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Low-Dose Transdermal Estrogen Has Minimal Effect on Incontinence: Presented at AUGS

By Paula Moyer

SAN DIEGO, CA -- August 6, 2004 -- Low-dose transdermal estrogen does not significantly exacerbate urinary incontinence, according to findings presented here July 31st at the 2004 American Urogynecologic Society/Society of Gynecologic Surgeons Joint Scientific Meeting.

"Our findings showed that low-dose estrogen administered by the transdermal route without a progestin has limited or no clinically significant effect on urinary incontinence," said principal investigator L. Elaine Waetjen, MD, assistant professor of obstetrics-gynecology at the University of California in Davis, California. She reported for the Ultra Low-dose Transdermal estRogen Assessment (ULTRA) Study.

Previous research had shown that standard-dose oral estrogen combined with progestin worsens urge incontinence in postmenopausal women. Dr. Waetjen and her coinvestigators undertook this study to assess the effect of 2 years of treatment with unopposed ultra low-dose transdermal estradiol on urge incontinence in this population.

The ULTRA study, a multicenter, double-blind, randomized, placebo-controlled trial, included 417 postmenopausal women who were taking transdermal estradiol, 0.014 mg per day, for the prevention of osteoporosis.

The investigators assessed urinary incontinence episode frequency by type using a validated, self-reported questionnaire at baseline and at several points during the 2-year study. An intention-to-treat ordinal model was used to analyze change in episode frequency and classify women as improved, no significant change, or worsened. Improvement was defined as a decrease in incontinence episodes of 2 or more per day while worsening consisted of an increase of 2 or more episodes per day.

The women were an average of 67 ± 5 years old and, at baseline, 42.6% were incontinent. Of these, 39.3% had stress incontinence; 38.7% had urge incontinence, and 22.0% had mixed incontinence. The distribution was similar within the 2 groups, Dr. Waetjen said.

After 2 years of estradiol treatment, the odds ratio for worsening urinary incontinence, among those who were already incontinent, was 1.3 (95% CI 0.9-2.0) compared with placebo. The odds ratio of worsening stress incontinence was 1.6 (95% CI 0.9-2.8); for urge incontinence, the risk was 1.0 (95% CI 0.6-1.7). For women who were continent at baseline, the odds ratio for developing incontinence on hormone treatment was 1.21 (95% CI 0.6-2.3).

Therefore, during 2 years of treatment, the investigators report that they observed weak evidence for worsening incontinence with the adverse effect on stress incontinence decreasing over time and no effect on urge incontinence.


[Presentation title: The Effect of Ultra Low-dose Transdermal Estradiol on Urinary Incontinence (UI) in Postmenopausal Women. Abstract 45]

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