Clinical Evaluation of the Femiset Device for Perineal Descent in Women
Launched by UNIVERSITY HOSPITAL, ANTWERP · Jun 18, 2025
Trial Information
Current as of June 28, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new device called Femiset, designed to help women who have trouble with bowel movements due to a condition called Descending Perineum Syndrome (DPS). In this condition, part of the pelvic area (called the perineum) moves down too much during bowel movements, making it hard to pass stool. The Femiset device works by gently supporting this area to stop it from moving down too far, helping stool to come out more easily. The study will look at whether using Femiset improves bowel movements and is safe to use compared to not using any support.
Women who are 18 years or older, have symptoms of difficult bowel movements linked to DPS, and have had an MRI showing a certain level of perineal descent may be eligible. Participants will use the Femiset device at home for four weeks and will share how their bowel movements feel using simple questionnaires. The study will also check for any side effects and see how easy the device is to use compared to supporting the area by hand. This trial will help determine if Femiset is a good option for women with this condition.
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • Woman at birth
- • Adult (aged 18+)
- • ODS complaints
- • MRI has been performed within the past three years and a perineal descent of \>4cm on MRI (M-Line) is present
- • Functional pelvic floor (no dyssynergia)
- Exclusion Criteria:
- • Scoring less than 7/24 on the modified Longo Score for ODS
- • Need for vaginal splinting
- • Severe perineal malformations
- • Recent perineal surgery (\<6 weeks)
- • Recent vaginal delivery (\<6 weeks)
- • Pregnant or actively trying to conceive
- • Known allergy to the material of the investigational device
- • Inability to follow instructions or handle the device
- • Not able to understand the language of the questionnaires (NL/English)
- • Incapable of giving informed consent
About University Hospital, Antwerp
University Hospital Antwerp is a leading academic medical center dedicated to advancing healthcare through innovative research and clinical trials. With a strong emphasis on patient-centered care, the hospital fosters a collaborative environment that integrates cutting-edge scientific inquiry with state-of-the-art medical practices. As a prominent sponsor of clinical trials, University Hospital Antwerp is committed to enhancing medical knowledge and improving treatment outcomes across a wide range of specialties, leveraging its expertise to contribute significantly to the global medical community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported