Abstract:
OBJECTIVE:To determine the safety, efficacy and pharmacokinetics of tolterodine in children with an overactive bladder. PATIENTS AND METHODS:Thirty-three children (20 boys and 13 girls, aged 5-10 years) with an overactive bladder and symptoms of urgency, frequency and/or urge incontinence were enrolled in an open, dose-escalation study. Patients were treated with oral tolterodine 0.5 mg (n = 11), 1 mg (n = 10) or 2 mg (n = 12) twice daily for 14 days. The primary safety endpoint was the change in residual urinary volume, as determined by ultrasonography. In addition, voiding diary variables (frequency and incontinence episodes) and pharmacokinetics were evaluated. Other safety endpoints included laboratory variables, electrocardiogram recordings and reported adverse events. RESULTS:There were no safety concerns in terms of the change in residual urinary volume for any of the three dosage groups; values were comparable with baseline after 2 weeks of treatment for all three dosages. Adverse events were reported by 20 patients (six on 0.5 mg, five on 1 mg, and nine on 2 mg). Most adverse events were not considered to be drug-related; of the 13 possibly related events, 10 occurred in those taking 2 mg. Headache was the most commonly reported adverse event. No serious adverse events were reported and there were no general safety concerns. There was an improvement in voiding diary variables in all treatment groups after 2 weeks of treatment, although the efficacy was greatest in those taking 1 mg and 2 mg. Pharmacokinetic findings were consistent with dose linearity over the range 0.5-2 mg. CONCLUSION:The results support the use of 1 mg twice daily as the optimal dose of tolterodine for treating children aged 5-10 years with an overactive bladder.
journal_name
BJU Intjournal_title
BJU internationalauthors
Hjälmås K,Hellström AL,Mogren K,Läckgren G,Stenberg Adoi
10.1046/j.1464-410x.2001.00084.xkeywords:
subject
Has Abstractpub_date
2001-04-01 00:00:00pages
569-74issue
6eissn
1464-4096issn
1464-410Xpii
bju084journal_volume
87pub_type
临床试验,杂志文章,多中心研究abstract:OBJECTIVE:•To determine the optimal treatment for incidentally detected small renal masses between radical nephrectomy, partial nephrectomy, ablative therapy (AT) and active surveillance (AS) using a decision-analytic Markov model. SUBJECTS AND METHODS:•The reference case was an otherwise healthy 60-year-old patient. ...
journal_title:BJU international
pub_type: 杂志文章
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pub_type: 临床试验,杂志文章,多中心研究
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pub_type: 临床试验,杂志文章,多中心研究
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更新日期:2005-02-01 00:00:00
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pub_type: 杂志文章,随机对照试验
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pub_type: 杂志文章,评审
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