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).
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.
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.
- Conditions
- Overactive Bladder
- 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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: NERVE GROWTH FACTOR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted20 Aug 2024
- Study start15 Aug 2024
- Primary completion1 May 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 44 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Erzincan Binali Yildirim Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, OZGUR EKICI, Erzincan Binali Yildirim Universitesi
- Investigators
- Ozgur EKICI, Study chair, ErzincanBinaliYildirim
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Neurotrophin Levels as Potential Biomarkers for Overactive Bladder: A Case-Control Study
- ClinicalTrials.gov ID
- NCT06563193
- Acronym / sponsor ID
- urinary / ERZ-OE-01
- Conditions
- Overactive Bladder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Erzincan Binali Yildirim UniversitesiUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 20 Aug 2024 (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.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Diagnostic Test: NERVE GROWTH FACTORAs 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- adult patients (aged 18-75 years) presenting to the urology outpatient clinic with a preliminary OAB diagnosis -
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| NERVE GROWTH FACTORAlso: BRAIN DERIVED NEUROTRPHIC FACTORurinary neurotrophins | Diagnostic test | control group |
Primary outcome
NGF anf BDNF levels in overactive bladder patients
Time frame: 6 months
NGF AND BDNF LEVELS ARE HIGH IN PATIENTS WITH OVERACTIVE BLADDER.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Ozgur EKICI study chair
ErzincanBinaliYildirim
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 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.