Summary
Background
Solifenacin is an anticholinergic that is used to treat overactive bladder syndrome
(OAB) in children. It is important to ascertain the safety and tolerability of solifenacin
in the paediatric population as solifenacin offers an alternative, is more bladder
specific, and should have less anticholinergic side effects than other therapies.
Objective
The aim of this study is to systematically evaluate the safety and tolerability of
solifenacin in children and adolescents with OAB.
Study design
We included studies that reported the safety and tolerability of solifenacin in children
and adolescents. All study types were included. Electronic searches were conducted
in Ovid MEDLINE, Ovid Embase, TRIP, CINAHL and ICTRP on the 18th of January 2022.
Risk of bias was assessed with the Cochrane Risk of Bias tool 2.0 (ROB-2) for randomised
controlled trials (RCTs) and the Newcastle–Ottowa scale for cohort studies.
Results
A total of twelve studies including two RCTs were included in this review. Results
from the meta-analysis of RCTs showed the commonest side effects were constipation
(RR 3.5, 95%CI 0.9–13.7) and dry mouth (RR 3.1 95%CI 0.2–53). In terms of tolerability,
the effect estimate of ceasing solifenacin due to an adverse effect was 2.7 (95%CI
0.8–9.1). Within the cohort studies, out of the 779 patients 21.7% experienced side
effects. The most common side effects were constipation (6.8%) and dry mouth/lips
(6.0%) and 3.5% of patients ceased solifenacin due to adverse effects. Overall, the
certainty of the evidence for side effects and tolerability were very low.
Discussion
The reported incidence of side effects is low, and less than reported with oxybutynin
use. However, the very low certainty of the evidence means the findings should be
interpreted with caution. There is limited reporting of a prolonged QTc interval on
ECG. Studies that described this only had an increase of QTc from baseline and not
a clinically significant prolonged QTc that resulted in arrhythmias.
Conclusion
Summary TableSummary of evidence and GRADE rating.
| Outcomes | Type of study (N) | Results | Risk of bias | Inconsistency | Indirectness | Imprecision | Publication bias | Overall GRADE rating |
|---|---|---|---|---|---|---|---|---|
| Adverse effects of solifenacin | RCT (2) Cohort studies (10) |
Constipation:RR 3.5, (95%CI 0.9–13.7) Dry mouth:RR 3.1 (95%CI 0.2–53), Dizziness (RR 1.5 95%CI 0.1–16.3) Behavioural difficulties (RR 3.8, 95% CI 0.4–34.4) Constipation6.8% Dry mouth 6.0% Other gastrointestinal side effects 6.2% |
Some concerns 1 RCT had a low risk of bias and the other high. 6/10 cohort studies were of good quality and therefore low risk of bias |
No concerns Of the common side effects in the RCT, 3 out of 4 had low heterogeneity. |
No concerns Studies were performed in the population of interest. |
Some concerns Only 2 studies in the meta-analysis with wide confidence intervals crossing the null |
Some concerns Most studies had a small sample size and some were in abstract form only. |
Very Low (+) |
| Tolerability | RCT (2) Cohort studies (7) (Single dose studies removed as not applicable to tolerability) |
Risk of ceasing due to side effects; RR 2.7 (95%CI 0.8–9.1). I2 statistic = 0%, p value = 0.49 3.5% of patients in the cohort studies ceased solifenacin due to adverse effects. |
Some concerns 1 RCT had a low risk of bias and the other high. 6/10 of the cohort studies were of good quality and therefore low risk of bias |
No concerns Low heterogeneity |
No concerns Studies were performed in the population of interest |
Some concerns Only 2 studies in the meta-analysis with a wide confidence interval |
Some concerns Most studies had a small sample size and some were in abstract form only. |
Very Low (+) |
Keywords
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Article info
Publication history
Published online: September 30, 2022
Accepted:
September 15,
2022
Received in revised form:
September 13,
2022
Received:
May 10,
2022
Identification
Copyright
Crown Copyright © 2022 Published by Elsevier Ltd on behalf of Journal of Pediatric Urology Company. All rights reserved.
