Efficacy of Surface Electrical Stimulation for Urge Urinary Incontinence in Women

Inclusion Criteria:

• Predominant urge urinary incontinence as determined by responses to a series ofthree standard questions from the King's Health Questionnaire; specifically:

• An affirmative response to "Is it very difficult to control when you have astrong urge to urinate?",

• An affirmative or negative response to "Do you lose urine with physicalactivities such as coughing, sneezing, running?",

• And, if an affirmative response to the second question, an affirmative responseto "Are more of your incontinence episodes due to a strong urge to urinate thanto abdominal pressure such as sneezing?"

• Mild-moderate incontinence symptoms as determined by self-reported typical number ofaccidents of 1 or more per 24 hours. Symptom severity is later verified with datafrom the Daily Log (See 5.4)

Exclusion Criteria:

• Less than 1 incontinence accident (leak) per day*

• Severe incontinence as determined by self-reported >5 accidents per day

• Currently pregnant, may be pregnant, attempting to become pregnant, or deliverywithin previous 6 weeks

• Vaginal or pelvic surgery within previous 6 months

• Severe Obesity as defined by BMI >= 35

• Change in incontinence medication type or dosing within the last 3 months.

• History or symptoms of urinary retention, extra-urethral incontinence, overflowincontinence

• Pelvic pain/painful bladder syndrome

• Active urinary tract infection (UTI) or history of recurrent UTIs (more than threein a year), or recurrent vaginitis (bacterial/fungal)

• Tissues protruding outside the vagina at rest

• Presence of incontinence-associated dermatitis or other perineal skin disorders orlesions,

• Complete denervation of the pelvic floor

• Conductive inter-uterine devise (IUD/Coil) or metal implants in the abdominal orpelvic area, including the hip and lumbar spine,

• Chronic coughing

• Previous use of Interstim device or Botox for UI

• Implanted cardiac device, untreated cardiac arrhythmia or suffer from other heartproblems.

• Cancer, epilepsy or cognitive dysfunction

• Underlying neurologic/neuromuscular disorder

• Impaired decision making, suicidal thoughts, or drug/alcohol dependence

• Lacks capacity to consent for themselves.