NCT01455779

Lyrette: Renewing Continence Objective and Subjective Efficacy Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Verathon · Industry
• Sex: Female
• Age: 35 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to demonstrate the treatment efficacy of the Lyrette® System in women most likely to be treated in an office setting for the condition of stress urinary incontinence, secondary to urethral hypermobility.

Detailed description

This is a prospective, open-label, single arm clinical study to evaluate the Lyrette System (formerly Renessa System) in a population likely to be treated in a physician's office.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	Lyrette	The Verathon Transurethral RF System (Lyrette® System) is indicated for the treatment of female urinary stress incontinence (SUI) due to hypermobility in women who have failed conservative treatment and who are not candidates for surgical therapy. The treatment is a 9 minute non-surgical procedure completed using local anesthesia during a single office visit. Women are discharged home with no incisions, dressings, or catheters immediately following treatment.

Timeline

• Start date: 2011-09-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2011-10-20
• Last updated: 2014-12-09

Locations

6 sites across 1 country: United States