Study of Non-Ablative Radiofrequency Treatment for Stress Urinary Incontinence

This is a prospective, pilot clinical study involving two study groups. Subjects meeting the all the inclusion criteria and none of the exclusion criteria will be enrolled in the study. Subjects will receive a single SUI treatment; subjects in Group 2 will receive two SUI Treatments.

At the Screening Visit, and at each pre-designated study follow-up timepoint, subjects will be asked to complete several quality of life questionnaires related to the treated condition. In addition, subjects will provide a bladder voiding diary for review and data collection, and a pad weight test will be conducted and results collected.

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.