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Silodosin in Retrograde Intrarenal Surgery

NCT05921370 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-07-16

No results posted yet for this study

Summary

Selective alpha-blockers have been used for the treatment of ureteric stones as medical expulsive therapy (MET). Recently they have been successfully used in passive ureteric dilatation before semirigid ureteroscopy. This study enables us to know the role of silodosin in ureteric dilatation to facilitate ureteral access sheath placement in Retrograde Intrarenal Surgery with flexible ureteroscopy.

Conditions

  • Urolithiasis

Interventions

DRUG

Silodosin 8 mg

This prospective study will be conducted on patients prepared for Retrograde intrarenal surgery presented to Ain Shams University Hospital. Patients will be randomized with 1:1 ratio into 2 equal groups. Group A (the study group): Patients will receive silodosin 8 mg one tablet per day for 7 days before their scheduled retrograde intrarenal surgery. silodosin is an alpha blocker which act to dilate the ureter to facilitate access sheath placement

DRUG

Placebo

This prospective study will be conducted on patients prepared for Retrograde intrarenal surgery presented to Ain Shams University Hospital. Patients will be randomized with 1:1 ratio into 2 equal groups. Group A (the study group): Patients will receive silodosin 8 mg one tablet per day for 7 days before their scheduled retrograde intrarenal surgery. Group B (the control group): Patients will receive Placebo for 7 days before their scheduled retrograde intrarenal surgery.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-04
Primary Completion
2023-07-01
Completion
2023-09-01

Countries

  • Egypt

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05921370 on ClinicalTrials.gov