Clinical trial NCT03923348: Pelvic Floor Muscle Training With Leva System for Urge Incontinence
Official title: Pelvic Floor Muscle Training With the Leva® System for Treatment of Urge Predominant Urinary Incontinence: A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Overactive Bladder
Urge Urinary Incontinence
Mixed Urinary Incontinence
Keywords: female urinary incontinence
urge urinary incontinence
urgency
frequency
overactive bladder
pelvic floor muscle training
biofeedback
Lead sponsor: The Christ Hospital
Sponsor class: OTHER
Collaborators: name: Renovia, Inc.
First posted: 2019-04-22
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Urogenital Distress Inventory
timeFrame: Change from Baseline UDI score to 8 weeks and 6 months post-intervention
Secondary outcomes:
measure: Incontinence Impact Questionnaire Short Form (IIQ-7)
timeFrame: Change from Baseline IIQ-7 score to 8 weeks and 6 months post-intervention
measure: Urge Urinary Incontinence Episode Frequency on a Three-Day Voiding Diary
timeFrame: Change from Baseline urge urinary incontinence episode frequency to 8 weeks and 6 months post-intervention
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
Study officials:
affiliation: Urogynecology Fellow
name: Anne M Stachowicz, MD
role: PRINCIPAL_INVESTIGATOR
References:
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