Prevalence and Treatment of Urinary Incontinence in Women With Cystic Fibrosis and Chronic Obstructive Pulmonary Disease
Primary Purpose
Cystic Fibrosis, Chronic Obstructive Pulmonary Disease (COPD)
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Pelvic floor training group
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Fibrosis focused on measuring Incontinence, physiotherapy, treatment, pelvic floor muscle function, coughing, forced expirations, lung disease
Eligibility Criteria
Inclusion Criteria: Women with CF and COPD Exclusion Criteria: -
Sites / Locations
- The Alfred Hospital
- School of Physiotherapy, The University of Melbourne
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pelvic Floor Training Group
Arm Description
Pelvic floor training, biofeedback.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00164138
First Posted
September 13, 2005
Last Updated
November 26, 2013
Sponsor
Bayside Health
Collaborators
University of Melbourne
1. Study Identification
Unique Protocol Identification Number
NCT00164138
Brief Title
Prevalence and Treatment of Urinary Incontinence in Women With Cystic Fibrosis and Chronic Obstructive Pulmonary Disease
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)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
December 2001 (undefined)
Primary Completion Date
June 2004 (Actual)
Study Completion Date
June 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayside Health
Collaborators
University of Melbourne
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 (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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Chronic Obstructive Pulmonary Disease (COPD)
Keywords
Incontinence, physiotherapy, treatment, pelvic floor muscle function, coughing, forced expirations, lung disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pelvic Floor Training Group
Arm Type
Experimental
Arm Description
Pelvic floor training, biofeedback.
Intervention Type
Procedure
Intervention Name(s)
Pelvic floor training group
Intervention Description
pelvic floor training, electrotherapy, bladder retraining.
Primary Outcome Measure Information:
Title
Symptom measures:
Title
3-day frequency volume chart,
Title
24 hour pad weigh test,
Title
accident diary,
Title
quality of life using King's Health Questionnaire.
Title
pelvic floor muscle function:
Title
Trans-abdominal diagnostic ultra-sound
Title
EMG study of the pelvic floor muscles
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women with CF and COPD
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brenda M Button, DPhty, PhD
Organizational Affiliation
The Alfred
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John W Wilson, MBBS, PhD
Organizational Affiliation
The Alfred
Official's Role
Study Director
Facility Information:
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
School of Physiotherapy, The University of Melbourne
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Prevalence and Treatment of Urinary Incontinence in Women With Cystic Fibrosis and Chronic Obstructive Pulmonary Disease
We'll reach out to this number within 24 hrs