Xeomin vs Botox for Treatment of Overactive Bladder Syndrome
Overactive Bladder Syndrome
About this trial
This is an interventional treatment trial for Overactive Bladder Syndrome
Eligibility Criteria
Inclusion Criteria: Females 18 years of age or older Primary complaint of urinary urgency incontinence Failed at least one medication (inadequate or poorly tolerated response) or behavior modification technique (timed voiding, pelvic floor physical therapy, dietary modifications, etc.), or decline such interventions Willingness to perform self-catheterization Ability to follow study instructions and complete all required follow-up DEERS eligible Exclusion Criteria: Concurrent use of oral medications for treatment of OAB (anticholinergics or beta 3 agonists) Contraindication to onabotulinumtoxinA and/or incobotulinumtoxin Post void residual volume > 200 ml Symptomatic prolapse POP-Q (Pelvic Organ Prolapse Quantification) stage three or greater that is untreated Evidence of active bladder infection Any previous use of intradetrusor botulinum toxin within the preceding 6 months Total body onabotulinumtoxinA and/or incobotulinumtoxinA dose of ≥ 400 Units in the 3 months prior to scheduled appointment Procedure performed in the main operating room (not outpatient setting) Concurrent diagnosis of interstitial cystitis/painful bladder syndrome Females who are pregnant or planning a pregnancy during the study or who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study Neurogenic bladder or other neurological disease that may cause voiding dysfunction Inability to speak or read English. Non-English speakers will be excluded from this study for ease of being able to allow the principal investigator to communicate with the patients during the consents, initial and all follow-up communication. Some of the questionnaires used have also only been validated in English.
Sites / Locations
- Walter Reed National Military Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Xeomin
Botox
100units xeomin dilated in 10mL injectable saline will be injected into the detrusor muscle to a depth of 3mm at 20 sites at 0.5mL volume each
100units Botox dilated in 10mL injectable saline will be injected into the detrusor muscle to a depth of 3mm at 20 sites at 0.5mL volume each