Duchenne Muscular DystrophyNCT05464446
Examination of Lower Urinary System Symptoms With Duchenne Muscular Dystrophy
An observational study of Duchenne Muscular Dystrophy and Lower Urinary Tract Symptoms, run by Lokman Hekim University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 5 to 18 years, men only
- Conditions the study is for
- Duchenne Muscular Dystrophy, Lower Urinary Tract Symptoms, Muscle Weakness
- What is being tested?
- Baseline Bubble Inclinometer, Baseline Digital İnclinometer and Hoggan microFET2 devices
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2021to 20 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- Men only
- No healthy volunteers
- Child, Adult
Study population: It consisted of children aged 5-18 years with a diagnosis of DMD and their families.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Duchenne Muscular Dystrophy, Lower Urinary Tract Symptoms, Muscle Weakness, Posture Disorders in Children, Lumbar Lordosis, Pelvic Floor Muscle Weakness
- Being tested
- Baseline Bubble Inclinometer, Baseline Digital İnclinometer and Hoggan microFET2 devices
- Medical subject headings
- Muscular Dystrophy, Duchenne, Lower Urinary Tract Symptoms, Muscle Weakness, Lordosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline Bubble Inclinometer, Baseline Digital İnclinometer and Hoggan microFET2 devicesDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Baseline Bubble Inclinometer, Baseline Digital İnclinometer and Hoggan microFET2 devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 hour
Secondary outcomes (1)
Urologist evaluation
It will investigate whether children with DMD have ever been to a urologist in their life.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start1 Oct 2021
- Primary completion1 Jun 2022
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Duchenne Muscular DystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lokman Hekim University
- Sponsor type
- Other government
- Collaborators
- Hacettepe University
- Responsible party
- Principal investigator, Demet Öztürk, Lokman Hekim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05464446
- Sponsor's protocol ID
- 16969557-1784
- Status last verified
- Jul 2022
- First submitted
- 25 Jun 2022
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ozturk D, Karaduman AA, Akbayrak T. The relationship between lower urinary system symptoms and the level of independence and quality of life in children with Duchenne muscular dystrophy. Pediatr Nephrol. 2024 Oct;39(10):3005-3012. doi: 10.1007/s00467-024-06419-0. Epub 2024 Jun 1.
PubMed 38822858
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Lower Urinary System Symptoms and Related Factors in Children With Duchenne Muscular Dystrophy
- ClinicalTrials.gov ID
- NCT05464446
- Acronym / sponsor ID
- 16969557-1784
- Conditions
- Duchenne Muscular Dystrophy, Lower Urinary Tract Symptoms, Muscle Weakness, Posture Disorders in Children, Lumbar Lordosis, Pelvic Floor Muscle Weakness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Lokman Hekim UniversityOther government
- Collaborators
- Hacettepe University
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 19 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Duchenne Muscular Dystrophy | – | Device: Baseline Bubble Inclinometer, Baseline Digital İnclinometer and Hoggan microFET2 devicesChildren 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. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- It consisted of children aged 5-18 years with a diagnosis of DMD and their families.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baseline Bubble Inclinometer, Baseline Digital İnclinometer and Hoggan microFET2 devicesBubble 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. | Device | Duchenne Muscular Dystrophy |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
1 secondary outcome
Urologist evaluation
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Derived from this study: PubMed 38822858Ozturk D, Karaduman AA, Akbayrak T. The relationship between lower urinary system symptoms and the level of independence and quality of life in children with Duchenne muscular dystrophy. Pediatr Nephrol. 2024 Oct;39(10):3005-3012. doi: 10.1007/s00467-024-06419-0. Epub 2024 Jun 1.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Duchenne Muscular Dystrophy and Lower Urinary Tract Symptoms, run by Lokman Hekim University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower urinary system symptoms (time frame: 1 hour). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05464446, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022.