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

Fecal Incontinence Clinical Trial

Official title:

Use of the Leva Pelvic Digital Health System in Women With Fecal Incontinence: a Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04027335
• Other study ID #: REN-17
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 27, 2019
• Est. completion date: April 30, 2021

Study information

• Verified date: January 2021
• Source: Renovia, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 31
• Est. completion date: April 30, 2021
• Est. primary completion date: December 21, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

Device:
• leva
Vaginal device used for pelvic floor muscle exercises

Locations

Country	Name	City	State
United States	University of Alabama	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Renovia, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	St. Mark's Incontinence Score	Validated survey of fecal incontinence severity, score ranges from 0-24, Higher scores indicate more severe symptoms	Baseline to 10 weeks
Secondary	Change in Fecal incontinence episodes	Percent improvement= number of fecal incontinence episodes at 10 weeks divided by the number of incontinence epsiodes at baseline.	Baseline to 10 weeks
Secondary	Fecal Incontinence Quality of Life Scale (FIQoL)	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	Change in score from baseline to 10 weeks
Secondary	Cumulative adherence correlation with change in St. Mark's score	Adherence as a percentage of all expected exercise sessions (140) correlation with change in St Mark's Incontinence Score (1-24)	baseline to 10 weeks