Previous randomized controlled trials have reported a 6.1-6.9% incidence of clean intermittent catheterization (CIC) following treatment with onabotulinumtoxinA in non-neurogenic overactive bladder (OAB) patients who were inadequately managed by ≥1 anticholinergic. A multi-center retrospective chart review assessed the real-world rate of voiding dysfunction requiring catheterization.
Patients received onabotulinumtoxinA 100U (approved dose) administered by experienced injectors between January 2013 and June 2015. Patients using CIC or an indwelling catheter for ≥24 hours for voiding dysfunction prior to onabotulinumtoxinA injections were excluded. The primary outcome was post-treatment CIC (lasting >24 hours; per individual physician's clinical judgement considering patient's voiding symptoms, post-void residual [PVR] urine volumes, and patient bother). Potential baseline predictors of CIC (history of pelvic prolapse, cystocele, diabetes, PVR urine volume and age) were assessed using multivariable logistic regression.
Overall, 299 patients received their first treatment with onabotulinumtoxinA 100U. Mean age was 66.4 years; 98.3% were female. The incidence of CIC was 2.7% in the total study population after the first treatment with onabotulinumtoxinA. De novo CIC rate in treatments 2 and 3 combined was similarly low (3.2%). None of the evaluated baseline characteristics were significant predictors of CIC initiation due to the low CIC incidence.
This real-world study of non-neurogenic OAB patients treated with onabotulinumtoxinA suggests that the CIC rate is lower than the rates reported in previous studies. There were no significant correlations between baseline predictors and CIC initiation, although statistical significance may not have been reached because of the low incidence of CIC.
Current medical research and opinion. 2018 Feb 19 [Epub ahead of print]
Michael Kennelly, Lonny Green, Nancy Alvandi, Salim Wehbe, John Joseph Smith, Scott MacDiarmid, Jeffrey Mangel, Marc Schwartz, Tamer Aboushwareb, Brian Murray
a Women's Center for Pelvic Health , Charlotte , NC , USA., b Virginia Women's Center , Richmond , VA , USA., c Allergan plc , Irvine , CA , USA., d University of California at Davis , Sacramento , CA , USA., e Novant Health Urology Partners , Winston-Salem , NC , USA., f Alliance Urology Specialists , Greensboro , NC , USA., g MetroHealth Medical Center , Cleveland , OH , USA., h MedNet Solutions Inc. , Minnetonka , MN , USA., i Capital Region Urology , Albany , NY , USA.