Not Yet RecruitingNot Applicable

Vaginal Prolapse Pessary Material Trial PVC vs Silicon

140 participantsStarted 2024-10-15

Plain-language summary

The goal of this clinical trial is to determine the effect of vaginal ring pessary material on pessary complications and patients' satisfaction. Participants who are using PVC (polyvinyl chloride) pessary will be randomized to 1. PVC vaginal ring pessary 2. Silicon vaginal ring pessary Their pessary-related complications, patients' satisfaction, pain during pessary exchange and prolapse related symptoms with reference to PFDI-20 score will be assessed in a period of six months.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria * At least 18 years old who understand written traditional Chinese * Diagnosed with stage 1-4 POP according to the standard of Pelvic organ prolapse Quantification (POP-Q) * Using PVC pessary as long term management for POP * Willing to participate and provide a written informed consent. Exclusion criteria * Do not understand or comprehend written traditional Chinese * Cannot provide written consent * Vaginal complication requiring discontinuation of pessary use * Unable to follow up clinic 6 months later * Pregnant or lactating * Recruited in other research studies

What they're measuring

Pessary related complications

Timeframe: 6 months

Patient satisfaction

Timeframe: 6 months

Trial details

NCT IDNCT06641804

SponsorPrincess Margaret Hospital, Hong Kong

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2025-12-31

Contact for this trial

Cheuk Yin Lo, MBBS

852- 29903430 lcy790@ha.org.hk

View on ClinicalTrials.gov More Pelvic Organ Prolapse trials