MENUI - Cohort of children with isolated nocturnal enuresis : a study of the safety of Minirinmelt in actual prescription 
Responsable(s) :
Niez Philippe, Laboratoire FERRING S.A.S
Date de modification : 01/01/2020 | Version : 1 | ID : 185
| Général | |
| Identification | |
| Nom détaillé | Cohort of children with isolated nocturnal enuresis : a study of the safety of Minirinmelt in actual prescription |
| Sigle ou acronyme | MENUI |
| Numéro d'enregistrement (ID-RCB ou EUDRACT, CNIL, CPP, etc.) | CCTIRS (04/06/07), CNIL n°907222 (30/10/07) |
| Thématiques générales | |
| Domaine médical |
Endocrinology and metabolism Urology, andrology and nephrology |
| Autres, précisions | Isolated nocturnal enuresis |
| Mots-clés | desmopressin, Minirin® tablet, Minirinmelt® |
| Responsable(s) scientifique(s) | |
| Nom du responsable | Niez |
| Prénom | Philippe |
| Adresse | 7 rue Jean Baptiste Clément, 94250 GENTILLY |
| Téléphone | + 33 (0)1 49 08 91 23 |
| Laboratoire | Laboratoire FERRING S.A.S |
| Collaborations | |
| Financements | |
| Financements |
Private |
| Précisions | FERRING S.A.S |
| Gouvernance de la base de données | |
| Organisation(s) responsable(s) ou promoteur | Laboratoire FERRING SAS |
| Statut de l’organisation |
Secteur Privé |
| Contact(s) supplémentaire(s) | |
| Caractéristiques | |
| Type de base de données | |
| Type de base de données |
Study databases |
| Base de données issues d'enquêtes, précisions |
Longitudinal study (except cohorts) |
| Origine du recrutement des participants |
A selection of health institutions and services |
| Critère de sélection des participants |
Medication(s) taken |
| Le recrutement dans la base de données s'effectue dans le cadre d'une étude interventionnelle |
No |
| Informations complémentaires concernant la constitution de l'échantillon | Using the survey base, a preliminary list of 830 doctors (415 pediatricians and 415 general practitioners) will be compiled by random drawing. A letter presenting the survey along with a detailed synopsis of the project and a response coupon will be sent to each doctor on this list. Interested doctors will return the response coupon. If the response rate is insufficient, contacting doctors who have not responded may be considered. If the number of positive responses is too high, a random drawing from the interested doctors will be conducted, complying with the defined proportion of general practitioners and pediatricians. If the number is insufficient, an additional list of doctors will be randomly selected from the survey base described hereinabove, still in compliance with the defined proportion. |
| Objectif de la base de données | |
| Objectif principal | Show that the two oral forms (tablet and lyophilisate) of desmopressin have a similar safety profile and in particular in terms of frequency of the symptoms of alarms of an intoxication via water, in actual prescription situations, i.e. at general practitioners. |
| Critères d'inclusion |
Criteria for inclusion: -patient having an isolated nocturnal enuresis, defined by the number of wet nights per week, -patient aged 6 to 18 years, -patient in which the family doctor has decided to prescribe a treatment via desmopressin, or Minirin® tablets or Minirinmelt® lyophilisate. Criteria for non-inclusion: -patient who has already received prior treatment via desmopressin regardless of its form, -patient who has a treatment in progress via desmopressin, -patient participating in a therapeutic study. |
| Type de population | |
| Age |
Childhood (6 to 13 years) Adolescence (13 to 18 years) |
| Population concernée |
Sick population |
| Sexe |
Male Woman |
| Champ géographique |
National |
| Détail du champ géographique | Metropolitan France |
| Collecte | |
| Dates | |
| Année du premier recueil | 2007 |
| Année du dernier recueil | 2010 |
| Taille de la base de données | |
| Taille de la base de données (en nombre d'individus) |
[500-1000[ individuals |
| Détail du nombre d'individus | 750 |
| Données | |
| Activité de la base |
Data collection completed |
| Type de données recueillies |
Clinical data Declarative data Biological data |
| Données cliniques, précisions |
Direct physical measures |
| Données déclaratives, précisions |
Paper self-questionnaire Face to face interview |
| Données biologiques, précisions | Natremia collected in the case of an undesirable event if this was requested by the doctor |
| Existence d’une biothèque |
No |
| Paramètres de santé étudiés |
Quality of life/health perception Others |
| Autres, précisions | Profile of the patients treated, description of the impact of isolated nocturnal enuresis in patients treated and their families, description of the methods for use of Minirin® tablets and Minirinmelt® lyophilisate |
| Modalités | |
| Mode de recueil des données | Data collected in a paper observation notebook by the doctor using the data from the patient's medical dossier and following the information collected during consultations of the child with his or her parents or legal guardian. Satisfaction of the parents and of the children as well as the information pertaining to the quality of life of the patients (supplemented by the children and by the parents) were collected during the consultations via the filling out of the self-questionnaires at inclusions and when the treatment was stopped for the study. |
| Suivi des participants |
Yes |
| Détail du suivi | Each patient was followed in the study for a maximum period of 9 months after inclusion. The rate of visits was that of the consultations as normally practiced by the doctors. Following the inclusion the patient was followed for a period referred to as the desmopressin posology adaptation period, until the effective or maximum posology has been reached. This was then followed by a treatment period for the retained posology (1st cure). If the patient benefitted from a 2nd cure of desmopressin, the information was collected by the doctor until the end of the treatment. At each consultation, the doctor checked if the patient had any undesirable events. If so, the doctor filled out the undesirable event collection form and then faxed it to the pharmacovigilance department of Ferring S.A.S. Each serious or non-serious undesirable event was follow-up until its end. |
| Appariement avec des sources administratives |
No |
| Valorisation et accès | |
| Valorisation et accès | |
| Accès | |
| Charte d'accès aux données (convention de mise à disposition, format de données et délais de mise à disposition) |
Methods for accessing the results: study report, submitted congress abstract, publication: manuscript currently being drafted. Methods for accessing the database are currently being defined. |
| Accès aux données agrégées |
Access on specific project only |
| Accès aux données individuelles |
Access on specific project only |
