Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2026-02-25 @ 12:55 AM
Study NCT ID:
NCT04682366
Status:
TERMINATED
Last Update Posted:
2024-01-31
First Post:
2020-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of Tamsulosin on Postoperative Urinary Retention
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D016055', 'term': 'Urinary Retention'}, {'id': 'D014552', 'term': 'Urinary Tract Infections'}], 'ancestors': [{'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': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077409', 'term': 'Tamsulosin'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mmirzaza@wakehealth.edu', 'phone': '336-716-4131', 'title': 'Majid Mirzazadeh', 'organization': 'Wake Forest'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Tamsulosin', 'description': 'Patients in this arm will receive 10 days of 0.4 mg of oral tamsulosin once daily starting 5 days pre-operatively and continuing until all pills are completed.\n\nTamsulosin: Oral drug: 10 days of 0.4 mg of oral Tamsulosin', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Patients in this arm will receive 10 days of identical-appearing placebo once daily starting 5 days pre-operatively and continuing until all pills are completed.\n\nPlacebo: Oral drug: 10 days of identical-appearing placebo', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Postoperative (Day 0) Urinary Retention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tamsulosin', 'description': 'Patients in this arm will receive 10 days of 0.4 mg of oral tamsulosin once daily starting 5 days pre-operatively and continuing until all pills are completed.\n\nTamsulosin: Oral drug: 10 days of 0.4 mg of oral Tamsulosin'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients in this arm will receive 10 days of identical-appearing placebo once daily starting 5 days pre-operatively and continuing until all pills are completed.\n\nPlacebo: Oral drug: 10 days of identical-appearing placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 6 weeks postoperatively', 'description': 'Urinary retention can be defined as \\>150cc residual volume during an active voiding trial', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Urinary Tract Infection Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tamsulosin', 'description': 'Patients in this arm will receive 10 days of 0.4 mg of oral tamsulosin once daily starting 5 days pre-operatively and continuing until all pills are completed.\n\nTamsulosin: Oral drug: 10 days of 0.4 mg of oral Tamsulosin'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients in this arm will receive 10 days of identical-appearing placebo once daily starting 5 days pre-operatively and continuing until all pills are completed.\n\nPlacebo: Oral drug: 10 days of identical-appearing placebo'}], 'timeFrame': 'Week 6', 'description': 'Urinary tract infection rate', 'reportingStatus': 'POSTED', 'populationDescription': 'No Data was collected'}, {'type': 'SECONDARY', 'title': 'Incidence of Delayed Urinary Retention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tamsulosin', 'description': 'Patients in this arm will receive 10 days of 0.4 mg of oral tamsulosin once daily starting 5 days pre-operatively and continuing until all pills are completed.\n\nTamsulosin: Oral drug: 10 days of 0.4 mg of oral Tamsulosin'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients in this arm will receive 10 days of identical-appearing placebo once daily starting 5 days pre-operatively and continuing until all pills are completed.\n\nPlacebo: Oral drug: 10 days of identical-appearing placebo'}], 'timeFrame': 'Week 6', 'description': 'Delayed urinary retention will be defined as post-void residual \\> 150 cc', 'reportingStatus': 'POSTED', 'populationDescription': 'No Data was collected'}, {'type': 'SECONDARY', 'title': 'Number Emergency Department (ED) Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tamsulosin', 'description': 'Patients in this arm will receive 10 days of 0.4 mg of oral tamsulosin once daily starting 5 days pre-operatively and continuing until all pills are completed.\n\nTamsulosin: Oral drug: 10 days of 0.4 mg of oral Tamsulosin'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients in this arm will receive 10 days of identical-appearing placebo once daily starting 5 days pre-operatively and continuing until all pills are completed.\n\nPlacebo: Oral drug: 10 days of identical-appearing placebo'}], 'timeFrame': 'Up to 30 days postoperatively', 'reportingStatus': 'POSTED', 'populationDescription': 'No Data was collected'}, {'type': 'SECONDARY', 'title': 'Total Number of Days of Bladder Catheterization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tamsulosin', 'description': 'Patients in this arm will receive 10 days of 0.4 mg of oral tamsulosin once daily starting 5 days pre-operatively and continuing until all pills are completed.\n\nTamsulosin: Oral drug: 10 days of 0.4 mg of oral Tamsulosin'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients in this arm will receive 10 days of identical-appearing placebo once daily starting 5 days pre-operatively and continuing until all pills are completed.\n\nPlacebo: Oral drug: 10 days of identical-appearing placebo'}], 'timeFrame': 'Week 6', 'reportingStatus': 'POSTED', 'populationDescription': 'No Data was collected'}, {'type': 'SECONDARY', 'title': 'Patient Level of Satisfaction With Voiding Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tamsulosin', 'description': 'Patients in this arm will receive 10 days of 0.4 mg of oral 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Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tamsulosin', 'description': 'Patients in this arm will receive 10 days of 0.4 mg of oral tamsulosin once daily starting 5 days pre-operatively and continuing until all pills are completed.\n\nTamsulosin: Oral drug: 10 days of 0.4 mg of oral Tamsulosin'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Patients in this arm will receive 10 days of identical-appearing placebo once daily starting 5 days pre-operatively and continuing until all pills are completed.\n\nPlacebo: Oral drug: 10 days of identical-appearing placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '1 Subject was Lost-to-Follow'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 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'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '1 Subject in each group was LTF'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Lost to follow-up', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '2 Subjects were Lost To Follow - 1 in each Group'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-08-19', 'size': 317681, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_003.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-01-29T14:13', 'hasProtocol': True}, {'date': '2022-04-12', 'size': 139191, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-12-04T19:25', 'hasProtocol': False}]}}, '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': 4}}, 'statusModule': {'whyStopped': 'Challenges in enrollment led to decission for termination', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-29', 'studyFirstSubmitDate': '2020-12-18', 'resultsFirstSubmitDate': '2023-09-28', 'studyFirstSubmitQcDate': '2020-12-18', 'lastUpdatePostDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-29', 'studyFirstPostDateStruct': {'date': '2020-12-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Postoperative (Day 0) Urinary Retention', 'timeFrame': 'Up to 6 weeks postoperatively', 'description': 'Urinary retention can be defined as \\>150cc residual volume during an active voiding trial'}], 'secondaryOutcomes': [{'measure': 'Urinary Tract Infection Rate', 'timeFrame': 'Week 6', 'description': 'Urinary tract infection rate'}, {'measure': 'Incidence of Delayed Urinary Retention', 'timeFrame': 'Week 6', 'description': 'Delayed urinary retention will be defined as post-void residual \\> 150 cc'}, {'measure': 'Number Emergency Department (ED) Visits', 'timeFrame': 'Up to 30 days postoperatively'}, {'measure': 'Total Number of Days of Bladder Catheterization', 'timeFrame': 'Week 6'}, {'measure': 'Patient Level of Satisfaction With Voiding Function', 'timeFrame': 'Day 0 and 1 week postoperatively', 'description': 'Patient satisfaction questionnaire: Patient Global Impression of Improvement (PGI-I) - Patient level of satisfaction (scale of 1 -7) - very dissatisfied, moderately dissatisfied, slightly dissatisfied, neutral, slightly satisfied, moderately satisfied, very satisfied - the lower the score denotes the more satisfaction)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postoperative care', 'Urinary tract infection', 'Female pelvic reconstructive surgery', 'Enhanced recovery after surgery', 'Tamsulosin', 'Flomax'], 'conditions': ['Urinary Retention']}, 'referencesModule': {'references': [{'pmid': '28538495', 'type': 'BACKGROUND', 'citation': 'Committee Opinion No 701: Choosing the Route of Hysterectomy for Benign Disease. Obstet Gynecol. 2017 Jun;129(6):e155-e159. doi: 10.1097/AOG.0000000000002112.'}, {'pmid': '27286124', 'type': 'BACKGROUND', 'citation': 'Akkoc A, Aydin C, Topaktas R, Kartalmis M, Altin S, Isen K, Metin A. Prophylactic effects of alpha-blockers, Tamsulosin and Alfuzosin, on postoperative urinary retention in male patients undergoing urologic surgery under spinal anaesthesia. Int Braz J Urol. 2016 May-Jun;42(3):578-84. doi: 10.1590/S1677-5538.IBJU.2015.0256.'}, {'pmid': '29913175', 'type': 'BACKGROUND', 'citation': 'Carter-Brooks CM, Du AL, Ruppert KM, Romanova AL, Zyczynski HM. Implementation of a urogynecology-specific enhanced recovery after surgery (ERAS) pathway. Am J Obstet Gynecol. 2018 Nov;219(5):495.e1-495.e10. doi: 10.1016/j.ajog.2018.06.009. Epub 2018 Jun 18.'}, {'pmid': '30418263', 'type': 'BACKGROUND', 'citation': 'Chapman GC, Sheyn D, Petrikovets A, Mahajan ST, El-Nashar S, Pollard R, Mangel JM. Tamsulosin to Prevent Postoperative Urinary Retention After Female Pelvic Reconstructive Surgery. Female Pelvic Med Reconstr Surg. 2020 Nov;26(11):682-687. doi: 10.1097/SPV.0000000000000650.'}, {'pmid': '27004205', 'type': 'BACKGROUND', 'citation': 'Chong C, Kim HS, Suh DH, Jee BC. Risk factors for urinary retention after vaginal hysterectomy for pelvic organ prolapse. Obstet Gynecol Sci. 2016 Mar;59(2):137-43. doi: 10.5468/ogs.2016.59.2.137. Epub 2016 Mar 16.'}, {'pmid': '28341140', 'type': 'BACKGROUND', 'citation': "Clancy C, Coffey JC, O'Riordain MG, Burke JP. A meta-analysis of the efficacy of prophylactic alpha-blockade for the prevention of urinary retention following primary unilateral inguinal hernia repair. Am J Surg. 2018 Aug;216(2):337-341. doi: 10.1016/j.amjsurg.2017.02.017. Epub 2017 Mar 14."}, {'pmid': '19829032', 'type': 'BACKGROUND', 'citation': 'Costantini E, Lazzeri M, Bini V, Zucchi A, Fioretti F, Frumenzio E, Porena M. Open-label, longitudinal study of tamsulosin for functional bladder outlet obstruction in women. Urol Int. 2009;83(3):311-5. doi: 10.1159/000241674. Epub 2009 Oct 13.'}, {'pmid': '27168235', 'type': 'BACKGROUND', 'citation': 'Doll KM, Dusetzina SB, Robinson W. Trends in Inpatient and Outpatient Hysterectomy and Oophorectomy Rates Among Commercially Insured Women in the United States, 2000-2014. JAMA Surg. 2016 Sep 1;151(9):876-7. doi: 10.1001/jamasurg.2016.0804. No abstract available.'}, {'pmid': '11135378', 'type': 'BACKGROUND', 'citation': 'FitzGerald MP, Brubaker L. The etiology of urinary retention after surgery for genuine stress incontinence. Neurourol Urodyn. 2001;20(1):13-21. doi: 10.1002/1520-6777(2001)20:13.0.co;2-r.'}, {'pmid': '29509646', 'type': 'BACKGROUND', 'citation': 'Geynisman-Tan J, Dave-Heliker B, Bochenska K, Collins S, Lewicky-Gaupp C, Mueller M, Kenton K. Duration of Catheterization After Retropubic Midurethral Sling. Female Pelvic Med Reconstr Surg. 2019 Sep-Oct;25(5):369-371. doi: 10.1097/SPV.0000000000000569.'}, {'pmid': '20175247', 'type': 'BACKGROUND', 'citation': 'Hooton TM, Bradley SF, Cardenas DD, Colgan R, Geerlings SE, Rice JC, Saint S, Schaeffer AJ, Tambayh PA, Tenke P, Nicolle LE; Infectious Diseases Society of America. Diagnosis, prevention, and treatment of catheter-associated urinary tract infection in adults: 2009 International Clinical Practice Guidelines from the Infectious Diseases Society of America. Clin Infect Dis. 2010 Mar 1;50(5):625-63. doi: 10.1086/650482.'}, {'pmid': '30734011', 'type': 'BACKGROUND', 'citation': 'Jackson J, Davies P, Leggett N, Nugawela MD, Scott LJ, Leach V, Richards A, Blacker A, Abrams P, Sharma J, Donovan J, Whiting P. Systematic review of interventions for the prevention and treatment of postoperative urinary retention. BJS Open. 2018 Nov 19;3(1):11-23. doi: 10.1002/bjs5.50114. eCollection 2019 Feb.'}, {'pmid': '25981843', 'type': 'BACKGROUND', 'citation': 'Jennings AJ, Spencer RJ, Medlin E, Rice LW, Uppal S. Predictors of 30-day readmission and impact of same-day discharge in laparoscopic hysterectomy. Am J Obstet Gynecol. 2015 Sep;213(3):344.e1-7. doi: 10.1016/j.ajog.2015.05.014. Epub 2015 May 14.'}, {'pmid': '18060968', 'type': 'BACKGROUND', 'citation': 'Kenton K, Pham T, Mueller E, Brubaker L. Patient preparedness: an important predictor of surgical outcome. Am J Obstet Gynecol. 2007 Dec;197(6):654.e1-6. doi: 10.1016/j.ajog.2007.08.059.'}, {'pmid': '27261788', 'type': 'BACKGROUND', 'citation': 'Kowalik U, Plante MK. Urinary Retention in Surgical Patients. Surg Clin North Am. 2016 Jun;96(3):453-67. doi: 10.1016/j.suc.2016.02.004.'}, {'pmid': '2850917', 'type': 'BACKGROUND', 'citation': 'Koyanagi T, Morita H, Taniguchi K, Kubota M, Shinno Y, Takamatsu T. 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Effectiveness of tamsulosin in prevention of post-operative urinary retention: a randomized double-blind placebo-controlled study. Int Braz J Urol. 2014 Jan-Feb;40(1):30-6. doi: 10.1590/S1677-5538.IBJU.2014.01.05.'}, {'pmid': '21508753', 'type': 'BACKGROUND', 'citation': 'Perron-Burdick M, Yamamoto M, Zaritsky E. Same-day discharge after laparoscopic hysterectomy. Obstet Gynecol. 2011 May;117(5):1136-1141. doi: 10.1097/AOG.0b013e318215dd4e.'}, {'pmid': '26099320', 'type': 'BACKGROUND', 'citation': 'Poylin V, Curran T, Cataldo T, Nagle D. Perioperative use of tamsulosin significantly decreases rates of urinary retention in men undergoing pelvic surgery. Int J Colorectal Dis. 2015 Sep;30(9):1223-8. doi: 10.1007/s00384-015-2294-7. Epub 2015 Jun 23.'}, {'pmid': '27399998', 'type': 'BACKGROUND', 'citation': "Propst K, Tunitsky-Bitton E, O'Sullivan DM, Steinberg AC, LaSala C. Phenazopyridine for Evaluation of Ureteral Patency: A Randomized Controlled Trial. 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Am J Obstet Gynecol. 2016 Nov;215(5):656.e1-656.e6. doi: 10.1016/j.ajog.2016.06.010. Epub 2016 Jun 16.'}, {'pmid': '23107080', 'type': 'BACKGROUND', 'citation': 'Schiavone MB, Herzog TJ, Ananth CV, Wilde ET, Lewin SN, Burke WM, Lu YS, Neugut AI, Hershman DL, Wright JD. Feasibility and economic impact of same-day discharge for women who undergo laparoscopic hysterectomy. Am J Obstet Gynecol. 2012 Nov;207(5):382.e1-9. doi: 10.1016/j.ajog.2012.09.014. Epub 2012 Sep 17.'}, {'pmid': '25434837', 'type': 'BACKGROUND', 'citation': 'Tunitsky-Bitton E, Murphy A, Barber MD, Goldman HB, Vasavada S, Jelovsek JE. Assessment of voiding after sling: a randomized trial of 2 methods of postoperative catheter management after midurethral sling surgery for stress urinary incontinence in women. Am J Obstet Gynecol. 2015 May;212(5):597.e1-9. doi: 10.1016/j.ajog.2014.11.033. Epub 2014 Nov 27.'}, {'pmid': '25185611', 'type': 'BACKGROUND', 'citation': 'Turner LC, Kantartzis K, Shepherd JP. Predictors of postoperative acute urinary retention in women undergoing minimally invasive sacral colpopexy. Female Pelvic Med Reconstr Surg. 2015 Jan-Feb;21(1):39-42. doi: 10.1097/SPV.0000000000000110.'}]}, 'descriptionModule': {'briefSummary': 'This is a double-blinded randomized controlled trial of perioperative use of tamsulosin to prevent postoperative urinary retention in female pelvic reconstructive surgery undergoing same-day discharge with an enhanced recovery after surgery protocol.', 'detailedDescription': 'The primary objective is to determine the effect of Tamsulosin on same-day active voiding trial in women undergoing female pelvic reconstructive surgery with vaginal native tissue repair with same-day discharge planned.\n\nDuration of catheterization, postoperative urinary tract infection rates, patient level of satisfaction, Emergency Department (ED) visits and adverse events postoperatively will also be compared between women receiving Tamsulosin versus placebo.\n\nPatients will be offered participation in the study at their postoperative visit if they meet study criteria. Once consent is obtained, patients will be randomized to receive Tamsulosin 0.4 mg orally once daily or matching placebo capsules for a total of 10 days starting 5 days pre-operatively.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '21 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stage II or greater pelvic organ prolapse in \\> 1 vaginal compartment\n* Plan for multicompartment native tissue vaginal repair (which would include any combination of uterosacral ligament suspension, sacrospinous ligament suspension, cystocele and/or rectocele repair, with or without hysterectomy and with or without concomitant mid-urethral sling) or vaginal closure with female pelvic medicine and reconstructive surgery (FPMRS) - trained surgeons at Wake Forest Baptist Health\n* Participation in Enhanced-Recovery-After-Surgery protocol with plan for same-day hospital discharge\n* Willing to remain compliant with Investigation Product (IP)\n\nExclusion Criteria:\n\n* Intraoperative complication necessitating prolonged bladder drainage or placement of a vaginal pack x 24 hours (patients would exit study after randomization and will be excluded from the per-protocol analysis)\n* Patients whose surgical plan would necessitate a voiding trial on postop day \\>0\n* Less than 21 years of age\n* Unable to understand English\n* Patients who are scheduled to undergo combined colorectal procedures such as rectopexy, sphincteroplasty\n* Patient with known allergy to Tamsulosin or sulfa drugs\n* Patients with upcoming cataract surgery\n* Patient with orthostatic hypotension\n* History of postvoid residual (PVR\\>150) prior to surgery with prolapse reduction\n* Patients with hypertension on alpha-blockers\n* Single compartment prolapse repair (anterior or posterior repair only)\n* Use of mesh for prolapse repair\n* High tone pelvic floor dysfunction'}, 'identificationModule': {'nctId': 'NCT04682366', 'briefTitle': 'The Effect of Tamsulosin on Postoperative Urinary Retention', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Evaluating the Effect of Tamsulosin on Postoperative Urinary Retention in Women Undergoing Same Day Hospital Discharge Following Pelvic Reconstructive Surgery: A Randomized Trial', 'orgStudyIdInfo': {'id': 'IRB00070462'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tamsulosin', 'description': 'Patients in this arm will receive 10 days of 0.4 mg of oral tamsulosin once daily starting 5 days pre-operatively and continuing until all pills are completed.', 'interventionNames': ['Drug: Tamsulosin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients in this arm will receive 10 days of identical-appearing placebo once daily starting 5 days pre-operatively and continuing until all pills are completed.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tamsulosin', 'type': 'DRUG', 'description': 'Oral drug: 10 days of 0.4 mg of oral Tamsulosin', 'armGroupLabels': ['Tamsulosin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral drug: 10 days of identical-appearing placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Majid Mirzazadeh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}