NCT06152224

Use of the LEVA® Pelvic Health System for Fecal Incontinence

Comparison of the Duration of Use of the Leva® Pelvic Health System in Women With Fecal Incontinence

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn about how the duration of use of The Leva Pelvic Health System® affects treatment of fecal incontinence in women. The main question it aims to answer is to test whether use of the The Leva Pelvic Health System® for 8 weeks is as good as using it for 16 weeks. Participants will complete surveys, and use the Leva device.

Detailed description

This study will assess whether 8 weeks of use of the Leva Pelvic Health System (Leva) is non-inferior to 16 weeks of use for the treatment of chronic fecal incontinence (symptoms \>/= 3 months) in adults with a vagina. Participants will be instructed to complete pelvic floor muscle training using the Leva for 8 or 16 weeks. The hypothesis is that 8 weeks of use of Leva is non-inferior to 16 weeks of use, assessed by a validated FI symptom severity survey. Surveys will be completed at 0 weeks, 16 weeks, and 24 weeks. Long-term surveys will be completed at 1 year and 2 years from enrollment.

Conditions

• Fecal Incontinence

Interventions

Type	Name	Description
DEVICE	The Leva Pelvic Health System	The Leva Pelvic Health System includes an intra-vaginal device that pairs with a smartphone application to provide real-time visual feedback about pelvic floor muscle performance during usage.

Timeline

• Start date: 2024-01-17
• Primary completion: 2024-12-17
• Completion: 2026-09-01
• First posted: 2023-11-30
• Last updated: 2025-10-30
• Results posted: 2025-05-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study