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Injection site number and outcomes of intradetrusor onabotulinumtoxinA for refractory overactive bladder syndrome: a randomized clinical trial
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Injection site number and outcomes of intradetrusor onabotulinumtoxinA for refractory overactive bladder syndrome: a randomized clinical trial
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Injection site number and outcomes of intradetrusor onabotulinumtoxinA for refractory overactive bladder syndrome: a randomized clinical trial
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Journal Article
Injection site number and outcomes of intradetrusor onabotulinumtoxinA for refractory overactive bladder syndrome: a randomized clinical trial
2024
Overview
Introduction and hypothesis
The optimal number of onabotulinumtoxinA injections for the treatment of refractory overactive bladder syndrome is unknown. Our primary objective was to determine whether 10-injections sites with 100 units of onabotulinumtoxinA each were associated with less pain than 20-injections sites.
Methods
In a single-blinded randomized trial, 100 units of onabotulinumtoxinA was administered, either as 10 × 1 ml or as 20 × 0.5 ml injections following the instillation of 30 ml of bupivacaine and 5 ml of NaHCO
3
solution for 15 min. The primary outcome was procedural pain, as measured on an 11-point Numerical Pain Rating Scale (NPRS) immediately following the procedure. A power calculation estimated that 16 subjects in each arm were needed to detect a mean difference of 1 with a standard deviation of 1, on the NPRS score between the two treatment groups, with α 0.05 and power 80%. To adjust for an estimated 20% dropout rate, the final sample size was planned for 20 patients per group.
Results
From October 2020 to November 2022, a total of 56 patients were approached and 40 were enrolled and randomized to two groups (21 in the 10-injections group and 19 in 20-injections group). The difference in the median pain score between the group was not statistically significant (4 [1.5–5] for 10 injections vs 3 [1–4] for 20 injections,
p
=0.823).
Conclusion
Patients’ perception of pain, efficacy, and adverse events did not significantly differ between patients receiving 10 and those receiving 20 injections of 100 units of onabotulinumtoxinA.
Publisher
Springer International Publishing,Springer Nature B.V
