Clinical trial NCT04380558: Prevalence and Consequences of Urinary Incontinence in People with Chronic Pulmonary Diseases Referred for Pulmonary Rehabilitation
Official title: Prevalence and Consequences of Urinary Incontinence in People with Chronic Pulmonary Diseases Referred for Pulmonary Rehabilitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pulmonary Disease
Pulmonary Rehabilitation
Urinary Incontinence
Lead sponsor: ADIR Association
Sponsor class: OTHER
First posted: 2020-05-08
Enrollment: 341
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: People reffered for pulmonary rehabilitation.

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.

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.

Primary outcomes:
measure: Prevalence of urinary incontinence symptoms
timeFrame: The questionnaire will be administered at baseline
measure: Prevalence of urinary incontinence symptoms
timeFrame: The questionnaire will be administered at the end of the program (8weeks)
Secondary outcomes:
measure: Type of urinary incontinence symptoms
timeFrame: The questionnaire will be administered at baseline
measure: Type of urinary incontinence symptoms
timeFrame: The questionnaire will be administered at the end of the program (8weeks)
measure: Exercise capacity - Six-minute walk test (meters)
timeFrame: The test will be administered at baseline
measure: Exercise capacity - Six-minute walk test (meters)
timeFrame: The test will be administered at the end of the program (8weeks)
measure: Exercise capacity - Six-minute stepper test (steps)
timeFrame: The test will be administered at baseline
measure: Exercise capacity - Six-minute stepper test (steps)
timeFrame: The test will be administered at the end of the program (8weeks)
measure: Exercise capacity - Constant workload exercise testing
timeFrame: The test will be administered at baseline
measure: Exercise capacity - Constant workload exercise testing
timeFrame: The test will be administered at the end of the program (8weeks)
measure: Quality of life - Saint Georges Respiratory Questionnaire (ranging from 0 to 100, higher score indicates worst quality of life)
timeFrame: The questionnaire will be administered at baseline
measure: Quality of life - Saint Georges Respiratory Questionnaire (ranging from 0 to 100, higher score indicates worst quality of life)
timeFrame: The questionnaire will be administered at the end of the program (8weeks)
measure: Mood status - Anxiety
timeFrame: The questionnaire will be administered at baseline
measure: Mood status - Anxiety
timeFrame: The questionnaire will be administered at the end of the program (8weeks)
measure: Mood status - Depression
timeFrame: The questionnaire will be administered at baseline
measure: Mood status - Depression
timeFrame: The questionnaire will be administered at the end of the program (8weeks)
Other outcomes:
Locations:
city: Bois-Guillaume
country: France
facility: ADIR Association
city: Le Havre
country: France
facility: Groupe Hospitalier du Havre
Study officials:
affiliation: CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France
name: David Debeaumont, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 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.
name: Antoine Cuvelier, Prof, PhD
role: STUDY_CHAIR
affiliation: ADIR Association, Bois-Guillaume, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France
name: Tristan Bonnevie, MsC
role: STUDY_CHAIR
affiliation: ADIR Association, Bois-Guillaume, France
name: Francis-Edouard Gravier, PT
role: STUDY_CHAIR
affiliation: 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
name: Jean-François Muir, Prof, PhD
role: STUDY_CHAIR
affiliation: 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
name: Bouchra Lamia, Prof, PhD
role: STUDY_CHAIR
affiliation: Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers
name: Jean Quieffin, MD
role: STUDY_CHAIR
affiliation: Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers
name: Guillaume Prieur, PT, MsC
role: STUDY_CHAIR
affiliation: 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
name: Clément Médrinal, PT, MsC
role: STUDY_CHAIR
References: