An interventional study of Preoperative sioldosin to facilitate ureteric access sheath insertion in RIRS and ureteric access sheath insertion in RIRS without silodosin (Placebo) in Stone Ureter and Stone, Kidney, sponsored by Ain Shams University. Active, not recruiting at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-07-16.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
This study aims to provide robust evidence on whether a specific, potent pre-operative medication (silodosin) can make the critical step of ureteral access (UAS placement after dilation) easier and safer during f-URS for kidney stones in non-stented patients, potentially reducing complications and the need for pre-stenting.
This study specifically evaluates the effect of administering pre-operative silodosin (8mg daily for one week) on facilitating ureteral dilation prior to ureteral access sheath (UAS) placement during flexible ureteroscopy (f-URS), aiming to leverage the drug's potent ureteral smooth muscle relaxation to ease mechanical dilation with Teflon dilators (6-14Fr) and subsequent UAS insertion. Its primary endpoint directly measures the ease of UAS placement (categorized as smooth, resistant, or failed) after sequential dilation. To objectively assess safety, post-operative diagnostic ureteroscopy by a second surgeon grades ureteral wall injuries using a specific 5-grade scale. Employing a rigorous randomized, placebo-controlled trial (RCT) design with strict criteria (non-stented patients, stone burden 1-2 cm, no prior interventions), the study also evaluates secondary outcomes including ureteral injury severity, stone-free rates (SFR), post-operative pain (VAS), complications, hospital stay length, and medication side effects.
84 studies on the registry are indexed under Ureterolithiasis; 19 are open to participants now.
This study's enrollment of 42 is below the median of 101 across 66 interventional studies indexed under Ureterolithiasis.
Browse Ureterolithiasis studies →Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Procedure: Preoperative sioldosin to facilitate ureteric access sheath insertion in RIRS
Procedure: ureteric access sheath insertion in RIRS without silodosin (Placebo)
group A (study group) that included 21 patients who received silodosin 'one capsule 8 mg per day for 1 week preoperatively
group B (study group) that included 21 patients who received Placebo'one capsule per day for 1 week preoperatively
Assess success of ureteric access sheath placement.
assess success of ureteric access sheath placement as follows: 1. spontaneous passage of UAS without dilatation or 2. passage of UAS after dilatation or 3. failure of the UAS insertion.
Time frame: during the operation in the OR
Operative time
Time frame: from time of induction of anaesthesia in surgery till the end of procedure.
Cost of the procedure
Overall cost of each procedure included cost of standard procedure of flexible URS added to cost of medication prior to operations. If any case needed ureteral dilatation, the cost of dilators was added. Also, in case of complications occurred, additional cost of management of these complications was added. Finally, in cases of failed UAS insertion, the cost of auxiliary procedure was added. Cost was calculated initially in Egyptian pounds and was converted to U.S dollars for standardization.
Time frame: from admission and through study completion
complications
Assess postoperativePain, fever and Residual stones
Time frame: Perioperative and up to 24 weeks
Plan to share: No
Started Feb 2025 (actual). Primary completion is estimated for Aug 2025, 6 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 6 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.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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