drugset / Trial / NCT06999135
Comparison of Silodosin and Tamsulosin for Medical Expulsive Therapy in Patients With Ureteral Stones
RandomizedParallel-groupOpen-labelTreatment
Summary
This study compares the effectiveness and side effect profiles of Tamsulosin and Silodosin in medical expulsive therapy (MET) for ureteric stones. Conducted as a randomized control trial at Sir Ganga Ram Hospital, Lahore, 180 patients were analyzed-89 on Tamsulosin and 93 on Silodosin. Results showed that Silodosin had a higher stone expulsion rate, especially within 14 days, and fewer side effects compared to Tamsulosin. Common side effects included orthostatic hypotension, abnormal ejaculation, and headaches, with Silodosin showing a better overall safety profile.
Timeline
- Start
- 2023-10-01
- Primary completion
- 2024-04-01
- Completion
- 2024-08-15
Publications
- Background Itoh Y, Okada A, Yasui T, Hamamoto S, Hirose M, Kojima Y, Tozawa K, Sasaki S, Kohri K. Efficacy of selective alpha1A adrenoceptor antagonist silodosin in the medical expulsive therapy for ureteral stones. Int J Urol. 2011 Sep;18(9):672-4. doi: 10.1111/j.1442-2042.2011.02810.x. Epub 2011 Jun 26.
- Background Thongprayoon C, Krambeck AE, Rule AD. Determining the true burden of kidney stone disease. Nat Rev Nephrol. 2020 Dec;16(12):736-746. doi: 10.1038/s41581-020-0320-7. Epub 2020 Aug 4.
- Background Kino M, Hayashi T, Hino D, Nakada T, Kitoh H, Akakura K. Patients' poor performance status is an independent risk factor for urosepsis induced by kidney and ureteral stones. Urolithiasis. 2021 Oct;49(5):477-484. doi: 10.1007/s00240-021-01256-4. Epub 2021 Mar 23.
- Background 17. REHMAN I, KHAN H, FAROOQ A, MAHMOOD A, DIN QAM, HABIB B. Study on Uroliths Composition in Tertiary Care Hospital of Pakistan. Magnesium. 2021;7:18-9.
- Background Halinski A, Bhatti KH, Boeri L, Cloutier J, Davidoff K, Elqady A, Fryad G, Gadelmoula M, Hui H, Petkova K, Popov E, Rawa B, Saltirov I, Spivacow FR, Belthangady Monu Zeeshan Hameed, Trinchieri A, Buchholz N. Stone composition of renal stone formers from different global regions. Arch Ital Urol Androl. 2021 Oct 1;93(3):307-312. doi: 10.4081/aiua.2021.3.307.
- Background Hsu YP, Hsu CW, Bai CH, Cheng SW, Chen KC, Chen C. Silodosin versus tamsulosin for medical expulsive treatment of ureteral stones: A systematic review and meta-analysis. PLoS One. 2018 Aug 28;13(8):e0203035. doi: 10.1371/journal.pone.0203035. eCollection 2018.
- Background Rahman MJ, Faridi MS, Mibang N, Singh RS. Comparing tamsulosin, silodosin versus silodosin plus tadalafil as medical expulsive therapy for lower ureteric stones: A randomised trial. Arab J Urol. 2017 Dec 24;16(2):245-249. doi: 10.1016/j.aju.2017.11.012. eCollection 2018 Jun.
- Background Sharma G, Pareek T, Kaundal P, Tyagi S, Singh S, Yashaswi T, Devan SK, Sharma AP. Comparison of efficacy of three commonly used alpha-blockers as medical expulsive therapy for distal ureter stones: A systematic review and network meta-analysis. Int Braz J Urol. 2022 Sep-Oct;48(5):742-759. doi: 10.1590/S1677-5538.IBJU.2020.0548.
- Background Malin JM Jr, Deane RF, Boyarsky S. Characterisation of adrenergic receptors in human ureter. Br J Urol. 1970 Apr;42(2):171-4. doi: 10.1111/j.1464-410x.1970.tb10018.x. No abstract available.
- Background Segura JW, Preminger GM, Assimos DG, Dretler SP, Kahn RI, Lingeman JE, Macaluso JN Jr. Ureteral Stones Clinical Guidelines Panel summary report on the management of ureteral calculi. The American Urological Association. J Urol. 1997 Nov;158(5):1915-21. doi: 10.1016/s0022-5347(01)64173-9.
- Background Ibrahim AI, Shetty SD, Awad RM, Patel KP. Prognostic factors in the conservative treatment of ureteric stones. Br J Urol. 1991 Apr;67(4):358-61. doi: 10.1111/j.1464-410x.1991.tb15161.x.
- Background Pietropaolo A, Proietti S, Geraghty R, Skolarikos A, Papatsoris A, Liatsikos E, Somani BK. Trends of 'urolithiasis: interventions, simulation, and laser technology' over the last 16 years (2000-2015) as published in the literature (PubMed): a systematic review from European section of Uro-technology (ESUT). World J Urol. 2017 Nov;35(11):1651-1658. doi: 10.1007/s00345-017-2055-z. Epub 2017 Jun 7.
- Background Hughes T, Ho HC, Pietropaolo A, Somani BK. Guideline of guidelines for kidney and bladder stones. Turk J Urol. 2020 Nov;46(Supp. 1):S104-S112. doi: 10.5152/tud.2020.20315. Epub 2020 Oct 9.
- Background Strohmaier WL, Wrobel BM, Schubert G. Overweight, insulin resistance and blood pressure (parameters of the metabolic syndrome) in uric acid urolithiasis. Urol Res. 2012 Apr;40(2):171-5. doi: 10.1007/s00240-011-0403-9. Epub 2011 Aug 25.
- Background Ahmed AF, Al-Sayed AY. Tamsulosin versus Alfuzosin in the Treatment of Patients with Distal Ureteral Stones: Prospective, Randomized, Comparative Study. Korean J Urol. 2010 Mar;51(3):193-7. doi: 10.4111/kju.2010.51.3.193. Epub 2010 Mar 19.
- Results Soliman MG, El-Gamal O, El-Gamal S, Abdel Raheem A, Abou-Ramadan A, El-Abd A. Silodosin versus Tamsulosin as Medical Expulsive Therapy for Children with Lower-Third Ureteric Stones: Prospective Randomized Placebo-Controlled Study. Urol Int. 2021;105(7-8):568-573. doi: 10.1159/000513074. Epub 2021 Feb 1.
- Results Morita T, Wada I, Saeki H, Tsuchida S, Weiss RM. Ureteral urine transport: changes in bolus volume, peristaltic frequency, intraluminal pressure and volume of flow resulting from autonomic drugs. J Urol. 1987 Jan;137(1):132-5. doi: 10.1016/s0022-5347(17)43904-8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Silodosin | Unknown | 8 mg | Oral |
Indications
No indication recorded.