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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00164138
First Posted: September 14, 2005
Last Update Posted: November 28, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Melbourne
Information provided by (Responsible Party):
Bayside Health
  Purpose
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.

Condition Intervention
Cystic Fibrosis Chronic Obstructive Pulmonary Disease (COPD) Procedure: Pelvic floor training group

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Bayside Health:

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

Enrollment: 99
Study Start Date: December 2001
Study Completion Date: June 2004
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pelvic Floor Training Group
Pelvic floor training, biofeedback.
Procedure: Pelvic floor training group
pelvic floor training, electrotherapy, bladder retraining.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women with CF and COPD

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00164138


Locations
Australia, Victoria
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
School of Physiotherapy, The University of Melbourne
Melbourne, Victoria, Australia, 3052
Sponsors and Collaborators
Bayside Health
University of Melbourne
Investigators
Principal Investigator: Brenda M Button, DPhty, PhD The Alfred
Study Director: John W Wilson, MBBS, PhD The Alfred
  More Information

Responsible Party: Bayside Health
ClinicalTrials.gov Identifier: NCT00164138     History of Changes
Other Study ID Numbers: 108/01
Dept. of Health and Aged Care
First Submitted: September 13, 2005
First Posted: September 14, 2005
Last Update Posted: November 28, 2013
Last Verified: September 2005

Keywords provided by Bayside Health:
Incontinence
physiotherapy
treatment
pelvic floor muscle function
coughing
forced expirations
lung disease

Additional relevant MeSH terms:
Urinary Incontinence
Lung Diseases
Fibrosis
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Cystic Fibrosis
Enuresis
Respiratory Tract Diseases
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders