Xeomin vs Botox for Treatment of Overactive Bladder Syndrome
Status:
Recruiting
Trial end date:
2024-09-30
Target enrollment:
Participant gender:
Summary
Purpose: Multiple formulations and brands of botulinum toxin exist on the market today. Only
OnabotulinumtoxinA (BOTOX®) is currently FDA approved for treatment of overactive bladder.
IncobotulinumtoxinA (XEOMIN®) is a similar formulation of botulinum toxin A that has similar
dosing and safety profile at onabotulinumtoxinA. OnabotulinumtoxinA is the most expensive
formulation on the market. Compare the efficacy of incobotulinumtoxinA (Xeomin®, Merz
Pharmaceuticals) to onabotulinumtoxinA (Botox®, Allergan) for treatment of OAB. Study design:
A single-blinded, randomized non-inferiority trial of IncobotulinumtoxinA (Xeomin®, Merz
Pharmaceuticals) to OnabotulinumtoxinA (Botox®, Allergan) in treatment of OAB. Target
Population: The study findings will be applicable to all women 18 years of age or older with
OAB symptoms associated with urinary urgency incontinence. Procedure: All patients that
presents to urogynecology clinic at Walter Reed National Medical Military Center will be
screened for inclusion and exclusion criteria. Patients that meet criteria will be offered to
participate in the study. After enrollment patient will complete demographics data sheet, 24
hours bladder diary, OAB-q SF, PGI-S, PISQ-IR. Patients will be randomized by the principal
investigator and the allocated treatment will be reveled by the treating provider to the
treating provider only. Patient will have a follow up at 2-6 weeks and 6-9 months after
procedure. During the follow up appointments patient will be asked to fill out 24-hour
voiding diary, OAB-q SF, PGI-I, PGI-S, and PISQ-IR surveys.