Study of Non-Ablative Radiofrequency Treatment for Stress Urinary Incontinence

Inclusion Criteria: * Able to understand and has voluntarily signed and dated the informed consent form (ICF) prior to initiation of any screening or study-specific procedures. * Willing to comply with study requirements and instructions. * Female, ≥ 18 years of age. * Normal pelvic exam at Screening. * Negative pregnancy test at Screening. * Diagnosed with mild or moderate Stress Urinary Incontinence (SUI) by the 1-hour pad weight test ("mild" defined as 1 - 10 g; "moderate" defined as 11 - 50 g; and "severe" defined as \>50 g ) at Screening. Exclusion Criteria: * Subject is currently breastfeeding or discontinued breast feeding fewer than 6 months prior to enrollment. * Any condition, illness, or surgery that might confound the results of urinary incontinence assessment, including, but not limited to: * Categories of urinary incontinence other than the categories being investigated. * Prominent (i.e., greater than stage II as defined by the International Continence Society) pelvic organ prolapse (e.g., cystocele, rectocele). * Neurological disorders (e.g., multiple sclerosis, Parkinson's disease). * Spastic bladder. * Concurrent infections (e.g., urinary tract infection \[UTI\], cystitis, urethritis, active genital herpes flare-up, active genital/pelvic infection). * Vesicoureteral reflux. * Bladder stones. * Bladder tumors. * Morbid obesity. * Any underlying condition that may pose unreasonable risks to the subject, such as: * Coagulation abnormalities. * Abnormal kidney function. * Uncontrolled diabetes. * Has an implantable electrical device \[e.g., implantable pacemaker, automatic implantable cardioverter-defibrillator (AICD)\] that could potentially be affected by the use of radiofrequency. * Taking any new medication (\< 3 months) that affects urination, or change in the dosage of any medication that affects urination within the past 3 months. * Medical history of keloid formation, genital fistula, thin recto-vaginal septum (defined as a distance of \< 2 cm between the vaginal opening and the anal opening, as measured by a flexible tape measure); or history of fourth-degree laceration, hypertrophic scar formation, or mediolateral episiotomy. * Active malignancy or undergoing treatment (using chemotherapeutic agents, radiation therapy, and/or cytostatic medications) that may interfere with adequate wound healing response. * Previous vaginal, energy-based device treatment for vaginal laxity, urinary incontinence, or sexual function (e.g., radiofrequency treatment, cosmetic, laser, surgical, and/or genital enhancement procedure). * Chronic use of anti-inflammatory drugs, including ibuprofen, aspirin, and steroids. * Subject has been in another clinical study within 6 months of screening, or is not willing to abstain from participating in other clinical studies for duration of trial.