Chronic Obstructive Pulmonary DiseaseNCT04180670
Prevalence of Urinary Incontinence and Evaluation of Related Factors in Patients With COPD
An observational study of Chronic Obstructive Pulmonary Disease and Urinary Incontinence, run by Sanko University at 1 site in Turkey (Türkiye).
Trial summary
Urinary incontinence (UI) is defined as involuntary urinary incontinence. In women with COPD, chronic coughing can often lead to UI. In this patient group, incontinence may be related to functional impairment, concomitant diseases and medications used. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Urinary Incontinence
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2019to Sep 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with COPD
Who may be able to join
- Patients diagnosed with COPD
Who cannot join
- 65 and above patients Patients with congenital anomalies that may cause incontinence Patients with neurological diagnosis that may cause incontinence
- Obese patients with BMI over 30
- Female patients with traumatic gynecological history
- Patients with incontinence after severe gynecological operation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
SANKO University
Gaziantep, Please Select, 27060
MELTEM İ UZUN, Ph.D(c), 05346390534, meuzun@sanko.edu.tr
About this study
Official title: Prevalence of Urinary Incontinence and Evaluation of Related Factors in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Urinary incontinence (UI) is defined as involuntary urinary incontinence. In women with COPD, chronic coughing can often lead to UI. In this patient group, incontinence may be related to functional impairment, concomitant diseases and medications used. The aim of this study was to determine the incidence of urinary incontinence in patients with chronic obstructive pulmonary disease (COPD) and the factors that may be associated with urinary incontinence. The study included individuals who applied to the Pulmonary Diseases Policlinic of SANKO University Sani Konukoğlu Practice and Research Hospital and followed up with the diagnosis of COPD. The age, sex, height, weight, education level, smoking, exercise habits, fluid intake, medications and accompanying diseases such as heart disease, hypertension and diabetes will be recorded. Any prolapse or surgery will be questioned and noted. The disease severity will be determined by the forced expiratory volume (FEV1) value of the first second obtained from pulmonary function tests. Dyspnea score will also be determined by the Modified British Research Council (MBRC). Symptoms will be evaluated with the COPD Assessment Test (CAT). For urinary incontinence, the ICIQ-SF (International Urinary Incontinence Consultation) Questionnaire and Urinary Distress Inventory will be applied. In addition, the Leicester Cough Questionnaire will be used to assess your coughing functions, and the Activity-Self Assessment will be performed to determine the individual activity adequacy and the value of activities for individuals. All evaluations will be done only once with the help of the physiotherapist and asking the questions and recording the answers of the individual.
Read the detailed description
rinary incontinence (UI) is defined as involuntary urinary incontinence. In women with COPD, chronic coughing can often lead to UI. In this patient group, incontinence may be related to functional impairment, concomitant diseases and medications used. The aim of this study was to determine the incidence of urinary incontinence in patients with chronic obstructive pulmonary disease (COPD) and the factors that may be associated with urinary incontinence. The study included individuals who applied to the Pulmonary Diseases Policlinic of SANKO University Sani Konukoğlu Practice and Research Hospital and followed up with the diagnosis of COPD. The age, sex, height, weight, education level, smoking, exercise habits, fluid intake, medications and accompanying diseases such as heart disease, hypertension and diabetes will be recorded. Any prolapse or surgery will be questioned and noted. The disease severity will be determined by the forced expiratory volume (FEV1) value of the first second obtained from pulmonary function tests. Dyspnea score will also be determined by the Modified British Research Council (MBRC). Symptoms will be evaluated with the COPD Assessment Test (CAT). For urinary incontinence, the ICIQ-SF (International Urinary Incontinence Consultation) Questionnaire and Urinary Distress Inventory will be applied. In addition, the Leicester Cough Questionnaire will be used to assess your coughing functions, and the Activity-Self Assessment will be performed to determine the individual activity adequacy and the value of activities for individuals. All evaluations will be done only once with the help of the physiotherapist and asking the questions and recording the answers of the individual.
- Keywords
- chronic Obstructive Pulmonary Disease, urinary incontinence, self-activity assesment
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Urinary Incontinence
What is being measured
The primary outcome is the main question the study is designed to answer.
MMRC Dyspnea score
Grade shortness of breath that may occur during daily exercises. "0" means shortness of breath with heavy exercise and 5 means shortness of breath even when dressing and undressing.
Measured: First day
COPD Assessment Test CAT
It is an eight-item short, easy-to-apply test that measures the effects of COPD and deterioration in health status. The change in two units or more at the individual patient level is clinically significant.
Measured: First day
ICIQ-SF (International Urinary Incontinence Consultation) Survey
It consists of 6 questions. In the first two questions, the date of birth and gender are questioned, while in the third question the incidence of urinary incontinence is questioned in the fourth question. 5. Question "How much incontinence affects your daily life?" Is answered between 0 (does not affect it in any way) and 10 (very much affects) and makes you think that the quality of life gets worse as you get closer to 10. In question 6, the time of incontinence is questioned. The maximum value is 21. The higher the score, the lower the quality of life.
Measured: First day
Urinary Distress Inventory
It consists of 6 questions and is graded as a four-point Likert. The first two questions address irritative symptoms (urgency, frequency, and pain), while questions 3 and 4 aim at stress symptoms, and the last two questions address obstructive or voiding symptoms.
Measured: First day
Leicester Cough Survey
It consists of 19 items, three of which are physical, psychological and social. The items in the Leicester Cough Questionnaire were selected by clinical effect factor method. This method selects the subjects that the patients define as problems and differentiates them according to the importance of the patients. Topics are also divided into fields. The questionnaire is completed on a seven-point Likert Scale (1 = Always, 2 = Most of the time, 3 = Often, 4 = Sometimes, 5 = Occasionally, 6 = Rarely, 7 = Never). Higher scores indicate better health status. Total score; It is the sum of the scores of the three subheadings (physical, psychological and social).
Measured: First day
Activity-Self Assessment
It is an individual-centered assessment tool consisting of 21 questions related to the individual's kendisi self alı related to the activity activity (how well it performs the activity) and value (how valuable / important the relevant activity is for itself). The first 11 questions are skills; 12.-16. questions between habits and 17.-21. items related to requests.
Measured: First day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start1 Dec 2019
- Primary completionAug 2023 (estimated)
- Study completionSep 2023 (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 DiseaseStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Sanko University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Uzun, Sanko University
- Investigators
- Meltem Uzun, PhD(c), Principal investigator, Sanko University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04180670
- Sponsor's protocol ID
- Sanko
- Status last verified
- May 2023
- First submitted
- 26 Nov 2019
- Last updated
- 23 May 2023
- Results posted
- 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 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Urinary Incontinence and Evaluation of Related Factors in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT04180670
- Acronym / sponsor ID
- Sanko
- Keywords
- chronic Obstructive Pulmonary Disease, urinary incontinence, self-activity assesment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sanko UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 27 Nov 2019 (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.
Urinary incontinence (UI) is defined as involuntary urinary incontinence. In women with COPD, chronic coughing can often lead to UI. In this patient group, incontinence may be related to functional impairment, concomitant diseases and medications used. The aim of this study was to determine the incidence of urinary incontinence in patients with chronic obstructive pulmonary disease (COPD) and the factors that may be associated with urinary incontinence. The study included individuals who applied to the Pulmonary Diseases Policlinic of SANKO University Sani Konukoğlu Practice and Research Hospital and followed up with the diagnosis of COPD. The age, sex, height, weight, education level, smoking, exercise habits, fluid intake, medications and accompanying diseases such as heart disease, hypertension and diabetes will be recorded. Any prolapse or surgery will be questioned and noted. The disease severity will be determined by the forced expiratory volume (FEV1) value of the first second obtained from pulmonary function tests. Dyspnea score will also be determined by the Modified British Research Council (MBRC). Symptoms will be evaluated with the COPD Assessment Test (CAT). For urinary incontinence, the ICIQ-SF (International Urinary Incontinence Consultation) Questionnaire and Urinary Distress Inventory will be applied. In addition, the Leicester Cough Questionnaire will be used to assess your coughing functions, and the Activity-Self Assessment will be performed to determine the individual activity adequacy and the value of activities for individuals. All evaluations will be done only once with the help of the physiotherapist and asking the questions and recording the answers of the individual.
Detailed description
rinary incontinence (UI) is defined as involuntary urinary incontinence. In women with COPD, chronic coughing can often lead to UI. In this patient group, incontinence may be related to functional impairment, concomitant diseases and medications used. The aim of this study was to determine the incidence of urinary incontinence in patients with chronic obstructive pulmonary disease (COPD) and the factors that may be associated with urinary incontinence. The study included individuals who applied to the Pulmonary Diseases Policlinic of SANKO University Sani Konukoğlu Practice and Research Hospital and followed up with the diagnosis of COPD. The age, sex, height, weight, education level, smoking, exercise habits, fluid intake, medications and accompanying diseases such as heart disease, hypertension and diabetes will be recorded. Any prolapse or surgery will be questioned and noted. The disease severity will be determined by the forced expiratory volume (FEV1) value of the first second obtained from pulmonary function tests. Dyspnea score will also be determined by the Modified British Research Council (MBRC). Symptoms will be evaluated with the COPD Assessment Test (CAT). For urinary incontinence, the ICIQ-SF (International Urinary Incontinence Consultation) Questionnaire and Urinary Distress Inventory will be applied. In addition, the Leicester Cough Questionnaire will be used to assess your coughing functions, and the Activity-Self Assessment will be performed to determine the individual activity adequacy and the value of activities for individuals. All evaluations will be done only once with the help of the physiotherapist and asking the questions and recording the answers of the individual.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with COPD
Key inclusion criteria (1 listed)
- Patients diagnosed with COPD
Key exclusion criteria (4 listed)
- 65 and above patients Patients with congenital anomalies that may cause incontinence Patients with neurological diagnosis that may cause incontinence
- Obese patients with BMI over 30
- Female patients with traumatic gynecological history
- Patients with incontinence after severe gynecological operation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MMRC Dyspnea score
Time frame: First day
Grade shortness of breath that may occur during daily exercises. "0" means shortness of breath with heavy exercise and 5 means shortness of breath even when dressing and undressing.
COPD Assessment Test CAT
Time frame: First day
It is an eight-item short, easy-to-apply test that measures the effects of COPD and deterioration in health status. The change in two units or more at the individual patient level is clinically significant.
ICIQ-SF (International Urinary Incontinence Consultation) Survey
Time frame: First day
It consists of 6 questions. In the first two questions, the date of birth and gender are questioned, while in the third question the incidence of urinary incontinence is questioned in the fourth question. 5. Question "How much incontinence affects your daily life?" Is answered between 0 (does not affect it in any way) and 10 (very much affects) and makes you think that the quality of life gets worse as you get closer to 10. In question 6, the time of incontinence is questioned. The maximum value is 21. The higher the score, the lower the quality of life.
Urinary Distress Inventory
Time frame: First day
It consists of 6 questions and is graded as a four-point Likert. The first two questions address irritative symptoms (urgency, frequency, and pain), while questions 3 and 4 aim at stress symptoms, and the last two questions address obstructive or voiding symptoms.
Leicester Cough Survey
Time frame: First day
It consists of 19 items, three of which are physical, psychological and social. The items in the Leicester Cough Questionnaire were selected by clinical effect factor method. This method selects the subjects that the patients define as problems and differentiates them according to the importance of the patients. Topics are also divided into fields. The questionnaire is completed on a seven-point Likert Scale (1 = Always, 2 = Most of the time, 3 = Often, 4 = Sometimes, 5 = Occasionally, 6 = Rarely, 7 = Never). Higher scores indicate better health status. Total score; It is the sum of the scores of the three subheadings (physical, psychological and social).
Activity-Self Assessment
Time frame: First day
It is an individual-centered assessment tool consisting of 21 questions related to the individual's kendisi self alı related to the activity activity (how well it performs the activity) and value (how valuable / important the relevant activity is for itself). The first 11 questions are skills; 12.-16. questions between habits and 17.-21. items related to requests.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- 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. This study is not recruiting at the moment.
Meltem Uzun, PhD(c) principal investigator
Sanko University
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 and Urinary Incontinence, run by Sanko 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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 23 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact meltem uzun, Ph.D(c) (05346390534, meuzun@sanko.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MMRC Dyspnea score (time frame: First day). The study lists 6 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 23 May 2023; AzTrials last refreshed its copy on 8 Nov 2026.