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An Intervention to Improve Prolapse Using Femmeze® (v1)

NCT02280382 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2019-03-29

No results posted yet for this study

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).

Conditions

  • Rectocele
  • Pelvic Organ Prolapse

Interventions

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

Sponsors & Collaborators

  • Peninsula Health

    collaborator OTHER_GOV

  • Royal Cornwall Hospitals Trust

    lead OTHER

Principal Investigators

  • Sharon Eustice, BSc; MSc · RCHT

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2018-12-31
Completion
2019-03-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02280382 on ClinicalTrials.gov