Overall complications affected by the different intervals of vaginal pessary removal in the patients with pelvic organ prolapse: A randomized controlled trial.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

TCTR

Registry ID

TCTR20200609002

Enrollment

104

Registered

2020-06-09

Start date

2020-06-02

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

symptomatic pelvic organ prolapse patients pelvic organ prolapse pessary pessary removal interval complication

Interventions

the patients need to remove their pessaries themselves or by their caregivers at least once weekly.,the patients will have the pessary removal by a urogynecologist every 3 months.

Active Comparator Device,Experimental Device

at&#45

least&#45

1&#45

week interval of pessary removal ,3&#45

month&#45

interval of pessary removal

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
prolapse-related quality of life at 3 months and 6 months P-QoL questionnaire,patientâ€™s satisfaction at 3 months and 6 months VAS score	—

Countries

Thailand

Contacts

Public ContactSasima Kornsilp

Faculty of Medicine, Prince of Songkla University

sasima.kornsilp@gmail.com0846318181

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026