Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 2:05 AM
Study NCT ID:
NCT04626960
Status:
COMPLETED
Last Update Posted:
2020-11-13
First Post:
2020-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ADRB3, ROCK2 and GEF Levels in Overactive Bladder Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}, {'id': 'D009477', 'term': 'Hereditary Sensory and Autonomic Neuropathies'}], 'ancestors': [{'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009421', 'term': 'Nervous System Malformations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D011115', 'term': 'Polyneuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-06-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-08', 'studyFirstSubmitDate': '2020-11-02', 'studyFirstSubmitQcDate': '2020-11-08', 'lastUpdatePostDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum ADRB3 levels', 'timeFrame': '2019', 'description': 'Measurement of serum ADRB3 levels'}, {'measure': 'Serum GEF levels', 'timeFrame': '2019', 'description': 'Measurement of serum GEF levels'}, {'measure': 'Serum ROCK2 levels', 'timeFrame': '2019', 'description': 'Measurement of serum ROCK2 levels'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ADRB3; Biomarkers; GEF; Overactive bladder; ROCK2.'], 'conditions': ['Overactive Bladder']}, 'referencesModule': {'references': [{'pmid': '11857671', 'type': 'BACKGROUND', 'citation': 'Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. doi: 10.1002/nau.10052. No abstract available.'}, {'pmid': '26676700', 'type': 'BACKGROUND', 'citation': 'Meng E, Lin WY, Lee WC, Chuang YC. Pathophysiology of Overactive Bladder. Low Urin Tract Symptoms. 2012 Mar;4 Suppl 1:48-55. doi: 10.1111/j.1757-5672.2011.00122.x.'}, {'pmid': '31231010', 'type': 'BACKGROUND', 'citation': 'Antunes-Lopes T, Cruz F. Urinary Biomarkers in Overactive Bladder: Revisiting the Evidence in 2019. Eur Urol Focus. 2019 May;5(3):329-336. doi: 10.1016/j.euf.2019.06.006. Epub 2019 Jun 21.'}]}, 'descriptionModule': {'briefSummary': 'Aims: To evaluate changes in levels of ADRB3, ROCK2, and GEF which have key roles in the adrenergic and cholinergic pathways of contraction-relaxation harmony in voiding physiology, and to investigate the diagnostic potential of these proteins in OAB.\n\nMethods: This study included 60 idiopathic OAB patients and a healthy control group. All patients completed a validated OAB-V8 questionnaire. Serum levels of ADRB3, ROCK2, and GEF were examined by ELISA. ROC curves were generated to evaluate the diagnostic performance of these protein levels for OAB diagnosis.', 'detailedDescription': 'Overactive bladder (OAB) is defined by The Standardization Subcommittee of the International Continence Society (ICS) as a symptom syndrome consisting of urgency, with or without urge incontinence, usually with frequency and nocturia, in the absence of proven infection or other obvious pathology. OAB is a clinical diagnosis and its assessment is very important, especially for evaluation of treatment effectiveness. OAB is diagnosed by symptoms only, and symptoms are subjective definitions that vary from person to person. Therefore, various scoring systems and urodynamic tests are used to make an objective diagnosis and to determine the severity of symptoms. In recent studies, there are several substances that have been proposed as biomarkers of OAB, such as especially urinary proteins but studies that have compared these markers are lacking, also these proteins present low sensitivity and specificity. In the future, physicians may consider the use of biomarkers to identify distinct OAB phenotypes, with distinct causal mechanisms, selecting patients for specific target therapies with expected better outcomes. Biomarkers can be useful to phenotype patients and for selecting more effective target therapies. So, there is a need for stable and non-invasive biomarkers that can be used reliably for assessment of OAB.\n\nEven though the exact cause or causes of OAB have not yet been identified, the most powerful theory accepted in pathogenesis is detrusor muscle hyperactivity by relaxation decrease or contractions increase in detrusor smooth muscle. The molecular mechanisms underlying the OAB clinic are still not fully understood.\n\nBladder contractions are primarily controlled by parasympathetic cholinergic pathways. Guanine nucleotide exchange factors (GEF) and Rho-related kinase (ROCK) are important in this way. ROCKs are also important regulators of cellular apoptosis, growth, metabolism, and migration through control of the cell contraction. GEFs activate small GTPases and they are regulatory factors that facilitate the separation of GDP from Rho and the binding of GTP. GEF protein regulates Rho activity. Overexpression of GEF leads to an increase in GTP-dependent Rho. GTP-dependent Rho enables ROCK2 activation. ROCK2 especially has an important role in regulating smooth muscle contraction. So, functional disorder or alteration in levels of GEF and ROCK2 can cause an excessive contraction in smooth muscle and may be effective in the basis of pathophysiology in OAB.\n\nThe relaxation of the bladder smooth muscle is controlled by a sympathetic cholinergic pathway in which adrenergic receptor β3 (ADRB3) plays a major role. They have an important role in regulating smooth muscle tone, especially in the bladder, and show their effect in many tissues, such as adipose tissue, through relaxation or thermogenesis. The hypofunction of this receptor causes disruption of the bladder detrusor muscle and dysfunction of the urinary tract. So a decrease in ADRB3 levels may be responsible for reduced relaxation in the pathophysiology of overactive bladder.\n\nThe aim of this study was to understand whether ADRB3, ROCK2, and GEF levels could be auxiliary parameters for the evaluation of the molecular mechanisms of OAB and to diagnose. If changes in levels of these parameters affect the amounts and functions of proteins in these pathways, the pathogenesis of OAB can be better understood and new treatment goals can be recommended.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult OAB patients and healthy controls', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of Idiopathic Overactive Bladder\n* Must have at least 11 points on the OAB-V8 questionnaire\n\nExclusion Criteria:\n\n* Neurogenic bladder\n* Bladder obstruction\n* Urinary tract diseases such as stones, tumors, infections\n* Long QT syndrome\n* Severe liver failure\n* Renal failure\n* Myasthenia\n* Glaucoma\n* Autoimmune disease\n* Lower urinary tract dysfunction'}, 'identificationModule': {'nctId': 'NCT04626960', 'briefTitle': 'ADRB3, ROCK2 and GEF Levels in Overactive Bladder Patients', 'organization': {'class': 'OTHER', 'fullName': 'Pamukkale University'}, 'officialTitle': 'ADRB3, ROCK2 and GEF Levels in Overactive Bladder Patients', 'orgStudyIdInfo': {'id': '2019HZDP009'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient', 'description': 'OAB patients'}, {'label': 'Control', 'description': 'Healthy'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Denizli', 'country': 'Turkey (Türkiye)', 'facility': 'Pamukkale University', 'geoPoint': {'lat': 37.77417, 'lon': 29.0875}}], 'overallOfficials': [{'name': 'Elif Fırat', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'elifbasak43@hotmail.com'}, {'name': 'Hülya Aybek', 'role': 'STUDY_CHAIR', 'affiliation': 'haybek@pau.edu.tr'}, {'name': 'Zafer Aybek', 'role': 'STUDY_DIRECTOR', 'affiliation': 'zaybek@pau.edu.tr'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pamukkale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Medical Biochemistry Specialist', 'investigatorFullName': 'Elif Fırat', 'investigatorAffiliation': 'Pamukkale University'}}}}