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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02039830
Other study ID # CRC01:GROUP
Secondary ID CIHR258993
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 2012
Est. completion date December 2024

Study information

Verified date February 2023
Source Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 362
Est. completion date December 2024
Est. primary completion date June 2018
Accepts healthy volunteers No
Gender Female
Age group 60 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
Group physiotherapy
Multimodal Group physiotherapy 12 weeks of weekly Group physiotherapy treatments including education and pelvic floor muscle exercises
Individual one-on-one physiotherapy
Multimodal Individual physiotherapy 12 weeks of weekly Individual physiotherapy treatments including education and pelvic floor muscle exercises

Locations

Country Name City State
Canada Laboratoire incontinence et vieillissement CRIUGM Montréal Quebec

Sponsors (1)

Lead Sponsor Collaborator
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percent reduction in the number of UI episodes evaluated with a 7-day bladder diary at recruitment, 13 weeks after recruitment and 12 months after recruitment
Secondary Change in the symptoms and the degree to which UI-associated symptoms are troubling or bothersome evaluated using the 24h PAD test, International Consultation on Incontinence questionnaire on urinary incontinence (ICIQ-UI short form (symptoms), ICIQ-Nocturia (symptoms), ICIQ-Vaginal Symptoms(symptoms), ICIQ-FemaleLowerUrinaryTractSsex (symptoms) at recruitment, 13 weeks after recruitment and 12 months after recruitment
Secondary Change in UI related QOL evaluated using the ICIQ-Lower UrinaryTract Symptoms quality of life(QOL) at recruitment, 13 weeks after recruitment and 12 months after recruitment
Secondary Change in UI related self-efficacy evaluated using the Geriatric self-efficacy index at recruitment, 13 weeks after recruitment and 12 months after recruitment
Secondary Change in UI related self-efficacy evaluated using the Broom PFM Self-efficacy scale 13 weeks after recruitment (recollection of what was before recruitment and what is now) and 12 months after recruitment
Secondary Costs related to interventions evaluated using the modified Dowel-Bryant Incontinence Cost Index at recruitment, 13 weeks after recruitment and 12 months after recruitment
Secondary Changes in anthropometric measurements evaluated using height and weight measurements at recruitment, 13 weeks after recruitment and 12 months after recruitment
Secondary Change in PFM function evaluated using digital palpation (Oxford scale), Vaginal atrophy index, dynamometry at recruitment, 13 weeks after recruitment and 12 months after recruitment
Secondary Change in PFM morphology evaluated using transperineal US at recruitment, 13 weeks after recruitment and 12 months after recruitment
Secondary Patient reported improvement and satisfaction evaluated using Patient global impression of improvement (PGI-I), Benefit and willingness 13 weeks after recruitment and 12 months after recruitment
Secondary Adherence to intervention and home exercises evaluated using homemade questionnaire including attendance to intervention and assiduity to home exercises program 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
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