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CompletedNCT05464446Updated Jul 19, 2022

Examination of Lower Urinary System Symptoms With Duchenne Muscular Dystrophy

An observational study in Duchenne Muscular Dystrophy, Lower Urinary Tract Symptoms and Muscle Weakness, sponsored by Lokman Hekim Üniversitesi. Completed at 1 site in Turkey. Open to male participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2022-07-19.

Sponsored by Lokman Hekim Üniversitesi · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
45
Ages
5 Years to 18 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Duchenne Muscular Dystrophy
  • Lower Urinary Tract Symptoms
  • Muscle Weakness
  • Posture Disorders in Children
  • Lumbar Lordosis
  • Pelvic Floor Muscle Weakness
  • Quality of Life
03

In context

Muscular Dystrophies

548 studies on the registry are indexed under Muscular Dystrophies; 89 are open to participants now.

This study's enrollment of 45 is below the median of 69 across 179 observational studies indexed under Muscular Dystrophies.

Browse Muscular Dystrophies studies →

Lead sponsor

Lokman Hekim Üniversitesi is the lead sponsor of 13 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
5 Years to 18 Years
Sexes eligible
Male
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.

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

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.
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
45 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • DeviceBaseline 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 hour

  2. 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.

    Time frame: 1 hour

  3. 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.

    Time frame: 1 hour

  4. 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.

    Time frame: 1 hour

  5. 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.

    Time frame: 1 hour

  6. 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.

    Time frame: 1 hour

  7. 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.

    Time frame: 1 hour

  8. 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.

    Time frame: 1 hour

Secondary outcomes

  1. Urologist evaluation

    It will investigate whether children with DMD have ever been to a urologist in their life.

    Time frame: 1 hour

07

Study locations

1 site
  • Lokman Hekim University
    Ankara, 6510, Turkey
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05464446
Lead sponsor
Lokman Hekim Üniversitesi
Collaborators
Hacettepe University
Responsible party
Demet Öztürk (Research Assistant, Lokman Hekim Üniversitesi) — Principal investigator
First posted
Jul 19, 2022
Start date
Oct 1, 2021
Primary completion
Jun 1, 2022
Completion
Jun 20, 2022
Last update
Jul 19, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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