Examination of Lower Urinary System Symptoms With Duchenne Muscular Dystrophy

NCT05464446 | Completed

• 1 other identifier: 16969557-1784
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (8)

• Lower urinary system symptoms

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

  1 hour

• Lower urinary system dysfunction

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

  1 hour

• Muscle strength and lower urinary system symptoms

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

  1 hour

• Functionality and lower urinary system symptoms

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

  1 hour

• Posture and lower urinary system symptoms

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

  1 hour

• Pelvic floor muscle control and lower urinary system symptoms

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

  1 hour

• Activities of daily living and lower urinary system symptoms

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

  1 hour

• Quality of life and lower urinary system symptoms

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

  1 hour

Secondary Outcomes (1)

• Urologist evaluation

  1 hour

Study Arms (1)

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.

Device: Baseline Bubble Inclinometer, Baseline Digital İnclinometer and Hoggan microFET2 devices

Interventions

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.

Duchenne Muscular Dystrophy

Eligibility Criteria

• Age: 5 Years - 18 Years
• Gender Eligibility Details: Duchenne Muscular Dystrophy is an inherited recessive disease linked to the X chromosome. Therefore, only men get the diagnosis, women only become carriers.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

It consisted of children aged 5-18 years with a diagnosis of DMD and their families.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lokman Hekim University: lead
• Hacettepe University: collaborator

Study Sites (1)

Lokman Hekim University

Ankara, 6510, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 38822858 DERIVED

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne; Lower Urinary Tract Symptoms; Muscle Weakness; Lordosis

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Neurologic Manifestations; Pathologic Processes; Spinal Curvatures; Spinal Diseases; Bone Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: June 25, 2022
• First Posted: July 19, 2022
• Study Start: October 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 20, 2022
• Last Updated: July 19, 2022

Record last verified: 2022-07

Locations

TU (1)