Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT01409512
Status:
UNKNOWN
Last Update Posted:
2011-08-04
First Post:
2011-08-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Autonomic System Before and After Anticholinergic Treatment in Women With Overactive Bladder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-08-03', 'studyFirstSubmitDate': '2011-08-03', 'studyFirstSubmitQcDate': '2011-08-03', 'lastUpdatePostDateStruct': {'date': '2011-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in heart variability following treatment with Solifenacin succinate 10 mg', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'Correlation between changes in clinical symptoms of OAB abd changes in heart rate variability', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Heart rate variability, anti cholinergic medication'], 'conditions': ['Overactive Bladder']}, 'referencesModule': {'references': [{'pmid': '19058189', 'type': 'BACKGROUND', 'citation': 'Mehnert U, Knapp PA, Mueller N, Reitz A, Schurch B. Heart rate variability: an objective measure of autonomic activity and bladder sensations during urodynamics. Neurourol Urodyn. 2009;28(4):313-9. doi: 10.1002/nau.20641.'}, {'pmid': '20423739', 'type': 'BACKGROUND', 'citation': 'Liao WC, Jaw FS. A noninvasive evaluation of autonomic nervous system dysfunction in women with an overactive bladder. Int J Gynaecol Obstet. 2010 Jul;110(1):12-7. doi: 10.1016/j.ijgo.2010.03.007. Epub 2010 Apr 25.'}, {'pmid': '20140437', 'type': 'BACKGROUND', 'citation': 'Schiffers M, Sauermann P, Schurch B, Mehnert U. The effect of tolterodine 4 and 8 mg on the heart rate variability in healthy subjects. World J Urol. 2010 Oct;28(5):651-6. doi: 10.1007/s00345-010-0513-y. Epub 2010 Feb 7.'}, {'pmid': '17937953', 'type': 'BACKGROUND', 'citation': 'Hubeaux K, Deffieux X, Ismael SS, Raibaut P, Amarenco G. Autonomic nervous system activity during bladder filling assessed by heart rate variability analysis in women with idiopathic overactive bladder syndrome or stress urinary incontinence. J Urol. 2007 Dec;178(6):2483-7. doi: 10.1016/j.juro.2007.08.036. Epub 2007 Oct 15.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate changes in autonomic nervous system following treatment with anticholinergic medication for OAB symptoms.\n\nHeart variability as a measure of the functioning of the autonomic nervous system will be recorded before and three months following treatment with solifenacin succinate 10 mg daily.', 'detailedDescription': '30 women with clinical diagnosis of overactive bladder will be recruited for the study. An ECG strip for fifteen minutes at rest will be recorded through a 12-bit analog/digital data acquisition card (National Instruments, Austin TX) with a sampling frequency of 200 Hz and stored in a computer for offline studies. The digitized ECG signals will than processed and analyzed via dedicated robust software to detect the R wave peaks. The R point of each QRS complex was defined and the interval between two consecutive R points (the R-R interval) was computed. All R-R intervals will be visually inspected and manually edited if necessary to exclude background noise and artifacts. The edited segments accounts for less than 1% in each patient. A "clean" 2-5-min segment (preferably unedited) will be used for the analyses. An autoregressive model with the order of 16 was will be used to estimate the power spectrum densities of HRV. The power spectra are quantified by measuring the area under the following frequency bands: low-frequency (LF) (0.04-0.15 Hz) known to represents sympathetic activity, and high-frequency (HF) (0.15-0.4 Hz) which represents parasympathetic activity.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients were diagnosed as having OAB syndrome by an urogynecologist based on their clinical symptoms (urinary urgency, with or without urinary urgency incontinence, urinary frequency or nocturia).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nClinical diagnosis of OAB\n\nExclusion Criteria:\n\n1\\) stress urinary incontinence and voiding symptoms, 2) pregnancy, 3) pathological conditions that can interfere with the ANS, (e.g. coronary heart disease, heart failure, or other cardiac conditions, hypertension, neurological diseases or diabetes , 4) medications that can interfere with the ANS, including beta-receptor agonists or antagonists, antiarrhythmic agents or antihypertensive drugs, anticholinergic agents or adrenergic alpha-antagonists, tricyclic or serotoninergic antidepressants.'}, 'identificationModule': {'nctId': 'NCT01409512', 'briefTitle': 'Evaluation of Autonomic System Before and After Anticholinergic Treatment in Women With Overactive Bladder', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'Observational Study on the Effect of Anticholinergic on the Autonomic System in Women With OAB', 'orgStudyIdInfo': {'id': '117/2011'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women with OAB', 'description': 'Patients that will be diagnosed as having OAB syndrome by an urogynecologist based on their clinical symptoms (urinary urgency, with or without urinary urgency incontinence, urinary frequency or nocturia).', 'interventionNames': ['Procedure: ECG recording']}], 'interventions': [{'name': 'ECG recording', 'type': 'PROCEDURE', 'otherNames': ['Electro cardiogram recording'], 'description': 'At baseline and following 3 months on anticholinergic medications patients, ECG recording will be conducted.', 'armGroupLabels': ['Women with OAB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34987', 'city': 'Haifa', 'country': 'Israel', 'contacts': [{'name': 'Lior Lowenstein, MD', 'role': 'CONTACT', 'email': 'LowensteinMD@gmail.com', 'phone': '97248542612'}, {'name': 'Dalia Kesner, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lior Lowenstein, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Eyal Goldshmith, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Talma Rosen, RN', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Zvolon Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'centralContacts': [{'name': 'Dalia Kesner, MD', 'role': 'CONTACT', 'email': 'DALIAKE@clalit.org.il'}, {'name': 'Lior Lowenstein, MD', 'role': 'CONTACT', 'email': 'Lowensteinmd@gmail.com', 'phone': '0502061434'}], 'overallOfficials': [{'name': 'Lior Lowensrtein, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Rambam Health Care Campus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dalia Kesner', 'oldOrganization': 'Kupat Hulim Clalit'}}}}