Actively Recruiting
Bendable Suction Ureteral Access Sheath Versus Conventional Ureteral Access Sheath in Management of Renal Stones Using Flexible Ureteroscopy
Led by Menoufia University · Updated on 2025-03-11
172
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Urinary calculus is a globally recognized urological condition, with prevalence rates ranging from 1% to 13% across different geographical regions (1) Therapeutic approaches for renal calculi encompass extracorporeal shock wave lithotripsy (ESWL) and minimally invasive endoscopic surgical techniques, such as percutaneous nephrolithotomy (PCNL) and retrograde intrarenal surgery (RIRS). Treatment plans depend on the characteristics of calculi, patient factors, surgeon experience and the condition of medical centers. According to the guidelines of American Urologic Association (AUA) and European Association of Urology (EAU), patients with a burden of less than 20 mm in kidney calculi can choose RIRS as the frst-line surgical treatment with good stone-free rate (SFR). (2, 3) The application of RIRS for urinary stones has increased signifcantly, and the indications have expanded due to developments in minimally invasive technology and equipment. (4) With the development of stone retrieval devices and miniaturized fexible ureteroscopes, RIRS is more widely used for treating renal calculi, even for high burden stones. (5, 6) The application of ureteral access sheath (UAS) in RIRS can improve surgical vision, reduce intrarenal pressure (IRP), and decrease postoperative infectious complications. (7-9) Several reports have demonstrated the superiority of suctioning UAS, including shorter operation time, higher SFR and lower incidence of infectious complications compared with traditional ureteral access sheath, but none of these suctioning UAS can reach the renal calyces. (10-12) A novel tip-flexible suctioning ureteral access sheath with flexible terminal was designed, which delivered the tip of the ureteral access sheath to renal calyces. However, data comparing novel tip-flexible suctioning ureteral access and traditional ureteral access sheath is lacking in RIRS. Therefore, we designed a prospective controlled analysis to compare the efficacy and safety of novel tip-flexible suctioning ureteral access sheath and traditional ureteral access sheath combined with flexible ureteroscope (FURS) in treating renal calculi.
CONDITIONS
Official Title
Bendable Suction Ureteral Access Sheath Versus Conventional Ureteral Access Sheath in Management of Renal Stones Using Flexible Ureteroscopy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Radiologically confirmed kidney stones (e.g., CT, ultrasound, or X-ray)
- Stone size between 5 and 20 mm
- Indicated for flexible ureteroscopy treatment
- Normal or mildly altered kidney anatomy allowing safe sheath use
- Willing to participate and provide written informed consent
You will not qualify if you...
- Active urinary tract infection or sepsis
- Coagulopathy or inability to stop anticoagulation therapy
- Severe heart or lung disease
- Pregnant or breastfeeding individuals
- Severe ureteral stricture or blockage preventing sheath placement
- Congenital abnormalities of the urinary tract
- Stones larger than 20 mm
- Multiple stones in different kidney areas not accessible in one session
- Recent or repeated treatments for the same stones within 6 weeks
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Faculty of Medicine, Menoufia University
Shebin Elkom, Menoufia, Egypt, 35111
Actively Recruiting
Research Team
M
Mohamed Kamal Omar
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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