Pelvic Floor Muscle Training for Incontinence in Older Women.

Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00222248
• Other study ID #: 251632
• Status: Completed
• Phase: N/A
• Start date: March 3, 2003
• Est. completion date: March 6, 2006

Study information

• Verified date: April 2021
• Source: University of Melbourne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: March 6, 2006
• Est. primary completion date: March 6, 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Behavioral:
• Pelvic floor muscle training and bladder training

Locations

Country	Name	City	State
Australia	Austin Health	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
University of Melbourne

Country where clinical trial is conducted

Australia, 

References & Publications (1)

Sherburn M, Bird M, Carey M, Bø 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 — View Citation

Outcome

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