Vaginal Prolapse Pessary Material Trial PVC vs Silicon

Launched by PRINCESS MARGARET HOSPITAL, HONG KONG · Oct 10, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at two types of vaginal ring pessaries, which are devices used to help manage pelvic organ prolapse (POP). The goal is to see how these different materials—PVC (polyvinyl chloride) and silicone—affect complications, patient satisfaction, and any pain experienced during the process of changing the pessary. Over a period of six months, participants will share their experiences and answer questions about their symptoms related to prolapse.

To participate, women aged 18 and older who can read traditional Chinese and have been diagnosed with a specific stage of pelvic organ prolapse are eligible. They should currently be using a PVC pessary as a long-term solution for their condition. Participants will be randomly assigned to use either a PVC or silicone pessary and will need to attend follow-up appointments over the next six months to track their health and experiences with the device. This trial is currently not recruiting participants, but it aims to provide valuable information on which material may work better for women managing POP.

Gender

FEMALE

Eligibility criteria

• • 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