Examination of Lower Urinary System Symptoms With Duchenne Muscular Dystrophy

Examination of Lower Urinary System Symptoms and Related Factors in Children 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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Lower Urinary Tract Symptoms; Muscle Weakness; Duchenne Muscular Dystrophy; Pelvic Floor Muscle Weakness; Posture Disorders in Children; Lumbar Lordosis
• Intervention / Treatment: Device: Baseline Bubble Inclinometer, Baseline Digital İnclinometer and Hoggan microFET2 devices

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 6510
    • Lokman Hekim University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urologist evaluation	It will investigate whether children with DMD have ever been to a urologist in their life.	1 hour

Collaborators and Investigators

• Sponsor: Lokman Hekim Üniversitesi
• Collaborators: Hacettepe University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2021
• Primary Completion (ACTUAL): June 1, 2022
• Study Completion (ACTUAL): June 20, 2022

Study Registration Dates

• First Submitted: June 25, 2022
• First Submitted That Met QC Criteria: July 14, 2022
• First Posted (ACTUAL): July 19, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 14, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Urological Manifestations; Neurologic Manifestations; Genetic Diseases, Inborn; Genetic Diseases, X-Linked; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Neuromuscular Manifestations; Muscular Disorders, Atrophic; Spinal Diseases; Bone Diseases; Spinal Curvatures; Muscle Weakness; Muscular Dystrophies; Lower Urinary Tract Symptoms; Muscular Dystrophy, Duchenne; Paresis; Asthenia; Lordosis
• Other Study ID Numbers: 16969557-1784

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No