NCT07039188

Clinical Evaluation of the Femiset Device for Perineal Descent in Women

Clinical Evaluation of the Femiset Device for Perineal Descent in Women - Impact on Stool Evacuation

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University Hospital, Antwerp · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
DEVICE	Use device in home environment	Patients will use the device in their home environment for four weeks.

Timeline

• Start date: 2025-07-01
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2025-06-26
• Last updated: 2025-06-26