Prevalence and Consequences of Urinary Incontinence in People with Chronic Pulmonary Diseases Referred for Pulmonary Rehabilitation (PRECUI-PR)

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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence; Pulmonary Rehabilitation; Chronic Pulmonary Disease
• Intervention / Treatment: Other: Pulmonary rehabilitation

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.

• Study Type: Observational
• Enrollment (Actual): 341

Contacts and Locations

Study Locations

• France
  • Bois-Guillaume, France
    • ADIR Association
  • Le Havre, France
    • Groupe Hospitalier du Havre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

People reffered for pulmonary rehabilitation.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Prospective observational cohort; Every patient referred to pulmonary rehabilitation program will be eligible. They will 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).

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)
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
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)

Collaborators and Investigators

• Sponsor: ADIR Association
• Investigators: Principal Investigator: David Debeaumont, MD, CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France; Study Chair: Antoine Cuvelier, Prof, PhD, CHU-Hôpitaux de Rouen - Service de pneumologie, Hôpital de Bois-Guillaume, Rouen, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France.; Study Chair: Tristan Bonnevie, MsC, ADIR Association, Bois-Guillaume, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France; Study Chair: Francis-Edouard Gravier, PT, ADIR Association, Bois-Guillaume, France; Study Chair: Jean-François Muir, Prof, PhD, CHU-Hôpitaux de Rouen - Service de pneumologie, Hôpital de Bois-Guillaume, Rouen, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France ; ADIR Association, Bois-Guillaume, France; Study Chair: Bouchra Lamia, Prof, PhD, UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France ; Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers; Study Chair: Jean Quieffin, MD, Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers; Study Chair: Guillaume Prieur, PT, MsC, Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers; Study Chair: Clément Médrinal, PT, MsC, UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France. Service de réanimation, Groupe Hospitalier du Havre, France

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2020
• Primary Completion (Actual): December 20, 2023
• Study Completion (Actual): February 26, 2024

Study Registration Dates

• First Submitted: May 5, 2020
• First Submitted That Met QC Criteria: May 6, 2020
• First Posted (Actual): May 8, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 7, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Respiratory Tract Diseases; Urinary Incontinence; Enuresis; Lung Diseases
• Other Study ID Numbers: PRECUI-PR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No