An Intervention to Improve Prolapse Using Femmeze® (v1)

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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An Intervention to Improve the Management of Posterior Vaginal Compartment Prolapse Using Femmeze®: a Feasibility Study

Conditions
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Rectocele, Pelvic Organ Prolapse

Intervention / Treatment
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* Device: Femmeze®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult women (over 18 years of age) with symptoms of obstructive defaecation Not undergone posterior vaginal compartment prolapse surgery Exclusion Criteria: Cognitive impairment Hand disability Refuse to give informed consent Pregnancy Less than 12 weeks post-partum Neurological disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Femmeze®<br>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 | Device: Femmeze®<br>* 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<br>* Other names: 5060228630194;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life instrument (ICIQ-Vaginal Symptoms) | http://www.iciq.net/ICIQ-VS.html | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device feedback questionnaire | evaluating the device from the participants perspective | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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splinting