OBJECTIVE: To investigate whether a structured withdrawal program from a sublingual formulation of fast-melting oral desmopressin lyophilisate (MELT) is superior to a sudden withdrawal from this formulation in the treatment of monosymptomatic nocturnal enuresis. MATERIALS AND METHODS: One hundred and three children presented to our pediatric nephrology outpatient clinic for bedwetting. Eighty-one children, aged between 5½ and 14 years (mean age 8.64 years), were treated with MELT at a dosage of 120 mcg a day. Responders were randomized to been withdrawn from therapy, after 3 months, abruptly or in a structured withdrawal program (60 mcg/day for 15 days and then 60 mcg every second evening for another 15 days). Main outcome parameter was relapse rate 1 month after the end of treatment. Relapse was defined as bedwetting occurring more than 2 nights per month after the 1-month treatment-free period. RESULTS:Relapse rate at 1 month after the end of treatment was 47.83% in the group on a structured program versus 45.83% in the abrupt termination group (p = 0.89). CONCLUSION: Our study suggests that a structured withdrawal program from MELT therapy doesn't offer advantages compared to an abrupt termination in children with monosymptomatic nocturnal enuresis.
RCT Entities:
OBJECTIVE: To investigate whether a structured withdrawal program from a sublingual formulation of fast-melting oral desmopressin lyophilisate (MELT) is superior to a sudden withdrawal from this formulation in the treatment of monosymptomatic nocturnal enuresis. MATERIALS AND METHODS: One hundred and three children presented to our pediatric nephrologyoutpatient clinic for bedwetting. Eighty-one children, aged between 5½ and 14 years (mean age 8.64 years), were treated with MELT at a dosage of 120 mcg a day. Responders were randomized to been withdrawn from therapy, after 3 months, abruptly or in a structured withdrawal program (60 mcg/day for 15 days and then 60 mcg every second evening for another 15 days). Main outcome parameter was relapse rate 1 month after the end of treatment. Relapse was defined as bedwetting occurring more than 2 nights per month after the 1-month treatment-free period. RESULTS: Relapse rate at 1 month after the end of treatment was 47.83% in the group on a structured program versus 45.83% in the abrupt termination group (p = 0.89). CONCLUSION: Our study suggests that a structured withdrawal program from MELT therapy doesn't offer advantages compared to an abrupt termination in children with monosymptomatic nocturnal enuresis.
Authors: Pietro Ferrara; Maria Elisa Amodeo; Annamaria Sbordone; Francesca Ianniello; Alberto Verrotti; Tommaso Petitti; Antonio Ruggiero Journal: Turk J Urol Date: 2018-07