recurrent urinary tract infections in postmenopausal women recurrent urinary tract infections postmenopausal women with urinary tract infection postmenopausal women with recurrent urinary tract infections postmenopausal women
Conditions
Interventions
Vaginal estrogen - Femiest is a vaginal tablet containing 10 mcg of 17 Beta-estradiol
,Vaginal Lactobacillus: Infloran - containing L. acidophilus and Bifidobacterium bifidum
,Vaginal combination t
Vaginal estrogen: Femiest ,Vaginal Lactobacillus: Infloran,Vaginal combination therapy: Gynoflor
Sponsors
Thailand Science Research and Innovation (TSRI)
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Postmenopausal woman with a history of rUTIs opting for non-antibiotic prophylaxis. (Menopause is defined as 12 months or more since the last menstrual period or the minimum age of 55 years (if unknown duration from last menstrual period) or postmenopausal secondary to surgical menopause at any age, History of rUTIs defined as two or more episodes within six months or three or more episodes within 12 months, confirmed by positive standard urine culture. 2. Participants who have previously received systemic or topical hormonal replacement therapy must discontinue the therapy for six or more months before enrollment.
Exclusion criteria
Exclusion criteria: 1. Active UTI with positive standard urine culture and ongoing antibiotic treatment 2. Known congenital or acquired urologic or gynecologic abnormalities. 3. Known neuropathic or myogenic bladder 4. Intermittent catheterization/indwelling urethral catheter use. 5. History of pelvic radiation therapy. 6. Pelvic organ prolapses grade III-IV. 7. Morbid obesity (body mass index (BMI) more than35). 8. Immunocompromised state. 9. Known or suspected estrogen-dependent neoplasms or mammary, ovarian, cervical, or vaginal malignancies. 10. Clinically significant hepatic or kidney disease. 11. History of systemic hormonal replacement therapy or topical hormonal replacement therapy within the past 6 months. 12. Current use of probiotic products. 13. Current use of Herbal medicines. 14. Current participation in another UTI prophylaxis study. 15. Current use of intravaginal medication, products, or device. 16. Current use of spermicidal condoms 17. Unwillingness to use vaginal interventions 18. Participation in other UTI prophylaxis studies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| recurrent UTI episode 24 weeks episodes | — |
Secondary
| Measure | Time frame |
|---|---|
| Alpha diversity enrollment and 24 weeks observed operational taxonomic unit,Beta diversity enrollment and 24 weeks UniFrac phylogenetic distance between samples ,Vaginal pH enrollment and 24 weeks pH value,Lower urinary tract symptoms score from International Consultation on Incontinence Questionnaire-female lower urinary tract symptoms enrollment and 24 weeks the total score reported as a continuous value ,Adverse event enrollment and every 4 weeks until 24 weeks report ,Adherence enrollment and every 4 weeks until 24 weeks report | — |
Countries
Thailand
Contacts
Public ContactPea Pobpan
King Chulalongkorn Memorial hospital
Outcome results
None listed