Daily Intravesical Instillation of 1 mg Nociceptin/Orphanin FQ for the Control of Neurogenic Detrusor Overactivity

A Multicenter, Placebo Controlled, Randomized Exploratory Study

Massimo Lazzeri, Girolamo Calò, Michele Spinelli, Silvia Malaguti, Remo Guerrini, Severo Salvadori, Patrizia Beneforti, Domenico Regoli, Damiano Turini

Research output: Contribution to journalArticle

27 Citations (Scopus)

Abstract

Purpose: We studied the feasibility, safety and efficacy of daily intravesical instillation of 1 mg of the endogenous peptide nociceptin/orphanin FQ in a selected group of patients who perform clean intermittent self-catheterization for neurogenic detrusor overactivity incontinence. Materials and Methods: A total of 18 patients with neurogenic detrusor overactivity incontinence and on clean intermittent self-catheterization were prospectively randomized to receive 1 mg nociceptin/orphanin FQ in 10 cc saline (9) or placebo (saline) solution (9) at the first morning catheterization for 10 days. All patients completed a voiding diary using a frequency/volume chart according to International Continence Society guidelines, and reported daily incontinence frequency. Mean changes in incontinence episode frequency and voiding diary mean bladder capacity from baseline throughout treatment were the primary outcome variables. Urodynamic parameters (cystomanometric bladder capacity, maximum bladder pressure) were also recorded at baseline and during the study. Results: The 2 groups were well balanced and all patients completed the study. The urodynamic parameters recorded during the study showed an increase in cystomanometric bladder capacity and a decrease in maximum bladder pressure compared to baseline only in patients assigned to the nociceptin/orphanin FQ group. Mean daily urine leakage episodes during nociceptin/orphanin FQ treatment were 0.94 vs a pretreatment baseline of 2.18 (p

Original languageEnglish
Pages (from-to)2098-2102
Number of pages5
JournalJournal of Urology
Volume176
Issue number5
DOIs
Publication statusPublished - Nov 2006

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Intravesical Administration
Urinary Bladder
Placebos
Intermittent Urethral Catheterization
Urodynamics
Pressure
Sodium Chloride
Catheterization
nociceptin
Urine
Guidelines
Safety
Peptides
Therapeutics

Keywords

  • afferent
  • bladder
  • neurogenic
  • neurons
  • nociceptin receptor
  • spinal cord injuries
  • urinary incontinence

ASJC Scopus subject areas

  • Urology

Cite this

Daily Intravesical Instillation of 1 mg Nociceptin/Orphanin FQ for the Control of Neurogenic Detrusor Overactivity : A Multicenter, Placebo Controlled, Randomized Exploratory Study. / Lazzeri, Massimo; Calò, Girolamo; Spinelli, Michele; Malaguti, Silvia; Guerrini, Remo; Salvadori, Severo; Beneforti, Patrizia; Regoli, Domenico; Turini, Damiano.

In: Journal of Urology, Vol. 176, No. 5, 11.2006, p. 2098-2102.

Research output: Contribution to journalArticle

Lazzeri, Massimo ; Calò, Girolamo ; Spinelli, Michele ; Malaguti, Silvia ; Guerrini, Remo ; Salvadori, Severo ; Beneforti, Patrizia ; Regoli, Domenico ; Turini, Damiano. / Daily Intravesical Instillation of 1 mg Nociceptin/Orphanin FQ for the Control of Neurogenic Detrusor Overactivity : A Multicenter, Placebo Controlled, Randomized Exploratory Study. In: Journal of Urology. 2006 ; Vol. 176, No. 5. pp. 2098-2102.
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