Clinical trial NCT04027335: Use of the Leva Pelvic Digital Health System in Women With Fecal Incontinence
Official title: Use of the Leva Pelvic Digital Health System in Women With Fecal Incontinence: a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fecal Incontinence
Keywords: Fecal incontinence
Women
Lead sponsor: Renovia, Inc.
Sponsor class: INDUSTRY
First posted: 2019-07-19
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: St. Mark's Incontinence Score
timeFrame: Baseline to 10 weeks
Secondary outcomes:
measure: Change in Fecal incontinence episodes
timeFrame: Baseline to 10 weeks
measure: Fecal Incontinence Quality of Life Scale (FIQoL)
timeFrame: Change in score from baseline to 10 weeks
measure: Cumulative adherence correlation with change in St. Mark's score
timeFrame: baseline to 10 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Holly Richter, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: