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Silodosin in Retrograde Intrarenal Surgery

Primary Purpose

Urolithiasis

Status
Enrolling by invitation
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Silodosin 8 mg
Placebo
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urolithiasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ahmed Maher

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Silodosin group (the intervention group)

Placebo group (the control group)

Arm Description

Patients will receive silodosin 8 mg one tablet per day for 3 days before their scheduled retrograde intrarenal surgery.

Patients will receive Placebo for 3 days before their scheduled retrograde intrarenal surgery.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

operative time
time of the procedure will be recorded from the beginning of the diagnostic cystoscopy till placement of the flexible ureteroscopy
Perioperative complication
regarding of both intraoperative complications in the form of ureteric mucosal tear, ureteric avulsion, residual stones, postoperative pain, dysuria, hematuria, and fever
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

Full Information

First Posted
June 18, 2023
Last Updated
June 26, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05921370
Brief Title
Silodosin in Retrograde Intrarenal Surgery
Official Title
Effect of Perioperative Silodosin on Ureteric Dilatation in Retrograde Intrarenal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 4, 2023 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urolithiasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
This prospective study will be conducted in patients prepared for RIRS presented to Ain Shams University Hospital. 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.
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Silodosin group (the intervention group)
Arm Type
Experimental
Arm Description
Patients will receive silodosin 8 mg one tablet per day for 3 days before their scheduled retrograde intrarenal surgery.
Arm Title
Placebo group (the control group)
Arm Type
Placebo Comparator
Arm Description
Patients will receive Placebo for 3 days before their scheduled retrograde intrarenal surgery.
Intervention Type
Drug
Intervention Name(s)
Silodosin 8 mg
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
ureteric access sheath placement
Description
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.
Time Frame
intraoperative immediate diagnosis, at the beginning of surgery.
Secondary Outcome Measure Information:
Title
operative time
Description
time of the procedure will be recorded from the beginning of the diagnostic cystoscopy till placement of the flexible ureteroscopy
Time Frame
intraoperative diagnosis during the surgery from beginning of the surgery till the end of the procedure
Title
Perioperative complication
Description
regarding of both intraoperative complications in the form of ureteric mucosal tear, ureteric avulsion, residual stones, postoperative pain, dysuria, hematuria, and fever
Time Frame
till 7 days postoperative
Title
Cost analysis
Description
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
Time Frame
1 day post operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Ahmed Maher
City
Cairo
State/Province
القاهرة
ZIP/Postal Code
11757
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Silodosin in Retrograde Intrarenal Surgery

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