NCT Number: NCT07105150
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 :
* receive either the video-based education program or a paper information document (providing similar information) prior to the sessions with the physiotherapist * then follow pelvic floor rehabilitation sessions with the physiotherapist according to usual practice * complete the urinary incontinence questionnaire after the 4-week video education program (intervention group) or 4 weeks after receiving the paper document (control group), and after each pelvic floor rehabilitation session with the physiotherapist and at the end of the sessions * will be monitored at 1 and 2 years to evaluate urinary incontinence following the intervention.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Mme ROSSIGNOL Marie - Kinésithérapeute - 5 place du Lavoir, Buxy, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
The control group will receive a paper information document (containing the same information as the intervention group) during the 4-week period
Time frame: At the end of the video-based education program (5 weeks after inclusion)
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)
Time frame: from inclusion until the end of the video education program (5 weeks after inclusion)
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)
Time frame: from inclusion to 5 weeks following the distribution of the paper information document
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
Time frame: ICIQ-SF score recorded after each pelvic floor rehabilitation session, through end of rehabilitation, an average of 3 months
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
Time frame: ICIQ-SF score recorded after each pelvic floor rehabilitation session, through end of rehabilitation, an average of 3 months
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
Time frame: ICIQ-SF score recorded after each pelvic floor rehabilitation session, through end of rehabilitation, an average of 3 months
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
Time frame: ICIQ-SF score recorded after each pelvic floor rehabilitation sessions, through end of rehabilitation, an average of 3 months
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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 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
Time frame: 5 weeks after inclusion and at the end of the pelvic floor rehabilitation sessions, an average of 3 months
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
Time frame: 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 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)
Time frame: 5 weeks after inclusion and at the end of the pelvic floor rehabilitation sessions, an average of 3 months
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)
Time frame: 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 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)
Time frame: 5 weeks after inclusion and at the end of the pelvic floor rehabilitation sessions, an average of 3 months
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)
Time frame: at the end of the pelvic floor rehablitation sessions and after 12 and 24 months
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
Time frame: at the end of the pelvic floor rehablitation sessions and after 12 and 24 months
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
Time frame: at 12 and 24 months
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
Time frame: at 12 and 24 months
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
Time frame: after each video of the program, once a week for 4 weeks
Difference in correct answers on questionnaires before and after each video, and satisfaction rating (0 to 10) after each video of the program
Time frame: at the end of the video-based education program, 5 weeks after inclusion
number of views for each video, time of day, total time spent on viewings (automatically collected via the connection platform)
Time frame: 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
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
Time frame: at the end of the video-based education program versus the paper information document, 5 weeks after inclusion
ICIQ-SF score at the end of the video-based education program vs the paper information document according to the UI type
Time frame: after the video-based education program, 5 weeks after inclusion
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
Contact information is provided by the study sponsor or research team.
Anne Cecile Pizzoferrato, M.D
CONTACT
Veronique Blanchard
CONTACT
Poitiers University Hospital
Other
Efficacy of an Educational Video-Based Program to Treat Urinary Incontinence in Women Referred for Pelvic Floor Rehabilitation
Acronym: EVRP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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