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Vaginal Prolapse Pessary Material Trial PVC vs Silicon

ConditionPelvic Organ Prolapse
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorPrincess Margaret Hospital, Hong Kong

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pessary care, change of pessary

    Procedure/Surgery

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

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Silicon ring pessaryActive comparator 1 intervention
Group B: PVC ring pessaryPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pessary related complications

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

Time frame
6 months
2

Patient satisfaction

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

Time frame
6 months

Secondary outcomes

1

Pain during pessary exchange

Visual analogue scale 1- 10 \[Minimal pain: 1, Maximal pain: 10\]

Time frame
6 months
2

Prolapse related symptoms

PFDI 20 summary score (Pelvic Floor Disability Index) \[Minimal symptoms: 0 Maximal symptoms: 300\]

Time frame
6 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Princess Margaret Hospital, Hong Kong

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: