Clinical trial NCT02039830: Group Versus Individual Physiotherapy for Urinary Incontinence in Aging Women
Official title: Group Physiotherapy Compared to Individual Physiotherapy to Treat Urinary Incontinence in Aging Women: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Incontinence
Urinary Stress Incontinence
Keywords: female
aging
physiotherapy
pelvic floor
rehabilitation
Lead sponsor: Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Sponsor class: OTHER
First posted: 2014-01-20
Enrollment: 362
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent reduction in the number of UI episodes
timeFrame: at recruitment, 13 weeks after recruitment and 12 months after recruitment
Secondary outcomes:
measure: Change in the symptoms and the degree to which UI-associated symptoms are troubling or bothersome
timeFrame: at recruitment, 13 weeks after recruitment and 12 months after recruitment
measure: Change in UI related QOL
timeFrame: at recruitment, 13 weeks after recruitment and 12 months after recruitment
measure: Change in UI related self-efficacy
timeFrame: at recruitment, 13 weeks after recruitment and 12 months after recruitment
measure: Change in UI related self-efficacy
timeFrame: 13 weeks after recruitment (recollection of what was before recruitment and what is now) and 12 months after recruitment
measure: Costs related to interventions
timeFrame: at recruitment, 13 weeks after recruitment and 12 months after recruitment
measure: Changes in anthropometric measurements
timeFrame: at recruitment, 13 weeks after recruitment and 12 months after recruitment
measure: Change in PFM function
timeFrame: at recruitment, 13 weeks after recruitment and 12 months after recruitment
measure: Change in PFM morphology
timeFrame: at recruitment, 13 weeks after recruitment and 12 months after recruitment
measure: Patient reported improvement and satisfaction
timeFrame: 13 weeks after recruitment and 12 months after recruitment
measure: Adherence to intervention and home exercises
timeFrame: 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
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Laboratoire incontinence et vieillissement CRIUGM
state: Quebec
Study officials:
affiliation: Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
name: Chantal Dumoulin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cacciari LP, Kouakou CR, Poder TG, Vale L, Morin M, Mayrand MH, Tousignant M, Dumoulin C. Group-based pelvic floor muscle training is a more cost-effective approach to treat urinary incontinence in older women: economic analysis of a randomised trial. J Physiother. 2022 Jul;68(3):191-196. doi: 10.1016/j.jphys.2022.06.001. Epub 2022 Jun 23.
citation: Dumoulin C, Morin M, Danieli C, Cacciari L, Mayrand MH, Tousignant M, Abrahamowicz M; Urinary Incontinence and Aging Study Group. Group-Based vs Individual Pelvic Floor Muscle Training to Treat Urinary Incontinence in Older Women: A Randomized Clinical Trial. JAMA Intern Med. 2020 Oct 1;180(10):1284-1293. doi: 10.1001/jamainternmed.2020.2993.
citation: Dumoulin C, Morin M, Mayrand MH, Tousignant M, Abrahamowicz M. Group physiotherapy compared to individual physiotherapy to treat urinary incontinence in aging women: study protocol for a randomized controlled trial. Trials. 2017 Nov 16;18(1):544. doi: 10.1186/s13063-017-2261-4.