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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
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.
Tri Valley Urology Medical Group
Murrieta, California, United States
Center for Bladder Control
Arlington Heights, Illinois, United States
Women's Health Institute of Illinois
Oak Lawn, Illinois, United States
Female Pelvic Medicine and Urogynecology
Grand Rapids, Michigan, United States
Primary Safety Endpoint will be assessed by the incidence of device related Serious Adverse Event's during the procedure and 30 days following treatment.
Safety will be assessed by the incidence of device related Serious Adverse Events's during the procedure and 30 days following treatment.
Time frame: 30 days
Primary Effectiveness Endpoint will be the proportion of "dry" patients at the 12 month follow-up.
The primary effectiveness endpoint will be the proportion of "dry" patients at the 12 month follow-up.
Time frame: 12 months
Secondary Safety Endpoint will be the evaluation of Adverse Events through all follow-up visits
The secondary safety endpoints will be the evaluation of Adverse Events through all follow-up visits.
Time frame: 36 months
IQOL Score
An increase in overall IQOL score from baseline to 36 months.
Time frame: 36 months from baseline
Pad Weight
A 50% reduction in the amount of urine leaked during a 1-hour pad weight test
Time frame: 12 months
Cough Test Results
A negative cough test
Time frame: 12 months
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Dial Research, Tennessee Women's Care
Nashville, Tennessee, United States
Eastern Virginia Medical School
Norfolk, Virginia, United States