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Examination of Lower Urinary System Symptoms With Duchenne Muscular Dystrophy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05464446
Recruitment Status : Completed
First Posted : July 19, 2022
Last Update Posted : July 19, 2022
Sponsor:
Collaborator:
Hacettepe University
Information provided by (Responsible Party):
Demet Öztürk, Lokman Hekim Üniversitesi

Study Description
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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.


Condition or disease Intervention/treatment
Duchenne Muscular Dystrophy Lower Urinary Tract Symptoms Muscle Weakness Posture Disorders in Children Lumbar Lordosis Pelvic Floor Muscle Weakness Quality of Life Device: Baseline Bubble Inclinometer, Baseline Digital İnclinometer and Hoggan microFET2 devices

Study Design
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Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Examination of Lower Urinary System Symptoms and Related Factors in Children With Duchenne Muscular Dystrophy
Actual Study Start Date : October 1, 2021
Actual Primary Completion Date : June 1, 2022
Actual Study Completion Date : June 20, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Urologist evaluation [ Time Frame: 1 hour ]
    It will investigate whether children with DMD have ever been to a urologist in their life.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Duchenne Muscular Dystrophy is an inherited recessive disease linked to the X chromosome. Therefore, only men get the diagnosis, women only become carriers.
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
It consisted of children aged 5-18 years with a diagnosis of DMD and their families.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05464446


Locations
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Turkey
Lokman Hekim University
Ankara, Turkey, 6510
Sponsors and Collaborators
Lokman Hekim Üniversitesi
Hacettepe University
More Information
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Responsible Party: Demet Öztürk, Research Assistant, Lokman Hekim Üniversitesi
ClinicalTrials.gov Identifier: NCT05464446    
Other Study ID Numbers: 16969557-1784
First Posted: July 19, 2022    Key Record Dates
Last Update Posted: July 19, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Muscular Dystrophy, Duchenne
Muscular Dystrophies
Muscle Weakness
Lordosis
Paresis
Asthenia
Lower Urinary Tract Symptoms
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
 Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Urological Manifestations
Neuromuscular Manifestations
Neurologic Manifestations
Pathologic Processes
Spinal Curvatures
Spinal Diseases
Bone Diseases