Comparison of vaginal moisturizers with ultra-low dose estriol&Lactobacillus acidophilus vaginal tablets in pelvic organ prolapse women who were treated with vaginal pessary: a randomized controlled trial

Phase 4

Recruiting

• Conditions: pelvic organ prolapsevaginal estrogenvaginal moisturizerpessary; pelvic organ prolapse; vaginal estrogen; vaginal moisturizer; pessary

• Registration Number: TCTR20160621001
• Lead Sponsor: Faculty of Medicine Ramathibodi Hospital, Mahidol Universityv

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-21
• Study Completion: 2017-05-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

- Patient is able to take care, insert, and remove pessary by herself

- Did not use vaginal estrogen or vaginal mositurizers within 3 months

- Informed consent

Exclusion Criteria

- Using HRT

- Had contraindication for estrogen

- Undiagnosed abnormal vaginal bleeding

- Taking corticosteroid, or immunosuppresants

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
satisfaction of ultra-low dose estriol&Lactobacillus vaginal tablets and vaginal moisturizer in pess before, at 4 and 6 months after intervention likert scale

Secondary Outcome Measures

Name	Time	Method
subjective outcome before, at 4 and 6 months after intervention symptoms,objective outcome before, at 4 and 6 months after intervention pelvic exam, vaginal discharge, bacterial vaginosis,adverse events before, at 4 and 6 months after intervention death, cardiovascular events, cerebrovascular event, breast cancer