Efficacy, tolerability and safety of propiverine hydrochloride in children and adolescents with congenital or traumatic neurogenic detrusor overactivity--a retrospective study.
OBJECTIVE
Anticholinergic treatment combined with intermittent catheterisation is the cornerstone of the conservative treatment strategy in children with neurogenic detrusor overactivity, which in most cases is due to congenital causes. Efficacy, tolerability and safety of propiverine hydrochloride were evaluated retrospectively in these children.


METHODS
At four specialized outpatient clinics, all children's records were scrutinized for first-line propiverine hydrochloride treatment, or second- or third-line treatment after failure of a non-selective alpha-blocker (phenoxybenzamine) and/or other anticholinergics (oxybutynin, trospium chloride). The primary efficacy outcomes were urodynamic parameters, with clinical symptoms as secondary outcomes. Statistical analysis was performed by paired t-tests (significance level p < 0.05).


RESULTS
Altogether 74 children and adolescents (40 boys, 34 girls; age range 11 months-19 years) were treated with propiverine hydrochloride (average duration 2 years and approximately 4 months; individual dose range 5-75 mg). The primary efficacy outcome parameters improved significantly: maximum cystometric capacity 161.2 [standard deviation (SD) 97.3] to 252.2 ml (SD 117.2), p < 0.001; maximum detrusor pressure 43.8 (SD 39.2) to 27.1 cm H(2)O (SD 26.4), p = 0.002; bladder compliance 7.6 (SD 6.4) to 17.0 ml/cm H(2)O (SD 16.2), p < 0.001. Phasic detrusor overactivity was abolished by 63%; incontinence resolved by 54%. One patient spontaneously reported a typical anticholinergic adverse event, which resolved after dose reduction. No safety concerns were documented.


CONCLUSIONS
Propiverine hydrochloride is effective in neurogenic detrusor overactivity in children and adolescents, even in some of those cases unresponsive to other anticholinergics. The low incidence rate (<1.5%) of adverse events evidences a favourable risk-benefit profile of propiverine hydrochloride, considering in particular the total documented treatment and surveillance period of 171 patient years and nine months.
Department of Urology, Berufsgenossenschaftliche Unfallklinik Murnau, Germany.
Ute
U
Grigoleit
Gerd
G
Mürtz
Sebastian
S
Laschke
Matthias
M
Schuldt
Mark
M
Goepel
Guus
G
Kramer
Manfred
M
Stöhrer
D000293:Adolescent; D000328:Adult; D001561:Benzilates / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D018680:Cholinergic Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D012189:Retrospective Studies; D001750:Urinary Bladder, Neurogenic / Q000209:etiology*; D053201:Urinary Bladder, Overactive / Q000188:drug therapy*
D001561:Benzilates; D018680:Cholinergic Antagonists; C015586:propiverine