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Randomized Controlled Trial
. 2021 Jan;40(1):493-501.
doi: 10.1002/nau.24588. Epub 2020 Dec 11.

OnabotulinumtoxinA for the treatment of neurogenic detrusor overactivity in children

Paul F Austin  1 , Israel Franco  2 , Eric Dobremez  3 , Pawel Kroll  4 , Wilson Titanji  5 , Till Geib  5 , Brenda Jenkins  5 , Piet B Hoebeke  6
Affiliations
Randomized Controlled Trial

OnabotulinumtoxinA for the treatment of neurogenic detrusor overactivity in children

Paul F Austin et al. Neurourol Urodyn. 2021 Jan.

Abstract

Aims: This study evaluated whether one (or more) of three doses of onabotulinumtoxinA were safe and effective to treat neurogenic detrusor overactivity (NDO) in children.

Methods: This was a 48-week prospective, multicenter, randomized, double-blind study in children (aged 5-17 years) with NDO and urinary incontinence (UI) receiving one onabotulinumtoxinA treatment (50, 100, or 200 U; not to exceed 6 U/kg). Primary endpoint: change from baseline in daytime UI episodes. Secondary endpoints: change from baseline in urine volume at first morning catheterization, urodynamic measures, and positive response on the treatment benefit scale. Safety was also assessed.

Results: There was a similar reduction in urinary incontinence from baseline to Week 6 for all doses (-1.3 episodes/day). Most patients reported positive responses on the treatment benefit scale (75.0%-80.5%). From baseline to Week 6, increases were observed in urine volume at first morning clean intermittent catheterization (50 U, 21.9 ml; 100 U, 34.9 ml; 200 U, 87.5 ml; p = 0.0055, 200 U vs. 50 U) and in maximum cystometric capacity (range 48.6-63.6 ml) and decreases in maximum detrusor pressure during the storage phase (50 U, -12.9; 100 U, -20.1; 200 U, -27.3 cmH2 O; p = 0.0157, 200 U vs. 50 U). The proportion of patients experiencing involuntary detrusor contractions dropped from baseline (50 U, 94.4%; 100 U, 88.1%; 200 U, 92.6%) to Week 6 (50 U, 61.8%; 100 U, 44.7%; 200 U, 46.4%). Safety was similar across doses; urinary tract infection was most frequent.

Conclusions: OnabotulinumtoxinA was well tolerated and effective for the treatment of NDO in children; 200 U showed greater efficacy in reducing bladder pressure and increasing bladder capacity.

Keywords: Type A; botulinum toxins; neurogenic; pediatrics; urinary bladder.

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Conflict of interest statement

Dr. Austin has served as a consultant/advisor to Allergan, an AbbVie company. Dr. Franco has served as a consultant/advisor to Allergan, an AbbVie company, and is chief science officer of FIAS Inc. (a software company) and chief science officer for Gogoband Inc. (a software and bedwetting device maker). Dr. Dobremez has served as a consultant for Allergan, an AbbVie company. Pawel Kroll has served as a study investigator for Allergan, an AbbVie company. Dr. Titanji, Dr. Geib, and Ms. Jenkins are employees of AbbVie, and may hold AbbVie stock. Dr. Hoebeke has served as a consultant for Allergan, an AbbVie company and Astellas.

Figures

Figure 1
Figure 1
(A) LS mean change from baseline overtime in daytime UI episodes and (B) proportion of patients with a positive response on the TBS following onabotA treatment. Positive response was recorded as patients reporting their condition was “improved” or “greatly improved.” Error bars reflect standard error. LS, least squares; OnabotA, onabotulinumtoxinA; TBS, treatment benefit scale; UI, urinary incontinence
Figure 2
Figure 2
LS mean change from baseline in urine volume at first‐morning catheterization overtime (weeks). *Significant versus onabotA 50 U. p = 0.0055. Error bars reflect standard error. LS, least squares; OnabotA, onabotulinumtoxinA
Figure 3
Figure 3
3LS mean changes from baseline to Week 6 in (A) Pdetmax, (B) MCC, and (C) proportion of patients with IDC. *Statistically significant versus 50 U. Error bars reflect standard error. IDC, involuntary detrusor contraction; LS, least squares; MCC, maximum cystometric pressure; OnabotA, onabotulinumtoxinA; Pdetmax, largest decrease in maximum detrusor pressure during the storage phase
See this image and copyright information in PMC

Comment in

  • Pediatric Urology.
    Canning DA. Canning DA. J Urol. 2022 Jan;207(1):216-218. doi: 10.1097/JU.0000000000002267. Epub 2021 Oct 18. J Urol. 2022. PMID: 34661433 No abstract available.

References

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