Clinical trial NCT00222248: Pelvic Floor Muscle Training for Incontinence in Older Women.
Official title: The Effect of Pelvic Floor Muscle Training for the Management of Incontinence in Older Women: a Single Blind Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: Stress urinary incontinence
Pelvic floor muscle training
Bladder training
Older women
Lead sponsor: University of Melbourne
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 83
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quantity of urine lost over a 7-day period measured by self-report.
timeFrame: 1, 3, 5 (end of intervention) and 12 months
measure: Urine lost on stress test measured by pad weigh test.
timeFrame: 1, 3, 5 (end of intervention) and 12 months
Secondary outcomes:
measure: King's Health Questionnaire.
timeFrame: 1, 3, 5 (end of intervention) and 12 months
measure: Degree of bother
timeFrame: 1, 3, 5 (end of intervention) and 12 months
measure: Severity of stress incontinence
timeFrame: 1, 3, 5 (end of intervention) and 12 months
measure: Displacement of pelvic floor during muscle contraction
timeFrame: 1, 3, 5 (end of intervention) and 12 months
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Austin Health
state: Victoria
Study officials:
affiliation: University of Melbourne
name: Mary P Galea, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sherburn M, Bird M, Carey M, Bo K, Galea MP. Incontinence improves in older women after intensive pelvic floor muscle training: an assessor-blinded randomized controlled trial. Neurourol Urodyn. 2011 Mar;30(3):317-24. doi: 10.1002/nau.20968. Epub 2011 Jan 31.