Comparative evaluation of sulbutiamine and imipramine in the treatment of primary nocturnal enuresis: A randomized controlled clinical study.

BACKGROUND

Primary Monosymptomatic Nocturnal Enuresis (PMNE) remains a common and distressing condition in pediatric practice. Imipramine, a tricyclic antidepressant, is an established therapy but has limitations related to safety and relapse. Sulbutiamine, a lipophilic thiamine derivative with central neuromodulatory cholinergic and dopaminergic activity, may offer a novel therapeutic approach by modulating arousal and micturition control.

OBJECTIVE

To compare the efficacy and safety of sulbutiamine and imipramine in the management of PMNE in children.

METHODS

A total of 450 children aged 6-18 years with PMNE were prospectively randomized into three equal groups: Group A, imipramine alone (25 mg/day); Group B, sulbutiamine alone (100 mg/day); and Group C, combined imipramine plus sulbutiamine at the same doses. Patients were followed for six months. The primary outcomes were treatment response (complete, partial, or none) and relapse rate; secondary outcomes included duration to achieve dryness and adverse events.

RESULTS

Baseline characteristics did not differ significantly among groups. The mean duration to achieve successful therapy was shorter with sulbutiamine (3.2 ± 1.9 months) and combination therapy (3.3 ± 1.8 months) than with imipramine alone (3.8 ± 1.9 months; p = 0.017). After six months, complete response occurred in 60% of the combination group, 52.7% of the sulbutiamine group, and 37.3% of the imipramine group (p = 0.003). Relapse rates were markedly lower with sulbutiamine (28.7%) and combination therapy (24.8%) compared with imipramine (43.6%) (p = 0.01). Adverse effects were significantly less frequent with sulbutiamine (4.7%-6%) than with imipramine (12%-14%) (p = 0.017).

CONCLUSIONS

Sulbutiamine, either as monotherapy or combined with imipramine, produced faster and more sustained improvement in PMNE with fewer adverse effects and lower relapse rates than imipramine alone. These findings suggest that sulbutiamine may represent a safe and effective alternative or adjunct in the pharmacologic management of primary nocturnal enuresis.