Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Receiving Sioldosin 8 mg prior to intervention | Active Comparator |
| |
| Receiving Placebo prior to intervention | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative sioldosin to facilitate ureteric access sheath insertion in RIRS | Procedure | group A (study group) that included 21 patients who received silodosin 'one capsule 8 mg per day for 1 week preoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | during the operation in the OR |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mahmoud A. Mohammed, M.D. | Ain Shams University | Study Chair |
| Younan R. Samir, M.D. | Ain Shams University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University hospitals (Demerdash) | Cairo | Abasia | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Benedict, A., Rajenthiran, V., & Eswaramurthy, A. (2021). Effects of silodosin, darifenacin, and combination therapy for the treatment of ureteral stent related discomforts. International Surgery Journal, 8(10), 3031-3035. | ||
| 31507224 | Background | Alsaikhan B, Koziarz A, Lee JY, Pace KT. Preoperative Alpha-Blockers for Ureteroscopy for Ureteral Stones: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Endourol. 2020 Jan;34(1):33-41. doi: 10.1089/end.2019.0520. Epub 2019 Oct 9. | |
| Background | Alaridy, H. M., Zwain, K. M. A., Al-Mosawi, H. Q., & Hadi, N. R. (2020). Comparison of silodosin, tadalafil and combinations prior to ureteroscopic management of ureteral stones. Systematic Reviews in Pharmacy, 11(4), 238-242. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D053039 | Ureterolithiasis |
| D007669 | Kidney Calculi |
| ID | Term |
|---|---|
| D014515 | Ureteral Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| C095285 | silodosin |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ureteric access sheath insertion in RIRS without silodosin (Placebo) | Procedure | group B (study group) that included 21 patients who received Placebo'one capsule per day for 1 week preoperatively |
|
| from admission and through study completion |
| complications | Assess postoperativePain, fever and Residual stones | Perioperative and up to 24 weeks |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D052801 | Male Urogenital Diseases |
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014545 | Urinary Calculi |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |