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Completed

NCT Number: NCT02280382

An Intervention to Improve Prolapse Using Femmeze® (v1)

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).

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Key information

Conditions

Rectocele Digestive System Diseases Gastrointestinal Diseases Hernia Intestinal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse Rectal Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

RoyalCornwallHT

Truro, TR1 3JL, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Femmeze®

Device

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

Primary outcomes

  1. Quality of life instrument (ICIQ-Vaginal Symptoms)

    Time frame: 12 months

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

Secondary outcomes

  1. Device feedback questionnaire

    Time frame: 12 months

    evaluating the device from the participants perspective

Sponsors and collaborators

Lead sponsor

Royal Cornwall Hospitals Trust

Other

Collaborators

  • Peninsula Health

Registry information

Official study title

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

Acronym: Femmeze®

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Oct 31, 2014
Registry last updated
Mar 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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