Use of the LEVA® Pelvic Health System for Fecal Incontinence

Inclusion Criteria:

• Adult, age ≥ 18years, assigned female at birth

• Fecal incontinence, defined as any uncontrolled loss of liquid or solid fecalmaterial that occurs at least monthly over the last 3 months that is bothersomeenough to desire treatment

• Able to stand to perform daily training for at least 3 minutes

• Able to speak and read English due to Leva smartphone application availability inonly English at this time

• Have an email address, owns a smartphone, and can download an app

Exclusion Criteria:

• Inability to tolerate insertion of vaginal device (e.g., vaginal agenesis, vaginalstenosis, unremitting pelvic pain, within 12 weeks postpartum)

• Current diagnosis of colorectal or anal malignancy

• Diagnosis of uncontrolled inflammatory bowel disease

• Current rectovaginal fistula or cloacal defect

• Rectal prolapse (mucosal or full thickness)

• Inability to utilize smart phone technology ("app" use)

• Chronic Stool Types 6 or 7

• Fecal impaction by exam

• Stage 4 pelvic organ prolapse

• Concurrent supervised anal sphincter exercise/pelvic floor muscle training with orwithout biofeedback

• Presence of sacral neuromodulator

• Pelvic floor surgery (including anal sphincteroplasty) within the past 3 months

• Currently pregnant