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

Urinary Incontinence Clinical Trial

— PRECUI-PR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04380558
• Other study ID #: PRECUI-PR
• Status: Recruiting
• Start date: May 11, 2020
• Est. completion date: July 31, 2024

Study information

• Verified date: February 2023
• Source: ADIR Association
• Contact: Tristan Bonnevie, MsC
• Phone: 02 65 59 29 70
• Email: rehabilitation[@]adir-hautenormandie.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 341
• Est. completion date: July 31, 2024
• Est. primary completion date: May 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pulmonary Disease
• Enuresis
• Lung Diseases
• Pulmonary Rehabilitation
• Urinary Incontinence

Intervention

Other:
• Pulmonary rehabilitation
Patients 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).

Locations

Country	Name	City	State
France	ADIR Association	Bois-Guillaume
France	Groupe Hospitalier du Havre	Le Havre

Sponsors (1)

Lead Sponsor	Collaborator
ADIR Association

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of urinary incontinence symptoms	The prevalence of urinary incontinence symptoms will be assessed using the International Consultation on Incontinence Short Form	The questionnaire will be administered at baseline
Primary	Prevalence of urinary incontinence symptoms	The prevalence of urinary incontinence symptoms will be assessed using the International Consultation on Incontinence Short Form	The questionnaire will be administered at the end of the program (8weeks)
Secondary	Type of urinary incontinence symptoms	The type of urinary incontinence symptoms will be assessed using the Urinary Symptom Profile questionnaire.	The questionnaire will be administered at baseline
Secondary	Type of urinary incontinence symptoms	The type of urinary incontinence symptoms will be assessed using the Urinary Symptom Profile questionnaire.	The questionnaire will be administered at the end of the program (8weeks)
Secondary	Exercise capacity - Six-minute walk test (meters)	The six-minute walk test will be performed before and after the completion of the pulmonary rehabilitation program. In addition, the proportion of people who improve for more than 25meters will be compared between those people with or without urinary incontinence symptoms.	The test will be administered at baseline
Secondary	Exercise capacity - Six-minute walk test (meters)	The six-minute walk test will be performed before and after the completion of the pulmonary rehabilitation program. In addition, the proportion of people who improve for more than 25meters will be compared between those people with or without urinary incontinence symptoms.	The test will be administered at the end of the program (8weeks)
Secondary	Exercise capacity - Six-minute stepper test (steps)	The six-minute stepper test will be performed before and after the completion of the pulmonary rehabilitation program. In addition, the proportion of people who improve for more than 20steps will be compared between those people with or without urinary incontinence symptoms.	The test will be administered at baseline
Secondary	Exercise capacity - Six-minute stepper test (steps)	The six-minute stepper test will be performed before and after the completion of the pulmonary rehabilitation program. In addition, the proportion of people who improve for more than 20steps will be compared between those people with or without urinary incontinence symptoms.	The test will be administered at the end of the program (8weeks)
Secondary	Exercise capacity - Constant workload exercise testing	The constant workload exercise testing will be performed before and after the completion of the pulmonary rehabilitation program. In addition, the proportion of people who improve for more than 101sec will be compared between those people with or without urinary incontinence symptoms.	The test will be administered at baseline
Secondary	Exercise capacity - Constant workload exercise testing	The constant workload exercise testing will be performed before and after the completion of the pulmonary rehabilitation program. In addition, the proportion of people who improve for more than 101sec will be compared between those people with or without urinary incontinence symptoms.	The test will be administered at the end of the program (8weeks)
Secondary	Quality of life - Saint Georges Respiratory Questionnaire (ranging from 0 to 100, higher score indicates worst quality of life)	The questionnaire will be administered before and after the completion of the pulmonary rehabilitation program. In addition, the proportion of people who improve for more than 4points will be compared between those people with or without urinary incontinence symptoms.	The questionnaire will be administered at baseline
Secondary	Quality of life - Saint Georges Respiratory Questionnaire (ranging from 0 to 100, higher score indicates worst quality of life)	The questionnaire will be administered before and after the completion of the pulmonary rehabilitation program. In addition, the proportion of people who improve for more than 4points will be compared between those people with or without urinary incontinence symptoms.	The questionnaire will be administered at the end of the program (8weeks)
Secondary	Mood status - Anxiety	Anxiety will be assessed using the Hospital Anxiety and Depression Scale (ranging for 0 to 15, higher score indicates worst anxiety)	The questionnaire will be administered at baseline
Secondary	Mood status - Anxiety	Anxiety will be assessed using the Hospital Anxiety and Depression Scale (ranging for 0 to 15, higher score indicates worst anxiety)	The questionnaire will be administered at the end of the program (8weeks)
Secondary	Mood status - Depression	Depression will be assessed using the Hospital Anxiety and Depression Scale (ranging for 0 to 15, higher score indicates worst anxiety)	The questionnaire will be administered at baseline
Secondary	Mood status - Depression	Depression will be assessed using the Hospital Anxiety and Depression Scale (ranging for 0 to 15, higher score indicates worst anxiety)	The questionnaire will be administered at the end of the program (8weeks)