Randomized Trial for Botox Urinary Incontinence

Inclusion Criteria: Subjects must have ALL of the following:

• Completed a routine evaluation of incontinence (urodynamics, bladder diaries, and pad weights) through the urogynecology clinic at SMH within 3 months of the screening visit
• Symptoms of urge incontinence associated with leakage on bladder diary
• 24-hour pad weight >100 cc's (volume requiring multiple daily diaper changes)
• Absence of a bladder infection or other condition that could explain urinary leakage
• Absence of stress incontinence or a cough leak point pressure > 100 cm H2O on cystometry (this correlates with mild stress incontinence)
• Failed anticholinergic therapy
• Willingness and ability to perform intermittent clean catheterization (due to the risk of prolonged urinary retention from Botox)
• The ability and willingness to return for surveillance evaluations
• A negative urine pregnancy test if at risk for pregnancy
• Competent to give signed consent and complete all of the study measures

Exclusion Criteria:

• Children (< 21 years old), pregnant women and prisoners
• History of carcinoma of the bladder
• Absence of a measurable detrusor contraction on a pressure flow micturition study
• A foreign body in the bladder or other correctable etiology for the UUI
• Prior documented resistance to Botox
• Gross fecal incontinence (due to confounding effects on pad weights and counts)
• Known allergy to lidocaine or related compounds (used for local analgesia)
• Known allergy to or inability to take both Bactrim DS or Ciprofloxacin (used for urinary tract infection prophylaxis)
• Current use of an aminoglycoside or preparing for general anesthesia within 1 week (risk of synergetic effects
• Known neurologic conditions such as Parkinson's disease, myasthenia gravis, multiple sclerosis, autonomic dysfunction, Lambert-Eaton syndrome, Amyotrophic Lateral Sclerosis or other neurologic disorder that may impact urinary function or the effect of Botox.