AzTrials
AzTrials

COPD (Chronic Obstructive Pulmonary Disease)PURGENCT07134400

Prevalence and Functional Impact of Urinary Incontinence in Women With Chronic Obstructive Pulmonary Disease Undergoing Rehabilitation: a Cross-sectional Study

An observational study of COPD (Chronic Obstructive Pulmonary Disease) and Urinary Incontinence (UI), run by Fondation Hôpital Saint-Joseph at 1 site in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Chronic Obstructive Pulmonary Disease (COPD) is a pathology characterized by progressive bronchial obstruction associated with an abnormal inflammatory response, leading to chronic cough, increased bronchial secretions, and irreversible destruction of alveolar walls according to the French-Language Pulmonology… Read more about this study

Who is it for?
Ages 18 years and older, women only
How many people
100 participants
Where
1 siteFrance
Study dates
2 Feb 2026to Nov 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Women over 45 suffering from COPD (stage II to IV) undergoing rehabiliation for COPD.

Who may be able to join

  • Women aged 45 years or older
  • Patients diagnosed with GOLD stage II to IV Chronic Obstructive Pulmonary Disease (COPD)
  • Patients undergoing pulmonary rehabilitation for COPD in a specialized center
  • Patients able to complete the entire pad test
  • Patients with no more than 3 pregnancies in their lifetime [9]
  • Patients covered by a health insurance plan
  • French-speaking patients
  • Patients who have not objected to participating in this research

Who cannot join

  • Patients who have undergone surgery in the pelvic or thoracic region less than one year ago
  • Patients under guardianship or curatorship
  • Patients deprived of liberty
  • Patients under legal protection (safeguarding justice)
  • Pregnant or breastfeeding patients

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Juliette COURTIADE MAHLER, phd contact

+33144127963

jcourtiade@ghpsj.fr

France1 site
  • Hôpital Paris Saint Joseph

    Paris, 75014

Other trials in France

About this study

Chronic Obstructive Pulmonary Disease (COPD) is a pathology characterized by progressive bronchial obstruction associated with an abnormal inflammatory response, leading to chronic cough, increased bronchial secretions, and irreversible destruction of alveolar walls according to the French-Language Pulmonology Society, in 2023, over 1.3 million patients were treated for this condition in France. The World Health Organization ranks COPD as the third leading cause of mortality worldwide. Historically, COPD predominantly affected men due to higher smoking rates. However, with the rise in smoking among women, recent studies have shown that the prevalence of COPD in women increased from 28 to41 perr 10,000 between 2006 and 2015. Moreover, the clinical presentation of the disease differs between genders. For equivalent smoking exposure, women appear to be more severely affected than men, experiencing greater dyspnea and a higher risk of exacerbations, leading to more frequent hospitalizations and a generally poorer quality of life.

Beyond pulmonary impairment, another clinically significant but often underestimated symptom affecting quality of life is urinary incontinence. It appears more common in individuals with COPD, particularly due to chronic cough, repeated abdominal hyperpressure, and pelvic floor muscle imbalance. A few studies have investigated the prevalence of urinary incontinence in people with COPD. One study, involving 995 individuals with COPD, suggested that 34.9% experienced urinary leakage. However, this was a subjective measure based on self-reported data via a simple questionnaire in a case-control study.

Read more

Another Swedish study estimated the prevalence of urinary incontinence in individuals with COPD at 49.6% in women and 30.3% in men, indicating that women may be at higher risk of developing this symptom. Beyond these studies, the current scientific literature remains relatively limited on this topic, while the impact on patients' quality of life appears to be significant. Among the available studies, one of the most comprehensive was published in 2013 and relied solely on self-administered questionnaires distributed to a broad population (across all disease stages) outside the rehabilitation setting.

This overlapping symptomatology-combining COPD and urinary incontinence-profoundly affects patients' quality of life, physically, psychologically, as well as socially. The consequences include limited activities, social withdrawal, diminished self-esteem, and persistent discomfort in daily interactions. This situation can lead to social anxiety or fear of leakage, resulting in absenteeism or abandonment of pulmonary rehabilitation sessions, thereby compromising the effectiveness of treatment. Reduced participation in physical activity perpetuates a vicious cycle: muscle deconditioning, sarcopenia, or even malnutrition, which worsens dyspnea, loss of autonomy, and increases the risks of frailty, infections, and hospitalizations. The study by M. A. Ramon et al. (2018) illustrates this "vicious cycle," where impaired respiratory and physical capacities are self-sustaining. Without specific screening or management strategies for urinary incontinence in this context, breaking this downward spiral and improving overall care trajectories becomes challenging.

Raising awareness about the importance of screening for stress urinary incontinence in women with COPD-particularly during pulmonary rehabilitation sessions, where these symptoms are often overlooked due to lack of knowledge and available treatments-is crucial. Such screening would enhance our understanding of the link between chronic cough, stress urinary incontinence, and quality of life. Establishing a correlation between these factors would allow for tailored care pathways and referral of certain patients to targeted pelvic floor rehabilitation.

A better understanding of this phenomenon is essential to improve functional assessment and propose adapted therapeutic approaches, which could be the subject of an interventional study in the future. This study thus represents an initial exploratory step aimed at better understanding the prevalence of urinary incontinence in women with COPD undergoing rehabilitation, as well as its impact on quality of life and cough function. It is a preliminary, observational study whose results will lay the foundation for future interventional research.

Medical subject headings
Pulmonary Disease, Chronic Obstructive, Urinary Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07134400
Study groupRoleWhat they receive
PAD testPatient will be ask to answer to the Leicester Cough questionnaire and the ICIQ-FLUTS questionnaire. They will also performed a PAD test.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Estimate the prevalence of urinary incontinence during rehabilitation in individuals with Chronic Obstructive Pulmonary Disease (COPD) undergoing exercise-based pulmonary rehabilitation

    Presence of urinary incontinence (yes/no) measured by a pad test ≥ 1 gram at the end of the session

    Measured: at enrollment

Secondary outcomes (4)
  1. severity of urinary incontinence (if detected)

    Weigh of the pad test in gram. , an increase of 1 to 10 g represents mild incontinence, 11 to 50 g represents moderate incontinence and > 50 g represents severe incontinence.

    Measured: at enrollment

  2. Impact of urinary incontinence on quality of life

    score at the ICIQ FLUTS

    Measured: at enrollement

  3. Impact of chronic cough on quality of life

    scored with the Leicester Couch Questionnaire

    Measured: at enrollement

  4. relation between cough severity and urinary incontinence

    correlation between Leicester Cough questionnaire and ICIQ FLUTS questionnaire

    Measured: at enrollement

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2025
  2. Study start2 Feb 2026 (estimated)
  3. Primary completionNov 2027 (estimated)
  4. Study completionNov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07134400
Sponsor's protocol ID
790-PURGE
Other IDs
2025-A01834-45
Acronym
PURGE
Status last verified
Jan 2026
First submitted
14 Aug 2025
Last updated
2 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of COPD (Chronic Obstructive Pulmonary Disease) and Urinary Incontinence (UI), run by Fondation Hôpital Saint-Joseph at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Juliette COURTIADE MAHLER, phd (+33144127963, jcourtiade@ghpsj.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Estimate the prevalence of urinary incontinence during rehabilitation in individuals with Chronic Obstructive Pulmonary Disease (COPD) undergoing exercise-based pulmonary rehabilitation (time frame: at enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in