Status:
UNKNOWN
Use of the Leva Pelvic Digital Health System in Women With Fecal Incontinence
Lead Sponsor:
Renovia, Inc.
Conditions:
Fecal Incontinence
Eligibility:
FEMALE
18-89 years
Phase:
NA
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 healt...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2021
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04027335
Start Date
August 27 2019
End Date
April 30 2021
Last Update
January 20 2021
Active Locations (1)
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1
University of Alabama
Birmingham, Alabama, United States, 35233