Perineal DescentFEMISETNCT07039188
Clinical Evaluation of the Femiset Device for Perineal Descent in Women
A study testing Use device in home environment in people with Perineal Descent and Obstructed Defecation Syndrome (ODS), run by University Hospital, Antwerp.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Perineal Descent, Obstructed Defecation Syndrome (ODS)
- What is being tested?
- Use device in home environment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Evaluation of the Femiset Device for Perineal Descent in Women - Impact on Stool Evacuation
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.
- Being tested
- Use device in home environment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use device in home environmentDevice
Patients will use the device in their home environment for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Femiset | Experimental | Not described Receives: Device: Use device in home environment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy - improvement in defecation
PGIC Scale
Measured: 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.
Measured: 4 weeks
Secondary outcomes (1)
Efficacy - improvement in ODS symptoms
Modified Longo Score for ODS
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perineal DescentStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sylvie Van den Broeck, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07039188
- Sponsor's protocol ID
- 3975
- Acronym
- FEMISET
- Status last verified
- Jun 2025
- First submitted
- 18 Jun 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Femiset Device for Perineal Descent in Women - Impact on Stool Evacuation
- ClinicalTrials.gov ID
- NCT07039188
- Acronym / sponsor ID
- FEMISET / 3975
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 26 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Femiset | Experimental | Device: Use device in home environment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use device in home environmentPatients will use the device in their home environment for four weeks. | Device | Femiset |
Primary outcome
Efficacy - improvement in defecation
Time frame: 4 weeks
PGIC Scale
Safety - incidence of adverse events
Time frame: 4 weeks
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.
1 secondary outcome
Efficacy - improvement in ODS symptoms
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Use device in home environment in people with Perineal Descent and Obstructed Defecation Syndrome (ODS), run by University Hospital, Antwerp.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sien Heirbaut, MSc (+32 499212232, sien.heirbaut@uantwerpen.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy - improvement in defecation (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.