An Intervention to Improve Prolapse Using Femmeze® (v1)
NCT ID: NCT02280382
Last Updated: 2019-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2015-10-31
2019-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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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
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
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Not undergone posterior vaginal compartment prolapse surgery
Exclusion Criteria
* Hand disability
* Refuse to give informed consent
* Pregnancy
* Less than 12 weeks post-partum
* Neurological disease
18 Years
FEMALE
Yes
Sponsors
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Peninsula Health
OTHER_GOV
Royal Cornwall Hospitals Trust
OTHER
Responsible Party
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Sharon Eustice
Nurse Consultant
Principal Investigators
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Sharon Eustice, BSc; MSc
Role: PRINCIPAL_INVESTIGATOR
RCHT
Locations
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RoyalCornwallHT
Truro, , United Kingdom
Countries
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Other Identifiers
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2014.RCHT.76
Identifier Type: -
Identifier Source: org_study_id
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