Urinary Tract Infections
Conditions
Keywords
urinary tract infections, postmenopause, lactobacillus, estriol
Brief summary
Recurrent urinary tract infections (UTI) are a problem for postmenopausal women. The aim of this trial is to evaluate the effectiveness of lactobacilli in combination with low dose estriol for preventing recurrent urinary tract infections in postmenopausal women.
Interventions
DRUGGynoflor E (low dose estriol with lactobacillus)
The medication, in the form of one vaginal tablet, is administered in the evenings for 18 days
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Postmenopausal woman * History of urinary tract infection * Agree to abstain from self-medication with antibiotics for UTI symptoms * Agree to abstain from the use of any other intra-vaginal product * Capable of providing informed consent
Exclusion criteria
* Ovarian cancer, cervical cancer, breast cancer * Estrogen treatment within last 2 years * Vaginal bleeding * Antibiotic therapy fewer than three days prior to randomization visit * Known congenital urologic or gynecologic abnormalities * Indwelling urinary catheter * Thromboembolic disease * Uncompensated liver disease * Immunosuppressive drug within 60 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of urinary tract infection | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| vaginal pH | 6 months |
| lactobacillus colonization | 6 months |
Countries
South Korea
Outcome results
None listed