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.

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.

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

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".

The number of voids during 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.

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.

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.

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.

A surface Electromyography (EMG) will be used. Muscle electrical activity provides a "map" of muscle recruitment according to exercise conditions (position, relative load, type of resistance, type of support, etc.).

A surface Electromyography (EMG) will be used. Muscle electrical activity provides a "map" of muscle recruitment according to exercise conditions (position, relative load, type of resistance, type of support, etc.).

Modified Oxford gradient will be used. This is an assessment of pelvic floor muscle strength by the practitioner, using vaginal palpation.

The score is scored as follows: 0 → no detectable pelvic floor contraction , 1 → very weak pelvic floor contraction, 2 → weak pelvic floor contraction, 3 → moderate pelvic floor contraction, 4 → good pelvic floor contraction, 5 → strong pelvic floor contraction

This outcome will be assessed according to the practitioner's opinion regarding visual assessment, palpation assessment of the vagina.

The practitioners will indicated if on his opinion there is a an abnormal vaginal microcirculation and trophicity.

A surface Electromyography (EMG) and a vaginal intra-cavity probe will be used. Muscle electrical activity provides a "map" of muscle recruitment according to exercise conditions (position, relative load, type of resistance, type of support, etc.).

Modified Oxford gradient will be used. This is an assessment of pelvic floor muscle strength by the practitioner, using vaginal palpation.

The score is scored as follows: 0 → no detectable pelvic floor contraction , 1 → very weak pelvic floor contraction, 2 → weak pelvic floor contraction, 3 → moderate pelvic floor contraction, 4 → good pelvic floor contraction, 5 → strong pelvic floor contraction

This outcome will be assessed according to the practitioner's opinion

Rate of the incidence of adverse events related to the medical device

The Patient's Global Impression of Change (PGIC) Scale is a questionnaire designed to express the patient's overall impression of changes in symptoms, activities, emotions and quality of life following therapeutic treatment17. The patient answers the first question by ticking one of the proposed answers, each answer corresponding to a score from 1 to 7. The patient then scores his or her impression of progress on a scale from 0 to 10.

The satisfaction questionnaire is constructed on the basis of the Likert Scale. The sponsor has written an questionnaire regarding the use of the Phenix Liberty for the patient.

The Likert scale (or attitude scale) is a semantic rating system, generally consisting of 5 or 7 items, used in surveys to measure and evaluate perceptions, attitudes and opinions.

The evaluation will be based on the following responses: Strongly agree (=5) ; Agree (=4) ; Rather agree (=3) ; Rather disagree (=2) ; Disagree (=1= ; Strongly disagree (=0).

The minimum score 0 means a worse outcome and the maximum score 5 means a better outcome.

Vaginal lubrication and hydration can also be used to assess vaginal microcirculation and trophicity. This parameter is observed by the practitioner through visual and tactile observation. The score is as follows: 1 → no vaginal lubrication/hydration (altered mucosa), 2 → no vaginal lubrication/hydration (unaltered mucosa), 3 → very low vaginal lubrication/hydration, 4 → moderate vaginal lubrication/hydration, 5 → normal vaginal lubrication/hydration.

Vaginal pH is an important element in determining vaginal health, encompassing microcirculation and vaginal trophicity. The vagina is an acidic environment (pH ≤ 4.6) thanks to its healthy bacterial flora, which secrete lactic acid to limit the growth of many pathogenic microbes. A scale will be used to frame the different pH values. The score is as follows: 1 → pH ≥6.1, 2 → pH = 5.6-6, 3 → 5.1-5.5, 4 → 4.7-5.0, 5 → ≤4.6. (Appendix 6bis) Score 1 represents an abnormal pH and score 5 represents a normal pH.