Renessa Objective and Subjective Efficacy Study (ROSE)

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