Clinical trial NCT00164138: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Incontinence
physiotherapy
treatment
pelvic floor muscle function
coughing
forced expirations
lung disease
Lead sponsor: Bayside Health
Sponsor class: OTHER_GOV
Collaborators: name: University of Melbourne
First posted: 2005-09-14
Enrollment: 99
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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:

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.

Eligibility criteria: Inclusion Criteria:

* Women with CF and COPD

Exclusion Criteria:

-

Primary outcomes:
measure: Symptom measures:
measure: 3-day frequency volume chart,
measure: 24 hour pad weigh test,
measure: accident diary,
measure: quality of life using King's Health Questionnaire.
measure: pelvic floor muscle function:
measure: Trans-abdominal diagnostic ultra-sound
measure: EMG study of the pelvic floor muscles
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Melbourne
country: Australia
facility: School of Physiotherapy, The University of Melbourne
state: Victoria
Study officials:
affiliation: The Alfred
name: Brenda M Button, DPhty, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Alfred
name: John W Wilson, MBBS, PhD
role: STUDY_DIRECTOR
References: