Cystic FibrosisNCT00164138
Prevalence and Treatment of Urinary Incontinence in Women With Cystic Fibrosis and Chronic Obstructive Pulmonary Disease
A study testing Pelvic floor training group in people with Cystic Fibrosis and Chronic Obstructive Pulmonary Disease (COPD), run by Bayside Health at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis, Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Pelvic floor training group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 2 sitesAustralia
- Study dates
- Dec 2001to Jun 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women with CF and COPD
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
The Alfred Hospital
Melbourne, Victoria, 3004
School of Physiotherapy, The University of Melbourne
Melbourne, Victoria, 3052
About this study
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)
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.
Read the 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 (King's 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:
- A 7-day accident diary
- King's Health Questionnaire
- Severity index score
- ICIQ SF score
- Ultra-sound examination of movement of the pelvic floor muscles
- 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 women's 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.
- Being tested
- Pelvic floor training group
- Keywords
- Incontinence, physiotherapy, treatment, pelvic floor muscle function, coughing, forced expirations, lung disease
- Medical subject headings
- Cystic Fibrosis, Pulmonary Disease, Chronic Obstructive, Cough, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor training groupProcedure or surgery
pelvic floor training, electrotherapy, bladder retraining.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic Floor Training Group | Experimental | Pelvic floor training, biofeedback. Receives: Procedure: Pelvic floor training group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom measures:
3-day frequency volume chart,
24 hour pad weigh test,
accident diary,
quality of life using King's Health Questionnaire.
pelvic floor muscle function:
Trans-abdominal diagnostic ultra-sound
EMG study of the pelvic floor muscles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startDec 2001
- Primary completionJun 2004
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Collaborators
- University of Melbourne
- Responsible party
- Sponsor
- Investigators
- Brenda M Button, DPhty, PhD, Principal investigator, The AlfredJohn W Wilson, MBBS, PhD, Study director, The Alfred
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00164138
- Sponsor's protocol ID
- 108/01
- Other IDs
- Dept. of Health and Aged Care
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 28 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00164138
- Acronym / sponsor ID
- 108/01
- Keywords
- Incontinence, physiotherapy, treatment, pelvic floor muscle function, coughing, forced expirations, lung disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Bayside HealthOther government
- Collaborators
- University of Melbourne
- Study start
- Dec 2001
- Primary completion
- Jun 2004 (actual)
- Study completion
- Jun 2004 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (King's 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:
- A 7-day accident diary
- King's Health Questionnaire
- Severity index score
- ICIQ SF score
- Ultra-sound examination of movement of the pelvic floor muscles
- 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 women's 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pelvic Floor Training Group | Experimental | Procedure: Pelvic floor training groupPelvic floor training, biofeedback. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women with CF and COPD
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic floor training grouppelvic floor training, electrotherapy, bladder retraining. | Procedure or surgery | Pelvic Floor Training Group |
Primary outcome
Symptom measures:
3-day frequency volume chart,
24 hour pad weigh test,
accident diary,
quality of life using King's Health Questionnaire.
pelvic floor muscle function:
Trans-abdominal diagnostic ultra-sound
EMG study of the pelvic floor muscles
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brenda M Button, DPhty, PhD principal investigator
The Alfred
John W Wilson, MBBS, PhD study director
The Alfred
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor training group in people with Cystic Fibrosis and Chronic Obstructive Pulmonary Disease (COPD), run by Bayside Health at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom measures:. The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2013; AzTrials last refreshed its copy on 8 Nov 2026.