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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04027335
Recruitment Status : Not yet recruiting
First Posted : July 19, 2019
Last Update Posted : July 19, 2019
Information provided by (Responsible Party):
Renovia, Inc.

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

Condition or disease Intervention/treatment Phase
Fecal Incontinence Device: leva Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of the Leva Pelvic Digital Health System in Women With Fecal Incontinence: a Pilot Study
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : April 11, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

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

Primary Outcome Measures :
  1. St. Mark's Incontinence Score [ Time Frame: Baseline to 10 weeks ]
    Validated survey of fecal incontinence severity, score ranges from 0-24

Secondary Outcome Measures :
  1. Change in Fecal incontinence episodes [ Time Frame: Baseline to 10 weeks ]
    Change in the number of fecal incontinence episodes (%) recorded on a two week diary of fecal incontinence episodes

  2. Fecal Incontinence Quality of Life Score [ Time Frame: Change in score from baseline to 10 weeks ]
    Validated Survey evaluates four areas- coping, depression, lifestyle and embarrassment

  3. Cumulative adherence correlation with change in St. Mark's score [ Time Frame: baseline to 10 weeks ]
    Adherence as a percentage of all expected exercise sessions (140) correlation with change in St Mark's Incontinence Score (1-24)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Subject must have a vagina
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04027335

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Contact: Samantha J Pulliam, M.D. 866-735-8424 ext 1035

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United States, Alabama
University of Alabama Not yet recruiting
Birmingham, Alabama, United States, 35233
Contact: Holly Richter, MD PhD    205-934-1704   
Sponsors and Collaborators
Renovia, Inc.
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Principal Investigator: Holly Richter, MD PhD University of Alabama at Birmingham

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Responsible Party: Renovia, Inc. Identifier: NCT04027335     History of Changes
Other Study ID Numbers: REN-17
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Renovia, Inc.:
Fecal incontinence

Additional relevant MeSH terms:
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Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases