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The aim of this clinical trial is to assess the effectiveness of a 4-week video-based education program in enhancing urinary continence among women with urinary incontinence referred for pelvic floor rehabilitation
The main question it aims to answer is :
• Does a structured video-based education program reduce the symptoms of urinary incontinence before any pelvic floor muscle strengthening ? Researchers will compare this program to a paper document (providing similar information) to see if this improves urinary continence in women suffering from urinary incontinence.
Participants will :
The video-based education program will include 4 workshops of 20 minutes each, at a rate of 1 video per week:
Video 1: Anatomy and physiology of the pelvic floor; Video 2: Physiology of the urinary tract; Video 3: Physiology of the digestive tract; Video 4: Pathophysiology of urinary incontinence and other pelvic floor disorders (genital prolapse and anal incontinence) and preventive measures in daily activities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| video-based education program group | Experimental |
| |
| written information group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| video-based education program | Behavioral | The video-based education program will include 4 workshops of 20 minutes each, at a rate of 1 video per week: Video 1: Anatomy and physiology of the pelvic floor; Video 2: Physiology of the urinary tract; Video 3: Physiology of the digestive tract; Video 4: Pathophysiology of urinary incontinence and other pelvic floor disorders (genital prolapse and anal incontinence) and preventive measures in daily activities. |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary incontinence score comparison between the 2 groups | the urinary incontinence score will measured using the ICIQ-SF (International Consultation on Incontinence Questionnaire-Short Form), ranging from 0 (corresponding to 'no urinary incontinence') to 21 (corresponding to 'very severe urinary incontinence'), collected after the video-based education program in the intervention group (scheduled over 4 weeks) and within the same timeframe in the control group (which received only the information document) | At the end of the video-based education program (5 weeks after inclusion) |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary incontinence score evolution in the intervention group | Change in urinary incontinence score (International Consultation on Incontinence Questionnaire- Short Form, ICIQ-SF, ranging from 0 = 'no incontinence' to 21 = 'very severe incontinence') between inclusion and the end of the video education program in the intervention group (scheduled over 4 weeks) | from inclusion until the end of the video education program (5 weeks after inclusion) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Veronique Blanchard | Contact | +33614222885 | verobmsb@hotmail.com | |
| Anne Cecile Pizzoferrato, M.D | Contact | +33682176675 | anne-cecile.pizzoferrato@chu-poitiers.fr |
| Name | Affiliation | Role |
|---|---|---|
| Anne Cecile Pizzoferrato, M.D | University Hospital Center of Poitiers | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mme ROSSIGNOL Marie - Kinésithérapeute - 5 place du Lavoir | Not yet recruiting | Buxy | 71390 | France |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| written information | Other | The control group will receive a paper information document (containing the same information as the intervention group) during the 4-week period |
|
| Urinary incontinence score evolution in the control group | Change in urinary incontinence score (International Consultation on Incontinence Questionnaire- Short Form, ICIQ-SF, ranging from 0 = 'no incontinence' to 21 = 'very severe incontinence') between inclusion and 5 weeks following the distribution of the paper information document | from inclusion to 5 weeks following the distribution of the paper information document |
| Number of pelvic floor rehabilitation sessions required in the intervention group | The number of rehabilitation sessions needed to achieve a reduction of 3 points or more in the urinary incontinence score (ICIQ-SF) - a difference considered clinically significant - or a reduction of less than 3 points, provided that the decrease is deemed sufficient or satisfactory by the physiotherapist | ICIQ-SF score recorded after each pelvic floor rehabilitation session, through end of rehabilitation, an average of 3 months |
| Number of pelvic floor rehabilitation sessions required in the control group | The number of rehabilitation sessions needed to achieve a reduction of 3 points or more in the urinary incontinence score (ICIQ-SF) - a difference considered clinically significant - or a reduction of less than 3 points, provided that the decrease is deemed sufficient or satisfactory by the physiotherapist | ICIQ-SF score recorded after each pelvic floor rehabilitation session, through end of rehabilitation, an average of 3 months |
| Urinary incontinence score evolution during the pelvic floor rehabilitation sessions in the intervention group | The variation in the urinary incontinence score (ICIQ-SF) from first pelvic floor rehabilitation session to the 10th session and up to the last session | ICIQ-SF score recorded after each pelvic floor rehabilitation session, through end of rehabilitation, an average of 3 months |
| Urinary incontinence score evolution during the pelvic floor rehabilitation sessions in the control group | The variation in the urinary incontinence score (ICIQ-SF) from first pelvic floor rehabilitation session to the 10th session and up to the last session | ICIQ-SF score recorded after each pelvic floor rehabilitation sessions, through end of rehabilitation, an average of 3 months |
| Quality of life score evolution in the intervention group | The difference in the quality of life score associated with urinary symptoms (specific CONTILIFE questionnaire) and general quality of life (EuroQoL-5D questionnaire) at inclusion and after the video-based education program , as well as between inclusion and at the end of the pelvic floor rehabilitation sessions | at inclusion and after the video-based education program (5 weeks after inclusion) , as well as between inclusion and at the end of the pelvic floor rehabilitation sessions, an average of 3 months |
| Quality of life score evolution in the control group | The difference in the quality of life score associated with urinary symptoms (specific CONTILIFE questionnaire) and general quality of life (EuroQoL-5D questionnaire) at inclusion and 5 weeks after the distribution of the paper document information, as well as between inclusion and at the end of the pelvic floor rehabilitation sessions | at inclusion and 5 weeks after the distribution of the paper document information, as well as between inclusion and at the end of the pelvic floor rehabilitation sessions, an average of 3 months |
| Pelvic floor and sexual symptoms scores evolution in the intervention group | The difference in the score for pelvic floor and sexual symptoms that may be associated with urinary incontinence (FPFQ - Female Pelvic Floor Questionnaire) between inclusion and the end of the video-based education program, as well as between inclusion and the end of the pelvic floor rehabilitation sessions | between inclusion and the end of the video-based education program (5 weeks after inclusion), as well as between inclusion and the end of the pelvic floor rehabilitation sessions, an average of 3 months |
| Pelvic floor and sexual symptoms scores evolution in the control group | The difference in the score for pelvic floor and sexual symptoms that may be associated with urinary incontinence (FPFQ - Female Pelvic Floor Questionnaire) between inclusion and 4 weeks after the distribution of the paper information document, as well as between inclusion and the end of the pelvic floor rehabilitation sessions | at inclusion and 5 weeks after the distribution of the paper information document, as well as between inclusion and the end of the pelvic floor rehabilitation sessions, an average of 3 months |
| Patient-perceived improvement score evolution in the intervention group | Patient-perceived improvement score evaluated by the PGII (Patient Global Impression of Improvement) questionnaire after the video-based education program and at the end of the pelvic floor rehabilitation sessions | after the video-based education program (5 weeks after inclusion)and at the end of the pelvic floor rehabilitation sessions, an average of 3 months |
| Patient-perceived improvement score evolution in the control group | Patient-perceived improvement score evaluated by the PGII (Patient Global Impression of Improvement) questionnaire 5 weeks after the distribution of the paper information document and at the end of the pelvic floor rehabilitation sessions | 5 weeks after inclusion and at the end of the pelvic floor rehabilitation sessions, an average of 3 months |
| Patient-perceived improvement score evolution according to the urinary incontinence type in the intervention group | Patient-perceived improvement score evaluated by the PGII (Patient Global Impression of Improvement) questionnaire after the video-based education program and at the end of the pelvic floor rehabilitation sessions, according to the urinary incontinence type (Stress urinary incontinence, Urge urinary incontinence and mixed incontinence) | after the video-based education program (5 weeks after inclusion) and at the end of the pelvic floor rehabilitation sessions, an average of 3 months) |
| Patient-perceived improvement score evolution according to the type of urinary incontinence | Patient-perceived improvement score evaluated by the PGII (Patient Global Impression of Improvement) questionnaire 5 weeks after the distribution of the paper information document and at the end of the pelvic floor rehabilitation sessions, according to the urinary incontinence type (Stress urinary incontinence, Urge urinary incontinence and mixed incontinence) | 5 weeks after inclusion and at the end of the pelvic floor rehabilitation sessions, an average of 3 months |
| Patient-perceived improvement score evolution according to the dimensions of the Urinary Leakage Circumstances questionnaire in the intervention group | Patient-perceived improvement score evaluated by the PGII (Patient Global Impression of Improvement) questionnaire after the video-based education program and at the end of the pelvic floor rehabilitation sessions, according to the dimensions of the Urinary Leakage Circumstances questionnaire (ULCQ) | after the video-based education program (5 weeks after inclusion) and at the end of the pelvic floor rehabilitation sessions, an average of 3 months |
| Patient-perceived improvement score evolution according to the dimensions of the Urinary Leakage Circumstances questionnaire in the control group | Patient-perceived improvement score evaluated by the PGII (Patient Global Impression of Improvement) questionnaire 5 weeks after the disctribution of the paper information document and at the end of the pelvic floor rehabilitation sessions, according to the dimensions of the Urinary Leakage Circumstances questionnaire (ULCQ) | 5 weeks after inclusion and at the end of the pelvic floor rehabilitation sessions, an average of 3 months |
| ICIQ-SF score evolution 12 and 24 month after the end of the pelvic floor rehabilitation sessions in the intervention group | Difference between the ICIQ-SF score at the end of the pelvic floor rehablitation sessions and the ICIQ-SF score at 12 months and at 24 months in the intervention group | at the end of the pelvic floor rehablitation sessions and after 12 and 24 months |
| ICIQ-SF score evolution at 12 and 24 months after the end of the pelvic floor rehabilitation sessions | Difference between the ICIQ-SF score at the end of the pelvic floor rehablitation sessions and the ICIQ-SF score at 12 months and at 24 months in the control group | at the end of the pelvic floor rehablitation sessions and after 12 and 24 months |
| Urinary incontinence management 12 and 24 months after the end of the pelvic floor rehabilitation sessions in the intervention group | New management of urinary incontinence, defined by new pelvic floor rehabilitation sessions, urinary incontinence or prolapse surgery, initiation of anticholinergic treatment, or any other therapy for urinary urinary at 12 and 24 months | at 12 and 24 months |
| Urinary incontinence management 12 and 24 months after the end of the pelvic floor rehabilitation sessions in the control group | New management of urinary incontinence, defined by new pelvic floor rehabilitation sessions, urinary incontinence or prolapse surgery, initiation of anticholinergic treatment, or any other therapy for urinary urinary at 12 and 24 months | at 12 and 24 months |
| Impact of the videos on Knowledge and Satisfaction Ratings | Difference in correct answers on questionnaires before and after each video, and satisfaction rating (0 to 10) after each video of the program | after each video of the program, once a week for 4 weeks |
| Usage of the videos provided in the intervention group | number of views for each video, time of day, total time spent on viewings (automatically collected via the connection platform) | at the end of the video-based education program, 5 weeks after inclusion |
| Physical activity evolution after pelvic floor rehabilitation in the entire population and afetr 12 and 24 months | Compare the evolution of physical activity practice (intensity) from inclusion to the end of the pelvic floor rehabilitation sessions and after 12 and 24 months | from inclusion to the end of the pelvic floor rehabilitation sessions (an average of 3 months), and after 12 and 24 months after the end of rehabilitation |
| Urinary incontinence score between the 2 groups according the UI type | ICIQ-SF score at the end of the video-based education program vs the paper information document according to the UI type | at the end of the video-based education program versus the paper information document, 5 weeks after inclusion |
| Urinary incontinence score according to the dimensions of the Urinary Leakage Questionnaire | to compare the ICIQ-SF score in each of the dimensions of the urinary leakage circumstances questionnaire after the video-based education program versus the paper information document | after the video-based education program, 5 weeks after inclusion |
| Mme BLANCHARD Véronique - Kinésithérapeute | Recruiting | Chanceaux-sur-Choisille | 37390 | France |
|
| Mme GIRARD Delphine - kinésithérapeute - 14 rue de la Liberté | Not yet recruiting | Embrun | 05200 | France |
|
| Mme LIAGRE Blandine - Kinésithérapeute - 120 rue de Chanzy | Recruiting | Hellemmes-Lille | 59260 | France |
|
| Mme BESSON Alice - Kinésithérapeute - 22 rue Benjamin Franklin | Not yet recruiting | La Roche-sur-Yon | 85000 | France |
|
| Mme OLIVIER Mathilde - Groupe médical du Barry - 34 Bis Rue du Quatre Septembre | Not yet recruiting | Montignac | 24290 | France |
|
| Mme CALONNE Hélène - Kinésithérapeute - 23 rue Franiatte | Not yet recruiting | Montigny-lès-Metz | 57950 | France |
|
| Mme LE TILLY Marine - Kinésithérapeute - 181 rue Legendre | Not yet recruiting | Paris | 75017 | France |
|
| Mme GIEN Isabelle - Kinésithérapeute - 2 Rue Adrienne Bolland | Not yet recruiting | Saint-Jean-de-Braye | 45800 | France |
|
| Mme LACOMBE Florence - Kinésithérapeute - 2 Rue Gabriel Durand | Recruiting | Saint-Médard-en-Jalles | 33160 | France |
|
| Mme RIERE Claire - Kinésithérapeute - 62 Route de Saint-Aubin | Recruiting | Saint-Médard-en-Jalles | 53218 | France |
|
| Mme GRUYER DROUET Laurence - Kinésithérapeute - 7 Rue Jean Baptiste Clément | Recruiting | Villejuif | 94800 | France |
|
| 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 |