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

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ClinicalTrials.gov Identifier: NCT02280382
Recruitment Status : Recruiting
First Posted : October 31, 2014
Last Update Posted : April 13, 2018
Sponsor:
Collaborator:
Peninsula Health
Information provided by (Responsible Party):
Sharon Eustice, 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).

Condition or disease Intervention/treatment Phase
Rectocele Pelvic Organ Prolapse Device: Femmeze® Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: An Intervention to Improve the Management of Posterior Vaginal Compartment Prolapse Using Femmeze®: a Feasibility Study
Actual Study Start Date : October 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: 5060228630194




Primary Outcome Measures :
  1. Quality of life instrument (ICIQ-Vaginal Symptoms) [ Time Frame: 12 months ]
    http://www.iciq.net/ICIQ-VS.html


Secondary Outcome Measures :
  1. Device feedback questionnaire [ Time Frame: 12 months ]
    evaluating the device from the participants perspective



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02280382


Contacts
Contact: Trembath Lisa 0187225 ext 6499 rcht.sponsor@nhs.net
Contact: Nick Morley, BSc; PhD 0187225 ext 6422 nickmorley@nhs.net

Locations
United Kingdom
RoyalCornwallHT Recruiting
Truro, United Kingdom, TR1 3JL
Contact: Sharon Eustice, MSc    01726 873095    sharoneustice@nhs.net   
Sponsors and Collaborators
Royal Cornwall Hospitals Trust
Peninsula Health
Investigators
Principal Investigator: Sharon Eustice, BSc; MSc RCHT

Responsible Party: Sharon Eustice, Nurse Consultant, Royal Cornwall Hospitals Trust
ClinicalTrials.gov Identifier: NCT02280382     History of Changes
Other Study ID Numbers: 2014.RCHT.76
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Sharon Eustice, Royal Cornwall Hospitals Trust:
splinting

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Rectocele
Pathological Conditions, Anatomical
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hernia