Pelvic Floor Muscle Training With Leva System for Urge Incontinence

June 30, 2020 updated by: Anne Stachowicz, The Christ Hospital

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urogenital Distress Inventory
Time Frame: 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.
Change from Baseline UDI score to 8 weeks and 6 months post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incontinence Impact Questionnaire Short Form (IIQ-7)
Time Frame: 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.
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
Time Frame: 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
Change from Baseline urge urinary incontinence episode frequency to 8 weeks and 6 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Christ Hospital

Collaborators

Renovia, Inc.

Investigators

  • Principal Investigator: Anne M Stachowicz, MD, Urogynecology Fellow

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 6, 2019

Primary Completion (ACTUAL)

May 4, 2020

Study Completion (ACTUAL)

May 4, 2020

Study Registration Dates

First Submitted

March 18, 2019

First Submitted That Met QC Criteria

April 18, 2019

First Posted (ACTUAL)

April 22, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 1, 2020

Last Update Submitted That Met QC Criteria

June 30, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-71

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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