Introduction

The potential need for clean intermittent catheterization (CIC) is known to increase in overactive bladder (OAB) patients (pts) after onabotulinumtoxinA (onabotA) treatment. We determined the risk of CIC, and efficacy and quality of life (QOL) outcomes after treatment with onabotA in different age groups in a post hoc analysis of a large cohort of OAB pts.

Methods

Data from two onabotA randomized, placebo-controlled phase 3 trials and a post-marketing study were pooled for analysis (N=1177). Pts treated with onabotA 100U in treatment 1 and placebo pts who received open-label onabotA in treatment 2 were grouped by age: <40 (n=90), 40-49 (n=156), 50-59 (n=263), 60-69 (n=343) and ≥70 (n=325) years. Assessments at week 12 after treatment were: incidence and duration of CIC, mean and % change from baseline (BL) in urinary incontinence (UI) episodes, proportions of pts with ≥50% UI reduction, positive response (urinary symptoms 'improved'/'greatly improved') on the treatment benefit scale (TBS), and change from BL in Kings Health Questionnaire (KHQ) Social Limitations and Role Limitations domains. Adverse events (AEs) were assessed.

Results

CIC rates after onabotA treatment were lowest in the <40 group (1.1%) and increased slightly with age (3.2%, 5.3%, 5.3% and 7.2% in the 40-49, 50-59, 60-69 and ≥70 groups, respectively). Mean (median) CIC duration in the <40 and 40-49 groups was 3 (3) and 44 (26) days and ranged from 78 (68) to 88 (74) days in the other groups. Mean UI episodes/day at BL were 3.9, 4.8, 5.2, 5.7 and 6.0 in the <40, 40-49, 50-59, 60-69 and ≥70 groups. A robust treatment response was noted in all groups including substantial reductions in UI episodes/day (-2.4, -2.6, -3.1, -3.6 and -2.9) and % change in UI (-60.8%, -50.4%, -62.4%, -64.4% and -46.8%). High proportions of pts in all groups achieved ≥50% UI reduction (range: 58.2%-71.1%), a positive TBS response (range: 66.2%-73.8%) and improvements from BL in KHQ domain scores ~3-6x the minimally important difference (-5 points). Urinary tract infection was the most common AE in all groups.

Conclusions

In this large cohort of onabotA-treated OAB pts, CIC risk increased slightly with age but was low in all age groups and accompanied by substantial reductions in UI, improvements in QOL and treatment benefit. The <40 group had the lowest rate of CIC (1.1%) with a duration of 3 days. OnabotA was well tolerated in all age groups.

Funding

Allergan plc