An Intervention to Improve Prolapse Using Femmeze® (v1)

Not Applicable

Completed

• Conditions: Pelvic Organ Prolapse; Rectocele
• Interventions: Device: Femmeze®

• Registration Number: NCT02280382
• Lead Sponsor: Royal Cornwall Hospitals Trust

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-10-15
• Study First Submitted QC: 2014-10-29
• Study First Posted: 2014-10-31
• Study Start: 2015-10
• Primary Completion: 2018-12
• Status Verified: 2019-03
• Study Completion: 2019-03
• Last Update Submitted: 2019-03-27
• Last Update Posted: 2019-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Femmeze®	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

Primary Outcome Measures

Name	Time	Method
Quality of life instrument (ICIQ-Vaginal Symptoms)	12 months	http://www.iciq.net/ICIQ-VS.html

Secondary Outcome Measures

Name	Time	Method
Device feedback questionnaire	12 months	evaluating the device from the participants perspective

Trial Locations

Locations (1)

RoyalCornwallHT; 🇬🇧 Truro, United Kingdom