Retracted: Safety and efficacy of tramadol in the treatment of idiopathic detrusor overactivity: a double-blind, placebo-controlled, randomized study
Article first published online: 14 FEB 2006
British Journal of Clinical Pharmacology
Volume 61, Issue 4, pages 456–463, April 2006
How to Cite
Safarinejad, M. R. and Hosseini, S. Y. (2006), Retracted: Safety and efficacy of tramadol in the treatment of idiopathic detrusor overactivity: a double-blind, placebo-controlled, randomized study. British Journal of Clinical Pharmacology, 61: 456–463. doi: 10.1111/j.1365-2125.2006.02597.x
- Issue published online: 14 FEB 2006
- Article first published online: 14 FEB 2006
- Received 26 July 2005 Accepted 3 November 2005
- detrusor overactivity;
- urinary incontinence
To evaluate the efficacy and safety of tramadol in patients with idiopathic detrusor overactivity (IDO).
A 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.
After 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.
In 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.