Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT06830902
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-19
First Post:
2025-02-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Stent-Related Symptoms: Regular Double J Stent vs. Comfi J Stent
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single Blind, Randomised controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-18', 'studyFirstSubmitDate': '2025-02-12', 'studyFirstSubmitQcDate': '2025-02-12', 'lastUpdatePostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stent related symptom', 'timeFrame': '2 weeks', 'description': 'Comparison of Ureteral Stent Symptom Questionnaire (USSQ) scores between regular Double J stent and Comfi J stent at postoperative day 1, 7, and 14. Higher Scores means greater severity of the symptoms.'}], 'secondaryOutcomes': [{'measure': 'Complication rates', 'timeFrame': 'before 2 weeks', 'description': 'Incidence of stent-related complications such as fever, stent migration, expulsion, or readmission. Early removal of stent due to stent related symptoms.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stent Related Symptoms']}, 'descriptionModule': {'briefSummary': 'A prospective, single-blinded, randomized controlled trial conducted at a single center to compare stent related symptoms between two different stents using Ureteral Stent Symptom Questionnaire (USSQ) scores , Visual Analog Scale (VAS) pain scores.', 'detailedDescription': 'Ureteral stents are widely used in urology following retrograde intrarenal surgeries and ureteric lithotripsy and other endourological procedures. However, their use is associated with significant discomfort, infections, and reduced quality of life (QoL). Over time, different materials and designs have been developed to improve stent performance and reduce complications. This study aims to compare the stent-related symptoms (SRS) of two types of ureteral stents: the regular Double J stent and the Comfi J stent.\n\nObjectives of the study-\n\n1. Compare Ureteral Stent Symptom Questionnaire (USSQ) scores between the two stents.\n2. Compare Visual Analog Scale (VAS) pain scores.\n3. Assess complications associated with each stent.\n4. Evaluate the difficulty of stent insertion.\n\nStudy Design \\& Methods: A prospective, single-blinded, randomized controlled trial conducted at a single center. Sample Size: 100 patients undergoing retrograde intrarenal surgery, ureteroscopic lithotripsy\n\nRandomization: Intraoperative, using a computer-generated sequence, block randomization Assessments: USSQ and VAS scores at post-operative days (POD) 1, 7, and 14.\n\nStatistical Analysis: Statistical Package for the Social Sciences software with a significance threshold of p \\< 0.05.\n\nExpected Outcomes: Determining whether the Comfi J stent reduces pain, urinary symptoms, and other complications compared to the regular Double J stent.\n\nEvaluating if changes in design/material can improve patient QoL.\n\nEthical Considerations:\n\nInstitutional ethics approval and informed consent from all participants. Confidentiality ensured, with voluntary participation.\n\nThis study aims to provide evidence-based recommendations for improving ureteral stent tolerability and reducing patient morbidity'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible participants were adult patients (aged 18-80 years) who underwent unilateral retrograde ureteroscopy (URS) lithotripsy for stone disease\n* Retrograde intrarenal surgery (RIRS) lithotripsy with planned ureteric stent insertion for urinary tract stones\n\nExclusion Criteria:\n\n* Concomitant use of a-blockers, anticholinergics, corticosteroids, calcium channel blockers, and analgesics\n* Undergoing percutaneous nephrolithotomy, open ureteric surgery or laparoscopic ureteric surgery, including ureterolithotomy\n* Neurogenic bladder, Overactive bladder syndrome, and neurological and psychiatric diseases\n* Preoperative febrile Urinary Tract Infection (UTI)\n* Pregnancy or breastfeeding;\n* A single kidney\n* Moderate or severe cardiovascular or cerebrovascular disease\n* Hepatic dysfunction\n* History of pelvic surgery or irradiation\n* History of bladder or prostate surgery\n* Other acute medical conditions (including acute pancreatitis, acute gastroenteritis, musculoskeletal disorders) that might influence the USSQ pain score\n* Allergy to any medication'}, 'identificationModule': {'nctId': 'NCT06830902', 'acronym': 'COMFIJ', 'briefTitle': 'Comparison of Stent-Related Symptoms: Regular Double J Stent vs. Comfi J Stent', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bir Hospital'}, 'officialTitle': 'Comparison of Stent Related Symptoms Between Regular Double J Stent Versus Comfi J Stent: A Single Blinded Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'ComfiJ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Regular Double J stent', 'description': 'Regular Double J stent placement', 'interventionNames': ['Device: Regular Double J stent']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comfi J stent', 'description': 'Comfi J stent placement', 'interventionNames': ['Device: Comfi J stent']}], 'interventions': [{'name': 'Regular Double J stent', 'type': 'DEVICE', 'description': 'Regular Double J stent', 'armGroupLabels': ['Regular Double J stent']}, {'name': 'Comfi J stent', 'type': 'DEVICE', 'description': 'Comfi J stent', 'armGroupLabels': ['Comfi J stent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44600', 'city': 'Kathmandu', 'state': 'Bagmati', 'country': 'Nepal', 'contacts': [{'name': 'Anil Shrestha, M Ch Urology', 'role': 'CONTACT', 'email': 'anyl77@hotmail.com', 'phone': '009779851092274'}, {'name': 'Udita Mishra, M Ch Urology', 'role': 'CONTACT', 'email': 'uditamishra2014@gmail.com', 'phone': '009779841389895'}], 'facility': 'Bir Hospital', 'geoPoint': {'lat': 27.70169, 'lon': 85.3206}}], 'centralContacts': [{'name': 'Anil Shrestha, M Ch Urology', 'role': 'CONTACT', 'email': 'anyl77@hotmail.com', 'phone': '009779851092274'}, {'name': 'Udita Mishra, M Ch Urology', 'role': 'CONTACT', 'email': 'uditamishra2014@gmail.com', 'phone': '009779841389895'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bir Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Nepal Health Research Council', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Dr.', 'investigatorFullName': 'Anil Shrestha', 'investigatorAffiliation': 'Bir Hospital'}}}}