Safety and efficacy of tramadol in the treatment of idiopathic detrusor overactivity: a double-blind, placebo-controlled, randomized study.
OBJECTIVE
To evaluate the efficacy and safety of tramadol in patients with idiopathic detrusor overactivity (IDO).


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
Safarinejad
M R
MR
Urology Nephrology Research Centre, Shaheed Beheshti University of Medical Sciences, Tehran, Iran. sofarinejad@unrc.it
Hosseini
S Y
SY
D000328:Adult; D000701:Analgesics, Opioid / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009119:Muscle Contraction / Q000187:drug effects / Q000502:physiology; D009122:Muscle Hypertonia / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D009325:Nausea / Q000139:chemically induced; D014147:Tramadol / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D001743:Urinary Bladder / Q000187:drug effects / Q000503:physiopathology; D014549:Urinary Incontinence / Q000188:drug therapy / Q000209:etiology; D014554:Urination / Q000187:drug effects; D014563:Urodynamics / Q000187:drug effects
D000701:Analgesics, Opioid; D014147:Tramadol