NCT06563193

Brief Summary

Overactive bladder is a prevalent urological disorder marked by symptoms such as urinary urgency, increased frequency of urination, and nighttime urination (nocturia). Neurotrophins, including nerve growth factor and brain-derived neurotrophic factor, play crucial roles in the development and function of neurons. Recent research has suggested a possible connection between these neurotrophins and OAB. This study sought to explore the relationship between urinary levels of NGF and BDNF and the presence of OAB.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 20, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

August 20, 2024

Status Verified

August 1, 2024

Enrollment Period

9 months

First QC Date

August 17, 2024

Last Update Submit

August 17, 2024

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

  • NGF anf BDNF levels in overactive bladder patients

    NGF AND BDNF LEVELS ARE HIGH IN PATIENTS WITH OVERACTIVE BLADDER.

    6 months

Study Arms (2)

overactive bladder group

OAB was diagnosed according to the patient's complaint of urgency with or without urge incontinence as the core symptom according to the criteria defined by the International Continence Society

control group

As a control group, patients who were admitted to the outpatient clinic for other reasons and who did not have OAB symptoms and have normal voiding functions were included

Diagnostic Test: NERVE GROWTH FACTOR

Interventions

NERVE GROWTH FACTORDIAGNOSTIC_TEST

urinary neurotrophins

Also known as: BRAIN DERIVED NEUROTRPHIC FACTOR
control group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

adult patients (aged 18-75 years) presenting to the urology outpatient clinic with a preliminary OAB diagnosis \-

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erzincan Binali Yıldırım University

Erzincan, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ozgur EKICI

    ErzincanBinaliYildirim

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 17, 2024

First Posted

August 20, 2024

Study Start

August 15, 2024

Primary Completion

May 1, 2025

Study Completion

June 1, 2025

Last Updated

August 20, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)