Effect of vaginal estriol 0.03 mg with Lactobacillus acidophilus on incidence of bacterial vaginosis in patient using pessary for treatment of pelvic organ prolapse
Not Applicable
- Conditions
- Postmenopausal women who diagnosed as pelvic organ prolapse and chosing vaginal pessary for treatment optionpelvic organ prolapse,pessary,vaginal estrogen,gynoflor
- Registration Number
- TCTR20180329001
- Lead Sponsor
- Ratchadapiseksompotch Fund
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- Female
- Target Recruitment
- 80
Inclusion Criteria
Postmenopausal women
Symptomatic pelvic organ prolapse
Choose vaginal pessary as choice of treatment
Not using exogenous estrogen
Exclusion Criteria
Hypersensitivity to the anti-infective agent or test preparation
Vaginal bleeding of unknown origin
Estrogen-dependent neoplastic disease
Breast cancer
Immunosuppression and clinically manifest sexually transmitted diseases
History of bacterial vaginosis, trichomoniasis or vulvovaginal candidiasis before enrollment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The incidence of bacterial vaginosis 3 months Amsel’s criteria
- Secondary Outcome Measures
Name Time Method The pessary-related complications 3 months Normal flora index and Questionnaire (ICIQ-VS) and Visual analog scale