Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2025-12-25 @ 7:25 PM
Study NCT ID:
NCT05789732
Status:
COMPLETED
Last Update Posted:
2023-03-31
First Post:
2023-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Silodosin, Tadalafil Alone vs. Silodosin Plus Tadalafil as MET for Lower Ureteric Stones
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C095285', 'term': 'silodosin'}, {'id': 'D000068581', 'term': 'Tadalafil'}], 'ancestors': [{'id': 'D002243', 'term': 'Carbolines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 168}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-29', 'studyFirstSubmitDate': '2023-03-16', 'studyFirstSubmitQcDate': '2023-03-16', 'lastUpdatePostDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stone expulsion rate', 'timeFrame': 'Intraoperatively', 'description': 'Stone expulsion rate will be recorded'}], 'secondaryOutcomes': [{'measure': 'Stone expulsion time', 'timeFrame': 'Intraoperatively', 'description': 'Stone expulsion time will be recorded'}, {'measure': 'Amount of analgesia used', 'timeFrame': 'Intraoperatively', 'description': 'The amount of analgesia used will be recorded'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lower Ureteric Stones', 'Medical Expulsive Therapy', 'Tadalafil', 'Silodosin']}, 'descriptionModule': {'briefSummary': 'This study will compare the efficacy of silodosin, tadalafil versus silodosin plus tadalafil as Medical Expulsive Therapy (MET) for lower ureteric stones.', 'detailedDescription': 'The global incidence of urolithiasis, a disease with a high recurrence rate, is increasing. Urolithiasis is one of the most common disorders of the urinary tract with a lifetime prevalence of up to 15% with men affected three times more than women.\n\nUrolithiasis causes recurrent stone formers to experience a decline in quality of life, and there is an increasing socioeconomic burden associated with the management of urolithiasis. Improved quality of life may also have increased its prevalence. A significant proportion, about 1/5th of urinary tract stones, is found in the ureter, of which 2/3rd is seen in the distal ureter. Initially, a colicky pain of various grades presents with ureteric stone. It is one of the most common problems that compel a patient to an emergency room.\n\nMethods to manage ureteral stones include conservative treatment, pharmacological treatment (e.g., medical expulsive therapy), shock wave lithotripsy, and surgical treatment. Thus, urologists must select the appropriate treatment for each patient (i.e., non-surgical or surgical). Today, medical expulsive therapy has become the most used modality of treatment for urolithiasis. During this treatment, the ureter smooth muscle is treated via various drugs by different mechanisms.\n\nBlocking alpha-(α-) 1 adrenergic receptor, especially in the distal third decreases basal smooth muscle contraction and causes propulsive antegrade peristalsis helping stone expulsion. By increasing the intraureteral pressure gradient around the stone, alpha-1 adrenergic receptor antagonists eject distal ureteral stones.\n\nSignificant pathological changes can occur when ureteric stones are impacted. +is can cause an inflammatory reaction with mucosal edema which could further worsen the ureteric obstruction, increasing the risk of impaction and retention. However, selective alpha-1 blockers, such as tamsulosin and silodosin, have been the treatment of choice, with proven efficacy in multiple clinical trials. Silodosin is a more selective α-1A adrenoceptor blocker with a better stone expulsion rate than tamsulosin.\n\nRecently, a newer Phosphodiesterase type 5 inhibitor, tadalafil, has shown action on the nitric oxide-cyclic guanosine monophosphate signaling pathway of smooth muscles, resulting in increased levels of cyclic guanosine monophosphate, causing ureteric relaxation.\n\nDue to its smooth muscle relaxation mechanism, tadalafil has received US Food and Drug Administration approval to treat many urinary tract diseases. Therefore, the combination of silodosin and tadalafil drugs is aimed to facilitate stone passage by better ureteric relaxation and reducing intramural ureter pressure. Although there have been few similar studies using various combinations, comparing the efficacy of silodosin and tadalafil vs. silodosin are very few, and these studies have taken longer duration of treatment (4 to 6 weeks) which might have affected the outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 168 patients aged \\>18 years old.\n* Both sexes.\n* Diagnosed with lower ureteric stone from 5mm to 10mm in size.\n\nExclusion Criteria:\n\n* Patients with multiple or bilateral ureteric stones\n* single kidney or impairment of renal function\n* Urinary tract infection (UTI)\n* Marked hydronephrosis\n* Patients presenting with severe intractable pain and requiring emergency intervention\n* Any urologic anomalies or history of ureteral surgery\n* Pregnancy\n* Pediatric populations\n* Ischemic heart disease\n* Congestive cardiac failure\n* Complicated hypertension\n* Patients on concomitant treatment with nitrates or calcium channel blockers.'}, 'identificationModule': {'nctId': 'NCT05789732', 'briefTitle': 'Silodosin, Tadalafil Alone vs. Silodosin Plus Tadalafil as MET for Lower Ureteric Stones', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Efficacy of Silodosin, Tadalafil Alone Versus Silodosin Plus Tadalafil as Medical Expulsive Therapy for Lower Ureteric Stones: A Prospective Randomized Placebo Controlled Study', 'orgStudyIdInfo': {'id': 'Rc 22-3-2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Patients in this group will receive placebo treatment once daily.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Silodosin group', 'description': 'Patients will receive Silodosin 8 mg once daily.', 'interventionNames': ['Drug: Silodosin']}, {'type': 'EXPERIMENTAL', 'label': 'Tadalafil group', 'description': 'Patients will receive Tadalafil 5 mg once daily.', 'interventionNames': ['Drug: Tadalafil']}, {'type': 'EXPERIMENTAL', 'label': 'Silodosin and Tadalafil', 'description': 'Patients will receive Silodosin 8mg in combination with Tadalafil 5 mg once daily.', 'interventionNames': ['Drug: Silodosin and Tadalafil']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Patients will receive placebo treatment once daily.', 'armGroupLabels': ['Placebo group']}, {'name': 'Silodosin', 'type': 'DRUG', 'description': 'Patients will receive Silodosin 8 mg once daily.', 'armGroupLabels': ['Silodosin group']}, {'name': 'Tadalafil', 'type': 'DRUG', 'description': 'Patients will receive Tadalafil 5 mg once daily.', 'armGroupLabels': ['Tadalafil group']}, {'name': 'Silodosin and Tadalafil', 'type': 'DRUG', 'description': 'Patients will receive Silodosin 8mg in combination with Tadalafil 5 mg once daily.', 'armGroupLabels': ['Silodosin and Tadalafil']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Banhā', 'country': 'Egypt', 'facility': 'Benha University Hospitals', 'geoPoint': {'lat': 30.45977, 'lon': 31.1842}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'One year after the end of the study', 'ipdSharing': 'YES', 'description': 'The study will be available under a reasonable request of the corresponding author'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Urology, Faculty of Medicine, Benha University, Benha, Egypt', 'investigatorFullName': 'Tamer Abd El-Wahab Diab', 'investigatorAffiliation': 'Benha University'}}}}