A double-blind placebo-controlled trial on the effects of 25 mg estradiol implants on the urge syndrome in postmenopausal women

Abstract

The aim of this prospective double-blind randomized placebo-controlled trial was to determine the effect of systemic estrogen on the 'urge syndrome' in postmenopausal women. The trial took place in a tertiary referral urogynecology unit. Postmenopausal women with the 'urge syndrome' were randomly allocated to receive a 25 mg 17beta-estradiol implant or placebo implant. Serum estradiol levels and endometrial thickness were measured on entry to the trial and at 1, 3 and 6 months. The following outcome measures were employed: videocystourethrography, frequency volume chart, visual analogue score of symptoms, and King's Health Care Quality of life Questionnaire. Forty women were included. Subjectively there was a significant improvement in urgency in both groups and urge incontinence in the estradiol group, but no significant differences between the groups. Objectively no significant differences were demonstrated between the groups. Nine women in the estradiol group had vaginal bleeding, and 5 had a hysterectomy during or after the study. Despite using numerous outcome measures to examine its effect, 25 mg estradiol implants did not produce a greater improvement in the 'urge syndrome' than placebo and had a high complication rate.