Silodosin in Retrograde Intrarenal Surgery

Phase 3

Completed

• Conditions: Urolithiasis
• Interventions: Drug: Silodosin 8 mg; Drug: Placebo

• Registration Number: NCT05921370
• Lead Sponsor: Ain Shams University

Brief Summary

Selective alpha-blockers have been used for the treatment of ureteric stones as medical expulsive therapy (MET). Recently they have been successfully used in passive ureteric dilatation before semirigid ureteroscopy. This study enables us to know the role of silodosin in ureteric dilatation to facilitate ureteral access sheath placement in Retrograde Intrarenal Surgery with flexible ureteroscopy.

Detailed Description

The ureteral access sheaths (UAS) used during Retrograde Intrarenal Surgery (RIRS) were produced for easy access to the upper urinary tract. The main advantages of UAS are providing repetitive access to the ureteral and collecting duct system, decreasing intrarenal pressure, preventing bleeding-related distortion of vision by the acceleration of liquid flow, and eventually contributing toward the protection of the flexible device.

Nevertheless, there might be certain challenges during UAS placement. There are also risks, such as ureteral injury and the occurrence of ureteral stricture in the long term. However, considering the benefit/risk balance, RIRS is routinely performed in many clinics because of the ease provided by UAS.

Some problems might occur during the placement of UAS whose diameters vary between 9.5 and 14 Fr. In cases where UAS cannot be placed, manipulations can be used, such as ureteral balloon dilatation, providing access through a rigid ureteroscope with a guide wire, or dilatation with the inner sheath of the UAS, which may vary depending on the amount of personal experience. Despite such manipulations, if UAS placement is still unsuccessful, it is always more logical to place a double-J stent, enables passive dilatation, and postpone RIRS until the second operation.

This study will examine whether intramural ureteral resistance can be reduced or not and whether UAS placement can be facilitated using silodosin or not.

Study Timeline

• Study Start: 2023-04-04
• Study First Submitted: 2023-06-18
• Study First Submitted QC: 2023-06-26
• Study First Posted: 2023-06-27
• Primary Completion: 2023-07-01
• Study Completion: 2023-09-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-14
• Last Update Posted: 2024-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Both sex.
• Age >18 yrs old.
• Upper ureteric stones or renal stones < 2 cm.
• Patients with normal renal anatomy.
• No history of infectious or inflammatory renal condition.

Exclusion Criteria

• • < 18 years old.

  • Multiple or bilateral stones.
  • Pregnant women.
  • Ureteric strictures.
  • Urinary tract infection.
  • Coagulopathy and uncorrected bleeding disorders.
  • Refusal of the surgery and requiring stent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Silodosin group (the intervention group)	Silodosin 8 mg	Patients will receive silodosin 8 mg one tablet per day for 7 days before their scheduled retrograde intrarenal surgery.
Placebo group (the control group)	Placebo	Patients will receive Placebo for 7 days before their scheduled retrograde intrarenal surgery.

Primary Outcome Measures

Name	Time	Method
ureteric access sheath placement	intraoperative immediate diagnosis, at the beginning of surgery.	to assess the success of ureteric access sheath placement as follows: 1. Direct assessment: A. Success of ureteric access sheath insertion without ureteric dilatation. B. Success of ureteric access sheath insertion with ureteric dilatation. C. Failed ureteric access sheath insertion.

Secondary Outcome Measures

Name	Time	Method
operative time	intraoperative diagnosis during the surgery from beginning of the surgery till the end of the procedure	time of the procedure will be recorded from the beginning of the diagnostic cystoscopy till placement of the flexible ureteroscopy
Perioperative complication	till 7 days postoperative	regarding of both intraoperative complications in the form of ureteric mucosal tear, ureteric avulsion, residual stones, postoperative pain, dysuria, hematuria, and fever
Cost analysis	1 day post operative	evaluation of the cost in both arms by comparing the price for the medication for 7 days on one arm. and the cost of the supplies needed intraoperative for ureteric dilatation or the need for another surgical session

Trial Locations

Locations (1)

Ahmed Maher; 🇪🇬 Cairo, القاهرة, Egypt