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Completed

NCT Number: NCT05464446

Examination of Lower Urinary System Symptoms With Duchenne Muscular Dystrophy

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.

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Key information

Conditions

Duchenne Muscular Dystrophy Bone Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Lordosis Lower Urinary Tract Symptoms Lumbar Lordosis Muscle Weakness Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Muscular Dystrophy, Duchenne Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Floor Muscle Weakness Posture Disorders in Children Quality of Life Signs and Symptoms Spinal Curvatures Spinal Diseases Urological Manifestations

Age range

5 year–18 year

Sex eligibility

Male

Study type

Observational

Primary location

Lokman Hekim University

Ankara, 6510, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Baseline Bubble Inclinometer, Baseline Digital İnclinometer and Hoggan microFET2 devices

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.

Primary outcomes

  1. Lower urinary system symptoms

    Time frame: 1 hour

    It will be investigated how many of the children with DMD participating in the study will have lower urinary system symptoms.

  2. Lower urinary system dysfunction

    Time frame: 1 hour

    It will be investigated how many of the children with DMD participating in the study will have lower urinary system dysfunction.

  3. Muscle strength and lower urinary system symptoms

    Time frame: 1 hour

    It will be investigated whether there is a relationship between lower urinary tract symptoms and muscle strength in children with DMD.

  4. Functionality and lower urinary system symptoms

    Time frame: 1 hour

    It will be investigated whether there is a relationship between lower urinary tract symptoms and functionality in children with DMD.

  5. Posture and lower urinary system symptoms

    Time frame: 1 hour

    It will be investigated whether there is a relationship between lower urinary tract symptoms and posture in children with DMD.

  6. Pelvic floor muscle control and lower urinary system symptoms

    Time frame: 1 hour

    It will be investigated whether there is a relationship between lower urinary tract symptoms and pelvic floor muscle control in children with DMD.

  7. Activities of daily living and lower urinary system symptoms

    Time frame: 1 hour

    It will be investigated whether there is a relationship between lower urinary tract symptoms and activities of daily living in children with DMD.

  8. Quality of life and lower urinary system symptoms

    Time frame: 1 hour

    It will be investigated whether there is a relationship between lower urinary tract symptoms and quality of life in children with DMD.

Secondary outcomes

  1. Urologist evaluation

    Time frame: 1 hour

    It will investigate whether children with DMD have ever been to a urologist in their life.

Sponsors and collaborators

Lead sponsor

Lokman Hekim University

Other Gov

Collaborators

  • Hacettepe University

Registry information

Official study title

Examination of Lower Urinary System Symptoms and Related Factors in Children With Duchenne Muscular Dystrophy

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 19, 2022
Registry last updated
Jul 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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