NCT07068087

Brief Summary

This study aims to provide robust evidence on whether a specific, potent pre-operative medication (silodosin) can make the critical step of ureteral access (UAS placement after dilation) easier and safer during f-URS for kidney stones in non-stented patients, potentially reducing complications and the need for pre-stenting.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

February 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 16, 2025

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2025

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

June 10, 2025

Last Update Submit

July 14, 2025

Conditions

Stone UreterStone, Kidney

Keywords

Retrograde Intra Renal Surgery (RIRS)Flexible uretroscopyLaser disintegrationAlpha blocker selectiveSilodosin

Outcome Measures

Primary Outcomes (1)

  • Assess success of ureteric access sheath placement.

    assess success of ureteric access sheath placement as follows: 1. spontaneous passage of UAS without dilatation or 2. passage of UAS after dilatation or 3. failure of the UAS insertion.

    during the operation in the OR

Secondary Outcomes (3)

  • Operative time

    from time of induction of anaesthesia in surgery till the end of procedure.

  • Cost of the procedure

    from admission and through study completion

  • complications

    Perioperative and up to 24 weeks

Study Arms (2)

Receiving Sioldosin 8 mg prior to intervention

ACTIVE COMPARATOR
Procedure: Preoperative sioldosin to facilitate ureteric access sheath insertion in RIRS

Receiving Placebo prior to intervention

PLACEBO COMPARATOR
Procedure: ureteric access sheath insertion in RIRS without silodosin (Placebo)

Interventions

Preoperative sioldosin to facilitate ureteric access sheath insertion in RIRSPROCEDURE

group A (study group) that included 21 patients who received silodosin 'one capsule 8 mg per day for 1 week preoperatively

Receiving Sioldosin 8 mg prior to intervention
ureteric access sheath insertion in RIRS without silodosin (Placebo)PROCEDURE

group B (study group) that included 21 patients who received Placebo'one capsule per day for 1 week preoperatively

Receiving Placebo prior to intervention

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • adult male or female
  • single renal or ureteric stone
  • to 2 cm in size.

You may not qualify if:

  • pregnant women
  • Untreated urinary tract infections
  • Uncorrected bleeding disorders or coagulopathies
  • Bilateral ureteric stones or multiple ipsilateral ureteric stones
  • ureteral stricture,
  • Patients who had previous ureteric stenting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University hospitals (Demerdash)

Cairo, Abasia, Egypt

Location

Related Publications (3)

  • Benedict, A., Rajenthiran, V., & Eswaramurthy, A. (2021). Effects of silodosin, darifenacin, and combination therapy for the treatment of ureteral stent related discomforts. International Surgery Journal, 8(10), 3031-3035.

    BACKGROUND

  • Alsaikhan B, Koziarz A, Lee JY, Pace KT. Preoperative Alpha-Blockers for Ureteroscopy for Ureteral Stones: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Endourol. 2020 Jan;34(1):33-41. doi: 10.1089/end.2019.0520. Epub 2019 Oct 9.

    PMID: 31507224BACKGROUND

  • Alaridy, H. M., Zwain, K. M. A., Al-Mosawi, H. Q., & Hadi, N. R. (2020). Comparison of silodosin, tadalafil and combinations prior to ureteroscopic management of ureteral stones. Systematic Reviews in Pharmacy, 11(4), 238-242.

    BACKGROUND

MeSH Terms

Conditions

UreterolithiasisKidney Calculi

Interventions

silodosin

Condition Hierarchy (Ancestors)

Ureteral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital DiseasesNephrolithiasisKidney DiseasesUrinary CalculiCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Mahmoud A. Mohammed, M.D.

    Ain Shams University

    STUDY CHAIR

  • Younan R. Samir, M.D.

    Ain Shams University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of urology

Study Record Dates

First Submitted

June 10, 2025

First Posted

July 16, 2025

Study Start

February 1, 2025

Primary Completion

August 10, 2025

Study Completion

September 1, 2025

Last Updated

July 16, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)