[A randomized controlled clinical trial for treatment of children with primary nocturnal enuresis].

Objective: Applying three treatment methods for enuresis in children with primary nocturnal enuresis (PNE) in a randomized controlled clinical trial (RCT) to compare the curative effects and characteristics of the three methods.
Methods: If the parents and children consented to accept the treatment for 4 months and to keep on follow-up, the children diagnosed as primary nocturnal enuresis in the department of developmental and behavioral pediatrics in Shanghai Children's Medical Center from April 2003 to August 2004 were randomized into three groups: 52 children were in physio-psychological treatment group and were treated by utilizing the conditioning training role of alarm and other psychological and behavioral training programs; 46 children were in drug treatment group and were treated by taking DDAVP tablets orally; 40 children were in combined treatment group who were treated by applying the former two methods simultaneously. If the parents and children did not accept treatment, they were enrolled into the control group and were followed-up. Then, the curative effects of the four groups were compared statistically when the 4-month treatment was over and compared again 3 months later.
Results: Applying the physio-psychological treatment for 4 months, the short-term cure rate of children with enuresis was 75.0%. Three months after the end of the treatment, the long-term cure rate was 71.2%. As for drug treatment group, the short-term cure rate of children with enuresis was 47.8%, the long-term cure rate was 28.3%; As for combined treatment group, the short-term cure rate of children with enuresis was 85.0%, the long-term cure rate was 80.0%. The short-term and long-term curative effects of physio-psychological treatment group and combined treatment group were better than that of drug treatment group (P < 0.01). However, the short-term and long-term curative effects were not significantly different between physio-psychological treatment and combined treatment group (P > 0.05). Physio-psychological treatment exerts effects slowly, but showed sustained curative effects. While Drug treatment exerts effects rapidly, but the relapse rate was very high after discontinuation of the medication.
Conclusions: Physio-psychological treatment and drug treatment are currently generally recognized the best ways to treat enuresis, both of them are suitable for Chinese enuresis children, both of them showed good curative effects. Physio-psychological treatment develops children's ability to control nocturnal micturition, its curative effects were better than that of the drug treatment whilst its relapse rate is lower as compared to drug treatment. So, physio-psychological treatment is more suitable for widespread use to treat PNE in China.