Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06958042

The Prevalence of Lower Urinary Tract Symptoms in Individuals With Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease (COPD) is a chronic lung disease characterized by airflow limitations and respiratory symptoms due to structural changes in the airways. Common symptoms include dyspnea, chronic cough, and increased sputum production. Respiratory diseases are a risk factor for lower urinary tract symptoms, which can lead to leakage if pelvic floor muscles are weak. Lower urinary tract symptoms are classified into storage, emptying, and post-emptying groups. Current literature on urinary incontinence in COPD patients is limited, and there is a need for further research on the presence and effects of lower urinary system symptoms in individuals with COPD and the level of pelvic floor health knowledge.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kutahya Helath Sciences University- Health Sciences Faculty

Kütahya, Center, 43020, Turkey (Türkiye)

About this study

Chronic Obstructive Pulmonary Disease (COPD) is defined as a chronic lung disease characterized by progressive airflow limitation and chronic respiratory symptoms due to structural changes in the airways. Dyspnea (shortness of breath), chronic cough, and increased sputum production are the most common symptoms in individuals with COPD. Respiratory diseases are considered a risk factor for lower urinary tract symptoms due to cough and shortness of breath. Severe coughing and shortness of breath increase intra-abdominal pressure and stress on the bladder. These conditions can lead to leakage if the pelvic floor muscles are weak. In addition, regular coughing can further weaken the ligaments in the pelvic floor, causing symptoms.

Lower urinary tract symptoms is a general term covering various functional disorders of the bladder, pelvic floor, or specific pathologies. The International Continence Society classifies lower urinary tract symptoms in three main groups: storage (increased/decreased urination, urinary incontinence, nocturia, overactive bladder), emptying (delayed urination, painful urination, intermittent urination), and post-emptying (feeling of not being able to empty the bladder completely, repeated urge to urinate, urinary tract infections). When the current literature was examined, it was observed that there are studies on the presence of urinary incontinence in patients with chronic respiratory disease, but there are limited studies investigating the presence and effects of lower urinary system symptoms in individuals with COPD in general and investigating the level of pelvic floor health knowledge. In this context, our study is unique and may contribute to future rehabilitation studies in this field.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Being diagnosed with COPD (according to GOLD criteria)
  • Being clinically stable
  • Volunteering to participate in the study

Exclusion criteria

  • Having perception and cognitive problems
  • Having a diagnosis of unstable COPD

Treatment and study plan

Questionnaire and Physical Exam

Other
  • St George Respiratory Questionnaire (SGRQ): The SGRQ developed by Jones (2000), which is used specifically for respiratory diseases, consists of 50 questions. In the questionnaire, there are three categories in which symptom, activity and the effect of the disease on quality of life are questioned and each category is evaluated within itself and there is an evaluation scale between 0-100 points. In the evaluation, high scores indicate an inadequate and low quality of life.

Primary outcomes

  1. Incontinence Quality of Life Scale (IQOL)

    Time frame: Enrolllment

    The Turkish validity and reliability studies of the scale developed by Patrick et al. (1999) to determine the quality of life of patients with urinary incontinence were conducted by Özerdoğan et al. There are 22 questions in the scale and each question is evaluated with a Likert-type scale divided into five categories (1: very much, 2: quite, 3: moderately, 4: a little, 5: not at all). IQOL has three sub-dimensions: limiting behaviour, psychological impact and limiting social life. The total score of the scale ranges from 0-100 and it is concluded that the higher the score, the better the quality of life level.

  2. St George Respiratory Questionnaire (SGRQ)

    Time frame: Enrollment

    Quality of life will be evaluated using the SGRQ, which includes symptoms, activity, and impact domains.

    Scores range from 0 to 100, with higher scores indicating poorer quality of life.

Secondary outcomes

  1. International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)

    Time frame: Enrollment

    The ICIQ-SF was developed by the International Consultation on Incontinence to assess the frequency, severity and impact of incontinence. The scale consists of four dimensions. The first dimension assesses how often incontinence occurs, the second dimension assesses the amount of incontinence, the third dimension assesses the effect of incontinence on daily life and the last dimension assesses the conditions that cause incontinence. The first three dimensions are included in the scoring and the fourth dimension is used to determine the type of incontinence. The total score of the scale varies between 0-21 and an increase in score indicates an increase in severity.

  2. International Consultation on Incontinence Questionnaire-Male Lower Urinary System Symptoms (ICIQ-MLUTS)

    Time frame: Enrollment

    Turkish validity and reliability studies of the ICIQ-MLUTS scale developed by the International Consultation on Incontinence to evaluate lower urinary system symptoms in male individuals were conducted by Mertoğlu et al. The scale consists of 13 items in total. 5 items question voiding symptoms, 6 items question storage symptoms, frequent daytime urination and number of nighttime urination. The items in the storage and voiding subsections question the presence and severity of the symptom and rate it according to a Likert scale (0: Never, 1: Rarely, 2: Occasionally, 3: Mostly, 4: Always). The voiding symptom score of the scale is 0-20 and the storage symptom score is 0-24.

  3. International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)

    Time frame: Enrollment

    The Incontinence Questionnaire - Female Lower Urinary Tract Symptoms Long Form (ICIQ-FLUTS-LF) was divided into 6 subgroups of symptom measurements, which were storage, voiding, incontinence, bladder pain, post-micturition, and ability to stop voiding. Each severity item is rated from 0 to 4, and each bothersome item from 0 to 10. The total severity score ranges from 0 to 20, and the total bothersome score ranges from 0 to 50. Higher scores indicate worse outcomes.

Other outcomes

  1. Pelvic Floor Health Knowledge Test

    Time frame: Enrollment

    according to the subscales of this test: pelvic floor function/dysfunction (8 items), risk factors of pelvic floor dysfunctions (18 items), and diagnosis and treatment of 11 items. All items were created simply and understandably with three response categories: "yes," "no," and "I do not know." A dichotomous system was used for scoring: "1" point for the items that were answered correctly and "0" points for the items that were answered incorrectly or unknown.

  2. Prolapse and Incontinence Knowledge Questionnaire

    Time frame: Enrollment

    The participants read and indicated their agreement levels (agree, disagree, do not know) with 24 items (12 items for each subscale) in this knowledge scale. Each item has a correct response, and the participants were given a "1" point if they have marked that response. Incorrect, missing, or "don't know" answers were scored as "0" points. Scores of subscales (0-12 points), and the overall scale (0-24 points) were calculated, and higher scores indicated a higher level of knowledge.

Sponsors and collaborators

Lead sponsor

Kutahya Health Sciences University

Other

Registry information

Official study title

Investigation of the Prevalence of Lower Urinary Tract Symptoms and the Level of Knowledge About Pelvic Floor Health in Individuals With Chronic Obstructive Pulmonary Disease

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 6, 2025
Registry last updated
Sep 11, 2025

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.