Overall complications affected by the different intervals of vaginal pessary removal in the patients with pelvic organ prolapse: A randomized controlled trial.
- Conditions
- symptomatic pelvic organ prolapse patientspessarypessary removal intervalpelvic organ prolapsecomplication
- Registration Number
- TCTR20200609002
- Lead Sponsor
- Faculty of Medicine, Prince of Songkla University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 104
1.Female patients age over 18 years old
2.Diagnosed with symptomatic pelvic organ prolapse (POP) stage II or more classified by POP-Q assessment tool who has successful pessary fitting
3.The patient who has bacterial vaginosis or vaginal epithelial abnormalities is treated using standard treatment until she completely recovers and has free of antibiotics and hormonal medications before participates the trial.
4.The patients who has discontinued their pessaries for at least 2 weeks and re-start using pessary again
1.Unsuccessful ring pessary using defines as
1.1Feeling discomfort even if fit the appropriate size
1.2Patients withdraw the pessary
1.3The pessary fall out and is unable to be refitted
1.4All of above situations occur before randomization
2. Unable to follow-up
3.History of silicone allergy
4.Active pelvic infection
5.Currently participate other trials
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method overall complications affected by different intervals of vaginal pessary removal in patients with pe at 1 month, 3 months and 6 months 1. The symptoms from questionnaire 2. BV infection 3. epithelial abnnormality
- Secondary Outcome Measures
Name Time Method prolapse-related quality of life at 3 months and 6 months P-QoL questionnaire,patient’s satisfaction at 3 months and 6 months VAS score