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Overactive BladderurinaryNCT06563193

Urinary Neurotrophin Levels as Potential Biomarkers for Overactive Bladder: A Case-Control Study

An observational study of Overactive Bladder, run by Erzincan Binali Yildirim Universitesi at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Overactive Bladder
What is being tested?
NERVE GROWTH FACTOR
How many people
44 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Aug 2024to 1 Jun 2025
How long will I take part?
6 Months
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 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

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

Who may be able to join

None listed.

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Erzincan Binali Yıldırım University

    Erzincan

Other trials in Turkey (Türkiye)

About this study

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.

Read the detailed description

Ethics committee approval dated 22.02.2024 and numbered 2024-03/01 was obtained from Erzincan Binali Yıldırım University Faculty of Medicine Ethics committee for the study.

Between February 2024 and July 2024, patients between the ages of 18 and 75 who were admitted to the urology outpatient clinic with a preliminary diagnosis of OAB and diagnosed with OAB were prospectively included in the study. Patients were asked to complete a 3-day voiding diary. 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. The study was conducted in accordance with the principles of the 2008 Helsinki Declaration.

Demographic data including age, gender and BMI were recorded. With the OAB-V8 questionnaire scores (0-40), Indevus Urgency Severity Scale (IUSS) scores, the number of urgency, pollakiuria and nocturia episodes were also recorded. The OAB-V8 questionnaire is a form consisting of 8 questions with each question being scored between 0-5 and a total score of 40 points. A total score above 8 is considered significant [7]. Indevus Urgency Severity Scale (IUSS) classified as 0-4, representing no urgency, occasional urgency which was always tolerable, urgency which was tolerable for 5 min, urgency which was intolerable, and urgency which was usually accompanied by incontinence, respectively [6, 8]. Blood group, creatitine values from peripheral blood and urine samples were recorded at outpatient clinic visits. BDNF and NGF levels were measured from the urine samples taken at the patients' outpatient clinic admissions. Urine samples were studied before treatment was given. Informed consent was obtained from all participants before urine was collected.

Patients with urinary tract infection, systemic inflammation, renal function test disorders, patients with a history of previous urological surgery, patients with a history of urological malignancy, patients with bladder stones, benign prostatic hyperplasia and urethral stricture were excluded from the study. 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. Urine samples of these patients were also recorded.

Urine samples were collected from both OAB subjects and controls. Urine was collected in sterile specimen jars, transferred to sterile test tubes, and frozen at 80.8C. The samples were then thawed and centrifuged at 200 relative centrifugal force for 5 min. The supernatant was aliquoted and stored at 80.8C until further processing. A 3-ml urine sample was obtained concurrently for measuring urinary creatinine (Cr) levels. Urine samples were used for Human Brain Derived Neurotrophic Factor (BDNF) and Human Nerve Growth Factor (NGF) levels. The kits were used to test the level of BDNF (Shanghai Coon Koon Biotech Co., Ltd China. Cat No:CK-bio-10643) and NGF (Shanghai Coon Koon Biotech Co., Ltd China. Cat No:CK-bio-12600) based on the principle of double antibody sandwich technology enzyme linked immunosorbent assay (ELISA). The analytical (linear) detection range for BDNF was 1-24 ng/mL. The minimal detection limit for BDNF was 0.1 ng/mL . The analytical (linear) detection range for NGF was 10-160 pg/mL. The minimal detection limit for NGF was 1.0 pg/mL.

The data recorded at baseline were compared between the groups.

Being tested
NERVE GROWTH FACTOR
Medical subject headings
Urinary Bladder, Overactive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NERVE GROWTH FACTORDiagnostic test

    Also called BRAIN DERIVED NEUROTRPHIC FACTOR

    urinary neurotrophins

Study groups in NCT06563193
Study groupRoleWhat they receive
overactive bladder groupOAB 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 groupAs 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
Receives: Diagnostic Test: NERVE GROWTH FACTOR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. NGF anf BDNF levels in overactive bladder patients

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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2024
  2. Study start15 Aug 2024
  3. Primary completion1 May 2025 (estimated)
  4. Study completion1 Jun 2025 (estimated)

Resources

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
Case-control
Time perspective
Prospective
Enrolment
44 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06563193
Sponsor's protocol ID
ERZ-OE-01
Acronym
urinary
Status last verified
Aug 2024
First submitted
17 Aug 2024
Last updated
20 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Overactive Bladder, run by Erzincan Binali Yildirim Universitesi 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 0 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 20 Aug 2024. 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?

Results are not available in the source record.

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?

NGF anf BDNF levels in overactive bladder patients (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 20 Aug 2024.

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