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.

Last updated: December 10, 2024
Sponsor: Vivaltis
Overall Status: Completed

Phase

N/A

Condition

Urinary Incontinence

Enuresis

Treatment

Electrical stimulation and biofeedback group

Electrical stimulation and biofeedback with the medical device Phenix Liberty

Clinical Study ID

NCT05938855
2023-A02195-40
  • Ages 18-75
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient who is incontinent (involuntary loss of urine) and/or has an overactivebladder (pollakiuria defined as more than one nocturnal urination and more than sixdaytime urination or leakage per day); Incontinent patient requiring functionalrehabilitation 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 staticdisorder: pain, hypertonia, muscle weakness, decreased or loss of motor control,trophic abnormality;

  • Patient who can make herself available to participate in the sessions regularly andwho believes that she will be able to complete the tenth treatment session no laterthan 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 theinvestigator at the time of recruitment, to perform the procedures under study;

  • Patient with social protection.

Exclusion

Exclusion Criteria:

  • Patient with peripheral or central neurological involvement (perianal or perivulvarsensitivity 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 behavioralimpairment that may, in the practitioner's judgment, interact with theself-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-termtreatment;

  • Patient with vaginal pathology (undiagnosed bleeding, cancer in the area to betreated);

  • Patient who has renounced her liberty by administrative or judicial sentence, or whois under guardianship or limited judicial protection;

  • Patient participating in an interventional clinical trial or testing/having testedan investigational drug and/or medical device within 30 days prior to inclusion inthe study in relation to the relevant pathology;

  • Patient who cannot read or write French;

  • Patient refusing to participate in the study.

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Electrical stimulation and biofeedback group
Phase:
Study Start date:
May 06, 2024
Estimated Completion Date:
December 06, 2024

Study 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

Connect with a study center

  • Pôle santé de la Nartassière

    Mouans-Sartoux, 06370
    France

    Site Not Available

  • Espace Human Physion

    Nîmes, 30000
    France

    Site Not Available

  • Human Physio

    Nîmes, 30000
    France

    Site Not Available

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