Examination of Lower Urinary System Symptoms With Duchenne Muscular Dystrophy

NCT ID: NCT05464446

Last Updated: 2022-07-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2022-06-20

Brief Summary

The aim of this study is to examine the prevalence of lower urinary tract symptoms (LUTS) in children with Duchenne Muscular Dystrophy (DMD) and the relationship between functional level, posture, muscle strength, pelvic floor muscle control, participation in activities of daily living, and quality of life that may be associated with these symptoms.

Forty-five children with DMD between the ages of 5-18 (Age: 9.00±3.32 years, Weight: 31,10±12,59 kg, Height: 125,87±18,46 cm) and their families were included in the study. LUTS was assessed with Dysfunctional Voiding And Incontinence Scoring System, functional level with Brooke Upper Extremity Functional Classification and Vignos Scale, posture with the New York Posture Assessment Questionnaire, Baseline Bubble Inclinometer (10602, Fabrication Enterprises Inc. New York, USA) and Baseline Digital Inclinometer (12-1057, Fabrication Enterprises Inc, New York, USA), participation in activities of daily living was assessed with the Barthel Index and quality of life was assessed with the Pediatric Quality of Life Inventory 3.0 Neuromuscular Module. Also, using the Hoggan microFET2 (Hoggan Scientific, LLC, Salt Lake City UT, USA) device, hip flexors, quadriceps femoris muscles, shoulder flexors, elbow extensors, elbow flexors, trunk extensors and flexors were evaluated in terms of muscle strength. Evaluations were made once, and the associated factors were compared in the group with and without LUTS, and the relationship between the factors and the severity of LUTS was examined.

Conditions

Duchenne Muscular Dystrophy; Lower Urinary Tract Symptoms; Muscle Weakness; Posture Disorders in Children; Lumbar Lordosis; Pelvic Floor Muscle Weakness; Quality of Life

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Duchenne Muscular Dystrophy

Children with Duchenne Muscular Dystrophy (DMD) between the ages of 5 and 18 who were diagnosed with DMD by a specialist physician as a result of gene analysis and/or muscle biopsy and their families were included in the study.

Baseline Bubble Inclinometer, Baseline Digital İnclinometer and Hoggan microFET2 devices

Intervention Type: DEVICE

Bubble inclinometer was used to measure lumbar lordosis angle, Digital inclinometer was used to measure pelvic inclination angle and Hoggan microFET2 was used for muscle strength measurement.

Interventions

Baseline Bubble Inclinometer, Baseline Digital İnclinometer and Hoggan microFET2 devices

Bubble inclinometer was used to measure lumbar lordosis angle, Digital inclinometer was used to measure pelvic inclination angle and Hoggan microFET2 was used for muscle strength measurement.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Having been diagnosed with DMD by a specialist physician as a result of gene analysis and/or muscle biopsy,
• Being between the ages of 5-18,
• Volunteering by parents to participate in the study and reading and signing the informed consent form.

Exclusion Criteria

• Having a diagnosed neuromuscular disease other than DMD and/or with DMD,
• Having a diagnosed psychiatric and/or metabolic disease,
• Having a diagnosis of autism spectrum disorders,
• Presence of congenital and/or acquired anomalies that may affect communication,
• The family and/or the child has a problem of cooperation in completing the assessments for any reason,
• Using a catheter and/or a diaper all day,
• Having difficulty in understanding and speaking the Turkish language.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: collaborator

Lokman Hekim University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Demet Öztürk

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Lokman Hekim University

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Ozturk D, Karaduman AA, Akbayrak T. The relationship between lower urinary system symptoms and the level of independence and quality of life in children with Duchenne muscular dystrophy. Pediatr Nephrol. 2024 Oct;39(10):3005-3012. doi: 10.1007/s00467-024-06419-0. Epub 2024 Jun 1.

Reference Type: DERIVED

PMID: 38822858 (View on PubMed)

Other Identifiers

16969557-1784

Identifier Type: -

Identifier Source: org_study_id