Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2026-02-20 @ 6:05 PM
Study NCT ID:
NCT04602403
Status:
UNKNOWN
Last Update Posted:
2020-10-26
First Post:
2020-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Tamsulosin Facilitate Semi-rigid Ureteroscopic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053039', 'term': 'Ureterolithiasis'}], 'ancestors': [{'id': 'D014515', 'term': 'Ureteral 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': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2021-10-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-20', 'studyFirstSubmitDate': '2020-10-15', 'studyFirstSubmitQcDate': '2020-10-20', 'lastUpdatePostDateStruct': {'date': '2020-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of patients develop spontaneous expulsion of stone', 'timeFrame': 'up to 3 weeks pre operative', 'description': 'the stone spontaneously expelled without intervension'}, {'measure': 'Number of patients showing dilated ureteric orifice', 'timeFrame': 'intraoperative', 'description': 'during ureteroscopy easy introduction in the ureter'}, {'measure': 'Number of patients need dilatation below stone', 'timeFrame': 'intraoperative', 'description': 'difficult introduce the ureteroscope and reach the stone'}, {'measure': 'Number of patients need dormia extraction or forceps without disintegration', 'timeFrame': 'intraoperative', 'description': 'that is due to dilated ureter so easy remove the stone'}, {'measure': 'Time of operation from introduction of ureteroscope until stone extraction', 'timeFrame': 'intraoperative', 'description': 'to know how easy introduction and expulsion of the ureteroscope'}], 'secondaryOutcomes': [{'measure': 'Rate of patients developed side effect from tamsulosin', 'timeFrame': 'up to 3 weeks pre operative', 'description': 'any side effect from alpha blocker'}, {'measure': 'Rate of patients developed complication', 'timeFrame': 'intraoperative', 'description': 'any compliction during ureteroscopy such as perforation'}, {'measure': 'Number of patients show failure of ureteroscopy', 'timeFrame': 'intraoperative', 'description': 'failed introduction or extraction of stone'}, {'measure': 'Number of patients show residual stone post ureteroscopy', 'timeFrame': 'postoperative 4 weeks', 'description': 'difficulty in expulsion of all stones'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ureter Stone']}, 'descriptionModule': {'briefSummary': 'Ureteric calculi are one of the most common reasons for frequent Urolithiasis. The estimated prevalence is 8-13% of all calculi.\n\nMedical expulsive therapy (MET) is recommended by the European Association of Urology (EAU) (2013) for 5-10 mm ureteric stones to facilitate stone passage. For MET, alpha blockers, mainly tamsulosin, have shown efficacy in several randomized controlled trials. The underlying pathophysiology of this therapy is supported by the presence and distribution of adrenoreceptors in the ureter. Blocking the action of alpha-1 receptors by pharmacological agents (alpha blockers), such as alfuzosin, terazosin, doxazosin, and, most typically, tamsulosin, results in the relaxation of the ureteric smooth muscle.\n\nUreteroscopy (URS) is the most commonly performed procedure for the treatment of ureteral calculi, with a high (\\>90%) stone-free rate after a single treatment. Advancing a rigid ureteroscope into a non-dilated ureter may be difficult and cause complications. Ureteric dilatation may provide access to stones, but not in all cases, and ureteral mucosal injury up to perforation might occur.', 'detailedDescription': 'Based on the role of alpha blockers, mainly tamsulosin, in MET of ureteric calculus, the investigator will attempt to extend the use of alpha blockers prior to URS for procedural ease. the investigator will conduct a prospective, randomized double-blind study to evaluate whether alpha blockers facilitate the negotiation of the ureteroscope if administered preoperatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Lower ureteral stone.\n* Age: 18 - 75 years.\n* normal renal function.\n* single sided ureteral stone with normal other kideny.\n* sign the informed consent.\n* Be willing/able to adhere to follow up visits.\n\nExclusion Criteria:\n\n* Upper and middle ureteral stones.\n* renal impairment.\n* Age \\< 18 years or 75 \\< years.\n* female who were pregnant\n* bilateral ureteric stone or solitary kidney.\n* urinary tract infection need drainage.'}, 'identificationModule': {'nctId': 'NCT04602403', 'briefTitle': 'Does Tamsulosin Facilitate Semi-rigid Ureteroscopic', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Does Preoperative Tamsulosin Facilitate Semi-rigid Ureteroscopic Management of Lower Ureteric Calculi Prospective, Randomized Double Blind Study', 'orgStudyIdInfo': {'id': 'tamsulosin and uretroscopy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo group', 'description': 'people who given placebo to become agroup of comparison with the other group', 'interventionNames': ['Procedure: rigid ureteroscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'tamsulosin group', 'description': 'people who given tamsulosin to know the effect on ureteroscopy and compare with the control group', 'interventionNames': ['Procedure: rigid ureteroscopy']}], 'interventions': [{'name': 'rigid ureteroscopy', 'type': 'PROCEDURE', 'otherNames': ['endoscopic treatment of ureteric stone'], 'description': 'endoscopic treatment of ureteric stones by extraction or peumatic desintegration or laser', 'armGroupLabels': ['placebo group', 'tamsulosin group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71511', 'city': 'Asyut', 'state': 'Asyut Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'mahmoud a gaber, ph', 'role': 'CONTACT', 'email': 'aboshika52@gmail.com', 'phone': '+201129248656'}], 'facility': 'Mahmoud Ahmed Gaber', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'mahmoud a gaber', 'role': 'CONTACT', 'email': 'aboshika52@gmail.com', 'phone': '+201129248656'}], 'overallOfficials': [{'name': 'ahmed m abdel hamed', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer', 'investigatorFullName': 'Mahmoud Ahmed Gaber', 'investigatorAffiliation': 'Assiut University'}}}}