Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:31 AM
Study NCT ID:
NCT07415993
Status:
COMPLETED
Last Update Posted:
2026-02-17
First Post:
2026-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Randomized Trial Comparing the Effects of Anti-reflux Versus Standard Ureteral Stents on Male Sexual Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-10', 'studyFirstSubmitDate': '2026-02-10', 'studyFirstSubmitQcDate': '2026-02-10', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in IIEF score', 'timeFrame': 'Patients were followed up postoperatively according to a bi-weekly schedule, with clinical assessments at 2, 4, 6, and 8 weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anti-reflux Ureteral Stents', 'Standard Double J Tubes', 'ED', 'LUTS', 'IIEF'], 'conditions': ['Male Sexual Function']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '1.Sorokin I, Mamoulakis C, Miyazawa K, Rodgers A, Talati J, Lotan Y. Epidemiology of stone disease across the world. World J Urol. 2017;35(9):1301-1320. doi:10.1007/s00345-017-2008-6. 2.Arora A, Sane MS, Jadhao V, Maheshwari PN. Sexual dysfunction in Indian men undergoing Double J ureteral stenting following ureteroscopy-A prospective analysis. Andrologia. 2020;52(10):e13790. doi:10.1111/and.13790. 3.Mawhorter M, Streeper NM. Advances in ureteral stent technology. Curr Opin Urol. 2022;32(4):415-419. doi:10.1097/MOU.0000000000001003. 4.Chew BH, Lange D. Advances in ureteral stent development. Curr Opin Urol. 2016;26(3):277-282. doi:10.1097/MOU.0000000000000275. 5.CONSORT 2025 statement: updated guideline for reporting randomised trials. BMJ. 2025;389:e081123. Published 2025 Apr 14. doi:10.1136/bmj-2024-081123. 6.Arena S, Iacona R, Impellizzeri P, et al. Physiopathology of vesico-ureteral reflux. Ital J Pediatr. 2016;42(1):103. Published 2016 Nov 29. doi:10.1186/s13052-016-0316-x. 7.Zhang L, Wu Y, Chen Y, et al. Triangular prismatic JJ stent does not cause more discomfort than tubular ones: a randomised controlled trial comparison. World J Urol. 2024;42(1):67. Published 2024 Feb 3. doi:10.1007/s00345-023-04758-5. 8.Wen KC, Li ZA, Liu JH, Zhang C, Zhang F, Li FQ. Recent developments in ureteral stent: Substrate material, coating polymer and technology, therapeutic function. Colloids Surf B Biointerfaces. 2024;238:113916. doi:10.1016/j.colsurfb.2024.113916. 9.Hatzimouratidis K, Amar E, Eardley I, et al. Guidelines on male sexual dysfunction: erectile dysfunction and premature ejaculation. Eur Urol. 2010;57(5):804-814. doi:10.1016/j.eururo.2010.02.020. 10.De Nunzio C, Roehrborn CG, Andersson KE, McVary KT. Erectile Dysfunction and Lower Urinary Tract Symptoms. Eur Urol Focus. 2017;3(4-5):352-363. doi:10.1016/j.euf.2017.11.004.2024;383(6683):eade8064. doi:10.1126/sci'}, {'pmid': '41723278', 'type': 'DERIVED', 'citation': 'Xu L, Gao Z, Wang R, Sun Z, Gu L, Liu H. A prospective randomized trial comparing the effects of anti-reflux versus standard ureteral stents on male sexual function. Sci Rep. 2026 Feb 21. doi: 10.1038/s41598-026-41187-x. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': "Objective: To compare the effectiveness of anti-reflux ureteral stents on improving erectile function and quality of life of patients with ureteral stents.\n\nMethods and Populations: A total of 100 male patients who required ureteral stent placement after ureteroscopic lithotripsy were randomly assigned to two groups: those in Group T (n=50) received a standard double-J-stent, while those in Group A (n=50) underwent implantation with anti-reflux ureteral stent. Follow up for 8 weeks after surgery, including reproductive hormones and inflammation marks, Beck's depression scale, IIEF and statistics on the frequency of symptoms such as hematuria."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male sexually active patients with unilateral ureteral calculi who underwent ureteroscopy with laser lithotripsy and needed post-procedure stent\n\nExclusion Criteria:\n\n* Patients were excluded if they included the following criteria: (1) age under 18 or over 50 years, (2) history of previous ureteral stenting, (3) bilateral stents, (4) moderate or severe ureteral stricture need long-term stenting (on regular exchange), (5) bladder pathology and overactive bladder, (6) symptomatic benign prostatic hyperplasia, (7) moderate or severe urinary tract infection, (8) moderate or severe cardiovascular disease, hepatic dysfunction and diabetes, (9) previous use of selective alpha-1-blocker and/or antimuscarinic agent, (10) pre-op IIEF-5 ≤ 21.'}, 'identificationModule': {'nctId': 'NCT07415993', 'briefTitle': 'A Prospective Randomized Trial Comparing the Effects of Anti-reflux Versus Standard Ureteral Stents on Male Sexual Function', 'organization': {'class': 'OTHER', 'fullName': "Zhangjiagang First People's Hospital"}, 'officialTitle': 'A Prospective Randomized Trial Comparing the Effects of Anti-reflux Versus Standard Ureteral Stents on Male Sexual Function', 'orgStudyIdInfo': {'id': 'Zhangjiagang First Hospital'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'anti-reflux ureteral stent(INNOVEX, Shanghai, China)', 'interventionNames': ['Procedure: Routine laser lithotripsy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group-T', 'description': 'standard double-J-stent', 'interventionNames': ['Procedure: Routine laser lithotripsy']}], 'interventions': [{'name': 'Routine laser lithotripsy', 'type': 'PROCEDURE', 'description': "Routine laser lithotripsy was done for the ureteral calculi, and a 6 Fr polyurethane DJ stent (Inlay Optima®, Bard Medical, Covington, GA) or INNOVEX, according to the groups, was inserted under fluoroscopic and cystoscopic guidance. Appropriate length was adjusted according to patient's height. Routine X-ray of the kidneys, ureter and bladder (KUB) was taken for all patients before home discharge to confirm the proper stent positioning. All patients are advised to avoid alcohol, until 4 weeks after surgery when the ureteral stent is removed in our institution.\n\nGeneral information such as preoperative age, body mass index, diameter of ureteral calculi, and degree of hydronephrosis, operation time were obtained. Follow up for 8 weeks after surgery, including reproductive hormones and inflammation marks, Beck's depression scale, IIEF and statistics on the frequency of symptoms such as hematuria.", 'armGroupLabels': ['Group A', 'Group-T']}]}, 'contactsLocationsModule': {'locations': [{'zip': '213000', 'city': 'Changzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Jintan Affiliated Hospital of Jiangsu University', 'geoPoint': {'lat': 31.77359, 'lon': 119.95401}}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'timeFrame': 'Beginning 3 months and ending 3 years after the publication of results', 'ipdSharing': 'YES', 'description': 'The data that support the findings of this study are available from the corresponding author upon reasonable request.', 'accessCriteria': 'The data that support the findings of this study are available from the corresponding author upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rong Wang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief Physician', 'investigatorFullName': 'Rong Wang', 'investigatorAffiliation': "Zhangjiagang First People's Hospital"}}}}