Overview

This trial is active, not recruiting.

Condition stress urinary incontinence
Treatment lyrette
Sponsor Verathon
Start date September 2011
End date July 2015
Trial size 54 participants
Trial identifier NCT01455779, CP-3375

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
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.
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.

Primary Outcomes

Measure
Primary Safety Endpoint will be assessed by the incidence of device related Serious Adverse Event'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.
time frame: 12 months

Secondary Outcomes

Measure
Secondary Safety Endpoint will be the evaluation of Adverse Events through all follow-up visits
time frame: 36 months
IQOL Score
time frame: 36 months from baseline
Pad Weight
time frame: 12 months
Cough Test Results
time frame: 12 months

Eligibility Criteria

Female participants from 35 years up to 60 years old.

Inclusion Criteria: - Age 35 to 60 years - Female gender - Ability to complete all study requirements - Body Mass Index ≤ 35 - Incontinence Quality of Life score (IQOL) ≥ 55 - Leak Point Pressure (LPP) ≥ 90 cm H2O and - Maximal Urethral Closure Pressure (MUCP) ≥ 45 cm H2O - 3 to10 stress leaks recorded in the 3 day voiding diary - Clinical history of stress urinary incontinence for ≥ 12 months - Clinical diagnosis of stress urinary incontinence by study physician - Clinical diagnosis of mixed incontinence with predominant stress component. - Clinical diagnosis of bladder outlet hypermobility by a study physician - Has failed conservative therapy (Kegels, biofeedback) and/or has not received conservative therapy for a period of at least 3 months prior to enrollment in the study. - Medical Epidemiologic, and Social Aspects of Aging (MESA)stress symptom percentage score greater than urge symptom percentage score - Post-void residual ≤ 100 cc with Stage II or lower pelvic organ prolapsed - Urethral length ≥ 3 cm - Is not a current smoker - If subject has children, at least 1 year has elapsed after child birth and cessation of breastfeeding for at least 3 months, at enrollment. Exclusion Criteria: - ASA III or IV classification - Current or planned pregnancy within the next 12 months - Clinical diagnosis of detrusor overactivity by urodynamic evaluation - Clinical diagnosis of mixed urinary incontinence with predominant urge component - Clinical diagnosis of primary urge urinary incontinence - Clinical diagnosis of gravitational loss - Stage III, IV Pelvic Organ Prolapse - Less than 2 grams of urine leakage during 1 hour stress pad test - Previous surgery, RF micro-remodeling, or injection of bulking agents specifically for the treatment of urinary incontinence - Current incontinence treatment with electrical stimulation, biofeedback, and/or medications - Previous urethral and/or bladder surgery (excluding diagnostic endoscope) - Current urinary tract infection - History of chronic urinary tract infections - History of recurrent pyelonephritis - History of interstitial cystitis - History of upper or lower urinary tract neoplasm - History of upper or lower anatomic urinary tract abnormality or disorder - History of acute or chronic renal failure - Coagulopathy - Immunosuppression (pathological or medication induced) - Collagen vascular disease (scleroderma, etc.) - Presence of a pacemaker, AICD, or other electrical health maintenance device, bladder neuro-modulation device. - History of COPD or other obstructive pulmonary disease - Life expectancy < 12 months - Knowingly will be relocating out of practice area within 12 months of initiation of the study

Additional Information

Official title Lyrette: Renewing Continence Objective and Subjective Efficacy Study
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Verathon.