Objectives. To evaluate the acute urodynamic effects of the neuropeptide nociceptin/orphanin FQ (N/OFQ) in a selected group of patients with neurogenic detrusor overactivity incontinence in a randomized, placebo-controlled, double-blind study. Methods. The study involved 14 patients who presented with neurogenic detrusor overactivity due to spinal cord injury. They were randomized to receive intravesical infusion of 1 μM N/OFQ or the same dose of [desPhe1]N/OFQ (the placebo). The urodynamic parameters were the bladder capacity, volume threshold for the appearance of detrusor overactivity, and the maximal bladder pressure. The study was performed on a double-blind basis: neither the patients nor the doctors who performed the instillation could distinguish the solution containing N/OFQ from that containing [desPhe1]N/OFQ. Data are expressed as the mean ± SD of seven determinations. Data were statistically analyzed using the Student t test for paired or unpaired data and P 2O to 66 ± 12 cm H2O; however, this difference was not statistically significant. The intravesical infusion of the solution containing 1 μM [desPhe1]N/OFQ did not produce any statistically significant modification of the urodynamic parameters. Conclusions. The results of this study confirm and extend previous results showing that N/OFQ, but not the placebo, elicits a robust acute inhibitory effect on the micturition reflex in patients with a neurogenic bladder. These findings apply nociceptin orphan peptide receptor agonists as potential novel drugs for the treatment of neurogenic urinary incontinence.
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