Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT03344120
Status:
COMPLETED
Last Update Posted:
2020-12-30
First Post:
2017-11-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Symptoms Comparison: Suture-stent vs Conventional Double-J Stents After Ureterorenoscopy. A Prospective Randomized Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D014514', 'term': 'Ureteral Calculi'}], 'ancestors': [{'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-12-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-28', 'studyFirstSubmitDate': '2017-11-11', 'studyFirstSubmitQcDate': '2017-11-11', 'lastUpdatePostDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urinary Symptom Index Score', 'timeFrame': '14 days', 'description': 'to compare Urinary Symptom Index Score (sum of USSQ Urinary symptoms scores) of suture stent and double J group, 2 weeks after surgery.'}], 'secondaryOutcomes': [{'measure': "USSQ domains' scores", 'timeFrame': '14 days', 'description': "to compare USSQ domains' scores of suture stent and double J group, 2 weeks after surgery"}, {'measure': "USSQ domains' scores", 'timeFrame': '2 days', 'description': "to compare USSQ domains' scores of suture stent and double J group, 2 days after surgery"}, {'measure': 'USSQ single answers', 'timeFrame': '14 day', 'description': 'to compare USSQ single answers of suture stent and double J group, 2 weeks after surgery'}, {'measure': 'USSQ single answers', 'timeFrame': '2 days', 'description': 'to compare USSQ single answers of suture stent and double J group, 2 days after surgery'}, {'measure': "2 weeks USSQ domains' subscores adjusted for baseline", 'timeFrame': '6 weeks', 'description': "to compare 2 weeks USSQ domains' subscores adjusted for baseline of suture stent and double J group"}, {'measure': 'complications and adverse events', 'timeFrame': '2 weeks', 'description': 'to compare complications and adverse events of suture stent and double J group'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Symptoms and Signs', 'Pain', 'Ureteral Calculi', 'Ureteroscopy', 'Ureteral Stents'], 'conditions': ['Symptoms and Signs', 'Pain', 'Ureteral Calculi']}, 'referencesModule': {'references': [{'pmid': '34337527', 'type': 'DERIVED', 'citation': 'Bosio A, Alessandria E, Agosti S, Vitiello F, Vercelli E, Bisconti A, Piana P, Fop F, Gontero P. Pigtail Suture Stents Significantly Reduce Stent-related Symptoms Compared to Conventional Double J Stents: A Prospective Randomized Trial. Eur Urol Open Sci. 2021 May 10;29:1-9. doi: 10.1016/j.euros.2021.03.011. eCollection 2021 Jul.'}]}, 'descriptionModule': {'briefSummary': "Double J ureteral stents (DJ) are widely used in urological practice and commonly inserted after most of ureteroscopies. Stent-related symptoms (SRS) represent a major issue. Many research lines have been explored with the aim of decreasing SRS: Vogt et al. projected a self-made pigtail suture stent (PSS) replacing the distal pigtail with a 0.3 Fr suture reaching the bladder, showing decreased SRS and good tolerance. To date, these promising results hasn't been confirmed by a prospective randomized controlled trial (RCT) involving a marketed PSS. Thus, we designed a prospective single-blind RCT to compare SRS caused by marketed PSS and conventional DJ after uncomplicated URS for stone treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ureteral or renal stones \\< 2 cm needing treatment through semirigid or flexible URS and laser lithotripsy\n* stone-free procedure and absence of intraprocedural complications\n* WHO performance status 0-2\n\nExclusion Criteria:\n\n* significant residual fragments at the end of the procedure\n* intraprocedural complications (e.g. ureteral damage or stricture)\n* indwelling double J stent\n* acute kidney failure\n* urinary tract infection\n* urinary tract abnormalities\n* pathologies or medications potentially influencing voiding pattern and pain perception'}, 'identificationModule': {'nctId': 'NCT03344120', 'briefTitle': 'Symptoms Comparison: Suture-stent vs Conventional Double-J Stents After Ureterorenoscopy. A Prospective Randomized Trial', 'organization': {'class': 'OTHER', 'fullName': 'A.O.U. Città della Salute e della Scienza'}, 'officialTitle': 'Comparison Between Symptomps Related to Pigtail Suture Stent Versus Conventional Double J After Ureterorenoscopy for Stone Treatment. A Prospective Randomized Trial', 'orgStudyIdInfo': {'id': 'AOUCSSTURAB004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'suture stent', 'description': 'suture stent positioning after ureteroscopy. Intervention: administration of USSQ questionnaire.', 'interventionNames': ['Other: Administration of USSQ Symptoms questionnaire after stent positioning']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional double-J stent', 'description': 'conventional double-J stent positioning after ureteroscopy. Intervention: administration of USSQ questionnaire.', 'interventionNames': ['Other: Administration of USSQ Symptoms questionnaire after stent positioning']}], 'interventions': [{'name': 'Administration of USSQ Symptoms questionnaire after stent positioning', 'type': 'OTHER', 'description': 'Administration of USSQ Symptoms questionnaire to patients with two different type of stents after ureteroscopy', 'armGroupLabels': ['conventional double-J stent', 'suture stent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10126', 'city': 'Turin', 'country': 'Italy', 'facility': 'AOU Città della Salute e della Scienza', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}], 'overallOfficials': [{'name': 'Andrea Bosio', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'A.O.U. Città della Salute e della Scienza'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'A.O.U. Città della Salute e della Scienza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD Urologist, PhD', 'investigatorFullName': 'Andrea Bosio', 'investigatorAffiliation': 'A.O.U. Città della Salute e della Scienza'}}}}