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

NCT ID: NCT04380558

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 341 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-11
• Study Completion Date: 2024-02-26

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.

Conditions

Chronic Pulmonary Disease; Pulmonary Rehabilitation; Urinary Incontinence

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

Pulmonary rehabilitation

Intervention Type: OTHER

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).

Interventions

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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age > 18 ans ;
• Referred for pulmonary rehabilitation ;

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ADIR Association

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Debeaumont, MD

Role: PRINCIPAL_INVESTIGATOR

CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France

Antoine Cuvelier, Prof, PhD

Role: STUDY_CHAIR

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.

Tristan Bonnevie, MsC

Role: STUDY_CHAIR

ADIR Association, Bois-Guillaume, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France

Francis-Edouard Gravier, PT

Role: STUDY_CHAIR

ADIR Association, Bois-Guillaume, France

Jean-François Muir, Prof, PhD

Role: STUDY_CHAIR

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

Bouchra Lamia, Prof, PhD

Role: STUDY_CHAIR

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

Jean Quieffin, MD

Role: STUDY_CHAIR

Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers

Guillaume Prieur, PT, MsC

Role: STUDY_CHAIR

Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers

Clément Médrinal, PT, MsC

Role: STUDY_CHAIR

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

Locations

ADIR Association

Bois-Guillaume, , France

Groupe Hospitalier du Havre

Le Havre, , France

Countries

France

Other Identifiers

PRECUI-PR

Identifier Type: -

Identifier Source: org_study_id