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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00164138




Registration number
NCT00164138
Ethics application status
Date submitted
13/09/2005
Date registered
14/09/2005
Date last updated
28/11/2013

Titles & IDs
Public title
Prevalence and Treatment of Urinary Incontinence in Women With Cystic Fibrosis and Chronic Obstructive Pulmonary Disease
Scientific 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)
Secondary ID [1] 0 0
Dept. of Health and Aged Care
Secondary ID [2] 0 0
108/01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 0 0
Chronic Obstructive Pulmonary Disease (COPD) 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Cystic fibrosis
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Pelvic floor training group

Experimental: Pelvic Floor Training Group - Pelvic floor training, biofeedback.


Treatment: Surgery: Pelvic floor training group
pelvic floor training, electrotherapy, bladder retraining.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Symptom measures:
Timepoint [1] 0 0
Primary outcome [2] 0 0
3-day frequency volume chart,
Timepoint [2] 0 0
Primary outcome [3] 0 0
24 hour pad weigh test,
Timepoint [3] 0 0
Primary outcome [4] 0 0
accident diary,
Timepoint [4] 0 0
Primary outcome [5] 0 0
quality of life using King's Health Questionnaire.
Timepoint [5] 0 0
Primary outcome [6] 0 0
pelvic floor muscle function:
Timepoint [6] 0 0
Primary outcome [7] 0 0
Trans-abdominal diagnostic ultra-sound
Timepoint [7] 0 0
Primary outcome [8] 0 0
EMG study of the pelvic floor muscles
Timepoint [8] 0 0

Eligibility
Key inclusion criteria
- Women with CF and COPD
Minimum age
18 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2004
Sample size
Target
Accrual to date
Final
99
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [2] 0 0
School of Physiotherapy, The University of Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment postcode(s) [2] 0 0
3052 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Melbourne
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00164138
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Brenda M Button, DPhty, PhD
Address 0 0
The Alfred
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00164138