An Intervention to Improve Prolapse Using Femmeze® (v1)

Royal Cornwall Hospitals Trust

Status: Completed

Conditions: Pelvic Organ Prolapse; Rectocele

Treatments: Device: Femmeze®

Study type: Interventional

Funder types: Other

Identifiers

NCT02280382

2014.RCHT.76

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 36 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult women (over 18 years of age) with symptoms of obstructive defaecation
• Not undergone posterior vaginal compartment prolapse surgery

Exclusion criteria

• Cognitive impairment
• Hand disability
• Refuse to give informed consent
• Pregnancy
• Less than 12 weeks post-partum
• Neurological disease

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Femmeze®

Other group

Description:

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

Treatment:

Device: Femmeze®