An Intervention to Improve the Management of Posterior Vaginal Compartment Prolapse Using Femmeze®: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Quality of life instrument (ICIQ-Vaginal Symptoms)
研究概览
简要总结
The main purpose of the feasibility study is to identify the patient experience of Femmeze® which is a device aimed at improving posterior vaginal compartment prolapse (rectocele) for women with obstructive defaecation. The investigators want to investigate implementation and preliminary effectiveness of the device. The method of investigation will be a pre-post intervention design, which involves asking 30 women to use Femmeze® over a period of 8 weeks. This is an academic study on a labelled indication (http://www.nres.nhs.uk/search/?q=medical+devices).
详细描述
Aim Evaluate the feasibility of the Femmeze® device to improve management of posterior vaginal compartment prolapse addressing implementation of the intervention and preliminary effectiveness.
Objectives
- demonstrate effectiveness of the device (comfort, ease of use, empty the rectum of stool more easily than their current approach and quality of life)
- identify which stage of prolapse the device would be most suitable
- identify any changes to the device or instructions for use (needs adjustment to its design in terms of length/width)
The study will use a pre-post intervention design with the aim of evaluating the feasibility of the intervention (using the device); and identifying any implementation issues and preliminary effectiveness. The participants will be followed prospectively to compare the device against their own usual care. Usual care in this context will be using their fingers to help empty their rectum of stool.
Participants will be invited to complete a semi-structured interview to understand their lived experience. A Patient and Public Involvement Group has contributed to improving the study methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Adult women (over 18 years of age) with symptoms of obstructive defaecation
- •Not undergone posterior vaginal compartment prolapse surgery
排除标准
- •Cognitive impairment
- •Hand disability
- •Refuse to give informed consent
- •Pregnancy
- •Less than 12 weeks post-partum
- •Neurological disease
研究组 & 干预措施
Femmeze®
Femmeze® will be used by women in the intervention group for 8 weeks These women will be measuring against their usual care in a linear design; measurement will include validated questionnaires
干预措施: Femmeze® (Device)
结局指标
主要结局
Quality of life instrument (ICIQ-Vaginal Symptoms)
时间窗: 12 months
http://www.iciq.net/ICIQ-VS.html
次要结局
- Device feedback questionnaire(12 months)
研究者
Sharon Eustice
Nurse Consultant
Royal Cornwall Hospitals Trust