NCT05921370

Silodosin in Retrograde Intrarenal Surgery

Effect of Perioperative Silodosin on Ureteric Dilatation in Retrograde Intrarenal Surgery

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urolithiasis

Interventions

Type	Name	Description
DRUG	Silodosin 8 mg	This prospective study will be conducted on patients prepared for Retrograde intrarenal surgery presented to Ain Shams University Hospital. Patients will be randomized with 1:1 ratio into 2 equal groups. Group A (the study group): Patients will receive silodosin 8 mg one tablet per day for 7 days before their scheduled retrograde intrarenal surgery. silodosin is an alpha blocker which act to dilate the ureter to facilitate access sheath placement
DRUG	Placebo	This prospective study will be conducted on patients prepared for Retrograde intrarenal surgery presented to Ain Shams University Hospital. Patients will be randomized with 1:1 ratio into 2 equal groups. Group A (the study group): Patients will receive silodosin 8 mg one tablet per day for 7 days before their scheduled retrograde intrarenal surgery. Group B (the control group): Patients will receive Placebo for 7 days before their scheduled retrograde intrarenal surgery.

Timeline

• Start date: 2023-04-04
• Primary completion: 2023-07-01
• Completion: 2023-09-01
• First posted: 2023-06-27
• Last updated: 2024-07-16

Locations

1 site across 1 country: Egypt