- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07513363
The Role of Urinary RhoA, NGF, and BDNF Levels in Overactive Bladder and Vitamin D Deficiency
April 1, 2026 updated by: Tarik Emre Sener
The Role of Urinary RhoA, NGF, and BDNF Levels in Diagnosis and Follow-up in Children With Overactive Bladder and Vitamin D Deficiency.
The primary aim of this study is to evaluate the role of three specific urinary proteins-RhoA, Nerve Growth Factor (NGF), and Brain-Derived Neurotrophic Factor (BDNF)-as potential biomarkers for the diagnosis and follow-up of children aged 4-18 diagnosed with Overactive Bladder (OAB) and Vitamin D deficiency.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hamza Tunahan Midilli
- Phone Number: 905449695848
- Email: hamzamidilli@gmail.com
Study Locations
-
-
Istanbul
-
Pendik, Istanbul, Turkey (Türkiye), 34100
- Marmara University School of Medicine Urology Department
-
Contact:
- Cagri Akin Sekerci
- Phone Number: 05344525700
- Email: cagri_sekerci@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Children aged 4-18 years presenting with active OAB symptoms (frequency, urgency)
Exclusion Criteria:
- Neurological diseases
- Malignancy
- Active urinary tract infections
- Anatomical bladder anomalies
- History of prior OAB treatment/urological surgery.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Overactive Bladder Group
|
Diagnosis and first-line treatment (urotherapy) will be conducted per European Association of Urology (EAU) guidelines.
|
|
No Intervention: Healthy Group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Changes in Urinary Biomarker Levels: * Quantitative measurement of urinary RhoA, NGF (Nerve Growth Factor), and BDNF (Brain-Derived Neurotrophic Factor) levels using the ELISA method.
Time Frame: One year
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Clinical Symptom Improvement: * Reduction in LUTS (Lower Urinary Tract Symptoms) based on standardized voiding dysfunction symptom scores.
Time Frame: One year
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 1, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
January 1, 2027
Study Registration Dates
First Submitted
April 1, 2026
First Submitted That Met QC Criteria
April 1, 2026
First Posted (Actual)
April 7, 2026
Study Record Updates
Last Update Posted (Actual)
April 7, 2026
Last Update Submitted That Met QC Criteria
April 1, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Nutrition Disorders
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Urinary Bladder Diseases
- Avitaminosis
- Deficiency Diseases
- Malnutrition
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Vitamin D Deficiency
- Urinary Bladder, Overactive
Other Study ID Numbers
- MAR.UAD.0031
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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