Pelvic Organ ProlapseNCT06246721
Attitude and Success Rate of Women With Pelvic Organ Prolapse on Self-management of Vaginal Pessary
A study testing Self-management of vaginal pessary in people with Pelvic Organ Prolapse, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Self-management of vaginal pessary
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- 1 siteHong Kong
- Study dates
- 2 Feb 2024to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient who suffers from pelvic organ prolapse requiring use of vaginal ring pessary as treatment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Attitude and Success Rate of Women With Pelvic Organ Prolapse on Self-management of Vaginal Pessary: A Multi-centered Prospective 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.
Read the detailed description
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).
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Self-management of vaginal pessary
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-management of vaginal pessaryBehavioural
Self-management of vaginal pessary
| Study group | Role | What they receive |
|---|---|---|
| Subjects Agree Self-management Group | Active comparator | Women with pelvic organ prolapse requires ring pessary for treatment. Those who agree to join the study and agree to learn how to self-management of vaginal pessary. Receives: Behavioral: Self-management of vaginal pessary |
| Subjects Refuse Self-management Group | Placebo comparator | Women with pelvic organ prolapse requires ring pessary for treatment. Those who agree to join the study and refuse to learn how to self-management of vaginal pessary. Receives: Behavioral: Self-management of vaginal pessary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of patients willing to learn self-management of vaginal pessary
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.
Measured: Baseline
Secondary outcomes (4)
Successful rate in self-management of vaginal pessary
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.
Measured: 6 months follow up and 12 months follow up
Patient's satisfaction on self-management of vaginal pessary
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.
Measured: 6 months follow up and 12 months follow up
Basic demographics questions
Basic demographics will be collected in datasheet.
Measured: Baseline, 6 months follow up and 12 months follow up
Quality of life validated questionnaire (PFDI/PFIQ short form)
Quality of life related to pelvic floor disorders will be measured by answering validated questionnaire (PFDI/PFIQ short form).
Measured: Baseline, 6 months follow up and 12 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start2 Feb 2024
- Primary completion15 Dec 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Kwong Wah Hospital
- Responsible party
- Principal investigator, CHAN SYMPHOROSA SHING CHEE, Chinese University of Hong Kong
- Investigators
- Shing Chee Symphorosa CHAN, Principal investigator, O&G, PWH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246721
- Sponsor's protocol ID
- CREC 2023.603
- Status last verified
- Mar 2026
- First submitted
- 19 Jan 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Attitude and Success Rate of Women With Pelvic Organ Prolapse on Self-management of Vaginal Pessary: A Multi-centered Prospective Study
- ClinicalTrials.gov ID
- NCT06246721
- Acronym / sponsor ID
- CREC 2023.603
- Conditions
- Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Kwong Wah Hospital
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects Agree Self-management Group | Active comparator | Behavioral: Self-management of vaginal pessaryWomen with pelvic organ prolapse requires ring pessary for treatment. Those who agree to join the study and agree to learn how to self-management of vaginal pessary. |
| Subjects Refuse Self-management Group | Placebo comparator | Behavioral: Self-management of vaginal pessaryWomen with pelvic organ prolapse requires ring pessary for treatment. Those who agree to join the study and refuse to learn how to self-management of vaginal pessary. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient who suffers from pelvic organ prolapse requiring use of vaginal ring pessary as treatment
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-management of vaginal pessarySelf-management of vaginal pessary | Behavioural | Subjects Agree Self-management Group, Subjects Refuse Self-management Group |
Primary outcome
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.
4 secondary outcomes
Successful rate in self-management of vaginal pessary
Time frame: 6 months follow up and 12 months follow up
Patient's satisfaction on self-management of vaginal pessary
Time frame: 6 months follow up and 12 months follow up
Basic demographics questions
Time frame: Baseline, 6 months follow up and 12 months follow up
Quality of life validated questionnaire (PFDI/PFIQ short form)
Time frame: Baseline, 6 months follow up and 12 months follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Pelvic Organ Prolapse
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shing Chee Symphorosa CHAN principal investigator
O&G, PWH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-management of vaginal pessary in people with Pelvic Organ Prolapse, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of patients willing to learn self-management of vaginal pessary (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.