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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.

NCT05938855 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-12-16

No results posted yet for this 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.

Conditions

Interventions

DEVICE

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

Sponsors & Collaborators

  • CEISO

    collaborator INDUSTRY

  • Human Physio

    collaborator UNKNOWN

  • Pôle santé de la Nartassière

    collaborator UNKNOWN

  • Vivaltis

    lead INDUSTRY

Principal Investigators

  • Mathias Willame · Human Physio

  • Julie Perrin · Pôle santé de la Nartassière

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-06
Primary Completion
2024-12-06
Completion
2024-12-06

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05938855 on ClinicalTrials.gov