NCT06958042

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 6, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2026

Completed
Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

April 27, 2025

Last Update Submit

September 4, 2025

Conditions

Keywords

COPDIncontinancePelvic floor muscle

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Enrollment

Secondary Outcomes (3)

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

    Enrollment

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

    Enrollment

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

    Enrollment

Other Outcomes (2)

  • Pelvic Floor Health Knowledge Test

    Enrollment

  • Prolapse and Incontinence Knowledge Questionnaire

    Enrollment

Interventions

\- 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.

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

COPD patients who agreed to participate in the study

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kutahya Helath Sciences University- Health Sciences Faculty

Kütahya, Center, 43020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Surveys and QuestionnairesRestraint, Physical

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthBehavior ControlTherapeuticsImmobilization

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assos. Prof.

Study Record Dates

First Submitted

April 27, 2025

First Posted

May 6, 2025

Study Start

January 6, 2025

Primary Completion

January 6, 2026

Study Completion

January 6, 2026

Last Updated

September 11, 2025

Record last verified: 2025-09

Locations