Pre-Op Sildosine and Ureteral Dilation During F-URS

Benha University

Status: Completed

Conditions: Ureteral Dilatation; Sildosine; FURS

Treatments: Drug: Sildosin group; Procedure: Placebo/control group

Study type: Interventional

Funder types: Other

Identifiers

NCT05798572

Ms: 7-12-2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Sildosin group

Experimental group

Description:

included 70 patients for whom flexible ureteroscopy (F-URS) was done with the daily preoperative intake of 8 mg silodosin for one week.

Treatment:

Drug: Sildosin group

Placebo/control group

Experimental group

Description:

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

Treatment:

Procedure: Placebo/control group