Effects of oral estrogen and progestin on the lower urinary tract among female nursing home residents

OBJECTIVE: To examine the effects of oral estrogen/ progestin on incontinence and related lower urinary tract conditions among female nursing home (NH) residents. DESIGN: Randomized placebo-controlled trial. SETTING: Five NHs. PARTICIPANTS: Thirty-two incontinent female residents of average age 88. MEASUREMENTS: Subjects were randomized to receive either oral estrogen (0.625 mg) combined with progesterone (2.5 mg) or placebo, daily for 6 months. Measures of incontinence severity, the clinical appearance of the vagina, vaginal and urethral cytology, and urine and vaginal cultures were made at baseline, 3 months, and 6 months. In addition to active drug or placebo, all subjects received regular toileting assistance (prompted voiding) by trained research aides during 3-day data-collection periods to compensate for mobility and cognitive impairments. RESULTS: At 3 and 6 months there were no significant differences between the groups in the severity of incontinence, the prevalence of bacteriuria, or the results of vaginal cultures. Several clinical findings associated with atrophic vaginitis improved more in the active than the placebo group and vaginal pH and vaginal and urethral cytology exhibited a partial estrogenic effect. CONCLUSIONS: Our results must be interpreted with caution because of the size and the select nature of our subject sample. Up to 6 months of oral estrogen had only a partial estrogenic effect on vaginal and urethral epithelium and no clinical effects in this patient population. We believe that future studies of estrogen for urinary incontinence in frail NH residents should utilize a topical preparation and consider targeting urinary tract infection as an additional outcome measure.