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Vaginal Prolapse Pessary Material Trial PVC vs Silicon

NCT06641804 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2024-10-15

No results posted yet for this study

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.

Conditions

  • Pelvic Organ Prolapse

Interventions

PROCEDURE

Pessary care, change of pessary

Insertion of a new pessary by gynaecologist if not contraindicated, silicon or polyvinyl chloride pessary of same size, blinded to patient

Sponsors & Collaborators

  • Princess Margaret Hospital, Hong Kong

    lead OTHER_GOV

Principal Investigators

  • Cheuk Yin Lo, MBBS · Princess Margaret Hospital, Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-15
Primary Completion
2025-12-31
Completion
2026-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06641804 on ClinicalTrials.gov