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

NCT07134400 | Not Yet Recruiting

• 2 other identifiers: 790-PURGE2025-A01834-45
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Urinary Incontinence (UI); Pulmonary Rehabilitation; COPD (Chronic Obstructive Pulmonary Disease)

Outcome Measures

Primary Outcomes (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

  at enrollment

Secondary Outcomes (4)

• severity of urinary incontinence (if detected)

  at enrollment

• Impact of urinary incontinence on quality of life

  at enrollement

• Impact of chronic cough on quality of life

  at enrollement

• relation between cough severity and urinary incontinence

  at enrollement

Study Arms (1)

PAD test

Patient will be ask to answer to the Leicester Cough questionnaire and the ICIQ-FLUTS questionnaire. They will also performed a PAD test.

Eligibility Criteria

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

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Hôpital Paris Saint Joseph

Paris, 75014, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Urinary Incontinence

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; 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

Study Officials

• Christophe ROMANET

  Hôpital Paris Saint Joseph

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juliette COURTIADE MAHLER, phd

CONTACT

+33144127963; jcourtiade@ghpsj.fr

Study Design

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

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 21, 2025
• Study Start: February 2, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)