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DRUG THERAPY
OF URGE INCONTINENCE IN CHILDREN AND ADOLESCENTS - EFFICACY AND
TOLERABILITY OF PROPIVERINE
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Authors:
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B Schönberger1, J Siegert2,
F Schnabel, G Mürtz, G Schubert, T Gramatté
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Institution:
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1Urology Unit, University,
Charité Berlin; 2Apogepha, Dresden, Germany
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Aims of
study
There is a necessity to achieve data for the treatment of children and adolescents
aside data for adults [1]. Data of children and adolescents were achieved in
an international post marketing drug surveillance (PMS) with propiverine (prop.)
in the treatment of urge incontinence. It was to compare the efficacy, tolerability
and dosage of prop. for children, adolescents and adults.
Material and methods
The PMS comprised 4390 patients including subpopulations of children (age group
up to 11 years), adolescents (age group 12-17 years) and adults (age group 18-65
years). Pre (V0), after 4 weeks (V4) and after 12 weeks of therapy (V12), demographic
data as well as data from frequency/volume charts were evaluated for efficacy
(episodes of incontinence, frequency and pad use). Tolerability was assessed
by directly questioning of adverse events including typical anticholinergic
adverse events, and by documenting of residual urine, as well.
Results
Data of 547 children (mean age 7.4 y., mean body weight 28.0 kg), 92 adolescents
(mean age 13.0 y., 45.8 kg), and 2349 adults (mean age 50.0 y., 70.7 kg) were
analysed. Mean day time incontinence episodes, micturition frequency and pad
use decreased from V0 to V12 (compare table). The daily dosage adjusted to the
body weight was within a comparable range for all age groups displaying a decrease
of the daily dosage during the surveillance period. Dryness of the mouth was
reported in children in 11.0 %, in adolescents in 12.0 % and in adults in 41.0
%. In neither of the groups a clinical relevant increase of residual urine was
documented.
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children
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adolescents
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adults
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patients
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547
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92
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2369
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sex
male [%]
female [%]
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50.5
49.5
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44.6
55.4
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10.7
89.3
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incontinence day time
V0 [episodes/d]
V12
[episodes/d]
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6.7
5.5
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6.9
5.4
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9.3
5.7
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frequency day time
V0
[episodes/d]
V12
[episodes/d]
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6.8
5.5
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6.9
5.5
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9.2
5.8
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wet or damp pads
V0 [%
of patients]
V12 [%
of patients]
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34.2
6.6
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31.5
10.9
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58.2
21.9
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dryness of the mouth
V0 [%
of patients]
V12 [%
of patients]
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4.8
11.0
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7.6
12.0
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18.4
41.0
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premature termination
due
to improvement [% ]
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20.5
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15.2
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16.2
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premature termination
due
to insufficient therapy [%
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11.3
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5.4
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3.5
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mean prop. dosage V0
[mg/d]
[mg/kg body weight/d]
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12.7
0.4
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18.4
0.4
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36.4
0.5
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Conclusions
Prop. is effective and well tolerated in the treatment of urge incontinence
in children, adolescents and adults, as well. The rate of premature termination
due to insufficient therapy in children may be minimised, if the recommended
daily dosage - 0.8 mg/kg BW - would be applied as proven in clinical studies
[2]. Nevertheless, the rate of complete remissions of clinical symptoms was
higher than the assumed rate of spontaneous remissions of about 15 % per year.
Prop. is recommended for the treatment of urge incontinence in children, adolescents
and adults, as well. [1] CPMP and FDA Guidelines 462/95 [2] Siegert et al. Jahrbuch
der Urologie 1994: 177-181 The analysis was supported by an educational grant
of Apogepha.