Pelvic Floor Muscle Training With Leva System for Urge Incontinence

The Christ Hospital

Status: Terminated

Conditions: Mixed Urinary Incontinence; Urge Urinary Incontinence; Overactive Bladder

Treatments: Device: Leva device

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03923348

18-71

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Leva Users

Experimental group

Description:

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.

Treatment:

Device: Leva device