Silodosin in Facilitating Flexible Uretroscopy

N/AActive Not RecruitingNCT07068087

Ain Shams University42 enrolled

Overview

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.

This study specifically evaluates the effect of administering pre-operative silodosin (8mg daily for one week) on facilitating ureteral dilation prior to ureteral access sheath (UAS) placement during flexible ureteroscopy (f-URS), aiming to leverage the drug's potent ureteral smooth muscle relaxation to ease mechanical dilation with Teflon dilators (6-14Fr) and subsequent UAS insertion. Its primary endpoint directly measures the ease of UAS placement (categorized as smooth, resistant, or failed) after sequential dilation. To objectively assess safety, post-operative diagnostic ureteroscopy by a second surgeon grades ureteral wall injuries using a specific 5-grade scale. Employing a rigorous randomized, placebo-controlled trial (RCT) design with strict criteria (non-stented patients, stone burden 1-2 cm, no prior interventions), the study also evaluates secondary outcomes including ureteral injury severity, stone-free rates (SFR), post-operative pain (VAS), complications, hospital stay length, and medication side effects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Stone Ureter Stone, Kidney

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

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * adult male or female * single renal or ureteric stone * 1 to 2 cm in size. Exclusion Criteria: * 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

Locations (1)

Ain Shams University hospitals (Demerdash)

Cairo, Abasia, Egypt

Outcomes

Primary Outcomes

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.

Time frame: during the operation in the OR

Secondary Outcomes

Operative time

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

Cost of the procedure

Overall cost of each procedure included cost of standard procedure of flexible URS added to cost of medication prior to operations. If any case needed ureteral dilatation, the cost of dilators was added. Also, in case of complications occurred, additional cost of management of these complications was added. Finally, in cases of failed UAS insertion, the cost of auxiliary procedure was added. Cost was calculated initially in Egyptian pounds and was converted to U.S dollars for standardization.

Time frame: from admission and through study completion

complications

Assess postoperativePain, fever and Residual stones

Time frame: Perioperative and up to 24 weeks

Data from ClinicalTrials.gov

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