Randomized, Double-Blind, Multicenter Trial on Treatment of Frequency, Urgency and Incontinence Related to Detrusor Hyperactivity: Oxybutynin versus Propantheline versus Placebo

Thüroff, Joachim W.; Bunke, Björn; Ebner, A.; Faber, Peter; Geeter, Patrick de; Hannappel, J.; Heidler, H; Madersbacher, H.; Melchior, H.; Schäfer, Werner; Schwenzer, T.; Stöckle, Michael

doi:10.1016/s0022-5347(17)38459-8

Cited by 258 publications

(86 citation statements)

References 9 publications

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“…Up to now, there´s no study evaluating the effect of oxybutynin or another anticholinergic agent, much more selective for the bladder receptors, in these patients. A double-blind controlled study comparing propantheline bromide, placebo and oxybutynin in patients with overactive bladder without HTLV-1 did not reveal any signifi cant difference between the group that received propantheline bromide and those that received placebo 9 . In another study, among 39 patients with HAM/TSP who had received pulse therapy with methylprednisolone, improvement in motor disability was observed in more than 60% of cases, but no improvements in bladder dysfunction were noted 10 .…”

mentioning

confidence: 93%

The use of botulinum toxin type A in the treatment of HTLV-1-associated overactive bladder refractory to conventional therapy

Neto

Bittencourt

Oliveira

et al. 2014

Rev. Soc. Bras. Med. Trop.

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Urinary symptoms occur in 19% of human T-cell lymphotropic virus type 1 (HTLV-1)-infected patients who do not fulfi ll criteria for HTLV-1-associated myelopathy/tropical spastic paraparesis (HAM/TSP) and in almost 100% of HAM/TSP patients. Few studies have evaluated therapies for overactive bladder (OAB) caused by HTLV-1 infection. This case report describes the effect of onabotulinum toxin A on the urinary manifestations of three patients with HAM/TSP and OAB symptoms. The patients were intravesically administered 200 units of Botox®. Their incontinence episodes improved, and their OAB symptoms scores (OABSS) reduced signifi cantly. These data indicate that Botox® should be a treatment option for OAB associated with HTLV-1 infection.

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mentioning

confidence: 93%

The use of botulinum toxin type A in the treatment of HTLV-1-associated overactive bladder refractory to conventional therapy

Neto

Bittencourt

Oliveira

et al. 2014

Rev. Soc. Bras. Med. Trop.

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“…Their therapeutic efficacy is limited by their troublesome side-effects resulting in the discontinuation of treatment in a signif-icant number of patients [5,6]. The development of new drugs should therefore target alternative pathways affecting detrusor overactivity.…”

Section: Introductionmentioning

confidence: 99%

Retracted: Safety and efficacy of tramadol in the treatment of idiopathic detrusor overactivity: a double‐blind, placebo‐controlled, randomized study

Safarinejad

Hosseini

2006

Brit J Clinical Pharma

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AimTo evaluate the efficacy and safety of tramadol in patients with idiopathic detrusor overactivity (IDO). MethodsA total of 76 patients 18 years or older with IDO were randomly assigned to receive 100 mg tramadol sustained release (group 1, n = 38) or placebo (group 2, n = 38) every 12 h for 12 weeks. Clinical evaluation was performed at baseline and every 2 weeks during treatment. All patients underwent urodynamics and ice water test at baseline and 12-week treatment. Main outcome measures were number of voids per 24 h, urine volume per void and episodes of urge incontinence per 24 h on a frequency volume chart and detailed recording of adverse effect. ResultsAfter 12 weeks of treatment mean number of voids per 24 h ± SD decreased from 9.3 ± 3.2 to 5.1 ± 2.1 ( P < 0.001 vs. placebo) [95% confidence interval (CI) − 5.1-− 0.4]. At that time mean urine volume per void increased from 158 ± 32 to 198 ± 76 ml ( P < 0.001 vs. placebo) (95% CI 8-22), while mean number of incontinence episodes per 24 h decreased from 3.2 ± 3.3 to 1.6 ± 2.8 ( P < 0.001 vs. placebo) (95% CI − 2-0.3). Tramadol induced significant improvements in urodynamic parameters. More adverse effects were associated with tramadol treatment than with placebo ( P < 0.05). The main adverse event with tramadol was nausea. ConclusionsIn patients with non-neurogenic IDO tramadol provided beneficial clinical and urodynamic results. Further studies are required to draw final conclusions on the efficacy of this drug in IDO.

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“…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.…”

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confidence: 99%

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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Randomized, Double-Blind, Multicenter Trial on Treatment of Frequency, Urgency and Incontinence Related to Detrusor Hyperactivity: Oxybutynin versus Propantheline versus Placebo

Cited by 258 publications

References 9 publications

The use of botulinum toxin type A in the treatment of HTLV-1-associated overactive bladder refractory to conventional therapy

The use of botulinum toxin type A in the treatment of HTLV-1-associated overactive bladder refractory to conventional therapy

Retracted: Safety and efficacy of tramadol in the treatment of idiopathic detrusor overactivity: a double‐blind, placebo‐controlled, randomized study

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

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