Pre-Op Sildosine and Ureteral Dilation During F-URS

Is Preoperative Sildosine Adminstration Faciltate Ureteral Diltation During Flexible Ureterorenoscopy?

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.

Study Overview

• Status: Completed
• Conditions: Sildosine; FURS; Ureteral Dilatation
• Intervention / Treatment: Drug: Sildosin group; Procedure: Placebo/control group

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 Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Benha, Egypt, 13511
    • Benha University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Benha University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: March 23, 2023
• First Submitted That Met QC Criteria: March 23, 2023
• First Posted (Actual): April 4, 2023

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 9, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Dilatation, Pathologic
• Other Study ID Numbers: Ms: 7-12-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study will be available under a reasonable request from the corresponding author.
• IPD Sharing Time Frame: One year after the end of the study.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No