Efficacy and safety of propiverine in cpomparison to oxybutynin in children with neurogenic detrusor overactivity: an observational study

Background

Assessment of efficacy and safety of propiverine (prop.; Mictonetten™) and oxybutynin (oxy.) in children with neurogenic detrusor overactivity (NDO) aged 1 – 18 years.

Materials and methods

In a comparative cohort study 255 children with NDO (199 myelomeningocele (MMC), 46 spinal cord injury), were treated with anticholinergics for 2.5 years on average at 14 centers and were evaluated retrospectively. 127/255 children were allocated to prop., 128/255 to oxy.; median age at diagnosis and treatment initiation were 2.08 and 7.18 (prop.) vs. 3.37 and 7.98 (oxy) years, respectively.

Results

Primary efficacy outcome, max. detrusor pressure at micturition, was on average reduced to a significantly larger extent in the prop. than in the oxy. group. Correspondingly, clinically relevant reductions of detrusor pressure (below 40 cm H₂0 or reduction by > 50%) resulted significantly more often in the prop. than in the oxy. group (74% vs. 50%). Urodynamic results are in agreement with clinical findings (tab. 1).

Table 1 Efficacy

Both propiverine and oxybutynin demonstrated a resolution or downgrading of vesico-uretero-renal reflux (tab. 2).

Table 2 Reflux

Propiverine was better tolerated than oxybutynin (9.40 vs. 17.46% adverse events), in those children suffering from MMC significantly better.

Conclusion

Comparative studies of efficacy and tolerability of anticholinergics in NDO of children were missing so far. This cohort study demonstrates a more effective reduction of the max. detrusor pressure at micturition with prop. in comparison to oxy. Prop. was better tolerated than oxy. Urodynamic effects are correlated with improvement of reflux, indicating possibly more favourable long-term outcomes of the upper urinary tract