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

NCT04027335 | Unknown FDA Device

• 1 other identifier: REN-17
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fecal Incontinence

Keywords

Fecal incontinence; Women

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Fecal incontinence episodes

  Baseline to 10 weeks

• Fecal Incontinence Quality of Life Scale (FIQoL)

  Change in score from baseline to 10 weeks

• Cumulative adherence correlation with change in St. Mark's score

  baseline to 10 weeks

Study Arms (1)

Leva Arm

EXPERIMENTAL

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

Interventions

leva DEVICE

Vaginal device used for pelvic floor muscle exercises

Leva Arm

Eligibility Criteria

• Age: 18 Years - 89 Years
• Gender Eligibility Details: Subject must have a vagina
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• 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
• Ambulatory

You may not qualify if:

• Absence of a vagina
• Stool consistency over the last 3 months that includes items 1 or 7 based on the Bristol Stool form scale (severe constipation or diarrhea)
• Current or past diagnosis of colorectal or anal malignancy
• Diagnosis of inflammatory bowel disease
• Current or history of rectovaginal fistula or cloacal defect
• Rectal prolapse (mucosal or full thickness)
• Prior removal or diversion of any portion of colon or rectum
• Prior pelvic floor or abdominal radiation
• Refusal or inability to provide written consent
• Inability to utilize smart phone technology ("app" use)
• Fecal impaction by exam
• Stage 3 or 4 pelvic organ prolapse
• Incontinence only to flatus
• Supervised anal sphincter exercise/pelvic floor muscle training with or without biofeedback currently or within the past 6 months.
• Childbirth within the last 6 months

Sponsors & Collaborators

• Renovia, Inc.: lead

Study Sites (1)

University of Alabama

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Holly Richter, MD PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: July 19, 2019
• Study Start: August 27, 2019
• Primary Completion: December 21, 2020
• Study Completion: April 30, 2021
• Last Updated: January 20, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)