lyrette: renewing continence objective and subjective efficacy study

Conditions: Stress Urinary Incontinence

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.

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.

Eligibility criteria:
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

Keywords: stress urinary incontinence incontinence sui renessa