post-procedural pain associated with 5 versus 20 intravesical injections of onabotulinumtoxin a

Conditions: Urinary Bladder, Overactive; Incontinence, Urge; Incontinence, Urinary; Urinary Urge Incontinence; Urinary Frequency More Than Once at Night; Nocturia

Summary: currently, in clinical practice there has been no standardization in the number of injections a single dose of intradetrusor onabotulinumtoxin a is administered in. given the increasing use of this treatment modality, the aim of this study is to compare outcomes for patients given a 100 unit dose of onabotulinumtoxin a split into 5 as compared to 20 injections for the treatment of overactive bladder or urgency urinary incontinence refractory to medical treatment.

the intradetrusor injection of onabotulinumtoxin a for treatment of idiopathic overactive bladder and urgency urinary incontinence refractory to anticholinergic or β-agonist treatment was approved by the united states food and drug administration (fda) in 2013. since then, multiple randomized placebo-controlled trials have demonstrated the effectiveness of the treatment. currently, allergan, inc. and the fda recommend the intravesical administration of onabotulinumtoxin a with dilution to 100 units/10 ml with preservative-free 0.9% sodium chloride injection, as 20 injections of 0.5 ml each. currently, in clinical practice there has been no standardization in the number of intravesical injections, with a single dose of onabotulinumtoxin a being administered in as few as 1 injection to as many as 40 injections into the detrusor muscle. given the increasing use of this treatment modality, the investigators aim to compare patient outcomes for patients given a 100 unit dose of onabotulinumtoxin a split into 5 as compared to the recommended 20 injections for the treatment of idiopathic overactive bladder or urgency urinary incontinence refractory to medical treatment.

Eligibility criteria:
inclusion criteria: * women \>=18 years of age with diagnosis of urinary urgency, urinary frequency, urgency urinary incontinence, overactive bladder. * procedure scheduled in either the outpatient clinic or the operating room to be performed without use of sedation, general, or neuraxial anesthesia. exclusion criteria: * male gender. * women \<18 years of age. * non-english speaking. * pregnancy (patient will self-report pregnancy). * participant has symptoms of overactive bladder due to any known neurological reason (e.g. spinal cord injury, multiple sclerosis, cerebrovascular accident, alzheimer's disease, parkinson's disease, etc.) * participant uses clean intermittent catheterization or indwelling catheter to manage urinary incontinence. * participant has a history or current diagnosis of bladder cancer or other urothelial malignancy. * participant has a known allergy or sensitivity to any botulinum toxin preparation. * participant has any medical condition that may put her at increased risk with exposure to onabotulinumtoxin a, including diagnosed myasthenia gravis, eaton-lambert syndrome, or amyotrophic lateral sclerosis. * participant is scheduled for administration of onabotulinumtoxin a with use of sedation, general, or neuraxial anesthesia.

Keywords: overactive bladder urgency urinary incontinence onabotulinumtoxin bladder botox