Examination of Lower Urinary System Symptoms With Duchenne Muscular Dystrophy

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05464446
• Other study ID #: 16969557-1784
• Status: Completed
• Start date: October 1, 2021
• Est. completion date: June 20, 2022

Study information

• Verified date: July 2022
• Source: Lokman Hekim Üniversitesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 20, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 5 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthenia
• Duchenne Muscular Dystrophy
• Lordosis
• Lower Urinary Tract Symptoms
• Muscle Weakness
• Muscular Dystrophies
• Muscular Dystrophy, Duchenne
• Paresis
• Pelvic Floor Muscle Weakness
• Posture Disorders in Children
• Quality of Life

Intervention

Device:
• Baseline Bubble Inclinometer, Baseline Digital Inclinometer 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.

Locations

Country	Name	City	State
Turkey	Lokman Hekim University	Ankara

Sponsors (2)

Lead Sponsor	Collaborator
Lokman Hekim Üniversitesi	Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Urologist evaluation	It will investigate whether children with DMD have ever been to a urologist in their life.	1 hour