Skip to main content
OpenTrials
Completed

NCT Number: NCT06246721

Attitude and Success Rate of Women With Pelvic Organ Prolapse on Self-management of Vaginal Pessary

This is a prospective cohort study aims at assessing patient's attitude towards self-management of vaginal pessary, and identifying factors that affect patient's level of acceptance towards self-management.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Chinese University of Hong Kong

Hong Kong

About this study

Pelvic organ prolapse (POP) is a common gynaecological condition worldwide with significant morbidity. Use of vaginal pessary has been recommended by multiple national authorities such as NICE and ACOG as an effective conservative management to all patients suffering from POP. However, the use of vaginal pessary can also associate with risks such as increased vaginal discharge, discomfort, bleeding and ulcers. The long term follow-up for changing pessary also exerts a significant economic cost in the healthcare system. Self-management of vaginal pessaries helps improved patient satisfaction and their quality of life with a much lower complication rates. Nevertheless, the attitudes and knowledge in women about pessary use is reported to be deficient and warrant further study.

This is a prospective cohort study aims at assessing patient's attitude towards self-management of vaginal pessary, and identifying factors that affect patient's level of acceptance towards self-management.

Patients who suffers from pelvic organ prolapse requiring the use of ring pessary as treatment will be invited to join the study, with exclusion criteria.

Should patient agree to join the study, they will fill in a self-administered questionnaire focusing on various reasons and factors that may influence patients' attitude on the use of vaginal pessaries and also Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ) at different time intervals to assess the symptoms, severity of symptoms and their impact on a woman's activities and well-being. Both PFDI and PFIQ are reliable, valid and condition-specific symptoms and QoL instruments for women with pelvic floor disorders, . Chinese validated versions are available. The epidemiological background information, any significant medical disease, especially previous treatment and surgery for pelvic organ prolapse would be gathered from the patient and medical records, if any. Patient will then be divided into two intervention arms by patient's own choice: self management arms and traditional hospital-based care arm, after counselling on the pros and cons of the above options with written counselling material. For patients who agree to learn self-management of vaginal pessary, per vaginal exam and staging of prolapse will be assessed and documented using Pelvic Organ Prolapse Quantification system (POP-Q) by gynaecologists. Pelvic floor muscles contraction and symptom of stress incontinence will be assessed and documented. PVC ring pessary will be inserted in the recruitment session. For those who has been stable on ring pessary without complication, a silicon ring pessary of their size will be suggested. Participants will need to bring their own purchased silicon ring pessary for the teaching session. For patient who has never tried ring pessary, a PVC ring pessary will be fitted first.

For patient who does not agree to try self-management, routine clinical care with hospital-based management will be provided as per department protocol with changing of PVC ring pessary and follow-ups appointments.

A teaching session will be arranged for a 1-to-1 20-minute self-management education by doctors or incontinence nurses to patient who agrees to learn self-management. Patient will be taught on self-insertion/removal of the silicon ring pessary, and silicon ring pessary care techniques. Returned demonstration from patient will be carried out to ensure patient's competence in self-management. Hotline will be given to patient in case of any difficulties in self-management of vaginal pessary.

For patients who experience difficulty in self-management either from hotline call-backs or during 6-month follow-up session, a second teaching session will be offered to reinforce the self-management techniques if the patient agrees to continue learning self-management.

Follow up will be arranged in 6 months to review patient's pelvic floor disorder symptoms, look for and document any pessary-related complications, and PFDI and PFIQ will be repeated for quality-of-life assessment. The frequency of self replacement will also be explored. If patient is well on self-management of ring pessary, a second 6-monthly follow up will be arranged and again to review patient's pelvic floor disorder symptoms, look for and document any pessary-related complications, and PFDI and PFIQ will be repeated for quality-of-life assessment. The frequency of self-replacement will also be explored. Patient's satisfaction will be explored using Visual Analogue Scale (VAS).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient who suffers from pelvic organ prolapse requiring use of vaginal ring pessary as treatment

Exclusion criteria

  • Physically dependent in their daily living
  • Limited physical dexterity due to medical conditions, for example: Parkinsonism or stroke
  • Pregnancy
  • Cognitive deficit preventing informed consenting procedure and self management
  • Age lower than 18

Treatment and study plan

Self-management of vaginal pessary

Behavioral

Self-management of vaginal pessary

Primary outcomes

  1. Prevalence of patients willing to learn self-management of vaginal pessary

    Time frame: Baseline

    Questionnaire on attitude and knowledge will be asked. Descriptive analysis will be used to study the attitude of women on self-management of vaginal pessary. Prevalence of patients willing to learn self-management of vaginal pessary will be calculated.

Secondary outcomes

  1. Successful rate in self-management of vaginal pessary

    Time frame: 6 months follow up and 12 months follow up

    Outcome of self-replacement will be recorded in datasheet. Descriptive analysis will be used to study the outcome of self-management of vaginal pessary, successful rate of self-management will be calculated.

  2. Patient's satisfaction on self-management of vaginal pessary

    Time frame: 6 months follow up and 12 months follow up

    Question about patient's satisfaction on vaginal pessary and willing to continue self-management will be asked. Descriptive analysis will be used to study patient's satisfaction on self-management of vaginal pessary.

  3. Basic demographics questions

    Time frame: Baseline, 6 months follow up and 12 months follow up

    Basic demographics will be collected in datasheet.

  4. Quality of life validated questionnaire (PFDI/PFIQ short form)

    Time frame: Baseline, 6 months follow up and 12 months follow up

    Quality of life related to pelvic floor disorders will be measured by answering validated questionnaire (PFDI/PFIQ short form).

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Collaborators

  • Kwong Wah Hospital

Registry information

Official study title

The Attitude and Success Rate of Women With Pelvic Organ Prolapse on Self-management of Vaginal Pessary: A Multi-centered Prospective Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 7, 2024
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.