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This document summarizes the findings of a study on the incidence of clean intermittent catheterization (CIC), efficacy, and quality of life outcomes in female patients with overactive bladder (OAB) treated with onabotulinumtoxinA. The study analyzed data from two phase 3 trials and a postmarketing study, grouping the participants by age. The results showed that the incidence of CIC was low in all age groups, with the lowest rate in the <40 age group. The incidence of CIC slightly increased with age. The majority of patients in all age groups did not require CIC. <br /><br />Treatment with onabotulinumtoxinA resulted in substantial improvements in urinary incontinence (UI) episodes in all age groups, with nearly half of the patients in the <40 age group achieving a 100% reduction in UI episodes. High proportions of patients in all age groups achieved at least a 50% reduction in UI episodes. The treatment also led to clinically meaningful improvements in quality of life (QOL) across all age groups. Patients reported improvements in various domains including role limitations, social limitations, physical limitations, personal relationships, emotions, sleep/energy, severity/coping, general health, and incontinence impact. Adverse events were similar across all age groups and included urinary tract infection, dysuria, and bacteriuria.<br /><br />The study concluded that onabotulinumtoxinA was well tolerated in all age groups and resulted in low incidence of CIC with substantial improvements in UI and QOL. The treatment had an acceptable benefit/risk profile. Overall, the findings suggest that onabotulinumtoxinA is effective and safe for the treatment of OAB in female patients across different age groups.
Keywords
clean intermittent catheterization
efficacy
quality of life outcomes
female patients
overactive bladder
onabotulinumtoxinA
urinary incontinence episodes
reduction in UI episodes
improvements in quality of life
adverse events
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