The recommended treatment for urinary incontinence (UI) in women is individualised pelvic floor muscle (PFM) training, a costly and resource-intense approach; one Canada is currently unable to meet. This non-inferiority randomized control trial seeks to determine if group-based PFM training is as effective as individualised PFM training for treating UI in women 65 and over, and to establish the cost-effectiveness of both. Demonstrating that group-based treatment is at least as good as individualised one-on-one treatment and more cost-effective would warrant including group-based PFM training as a first-line UI treatment.
The incidence of urinary incontinence (UI) in women increases with age but, unbeknownst to many, it is not a normal part of aging and, in most cases, can be effectively treated. Yet today, the majority of senior women go untreated due to a lack of both human and financial resources. In Canada, there are currently 3 million senior women. Over the next 15 years their numbers are expected to grow significantly, as will the incidence of UI. The number of senior women requiring treatment, let alone the future demand, makes it imperative that more cost-effective treatments be identified. The prevalence of UI in community- dwelling women 65 and over is high - 55% experience stress or urge UI, or even both, and of these, 20 to 25% are classified as having severe symptoms. Not only is UI a serious medical condition but it is also undeniably a social problem, engendering embarrassment and negative self-perceptions. It is associated with reduced social interactions and physical activities, with poor self-rated health, impaired emotional and psychological well-being and impaired sexual relationships. Moreover, it doubles women's risk of being admitted to a nursing home, independent of age or the presence of any other co-morbid conditions. It severely undermines a woman's right to healthy aging. Without doubt, this pervasive and serious condition requires immediate attention. Demographics, the negative impact on older women's functional autonomy and the current unmet treatment needs alone renders improving continence care for older women a priority for the Institute of Aging. This study aims to evaluate if group- based physiotherapy treatment is at least as good as individualized one-on-one physiotherapy treatment for treating urinary incontinence in aging women. The treatment efficacy will be assessed in 364 women (aged 60 years and older) suffering from stress or mixed urinary incontinence and recruited in 4 hospitals and in the community.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
362
Multimodal Group physiotherapy 12 weeks of weekly Group physiotherapy treatments including education and pelvic floor muscle exercises
Multimodal Individual physiotherapy 12 weeks of weekly Individual physiotherapy treatments including education and pelvic floor muscle exercises
Laboratoire incontinence et vieillissement CRIUGM
Montreal, Quebec, Canada
Change in the number of UI episodes
evaluated with a 7-day bladder diary
Time frame: at recruitment, 13 weeks after recruitment and 12 months after recruitment, and 8 years after recruitment for those who completed the 12-month evaluation
Symptoms and degree to which UI-associated symptoms are troubling or bothersome
evaluated using the International Consultation on Incontinence questionnaire on urinary incontinence (ICIQ-UI short form)
Time frame: at recruitment, 13 weeks after recruitment and 12 months after recruitment, and 8 years after recruitment for those who completed the 12-month evaluation.
Symptoms and degree to which UI-associated symptoms are troubling or bothersome
evaluated using the International Consultation on Incontinence questionnaire on nocturia (ICIQ-Nocturia)
Time frame: at recruitment, 13 weeks after recruitment and 12 months after recruitment, and 8 years after recruitment for those who completed the 12-month evaluation.
Symptoms and degree to which UI-associated symptoms are troubling or bothersome
evaluated using the 24h PAD test
Time frame: at recruitment, 13 weeks after recruitment and 12 months after recruitment.
Symptoms and degree to which UI-associated symptoms are troubling or bothersome
evaluated using the International Consultation on Incontinence Questionnaire - Vaginal Symptoms Module (ICIQ-VS)
Time frame: at recruitment, 13 weeks after recruitment and 12 months after recruitment.
Symptoms and degree to which UI-associated symptoms are troubling or bothersome
evaluated using the International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS)
Time frame: at recruitment, 13 weeks after recruitment and 12 months after recruitment.
UI related QOL
evaluated using the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol)
Time frame: at recruitment, 13 weeks after recruitment and 12 months after recruitment, and 8 years after recruitment for those who completed the 12-month evaluation
UI related self-efficacy
evaluated using the Geriatric self-efficacy index
Time frame: at recruitment, 13 weeks after recruitment and 12 months after recruitment
UI related self-efficacy
evaluated using the Broom PFM Self-efficacy scale
Time frame: 13 weeks after recruitment (recollection of what was before recruitment and what is now) and 12 months after recruitment, and 8 years after recruitment for those who completed the 12-month evaluation
Costs related to interventions
evaluated using the modified Dowel-Bryant Incontinence Cost Index
Time frame: at recruitment, 13 weeks after recruitment and 12 months after recruitment, and 8 years after recruitment for those who completed the 12-month evaluation
Anthropometric measurements
evaluated using height and weight measurements, which will be combined to report BMI in kg/m\^2
Time frame: at recruitment, 13 weeks after recruitment and 12 months after recruitment
PFM function
evaluated combining digital palpation (Oxford scale), vaginal atrophy index and dynamometry
Time frame: at recruitment, 13 weeks after recruitment and 12 months after recruitment
PFM morphology
evaluated using transperineal US
Time frame: at recruitment, 13 weeks after recruitment and 12 months after recruitment
Patient reported improvement and satisfaction
evaluated using Patient global impression of improvement (PGI-I) and Benefit and willingness
Time frame: 13 weeks after recruitment and 12 months after recruitment
Adherence to intervention and home exercises
evaluated using homemade questionnaire including attendance to intervention and assiduity to home exercises program
Time frame: after recruitment (once/week during 12 weeks), 13 weeks after after recruitment, 6 months after recruitment, at 9 months after recruitment, 12 months after recruitment, and 8 years after recruitment for those who completed the 12-month evaluation
Qualitative interview
evaluated using homemade questionnaire including assiduity to lifestyle modification, changes in general health status, changes in medication, perceived change in UI symptoms, consultation with healthcare professionals for UI, and use of additional treatments for UI.
Time frame: 8 years after recruitement for those who completed the 12-month evaluation
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