Pelvic Floor Muscle Training for Incontinence in Older Women.

NCT ID: NCT00222248

Last Updated: 2021-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-03-03
• Study Completion Date: 2006-03-06

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.

Conditions

Stress Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Pelvic floor muscle training

Weekly group session of education and exercise to music incorporating pelvic floor muscle training incorporating motor control, strength, endurance, power and functional training in a variety of different positions.

Group Type: EXPERIMENTAL

Pelvic floor muscle training and bladder training

Intervention Type: BEHAVIORAL

Bladder training

Weekly group session of education regarding deferral techniques, timed voiding parameters and gentle exercise to music.

Group Type: ACTIVE_COMPARATOR

Pelvic floor muscle training and bladder training

Intervention Type: BEHAVIORAL

Interventions

Pelvic floor muscle training and bladder training

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Melbourne

OTHER

Sponsor Role: lead

Responsible Party

Mary Galea

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary P Galea, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Melbourne

Locations

Austin Health

Melbourne, Victoria, Australia

Countries

Australia

References

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.

Reference Type: RESULT

PMID: 21284022 (View on PubMed)

Other Identifiers

251632

Identifier Type: -

Identifier Source: org_study_id