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This prospective randomized controlled trial investigates the effects of alfuzosin, mirabegron, and their combination on stent-related symptoms and outcomes in patients undergoing DJ stent placement after retrograde intrarenal surgery (RIRS) for renal stones. The primary outcomes include stone-free rate and residual fragment status, while secondary outcomes focus on stent-related pain and lower urinary tract symptoms (LUTS). Patients will be randomly assigned to one of four groups: alfuzosin only, mirabegron only, combination therapy, or control. Pain and LUTS will be assessed using validated questionnaires such as the Ureteral Stent Symptom Questionnaire (USSQ) and IPSS.
Retrograde intrarenal surgery (RIRS) is a commonly used minimally invasive procedure for the treatment of renal stones. Postoperative placement of double-J (DJ) stents is often necessary but can result in significant stent-related discomfort and lower urinary tract symptoms (LUTS), which negatively impact patient quality of life. Alfuzosin, an alpha-blocker, and mirabegron, a beta-3 agonist, are pharmacological agents known to reduce stent-related symptoms. This study aims to compare the individual and combined efficacy of these agents on stent-related pain, LUTS, and postoperative stone outcomes. Patients will be evaluated for stone clearance, residual fragments (by imaging), and symptom scores over a follow-up period of 2 to 4 weeks post-RIRS
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Group 1 : The group that did not receive medical treatment | ||
| 2 | Group 2 : Alfuzosin 10 mg/d oral | ||
| 3 | Group 3 : Mirabegron 50 mg/d oral | ||
| 4 | Group 4 : Combination therapy with alfuzosin + Mirabegron |
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| Measure | Description | Time Frame |
|---|---|---|
| Stent-Related Pain Score | Pain score ranges from 0 to 39 (higher scores indicate worse pain). | Day 7 postoperatively and Day 14 postoperatively. |
| Lower Urinary Tract Symptom (LUTS) Score | IPSS ranges from 0 to 35 (higher scores indicate more severe LUTS). | Day 7 postoperatively and Day 14 postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Stone-Free Rate | Proportion of patients with no residual fragments > 2 mm on NCCT | Day 14 postoperatively |
| Residual Fragment Status | Categorization of residual fragments into 0 mm, 1-2 mm, or > 2 mm |
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Inclusion Criteria:
- Undergoing RIRS and DJ stenting
Ability to provide informed consent
Exclusion Criteria:
Prostate volume >40 mL or significant LUTS at baseline
Contraindications to alpha-blockers or mirabegron
Hepatic or severe renal impairment
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Adult patients aged 18 to 75 years undergoing retrograde intrarenal surgery (RIRS) for renal stones, followed by double-J (DJ) stent placement
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gaziantep University Faculty of Medicine Hospital | Gaziantep | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36244331 | Result | Zhang K, Yan W, Li H, Chen J, Wang Q, Chai Y, Yuan L, Zhu G. Comparison of Mirabegron plus Tamsulosin and Tamsulosin Monotherapy for the Treatment of Ureteral Stent-Related Symptoms: A Prospective Randomized Study. Urol Int. 2022;106(12):1226-1232. doi: 10.1159/000526607. Epub 2022 Oct 14. | |
| 37556003 | Result | Uslu M, Yildirim U, Ezer M, Erihan IB, Sarica K. Residual fragment size following retrograde intrarenal surgery: a critical evaluation of related variables. Urolithiasis. 2023 Aug 9;51(1):100. doi: 10.1007/s00240-023-01478-8. |
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Individual participant data (IPD) will not be shared due to patient privacy concerns and institutional policy restrictions. However, summary results will be published in scientific journals and presented at academic meetings.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 22, 2025 | May 22, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D059411 | Lower Urinary Tract Symptoms |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Day 14 postoperatively |
| 35927160 | Result | Geraghty RM, Davis NF, Tzelves L, Lombardo R, Yuan C, Thomas K, Petrik A, Neisius A, Turk C, Gambaro G, Skolarikos A, Somani BK. Best Practice in Interventional Management of Urolithiasis: An Update from the European Association of Urology Guidelines Panel for Urolithiasis 2022. Eur Urol Focus. 2023 Jan;9(1):199-208. doi: 10.1016/j.euf.2022.06.014. Epub 2022 Aug 1. |
| 32928162 | Result | Yuk HD, Park J, Cho SY, Sung LH, Jeong CW. The effect of preoperative ureteral stenting in retrograde Intrarenal surgery: a multicenter, propensity score-matched study. BMC Urol. 2020 Sep 14;20(1):147. doi: 10.1186/s12894-020-00715-1. |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |