Clinical Evaluation of the Femiset Device for Perineal Descent in Women

NCT07039188 | Not Yet Recruiting

• 1 other identifier: 3975
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The University of Antwerp developed a device (Femiset) to alleviate defecation difficulties in women suffering from Descending Perineum Syndrome (DPS). The device allows the patient to apply counterpressure to the site of descent (perineal body) during defecation, thereby correcting the excessive descent of the perineum so that the increase in abdominal pressure during the (attempted) defecation results in the evacuation of the stool from the rectum and anus, rather than a further downward pressure on the already descended perineum. The aim of the clinical study is to validate the efficacy (improvement in defecation) and safety of Femiset as compared to the standard of care of no support to the perineum through a clinical study on 20 patients. The population to be studied consists of adult women suffering from DPS with symptoms of obstructive defecation. Patients will use the device in their home environment for four weeks. The improvement in defecation as perceived by the patient will be assessed with the Patient Global Impression of Change (PGIC) scale. Secondarily, their ODS symptoms will be assessed prior to the test period and at the end of the test period using the Modified Longo Score for ODS. These scores will be compared to determine if there has been an improvement in ODS symptoms. The safety of the device will be validated based on monitoring the incidence of adverse events during the test period. The study will also explore the usability of the device and how it compares to manual perineal support. The results of the study will determine the product's viability.

Conditions

Perineal Descent; Obstructed Defecation Syndrome (ODS)

Outcome Measures

Primary Outcomes (2)

• Efficacy - improvement in defecation

  PGIC Scale

  4 weeks

• Safety - incidence of adverse events

  Absence of any adverse events classified with a device-related causality level higher than "not related", as per MDCG 2020-10/1, and assessed by the PI as severe.

  4 weeks

Secondary Outcomes (1)

• Efficacy - improvement in ODS symptoms

  4 weeks

Study Arms (1)

Femiset

EXPERIMENTAL

Device: Use device in home environment

Interventions

Use device in home environment DEVICE

Patients will use the device in their home environment for four weeks.

Femiset

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Central Study Contacts

Sien Heirbaut, MSc

CONTACT

+32 499212232; sien.heirbaut@uantwerpen.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: June 26, 2025
• Study Start: July 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06