Clinical Evaluation of the Femiset Device for Perineal Descent in Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Use device in home environment.
- Who it may be relevant to
- Registry conditions: Perineal Descent, Obstructed Defecation Syndrome (ODS). Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Evaluation of the Femiset Device for Perineal Descent in Women - Impact on Stool Evacuation
Overview
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.
Interventions
- Device Use device in home environment
Patients will use the device in their home environment for four weeks.
Primary outcome measures
- Efficacy - improvement in defecation [Time frame: 4 weeks]
- Safety - incidence of adverse events [Time frame: 4 weeks]
Secondary outcome measures (1)
- Efficacy - improvement in ODS symptoms [Time frame: 4 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Device feasibility
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07039188 · 3975