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.
Urology Nephrology Research Centre, Shaheed Beheshti University of Medical Sciences, Tehran, Iran. sofarinejad@unrc.it
M R
MR
Safarinejad
S Y
SY
Hosseini
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