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Clinical Trials/NCT04380558
NCT04380558
Completed
Not Applicable

Prevalence and Consequences of Urinary Incontinence in People with Chronic Pulmonary Diseases Referred for Pulmonary Rehabilitation

ADIR Association2 sites in 1 country341 target enrollmentMay 11, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pulmonary Disease
Sponsor
ADIR Association
Enrollment
341
Locations
2
Primary Endpoint
Prevalence of urinary incontinence symptoms
Status
Completed
Last Updated
last year

Overview

Brief Summary

Urinary incontinence is a frequent chronic condition in general population. It is even more frequent in people with chronic respiratory disease due to several factors, including but not limited to frequent cough. Urinary incontinence may be more frequent during exercise so that it may contribute to the general deconditioning associated with chronic respiratory disease.

Although pulmonary rehabilitation is a cornerstone in the management of people with chronic respiratory disease to break this spiral of worsening dyspnea, little is known about the prevalence of urinary incontinence among those people referred for pulmonary rehabilitation nor about its impact on the effects of the program.

Detailed Description

Experimental design: People referred for pulmonary rehabilitation in two centres will be offer to participate in the study. Those people who will agree to participate and give their formal consent will be asked to answer two questionnaires about urinary incontinence symptoms (see outcomes) to assess the prevalence and the type of these symptoms. They will subsequently participate in their usual pulmonary rehabilitation program consisting in 90min sessions (including endurance training, muscle strengthening and self-management), 3x/week for 8weeks (centre 1) or 2x60min sessions (including the same components), 3x/week for 8weeks (centre 2). The effects of the pulmonary rehabilitation program on usual clinical outcomes (according to each centre routine practice; tests may differ between centres) will be compared between those people with or without urinary incontinence symptoms. As no prevalence data about urinary incontience was available at the time of study design, we planned to recruit the first 100 participants within the first year and to update the sample size calculation based on these preliminary data. Among the 70 people actually included, 21 (30%) experienced urinary incontinence. Therefore, assuming a true prevalence of 30% in this population and a total width for the 95% confidence interval of 10%, we planned to recruit a total 341 participants. The ethical approval to recruit this updated number of participants and to increase the duration of recruitment accordingly was obtained.

Registry
clinicaltrials.gov
Start Date
May 11, 2020
End Date
February 26, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
ADIR Association
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age \> 18 ans ;
  • Referred for pulmonary rehabilitation ;
  • Non inclusion Criteria:
  • History of pathology or prostate surgery ;
  • Contra indication to pulmonary rehabilitation ;

Exclusion Criteria

  • Pregnant woman or likely to be ;
  • Patient under guardianship ;
  • Patient withdrawal ;
  • Did not complete at least 18 pulmonary rehabilitation sessions.

Outcomes

Primary Outcomes

Prevalence of urinary incontinence symptoms

Time Frame: The questionnaire will be administered at the end of the program (8weeks)

The prevalence of urinary incontinence symptoms will be assessed using the International Consultation on Incontinence Short Form

Secondary Outcomes

  • Type of urinary incontinence symptoms(The questionnaire will be administered at the end of the program (8weeks))
  • Exercise capacity - Six-minute walk test (meters)(The test will be administered at the end of the program (8weeks))
  • Mood status - Anxiety(The questionnaire will be administered at the end of the program (8weeks))
  • Mood status - Depression(The questionnaire will be administered at the end of the program (8weeks))
  • Quality of life - Saint Georges Respiratory Questionnaire (ranging from 0 to 100, higher score indicates worst quality of life)(The questionnaire will be administered at the end of the program (8weeks))
  • Exercise capacity - Six-minute stepper test (steps)(The test will be administered at the end of the program (8weeks))
  • Exercise capacity - Constant workload exercise testing(The test will be administered at the end of the program (8weeks))

Study Sites (2)

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