Use of the LEVA® Pelvic Health System for Fecal Incontinence

Comparison of the Duration of Use of the Leva® Pelvic Health System in Women With Fecal Incontinence

The goal of this clinical trial is to learn about how the duration of use of The Leva Pelvic Health System® affects treatment of fecal incontinence in women. The main question it aims to answer is to test whether use of the The Leva Pelvic Health System® for 8 weeks is as good as using it for 16 weeks.

Participants will complete surveys, and use the Leva device.

Study Overview

• Status: Recruiting
• Conditions: Fecal Incontinence
• Intervention / Treatment: Device: The Leva Pelvic Health System

Detailed Description

This study will assess whether 8 weeks of use of the Leva Pelvic Health System (Leva) is non-inferior to 16 weeks of use for the treatment of chronic fecal incontinence (symptoms >/= 3 months) in adults with a vagina. Participants will be instructed to complete pelvic floor muscle training using the Leva for 8 or 16 weeks.

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ushma Patel, MD; Phone Number: 608-720-5212; Email: UPatel@uwhealth.org
• Study Contact Backup: Name: Sharon Blohowiak; Email: sblohowiak@wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • Recruiting
      • University of Wisconsin
      • Contact: Ushma Patel, MD; Email: UPatel@uwhealth.org
      • Principal Investigator: Dobie Giles, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult, age ≥ 18years, assigned female at birth
• Fecal incontinence, defined as any uncontrolled loss of liquid or solid fecal material that occurs at least monthly over the last 3 months that is bothersome enough to desire treatment
• Able to stand to perform daily training for at least 3 minutes
• Able to speak and read English due to Leva smartphone application availability in only English at this time
• Have an email address, owns a smartphone, and can download an app

Exclusion Criteria:

• Inability to tolerate insertion of vaginal device (e.g., vaginal agenesis, vaginal stenosis, unremitting pelvic pain, within 12 weeks postpartum)
• Current diagnosis of colorectal or anal malignancy
• Diagnosis of uncontrolled inflammatory bowel disease
• Current rectovaginal fistula or cloacal defect
• Rectal prolapse (mucosal or full thickness)
• Inability to utilize smart phone technology ("app" use)
• Chronic Stool Types 6 or 7
• Fecal impaction by exam
• Stage 4 pelvic organ prolapse
• Concurrent supervised anal sphincter exercise/pelvic floor muscle training with or without biofeedback
• Presence of sacral neuromodulator
• Pelvic floor surgery (including anal sphincteroplasty) within the past 3 months
• Currently pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 8 week use of Leva	Device: The Leva Pelvic Health System; The Leva Pelvic Health System includes an intra-vaginal device that pairs with a smartphone application to provide real-time visual feedback about pelvic floor muscle performance during usage.
Active Comparator: 16 week use of Leva	Device: The Leva Pelvic Health System; The Leva Pelvic Health System includes an intra-vaginal device that pairs with a smartphone application to provide real-time visual feedback about pelvic floor muscle performance during usage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare effectiveness of improving fecal incontinence between 8 weeks and 16 weeks of use	Treatment response as length of use on symptom improvement at 16 weeks (comparing 8 weeks vs 16 weeks of use of Leva) as assessed by St Mark's Incontinence score, score ranges from 0-24, higher scores indicate more severe symptoms. A difference of -3 ± 4.37 is expected at 8 weeks and 16 weeks (compared to baseline), with an allowable difference of 1.	Baseline to 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in fecal incontinence severity	Using St. Mark's Incontinence score, score ranges from 0-24, higher scores indicate more severe symptoms.	Baseline to 16 and 24 weeks
Cumulative adherence correlation with change in St. Mark's score	Adherence as a percentage of all expected exercise sessions correlated with change in St Mark's Incontinence Score (1-24)	Baseline to 24 weeks
Patient satisfaction and usability of the smartphone application component of the Leva Pelvic Health System	Measured through the mHealth App Usability Questionnaire. In this questionnaire, 1 - strongly disagree, 2 - disagree, 3 - somewhat disagree, 4 - neither agree nor disagree, 5 - somewhat agree, 6 - agree, 7 - strongly agree. To determine the usability of an app, calculate the total and determine the average of the responses to all statements. The higher the overall average, the higher the usability of the app.	Baseline to 16 and 24 weeks
Change in fecal incontinence from baseline to 24 weeks after 8 or 16 weeks of treatment	Treatment response as length of use on symptom improvement at 24 weeks (comparing 8 weeks vs 16 weeks of use of Leva) as assessed by St Mark's (Vaizey) scores.	Baseline to 24 weeks
Change in Pelvic Organ Prolapse Quantification System (POP-Q)	The POP-Q system is an objective, site-specific system used to describe, quantify, and stage pelvic support. Measurements are rated as Stage 0-Stage 4, with Stage 4 being complete prolapse.	Baseline to 16 weeks
Change in Brink Scale Score	The Brink scale evaluates 3 PFM contraction variables: vaginal pressure or muscle force, elevation or vertical displacement of the examiner's fingers, and duration of contraction. Each muscle contraction variable is rated on a 4-point ordinal scale. Ratings are summed to obtain total scores, with a possible range of scores of 3 to 12 and higher scores indicating greater strength.	Baseline to 16 weeks
Change in stool consistency	Use the Bristol Stool Scale to evaluate stool consistency. Ranges from Type 1 to Type 7, where Type 1 is hardest consistency and Type 7 is entirely liquid.	Baseline to 16 and 24 weeks
Change in fecal Incontinence Quality of Life (FIQoL)	Use FIQoL scale, in which participants rate questions about how often an issue is a concern, and how much they agree with statements on a scale of 1-5. Higher scores indicate lower quality of life.	Baseline to 16 and 24 weeks
Change in sexual function (PISQ-IR)	PISQ-IR is a 20 item survey, where higher scores indicate lower sexual function.	Baseline to 16 and 24 weeks
Patient Global Impression of Improvement (PGI-I)	PGI-I is a 2 question qualitative survey in which participants state their satisfaction and perception of improvement.	16 and 24 weeks
Patient Satisfaction (PGI-I)	PGI-I is a 2 question qualitative survey in which participants state their satisfaction and perception of improvement.	16 and 24 weeks
Change in Global Pelvic Floor Symptoms	Use the Pelvic Floor Distress Inventory (PFDI-20) to evaluate change in pelvic floor symptoms. It is a 20 item survey with a range from 0-100 where higher scores indicate greater symptoms.	Baseline to 16 and 24 weeks
Evaluate self-continuation of pelvic floor muscle exercises	Participant self-report on whether and how often they continued the pelvic floor muscle exercises.	Baseline and 24 weeks
Number of cumulative adverse events	Systematic assessment of all adverse events over the course of the study, reported as a number of total AEs.	Baseline and 24 weeks
Estimated percentage of change	Qualitative question in which participants state their estimate of how much better they are, on a scale from 0% (no better) to 100% (completely better).	16 and 24 weeks

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Dobie Giles, MD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2024
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: November 21, 2023
• First Submitted That Met QC Criteria: November 21, 2023
• First Posted (Actual): November 30, 2023

Study Record Updates

• Last Update Posted (Actual): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: anal incontinence; accidental bowel leakage; pelvic health system
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Fecal Incontinence
• Other Study ID Numbers: 2023-1304; Protocol Version 10/12/2023 (Other Identifier: UW - Madison); A532810 (Other Identifier: UW- Madison); SMPH/OBGYN BENIGN GYN (Other Identifier: UW - Madison)

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