Urinary Incontinence, Urinary Stress Incontinence
Conditions
Keywords
female, aging, physiotherapy, pelvic floor, rehabilitation
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALGroup physiotherapy
Multimodal Group physiotherapy 12 weeks of weekly Group physiotherapy treatments including education and pelvic floor muscle exercises
BEHAVIORALIndividual one-on-one physiotherapy
Multimodal Individual physiotherapy 12 weeks of weekly Individual physiotherapy treatments including education and pelvic floor muscle exercises
Sponsors
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 60 years or older * suffering from stress urinary incontinence (SUI) or mixed urinary incontinence (MUI) symptoms * at least 3 urinary incontinence episodes per week x 3 months or more * ambulatory without the need of assisted device * understand French or English instruction * hormonal replacement stable for 6 months
Exclusion criteria
* present risk factors known to interfere with the effects of PFM training * \>2 degree Pop-Q * body mass index \>35 * chronic constipation * have received physiotherapy or surgical treatment within the last year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the number of UI episodes | at recruitment, 13 weeks after recruitment and 12 months after recruitment, and 8 years after recruitment for those who completed the 12-month evaluation | evaluated with a 7-day bladder diary |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| UI related QOL | at recruitment, 13 weeks after recruitment and 12 months after recruitment, and 8 years after recruitment for those who completed the 12-month evaluation | evaluated using the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol) |
| UI related self-efficacy | at recruitment, 13 weeks after recruitment and 12 months after recruitment | evaluated using the Geriatric self-efficacy index |
| Costs related to interventions | at recruitment, 13 weeks after recruitment and 12 months after recruitment, and 8 years after recruitment for those who completed the 12-month evaluation | evaluated using the modified Dowel-Bryant Incontinence Cost Index |
| Anthropometric measurements | at recruitment, 13 weeks after recruitment and 12 months after recruitment | evaluated using height and weight measurements, which will be combined to report BMI in kg/m\^2 |
| Symptoms and degree to which UI-associated symptoms are troubling or bothersome | at recruitment, 13 weeks after recruitment and 12 months after recruitment, and 8 years after recruitment for those who completed the 12-month evaluation. | evaluated using the International Consultation on Incontinence questionnaire on urinary incontinence (ICIQ-UI short form) |
| PFM morphology | at recruitment, 13 weeks after recruitment and 12 months after recruitment | evaluated using transperineal US |
| Patient reported improvement and satisfaction | 13 weeks after recruitment and 12 months after recruitment | evaluated using Patient global impression of improvement (PGI-I) and Benefit and willingness |
| Adherence to intervention and home exercises | 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 | evaluated using homemade questionnaire including attendance to intervention and assiduity to home exercises program |
| Qualitative interview | 8 years after recruitement for those who completed the 12-month evaluation | 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. |
| PFM function | at recruitment, 13 weeks after recruitment and 12 months after recruitment | evaluated combining digital palpation (Oxford scale), vaginal atrophy index and dynamometry |
Countries
Canada
Outcome results
None listed