Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00164138
Status:
COMPLETED
Last Update Posted:
2013-11-28
First Post:
2005-09-13
Brief Title:
Prevalence and Treatment of Urinary Incontinence in Women With Cystic Fibrosis and Chronic Obstructive Pulmonary Disease
Sponsor:
Bayside Health
Organization:
Bayside Health
Study Overview
Official Title:
Development of an Intervention and and Education Program for Adult Women With Urinary Incontinence and Chronic Lung Disease Including Cystic Fibrosis CF and Chronic Obstructive Pulmonary Disease COPD
Status:
COMPLETED
Status Verified Date:
2005-09
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:
Women with chronic lung disease characterised by chronic cough report urinary incontinence Recently there have been reports of increased urinary incontinence in girls and women with cystic fibrosis While coughing is a known risk factor for stress incontinence other risk factors and causes are poorly understood in this population Treatment of incontinence for patients with chronic lung disease is also poorly addressed adding to the burden of disease for women with chronic lung disease carers and the health system This project will estimate the prevalence of women with CF and COPD compared to healthy age matched controls and will evaluate the effect of a specific treatment and management program for these patients The results will be disseminated to respiratory health professionals We hypothesise that women with chronic cough will have a higher incidence of urinary incontinence than healthy controls and that a specific treatment program will result in alleviation of the problems and improved quality of life
Detailed Description:
This project will be undertaken in two phases
Phase 1 will involve a mailed out screening questionnaire survey of a sample of 50-60 women with CF and 50-60 women with COPD to investigate the prevalence of incontinence in these populations For subjects requiring assistance an independent physiotherapist is available to assist them with completion of the questionnaire over the telephone Return stamped addressed envelopes will be provided to each subject in the initial mail-out The following types of incontinence will be investigated stress incontinence urge incontinence faecal incontinence faecal urgency nocturnal enuresis voiding dysfunction insensible urine loss defaecation difficulty known prolapse childhood enuresis
Phase 2 will be an assessment and interventional study Subjects will be measured before and after the treatment intervention and followed up for three months using the following validated outcome measures
Symptoms measures 3-day frequency-volume chart 24-hour pad weigh test 7-day accident diary quality of life measure Kings Health Questionnaire
Pelvic floor muscle function
Electromyographic study EMG of the pelvic floor muscles using an intravaginal electrode
Transabdominal diagnostic ultrasound
Adherence to program self report diary
Subjects being assessed for pelvic floor muscle activity will attend the School of Physiotherapy Movement Laboratory to undertake the following tests
1 A 7-day accident diary
2 Kings Health Questionnaire
3 Severity index score
4 ICIQ SF score
5 Ultra-sound examination of movement of the pelvic floor muscles
6 EMG measurement of pelvic floor muscle activity
Ultrasound measurement using an Acoustic Imaging Performa ultrasound unit Dornier Medtech USA and its accompanying software will be used for imaging and measurement The aim is to obtain images showing the greatest degree of displacement during pelvic floor muscle activity The mean value of three recorded measurement will be used for statistical analysis for the following activities 20 second maximum effort endurance hold 3 deep coughs 3 huffs
EMG pelvic floor activity will be measured using an intravaginal electrode at rest following a brief maximum voluntary contraction over 1 second and a sustained maximum voluntary contraction over 20 seconds to determine the strength and timing of pelvic floor muscle activity in subjects with chronic cough compared to healthy controls In order to investigate pelvic floor muscle activity during forced expirations and coughing EMG recording will be recorded with thoracic movement during huffing and coughs and during the preceding inspiration
The effects of a physiotherapeutic intervention over a three-month period on incontinence will be investigated All subjects will be referred for treatment to one of 9 selected continence physiotherapists working in continence clinics or womens health practices providing state of the art treatment conveniently located for each subject Treatment will comprise standard physiotherapy interventions with up to 5 treatments within the 3-months period customised on the basis of the assessment Details of treatments will subsequently be examined for broad consistency Pelvic floor muscle training biofeedback electrotherapy and bladder training will be included in treatment as individually indicated A further assessment will occur immediately post-treatment program followed by a follow-up assessment 3-months after the completion of the treatment program Results of the study will be provided to medical practitioners and physiotherapists
Phase 1 will involve a mailed out screening questionnaire survey of a sample of 50-60 women with CF and 50-60 women with COPD to investigate the prevalence of incontinence in these populations For subjects requiring assistance an independent physiotherapist is available to assist them with completion of the questionnaire over the telephone Return stamped addressed envelopes will be provided to each subject in the initial mail-out The following types of incontinence will be investigated stress incontinence urge incontinence faecal incontinence faecal urgency nocturnal enuresis voiding dysfunction insensible urine loss defaecation difficulty known prolapse childhood enuresis
Phase 2 will be an assessment and interventional study Subjects will be measured before and after the treatment intervention and followed up for three months using the following validated outcome measures
Symptoms measures 3-day frequency-volume chart 24-hour pad weigh test 7-day accident diary quality of life measure Kings Health Questionnaire
Pelvic floor muscle function
Electromyographic study EMG of the pelvic floor muscles using an intravaginal electrode
Transabdominal diagnostic ultrasound
Adherence to program self report diary
Subjects being assessed for pelvic floor muscle activity will attend the School of Physiotherapy Movement Laboratory to undertake the following tests
1 A 7-day accident diary
2 Kings Health Questionnaire
3 Severity index score
4 ICIQ SF score
5 Ultra-sound examination of movement of the pelvic floor muscles
6 EMG measurement of pelvic floor muscle activity
Ultrasound measurement using an Acoustic Imaging Performa ultrasound unit Dornier Medtech USA and its accompanying software will be used for imaging and measurement The aim is to obtain images showing the greatest degree of displacement during pelvic floor muscle activity The mean value of three recorded measurement will be used for statistical analysis for the following activities 20 second maximum effort endurance hold 3 deep coughs 3 huffs
EMG pelvic floor activity will be measured using an intravaginal electrode at rest following a brief maximum voluntary contraction over 1 second and a sustained maximum voluntary contraction over 20 seconds to determine the strength and timing of pelvic floor muscle activity in subjects with chronic cough compared to healthy controls In order to investigate pelvic floor muscle activity during forced expirations and coughing EMG recording will be recorded with thoracic movement during huffing and coughs and during the preceding inspiration
The effects of a physiotherapeutic intervention over a three-month period on incontinence will be investigated All subjects will be referred for treatment to one of 9 selected continence physiotherapists working in continence clinics or womens health practices providing state of the art treatment conveniently located for each subject Treatment will comprise standard physiotherapy interventions with up to 5 treatments within the 3-months period customised on the basis of the assessment Details of treatments will subsequently be examined for broad consistency Pelvic floor muscle training biofeedback electrotherapy and bladder training will be included in treatment as individually indicated A further assessment will occur immediately post-treatment program followed by a follow-up assessment 3-months after the completion of the treatment program Results of the study will be provided to medical practitioners and physiotherapists
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Dept of Health and Aged Care | None | None | None |