Propiverine vs oxybutynin for treating neurogenic detrusor overactivity in children and adolescents: results of a multicentre observational cohort study.
OBJECTIVE
To compare, in a retrospective observational cohort study, the efficacy, tolerability, safety and clinical effectiveness of propiverine and oxybutynin in children and adolescents with neurogenic detrusor overactivity (NDO).


METHODS
In all, 255 children and adolescents (aged 1-18 years) with NDO (199 myelomeningocele, 46 spinal cord injury, 10 other diagnoses) were enrolled at 14 study centres. To evaluate the efficacy of propiverine and oxybutynin, urodynamic and clinical variables were assessed before and after at least 12 month of the antimuscarinic agents administered at variable doses.


RESULTS
In all, 127 patients given propiverine and 128 given oxybutynin were enrolled. The primary efficacy outcome, i.e. reductions in urodynamically assessed individual maximum detrusor pressure (P(detmax)), was assumed to indicate success in 74.2% of those on propiverine vs 49.6% on oxybutynin. The mean P(detmax) was significantly reduced during treatment, from 59.8 to 36.7 cmH(2)O in the propiverine and from 65.2 to 54.9 cmH(2)O in the oxybutynin groups. The mean maximum cystometric bladder capacity increased from 146 to 242 mL in the propiverine and from 222 to 310 mL in the oxybutynin group. Propiverine was better tolerated than oxybutynin, having fewer adverse drug reactions (9.4% vs 17.2%, odds ratio 2.04), and for its severity grades and premature treatment termination (none vs 11 cases).


CONCLUSIONS
In this non-interventional study, reflecting 'real-life' clinical practice, comparing the efficacy, tolerability and safety of propiverine and oxybutynin in children and adolescents with NDO, propiverine was at least as effective as oxybutynin, but better tolerated, resulting in superior clinical effectiveness than for oxybutynin.
Madersbacher
Helmut
H
Neuro-Urology Unit, University Hospital Innsbruck, Austria. helmut.madersbacher@tilak.at
Mürtz
Gerd
G
Alloussi
Schahnaz
S
Domurath
Burghard
B
Henne
Thomas
T
Körner
Iris
I
Niedeggen
Andreas
A
Nounla
Joseph
J
Pannek
Jürgen
J
Schulte-Baukloh
Heinrich
H
Schultz-Lampel
Daniela
D
Bock
Paul
P
Strugala
Gerhard
G
D000293:Adolescent; D001561:Benzilates / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004812:Epidemiologic Methods; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008333:Mandelic Acids / Q000009:adverse effects / Q000627:therapeutic use*; D008591:Meningomyelocele / Q000150:complications; D018727:Muscarinic Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index; D013119:Spinal Cord Injuries / Q000150:complications; D016896:Treatment Outcome; D001750:Urinary Bladder, Neurogenic / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D053201:Urinary Bladder, Overactive / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D014563:Urodynamics
D001561:Benzilates; D008333:Mandelic Acids; D018727:Muscarinic Antagonists; C015586:propiverine; C005419:oxybutynin