SCOTTSDALE, AZ USA (UroToday.com) - The purpose of this study was to determine the efficacy and safety of onabotulinum toxin A (BTA) in younger and older patients with non-neurogenic detrusor overactivity who had been inadequately managed with ≥ one anticholinergic. This was a sub-analysis of 2 phase 3 trials that included patients with non-neurogenic OAB aged < 65 and ≥ 65 years injected with 100U BTA or placebo. Parameters evaluated were changed in UI episodes, positive response on the Treatment Benefit Scale (TBS), PVR urine volume (PVR) ≥ 200mL, intermittent catheterization (IC) rates, and adverse events (AEs).
The TBS (Colman, Chapple, et al. 2008) is a validated single-item scale that is used to compare a person’s present condition with his/her condition before the start of a treatment:
“My condition (urinary problems, urinary incontinence) has 1=greatly improved, 2=improved, 3= not changed, 4= worsened during treatment.”
Score 1 or 2 = yes, perceived benefit from treatment
Score 3 or 4 = no, NOT having perceived benefit from treatment
Patients < 65-years old (placebo=323, BTA=312) and ≥ 65-years old (placebo=225, BTA=245) had similar baseline characteristics: UI episodes (5.0 and 6.1 UI episodes/day) and PVR (18.9mL and 23.6mL), respectively.
At week 12, BTA group had statistically significant reduction UI episodes compared with placebo, regardless of age (< 65y: -2.6 vs -1.0, p < 0.001 ; ≥ 65y: -3.1 vs -0.9, p < 0.001). More BTA patients reported a positive TBS response versus placebo (< 65y: 61.7% vs 30.6%, p < 0.001; > 65y: 61.8% vs 24.2%, p < 0.001).
In regards to complete bladder emptying, in both age groups, PVR of 200mLwas greater for BTA vs placebo (< 65y: 9.0% vs 0.6%, p < 0.001; ≥ 65y:12.9% vs 1.3%, p < 0.001), as were IC rates (< 65y: 5.4% vs 0.3%; ≥ 65y: 7.9% vs 0.4%). Not surprisingly, older patients experienced more UTIs (32.9% BTA, 15.2% placebo) than younger patients (19.9% BTA, 5.7% placebo).
The authors conclusions were that regardless of age, BTA provided similar and clinically relevant efficacy, but patients ≥ 65 years experienced more UTIs with both BTA and placebo than patients < 65 years.
Funding: Allergan, Inc.
Reference:
Colman S, Chapple C, Nitti V, Haag-Molkenteller C, Hastedt C, Massow U. Validation of treatment benefit scale for assessing subjective outcomes in treatment of overactive bladder. Urology. 2008 Oct;72(4):803-7
Presented by C. Moore, A. Kaufmann, M. Joshi, Y. Zheng, and S. Herschorn at the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU) Winter Meeting - February 24 - 28, 2015 - JW Marriott Camelback Inn Resort & Spa - Scottsdale, AZ USA
Reported by Diane K. Newman, DNP, FAAN, BCB-PMD, medical writer for UroToday.com.