Randomized Trial for Botox Urinary Incontinence
Urinary Incontinence
About this trial
This is an interventional treatment trial for Urinary Incontinence
Eligibility Criteria
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.
Sites / Locations
- University of Rochester
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
200 units Botox
300 units Botox
Placebo
200 units Botulinum-A toxin
300 units Botulinum-A toxin
Placebo