Clinical Evaluation of the Femiset Device for Perineal De... | NCT07039188

Studies
Clinical Evaluation of the Femiset Device for Perineal Descent in Women

NCT07039188

Sponsor

University Hospital, Antwerp

Status

Not yet recruiting

Last Update Posted

Jun 26, 2025Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Perineal Descent
Obstructed Defecation Syndrome (ODS)

Interventions

Use device in home environment

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2025Estimated

Primary Completion Date

Sep 30, 2025Estimated

Completion Date

Sep 30, 2025Estimated

First Submitted Date

Jun 18, 2025

First Submission Date that Met QC Criteria

Jun 18, 2025

First Posted Date

Jun 26, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2025

Last Update Posted Date

Jun 26, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sylvie Van den Broeck, Dr., University Hospital, AntwerpPrincipal Investigator

Lead Sponsor

University Hospital, AntwerpOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Femiset	Experimental		Device: Use device in home environment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Use device in home environment	Device	Patients will use the device in their home environment for four weeks.	Femiset

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Efficacy - improvement in ODS symptoms	Modified Longo Score for ODS	4 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sien Heirbaut, MSc	Contact	+32 499212232		sien.heirbaut@uantwerpen.be

Overall Officials

Not provided

Locations

Not provided