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Group Versus Individual Physiotherapy for Urinary Incontinence in Aging Women (GROUP)

U

University Institute of Geriatrics of Montreal (IUGM)

Status

Active, not recruiting

Conditions

Urinary Stress Incontinence
Urinary Incontinence

Treatments

Behavioral: Individual one-on-one physiotherapy
Behavioral: Group physiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02039830
CRC01:GROUP
CIHR258993 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

362 patients

Sex

Female

Ages

60+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

362 participants in 2 patient groups

Group physiotherapy
Experimental group
Description:
12 weekly treatment visit + daily home exercise program
Treatment:
Behavioral: Group physiotherapy
Individual one-on-one physiotherapy
Active Comparator group
Description:
12 weekly treatment visit + daily home exercise program
Treatment:
Behavioral: Individual one-on-one physiotherapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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