Hypothesis / aims of study
Prospective randomised trial data shows significant benefit from intravesical Onabotulinum Toxin A (Botox A) in 60% of index patients with symptomatic overactive bladder (OAB). The evidence also suggests that efficacy following the first injection persists throughout subsequent cycles of treatment. However, the available data may not reflect outcomes in all-comers. We aimed to assess the outcomes of treatment with Botox A in real world patients.
Study design, materials and methods
The notes of 418 consecutive patients (median age 61 years, range 22-90 years) with symptomatic OAB refractory to behavioural and medical treatment, and urodynamically-proven idiopathic detrusor overactivity, having their first intravesical Botox A treatment between 1st January 2006 and 31st December 2018, were reviewed. Any patient who had not been seen within the last six months was contacted by telephone. Five patients had inadequate notes and were excluded from assessment. Data was collected on patient demographics, improvement after treatment, continuance of Botox A treatment, number and dosage of repeat treatments and the need for intermittent self-catheterisation (ISC). Improvement was assessed using the Patient Global Impression of Improvement (PGI-I) score following the first Botox injection. This is a validated tool for symptoms of OAB in the form of a single question asking patients to rate their condition after treatment as compared to baseline on a scale of 1 (very much better) to 7 (very much worse). Patients were then stratified based on PGI-I scores into three groups; Good Response (PGI-I scores 1 and 2), Partial Response (PGI-I score 3) and No Response (PGI-I scores of greater than or equal to 4).
Interpretation of results
A total of 235 (56.9%) patients had a good response to treatment with Botox A. A partial response was observed in 48 (11.6%) patients. The remaining 130 (31.4%) had no response. Of those in the Good Response group, 174 (74%) were female and in the Partial Response group 32 (66.7%) were female. Although 69% of the total patients were female this was statistically significant. There were no significant differences between age ranges or rates of previous pelvic surgery across the treatment response groups, as shown in Table 1.
A total of 269 patients (65.1%) had more than one Botox A injection; the number of repeat treatments ranged from 1-19. Treatment with Botox A resulted in the need for ISC in 146 (35.4%) patients.