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

Primary Purpose

Fecal Incontinence

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

leva

About this trial

This is an interventional treatment trial for Fecal Incontinence focused on measuring Fecal incontinence, Women

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
Neurological disorders known to affect continence, including spinal cord injury, advanced multiple sclerosis or Parkinson's disease and debilitating stroke
Chronic abdominal pain in the absence of diarrhea
Presence of an active (turned on) sacral neuromodulator within the last 6 months
Pelvic floor surgery (including anal sphincteroplasty) within the past 6 months.

Sites / Locations

University of Alabama

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Leva Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

St. Mark's Incontinence Score

Validated survey of fecal incontinence severity, score ranges from 0-24, Higher scores indicate more severe symptoms

Secondary Outcome Measures

Change in Fecal incontinence episodes

Percent improvement= number of fecal incontinence episodes at 10 weeks divided by the number of incontinence epsiodes at baseline.

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

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)

Full Information

NCT ID

NCT04027335

First Posted

July 18, 2019

Last Updated

January 18, 2021

Sponsor

Renovia, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04027335

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Unknown status

Study Start Date

August 27, 2019 (Actual)

Primary Completion Date

December 21, 2020 (Actual)

Study Completion Date

April 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Renovia, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fecal Incontinence

Keywords

Fecal incontinence, Women

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Leva Arm

Arm Type

Experimental

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

leva

Intervention Description

Vaginal device used for pelvic floor muscle exercises

Primary Outcome Measure Information:

Title

St. Mark's Incontinence Score

Description

Validated survey of fecal incontinence severity, score ranges from 0-24, Higher scores indicate more severe symptoms

Time Frame

Baseline to 10 weeks

Secondary Outcome Measure Information:

Title

Change in Fecal incontinence episodes

Description

Percent improvement= number of fecal incontinence episodes at 10 weeks divided by the number of incontinence epsiodes at baseline.

Time Frame

Baseline to 10 weeks

Title

Fecal Incontinence Quality of Life Scale (FIQoL)

Description

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

Time Frame

Change in score from baseline to 10 weeks

Title

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

Description

Adherence as a percentage of all expected exercise sessions (140) correlation with change in St Mark's Incontinence Score (1-24)

Time Frame

baseline to 10 weeks

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Subject must have a vagina

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

89 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 Neurological disorders known to affect continence, including spinal cord injury, advanced multiple sclerosis or Parkinson's disease and debilitating stroke Chronic abdominal pain in the absence of diarrhea Presence of an active (turned on) sacral neuromodulator within the last 6 months Pelvic floor surgery (including anal sphincteroplasty) within the past 6 months.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Holly Richter, MD PhD

Organizational Affiliation

University of Alabama at Birmingham

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Alabama

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35233

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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