Objective: To assess the efficacy of cyclic postmenopausal hormone rep
lacement in treating urinary incontinence in hypoestrogenic women. Met
hods: Eighty-three hypoestrogenic women complaining of urinary inconti
nence were included. All patients were community-dwelling, age 45 year
s or older, with involuntary loss of urine occurring at least once a w
eek and urodynamic evidence of genuine stress incontinence and/or detr
usor instability. Evaluation consisted of a comprehensive clinical and
urodynamic research protocol. The hypoestrogenic entry criterion was
a plasma estradiol level of 30 pg/mL or less. Parabasal cells on vagin
al smears were also monitored. The primary outcome was the number of i
ncontinent episodes per week, as documented on a standardized urinary
diary. Secondary outcomes were the quantity of fluid loss, voluntary d
iurnal and nocturnal micturition frequency, generic and condition-spec
ific health-related quality of life measurements, and patient satisfac
tion. A randomized, placebo-controlled, double-blind design was used.
Subjects in the treatment group were given conjugated equine estrogens
(0.625 mg) and medroxyprogesterone (10 mg) cyclically for 3 months. C
ontrols received placebo tablets. Results: (All results are presented
as mean +/- standard deviation.) Subjects were 67 +/- 9 years old. The
menopause duration was 18 +/- 11 years. The duration of incontinence
was 9 +/- 9 years. Estradiol level at baseline was 9 +/- 9 pg/mL, and
the parabasal cell count was 42 +/- 44%. The number of incontinent epi
sodes at baseline was 13 +/- 10 for the treatment group and 16 +/- 4 f
or controls. No significant changes occurred in the number of incontin
ent episodes after treatment: 10 +/- 10 for the treatment group, and 1
3 +/- 14 for the controls (P = .7). Also, fluid loss was not changed:
176 +/- 106 g for the treatment group and 64 +/- 88 g for the control
group at baseline, and 101 +/- 150 and 51 +/- 69 g after treatment, re
spectively (P = .7). There were no significant differences for either
diurnal or nocturnal voluntary micturition, quality of life measures,
or patient's perception of improvement. Conclusion: Three-month cyclic
hormone replacement therapy did not affect either clinical or quality
of life variables of incontinent, hypoestrogenic women. Long-term eff
ects are unlikely to be substantially different. The use of estrogen s
upplementation as preventive or adjuvant therapy was not evaluated in
this study.