Pre-Op Sildosine and Ureteral Dilation During F-URS

Not Applicable

Completed

• Conditions: FURS; Ureteral Dilatation; Sildosine
• Interventions: Drug: Sildosin group; Procedure: Placebo/control group

• Registration Number: NCT05798572
• Lead Sponsor: Benha University

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.

Study Timeline

• Study Start: 2022-03-01
• Primary Completion: 2023-03-01
• Study Completion: 2023-03-01
• Study First Submitted: 2023-03-23
• Study First Submitted QC: 2023-03-23
• Study First Posted: 2023-04-04
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-09
• Last Update Posted: 2023-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sildosin group	Sildosin group	included 70 patients for whom flexible ureteroscopy (F-URS) was done with the daily preoperative intake of 8 mg silodosin for one week.
Placebo/control group	Placebo/control group	included 70 patients for whom flexible ureteroscopy (F-URS) was done with daily preoperative intake of placebo tablets.

Primary Outcome Measures

Name	Time	Method
Entrance to bladder time (ETBT)	Intraoperatively	Entrance to bladder time (ETBT) will be recorded

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Benha University Hospitals; 🇪🇬 Benha, Egypt