Effect of Preoperative Silodosin on Feasibility of Ureteral Access Sheath Insertion for Flexible Ureteroscope in Treating Renal Stones; A Prospective, Multicentre, Randomized Trial
Study Details
Study Description
Brief Summary
The ureteral access sheath (UAS) is an ancillary device widely used by urologists to facilitate fast, repeatable, and safe access to ureters and collecting systems; improve visibility; reduce the risk of infection by reducing intrarenal pressure; and protect ureters and scopes when extracting multiple stones during surgery.
Insertion of ureteric access sheath may be difficult due to tight ureter, so sometimes preoperative stenting might be needed. Silodosin is an α1A adrenoceptor with high affinity and selectivity for the ureteric muscle, which may reduce ureteral spasm.
Oral a1-blockers can reduce intraureteral pressure, and may reduce maximal ureteral access sheath insertion force.¹ Preoperative silodosin protects against significant ureteral injury related to UAS insertion during fURS and decreases postoperative pain level. Silodosin premedication might be an effective and safe technique to replace prestenting.²
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Silodosin group all patients will receive oral silodosin 8 mg orally for 0ne week prior to surgery |
Procedure: Ureteral access sheath placement during flexible ureteroscope for renal stones
Ureteral access sheath placement during flexible ureteroscope
|
| Active Comparator: Non premedicated group None of this group will receive alpha blocker prior to surgery |
Procedure: Ureteral access sheath placement during flexible ureteroscope for renal stones
Ureteral access sheath placement during flexible ureteroscope
|
Outcome Measures
Primary Outcome Measures
- failure rate of UAS insertion during FURS [2 hours]
Secondary Outcome Measures
- Ureteral injuries after UAS insertion [3 hours]
Ureter wall injury will be classified according to the following five grades: Grade 0: No lesion or only mucosal petechiae. Grade 1: Mucosal erosion or a mucosal flap without smooth muscle injury. Grade 2: Erosion involving the mucosa and smooth muscle but sparing the adventitia. Grade 3: Ureteral perforation involving the full thickness of the ureteral wall, including the adventitia. Grade 4: Total ureteral avulsion with a complete rupture of ureteral continuity.
- Post operative pain [12 hours after surgery]
a visual analog scale (VAS) score (0 = no pain to 10 = excruciating pain) to indicate the intensity of postoperative pain 12 h after surgery.
- Complications related to the procedure [3 months]
will be graded using the modified Clavien-Dindo classification system.
Eligibility Criteria
Criteria
Inclusion Criteria:
- All patients with renal stones who will undergo flexible ureteroscopy and planned for using ureteral access sheath
Exclusion Criteria:
- Paediatric age group (less than 18 year)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Urology department - AlAzhar university | Cairo | Egypt |
Sponsors and Collaborators
- Al-Azhar University
- Benha University
- Alexandria University
- Cairo University
- Menoufia University
- Tanta University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Kim JK, Choi CI, Lee SH, Han JH, Shim YS, Choo MS; Young Endourological Study group. Silodosin for Prevention of Ureteral Injuries Resulting from Insertion of a Ureteral Access Sheath: A Randomized Controlled Trial. Eur Urol Focus. 2022 Mar;8(2):572-579. doi: 10.1016/j.euf.2021.03.009. Epub 2021 Mar 23.
- Koo KC, Yoon JH, Park NC, Lee HS, Ahn HK, Lee KS, Kim DK, Cho KS, Chung BH, Hong CH. The Impact of Preoperative alpha-Adrenergic Antagonists on Ureteral Access Sheath Insertion Force and the Upper Limit of Force Required to Avoid Ureteral Mucosal Injury: A Randomized Controlled Study. J Urol. 2018 Jun;199(6):1622-1630. doi: 10.1016/j.juro.2017.09.173. Epub 2018 Feb 2.
- Traxer O, Thomas A. Prospective evaluation and classification of ureteral wall injuries resulting from insertion of a ureteral access sheath during retrograde intrarenal surgery. J Urol. 2013 Feb;189(2):580-4. doi: 10.1016/j.juro.2012.08.197. Epub 2012 Oct 8.
- pre-FURS sildosin