An Intervention to Improve Prolapse Using Femmeze® (v1) (Femmeze®)

March 27, 2019 updated by: Sharon Eustice, Royal Cornwall Hospitals Trust

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Device: 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
Other Names:
  • 5060228630194

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Cornwall Hospitals Trust

Collaborators

Peninsula Health

Investigators

  • Principal Investigator: Sharon Eustice, BSc; MSc, RCHT

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

October 15, 2014

First Submitted That Met QC Criteria

October 29, 2014

First Posted (Estimate)

October 31, 2014

Study Record Updates

Last Update Posted (Actual)

March 29, 2019

Last Update Submitted That Met QC Criteria

March 27, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014.RCHT.76

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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