An Intervention to Improve Prolapse Using Femmeze® (v1) (Femmeze®)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02280382|
Recruitment Status : Completed
First Posted : October 31, 2014
Last Update Posted : March 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Rectocele Pelvic Organ Prolapse||Device: Femmeze®||Not Applicable|
Aim Evaluate the feasibility of the Femmeze® device to improve management of posterior vaginal compartment prolapse addressing implementation of the intervention and preliminary effectiveness.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||An Intervention to Improve the Management of Posterior Vaginal Compartment Prolapse Using Femmeze®: a Feasibility Study|
|Actual Study Start Date :||October 2015|
|Actual Primary Completion Date :||December 2018|
|Actual Study Completion Date :||March 2019|
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 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 Name: 5060228630194
- Quality of life instrument (ICIQ-Vaginal Symptoms) [ Time Frame: 12 months ]http://www.iciq.net/ICIQ-VS.html
- Device feedback questionnaire [ Time Frame: 12 months ]evaluating the device from the participants perspective
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02280382
|Truro, United Kingdom, TR1 3JL|
|Principal Investigator:||Sharon Eustice, BSc; MSc||RCHT|