Silodosin in Retrograde Intrarenal Surgery

Urolithiasis Clinical Trial

Official title:

Effect of Perioperative Silodosin on Ureteric Dilatation in Retrograde Intrarenal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05921370
• Other study ID #: MS 231/2023
• Status: Completed
• Phase: Phase 3
• Start date: April 4, 2023
• Est. completion date: September 1, 2023

Study information

• Verified date: January 2024
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Urolithiasis

Intervention

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 3 days before their scheduled retrograde intrarenal surgery. silodosin is an alpha blocker which act to dilate the ureter to facilitate access sheath placement
• 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 3 days before their scheduled retrograde intrarenal surgery. Group B (the control group): Patients will receive Placebo for 3 days before their scheduled retrograde intrarenal surgery.

Locations

Country	Name	City	State
Egypt	Ahmed Maher	Cairo	???????

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ureteric access sheath placement	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.	intraoperative immediate diagnosis, at the beginning of surgery.
Secondary	operative time	time of the procedure will be recorded from the beginning of the diagnostic cystoscopy till placement of the flexible ureteroscopy	intraoperative diagnosis during the surgery from beginning of the surgery till the end of the procedure
Secondary	Perioperative complication	regarding of both intraoperative complications in the form of ureteric mucosal tear, ureteric avulsion, residual stones, postoperative pain, dysuria, hematuria, and fever	till 7 days postoperative
Secondary	Cost analysis	evaluation of the cost in both arms by comparing the price for the medication for 3 days on one arm. and the cost of the supplies needed intraoperative for ureteric dilatation or the need for another surgical session	1 day post operative