Mixed Urinary Incontinence, Overactive Bladder, Urge Urinary Incontinence
Conditions
Keywords
female urinary incontinence, urge urinary incontinence, urgency, frequency, overactive bladder, pelvic floor muscle training, biofeedback
Brief summary
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.
Detailed description
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.
Interventions
DEVICELeva device
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.
Sponsors
Renovia, Inc.
The Christ Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Non-blinded non-comparative pilot trial in which subjects with pure urge urinary incontinence (UUI) or urge-predominant mixed urinary incontinence (U-MUI) who are candidates for pelvic floor physical therapy or other first line treatments for UUI/U-MUI use the leva® system twice-daily at home in addition to behavioral therapies for 8 weeks.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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™
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urogenital Distress Inventory | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incontinence Impact Questionnaire Short Form (IIQ-7) | Change from Baseline IIQ-7 score to 8 weeks and 6 months post-intervention | Validated short-form version of the Incontinence Impact Questionnaire used to describe incontinence-related quality of life. It consists of 7 items assessing four general areas including travel, social, emotional, and physical activities. For each item, the subject responds by choosing from one of four answer options from 0 to 3 with higher scores indicating a greater severity of symptom. Scores are generated by finding the mean score for each item and multiplying that by 100/3. Higher scores indicate greater negative impact on quality of life. |
| 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 | A voiding diary is considered standard of care in the work-up of a patient with incontinence to better characterize real-life drinking and voiding habits. The number of urge urinary incontinence episodes is determined by adding up the incontinence episodes recorded by the patient that were associated with an urge to get to the bathroom. More incontinence episodes means a greater severity of incontinence |
Countries
United States
Outcome results
None listed