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
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
Treatments tested in this trial
- Pessary care, change of pessary
Treatment groups
140 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov