An Intervention to Improve Prolapse Using Femmeze® (v1)
Femmeze®
An Intervention to Improve the Management of Posterior Vaginal Compartment Prolapse Using Femmeze®: a Feasibility Study
1 other identifier
interventional
36
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2014
CompletedFirst Posted
Study publicly available on registry
October 31, 2014
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedMarch 29, 2019
March 1, 2019
3.2 years
October 15, 2014
March 27, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality of life instrument (ICIQ-Vaginal Symptoms)
http://www.iciq.net/ICIQ-VS.html
12 months
Secondary Outcomes (1)
Device feedback questionnaire
12 months
Study Arms (1)
Femmeze®
OTHERFemmeze® 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
Interventions
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
Eligibility Criteria
You may qualify if:
- Adult women (over 18 years of age) with symptoms of obstructive defaecation
- Not undergone posterior vaginal compartment prolapse surgery
You may not qualify if:
- Cognitive impairment
- Hand disability
- Refuse to give informed consent
- Pregnancy
- Less than 12 weeks post-partum
- Neurological disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Royal Cornwall Hospitals Trustlead
- Peninsula Healthcollaborator
Study Sites (1)
RoyalCornwallHT
Truro, TR1 3JL, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sharon Eustice, BSc; MSc
RCHT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Nurse Consultant
Study Record Dates
First Submitted
October 15, 2014
First Posted
October 31, 2014
Study Start
October 1, 2015
Primary Completion
December 1, 2018
Study Completion
March 1, 2019
Last Updated
March 29, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will share