Silodosin in Management of Lower Ureteral Stones | NCT06381206

Studies
Silodosin in Management of Lower Ureteral Stones

NCT06381206

Sponsor

Syrian Private University

Status

Completed

Last Update Posted

Apr 24, 2024Actual

Enrollment

100Actual

Phase

Phase 1Phase 2

Conditions

Stone, Kidney

Interventions

Silodosin

Countries

Syria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 20, 2022Actual

Primary Completion Date

Oct 20, 2023Actual

Completion Date

Oct 25, 2023Actual

First Submitted Date

Feb 9, 2024

First Submission Date that Met QC Criteria

Apr 19, 2024

First Posted Date

Apr 24, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2024

Last Update Posted Date

Apr 24, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
case group	Experimental	patients who had given silodosin	Drug: Silodosin
Control group	No Intervention	patients who had not given silodosin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Silodosin	Drug	Selective Alpha Blocker drug	case group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Damascus university		Damascus		1	Syria

Condition Browse Module

MeSH Terms

ID	Term
D007669	Kidney Calculi

Ancestor Terms

ID	Term
D053040	Nephrolithiasis
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C095285	silodosin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided