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An Intervention to Improve Prolapse Using Femmeze® (v1)

Sponsor
Royal Cornwall Hospitals Trust (Other)
Overall Status
Completed
CT.gov ID
NCT02280382
Collaborator
Peninsula Health (Other)
36
Enrollment
1
Location
1
Arm
41
Actual Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Femmeze®
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
N/A
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 :
Oct 1, 2015
Actual Primary Completion Date :
Dec 1, 2018
Actual Study Completion Date :
Mar 1, 2019

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Quality of life instrument (ICIQ-Vaginal Symptoms) [12 months]

      http://www.iciq.net/ICIQ-VS.html

    Secondary Outcome Measures

    1. Device feedback questionnaire [12 months]

      evaluating the device from the participants perspective

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 RoyalCornwallHT Truro United Kingdom TR1 3JL

    Sponsors and Collaborators

    • Royal Cornwall Hospitals Trust
    • Peninsula Health

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sharon Eustice, Nurse Consultant, Royal Cornwall Hospitals Trust
    ClinicalTrials.gov Identifier:
    NCT02280382
    Other Study ID Numbers:
    • 2014.RCHT.76
    First Posted:
    Oct 31, 2014
    Last Update Posted:
    Mar 29, 2019
    Last Verified:
    Mar 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Sharon Eustice, Nurse Consultant, Royal Cornwall Hospitals Trust
    splinting
    Additional relevant MeSH terms:
    Rectocele
    Prolapse
    Pelvic Organ Prolapse

    Study Results

    No Results Posted as of Mar 29, 2019