Use of the Leva Pelvic Digital Health System in Women With Fecal Incontinence

Use of the Leva Pelvic Digital Health System in Women With Fecal Incontinence: a Pilot Study

Pilot study to understand the impact of a digital health system, including a phone app and a vaginal probe to treat fecal incontinence in women

Study Overview

• Status: Unknown
• Conditions: Fecal Incontinence
• Intervention / Treatment: Device: leva

Detailed Description

Subjects meeting inclusion/exclusion criteria at screening will complete training in behavioral therapy for the treatment of fecal incontinence and training in the use of the Leva pelvic digital health system.

Subjects will then participate in 10 weeks of at home pelvic floor muscle training using the leva device twice daily for 2 ½ minutes of training.

Adherence to the training protocol will be observed digitally, and subjects will receive phone calls every other week from research assistants reviewing their adherence.

Subjects are expected to participate in at least 80% of the weekly exercises (11 weekly).

Subjects will return to clinic at 5- and 10-weeks during the study to complete questionnaires. At 5-weeks, subjects will review the use of the device with the study assistant, who will answer any questions and repeat training if the subject desires additional training.

Following 10 weeks of training, subjects will be free to pursue any additional therapies, but will also retain the leva device and may continue its use if desired. Adherence will be monitored for one additional year, with follow up surveys to be completed by mail or digitally at 6- and 12-months

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Age ≥18 years
2. 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
3. Ambulatory

Exclusion Criteria:

1. Absence of a vagina
2. Stool consistency over the last 3 months that includes items 1 or 7 based on the Bristol Stool form scale (severe constipation or diarrhea)
3. Current or past diagnosis of colorectal or anal malignancy
4. Diagnosis of inflammatory bowel disease
5. Current or history of rectovaginal fistula or cloacal defect
6. Rectal prolapse (mucosal or full thickness)
7. Prior removal or diversion of any portion of colon or rectum
8. Prior pelvic floor or abdominal radiation
9. Refusal or inability to provide written consent
10. Inability to utilize smart phone technology ("app" use)
11. Fecal impaction by exam
12. Stage 3 or 4 pelvic organ prolapse
13. Incontinence only to flatus
14. Supervised anal sphincter exercise/pelvic floor muscle training with or without biofeedback currently or within the past 6 months.
15. Childbirth within the last 6 months
16. Neurological disorders known to affect continence, including spinal cord injury, advanced multiple sclerosis or Parkinson's disease and debilitating stroke
17. Chronic abdominal pain in the absence of diarrhea
18. Presence of an active (turned on) sacral neuromodulator within the last 6 months
19. Pelvic floor surgery (including anal sphincteroplasty) within the past 6 months.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Leva Arm; Subjects will undergo training in the use of a vaginal device and its associated app, to be used twice daily to perform pelvic floor muscle exercises guided by the device/app for 10 weeks.	Device: leva; Vaginal device used for pelvic floor muscle exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
St. Mark's Incontinence Score	Validated survey of fecal incontinence severity, score ranges from 0-24, Higher scores indicate more severe symptoms	Baseline to 10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fecal incontinence episodes	Percent improvement= number of fecal incontinence episodes at 10 weeks divided by the number of incontinence epsiodes at baseline.	Baseline to 10 weeks
Fecal Incontinence Quality of Life Scale (FIQoL)	Validated Survey evaluates four areas- coping, depression, lifestyle and embarrassment. Each area is scored from 1-5. Higher numbers indicate more severe symptoms. Area scores are not combined	Change in score from baseline to 10 weeks
Cumulative adherence correlation with change in St. Mark's score	Adherence as a percentage of all expected exercise sessions (140) correlation with change in St Mark's Incontinence Score (1-24)	baseline to 10 weeks

Collaborators and Investigators

• Sponsor: Renovia, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 27, 2019
• Primary Completion (ACTUAL): December 21, 2020
• Study Completion (ANTICIPATED): April 30, 2021

Study Registration Dates

• First Submitted: July 18, 2019
• First Submitted That Met QC Criteria: July 18, 2019
• First Posted (ACTUAL): July 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 18, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Women; Fecal incontinence
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Fecal Incontinence
• Other Study ID Numbers: REN-17

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