Prevalence and Treatment of Urinary Incontinence in Women With Cystic Fibrosis and Chronic Obstructive Pulmonary Disease

NCT ID: NCT00164138

Last Updated: 2013-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-12-31
• Study Completion Date: 2004-06-30

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.

Conditions

Cystic Fibrosis; Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Incontinence; physiotherapy; treatment; pelvic floor muscle function; coughing; forced expirations; lung disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pelvic Floor Training Group

Pelvic floor training, biofeedback.

Group Type: EXPERIMENTAL

Pelvic floor training group

Intervention Type: PROCEDURE

pelvic floor training, electrotherapy, bladder retraining.

Interventions

Pelvic floor training group

pelvic floor training, electrotherapy, bladder retraining.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Women with CF and COPD

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Melbourne

OTHER

Sponsor Role: collaborator

Bayside Health

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brenda M Button, DPhty, PhD

Role: PRINCIPAL_INVESTIGATOR

The Alfred

John W Wilson, MBBS, PhD

Role: STUDY_DIRECTOR

The Alfred

Locations

The Alfred Hospital

Melbourne, Victoria, Australia

School of Physiotherapy, The University of Melbourne

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

Dept. of Health and Aged Care

Identifier Type: -

Identifier Source: secondary_id

108/01

Identifier Type: -

Identifier Source: org_study_id