Fecal Incontinence
Conditions
Keywords
Fecal incontinence, Women
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
Interventions
DEVICEleva
Vaginal device used for pelvic floor muscle exercises
Sponsors
Renovia, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 89 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| St. Mark's Incontinence Score | Baseline to 10 weeks | Validated survey of fecal incontinence severity, score ranges from 0-24, Higher scores indicate more severe symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fecal incontinence episodes | Baseline to 10 weeks | 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) | Change in score from baseline to 10 weeks | 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 | 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) |
Countries
United States
Outcome results
None listed