Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-26 @ 6:04 PM
Study NCT ID:
NCT03976934
Status:
COMPLETED
Last Update Posted:
2021-11-26
First Post:
2019-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prophylactic Administration of Alpha Blockers for Prevention of Urinary Retention in Males Undergoing Inguinal Hernia Repair Under Spinal Anaesthesia.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006552', 'term': 'Hernia, Inguinal'}, {'id': 'D016055', 'term': 'Urinary Retention'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-23', 'studyFirstSubmitDate': '2019-05-31', 'studyFirstSubmitQcDate': '2019-06-04', 'lastUpdatePostDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of urinary retention', 'timeFrame': '8 hours post surgery', 'description': 'inability to voluntarily void urine up to 8 hours post surgery'}], 'secondaryOutcomes': [{'measure': 'Prostate related Symptoms', 'timeFrame': 'Baseline', 'description': 'identification of Prostate related Symptoms as preoperative risk factor of post surgery urinary retention. For the assessment of the prostate related symptomatology will be used the International Prostate Symptom Score questionnaire'}, {'measure': 'Scrotal hernia Repair', 'timeFrame': 'Baseline, Inta-operative', 'description': 'evaluation of Scrotal hernia repair as preoperative risk factor of post surgery urinary retention.'}, {'measure': 'Duration of Surgery', 'timeFrame': 'Duration of Surgical procedure', 'description': 'Evaluation of the surgery duration as inta-operative risk factor of post surgery urinary retention.'}, {'measure': 'Use of opioids', 'timeFrame': '24 hours', 'description': 'Evaluation of the peri-operative administration of iv opioids as a peri-operative risk factor of post surgery urinary retention.'}, {'measure': 'Iv fluid administration', 'timeFrame': '24 hours', 'description': 'Evaluation of the peri-operative iv fluid administration as a peri-operative risk factor of post surgery urinary retention.'}, {'measure': 'Post-operative Pain', 'timeFrame': '24 hours', 'description': 'Evaluation of the post operative pain as a risk factor of post surgery urinary retention. For the assessment of the pain will be used the Visual Analog Scale (VAS) score at 6, 12 and 24 hours after surgery. (VAS Score Scale from 0-10, 0 no pain, 10 max pain)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['open inguinal hernia repair', 'spinal anaesthesia', 'urinary retention', 'elective alpha blockers'], 'conditions': ['Inguinal Hernia', 'Urinary Retention']}, 'referencesModule': {'references': [{'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': '28584678', 'type': 'BACKGROUND', 'citation': 'Basheer A, Alsaidi M, Schultz L, Chedid M, Abdulhak M, Seyfried D. Preventive effect of tamsulosin on postoperative urinary retention in neurosurgical patients. Surg Neurol Int. 2017 May 10;8:75. doi: 10.4103/sni.sni_5_17. eCollection 2017.'}, {'pmid': '25935942', 'type': 'BACKGROUND', 'citation': 'Shaw MK, Pahari H. The role of peri-operative use of alpha-blocker in preventing lower urinary tract symptoms in high risk patients of urinary retention undergoing inguinal hernia repair in males above 50 years. J Indian Med Assoc. 2014 Jan;112(1):13-4, 16.'}]}, 'descriptionModule': {'briefSummary': "Open inguinal hernia repair is one of the most common surgical procedures. Despite the fact that different of anesthetic procedures are proposed as alternatives to spinal anesthesia, the combination of spinal anesthesia with open inguinal hernia repair is preferred from both surgeons and patients. One disadvantage of this combination is the high incidence of post-surgery urinary retention, especially in men above 50 years old. This complication is partially attribute to overstimulation of the a1 adrenergic receivers of the bladder and the prostate. Preoperative administration of elective a1 blockers could inhibit this effect without side effects, since this drugs don't have systemic effect."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* unilateral inguinal hernia\n\nExclusion Criteria:\n\n* ASA score \\>3\n* hypotension\n* prostatic hypertrophy\n* complicated inguinal hernia\n* neurological diseases\n* inguinal hernia repair under general or local anaesthesia'}, 'identificationModule': {'nctId': 'NCT03976934', 'briefTitle': 'Prophylactic Administration of Alpha Blockers for Prevention of Urinary Retention in Males Undergoing Inguinal Hernia Repair Under Spinal Anaesthesia.', 'organization': {'class': 'OTHER', 'fullName': 'General Hospital of Larissa'}, 'officialTitle': 'Prophylactic Administration of Alpha Blockers for Prevention of Post Operative Urinary Retention in Males Undergoing Open Inguinal Hernia Repair Under Spinal Anaesthesia.', 'orgStudyIdInfo': {'id': '1725'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tamsulosin group', 'description': 'administration of 0,4mg of tamsulosin 24 hours before surgery and 0,4mg 6 hours before surgery', 'interventionNames': ['Drug: Tamsulosin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'administration of placebo 24 and 6 hours before surgery', 'interventionNames': ['Drug: Placebo oral tablet']}], 'interventions': [{'name': 'Tamsulosin', 'type': 'DRUG', 'otherNames': ['omnic tocas'], 'description': 'administration of tamsulosin tablets', 'armGroupLabels': ['Tamsulosin group']}, {'name': 'Placebo oral tablet', 'type': 'DRUG', 'description': 'sugar pills', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41110', 'city': 'Larissa', 'country': 'Greece', 'facility': 'University General Hospital of Larissa', 'geoPoint': {'lat': 39.62847, 'lon': 22.42112}}, {'zip': '41221', 'city': 'Larissa', 'country': 'Greece', 'facility': 'General Hospital Of Larissa', 'geoPoint': {'lat': 39.62847, 'lon': 22.42112}}], 'overallOfficials': [{'name': 'Konstantinos Tepetes, MD, PHD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital of Larisa and Medical School, University of Thessaly'}, {'name': 'Georgios D Koukoulis, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'General Hospital of Larissa'}, {'name': 'Konstantinos Mpouliaris, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'General Hospital of Larissa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Georgios Koukoulis', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Thessaly', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'General Surgery Consultant', 'investigatorFullName': 'Georgios Koukoulis', 'investigatorAffiliation': 'General Hospital of Larissa'}}}}