Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-31 @ 4:04 AM
Study NCT ID:
NCT06955533
Status:
COMPLETED
Last Update Posted:
2025-05-02
First Post:
2025-04-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Dose Versus Double Dose Tamsulosin 0.4 and Solifenacin 5 in Management of Stent Related Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069464', 'term': 'Solifenacin Succinate'}, {'id': 'D000077409', 'term': 'Tamsulosin'}], 'ancestors': [{'id': 'D011812', 'term': 'Quinuclidines'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D044005', 'term': 'Tetrahydroisoquinolines'}, {'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-25', 'studyFirstSubmitDate': '2025-04-25', 'studyFirstSubmitQcDate': '2025-04-25', 'lastUpdatePostDateStruct': {'date': '2025-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement of ussq', 'timeFrame': '2 weeks', 'description': 'This is a pilot study aiming to evaluate the effectiveness of Double dose versus standard dose of tamsulosin with solifenacin in relieving stent related symptoms.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stent Related Symptoms']}, 'descriptionModule': {'briefSummary': 'This study was a randomized clinical trial conducted on 64 Egyptian patients from the outpatient clinic at Ain Shams University Hospital over a six-month period from 3/2024 to 9/2024.The study population was randomized into 2 groups. Group A included 32 patients with stent related symptoms receiving double doses of tamsulosin (Tamsulin® 0.4 mg 2 capsules taken together per day) and Solifenacin 10mg (Sofenacin® 10mg tab taken once daily).Group B included 32 patients with stent related symptoms receiving a standard dose of tamsulosin (0.4 mg once daily) and solifenacin (5 mg once daily).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- We included patients older than18 years of age, with presence of a double-J (DJ) stent in place, suffering from lower urinary tract symptoms (LUTS).Patients younger than 18 years of age, patients with a history of prostate or bladder surgery, lower urinary tract procedures, cancer, neurological conditions, pelvic radiation, diabetes, kidney dysfunction (acute or chronic), a solitary kidney, congenital urinary anomalies, or those taking medications such as α-blockers, beta-blockers, calcium channel blockers, 5-alpha reductase inhibitors, PDE5 inhibitors, anticholinergics, or nitrates were excluded. Additionally, patients with cardiac issues, residual stone fragments after surgery, multiple or bilateral ureteral stones, long-term or bilateral stents requiring frequent changes, interstitial cystitis, chronic cystitis, prostatitis, pregnant or breastfeeding women, and those unavailable for follow-up were also excluded from the study.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06955533', 'briefTitle': 'Single Dose Versus Double Dose Tamsulosin 0.4 and Solifenacin 5 in Management of Stent Related Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Single Dose Versus Double Dose Tamsulosin 0.4 and Solifenacin 5 in Management of Stent Related Symptoms', 'orgStudyIdInfo': {'id': 'FMASU MS23/ 2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Double dose tamsulosin ans solifenacin', 'interventionNames': ['Drug: Double dose tamsulosin and solifenacin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Single dose tamsulosin and solifenacin', 'interventionNames': ['Drug: Single dose tamsulosin and solifenacin']}], 'interventions': [{'name': 'Double dose tamsulosin and solifenacin', 'type': 'DRUG', 'description': 'Odd number', 'armGroupLabels': ['Double dose tamsulosin ans solifenacin']}, {'name': 'Single dose tamsulosin and solifenacin', 'type': 'DRUG', 'description': 'Even number', 'armGroupLabels': ['Single dose tamsulosin and solifenacin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain shams university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'H arafa', 'investigatorFullName': 'Hisham Arafa', 'investigatorAffiliation': 'Ain Shams University'}}}}