Clean intermittent catheterization rates after initial and subsequent treatments with onabotulinumtoxinA for non-neurogenic overactive bladder in real-world clinical settings

Abstract

Objective: 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.

Methods: Patients received onabotulinumtoxinA 100 U (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 judgment 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.

Results: Overall, 299 patients received their first treatment with onabotulinumtoxinA 100 U. 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. The 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.

Conclusions: 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.

Keywords:

• Intermittent urethral catheterization
• urinary bladder
• overactive
• onabotulinumtoxinA
• urinary retention
• retrospective studies

Transparency

Declaration of funding

This study was funded by Allergan plc, Dublin, Ireland. Neither honoraria nor payments were made for authorship.

Author contributions: All authors had complete access to the study data upon request, and were involved in data analysis and interpretation, drafting of the manuscript and critical revision of the manuscript for important intellectual content. All authors provided final approval to submit the manuscript. All authors met the ICMJE authorship criteria.

Declaration of financial/other relationships

M.K. has disclosed that he has served as a consultant/advisor to Allergan plc, Astellas, Boston Scientific, Cogentix and Taris Biomedical; and as study investigator for Allergan plc, Astellas, Coloplast, Cook and Watson. L.G. has disclosed that he has served as a consultant/advisor to Astellas; as a study investigator for Allergan plc and Solace Therapeutics; and as a meeting participant/lecturer to Astellas. S.W. has disclosed that he has no significant relationships with or financial interests in any commercial companies related to this study or article. J.J.S. has disclosed that he has served as a study investigator for Coloplast. S.M. has disclosed that he has served as a consultant and speaker to Allergan plc, Astellas, Cogentix and Medtronic. J.M. has disclosed that he has served as a consultant to Caldera Medical; and as a study investigator for Allergan plc, AMS, Astellas, Medline Industries, Medtronic and Urigen. M.S. has disclosed that he is an employee of MedNet Solutions, Inc, which provided technology and consulting services to support the study under contract to Allergan plc. B.M. has disclosed that he has served as a consultant/advisor to Allergan plc, AMS, Astellas and Medtronic; and as a study investigator for Allergan plc. N.A. and T.A. have disclosed that they are employees of Allergan plc.

CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgements

Assistance with the writing and development of the manuscript was provided by Jaya Kolipaka of Evidence Scientific Solutions, Inc., Philadelphia, PA, USA, and was funded by Allergan plc, Dublin, Ireland.

Previous presentation: Previously presented at the Annual Meeting of the American Urological Association (AUA), San Diego, CA, USA, 6–10 May 2016.