The aim of the present study was to prospectively evaluate the effect of aclatonium on dry mouth in patients with overactive bladder (OAB) after treatment with solifenacin.Methods:
A multicenter randomized double-blind controlled trial was conducted. The study subjects were men and women who had been diagnosed with OAB for ≥3 months and presented with a total Overactive Bladder Symptom Score (OABSS) ≥3. Eligible subjects were randomized to receive 5 mg solifenacin with placebo or 5 mg solifenacin with 150 mg aclatonium once daily for 8 weeks. Subjects rated dry mouth using a visual analog scale (VAS) and completed the OAB-questionnaire (OAB-q) short form (SF) and OABSS questionnaires at baseline and after 8 weeks treatment. Dry mouth was defined as a VAS score >30 points (range 0–100).Results:
Overall, 92 patients (49 and 43 in the placebo and aclatonium groups, respectively) completed the 8-week treatment. In patients who had dry mouth at baseline, no differences were detected in changes in the dry mouth VAS, OABSS, or OAB-q SF scores between the 2 groups. However, in patients who had no dry mouth at baseline, the change in dry mouth VAS score was significantly lower in the aclatonium- than placebo-treated group: the VAS score increased 20 points in the placebo group compared with 9 points in the aclatonium group (P = .03). However, there were no significant differences in changes in the OABSS and OAB-q SF scores between the 2 groups.Conclusions:
Aclatonium decreased dry mouth without disturbing treatment efficacy in patients who did not have dry mouth before treatment.