Pre-Op Sildosine and Ureteral Dilation During F-URS

Study Overview
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Brief Summary
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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
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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.

Official Title
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Is Preoperative Sildosine Adminstration Faciltate Ureteral Diltation During Flexible Ureterorenoscopy?

Conditions
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FURS, Ureteral Dilatation, Sildosine

Intervention / Treatment
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* Drug: Sildosin group
* Procedure: Placebo/control group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sildosin group<br>included 70 patients for whom flexible ureteroscopy (F-URS) was done with the daily preoperative intake of 8 mg silodosin for one week. | Drug: Sildosin group<br>* Patients in this group had flexible ureteroscopy (F-URS) with preoperative daily uptake of 8 mg silodosin for one week.<br>|
| Experimental: Placebo/control group<br>included 70 patients for whom flexible ureteroscopy (F-URS) was done with daily preoperative intake of placebo tablets. | Procedure: Placebo/control group<br>* included 70 patients for whom flexible ureteroscopy (F-URS) was done with daily preoperative intake of placebo tablets.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Entrance to bladder time (ETBT) | Entrance to bladder time (ETBT) will be recorded | Intraoperatively | 

Secondary Outcome Measures

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