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

NCT04380558 | Completed

• 1 other identifier: PRECUI-PR
• Study Type: observational
• Target: 341
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Pulmonary Disease; Pulmonary Rehabilitation; Urinary Incontinence

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• Type of urinary incontinence symptoms

  The questionnaire will be administered at baseline

• 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 baseline

• Exercise capacity - Six-minute walk test (meters)

  The test will be administered at the end of the program (8weeks)

• Exercise capacity - Six-minute stepper test (steps)

  The test will be administered at baseline

Study Arms (1)

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

Interventions

Pulmonary rehabilitation 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).

Prospective observational cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

People reffered for pulmonary rehabilitation.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• ADIR Association: lead

Study Sites (2)

ADIR Association

Bois-Guillaume, France

Location

Groupe Hospitalier du Havre

Le Havre, France

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David Debeaumont, MD

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

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 8, 2020
• Study Start: May 11, 2020
• Primary Completion: December 20, 2023
• Study Completion: February 26, 2024
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)