What ' s known on the subject? and What does the study add?The desmopressin analogue to antidiuretic vasopressin is an evidence-based therapy but confl icting results are provided regarding the initial dose of oral desmopressin. Previous studies report the use of a combined therapy with desmopressin and oxybutynin to treat desmopressin-resistant monosymptomatic nocturnal enuresis. These studies show promising results, but they suffer from lack of randomization and lack of a placebo-controlled patient group and are of small sample size. In addition to this, no predictive factors of response to the combined therapy have been considered. This study showed no signifi cant difference between either a 120 μ g or a 240 μ g desmopressin initial dose with regard to degree of response. The study is the fi rst randomized, double-blinded, placebo-controlled trial showing the effi cacy of combination therapy with desmopressin plus oxybutynin for monosymptomatic nocturnal enuresis. Furthermore, bladder volume and wall thickness index, nocturnal polyuria and voiding latency were assessed as predictive factors of response to the therapy.
OBJECTIVES• To assess the effi cacy of desmopressin plus oxybutynin and compare two starting dosages of desmopressin (120 and 240 μ g) in a randomized, double-blinded, placebocontrolled trial for children with monosymptomatic nocturnal enuresis (MNE) resistant to desmopressin.• The predictive factors of children with MNE responsive to desmopressin and combination therapy were also evaluated.
PATIENTS AND METHODS• Our sample included 206 patients aged between 6 and 13 (mean age 10.6 ± 2.9 years), 117 males. All patients were required to have MNE.• The patients were randomly divided into two groups: the fi rst group was given oral melt 120 μ g and the second group 240 μ g, for 2 weeks.• All patients who had experienced failure of treatment with sublingually administered desmopressin alone were given either desmopressin plus 5 mg oxybutynin or desmopressin plus placebo in a randomized, double-blinded trial for 4 weeks.• As predictive factors, bladder volume and wall thickness index, nocturnal polyuria and voiding latency were considered.
RESULTS• There was no signifi cant difference between the 120 μ g and 240 μ g patients in terms of response.• The oxybutynin group showed a higher rate of full and partial responses (45% success) compared with the placebo group (17% success), P < 0.01.• The responders to combined oxybutynin and desmopressin had signifi cantly lower bladder volume and wall thickness index than the other patients.
CONCLUSIONS• Our fi ndings highlight that anticholinergic agents may play an important role for a subset of children with enuresis who have a restricted bladder capacity and thickened bladder wall.• Ultrasonography-measured bladder variables can provide useful predictive clues for MNE.• Predictive factors can help to differentiate treatment subtypes and guide clinical management in primary nocturnal enuresis.
KEYWORDS desmopressin , nocturnal enuresis , oxybutyninStudy Typ...
US-measured bladder wall was thickened. After 6 months of antimuscarinic treatment, we re-assessed the children with US and UD; the relation between UD and US measurements was confirmed. After analysing these data, we considered the use of a new diagnostic assessment for patients with NMPNE. In children with a significant US measurement, i.e. a bladder wall with a thickness of > 3 mm (full bladder) and > 5 mm (empty bladder), the diagnostic assessment was concluded and therapy was started. We restricted the UD examination exclusively to those patients who either had severe intractable symptoms or did not respond to treatment. This new management was applied to 453 patients with NMPNE. After the first 6 months of therapy all the patients were assessed with a new US study.
RESULTSIn all, 343 patients (75.7%) were fullresponders, with a normal bladder wall thickness; 82 (18.1%) were partial responders but with no normalization of bladder wall thickness; only 28 (6.2%) were classified as nonresponders with a persistent thickened bladder wall.
These findings enabled a close connection between nocturia in adulthood and enuresis in childhood to be hypothesized. Furthermore, this analysis provided evidence of the link between suffering from nocturia, and previously from enuresis, and having children affected by enuresis.
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