Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06563193
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-08-17
Brief Title:
Urinary Neurotrophin Levels as Potential Biomarkers for Overactive Bladder A Case-Control Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Urinary Neurotrophin Levels as Potential Biomarkers for Overactive Bladder A Case-Control Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
urinary
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
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 22022024 and numbered 2024-0301 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 patients 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 808C The samples were then thawed and centrifuged at 200 relative centrifugal force for 5 min The supernatant was aliquoted and stored at 808C 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 NoCK-bio-10643 and NGF Shanghai Coon Koon Biotech Co Ltd China Cat NoCK-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 ngmL The minimal detection limit for BDNF was 01 ngmL The analytical linear detection range for NGF was 10-160 pgmL The minimal detection limit for NGF was 10 pgmL
The data recorded at baseline were compared between the groups
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 patients 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 808C The samples were then thawed and centrifuged at 200 relative centrifugal force for 5 min The supernatant was aliquoted and stored at 808C 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 NoCK-bio-10643 and NGF Shanghai Coon Koon Biotech Co Ltd China Cat NoCK-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 ngmL The minimal detection limit for BDNF was 01 ngmL The analytical linear detection range for NGF was 10-160 pgmL The minimal detection limit for NGF was 10 pgmL
The data recorded at baseline were compared between the groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None