The Role of Urinary RhoA, NGF, and BDNF Levels in Overact... | NCT07513363

Studies
The Role of Urinary RhoA, NGF, and BDNF Levels in Overactive Bladder and Vitamin D Deficiency

NCT07513363

Sponsor

Tarik Emre Sener

Status

Not yet recruiting

Last Update Posted

Apr 7, 2026Actual

Enrollment

52Estimated

Phase

Not Applicable

Conditions

Overactive Bladder
Vitamin D Deficiency

Interventions

Urotherapy

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2026Estimated

Primary Completion Date

Dec 1, 2026Estimated

Completion Date

Jan 1, 2027Estimated

First Submitted Date

Apr 1, 2026

First Submission Date that Met QC Criteria

Apr 1, 2026

First Posted Date

Apr 7, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 1, 2026

Last Update Posted Date

Apr 7, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Overactive Bladder Group	Active Comparator		Behavioral: Urotherapy
Healthy Group	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Urotherapy	Behavioral	Diagnosis and first-line treatment (urotherapy) will be conducted per European Association of Urology (EAU) guidelines.	Overactive Bladder Group

Outcomes Module

Primary Outcomes

Measure	Description	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.		One year

Secondary Outcomes

Measure	Description	Time Frame
Clinical Symptom Improvement: * Reduction in LUTS (Lower Urinary Tract Symptoms) based on standardized voiding dysfunction symptom scores.		One year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hamza Tunahan Midilli	Contact	905449695848		hamzamidilli@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Marmara University School of Medicine Urology Department		Pendik	Istanbul	34100	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D053201	Urinary Bladder, Overactive
D014808	Vitamin D Deficiency

Ancestor Terms

ID	Term
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided