Pelvic Floor Muscle Training With Leva System for Urge Incontinence

Sponsor

The Christ Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT03923348

Collaborator

Renovia, Inc. (Industry)

Enrollment

Location

Arm

10.9

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder Urge Urinary Incontinence Mixed Urinary Incontinence	Device: Leva device	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Pelvic Floor Muscle Training With the Leva® System for Treatment of Urge Predominant Urinary Incontinence: A Pilot Study

Actual Study Start Date :

Jun 6, 2019

Actual Primary Completion Date :

May 4, 2020

Actual Study Completion Date :

May 4, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Leva Users 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.	Device: Leva 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.

Arm

Intervention/Treatment

Experimental: Leva Users

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.

Device: Leva 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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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