Fikret Fatih Önol1, Rasim Guzel2, Ahmet Tahra2, Cevdet Kaya2, Ugur Boylu2. 1. Urology Clinic, Ümraniye Training and Research Hospital, Istanbul, Turkey; Urology Clinic, Haydarpasa Training and Research Hospital (CK), Istanbul, Turkey. Electronic address: ffonol@yahoo.com. 2. Urology Clinic, Ümraniye Training and Research Hospital, Istanbul, Turkey; Urology Clinic, Haydarpasa Training and Research Hospital (CK), Istanbul, Turkey.
Abstract
PURPOSE: We compared the long-term success of desmopressin sublingual lyophilisate formulation and enuretic alarm therapy in children with primary monosymptomatic nocturnal enuresis, and determined predictive factors for treatment success. MATERIALS AND METHODS: A total of 142 children with primary monosymptomatic nocturnal enuresis were randomized to receive treatment consisting of desmopressin or enuretic alarm for 6 months. Treatment compliance and response were reviewed monthly in each patient using a 30-day bed-wetting diary. Outcomes were assessed according to International Children's Continence Society criteria, and success rates at 6 and 12 months were compared for desmopressin and enuretic alarm. Additional intention to treat analyses were performed, considering cases with missing data as failures. Possible demographic factors predicting success were investigated by logistic regression analysis. RESULTS: Overall 4 children (5.2%) in the desmopressin group and 20 (30.7%) in the enuretic alarm group withdrew after randomization. Based on patients who completed 6 months of treatment, success (more than 90% reduction in wet nights per month) was achieved in 76.8% and 61.8% of children in the desmopressin and enuretic alarm groups, respectively. At 12 months 77.8% of those receiving desmopressin and 75% of those treated with enuretic alarm had success. However, long-term success rate was significantly higher with desmopressin (68.8% vs 46.2%) if intention to treat population was considered. Multivariate analysis revealed treatment group, severity of enuresis and monthly income as independent predictors of cure at 6 months. CONCLUSIONS: In compliant patients desmopressin lyophilisate and enuretic alarm provided equivalent success at the end of treatment and after extended followup. Alarm therapy had a high rate of early withdrawal from therapy and consequently lower rates of success on intention to treat analyses. Severe enuresis (more than 5 wet nights weekly) is an important predictive factor for cure after first-line treatment.
RCT Entities:
PURPOSE: We compared the long-term success of desmopressin sublingual lyophilisate formulation and enuretic alarm therapy in children with primary monosymptomatic nocturnal enuresis, and determined predictive factors for treatment success. MATERIALS AND METHODS: A total of 142 children with primary monosymptomatic nocturnal enuresis were randomized to receive treatment consisting of desmopressin or enuretic alarm for 6 months. Treatment compliance and response were reviewed monthly in each patient using a 30-day bed-wetting diary. Outcomes were assessed according to International Children's Continence Society criteria, and success rates at 6 and 12 months were compared for desmopressin and enuretic alarm. Additional intention to treat analyses were performed, considering cases with missing data as failures. Possible demographic factors predicting success were investigated by logistic regression analysis. RESULTS: Overall 4 children (5.2%) in the desmopressin group and 20 (30.7%) in the enuretic alarm group withdrew after randomization. Based on patients who completed 6 months of treatment, success (more than 90% reduction in wet nights per month) was achieved in 76.8% and 61.8% of children in the desmopressin and enuretic alarm groups, respectively. At 12 months 77.8% of those receiving desmopressin and 75% of those treated with enuretic alarm had success. However, long-term success rate was significantly higher with desmopressin (68.8% vs 46.2%) if intention to treat population was considered. Multivariate analysis revealed treatment group, severity of enuresis and monthly income as independent predictors of cure at 6 months. CONCLUSIONS: In compliant patients desmopressin lyophilisate and enuretic alarm provided equivalent success at the end of treatment and after extended followup. Alarm therapy had a high rate of early withdrawal from therapy and consequently lower rates of success on intention to treat analyses. Severe enuresis (more than 5 wet nights weekly) is an important predictive factor for cure after first-line treatment.