Phase 1 Study With OAB Assessing the Safety and Activity of hMaxi-K Gene Transfer

Exclusion Criteria

• •A woman with a positive serum (HCG) pregnancy test or who is lactating
• •History of three or more culture-documented recurrent urinary tract infections per year
• •Current history or previous diagnosis of painful bladder syndrome (interstitial cystitis) with pain in the region of the pelvis, perineum, or lower abdomen relieved by voiding
• •Current history of neurological bladder dysfunction
• •A life expectancy of less than 12 months
• •Current history of Grade 2 or greater cystocele
• •An indwelling urethral catheter or need for clean intermittent self-catheterization
• •Recent heart attack
• •Uncontrolled diabetes
• •Latex allergy
• •Stress urinary incontinence as determined by observation of the participant coughing while standing with a full bladder and/or response of 2 or 3 on the following Stress Urinary Incontinence question: Do you experience leakage when laughing, coughing, lifting heavy objects or other types of discreet, moderately intense activities? 0=NONE: No leakage. 1=MILD: Minimal leakage on rare occasions during these types of activities; easily tolerated; do not use pads for this. 2=MODERATE: Enough leakage that it requires occasional use of pads and may interfere with usual activity and tasks. 3=SEVERE: Extreme leakage and discomfort that stops all activity and tasks and requires the use of pads on all occasions