Ignite Creation Date:
2025-12-24 @ 5:20 PM
Ignite Modification Date:
2026-02-26 @ 7:24 PM
Study NCT ID:
NCT02315950
Status:
RECRUITING
Last Update Posted:
2018-07-18
First Post:
2014-10-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of cineMRI to Evaluate Botox in Patients With Medication Refractory 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001905', 'term': 'Botulinum Toxins'}], 'ancestors': [{'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-17', 'studyFirstSubmitDate': '2014-10-28', 'studyFirstSubmitQcDate': '2014-12-10', 'lastUpdatePostDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Improvement in overactive bladder symptoms by smooth muscle paralysis via botulinum toxin injection (100U)', 'timeFrame': 'About 10 Months', 'description': 'This injection is performed under local anesthesia in the office. 100U of botulinum toxin (Botox ®) will be mixed under sterile conditions with 10cc of sterile saline and injected into 10 discrete locations in the bladder. Participants will be asked to fill out questionnaires for the management of clinical and statistical measures.'}], 'primaryOutcomes': [{'measure': 'Time-resolved views by CineMRI with urodynamics on overactive bladder physiology', 'timeFrame': 'About 10 Months', 'description': 'CineMRI and urodynamics technology will be used to obtain time-resolved views of the human bladder during filling and voiding. The investigators aim to reveal a new understanding of diseased lower urinary tract physiology during pre and post treatment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Overactive Bladder']}, 'referencesModule': {'references': [{'pmid': '12493342', 'type': 'BACKGROUND', 'citation': 'Wein AJ, Rovner ES. Definition and epidemiology of overactive bladder. Urology. 2002 Nov;60(5 Suppl 1):7-12; discussion 12. doi: 10.1016/s0090-4295(02)01784-3.'}, {'pmid': '21461663', 'type': 'BACKGROUND', 'citation': 'Lin K, Bi X, Taimen K, Zuehlsdorff S, Lu B, Carr J, Li D. Coronary wall MR imaging in patients with rapid heart rates: a feasibility study of black-blood steady-state free precession (SSFP). Int J Cardiovasc Imaging. 2012 Mar;28(3):567-75. doi: 10.1007/s10554-011-9852-z. Epub 2011 Apr 2.'}, {'pmid': '21394764', 'type': 'BACKGROUND', 'citation': 'Zhou X, Rundell V, Liu Y, Tang R, Shah S, Zuehlsdorff S, Li D, Dharmakumar R. On the mechanisms enabling myocardial edema contrast in bSSFP-based imaging approaches. Magn Reson Med. 2011 Jul;66(1):187-91. doi: 10.1002/mrm.22794. Epub 2011 Mar 9.'}, {'pmid': '22246681', 'type': 'BACKGROUND', 'citation': 'Tsaftaris SA, Tang R, Zhou X, Li D, Dharmakumar R. Ischemic extent as a biomarker for characterizing severity of coronary artery stenosis with blood oxygen-sensitive MRI. J Magn Reson Imaging. 2012 Jun;35(6):1338-48. doi: 10.1002/jmri.23577. Epub 2012 Jan 13.'}, {'pmid': '16813681', 'type': 'BACKGROUND', 'citation': 'Borghesi G, Simonetti R, Goldman SM, Szejnfeld J, Srougi M, Ortiz V, Bruschini H. Magnetic resonance imaging urodynamics. Technique development and preliminary results. Int Braz J Urol. 2006 May-Jun;32(3):336-41; discussion 341. doi: 10.1590/s1677-55382006000300015.'}, {'pmid': '18499184', 'type': 'BACKGROUND', 'citation': 'Brubaker L, Richter HE, Visco A, Mahajan S, Nygaard I, Braun TM, Barber MD, Menefee S, Schaffer J, Weber AM, Wei J; Pelvic Floor Disorders Network. Refractory idiopathic urge urinary incontinence and botulinum A injection. J Urol. 2008 Jul;180(1):217-22. doi: 10.1016/j.juro.2008.03.028. Epub 2008 May 21.'}, {'pmid': '23246476', 'type': 'BACKGROUND', 'citation': 'Nitti VW, Dmochowski R, Herschorn S, Sand P, Thompson C, Nardo C, Yan X, Haag-Molkenteller C; EMBARK Study Group. OnabotulinumtoxinA for the treatment of patients with overactive bladder and urinary incontinence: results of a phase 3, randomized, placebo controlled trial. J Urol. 2013 Jun;189(6):2186-93. doi: 10.1016/j.juro.2012.12.022. Epub 2012 Dec 14.'}, {'pmid': '20400142', 'type': 'BACKGROUND', 'citation': 'Anger JT, Weinberg A, Suttorp MJ, Litwin MS, Shekelle PG. Outcomes of intravesical botulinum toxin for idiopathic overactive bladder symptoms: a systematic review of the literature. J Urol. 2010 Jun;183(6):2258-64. doi: 10.1016/j.juro.2010.02.009. Epub 2010 Apr 18.'}, {'pmid': '20952013', 'type': 'BACKGROUND', 'citation': 'Dmochowski R, Chapple C, Nitti VW, Chancellor M, Everaert K, Thompson C, Daniell G, Zhou J, Haag-Molkenteller C. Efficacy and safety of onabotulinumtoxinA for idiopathic overactive bladder: a double-blind, placebo controlled, randomized, dose ranging trial. J Urol. 2010 Dec;184(6):2416-22. doi: 10.1016/j.juro.2010.08.021. Epub 2010 Oct 16.'}, {'pmid': '8705212', 'type': 'BACKGROUND', 'citation': 'Jackson S, Donovan J, Brookes S, Eckford S, Swithinbank L, Abrams P. The Bristol Female Lower Urinary Tract Symptoms questionnaire: development and psychometric testing. Br J Urol. 1996 Jun;77(6):805-12. doi: 10.1046/j.1464-410x.1996.00186.x.'}, {'pmid': '8777617', 'type': 'BACKGROUND', 'citation': "Donovan JL, Abrams P, Peters TJ, Kay HE, Reynard J, Chapple C, De La Rosette JJ, Kondo A. The ICS-'BPH' Study: the psychometric validity and reliability of the ICSmale questionnaire. Br J Urol. 1996 Apr;77(4):554-62. doi: 10.1046/j.1464-410x.1996.93013.x."}, {'pmid': '12206577', 'type': 'BACKGROUND', 'citation': 'Coyne K, Revicki D, Hunt T, Corey R, Stewart W, Bentkover J, Kurth H, Abrams P. Psychometric validation of an overactive bladder symptom and health-related quality of life questionnaire: the OAB-q. Qual Life Res. 2002 Sep;11(6):563-74. doi: 10.1023/a:1016370925601.'}, {'pmid': '21560153', 'type': 'BACKGROUND', 'citation': 'Chung SD, Liao CH, Chen YC, Kuo HC. Urgency severity scale could predict urodynamic detrusor overactivity in patients with overactive bladder syndrome. Neurourol Urodyn. 2011 Sep;30(7):1300-4. doi: 10.1002/nau.21057. Epub 2011 May 10.'}]}, 'descriptionModule': {'briefSummary': 'With the goal of providing improved treatment to patients with overactive bladder symptoms (OAB), the investigators seek to apply the new technology of time-resolved (cine) MRI combined with urodynamics (UDS) to understand the exact effect of intravesical botulinum toxin on bladder physiology. The investigators will specifically aim to assess the physiological mechanism by which intravesical botulinum alleviates urgency and urge incontinence symptoms in women with OAB refractory to medical therapy.', 'detailedDescription': 'Overactive bladder (OAB) is defined by the International Continence Society as urinary frequency and urgency, with or without urge urinary incontinence. The burden of OAB on the American public is immense in both human and financial terms. Despite this burden, there is a lack of effective diagnostic and treatment modalities for OAB. Other than two-dimensional video urodynamics, which has remained relatively unchanged for decades, there is a lack of diagnostic modalities that will allow investigators to characterize subtypes of OAB and measure the effects of treatment on bladder physiology. Newer imaging techniques are desperately needed to help guide treatment and predict and improve outcomes of different treatment modalities. Intravesical botulinum toxin is a minimally invasive treatment for OAB refractory to medical therapy. Despite the widespread use of intravesical botulinum toxin injection for OAB refractory to medical therapy, to date the optimal placement of the drug has not been determined. Typically ten injections are given, either dispersed evenly across the bladder or in two rows of five injections. However, it remains unknown which injection method will optimize outcomes and reduce the risk of urinary retention after Botox®. This lack of knowledge is a direct result of the fact that there has been no mechanism to study the effect of Botox® on bladder filling and emptying in a three-dimensional fashion. CineMRI-UDS will provide this mechanism, and has the potential to significantly improve care and urologic education by enhancing the understanding of bladder physiology.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* Age 21 years or older\n* Overactive bladder symptoms\n\nExclusion Criteria:\n\n* Age less than 21 years\n* Inability to give informed consent\n* Claustrophobic'}, 'identificationModule': {'nctId': 'NCT02315950', 'briefTitle': 'The Use of cineMRI to Evaluate Botox in Patients With Medication Refractory Overactive Bladder', 'organization': {'class': 'OTHER', 'fullName': 'Cedars-Sinai Medical Center'}, 'officialTitle': 'CineMRI/UDS for Evaluating the Physiologic Effect of Botox in Women With Overactive Bladder', 'orgStudyIdInfo': {'id': 'Pro00037210'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Arm 1', 'description': 'Botulinum toxin and cineMRI-UDS', 'interventionNames': ['Other: Botulinum toxin and cineMRI-UDS']}], 'interventions': [{'name': 'Botulinum toxin and cineMRI-UDS', 'type': 'OTHER', 'description': 'The investigators will be testing the capability of cineMRI combined with simultaneous urodynamics in the context of OAB in this proposal and expect to reveal a new understanding of diseased lower urinary tract physiology. Participants will receive an injection of intravesical botulinum toxin after filling out validated questionnaires and receiving a pre-treatment cineMRI-UDS.', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer Anger, MD, MPH', 'role': 'CONTACT', 'phone': '310-385-2992'}, {'name': 'Jennifer Anger, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}], 'centralContacts': [{'name': 'Jennifer Anger, MD, MPH', 'role': 'CONTACT', 'phone': '3103852992'}], 'overallOfficials': [{'name': 'Jennifer Anger, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cedars-Sinai Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cedars-Sinai Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Jennifer T. Anger', 'investigatorAffiliation': 'Cedars-Sinai Medical Center'}}}}