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| Name | Class |
|---|---|
| Peninsula Health | OTHER_GOV |
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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).
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Femmeze® | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life instrument (ICIQ-Vaginal Symptoms) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Device feedback questionnaire | evaluating the device from the participants perspective | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon Eustice, BSc; MSc | RCHT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RoyalCornwallHT | Truro | TR1 3JL | United Kingdom |
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| ID | Term |
|---|---|
| D020047 | Rectocele |
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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|
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011391 | Prolapse |