Prospective US Radiofrequency SUI Trial

Exclusion Criteria

• •E.1 Currently breastfeeding or have discontinued breastfeeding fewer than 6 months prior to screening.
• •E.2 Undergone other stress urinary incontinence treatment(s), excluding behavioral modifications 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 on questions 10 - 15 at the screening visit (see appendix).
• •E.4 A post void residual measurement of greater than 150 ml as measured with ultrasound or bladder scanner at the screening visit.
• •E.5 Greater than 10 voids per day on average as measured with the 3-day diary at Baseline Visit.
• •E.6 Greater than 1 nocturia episode per day on average as measured with the 3-day diary at Baseline Visit.
• •E.7 Abnormal, clinically significant laboratory results at the Baseline Visit (as determined by the Investigator) that could impact the subject participation or evaluation for 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-day diary at baseline Visit.
• •E.9 History of, or any current condition, illness, or surgery that might confound the results 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-Q evaluation (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 associated urinary tract infection symptoms at the Baseline or Randomization Visit. If the subject has a UTI at the Baseline or Randomization Visit they may be treated with antibiotics, at the Investigator's discretion, and return within 7 days after UTI treatment completion.
• •5. Vesicoureteral reflux
• •6. Bladder stones
• •7. Bladder tumors
• •8. Interstitial cystitis E.10 Has any implantable electrical device \[e.g., implantable pacemaker, automatic implantable cardioverter-defibrillator (AICD)\].
• •E.11 A rectovaginal septum \<2 cm. E.12 Planning on future pregnancies after the Viveve procedure.
• •E.13 Medical or immunological condition, including, but not limited to:
• •1. Uncontrolled cardiovascular, respiratory, neoplastic, infectious, and/or endocrinological condition that could impact the subject's ability to complete the trial.
• •2. Uncontrolled diabetes defined as hemoglobin A1c \> 7%
• •3. Untreated chronic abdominal/pelvic pain disorder \[including, but not limited to, dyspareunia, vaginismus, endometriosis, significant vulvovaginal atrophy (VVA), genitourinary syndrome of menopause (GSM), irritable bowel syndrome, or Crohn's disease\].
• •4. Untreated medical condition or medication that, in investigator's opinion, may interfere with adequate wound healing response (e.g., congenital connective tissue disease) or the subject's ability to complete the clinical trial requirements.
• •5. Untreated active malignancy (with the exception of basal cell carcinoma of the skin) or undergoing treatment (using chemotherapeutic agents, radiation therapy, and/or cytostatic medications) that may interfere with adequate wound healing response or the subject's ability to complete the trial.
• •6. Untreated acute or chronic vaginal or vulvar disorder including, but not limited to, vulvovaginal atrophy/GSM; pain, including provoked/generalized vulvodynia, vulvar vestibulitis, dysesthetic vulvodynia, or vulvar dystrophy; current/chronic papulosquamous vulvar dermatoses (e.g., psoriasis, lichen planus, tinea cruris, lichen sclerosis, 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.
• •7. Active genital/pelvic infection (e.g., herpes, gonorrhea, chlamydia) observed on physical or pelvic exam at Baseline.
• •8. Active yeast infection. If the subject has an active vaginal yeast infection at the Baseline or Randomization Visit, they may be treated with an antifungal, at the Investigator's discretion, and return within 7 days after completion of vaginal yeast infection treatment.
• •E.14 Chronic use of anti-inflammatory drugs, including ibuprofen, aspirin, and oral steroids (excluding aspirin that is taken for cardiovascular prophylaxis).
• •E.15 Started taking any new medication, including herbal supplements and those taken in teas that potentially affects urination within 28 days prior to the Screening Visit, or had a change in the dosage of any medication that potentially affects urination within 28 days of the Screening Visit. Dosage should not change for the remainder of the study unless medically 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 radiofrequency treatment; injectable bulking agent, cosmetic, laser, surgical, and/or genital enhancement procedure).
• •E.18 Participated 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.
• •E.19 Employed by Viveve or participating investigative sites.