NCT03536923

Use of the Leva Incontinence System in Treating Bladder Incontinence.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Renovia, Inc. · Industry
• Sex: Female
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

This open-label proof-of-concept study is designed to evaluate the impact of the leva digital incontinence system on the treatment of stress and mixed urinary incontinence in women over a six week period. Subjects will participate in a 2.5 minute exercise program twice daily (performed at a clinic with therapist assistance 5x weekly, and at home once daily on weekdays and twice daily on weekends. Validated surveys (UDI-6, IIQ-7 and PGI-I) will be used to evaluate symptom relief. A battery of pelvic floor muscle exercises will be performed weekly to evaluate progress in muscle strengthening.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	Leva Incontinence System For Pelvic Floor Muscle strengthening	The leva device is placed vaginally for 2.5 minutes twice daily, and pelvic floor muscle exercises are performed based on guidance from data sent from the device to their mobile phone.

Timeline

• Start date: 2017-04-10
• Primary completion: 2017-08-12
• Completion: 2017-10-20
• First posted: 2018-05-25
• Last updated: 2018-12-12
• Results posted: 2018-12-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study