Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT04550559
Status:
COMPLETED
Last Update Posted:
2020-09-16
First Post:
2020-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rate of Spontaneous Stone Passage as Assessed Using Urinary Ultrasonography and Direct Urinary System Radiography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014514', 'term': 'Ureteral Calculi'}, {'id': 'D008418', 'term': 'Masturbation'}], 'ancestors': [{'id': 'D053039', 'term': 'Ureterolithiasis'}, {'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': 'D014545', 'term': 'Urinary Calculi'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 149}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-15', 'studyFirstSubmitDate': '2020-09-01', 'studyFirstSubmitQcDate': '2020-09-15', 'lastUpdatePostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rates of spontaneous distal ureteral stone (5-10 mm size) passage after 4 weeks masturbation', 'timeFrame': '4 weeks', 'description': 'The rates of spontaneous distal ureteral stone (5-10 mm size) passage of patients who were instructed to masturbate at least 3-4 times a week (Group1); received tamsulosin 0.4 mg/day (Group2); received standard medical therapy alone Group3.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ureteral Calculi', 'Masturbation']}, 'descriptionModule': {'briefSummary': 'To evaluate the effect of masturbation on the spontaneous expulsion of distal ureteral stones 5-10 mm in size.', 'detailedDescription': 'This prospective randomized controlled study was performed between February 2018 and March 2020 after obtaining ethics committee approval.A total of 128 men with distal ureteral stones were randomly divided into 3 groups. All patients received standard medical therapy. Patients in group 1 (n=43) were instructed to masturbate at least 3-4 times a week, patients in group 2 (n=41) received tamsulosin 0.4 mg/day, and patients in group 3 (controls, n=44) received standard medical therapy alone. Rates of expulsion, need for analgesic, and ureterorenoscopic lithotripsy were compared between the groups.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥18 years\n* presenting with renal colic and inguinal or lumbar pain\n* being diagnosed as having distal ureteral stones ≥5 mm and \\<10 mm in size\n\nExclusion Criteria:\n\n* age \\<18 years,\n* stones \\<5 mm or ≥10 mm in size,\n* intermediate (stones on the ureter-iliac artery cross)\n* proximal ureteral stones, multiple ureteral stones,\n* presence of urinary infection,\n* renal insufficiency,\n* high creatinine level,\n* severe hydroureteronephrosis,\n* history of open or endoscopic ureteral surgery,\n* vesicoureteral reflux,\n* neurogenic bladder,\n* erectile dysfunction,\n* inability or refusal to masturbate for any reason (such as religious beliefs)'}, 'identificationModule': {'nctId': 'NCT04550559', 'briefTitle': 'Rate of Spontaneous Stone Passage as Assessed Using Urinary Ultrasonography and Direct Urinary System Radiography', 'organization': {'class': 'OTHER', 'fullName': 'Avrasya University'}, 'officialTitle': 'Evaluation of the Effect of Masturbation on Distal Ureteral Stones: A Prospective Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'masturbation and stone'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': 'The patients in group 1 were instructed to masturbate at least 3-4 times a week', 'interventionNames': ['Procedure: Endoscopic ureterolitotripsy']}, {'type': 'OTHER', 'label': 'Group 2', 'description': 'The patients in group 2 were prescribed oral tamsulosin 0.4 mg once daily', 'interventionNames': ['Procedure: Endoscopic ureterolitotripsy']}, {'type': 'NO_INTERVENTION', 'label': 'Group 3', 'description': 'The patients in group 3 acted as controls and received only standard medical therapy'}], 'interventions': [{'name': 'Endoscopic ureterolitotripsy', 'type': 'PROCEDURE', 'description': 'Endoscopic ureterolithotripsy', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61000', 'city': 'Trabzon', 'country': 'Turkey (Türkiye)', 'facility': 'Hasan Turgut', 'geoPoint': {'lat': 41.005, 'lon': 39.72694}}], 'overallOfficials': [{'name': 'Hasan Turgut, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Avrasya University Health Science Faculty'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Avrasya University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'urolog dr ,Principal Investigator', 'investigatorFullName': 'Hasan Turgut', 'investigatorAffiliation': 'Avrasya University'}}}}