Authors' objectives:

To assess the efficacy, safety and economic impact of alarm devices used to treat primary monosymptomatic nocturnal enuresis (PMNE) in children, and to assess their accessibility, compared with desmopressin therapy.

Authors' results and conclusions: Trials selected. We analysed: - 6 prospective controlled clinical trials. Internal validity was average for 2 trials and poor for the other 4. - 3 economic studies with a low level of internal validity. Only one was a comparative study. - 8 articles dealing with the psychosocial impact of PMNE and its treatment. Efficacy. - In the short term, desmopressin seems to be more effective than alarm devices, and the combination of an alarm device and desmopressin seems to be more effective than use of an alarm alone. - At the end of treatment, irrespective of duration, there was no difference in efficacy between alarm devices and desmopressin. - Some time after the end of treatment, which is clinically more relevant, the alarm device was more effective than desmopressin, but the benefit of a combination of alarm device and desmopressin has not been assessed. Predictive factors for results of alarm device treatment were not studied. Safety. There were no reports of the serious adverse events described elsewhere (21 cases of water intoxication have been described with desmopressin since 1992). Psychosocial impact of PMNE. Trial conclusions varied. Globally, children felt better when they received treatment, or at least were managed. This improvement seemed to be independent of type of treatment.

Authors' recommendations: Clinical trials. The following clinical trials are needed : - randomised controlled trials of different forms of treatment. These trials should be sufficiently powerful, be analysed by intention to treat with extended follow-up, use common and relevant judgement criteria, analyse adverse events and the acceptability of treatment and patient compliance. - studies of the psychosocial impact of PMNE in children and on parents' quality of life. They should use psychometric scales specific to PMNE translated into a number of languages and validated so that the results can be compared. Economic evaluation studies. Studies will be needed to provide a better assessment of medium- and long-term cost-efficacy ratios of the different forms of treatment, to be used for decision-making in the management of PMNE. Some manufacturers would like alarm devices to be included in the list of products and services that may be reimbursed; it might be possible to create a generic heading which would cover these devices.

Authors' methods: Review

Project Status: Completed

URL for project: http://www.has-sante.fr/

Year Published: 2003

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: France

Organisation Name: L'Agence Nationale d'Accreditation d'Evaluation en Santé

Contact Address: 2 avenue du Stade de France, 93218 Saint-Denis La Plaine Cedex, France. Tel: +33 01 55 93 71 88; Fax: +33 01 55 93 74 35;

Contact Name: sh.leerobin@has-sante.fr

Contact Email: sh.leerobin@has-sante.fr

Copyright: L'Agence Nationale d'Accreditation d'Evaluation en Sante (ANAES)