An Intervention to Improve Prolapse Using Femmeze® (v1)

Pelvic Organ Prolapse Clinical Trial

— Femmeze®  

Official title:

An Intervention to Improve the Management of Posterior Vaginal Compartment Prolapse Using Femmeze®: a Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02280382
• Other study ID #: 2014.RCHT.76
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: March 2019

Study information

• Verified date: March 2019
• Source: Royal Cornwall Hospitals Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse
• Rectocele

Intervention

Device:
• 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

Locations

Country	Name	City	State
United Kingdom	RoyalCornwallHT	Truro

Sponsors (2)

Lead Sponsor	Collaborator
Royal Cornwall Hospitals Trust	Peninsula Health

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life instrument (ICIQ-Vaginal Symptoms)	http://www.iciq.net/ICIQ-VS.html	12 months
Secondary	Device feedback questionnaire	evaluating the device from the participants perspective	12 months