Prospective US Radiofrequency SUI Trial

Inclusion Criteria: I.1 Able to understand and has voluntarily signed and dated the most current informedconsent form (ICF) prior to initiation of any screening or study-specific procedures. I.2 Willing to comply with study requirements and instructions. I.3 Symptoms and diagnosis of stress urinary incontinence as determined by the following:

1. If there are mixed symptoms there must be a predominant stress component as determinedby the 3-day diary results and MESA questionnaire
2. Patient-reported or history of SUI symptoms for > 6 months prior to screening.
3. Positive Bladder Stress Test at the Baseline Visit.
4. Positive Q-tip test at the Baseline Visit (the observation of an angle that exceeds 30degrees from horizontal in the opinion of the investigator or designee to denotehypermobility).
5. 1-hour pad weight at the Baseline Visit with a >10 and <50 g net increase from thepre-test pad weight.
6. Subjects must complete 3 days in the 3-day voiding diary during 3 consecutive days inthe 7 days prior to the Baseline Visit, and subjects must report a minimum of 1incontinence episode per day or > 4 incontinence episodes over the 3 days as reportedin the 3-day voiding diary.
7. For the Baseline 3-day diary, subjects must be compliant with recording events (i.e.void, leak or fluid intake) as determined through coordinator interview with thesubject and review of voids and fluid intake reported in the diary compared to normaldaily measurements. I.4 Pre-menopausal females, ≥18 years of age. Premenopausal is defined as a woman who hashad menstrual cycles over the previous 12 months or who is determined to be premenopausalby the PI or sub-investigator (e.g. premenopausal woman with hysterectomy). I.5 Body mass index (BMI) of ≤35 kg/m² at the Screening Visit. I.6 Normal, or abnormal butnot clinically significant (i.e., mild atrophy with rugae present, low grade prolapse),physical, pelvic and neurologic exam at the Baseline Visit as determined by theinvestigator. I.7 Negative urine pregnancy test at the Baseline and Randomization Visits and subjectagrees to not become pregnant during the study and uses an acceptable form of birth controlstarted at least 3 months prior to screening (with the exception of double barriercontraception, where the 3-months required prior to screening does not apply).
8. Examples of acceptable forms of birth control include: abstinence from heterosexualvaginal intercourse, hysterectomy, bilateral tubal ligation, vasectomy, double barriercontraception (note that condom and spermicide is not considered double barriercontraception), intrauterine device or hormonal contraceptive.
9. Rhythm and withdrawal are not considered acceptable forms of contraception.

Exclusion Criteria: E.1 Currently breastfeeding or have discontinued breastfeeding fewer than 6 months prior toscreening. E.2 Undergone other stress urinary incontinence treatment(s), excluding behavioralmodifications started >3 months prior to screening (e.g., Kegel exercises). E.3 A MESA score of greater than 5 in sum on questions 10 - 12, or greater than 9 in sum onquestions 10 - 15 at the screening visit (see appendix). E.4 A post void residual measurement of greater than 150 ml as measured with ultrasound orbladder scanner at the screening visit. E.5 Greater than 10 voids per day on average as measured with the 3-day diary at BaselineVisit. E.6 Greater than 1 nocturia episode per day on average as measured with the 3-day diary atBaseline Visit. E.7 Abnormal, clinically significant laboratory results at the Baseline Visit (asdetermined by the Investigator) that could impact the subject participation or evaluationfor SUI. Retest is allowed with Sponsor approval. E.8 Greater than 100 ounces of fluid consumed per day on average as measured with the 3-daydiary at baseline Visit. E.9 History of, or any current condition, illness, or surgery that might confound theresults of urinary incontinence assessment, including, but not limited to:

1. Prominent (i.e., greater than Stage II pelvic organ prolapse as determined by a POP-Qevaluation (at Baseline) e.g., cystocele, rectocele
2. Neurological disorders (e.g., multiple sclerosis, Parkinson's disease, fibromyalgia)
3. Recurrent Urinary Tract Infections (UTI)
4. Current Urinary Tract Infection (UTI) as assessed by urine dipstick and associatedurinary tract infection symptoms at the Baseline or Randomization Visit. If thesubject has a UTI at the Baseline or Randomization Visit they may be treated withantibiotics, at the Investigator's discretion, and return within 7 days after UTItreatment completion.
5. Vesicoureteral reflux
6. Bladder stones
7. Bladder tumors
8. Interstitial cystitis E.10 Has any implantable electrical device [e.g., implantablepacemaker, automatic implantable cardioverter-defibrillator (AICD)]. E.11 A rectovaginal septum <2 cm. E.12 Planning on future pregnancies after the Viveveprocedure. E.13 Medical or immunological condition, including, but not limited to:
9. Uncontrolled cardiovascular, respiratory, neoplastic, infectious, and/orendocrinological condition that could impact the subject's ability to complete thetrial.
10. Uncontrolled diabetes defined as hemoglobin A1c > 7%
11. Untreated chronic abdominal/pelvic pain disorder [including, but not limited to,dyspareunia, vaginismus, endometriosis, significant vulvovaginal atrophy (VVA),genitourinary syndrome of menopause (GSM), irritable bowel syndrome, or Crohn'sdisease].
12. Untreated medical condition or medication that, in investigator's opinion, mayinterfere with adequate wound healing response (e.g., congenital connective tissuedisease) or the subject's ability to complete the clinical trial requirements.
13. Untreated active malignancy (with the exception of basal cell carcinoma of the skin)or undergoing treatment (using chemotherapeutic agents, radiation therapy, and/orcytostatic medications) that may interfere with adequate wound healing response or thesubject's ability to complete the trial.
14. Untreated acute or chronic vaginal or vulvar disorder including, but not limited to,vulvovaginal atrophy/GSM; pain, including provoked/generalized vulvodynia, vulvarvestibulitis, dysesthetic vulvodynia, or vulvar dystrophy; current/chronicpapulosquamous vulvar dermatoses (e.g., psoriasis, lichen planus, tinea cruris, lichensclerosis, seborrheic dermatitis, contact/irritant dermatitis, lichen simplex,eczema); bullous dermatoses; systemic diseases with potential involvement of vulva;genital warts; past/current vaginal or vulvar radiotherapy or brachytherapy.
15. Active genital/pelvic infection (e.g., herpes, gonorrhea, chlamydia) observed onphysical or pelvic exam at Baseline.
16. Active yeast infection. If the subject has an active vaginal yeast infection at theBaseline or Randomization Visit, they may be treated with an antifungal, at theInvestigator's discretion, and return within 7 days after completion of vaginal yeastinfection treatment. E.14 Chronic use of anti-inflammatory drugs, including ibuprofen, aspirin, and oralsteroids (excluding aspirin that is taken for cardiovascular prophylaxis). E.15 Started taking any new medication, including herbal supplements and those taken inteas that potentially affects urination within 28 days prior to the Screening Visit, or hada change in the dosage of any medication that potentially affects urination within 28 daysof the Screening Visit. Dosage should not change for the remainder of the study unlessmedically necessary. E.16 Started or changed dose of local vaginal hormones <6 weeks before screening. E.17 Undergone previous elective surgical or non-invasive procedure(s) in the vaginal canal (including previous treatment with the Viveve System or any other genital radiofrequencytreatment; injectable bulking agent, cosmetic, laser, surgical, and/or genital enhancementprocedure). E.18 Participated in another clinical study within 6 months of screening or is not willingto abstain from participating in other clinical studies for duration of trial. E.19 Employed by Viveve or participating investigative sites.