Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07134400

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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

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

Secondary outcomes

  1. severity of urinary incontinence (if detected)

    Time frame: at enrollment

    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.

  2. Impact of urinary incontinence on quality of life

    Time frame: at enrollement

    score at the ICIQ FLUTS

  3. Impact of chronic cough on quality of life

    Time frame: at enrollement

    scored with the Leicester Couch Questionnaire

  4. relation between cough severity and urinary incontinence

    Time frame: at enrollement

    correlation between Leicester Cough questionnaire and ICIQ FLUTS questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Juliette COURTIADE MAHLER, phd

CONTACT

[email protected]

+33144127963

Sponsors and collaborators

Lead sponsor

Fondation Hôpital Saint-Joseph

Other

Registry information

Acronym: PURGE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 21, 2025
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.