OBJECTIVE: To compare the efficacy of long-term primary nocturnal enuresis (PNE) treatment using desmopressin versus enuresis alarm. MATERIALS AND METHODS: A 6-month randomized trial was performed with patients from 29 enuresis clinics: 251 patients ≥ 5 years in age with severe PNE (mean 5.5-5.6 wet nights/week) were randomized to desmopressin (0.2-0.4 mg daily) or alarm. Efficacy was assessed by percentage reduction in mean number of wet nights/week; patients achieving dryness, mean initial duration of sleep and compliance were evaluated. Efficacy analyses were performed using the intent-to-treat population (all patients) and excluding patients who withdrew; 12-month follow-up data were collected. RESULTS: Data could not be evaluated for the 32% of alarm patients and 7% of desmopressin patients who withdrew early. In intent-to-treat analyses, a similar proportion of patients across groups showed a ≥ 50% reduction in wet nights/week (desmopressin: 37.5%, alarm: 32.2%) and achieved dryness (desmopressin: 32%, alarm: 37%). Compliance was higher with desmopressin: 95-98% of patients took >75% of tablets; 50-78% used alarm >75% of nights. Initial sleep duration was 1.02 h longer at the end of treatment with desmopressin (95% CI: 0.045, 1.99). CONCLUSION:Desmopressin and alarm demonstrated comparable efficacy in the treatment of PNE. Withdrawal from the alarm group was high, indicating the importance of considering family motivation before selecting treatment, for optimal outcome.
RCT Entities:
OBJECTIVE: To compare the efficacy of long-term primary nocturnal enuresis (PNE) treatment using desmopressin versus enuresis alarm. MATERIALS AND METHODS: A 6-month randomized trial was performed with patients from 29 enuresis clinics: 251 patients ≥ 5 years in age with severe PNE (mean 5.5-5.6 wet nights/week) were randomized to desmopressin (0.2-0.4 mg daily) or alarm. Efficacy was assessed by percentage reduction in mean number of wet nights/week; patients achieving dryness, mean initial duration of sleep and compliance were evaluated. Efficacy analyses were performed using the intent-to-treat population (all patients) and excluding patients who withdrew; 12-month follow-up data were collected. RESULTS: Data could not be evaluated for the 32% of alarm patients and 7% of desmopressin patients who withdrew early. In intent-to-treat analyses, a similar proportion of patients across groups showed a ≥ 50% reduction in wet nights/week (desmopressin: 37.5%, alarm: 32.2%) and achieved dryness (desmopressin: 32%, alarm: 37%). Compliance was higher with desmopressin: 95-98% of patients took >75% of tablets; 50-78% used alarm >75% of nights. Initial sleep duration was 1.02 h longer at the end of treatment with desmopressin (95% CI: 0.045, 1.99). CONCLUSION: Desmopressin and alarm demonstrated comparable efficacy in the treatment of PNE. Withdrawal from the alarm group was high, indicating the importance of considering family motivation before selecting treatment, for optimal outcome.
Authors: Noreen Caswell; Kaya Kuru; Darren Ansell; Martin J Jones; Benjamin Jon Watkinson; Peter Leather; Andrew Lancaster; Paula Sugden; Eleanor Briggs; Carl Davies; Chooi Oh; Kina Bennett; Christian DeGoede Journal: Pharmaceut Med Date: 2020-02
Authors: José Murillo Bastos; Atila Victal Rondon; George Rafael Martins de Lima; Miguel Zerati; Edison Daniel Schneider-Monteiro; Carlos Augusto F Molina; Adriano de Almeida Calado; Ubirajara Barroso Journal: Int Braz J Urol Date: 2019 Sep-Oct Impact factor: 3.050