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.

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.

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Behavioral: Pelvic floor muscle training and bladder training

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.

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3084
      • Austin Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Behavioral: Pelvic floor muscle training and bladder training
ACTIVE_COMPARATOR: Bladder training; Weekly group session of education regarding deferral techniques, timed voiding parameters and gentle exercise to music.	Behavioral: Pelvic floor muscle training and bladder training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantity of urine lost over a 7-day period measured by self-report.	Self report of urine leakage	1, 3, 5 (end of intervention) and 12 months
Urine lost on stress test measured by pad weigh test.	Pad weight following stress test	1, 3, 5 (end of intervention) and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
King's Health Questionnaire.	Quality of life questionnaire	1, 3, 5 (end of intervention) and 12 months
Degree of bother	Visual Analogue Scale of degree of bother	1, 3, 5 (end of intervention) and 12 months
Severity of stress incontinence	Severity of stress incontinence measured by the ICIQ-UI SF	1, 3, 5 (end of intervention) and 12 months
Displacement of pelvic floor during muscle contraction	Displacement measured using transabdominal ultrasound imaging.	1, 3, 5 (end of intervention) and 12 months

Collaborators and Investigators

• Sponsor: University of Melbourne

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 3, 2003
• Primary Completion (ACTUAL): March 6, 2006
• Study Completion (ACTUAL): March 6, 2006

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (ESTIMATE): September 22, 2005

Study Record Updates

• Last Update Posted (ACTUAL): May 3, 2021
• Last Update Submitted That Met QC Criteria: April 28, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Pelvic floor muscle training; Stress urinary incontinence; Older women; Bladder training
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: 251632