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临床试验/NCT06246721
NCT06246721已完成不适用

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

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2024年2月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
176
试验地点
1
主要终点
Prevalence of patients willing to learn self-management of vaginal pessary

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Patient's satisfaction on self-management of vaginal pessary(6 months follow up and 12 months follow up)
  • Basic demographics questions(Baseline, 6 months follow up and 12 months follow up)
  • Successful rate in self-management of vaginal pessary(6 months follow up and 12 months follow up)
  • Quality of life validated questionnaire (PFDI/PFIQ short form)(Baseline, 6 months follow up and 12 months follow up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

CHAN SYMPHOROSA SHING CHEE

Doctor, Chief of Service (O&G), Clinical Associate Professor (honorary)

Chinese University of Hong Kong

研究点 (1)

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