
Fellow Physician
The Christ Hospital