Evaluation of the Efficacy of PHENIX LIBERTY, Electrical Stimulation and Biofeedback Medical Device, in the Treatment of Urinary Incontinence

Study Overview
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Brief Summary
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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
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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 observational, non-comparative, single-center, open-label study of a CE-marked medical device. Intervention : This study is part of a routine observational study. As a result, management will not be modified. The intervention will be conduct as follow: 10 sessions of electrical stimulation and biofeedback performed between 6 and 8 weeks ; Sessions performed at regular intervals according to a schedule drawn up by the physiotherapist. The patients follow-up are up to 8 weeks after the first intervention.

Official Title
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Prospective Evaluation of the Efficacy of PHENIX LIBERTY, Electrical Stimulation and Biofeedback Medical Device, in the Treatment of Pelvic Static Disorders in Women With Urinary Incontinence

Conditions
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Urinary Incontinence, Pelvic Floor Disorders

Intervention / Treatment
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* Device: Electrical stimulation and biofeedback group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with incontinence (involuntary loss of urine) and/or overactive bladder (pollakiuria defined as more than one nocturnal micturition and more than six daytime micturitions or one leak per day); Adult patients (between 18 and 65 years of age); Patient presenting at least one of the following symptoms linked to a pelvic static disorder: pain, hypertonia, muscle weakness, reduction or loss of motor control, trophic anomaly; Patient able to make herself available to attend sessions regularly and expecting to be able to complete the tenth treatment session no later than 8 weeks after V0; Patient who has not expressed any objection to participating in the study; Patient physically and mentally willing and able, according to the investigator's judgement at the time of recruitment, to carry out the procedures under study; The patient is covered by social security. Exclusion Criteria: Patients with peripheral or central neurological damage (sensitivity disorder in the perianal or perivulvar area); Patients who have had more than 3 pregnancies; Patients who have suffered a stroke, have Alzheimer's disease, have multiple sclerosis or have cognitive and/or behavioural disorders which, in the practitioner's judgement, are likely to interact with the evaluation by self-questionnaire or biofeedback; Pregnant at the time of the inclusion visit; Patient with an implanted cardiac or spinal cord pacemaker; Patient with hypersensitivity to electrostimulation; Patient with chronic or recurrent vaginal or urinary infection on long-term TT; Patient with a vaginal pathology (undiagnosed bleeding, cancer in the area to be treated); Patients who have relinquished their liberty by administrative or judicial decision, or who are under guardianship or limited judicial protection; Patient taking part in another interventional clinical trial or testing/having tested an investigational medicinal product in the 30 days prior to inclusion in the study; Patient who cannot read or write French; Patient refusing to participate in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard of care<br>Electrical stimulation and biofeedback by the medical device PHENIX LIBERTY | Device: Electrical stimulation and biofeedback group<br>* 10 sessions of electrical stimulation and biofeedback performed between 6 and 8 weeks at regular intervals according to a schedule drawn up by the physiotherapist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 8 (end of 10th seance) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the Pelvic Floor Impact Questionnaire (PFIQ-7) score assessing the impact of pelvic static disorders | The Pelvic Floor Impact Questionnaire (PFIQ-7) will be used, it assess the social impact of pelvic statics disorders. The questionnaire has 7 questions and 3 columns. The first column concerns urinary symptoms, the 2nd column concerns colorectal-anal symptoms and the 3rd column concerns genital prolapse symptoms. All questions use the following answer format: Not at all = 0 Somewhat = 1 Moderately = 2 A lot = 3 Each column gives a score between 0 and 100, which will be added to give the total score of the PFIQ-7 scale between 0 and 300. A high score indicates a significant impact of pelvic static disorders | Day 0 and Week 8 (end of 10th seance) | 
| Change in patients' visual analog scale (VAS) pain scores | The pain caused by the pelvic floor disorder will be assessed by the Visual Analogue Scale (VAS). The VAS is made up of a 10-centimeter line anchored by two ends of the pain. 10 is the first end being the maximum pain imaginable and 0 is the other end being no pain. | Day 0 and Week 8 (end of 10th seance) | 
| Changes in the number of voids during the day and at night, | The number of voids durind the day and at night will be assessed. The same 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 8 (end of 10th seance) | 
| Change in the severity of leakage | The severity of leakage will be assessed (small drops, onset of micturition or massive leakage) The same 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 8 (end of 10th seance) | 
| Change in diuresis over twenty-four hours; | The number of voiding sensation over twenty-four hours will be assessed The same 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 8 (end of 10th seance) | 
| Change in the volume of urine voided at each voiding | The volume of urine voided at each voiding will be assessed in deciliter The same 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 8 (end of 10th seance) | 
| Changes in the rate of improvement in perineal protection reflex | A surface Electromyography (EMG) will be used. | Day 0 and Week 8 (end of 10th seance) | 
| Changes in the rate of improvement of hypertonia assessed through measurement of myoelectric activity | A surface Electromyography (EMG) will be used | Day 0 and Week 8 (end of 10th seance) | 
| Changes in the rate of improvement in hypertonia assessed through measurement of perineal muscle tone | Modified Oxford gradient will be used. This is an assessment of pelvic floor muscle strength by the practitioner, using vaginal palpation. | Day 0 and Week 8 (end of 10th seance) | 
| Change in Vaginal Health Index Score (VHIS) | The Vaginal Health Index Score (VHIS) will be used. The Vaginal Health Score (VHIS) analyses 5 vaginal parameters: vaginal elasticity, volume of vaginal secretions, vaginal pH, integrity of vaginal wall epithelium and vaginal lubrication/hydration. | Day 0 and Week 8 (end of 10th seance) | 
| Changes in the rate of improvement in awakening and muscle strengthening assessed through measurement of myoelectric activity | A surface Electromyography (EMG) will be used. | Day 0 and Week 8 (end of 10th seance) | 
| Changes in the rate of improvement in awakening and muscle strengthening assessed through measurement of perineal muscle tone | Modified Oxford gradient will be used. This is an assessment of pelvic floor muscle strength by the practitioner, using vaginal palpation | Day 0 and Week 8 (end of 10th seance) | 
| Percentage of patients with an improvement in pelvic statics | This outcome will be assessed according to the practitioner's opinion | Day 0 and Week 8 (end of 10th seance) | 
| Incidence of adverse events | Rate of the incidence of adverse events related to the medical device | Day 0 and Week 8 (end of 10th seance) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electrical stimulation, Biofeedback