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| Name | Class |
|---|---|
| CEISO | INDUSTRY |
| Human Physio | UNKNOWN |
| Pôle santé de la Nartassière | UNKNOWN |
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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.
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:
In total, the patient will be followed 15 weeks maximum
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 :
|
| 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 15 (at the end visit within the week after the 10th seance) |
| 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:
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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mathias Willame | Human Physio | Principal Investigator |
| Julie Perrin | Pôle santé de la Nartassière | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pôle santé de la Nartassière | Mouans-Sartoux | 06370 | France | |||
| Human Physio |
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|
| 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 | 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 15 (at the end visit within the week after the 10th seance) |
| Changes in the number of voids during the day and at night, | 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. | Day 0 and Week 15 (at the end visit within the week after the 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 15 (at the end visit within the week after the 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 15 (at the end visit within the week after the 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 15 (at the end visit within the week after the 10th seance) |
| Changes in the rate of improvement in perineal protection reflex during a coughing effort | 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.). | Day 0 and Week 15 (at the end visit within the week after the 10th seance) |
| Changes in the rate of improvement of hypertonia assessed through measurement of myoelectric activity | 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.). | Day 0 and Week 15 (at the end visit within the week after the 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. 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 | Day 0 and Week 15 (at the end visit within the week after the 10th seance) |
| Evolution of vaginal microcirculation and trophicity according to the practitioner's subjective opinion | 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. | Day 0 and Week 15 (at the end visit within the week after the 10th seance) |
| Changes in the rate of improvement in awakening and muscle strengthening assessed through measurement of myoelectric activity | 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.). | Day 0 and Week 15 (at the end visit within the week after the 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. 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 | Day 0 and Week 15 (at the end visit within the week after the 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 15 (at the end visit within the week after the 10th seance) |
| Incidence of adverse events | Rate of the incidence of adverse events related to the medical device | At each visit, from day 0 to Week 15 (at the end visit within the week after the 10th seance) |
| Evaluation of the Global Impression of Change Scale score after therapeutic management | 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. | Week 15 (at the end visit within the week after the 10th seance) |
| Evaluation of responses to the patient satisfaction questionnaire on the use of the PHENIX LIBERTY device after therapeutic management | 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. | Week 15 (at the end visit within the week after the 10th seance) |
| Evolution of the vaginal lubrication and hydration score for the evaluation of microcirculation and vaginal trophicity | 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. | Day 0 and Week 15 (at the end visit within the week after the 10th seance) |
| Evolution of the vaginal acidity score for assessing vaginal microcirculation and trophicity | 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. | Day 0 and Week 15 (at the end visit within the week after the 10th seance) |
| Nîmes |
| 30000 |
| France |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D059952 | Pelvic Floor Disorders |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011248 | Pregnancy Complications |
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| ID | Term |
|---|---|
| D004558 | Electric Stimulation |
| D001676 | Biofeedback, Psychology |
| ID | Term |
|---|---|
| D010812 | Physical Stimulation |
| D008919 | Investigative Techniques |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |
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