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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02280382
Recruitment Status : Completed
First Posted : October 31, 2014
Last Update Posted : March 29, 2019
Sponsor:
Collaborator:
Peninsula Health
Information provided by (Responsible Party):
Sharon Eustice, Royal Cornwall Hospitals Trust

Tracking Information
First Submitted Date  ICMJE October 15, 2014
First Posted Date  ICMJE October 31, 2014
Last Update Posted Date March 29, 2019
Actual Study Start Date  ICMJE October 2015
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2014)
Quality of life instrument (ICIQ-Vaginal Symptoms) [ Time Frame: 12 months ]
http://www.iciq.net/ICIQ-VS.html
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2014)
Device feedback questionnaire [ Time Frame: 12 months ]
evaluating the device from the participants perspective
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Intervention to Improve Prolapse Using Femmeze® (v1)
Official Title  ICMJE An Intervention to Improve the Management of Posterior Vaginal Compartment Prolapse Using Femmeze®: a Feasibility Study
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Rectocele
  • Pelvic Organ Prolapse
Intervention  ICMJE 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
Study Arms  ICMJE 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
Intervention: Device: Femmeze®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 27, 2019)
36
Original Estimated Enrollment  ICMJE
 (submitted: October 29, 2014)
30
Actual Study Completion Date  ICMJE March 2019
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02280382
Other Study ID Numbers  ICMJE 2014.RCHT.76
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Sharon Eustice, Royal Cornwall Hospitals Trust
Study Sponsor  ICMJE Royal Cornwall Hospitals Trust
Collaborators  ICMJE Peninsula Health
Investigators  ICMJE
Principal Investigator: Sharon Eustice, BSc; MSc RCHT
PRS Account Royal Cornwall Hospitals Trust
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP