Lyrette: Renewing Continence Objective and Subjective Efficacy Study
This trial is active, not recruiting.
|Condition||stress urinary incontinence|
|Start date||September 2011|
|End date||July 2015|
|Trial size||54 participants|
|Trial identifier||NCT01455779, CP-3375|
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|
|Murrieta, CA||Tri Valley Urology Medical Group||no longer recruiting|
|Arlington Heights, IL||Center for Bladder Control||no longer recruiting|
|Oak Lawn, IL||Women's Health Institute of Illinois||no longer recruiting|
|Grand Rapids, MI||Female Pelvic Medicine and Urogynecology||no longer recruiting|
|Nashville, TN||Dial Research, Tennessee Women's Care||no longer recruiting|
|Norfolk, VA||Eastern Virginia Medical School||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
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 Safety Endpoint will be the evaluation of Adverse Events through all follow-up visits
time frame: 36 months
time frame: 36 months from baseline
time frame: 12 months
Cough Test Results
time frame: 12 months
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
|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.|
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