Efficacy and safety of tolterodine in patients with detrusor instability: a dose‐ranging study

Rentzhog,; Stanton,; Cardozo,; Nelson, Bradley J.; Fall,; Abrams,

doi:10.1046/j.1464-410x.1998.00501.x

Cited by 131 publications

(48 citation statements)

References 10 publications

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“…This measurement has been used in other studies, not only as a measure of safety but also as a measure of drug effect on the bladder. This finding is in contrast to dose-finding studies of tolterodine in adults, where there was a clear dose-response relationship for residual urinary volume [26][27][28]. The reason for the difference is not clear but might be a result of there being few patients and that the patients were children in a stressful situation, which may lead to greater variability.…”

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confidence: 83%

The overactive bladder in children: a potential future indication for tolterodine

et al. 2001

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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. Keywords tolterodine, antimuscarinic agents, children, overactive bladder, dose-finding study IntroductionThe symptoms of an overactive bladder are urgency and frequency, with or without urge incontinence, caused by uncontrolled contractions of the detrusor muscle. As uncontrolled detrusor contractions are mediated by muscarinic receptor stimulation, antimuscarinic agents are the most frequently used medications for treating this condition [1]. Historically, antimuscarinic agents like oxybutynin have been effective for treating the overactive bladder but they are poorly tolerated because they are not selective for the bladder [2]. Side-effects on the parotid gland, CNS, gastrointestinal tract and on the eye limit their clinical usefulness [3]. Particularly frequent and troublesome is dry mouth, which has been shown to cause poor compliance and frequent discontinuation of treatment [1,[4][5][6].Tolterodine is a muscarinic receptor antagonist that has been shown to be effective for treating the overactive bladder [7][8][9]. The advantages of tolterodine are numerous and are ascribed to its selectivity for the bladder over other tissues and to its low lipophilicity. Differences between tolterodine and oxybutynin have been reported in several preclinical studies, including pharmacologi...

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confidence: 83%

The overactive bladder in children: a potential future indication for tolterodine

et al. 2001

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“…Filling cystometry is the key urodynamic investigation in the diagnosis of overactive detrusor [1, 2], and has been used as one of the outcome measures in clinical trials for this condition [6, 7, 8, 9]. In the present study we evaluated its reliability by comparing the first test with the second, which was performed after placebo treatment for 2~4 weeks.…”

Section: Discussionmentioning

confidence: 99%

“…Some indicated a minimal change in the mean cystometric capacity, for example, +4 ml (sample size; n = 44) [6]or –17 ml (n = 13) [7]. In contrast, others documented an increase of mean cystometric capacity by 22.5 ml (n = 47) [8]or 52 ml (n = 63) [9], although the increase was significantly smaller than in active drug groups.…”

Section: Discussionmentioning

confidence: 99%

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Reproducibility of Cystometry in Overactive Detrusor

Homma

Kondo²,

Takahashi³

et al. 2000

European Urology

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“…A sample size calculation was performed based on the few, available literature references and own pilot investigations (Jonas et al, 1997;Rentzhog et al, 1998;Stahl et al, 1995). The alpha level was set at 5% and the power at 80%.…”

Section: Methodsmentioning

confidence: 99%

Proof of principle: The effect of antimuscarinics on bladder filling sensations in healthy subjects—A placebo controlled double blind investigation using 4 and 8 mg tolterodine extended release

Mehnert

Reitz

Youssef

et al. 2009

Neurourology and Urodynamics

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AimsThere is evidence that antimuscarinic drugs have depressant influence not only on bladder muscle activity, but also on bladder sensations. The aim of this study was to evaluate the effect of a single dose tolterodine extended release (ER) 4 and 8 mg on bladder sensations during filling cystometry.MethodsAfter approval of the local ethics committee, 30 healthy female subjects (23.7 ± 2.3 years) were included and randomly assigned to three groups: (A) placebo, (B) tolterodine ER 4 mg, and (C) tolterodine ER 8 mg in a double blind manner. Measurements were performed at baseline and 4 hr postmedication in each group, consisting of: (1) Filling cystometry with 25 ml/min at which subjects had to indicate first sensation of filling (FSF), first desire to void (FDV), and strong desire to void (SDV). (2) Uroflowmetry and ultrasound control for residual urine.ResultsIn the placebo group, filling volumes at FDV and SDV decreased significantly posttreatment. This effect could not be observed for the tolterodine 8 mg group and only at SDV in the 4 mg group. No significant difference between groups was found regarding uroflowmetry parameters and postvoid residual volume.ConclusionsNo increase of filling volumes in healthy subjects could be observed with tolterodine. However, the results suggest that tolterodine is able to alleviate irritation caused by repeated catheterization and cystometry. There was no significant influence of tolterodine ER 4 or 8 mg on voiding function. Neurourol. Urodynam. 29:464–469, 2010. © 2009 Wiley‐Liss, Inc.

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Efficacy and safety of tolterodine in patients with detrusor instability: a dose‐ranging study

Cited by 131 publications

References 10 publications

The overactive bladder in children: a potential future indication for tolterodine

The overactive bladder in children: a potential future indication for tolterodine

Reproducibility of Cystometry in Overactive Detrusor

Proof of principle: The effect of antimuscarinics on bladder filling sensations in healthy subjects—A placebo controlled double blind investigation using 4 and 8 mg tolterodine extended release

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