An interventional study of Flexible URS and Semi-Rigid URS in Ureteric Stone, Flexible Ureteroscopy and Upper Urinary Tract Stones, sponsored by Assiut University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-25.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
To compare the efficacy, safety, success rate, operative time, and cost-effectiveness of flexible ureteroscopy versus semirigid ureteroscopy in the management of upper ureteric stones smaller than 2 cm.
The investigators' main concern in this study is Upper third ureteric stones to determine which cases can be treated with Semi-Rigid Ureteroscopy, and which one needs flexible ureteroscopy. This depends on several factors:
Ureteroscopy (URS) is a widely accepted minimally invasive approach for treating ureteric stones, particularly proximal (upper) ureteral stones. Options include rigid, semirigid (often grouped as one), and flexible ureteroscopes. Flexible ureteroscopy allows deflection and access to the proximal ureter and intrarenal collecting system, facilitating treatment of stones that are difficult to reach with rigid ureteroscopes due to anatomical constraints or stone migration. Semirigid ureteroscopy has shown good efficacy, particularly for stones amenable to direct access without complex deflection, offering shorter operative times and lower costs. Studies report stone-free rates of approximately 90-93% for flexible URS and 81-90% for semirigid URS, with flexible URS having somewhat higher success in accessing stones and managing fragment migration. However, flexible URS typically incurs higher costs and longer operative times. Semirigid ureteroscopy is often the initial approach for upper ureteric stones where anatomy, stone size (\<2 cm), and location allow straightforward access.
Despite advances, there is ongoing debate about the optimal first-line ureteroscopic approach for upper ureteric stones, balancing efficacy, safety, cost, and procedure time. Comparing flexible and rigid/semirigid ureteroscopy outcomes informs treatment algorithms, improving patient care and resource utilization, especially in differing healthcare settings.
84 studies on the registry are indexed under Ureterolithiasis; 19 are open to participants now.
This study's planned enrollment of 100 is close to the median of 101 across 66 interventional studies indexed under Ureterolithiasis.
Browse Ureterolithiasis studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Procedure: Flexible URS
Procedure: Semi-Rigid URS
Flexible URS
Semi-Rigid URS
- Stone-free rate at 3 months duration
Time frame: 3 months
Plan to share: Undecided
Started Oct 2025 (actual). Primary completion is estimated for Oct 2026, 12 months after the start.
Of 36 non-industry interventional studies with no phase under Ureterolithiasis, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 30. This study's planned 12 months is below that.
Counting every sponsor, half of 38 studies reached it within 20 months; a quarter within 11 and three quarters within 30.
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