Chronic Obstructive Pulmonary Disease (COPD)NCT06958042
The Prevalence of Lower Urinary Tract Symptoms in Individuals With Chronic Obstructive Pulmonary Disease
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Questionnaire and Physical Exam
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jan 2025to 6 Jan 2026
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD patients who agreed to participate in the study
Who may be able to join
- Being diagnosed with COPD (according to GOLD criteria)
- Being clinically stable
- Volunteering to participate in the study
Who cannot join
- Having perception and cognitive problems
- Having a diagnosis of unstable COPD
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kutahya Helath Sciences University- Health Sciences Faculty
Kütahya, Center, 43020
About this study
Official 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
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.
Read the detailed description
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.
- Being tested
- Questionnaire and Physical Exam
- Keywords
- COPD, Incontinance, Pelvic floor muscle
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire and Physical ExamOther
- 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incontinence Quality of Life Scale (IQOL)
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.
Measured: Enrolllment
St George Respiratory Questionnaire (SGRQ)
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.
Measured: Enrollment
Secondary outcomes (3)
International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
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.
Measured: Enrollment
International Consultation on Incontinence Questionnaire-Male Lower Urinary System Symptoms (ICIQ-MLUTS)
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.
Measured: Enrollment
International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)
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.
Measured: Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start6 Jan 2025
- Primary completion6 Jan 2026 (estimated)
- Study completion6 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Kurt, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06958042
- Sponsor's protocol ID
- COPD_INCONTINENCE
- Status last verified
- Sep 2025
- First submitted
- 27 Apr 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06958042
- Acronym / sponsor ID
- COPD_INCONTINENCE
- Keywords
- COPD, Incontinance, Pelvic floor muscle
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 6 Jan 2026 (estimated)
- Study completion
- 6 Jan 2026 (estimated)
- First posted
- 6 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients who agreed to participate in the study
Key inclusion criteria (3 listed)
- Being diagnosed with COPD (according to GOLD criteria)
- Being clinically stable
- Volunteering to participate in the study
Key exclusion criteria (2 listed)
- Having perception and cognitive problems
- Having a diagnosis of unstable COPD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire and Physical Exam- 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. | Other | – |
Primary outcome
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.
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.
3 secondary outcomes
International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
Time frame: Enrollment
International Consultation on Incontinence Questionnaire-Male Lower Urinary System Symptoms (ICIQ-MLUTS)
Time frame: Enrollment
International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)
Time frame: Enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
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 3 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 11 Sep 2025. 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 Turkey (Türkiye). 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incontinence Quality of Life Scale (IQOL) (time frame: Enrolllment). The study lists 2 primary outcomes in all. 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 11 Sep 2025.