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

NCT ID: NCT04027335

Last Updated: 2021-01-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-27
• Study Completion Date: 2021-04-30

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

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

Conditions

Fecal Incontinence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

leva

Intervention Type: DEVICE

Vaginal device used for pelvic floor muscle exercises

Interventions

leva

Vaginal device used for pelvic floor muscle exercises

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Renovia, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Holly Richter, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

REN-17

Identifier Type: -

Identifier Source: org_study_id