Clinical trial NCT05938855: 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.
Official title: Prospective Evaluation of the Performance and Safety of PHENIX LIBERTY, a Medical Device for Electrostimulation and Biofeedback, in the Treatment of Pelvic Static Disorders in Women With Urinary Incontinence.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Pelvic Floor Disorders
Keywords: Electrical stimulation
Biofeedback
Lead sponsor: Vivaltis
Sponsor class: INDUSTRY
Collaborators: name: CEISO
name: Human Physio
name: Pôle santé de la Nartassière
First posted: 2023-07-11
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Changes in the frequency of bladder weakness
timeFrame: Day 0 and Week 15 (at the end visit within the week after the 10th seance)
Secondary outcomes:
measure: Changes in the Pelvic Floor Impact Questionnaire (PFIQ-7) score assessing the impact of pelvic static disorders
timeFrame: Day 0 and Week 15 (at the end visit within the week after the 10th seance)
measure: Change in patients' visual analog scale (VAS) pain scores
timeFrame: Day 0 and Week 15 (at the end visit within the week after the 10th seance)
measure: Changes in the number of voids during the day and at night,
timeFrame: Day 0 and Week 15 (at the end visit within the week after the 10th seance)
measure: Change in the severity of leakage
timeFrame: Day 0 and Week 15 (at the end visit within the week after the 10th seance)
measure: Change in diuresis over twenty-four hours;
timeFrame: Day 0 and Week 15 (at the end visit within the week after the 10th seance)
measure: Change in the volume of urine voided at each voiding
timeFrame: Day 0 and Week 15 (at the end visit within the week after the 10th seance)
measure: Changes in the rate of improvement in perineal protection reflex during a coughing effort
timeFrame: Day 0 and Week 15 (at the end visit within the week after the 10th seance)
measure: Changes in the rate of improvement of hypertonia assessed through measurement of myoelectric activity
timeFrame: Day 0 and Week 15 (at the end visit within the week after the 10th seance)
measure: Changes in the rate of improvement in hypertonia assessed through measurement of perineal muscle tone
timeFrame: Day 0 and Week 15 (at the end visit within the week after the 10th seance)
measure: Evolution of vaginal microcirculation and trophicity according to the practitioner's subjective opinion
timeFrame: Day 0 and Week 15 (at the end visit within the week after the 10th seance)
measure: Changes in the rate of improvement in awakening and muscle strengthening assessed through measurement of myoelectric activity
timeFrame: Day 0 and Week 15 (at the end visit within the week after the 10th seance)
measure: Changes in the rate of improvement in awakening and muscle strengthening assessed through measurement of perineal muscle tone
timeFrame: Day 0 and Week 15 (at the end visit within the week after the 10th seance)
measure: Percentage of patients with an improvement in pelvic statics
timeFrame: Day 0 and Week 15 (at the end visit within the week after the 10th seance)
measure: Incidence of adverse events
timeFrame: At each visit, from day 0 to Week 15 (at the end visit within the week after the 10th seance)
measure: Evaluation of the Global Impression of Change Scale score after therapeutic management
timeFrame: Week 15 (at the end visit within the week after the 10th seance)
measure: Evaluation of responses to the patient satisfaction questionnaire on the use of the PHENIX LIBERTY device after therapeutic management
timeFrame: Week 15 (at the end visit within the week after the 10th seance)
measure: Evolution of the vaginal lubrication and hydration score for the evaluation of microcirculation and vaginal trophicity
timeFrame: Day 0 and Week 15 (at the end visit within the week after the 10th seance)
measure: Evolution of the vaginal acidity score for assessing vaginal microcirculation and trophicity
timeFrame: Day 0 and Week 15 (at the end visit within the week after the 10th seance)
Other outcomes:
Locations:
city: Mouans-Sartoux
country: France
facility: Pôle santé de la Nartassière
city: Nîmes
country: France
facility: Human Physio
Study officials:
affiliation: Human Physio
name: Mathias Willame
role: PRINCIPAL_INVESTIGATOR
affiliation: Pôle santé de la Nartassière
name: Julie Perrin
role: PRINCIPAL_INVESTIGATOR
References: