Efficacy, tolerability and safety of propiverine hydrochloride in comparison to oxybutynin in children with urge incontinence due to overactive bladder: Results of a multicentre observational cohort study.
OBJECTIVE
To compare, in a retrospective observational cohort study, the efficacy, tolerability and safety of propiverine and oxybutynin in children with urge incontinence (UI) due to overactive bladder.


METHODS
Medical records were scrutinized for children with UI. As a primary efficacy outcome variable the achievement of continence after treatment with variable doses of propiverine or oxybutynin was assessed. Weekly UI episodes and daily voiding frequency were evaluated as secondary efficacy outcomes. Tolerability was evaluated by the rate of adverse events, adverse drug reactions caused by antimuscarinics and premature treatment termination.


RESULTS
At 16 study centres, 621 children aged 5-14 years with UI due to overactive bladder were enrolled. After anticholinergic treatment (437 propiverine, 184 oxybutynin) continence was achieved in 61.6% and 58.7% of the patients after 186 and 259 days, respectively. There were clinically relevant improvements in voiding frequency across treatment groups. Daily doses of propiverine were markedly below the recommendations (0.54 vs 0.8 mg/kg body weight), daily doses of oxybutynin were according to the recommendations (0.31 vs 0.2-0.4 mg/kg body weight) at treatment initiation. There was a significantly more favourable tolerability to propiverine than oxybutynin for the overall rate of adverse events (3.9% vs 16.3%, odds ratio 4.813), adverse drug reactions caused by propiverine or oxybutynin (2.8% vs 9.2%) and premature treatment termination due to adverse drug reactions (1.6% vs 4.4%).


CONCLUSIONS
Propiverine and oxybutynin are effective in children with UI due to overactive bladder. Sufficient treatment periods of at least 2, preferably 3-4, months are the crucial factors for a successful treatment. The tolerability profile of propiverine is better than for oxybutynin.
Alloussi
Schahnaz
S
Department of Urology and Paediatric Urology, Krankenhaus Neunkirchen GmbH, Germany.
Mürtz
Gerd
G
Braun
Reinhard
R
Gerhardt
Ulrich
U
Heinrich
Martina
M
Hellmis
Eva
E
Horn
Werner
W
Marschall-Kehrel
Daniela
D
Niklas
Kurt
K
Raabe
Michael
M
Rössler
Thomas
T
Seibt
Beatrix
B
Siemer
Stefan
S
Schultz-Lampel
Daniela
D
Walter
Heiko
H
Wiedeking
Burkhard
B
Alloussi
Saladin
S
Bock
Paul
P
Strugala
Gerhard
G
Madersbacher
Helmut
H
D000293:Adolescent; D001561:Benzilates / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D018680:Cholinergic Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D004812:Epidemiologic Methods; D005260:Female; D006801:Humans; D008297:Male; D008333:Mandelic Acids / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000150:complications / Q000188:drug therapy*; D053202:Urinary Incontinence, Urge / Q000188:drug therapy* / Q000209:etiology
D001561:Benzilates; D018680:Cholinergic Antagonists; D008333:Mandelic Acids; C015586:propiverine; C005419:oxybutynin