Prevalence of Urinary Incontinence and Evaluation of Related Factors in Patients With COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Prevalence of Urinary Incontinence and Evaluation of Related Factors in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04180670
• Other study ID #: Sanko
• Status: Recruiting
• Start date: December 1, 2019
• Est. completion date: September 2023

Study information

• Verified date: May 2023
• Source: Sanko University
• Contact: meltem uzun, Ph.D(c)
• Phone: 05346390534
• Email: meuzun[@]sanko.edu.tr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Enuresis
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Urinary Incontinence

Locations

Country	Name	City	State
Turkey	SANKO University	Gaziantep	Please Select

Sponsors (1)

Lead Sponsor	Collaborator
Sanko University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	First day
Primary	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.	First day
Primary	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.	First day
Primary	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.	First day
Primary	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).	First day
Primary	Activity-Self Assessment	It is an individual-centered assessment tool consisting of 21 questions related to the individual's kendisi self ali 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