NCT06381206

Brief Summary

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2023

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 24, 2024

Completed
Last Updated

April 24, 2024

Status Verified

April 1, 2024

Enrollment Period

1 year

First QC Date

February 9, 2024

Last Update Submit

April 19, 2024

Conditions

Stone, Kidney

Keywords

SilodosinLower UreteralUreteral Stones

Outcome Measures

Primary Outcomes (2)

  • Stone expulsion (yes)

    patients who were able to expel the stone

    1 year

  • Stone expulsion (no)

    patients who were not able to expel the stone

    1 year

Study Arms (2)

case group

EXPERIMENTAL

patients who had given silodosin

Drug: Silodosin

Control group

NO INTERVENTION

patients who had not given silodosin

Interventions

SilodosinDRUG

Selective Alpha Blocker drug

case group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients attending the urology Clinic with a distal unilateral ureteral stone larger than 6 mm in diameter.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damascus university

Damascus, 1, Syria

Location

MeSH Terms

Conditions

Kidney Calculi

Interventions

silodosin

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor Diaa Haj Ali

Study Record Dates

First Submitted

February 9, 2024

First Posted

April 24, 2024

Study Start

October 20, 2022

Primary Completion

October 20, 2023

Study Completion

October 25, 2023

Last Updated

April 24, 2024

Record last verified: 2024-04

Locations

SY(1)