Clinical trial

The Use of Selective Alpha Blockers (Silodosin) in Management of Lower Ureteral Stones Larger Than 6 mm in Diameter

Name
No 475
Description
This research aims to study the effectiveness of silodosin in the management of lower ureter stones larger than 6 mm in diameter in terms of affected ureter (right or left), the size of the stone, the degree of hydronephrosis, the rate of stone expulsion(day), whether the stone was completely expelled or not, and the side effects of silodosin.
Trial arms
Trial start
2022-10-20
Estimated PCD
2023-10-20
Trial end
2023-10-25
Status
Completed
Phase
Early phase I
Treatment
Silodosin
Selective Alpha Blocker drug
Arms:
case group
Size
100
Primary endpoint
Stone expulsion (yes)
1 year
Stone expulsion (no)
1 year
Eligibility criteria
Inclusion Criteria: * Patients attending the urology Clinic with a distal unilateral ureteral stone larger than 6 mm in diameter. Exclusion Criteria: * Patients under 18 years of age * Pregnant women * Patients with whom we were unable to contact * Patients treated with silodosin for another reason * Single kidney patients * Patients with bilateral ureter stones * Patients with deteriorating kidney function * Patients with grades 3rd and 4th of hydronephrosis
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ACTUAL'}}
Updated at
2024-04-24

1 organization

1 product

2 indications

Product
Silodosin
Indication
Stone
Indication
kidney