Clinical trial NCT05464446: Examination of Lower Urinary System Symptoms With Duchenne Muscular Dystrophy
Official title: Examination of Lower Urinary System Symptoms and Related Factors in Children With Duchenne Muscular Dystrophy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Duchenne Muscular Dystrophy
Lower Urinary Tract Symptoms
Muscle Weakness
Posture Disorders in Children
Lumbar Lordosis
Pelvic Floor Muscle Weakness
Quality of Life
Lead sponsor: Lokman Hekim Üniversitesi
Sponsor class: OTHER_GOV
Collaborators: name: Hacettepe University
First posted: 2022-07-19
Enrollment: 45
Sex: MALE
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: It consisted of children aged 5-18 years with a diagnosis of DMD and their families.

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.


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.

Primary outcomes:
measure: Lower urinary system symptoms
timeFrame: 1 hour
measure: Lower urinary system dysfunction
timeFrame: 1 hour
measure: Muscle strength and lower urinary system symptoms
timeFrame: 1 hour
measure: Functionality and lower urinary system symptoms
timeFrame: 1 hour
measure: Posture and lower urinary system symptoms
timeFrame: 1 hour
measure: Pelvic floor muscle control and lower urinary system symptoms
timeFrame: 1 hour
measure: Activities of daily living and lower urinary system symptoms
timeFrame: 1 hour
measure: Quality of life and lower urinary system symptoms
timeFrame: 1 hour
Secondary outcomes:
measure: Urologist evaluation
timeFrame: 1 hour
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Lokman Hekim University
Study officials:
References: