Efficacy of a Video-Based Educational Program on Female Urinary Incontinence
ConditionUrinary Incontinence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorPoitiers University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Any woman referred for pelvic floor rehabilitation sessions for urinary incontinence (defined as 'any involuntary leakage reported by the patient' according to the International Continence Society)
Women requiring perineal rehabilitation for urinary incontinence
Aged 18 years or older
Having access to a connected device (tablet, smartphone, computer)
Disqualifiers
Women unable to complete questionnaires (unable to read French or unable to write)
Visually impaired individuals who cannot watch the video or read the printed material
Genital prolapse extending beyond the hymen
Documented neurological disorders
Trial design
Design model
Parallel
Treatments tested in this trial
video-based education program
BehavioralThe 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.
written information
Other interventionThe control group will receive a paper information document (containing the same information as the intervention group) during the 4-week period
Treatment groups
144 Participants
are divided into 2 treatment groupsGroup A: video-based education program groupExperimental treatment 1 intervention
Group B: written information groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
At the end of the video-based education program (5 weeks after inclusion)Secondary outcomes
1
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)
Time frame
from inclusion until the end of the video education program (5 weeks after inclusion)2
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
Time frame
from inclusion to 5 weeks following the distribution of the paper information document3
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
Time frame
ICIQ-SF score recorded after each pelvic floor rehabilitation session, through end of rehabilitation, an average of 3 months4
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
Time frame
ICIQ-SF score recorded after each pelvic floor rehabilitation session, through end of rehabilitation, an average of 3 monthsSponsors and contacts
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Source ClinicalTrials.gov