Randomized comparison of tolterodine with vaginal estrogen cream versus tolterodine alone for the treatment of postmenopausal women with overactive bladder syndrome

Abstract

To investigate whether vaginal estrogen cream combined with tolterodine is more effective than tolterodine alone in the treatment of postmenopausal women with overactive bladder (OAB). This is an unblinded study without placebo. A preliminary study consisted of tolterodine 2 mg twice per day for 3 months had been conducted for 25 postmenopausal women with OAB. Over a period of 11 months, 80 postmenopausal women with OAB underwent a prospective randomized trial. These patients were equally randomized into two groups. The interventions for the 12-week treatment period included 2 mg tolterodine twice per day for the group A and 2 mg tolterodine twice per day/vaginal conjugated equine estrogen 0.625 mg twice a week for the group B. Identical pre- and post-treatment assessments included bladder diary, Urogenital Distress Inventory-6 (UDI-6), and Incontinence Impact Questionnaire-7 (IIQ-7). All 80 women (65.2 years, range 58-73) completed this study. The between groups comparison showed that the group B had significant improvements in mean daytime frequency and voided volume after treatment (14.8-5.8 vs. 14.1-6.4, P = 0.001 and 115.8-141.9 vs. 108.5-134.5, P = 0.007, respectively). Additionally, a comparison of the final total scores of UDI-6 and IIQ-7 between the two groups revealed that the group B had a statistically significant improvement in quality of life than that in the group A (8.6-6.9 vs. 9.5-7.2, P < 0.001 and 9.4-6.1 vs. 10.2-6.5, P < 0.001, respectively). Changes in the other symptoms, including nocturia, urgency and urge incontinence, were not statistically significant but actually achieved improved in both groups. A combination of vaginal estrogen cream and tolterodine is a potential therapy for postmenopausal women with OAB.