Performance and Safety of the PHENIX LIBERTY, a Medical Device for Electrostimulation and Biofeedback, in the Treatment of Pelvic Static Disorders in Women With Urinary Incontinence.

NCT ID: NCT05938855

Last Updated: 2024-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-06
• Study Completion Date: 2024-12-06

Brief Summary

The goal of this clinical trial is to evaluate the short-term improvement in urinary incontinence after perineo-sphincter rehabilitation using functional electrostimulation and biofeedback (PHENIX LIBERTY VIVALTIS device) in patients with pelvic statics disorders.

• Does the use of the medical device in the treatment of pelvic static disorders lead to an improvement in urinary incontinence?

Participants will use the medical device, which provides electrical stimulation, biofeedback and pressure biofeedback to re-educate the pelvic floor muscles and improve urinary incontinence.

Detailed Description

Rational :

Urinary incontinence is a condition affecting many women in their adult lives. It is considered a public health problem, and has a high negative impact on patients' quality of life. Physiotherapy-based perineal rehabilitation is considered the first-line treatment for this condition. Treatments consist of pelvic floor muscle exercises (physiotherapy) with or without the use of other resources such as biofeedback, electrical electro-stimulation and vaginal cones.

In this context, the promoter wishes to carry out this study in order to reinforce the data currently available on the medical device PHENIX LIBERTY.

Design:

Prospective, interventional with non invasive and non burdensome procedure, non-comparative, multicenter, open-label study of a CE-marked medical device.

Intervention :

As part of this clinical investigation, the medical device under investigation is used in accordance with its usual use, and the patient's therapeutic procedure includes additional, non-invasive procedures. These additional procedures relate to the addition of an end-of-life visit and validated questionnaires assessing functional deficiencies and impact on daily life.

The care will be conduct as follow:

• 1 inclusion visit (V0) (from 1 say to 15 days prior the the first functional therapeutic re-education session)
• 10 sessions of functional therapeutic re-education, during which the PHENIX LIBERTY device may be used. Sessions performed at regular intervals according to a schedule drawn up by the physiotherapist (between 10 and 12 weeks)
• 1 end visit (V11), 1 week after the 10th session to complet questionnaires

In total, the patient will be followed 15 weeks maximum

Conditions

Urinary Incontinence; Pelvic Floor Disorders

Keywords

Electrical stimulation; Biofeedback

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of care plus additional questionaire

As part of this clinical investigation, the medical device under investigation is used in accordance with its usual use, and the patient's therapeutic procedure includes additional, non-invasive procedures. These additional procedures relate to the addition of an end-of-life visit and validated questionnaires assessing functional deficiencies and impact on daily life.

Group Type: OTHER

Electrical stimulation and biofeedback with the medical device Phenix Liberty

Intervention Type: DEVICE

The patient will undergo 10 therapeutic functional re-education sessions, at regular intervals according to a schedule drawn up by the physiotherapist, during which the PHENIX LIBERTY device may be used.

The patients will complete questionnaires at the end of the care Overall, the functional perineal rehabilitation sessions will include muscle testing, electrostimulation and biofeedback.

The follow up will be conduct as follow :

• 10 sessions between 10 and 12 weeks
• 1 end visit, within the week after the 10th session

Interventions

Electrical stimulation and biofeedback with the medical device Phenix Liberty

The patient will undergo 10 therapeutic functional re-education sessions, at regular intervals according to a schedule drawn up by the physiotherapist, during which the PHENIX LIBERTY device may be used.

The patients will complete questionnaires at the end of the care Overall, the functional perineal rehabilitation sessions will include muscle testing, electrostimulation and biofeedback.

The follow up will be conduct as follow :

• 10 sessions between 10 and 12 weeks
• 1 end visit, within the week after the 10th session

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient who is incontinent (involuntary loss of urine) and/or has an overactive bladder (pollakiuria defined as more than one nocturnal urination and more than six daytime urination or leakage per day); Incontinent patient requiring functional rehabilitation of pelvic static disorders by electrostimulation and biofeedback;
• Adult patient (between 18 / 75 years old);
• Patient with at least one of the following symptoms related to a pelvic static disorder: pain, hypertonia, muscle weakness, decreased or loss of motor control, trophic abnormality;
• Patient who can make herself available to participate in the sessions regularly and who believes that she will be able to complete the tenth treatment session no later than 8 weeks after V0;
• Patient who has signed the consent form to participate in the study;
• Patient physically and mentally willing and able, in the judgment of the investigator at the time of recruitment, to perform the procedures under study;
• Patient with social protection.

Exclusion Criteria

• Patient with peripheral or central neurological involvement (perianal or perivulvar sensitivity disorder);
• Patient with BMI ≥30 kg/m²
• Patient who has had more than 3 deliveries;
• Patient with stroke, Alzheimer's, multiple sclerosis, spinal cord involvement, narrow lumbar canal, cauda equina syndrome, or cognitive and/or behavioral impairment that may, in the practitioner's judgment, interact with the self-questionnaire or biofeedback assessment;
• Pregnant woman at the inclusion visit;
• Patient with an implanted pacemaker or spinal cord trainer;
• Patient with hypersensitivity to electrostimulation;
• Patient with such vaginal atrophy that an endovaginal probe cannot be used
• Patient with chronic or recurrent vaginal or urinary tract infection on long-term treatment;
• Patient with vaginal pathology (undiagnosed bleeding, cancer in the area to be treated);
• Patient who has renounced her liberty by administrative or judicial sentence, or who is under guardianship or limited judicial protection;
• Patient participating in an interventional clinical trial or testing/having tested an investigational drug and/or medical device within 30 days prior to inclusion in the study in relation to the relevant pathology;
• Patient who cannot read or write French;
• Patient refusing to participate in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

CEISO

INDUSTRY

Sponsor Role: collaborator

Human Physio

UNKNOWN

Sponsor Role: collaborator

Pôle santé de la Nartassière

UNKNOWN

Sponsor Role: collaborator

Vivaltis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mathias Willame

Role: PRINCIPAL_INVESTIGATOR

Human Physio

Julie Perrin

Role: PRINCIPAL_INVESTIGATOR

Pôle santé de la Nartassière

Locations

Pôle santé de la Nartassière

Mouans-Sartoux, , France

Human Physio

Nîmes, , France

Countries

France

Other Identifiers

2023-A02195-40

Identifier Type: -

Identifier Source: org_study_id