Silodosin in Retrograde Intrarenal Surgery

Effect of Perioperative Silodosin on Ureteric Dilatation in Retrograde Intrarenal Surgery

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.

Study Overview

• Status: Completed
• Conditions: Urolithiasis
• Intervention / Treatment: Drug: Silodosin 8 mg; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • القاهرة
    • Cairo, القاهرة, Egypt, 11757
      • Ahmed Maher

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Silodosin group (the intervention group); Patients will receive silodosin 8 mg one tablet per day for 3 days before their scheduled retrograde intrarenal surgery.	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 Comparator: Placebo group (the control group); Patients will receive Placebo for 3 days before their scheduled retrograde intrarenal surgery.	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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2023
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: June 18, 2023
• First Submitted That Met QC Criteria: June 26, 2023
• First Posted (Actual): June 27, 2023

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urolithiasis; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Silodosin
• Other Study ID Numbers: MS 231/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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