Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2025-12-30 @ 9:47 PM
Study NCT ID:
NCT00734968
Status:
COMPLETED
Last Update Posted:
2016-10-11
First Post:
2008-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Does Treatment With Macrobid Reduce Urinary Tract Infections in Patients Receiving a Sub-Urethral Sling for Incontinence
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014550', 'term': 'Urinary Incontinence, Stress'}, {'id': 'D014552', 'term': 'Urinary Tract Infections'}], 'ancestors': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'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': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009582', 'term': 'Nitrofurantoin'}], 'ancestors': [{'id': 'D009581', 'term': 'Nitrofurans'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005663', 'term': 'Furans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jacksondl@health.missouri.edu', 'phone': '573 499 6041', 'title': 'Daniel Jackson MD', 'organization': 'University of Missouri'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Arm randomly assigned to receive placebo 1 tablet PO BID x 3 days post-operatively.The incidence of UTI in this group will be compared with group one (1)\n\nPlacebo: 6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets.', 'otherNumAtRisk': 76, 'otherNumAffected': 0, 'seriousNumAtRisk': 76, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment', 'description': 'Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively\n\nNitrofurantoin: Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence', 'otherNumAtRisk': 75, 'otherNumAffected': 0, 'seriousNumAtRisk': 75, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Post-operative UTI Following the Placement of Sub-urethral Sling for the Treatment of Stress Urinary Incontinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively\n\nNitrofurantoin: Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Arm randomly assigned to receive placebo 1 tablet PO BID x 3 days post-operatively.The incidence of UTI in this group will be compared with group one (1)\n\nPlacebo: 6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks', 'description': 'The overall rate of UTI following the placement of sub-urethral sling for the treatment of stress urinary incontinence in our study was 24.8% (n = 37)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Incidence of Post-operative UTI in Placebo Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively\n\nNitrofurantoin: Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Arm randomly assigned to receive placebo 1 tablet PO BID x 3 days post-operatively.The incidence of UTI in this group will be compared with group one (1)\n\nPlacebo: 6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks', 'description': 'The incidence of UTI in the placebo group was 32%.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Incidence of Post-operative UTI in Treatment Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively\n\nNitrofurantoin: Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Arm randomly assigned to receive placebo 1 tablet PO BID x 3 days post-operatively.The incidence of UTI in this group will be compared with group one (1)\n\nPlacebo: 6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks', 'description': 'The incidence of UTI in the nitrofurantoin group was 17.6%.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Arm randomly assigned to receive placebo 1 tablet PO twice a day (BID) x 3 days post-operatively. The incidence of urinary tract infection (UTI) in this group will be compared with group one (1).\n\nPlacebo: 6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100 mg tablets.'}, {'id': 'FG001', 'title': 'Treatment', 'description': 'Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively\n\nNitrofurantoin: Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '76'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': '161 subjects were consecutively enrolled. 8 subjects were lost to protocol errors. 76 subjects were randomized to treatment and 77 to placebo. 1 subject from each arm was lost to follow up. 75 subjects in the treatment arm and 76 in the placebo arm were in the final analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment', 'description': 'Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively\n\nNitrofurantoin: Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Arm randomly assigned to receive placebo 1 tablet PO BID x 3 days post-operatively.The incidence of UTI in this group will be compared with group one (1)\n\nPlacebo: 6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '>18 years', 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 161}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-17', 'studyFirstSubmitDate': '2008-08-12', 'resultsFirstSubmitDate': '2016-05-20', 'studyFirstSubmitQcDate': '2008-08-13', 'lastUpdatePostDateStruct': {'date': '2016-10-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-08-17', 'studyFirstPostDateStruct': {'date': '2008-08-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Post-operative UTI Following the Placement of Sub-urethral Sling for the Treatment of Stress Urinary Incontinence', 'timeFrame': '6 weeks', 'description': 'The overall rate of UTI following the placement of sub-urethral sling for the treatment of stress urinary incontinence in our study was 24.8% (n = 37)'}, {'measure': 'Incidence of Post-operative UTI in Placebo Group', 'timeFrame': '6 weeks', 'description': 'The incidence of UTI in the placebo group was 32%.'}, {'measure': 'Incidence of Post-operative UTI in Treatment Group', 'timeFrame': '6 weeks', 'description': 'The incidence of UTI in the nitrofurantoin group was 17.6%.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Urinary tract infection (UTI)', 'suburethral sling', 'Prevention', 'Nitrofurantoin', 'Prophylaxis'], 'conditions': ['Stress Incontinence']}, 'referencesModule': {'references': [{'pmid': '17329524', 'type': 'BACKGROUND', 'citation': 'Anger JT, Litwin MS, Wang Q, Pashos CL, Rodriguez LV. Complications of sling surgery among female Medicare beneficiaries. Obstet Gynecol. 2007 Mar;109(3):707-14. doi: 10.1097/01.AOG.0000255975.24668.f2.'}, {'pmid': '12020306', 'type': 'BACKGROUND', 'citation': 'Bent S, Nallamothu BK, Simel DL, Fihn SD, Saint S. Does this woman have an acute uncomplicated urinary tract infection? JAMA. 2002 May 22-29;287(20):2701-10. doi: 10.1001/jama.287.20.2701.'}, {'pmid': '17203544', 'type': 'BACKGROUND', 'citation': 'Aubin C. Evidence-based emergency medicine/rational clinical examination abstract. Does this woman have an acute uncomplicated urinary tract infection? Ann Emerg Med. 2007 Jan;49(1):106-8. doi: 10.1016/j.annemergmed.2006.09.022. No abstract available.'}, {'pmid': '12066948', 'type': 'BACKGROUND', 'citation': 'Bodelsson G, Henriksson L, Osser S, Stjernquist M. Short term complications of the tension free vaginal tape operation for stress urinary incontinence in women. BJOG. 2002 May;109(5):566-9. doi: 10.1111/j.1471-0528.2002.01195.x.'}, {'pmid': '14520192', 'type': 'BACKGROUND', 'citation': 'Ferro A, Byck D, Gallup D. Intraoperative and postoperative morbidity associated with cystoscopy performed in patients undergoing gynecologic surgery. Am J Obstet Gynecol. 2003 Aug;189(2):354-7; discussion 357. doi: 10.1067/s0002-9378(03)00677-x.'}, {'pmid': '17290725', 'type': 'BACKGROUND', 'citation': 'Grover ML, Bracamonte JD, Kanodia AK, Bryan MJ, Donahue SP, Warner AM, Edwards FD, Weaver AL. Assessing adherence to evidence-based guidelines for the diagnosis and management of uncomplicated urinary tract infection. Mayo Clin Proc. 2007 Feb;82(2):181-5. doi: 10.4065/82.2.181.'}, {'pmid': '11434727', 'type': 'BACKGROUND', 'citation': 'Gupta K, Hooton TM, Roberts PL, Stamm WE. Patient-initiated treatment of uncomplicated recurrent urinary tract infections in young women. Ann Intern Med. 2001 Jul 3;135(1):9-16. doi: 10.7326/0003-4819-135-1-200107030-00004.'}, {'pmid': '12738152', 'type': 'BACKGROUND', 'citation': 'Karram MM, Segal JL, Vassallo BJ, Kleeman SD. Complications and untoward effects of the tension-free vaginal tape procedure. Obstet Gynecol. 2003 May;101(5 Pt 1):929-32. doi: 10.1016/s0029-7844(03)00122-4.'}, {'pmid': '11942891', 'type': 'BACKGROUND', 'citation': 'Kuuva N, Nilsson CG. A nationwide analysis of complications associated with the tension-free vaginal tape (TVT) procedure. Acta Obstet Gynecol Scand. 2002 Jan;81(1):72-7. doi: 10.1034/j.1600-0412.2002.810113.x.'}, {'pmid': '17132487', 'type': 'BACKGROUND', 'citation': "LaSala CA, Schimpf MO, Udoh E, O'Sullivan DM, Tulikangas P. Outcome of tension-free vaginal tape procedure when complicated by intraoperative cystotomy. Am J Obstet Gynecol. 2006 Dec;195(6):1857-61. doi: 10.1016/j.ajog.2006.06.060."}, {'pmid': '16650360', 'type': 'BACKGROUND', 'citation': 'Lim JL, Quinlan DJ. Safety of a new transobturator suburethral synthetic sling (TVT-O) procedure during the training phase. J Obstet Gynaecol Can. 2006 Mar;28(3):214-217. doi: 10.1016/S1701-2163(16)32111-9.'}, {'pmid': '15924538', 'type': 'BACKGROUND', 'citation': 'Pugsley H, Barbrook C, Mayne CJ, Tincello DG. Morbidity of incontinence surgery in women over 70 years old: a retrospective cohort study. BJOG. 2005 Jun;112(6):786-90. doi: 10.1111/j.1471-0528.2004.00522.x.'}, {'pmid': '16021057', 'type': 'BACKGROUND', 'citation': 'Schraffordt Koops SE, Bisseling TM, Heintz AP, Vervest HA. Prospective analysis of complications of tension-free vaginal tape from The Netherlands Tension-free Vaginal Tape study. Am J Obstet Gynecol. 2005 Jul;193(1):45-52. doi: 10.1016/j.ajog.2004.11.004.'}, {'pmid': '15902154', 'type': 'BACKGROUND', 'citation': 'Sokol AI, Jelovsek JE, Walters MD, Paraiso MF, Barber MD. Incidence and predictors of prolonged urinary retention after TVT with and without concurrent prolapse surgery. Am J Obstet Gynecol. 2005 May;192(5):1537-43. doi: 10.1016/j.ajog.2004.10.623.'}, {'pmid': '11704161', 'type': 'BACKGROUND', 'citation': 'Tamussino KF, Hanzal E, Kolle D, Ralph G, Riss PA; Austrian Urogynecology Working Group. Tension-free vaginal tape operation: results of the Austrian registry. Obstet Gynecol. 2001 Nov;98(5 Pt 1):732-6. doi: 10.1016/s0029-7844(01)01565-4.'}, {'pmid': '15311022', 'type': 'BACKGROUND', 'citation': 'Tsivian A, Mogutin B, Kessler O, Korczak D, Levin S, Sidi AA. Tension-free vaginal tape procedure for the treatment of female stress urinary incontinence: long-term results. J Urol. 2004 Sep;172(3):998-1000. doi: 10.1097/01.ju.0000135072.27734.4a.'}, {'pmid': '12790850', 'type': 'BACKGROUND', 'citation': 'Valpas A, Kivela A, Penttinen J, Kauko M, Kujansuu E, Tomas E, Haarala M, Meltomaa S, Nilsson CK. Tension-free vaginal tape and laparoscopic mesh colposuspension in the treatment of stress urinary incontinence: immediate outcome and complications--a randomized clinical trial. Acta Obstet Gynecol Scand. 2003 Jul;82(7):665-71.'}, {'pmid': '12114234', 'type': 'BACKGROUND', 'citation': 'Ward K, Hilton P; United Kingdom and Ireland Tension-free Vaginal Tape Trial Group. Prospective multicentre randomised trial of tension-free vaginal tape and colposuspension as primary treatment for stress incontinence. BMJ. 2002 Jul 13;325(7355):67. doi: 10.1136/bmj.325.7355.67.'}, {'pmid': '35349162', 'type': 'DERIVED', 'citation': 'Temtanakitpaisan T, Buppasiri P, Lumbiganon P, Laopaiboon M, Rattanakanokchai S. Prophylactic antibiotics for preventing infection after continence surgery in women with stress urinary incontinence. Cochrane Database Syst Rev. 2022 Mar 29;3(3):CD012457. doi: 10.1002/14651858.CD012457.pub2.'}, {'pmid': '23611930', 'type': 'DERIVED', 'citation': 'Jackson D, Higgins E, Bracken J, Yandell PM, Shull B, Foster RT Sr. Antibiotic prophylaxis for urinary tract infection after midurethral sling: a randomized controlled trial. Female Pelvic Med Reconstr Surg. 2013 May-Jun;19(3):137-41. doi: 10.1097/SPV.0b013e318285ba53.'}]}, 'descriptionModule': {'briefSummary': 'This project will determine whether post-operative prophylaxis with macrobid will decrease the incidence of postoperative urinary tract infection in women receiving sub-urethral slings for the treatment of urinary incontinence.', 'detailedDescription': 'This project will be a randomized, double blinded, placebo controlled clinical trial. The aim of the trial is to determine whether or not post-operative prophylaxis with macrobid will decrease the incidence of postoperative urinary tract infection in women receiving sub-urethral slings for the treatment of urinary incontinence.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women over the age of 18 who will undergo the placement of a sub-urethral sling for the treatment of stress urinary incontinence\n\nExclusion Criteria:\n\n* Exclusion criteria are those with a known allergy to macrobid, those with glucose-6-phosphate deficiency, renal impairment, women breast feeding or with a known pregnancy, patients taking medications for gout, and those with known risk factors for complicated UTI (polycystic renal disease, nephrolithiasis, neurogenic bladder, diabetes, immuno-suppression, etc).'}, 'identificationModule': {'nctId': 'NCT00734968', 'briefTitle': 'Does Treatment With Macrobid Reduce Urinary Tract Infections in Patients Receiving a Sub-Urethral Sling for Incontinence', 'organization': {'class': 'OTHER', 'fullName': 'University of Missouri-Columbia'}, 'officialTitle': 'Does Prophylaxis With Macrobid Reduce the Incidence of Urinary Tract Infection in Patients Who Receive a Sub-Urethral Sling for the Treatment of Stress Urinary Incontinence: Randomized, Double Blinded Placebo Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '1108717'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively', 'interventionNames': ['Drug: Nitrofurantoin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Arm randomly assigned to receive placebo 1 tablet PO BID x 3 days post-operatively.The incidence of UTI in this group will be compared with group one (1)', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Nitrofurantoin', 'type': 'DRUG', 'otherNames': ['Macrobid'], 'description': 'Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence', 'armGroupLabels': ['Treatment']}, {'name': 'Placebo', 'type': 'OTHER', 'description': '6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76508', 'city': 'Temple', 'state': 'Texas', 'country': 'United States', 'facility': 'Scott and White Hosptial, Texas A&M University', 'geoPoint': {'lat': 31.09823, 'lon': -97.34278}}], 'overallOfficials': [{'name': 'Daniel L Jackson, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Missouri-Columbia'}, {'name': 'Raymond T Foster, MD, MS, MHSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Missouri-Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Missouri-Columbia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Texas A&M University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}