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

Abstract

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.

Prospective pharmacologic therapies for the overactive bladder

“…Singh et al [2008] gave tramadol epidurally and found the drug to increase bladder capacity and compliance, and to delay filling sensations without ill effects on voiding. Safarinejad and Hosseini [2006] evaluated in a double-blind placebo-controlled randomized study, the efficacy and safety of tramadol in patients with idiopathic DO. A total of 76 patients 18 years of age or older were given 100 mg tramadol sustained release every 12 h for 12 weeks.…”

LUTS treatment: Future treatment options

“…207 Tramadol also inhibited DO induced by apomorphine in rats-a model of bladder dysfunction in Parkinson's disease. 208 In a double-blind, placebo-controlled, randomized study, Safarinejad and Hosseini 209 evaluated the efficacy and safety of tramadol in patients with idiopathic DO. A total of 76 patients !18 years old were given 100 mg tramadol sustained release every 12 hr for 12 weeks.…”

Diagnosis and Treatment of Overactive Bladder

“…Substance P has a specific receptor (NK1) that is expressed in the dorsal horn of the spinal cord and may play an important role in detrusor overactivity. (Grond & Sablotzki, 2004;Safarinejad & Hosseini, 2006) Aprepitant, an NK1 receptor antagonist, has been shown to significantly improve symptoms of OAB in postmenopausal women with a history of urgency incontinence or mixed incontinence in a small pilot. (Green et al, 2006) Aprepitant significantly decreased the average daily number of micturitions (−1.3 ± 1.9) compared with placebo (−0.4 ± 1.7).…”

“…(Andersson & Pehrson, 2003) Tramadol is an analgesic that is a weak μ-receptor agonist; however, it is metabolized to several different compounds, which inhibit serotonin (5-HT) and noradrenaline reuptake. (Grond & Sablotzki, 2004;Safarinejad & Hosseini, 2006) Both μ-receptor agonist and amine reuptake inhibition are useful in the treatment of OAB. In a double-blind, placebo-controlled, randomized study, 76 patients were given 100 mg tramadol sustained release every 12 hours for 12 weeks.…”