Pre-Op Sildosine and Ureteral Dilation During F-URS
Primary Purpose
FURS, Ureteral Dilatation, Sildosine
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Sildosin group
Placebo/control group
Sponsored by
About this trial
This is an interventional treatment trial for FURS
Eligibility Criteria
Inclusion Criteria: Upper ureteric stone or stone kidney (with stone burden equal to or less than 20mm). 2. Non stented. Age (Above 18 years old). Exclusion Criteria: Acute or chronic renal insufficiency. Uncorrected coagulopathy. Previous open (lumber or ureteric) surgery. Active urinary tract infection unless treated.
Sites / Locations
- Benha University Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Sildosin group
Placebo/control group
Arm Description
included 70 patients for whom flexible ureteroscopy (F-URS) was done with the daily preoperative intake of 8 mg silodosin for one week.
included 70 patients for whom flexible ureteroscopy (F-URS) was done with daily preoperative intake of placebo tablets.
Outcomes
Primary Outcome Measures
Entrance to bladder time (ETBT)
Entrance to bladder time (ETBT) will be recorded
Secondary Outcome Measures
Entrance to ureteric orifice time (ETUOT)
Entrance to ureteric orifice time (ETUOT) will be recorded
Application of access sheath time (AAST)
Application of access sheath time (AAST) will be recorded
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05798572
Brief Title
Pre-Op Sildosine and Ureteral Dilation During F-URS
Official Title
Is Preoperative Sildosine Adminstration Faciltate Ureteral Diltation During Flexible Ureterorenoscopy?
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
March 1, 2023 (Actual)
Study Completion Date
March 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha 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
We proposed that silodosin administration preoperatively may facilitate ureteral access sheath (UAS) placement prior to flexible ureteroscopy (F-URS) and decrease the incidence of ureteric injury in some difficult cases.
Detailed Description
Urolithiasis is a common urological disorder in the world and has a significant effect on the global health system. The goal of treatment is to achieve the highest stone-free rate (SFR) with the least invasive. Per¬cutaneous nephrolithotomy and flexible ureterorenoscopy (F-URS) are the two main minimally invasive procedures for the treatment of upper urinary tract stones.
The challenging step in flexible ureterorenoscopy (F-URS) is ureteroscopic access sheath (UAS) placement, which facilitates fast and safe access to the ureter and collecting system; improves visibility; reduces the risk of infection by reducing intrarenal pressure. However, in some cases, the acute ureteric injury may occur during ureteroscopic access sheath (UAS) placement.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
FURS, Ureteral Dilatation, Sildosine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sildosin group
Arm Type
Experimental
Arm Description
included 70 patients for whom flexible ureteroscopy (F-URS) was done with the daily preoperative intake of 8 mg silodosin for one week.
Arm Title
Placebo/control group
Arm Type
Experimental
Arm Description
included 70 patients for whom flexible ureteroscopy (F-URS) was done with daily preoperative intake of placebo tablets.
Intervention Type
Drug
Intervention Name(s)
Sildosin group
Intervention Description
Patients in this group had flexible ureteroscopy (F-URS) with preoperative daily uptake of 8 mg silodosin for one week.
Intervention Type
Procedure
Intervention Name(s)
Placebo/control group
Intervention Description
included 70 patients for whom flexible ureteroscopy (F-URS) was done with daily preoperative intake of placebo tablets.
Primary Outcome Measure Information:
Title
Entrance to bladder time (ETBT)
Description
Entrance to bladder time (ETBT) will be recorded
Time Frame
Intraoperatively
Secondary Outcome Measure Information:
Title
Entrance to ureteric orifice time (ETUOT)
Description
Entrance to ureteric orifice time (ETUOT) will be recorded
Time Frame
Intraoperatively
Title
Application of access sheath time (AAST)
Description
Application of access sheath time (AAST) will be recorded
Time Frame
Intraoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Upper ureteric stone or stone kidney (with stone burden equal to or less than 20mm).
2. Non stented.
Age (Above 18 years old).
Exclusion Criteria:
Acute or chronic renal insufficiency.
Uncorrected coagulopathy.
Previous open (lumber or ureteric) surgery.
Active urinary tract infection unless treated.
Facility Information:
Facility Name
Benha University Hospitals
City
Benha
ZIP/Postal Code
13511
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The study will be available under a reasonable request from the corresponding author.
IPD Sharing Time Frame
One year after the end of the study.
Learn more about this trial
Pre-Op Sildosine and Ureteral Dilation During F-URS
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