Pelvic Organ Prolapse Clinical Trial
Official title:
An Intervention to Improve the Management of Posterior Vaginal Compartment Prolapse Using Femmeze®: a Feasibility Study
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
- 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.
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