Clinical trial NCT06246721: Attitude and Success Rate of Women with Pelvic Organ Prolapse on Self-management of Vaginal Pessary
Official title: The Attitude and Success Rate of Women with Pelvic Organ Prolapse on Self-management of Vaginal Pessary: a Multi-centered Prospective Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pelvic Organ Prolapse
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Kwong Wah Hospital
First posted: 2024-02-07
Enrollment: 289
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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\&amp;amp;#39;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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Prevalence of patients willing to learn self-management of vaginal pessary
timeFrame: Baseline
Secondary outcomes:
measure: Successful rate in self-management of vaginal pessary
timeFrame: 6 months follow up and 12 months follow up
measure: Patient's satisfaction on self-management of vaginal pessary
timeFrame: 6 months follow up and 12 months follow up
measure: Basic demographics questions
timeFrame: Baseline, 6 months follow up and 12 months follow up
measure: Quality of life validated questionnaire (PFDI/PFIQ short form)
timeFrame: Baseline, 6 months follow up and 12 months follow up
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
affiliation: O&G, PWH
name: Shing Chee Symphorosa CHAN
role: PRINCIPAL_INVESTIGATOR
References: