Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00222248
Status:
COMPLETED
Last Update Posted:
2021-05-03
First Post:
2005-09-13
Brief Title:
Pelvic Floor Muscle Training for Incontinence in Older Women
Sponsor:
University of Melbourne
Organization:
University of Melbourne
Study Overview
Official Title:
The Effect of Pelvic Floor Muscle Training for the Management of Incontinence in Older Women a Single Blind Randomised Controlled Trial
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None