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 | Completed

• 1 other identifier: 2023-A02195-40
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Urinary Incontinence; Pelvic Floor Disorders

Keywords

Electrical stimulation; Biofeedback

Outcome Measures

Primary Outcomes (1)

• Changes in the frequency of bladder weakness

  A mictional grid will be used The mictional grid covers a period of forty-eight to seventy-two hours. It assesses the number of micturitions during the day and at night, and quantifies the volume of urine passed at each micturition, as well as diuresis over a 24-hour period. The mictional grid visualizes episodes of leakage, their quantity (small drops, beginning of micturition or massive leakage) and the moment of onset, such as during effort (coughing, sneezing, carrying a load, sport, etc.) or at rest.

  Day 0 and Week 15 (at the end visit within the week after the 10th seance)

Secondary Outcomes (18)

• Changes in the Pelvic Floor Impact Questionnaire (PFIQ-7) score assessing the impact of pelvic static disorders

  Day 0 and Week 15 (at the end visit within the week after the 10th seance)

• Change in patients' visual analog scale (VAS) pain scores

  Day 0 and Week 15 (at the end visit within the week after the 10th seance)

• Changes in the number of voids during the day and at night,

  Day 0 and Week 15 (at the end visit within the week after the 10th seance)

• Change in the severity of leakage

  Day 0 and Week 15 (at the end visit within the week after the 10th seance)

• Change in diuresis over twenty-four hours;

  Day 0 and Week 15 (at the end visit within the week after the 10th seance)

Study Arms (1)

Standard of care plus additional questionaire

OTHER

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.

Device: Electrical stimulation and biofeedback with the medical device Phenix Liberty

Interventions

Electrical stimulation and biofeedback with the medical device Phenix Liberty 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

Standard of care plus additional questionaire

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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 who cannot read or write French;
• Patient refusing to participate in the study.

Sponsors & Collaborators

• Vivaltis: lead
• CEISO: collaborator
• Human Physio: collaborator
• Pôle santé de la Nartassière: collaborator

Study Sites (2)

Pôle santé de la Nartassière

Mouans-Sartoux, 06370, France

Location

Human Physio

Nîmes, 30000, France

Location

MeSH Terms

Conditions

Urinary Incontinence; Pelvic Floor Disorders

Interventions

Electric Stimulation; Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pregnancy Complications

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Mathias Willame

  Human Physio

  PRINCIPAL INVESTIGATOR

• Julie Perrin

  Pôle santé de la Nartassière

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 11, 2023
• Study Start: May 6, 2024
• Primary Completion: December 6, 2024
• Study Completion: December 6, 2024
• Last Updated: December 16, 2024

Record last verified: 2024-12

Locations

FR (2)