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

Status unconfirmed · Not applicable

Conditions studied: Fecal Incontinence

In brief

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

Key facts

Study ID

NCT04027335

Run by

Renovia, Inc.

People needed

31

Starts

2019-08-27

Expected to finish

2021-04-30

Last updated by the study team

2021-01-20

Who can join

Age: 18 and older, up to 89. Sex: female. Healthy volunteers: not accepted.

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
• 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.

Where it is running

• University of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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