Pre-Op Sildosine and Ureteral Dilation During F-URS

Is Preoperative Sildosine Adminstration Faciltate Ureteral Diltation During Flexible Ureterorenoscopy?

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05798572

Enrollment

140

Registered

2023-04-04

Start date

2022-03-01

Completion date

2023-03-01

Last updated

2023-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

FURS, Sildosine, Ureteral Dilatation

Brief summary

We proposed that silodosin administration preoperatively may facilitate ureteral access sheath (UAS) placement prior to flexible ureteroscopy (F-URS) and decrease the incidence of ureteric injury in some difficult cases.

Detailed description

Urolithiasis is a common urological disorder in the world and has a significant effect on the global health system. The goal of treatment is to achieve the highest stone-free rate (SFR) with the least invasive. Per¬cutaneous nephrolithotomy and flexible ureterorenoscopy (F-URS) are the two main minimally invasive procedures for the treatment of upper urinary tract stones. The challenging step in flexible ureterorenoscopy (F-URS) is ureteroscopic access sheath (UAS) placement, which facilitates fast and safe access to the ureter and collecting system; improves visibility; reduces the risk of infection by reducing intrarenal pressure. However, in some cases, the acute ureteric injury may occur during ureteroscopic access sheath (UAS) placement.

Interventions

DRUGSildosin group

Patients in this group had flexible ureteroscopy (F-URS) with preoperative daily uptake of 8 mg silodosin for one week.

PROCEDUREPlacebo/control group

included 70 patients for whom flexible ureteroscopy (F-URS) was done with daily preoperative intake of placebo tablets.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Upper ureteric stone or stone kidney (with stone burden equal to or less than 20mm). * 2\. Non stented. * Age (Above 18 years old).

Exclusion criteria

* Acute or chronic renal insufficiency. * Uncorrected coagulopathy. * Previous open (lumber or ureteric) surgery. * Active urinary tract infection unless treated.

Design outcomes

Primary

Measure	Time frame	Description
Entrance to bladder time (ETBT)	Intraoperatively	Entrance to bladder time (ETBT) will be recorded

Secondary

Measure	Time frame	Description
Entrance to ureteric orifice time (ETUOT)	Intraoperatively	Entrance to ureteric orifice time (ETUOT) will be recorded
Application of access sheath time (AAST)	Intraoperatively	Application of access sheath time (AAST) will be recorded

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026