Cystic Fibrosis Clinical Trial
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.
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:
1. A 7-day accident diary
2. King's 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 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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04696198 -
Thoracic Mobility in Cystic Fibrosis Care
|
N/A | |
Completed |
NCT00803205 -
Study of Ataluren (PTC124™) in Cystic Fibrosis
|
Phase 3 | |
Terminated |
NCT04921332 -
Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD
|
N/A | |
Completed |
NCT03601637 -
Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Participants 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del
|
Phase 3 | |
Terminated |
NCT02769637 -
Effect of Acid Blockade on Microbiota and Inflammation in Cystic Fibrosis (CF)
|
||
Recruiting |
NCT06012084 -
The Development and Evaluation of iCF-PWR for Healthy Siblings of Individuals With Cystic Fibrosis
|
N/A | |
Recruiting |
NCT06032273 -
Lung Transplant READY CF 2: CARING CF Ancillary RCT
|
N/A | |
Recruiting |
NCT06030206 -
Lung Transplant READY CF 2: A Multi-site RCT
|
N/A | |
Recruiting |
NCT05392855 -
Symptom Based Performance of Airway Clearance After Starting Highly Effective Modulators for Cystic Fibrosis (SPACE-CF)
|
N/A | |
Recruiting |
NCT06088485 -
The Effect of Bone Mineral Density in Patients With Adult Cystic Fibrosis
|
||
Recruiting |
NCT04056702 -
Impact of Triple Combination CFTR Therapy on Sinus Disease.
|
||
Recruiting |
NCT04039087 -
Sildenafil Exercise: Role of PDE5 Inhibition
|
Phase 2/Phase 3 | |
Completed |
NCT04058548 -
Clinical Utility of the 1-minute Sit to Stand Test as a Measure of Submaximal Exercise Tolerance in Patients With Cystic Fibrosis During Acute Pulmonary Exacerbation
|
N/A | |
Completed |
NCT04038710 -
Clinical Outcomes of Triple Combination Therapy in Severe Cystic Fibrosis Disease.
|
||
Completed |
NCT03637504 -
Feasibility of a Mobile Medication Plan Application in CF Patient Care
|
N/A | |
Recruiting |
NCT03506061 -
Trikafta in Cystic Fibrosis Patients
|
Phase 2 | |
Completed |
NCT03566550 -
Gut Imaging for Function & Transit in Cystic Fibrosis Study 1
|
||
Recruiting |
NCT04828382 -
Prospective Study of Pregnancy in Women With Cystic Fibrosis
|
||
Completed |
NCT04568980 -
Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis
|
||
Recruiting |
NCT04010253 -
Impact of Bronchial Drainage Technique by the Medical Device Simeox® on Respiratory Function and Symptoms in Adult Patients With Cystic Fibrosis
|
N/A |