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CompletedNCT06381206Updated Apr 24, 2024

Silodosin in Management of Lower Ureteral Stones

A Phase 1/2 interventional study of Silodosin in Stone, Kidney, sponsored by Syrian Private University. Completed at 1 site in Syrian Arab Republic. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2024-04-24.

Sponsored by Syrian Private University · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Oct 2022, registered Feb 2024).
Phase
Phase 1/2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Stone, Kidney

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Keywords

  • Silodosin
  • Lower Ureteral
  • Ureteral Stones
03

In context

Kidney Calculi

509 studies on the registry are indexed under Kidney Calculi; 146 are open to participants now.

This study's enrollment of 100 is above the median of 86 across 391 interventional studies indexed under Kidney Calculi.

Browse Kidney Calculi studies →

Lead sponsor

Syrian Private University is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    case group

    patients who had given silodosin

    Drug: Silodosin

  • No intervention
    Control group

    patients who had not given silodosin

Interventions

06

What researchers measure

Primary outcomes

  1. Stone expulsion (yes)

    patients who were able to expel the stone

    Time frame: 1 year

  2. Stone expulsion (no)

    patients who were not able to expel the stone

    Time frame: 1 year

07

Study locations

1 site
  • Damascus university
    Damascus, 1, Syrian Arab Republic
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2022 to primary completion in Oct 2023, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 9, 2024
First posted
Apr 24, 2024
StartActual
Oct 20, 2022
Primary completionActual
Oct 20, 2023
CompletionActual
Oct 25, 2023
Last update
Apr 24, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06381206
Lead sponsor
Syrian Private University
Responsible party
Diaa Haj Ali (medical doctor Diaa Haj Ali, Syrian Private University) — Principal investigator
First posted
Apr 24, 2024
Start date
Oct 20, 2022
Primary completion
Oct 20, 2023
Completion
Oct 25, 2023
Last update
Apr 24, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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