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Urolithiasis is one of the most common urological diseases. The risk of stone disease ranges between 5% and 12% worldwide. Ureteric stones account for ≈20% of all urinary tract stones and >70% of the ureteric stones are located in the lower third of the ureter, i.e., distal ureteric stones (DUS). The colicky-type pain in the ureter, an increase in proximal peristalsis through activation of intrinsic ureteral pacemakers may contribute to the perception of pain. Muscle spasm increased proximal peristalsis, local inflammation, irritation, and oedema at the site of obstruction may contribute to the development of pain through chemoreceptor activation and stretching of submucosal free nerve endings. α-adrenergic blockers, anti-inflammatory drugs, antihistaminic and calcium channel blockers, which have a relaxant effect on the ureteric smooth musculature. The presence of histamine receptors in the ureter have been presented in various studies. The histamine-1 (H1) receptors have been shown to have a wide distribution Histamine, which is secreted from the mast cells, causes strong peristaltic contractions in the ureter. alpha adrenoreceptor antagonists (i.e., tamsulosin) have been employed in the treatment of ureteric colic due to smooth muscle relaxation so their potential ability to increase stone passage, reduce pain medication use and reduce urologic interventions. According to the currently accepted view, renal colic management starts with NSAI drugs also NSAI has role in decrease inflammation and oedema and increase expulsion rate . in this study we will compare the use of alpha blocker versus alpha blocker and antihistaminic in management of acute renal colic prevent pain recurrence and increase expulsion rate of ureteric stone ≤ 1cm, with analgesic use in case of acute stage.
All the patients will be included within inclusion criteria After providing written informed consent, these patients were randomly divided into 2 groups by use of a computer-generated random number table.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tamsulosin 0.4mg | group A receive Tamsulosin 0.4mg in combination of NSAI drug if patient present with colic, if not in renal colic at bed time Tamsulosin 0.4mg with analgesic on demand. |
| |
| fexofenadine 180 mg in combination of Tamsulosin 0.4mg | group B receive pheniramine maleate 50mg injection every 12hr for 24 hr in combination of Tamsulosin 0.4mg and NSAI drug then fexofenadine 180 mg in combination of Tamsulosin 0.4mg and NSAI drug on demand if patient present with colic. if not in renal colic at bed time fexofenadine 180 mg in combination of Tamsulosin with NSAI on demand. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamsulosin Hcl 0.4Mg Cap | Drug | alpha blocker |
|
| Measure | Description | Time Frame |
|---|---|---|
| Success rate of each treatment in case of patient presented with acute renal colic | (% of patients show relief of the pain). | 3 weeks |
| Duration of relieve of the symptoms | relieve of renal colic | in 24 hours |
| Rate of recurrence of pain and if need analgesic | how many times pain come again | 3 weeks |
| Numbers of patients showing expulsion of stone | how many people stone expulsed during treatment | 3 weeks |
| Number of patients underwent URS and duration taken from start of treatment | patient with persistent pain | 3 weeks |
| Rate of complication from treatment | any side effect from treatment | 3 weeks |
| Rate of hospital admission and number of admissions. | due to persistent pain | 3 weeks |
| Rate of drop out from the study due to complication or noncompliance. | patient exit from study | 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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All cases that fulfil the selection criteria that will be followed up in the department of Assiut university hospital (non-probability sample size) with Confidence Level 90 %, Population Size 10000, Margin of Error 8 % with expected size of 100 patients enrolled in the study. these patients were randomly divided into 2 groups 50 in each group.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| adel kurkar, MD | Contact | 01098197880 | adel.abdelmouteleb@med.aun.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| adel kurkar, MD | Assiut University | Principal Investigator |
| mostafa kamel, demonstrator | Assiut University | Principal Investigator |
| ahmed eltaher, MD |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22266271 | Result | Bader MJ, Eisner B, Porpiglia F, Preminger GM, Tiselius HG. Contemporary management of ureteral stones. Eur Urol. 2012 Apr;61(4):764-72. doi: 10.1016/j.eururo.2012.01.009. Epub 2012 Jan 14. | |
| 11756098 | Result | Coll DM, Varanelli MJ, Smith RC. Relationship of spontaneous passage of ureteral calculi to stone size and location as revealed by unenhanced helical CT. AJR Am J Roentgenol. 2002 Jan;178(1):101-3. doi: 10.2214/ajr.178.1.1780101. |
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| ID | Term |
|---|---|
| D056844 | Renal Colic |
| D053039 | Ureterolithiasis |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077409 | Tamsulosin |
| D002214 | Capsules |
| C093230 | fexofenadine |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| fexofenadine 180 mg Oral tablet | Drug | antihistaminic |
|
|
| Assiut University |
| Study Chair |
| ahmed elbadry, MD | Assiut University | Study Chair |
| ahmed abdelhameed, MD | Assiut University | Study Chair |
| rabee gadelkareem, MD | Assiut University | Study Chair |
| hosney behnsawy, MD | Assiut University | Study Chair |
| mohamed zarzour, MD | Assiut University | Study Chair |
| 17011944 | Result | Hollingsworth JM, Rogers MA, Kaufman SR, Bradford TJ, Saint S, Wei JT, Hollenbeck BK. Medical therapy to facilitate urinary stone passage: a meta-analysis. Lancet. 2006 Sep 30;368(9542):1171-9. doi: 10.1016/S0140-6736(06)69474-9. |
| 23018163 | Result | Giuliano F, Uckert S, Maggi M, Birder L, Kissel J, Viktrup L. The mechanism of action of phosphodiesterase type 5 inhibitors in the treatment of lower urinary tract symptoms related to benign prostatic hyperplasia. Eur Urol. 2013 Mar;63(3):506-16. doi: 10.1016/j.eururo.2012.09.006. Epub 2012 Sep 11. |
| 17102958 | Result | Gratzke C, Uckert S, Kedia G, Reich O, Schlenker B, Seitz M, Becker AJ, Stief CG. In vitro effects of PDE5 inhibitors sildenafil, vardenafil and tadalafil on isolated human ureteral smooth muscle: a basic research approach. Urol Res. 2007 Feb;35(1):49-54. doi: 10.1007/s00240-006-0073-1. Epub 2006 Nov 11. |
| 25530364 | Result | Kumar S, Jayant K, Agrawal MM, Singh SK, Agrawal S, Parmar KM. Role of tamsulosin, tadalafil, and silodosin as the medical expulsive therapy in lower ureteric stone: a randomized trial (a pilot study). Urology. 2015 Jan;85(1):59-63. doi: 10.1016/j.urology.2014.09.022. |
| 2466358 | Result | Ugaily-Thulesius L, Thulesius O. The effects of urine on mast cells and smooth muscle of the human ureter. Urol Res. 1988;16(6):441-7. doi: 10.1007/BF00280026. |
| 27908918 | Result | Hollingsworth JM, Canales BK, Rogers MA, Sukumar S, Yan P, Kuntz GM, Dahm P. Alpha blockers for treatment of ureteric stones: systematic review and meta-analysis. BMJ. 2016 Dec 1;355:i6112. doi: 10.1136/bmj.i6112. |
| 12072644 | Result | Shokeir AA. Renal colic: new concepts related to pathophysiology, diagnosis and treatment. Curr Opin Urol. 2002 Jul;12(4):263-9. doi: 10.1097/00042307-200207000-00001. |
| D014515 | Ureteral Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D052801 | Male Urogenital Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |