- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04180670
Prevalence of Urinary Incontinence and Evaluation of Related Factors in Patients With COPD
May 22, 2023 updated by: Meltem Uzun, Sanko University
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.
Study Overview
Status
Recruiting
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 Type
Observational
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: MELTEM UZUN, Ph.D(c)
- Phone Number: 05346390534
- Email: meuzun@sanko.edu.tr
Study Locations
-
-
Please Select
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Gaziantep, Please Select, Turkey, 27060
- Recruiting
- SANKO University
-
Contact:
- MELTEM İ UZUN, Ph.D(c)
- Phone Number: 05346390534
- Email: meuzun@sanko.edu.tr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients diagnosed with COPD
Description
Inclusion Criteria:
- Patients diagnosed with COPD
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
First day
|
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.
|
First day
|
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.
|
First day
|
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.
|
First day
|
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).
|
First day
|
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.
|
First day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Meltem Uzun, PhD(c), SANKO University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2019
Primary Completion (Anticipated)
August 1, 2023
Study Completion (Anticipated)
September 1, 2023
Study Registration Dates
First Submitted
November 26, 2019
First Submitted That Met QC Criteria
November 26, 2019
First Posted (Actual)
November 27, 2019
Study Record Updates
Last Update Posted (Actual)
May 23, 2023
Last Update Submitted That Met QC Criteria
May 22, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Pathologic Processes
- Respiratory Tract Diseases
- Urologic Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Disease Attributes
- Urination Disorders
- Elimination Disorders
- Chronic Disease
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Lung Diseases
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Urinary Incontinence
- Enuresis
Other Study ID Numbers
- Sanko
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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