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.
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT01455779
Ages eligible for Study
35 Years to 60 Years
Genders eligible for Study
Accepts Healthy Volunteers
Age 35 to 60 years
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.
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
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
All locations for NCT01455779
United States (6)
Tri Valley Urology Medical Group
Murrieta, California, United States, 92562
Center for Bladder Control
Arlington Heights, Illinois, United States, 60004
Women's Health Institute of Illinois
Oak Lawn, Illinois, United States, 60453
Female Pelvic Medicine and Urogynecology
Grand Rapids, Michigan, United States, 49503
Dial Research, Tennessee Women's Care
Nashville, Tennessee, United States, 37203
Eastern Virginia Medical School
Norfolk, Virginia, United States, 23507
View full eligibility
Tris trial is registered with FDA with number: NCT01455779. The sponsor of the trial is Verathon and it is looking for 54 volunteers for the current phase.
Official trial title: Lyrette: Renewing Continence Objective and Subjective Efficacy Study
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