Pre-Op Sildosine and Ureteral Dilation During F-URS

Sponsor

Benha University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05798572

Collaborator

(none)

134

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
FURS Ureteral Dilatation Sildosine	Drug: Sildosin group Procedure: Non-Silodosin group	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

134 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Is Preoperative Sildosine Adminstration Faciltate Ureteral Diltation During Flexible Ureterorenoscopy?

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sildosin group including 67 patients for whom flexible ureteroscopy (F-URS) will be done with a preoperative daily intake of 8 mg silodosin for one week.	Drug: Sildosin group Patients in this group will have flexible ureteroscopy (F-URS) with preoperative daily uptake of 8 mg silodosin for one week.
Experimental: Non-Silodosin group including 67 patients for whom flexible ureteroscopy (F-URS) will be done without silodosin intake.	Procedure: Non-Silodosin group Patients in this group will have flexible ureteroscopy (F-URS) without silodosin uptake

Arm

Intervention/Treatment

Experimental: Sildosin group

including 67 patients for whom flexible ureteroscopy (F-URS) will be done with a preoperative daily intake of 8 mg silodosin for one week.

Drug: Sildosin group

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

Experimental: Non-Silodosin group

including 67 patients for whom flexible ureteroscopy (F-URS) will be done without silodosin intake.

Procedure: Non-Silodosin group

Patients in this group will have flexible ureteroscopy (F-URS) without silodosin uptake

Outcome Measures

Primary Outcome Measures

Entrance to bladder time (ETBT) [Intraoperatively]
Entrance to bladder time (ETBT) will be recorded

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Upper ureteric stone or stone kidney (with stone burden equal to or less than 20mm).
1. 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Benha University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tamer Abd El-Wahab Diab, Lecturer of Urology, Faculty of Medicine, Benha University, Benha, Egypt, Benha University

ClinicalTrials.gov Identifier:

NCT05798572

Other Study ID Numbers:

Ms: 7-12-2022

First Posted:

Apr 4, 2023

Last Update Posted:

Apr 6, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dilatation, Pathologic

Study Results

No Results Posted as of Apr 6, 2023