Vaginal Prolapse Pessary Material Trial PVC vs Silicon

NCT06641804 | Not Yet Recruiting DMC

• 1 other identifier: Pessary material trial
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.PVC vaginal ring pessary
2. 2.Silicon vaginal ring pessary

Conditions

Pelvic Organ Prolapse

Keywords

pelvic organ prolpase; ring pessary; silicon ring pessary; PVC ring pessary

Outcome Measures

Primary Outcomes (2)

• Pessary related complications

  Patient reported symptoms such as vaginal bleeding, vaginal discharge, pessary dislodgement Physician reported complications such as ulcers formation, vaginitis

  6 months

• Patient satisfaction

  Visual analogue score 1- 10 \[Minimal satisfaction: 1, Maximal satisfaction: 10\]

  6 months

Secondary Outcomes (2)

• Pain during pessary exchange

  6 months

• Prolapse related symptoms

  6 months

Study Arms (2)

Silicon ring pessary

ACTIVE COMPARATOR

Change to silicon ring pessary of nearest size

Procedure: Pessary care, change of pessary

PVC ring pessary

PLACEBO COMPARATOR

Change of same PVC ring pessary

Procedure: Pessary care, change of pessary

Interventions

Pessary care, change of pessary PROCEDURE

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

PVC ring pessary; Silicon ring pessary

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patients with vaginal prolapse on pessary care
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Princess Margaret Hospital, Hong Kong: lead

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Cheuk Yin Lo, MBBS

  Princess Margaret Hospital, Canada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheuk Yin Lo, MBBS

CONTACT

852- 29903430; lcy790@ha.org.hk

Kai Wan Lee, FRCOG

CONTACT

852-29903430

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident, Department of Obstetrics and Gynaecology

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 15, 2024
• Study Start: October 15, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share