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Pelvic Floor Muscle Training for Incontinence in Older Women.

The Effect of Pelvic Floor Muscle Training for the Management of Incontinence in Older Women: a Single Blind Randomised Controlled Trial.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00222248
Enrollment
83
Registered
2005-09-22
Start date
2003-03-03
Completion date
2006-03-06
Last updated
2021-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Urinary Incontinence

Keywords

Stress urinary incontinence, Pelvic floor muscle training, Bladder training, Older women

Brief summary

To determine the effect of pelvic floor muscle training in women aged 70 years and over, who have proven stress urinary incontinence. The hypotheses to be tested are: 1. That pelvic floor muscle training is effective in relief of symptoms of stress urinary incontinence as measured by a greater reduction in the number of episodes of incontinence, quantity of urine lost and improvement of quality of life. 2. That women who undertake pelvic floor muscle training will show greater improvement of pelvic floor muscle function than women who have behavioural (bladder) training, as measured by real time transabdominal ultrasound.

Detailed description

Urinary incontinence is associated with significant personal stress, shame and social stigma and affects around one-third of women over 60 years of age. It restricts the amount of physical activity and can lead to social isolation and poor health. Pelvic floor muscle re-education by physiotherapists is the most commonly recommended method of conservative management. Although a recent Cochrane review concluded that it was an effective treatment for women with stress and mixed incontinence, there is still no strong evidence for the effectiveness of this intervention in elderly women. It has also been suggested that bladder training alone is equally effective in patients with stress urinary incontinence, urge and mixed incontinence. This is contrary to current clinical experience. It is therefore important to distinguish the relative effectiveness of these interventions used in isolation in order to ensure that urinary incontinence is managed in the most effective and efficient way. Comparisons: pelvic floor muscle training group and bladder training. Assessments will be conducted at baseline, 1 month, 3 months and 5 months during the intervention period. Both groups will then continue with their home program for a further 7 months until their final assessment (Assessment 5). Outcome measures will include: volume of urine lost during a stress test, completion of accident diaries, Degree of 'bother', quality of life using the Kings Health Questionnaire, and assessment of pelvic floor function using real time transabdominal diagnostic ultrasound.

Interventions

BEHAVIORALPelvic floor muscle training and bladder training

Sponsors

University of Melbourne
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
65 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Community-dwelling women aged over 65 years * urodynamically proven stress incontinence * Medically stable

Exclusion criteria

* Already receiving physiotherapy intervention * Neurogenic incontinence * Cannot comply with training program

Design outcomes

Primary

MeasureTime frameDescription
Quantity of urine lost over a 7-day period measured by self-report.1, 3, 5 (end of intervention) and 12 monthsSelf report of urine leakage
Urine lost on stress test measured by pad weigh test.1, 3, 5 (end of intervention) and 12 monthsPad weight following stress test

Secondary

MeasureTime frameDescription
Severity of stress incontinence1, 3, 5 (end of intervention) and 12 monthsSeverity of stress incontinence measured by the ICIQ-UI SF
Displacement of pelvic floor during muscle contraction1, 3, 5 (end of intervention) and 12 monthsDisplacement measured using transabdominal ultrasound imaging.
King's Health Questionnaire.1, 3, 5 (end of intervention) and 12 monthsQuality of life questionnaire
Degree of bother1, 3, 5 (end of intervention) and 12 monthsVisual Analogue Scale of degree of bother

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026