NCT05287490

Bi-Polar Radio-Frequency and Electrical Muscle Stimulation for Symptoms of Mixed Urinary Incontinence (MUI)

Clinical Evaluation of Combined Treatment With Bi-Polar Radio-Frequency and Electrical Muscle Stimulation for Symptoms of Mixed Urinary Incontinence (MUI)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: InMode MD Ltd. · Industry
• Sex: Female
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The objective of this trial is to evaluate the safety and efficacy of the combined FormaV and VTone Applicators for Symptoms of Mixed Urinary Incontinence. Eligible subjects will receive 3 treatments(every 2 weeks) with the FormaV and VTone Applicators according to the study protocol. The subject will return for 3 follow-up visits: 4 weeks (1M FU), 3 months follow up (3M FU), 6 months follow up (6M FU) after the treatment.

Conditions

• Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	FormaV and VTone	Eligible subjects will receive 3 treatments(every 2 weeks) with the FormaV and VTone Applicators according to the study protocol.

Timeline

• Start date: 2021-04-04
• Primary completion: 2022-07-30
• Completion: 2022-07-30
• First posted: 2022-03-18
• Last updated: 2022-08-11

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study