NCT04027335

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Renovia, Inc. · Industry
• Sex: Female
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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

Conditions

• Fecal Incontinence

Interventions

Type	Name	Description
DEVICE	leva	Vaginal device used for pelvic floor muscle exercises

Timeline

• Start date: 2019-08-27
• Primary completion: 2020-12-21
• Completion: 2021-04-30
• First posted: 2019-07-19
• Last updated: 2021-01-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study