OnabotulinumtoxinA is an effective treatment for both idiopathic and neurogenic overactive bladder and was FDA approved for this indication in 2013. The standard technique for injecting onabotulinumtoxinA into the detrusor is mixing 100 units of onabotulinumtoxinA into 10mL of injectable normal saline and injecting 20 sites with 0.5mL in the posterior wall of hte bladder for idiopathic overactive bladder and mixing 200 units into 30mL and injecting 30 sites with 1mL for neurogenic overactive bladder. The purpose of this study is to compare the efficacy of a technique using a reduced number of injections with the same dosage of onabotulinumtoxinA to the standard technique. The hypothesis is that the reduced technique will not be inferior in terms of efficacy as the standard technique and that there will be a lower incidence of urinary tract infections and urinary retention requiring catheterization post-procedure.
Males or Females ≥ 18 years of age
Predominant complaint of urinary urgency, urinary frequency or urge incontinence
Failed at least one medication (inadequate or poorly tolerated response) or behavior modification technique (timed voiding, pelvic floor physical therapy, etc.), or decline such interventions
Willingness to perform self-catheterization in the event of symptomatic urinary retention
Concurrent use of oral medications for treatment of OAB (anticholinergics or beta 3 agonists).
Post void residual volume > 200 ml
Symptomatic prolapse > POP-Q (Pelvic Organ Prolapse Quantification) stage 2 or greater that is untreated
Evidence of active UTI (bladder infection)
Parallel
onaBoNT-A
DrugIntradetrusor onabotulinumtoxinA in either the standard number of injections or a reduced number of injections
Mean change from baseline in overactive bladder symptom severity and health related quality of life scores on the overactive bladder questionnaire short form
The overactive bladder questionnaire short form is a validated questionnaire assessing both symptoms and quality of life related to overactive bladder. The survey has two subscales, a health related quality of life scale and a symptom severity scale. Each subscale is scored separately with a range of 0 to 100. For health related quality of life a score of 0 indicates worst quality of life and 100 indicating best quality of life. For symptom severity, the scores also range from 0 to 100 but with higher scores indicating greater symptom severity and lower scores less symptom severity.
Mean change from baseline in overactive bladder symptom severity and health related quality of life scores on the overactive bladder questionnaire short form
The overactive bladder questionnaire short form is a validated questionnaire assessing both symptoms and quality of life related to overactive bladder. The survey has two subscales, a health related quality of life scale and a symptom severity scale. Each subscale is scored separately with a range of 0 to 100. For health related quality of life a score of 0 indicates worst quality of life and 100 indicating best quality of life. For symptom severity, the scores also range from 0 to 100 but with higher scores indicating greater symptom severity and lower scores less symptom severity.
Mean change from baseline in overactive bladder symptoms on the International Consultation on Incontinence Questionnaire short form
The International Consultation on Incontinence Questionnaire short form is a validated questionnaire assessing symptoms of overactive bladder and effect on quality of life. The scores range from 0 to 21 with higher scores indicating worse symptom severity and effect on quality of life.
Mean change from baseline in overactive bladder symptoms on the International Consultation on Incontinence Questionnaire short form
The International Consultation on Incontinence Questionnaire short form is a validated questionnaire assessing symptoms of overactive bladder and effect on quality of life. Scores range from 0 to 21 with higher scores indicating greater symptom severity.
Incidence of urinary tract infection
Urinary tract infection is a common complication from intradetrusor onabotulinumtoxinA treatment
Incidence of urinary retention requiring intermittent catheterization
Urinary retention is a common complication following intradetrusor onabotulinumtoxinA treatment
Mean change in pain from baseline following intradetrusor onabotulinumtoxinA injection using visual analog scale
Visual Analog Scales are validated tools for assessing pain. The scale is scored from 0 to 10 with 0 being no pain and 10 being worst possible pain.
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