Group Versus Individual Physiotherapy for Urinary Incontinence in Aging Women

Urinary Incontinence Clinical Trial

— GROUP  

Official title:

Group Physiotherapy Compared to Individual Physiotherapy to Treat Urinary Incontinence in Aging Women: A Randomized Control Trial

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
• 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
• 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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence
• Urinary Incontinence, Stress
• Urinary Stress Incontinence

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