Role of Antihistaminic in Acute Renal Colic Prevent Pain Recurrence and Expulsion of Ureteric Stone ≤ 1cm

NCT05150899 | Unknown DMC FDA Drug

• 1 other identifier: antihistaminic in renal colic
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Renal Colic; Ureter Stone

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

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.

Drug: Tamsulosin Hcl 0.4Mg Cap

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.

Drug: Tamsulosin Hcl 0.4Mg Cap; Drug: fexofenadine 180 mg Oral tablet

Interventions

Tamsulosin Hcl 0.4Mg Cap DRUG

alpha blocker

Also known as: tamsule

Tamsulosin 0.4mg; fexofenadine 180 mg in combination of Tamsulosin 0.4mg

fexofenadine 180 mg Oral tablet DRUG

antihistaminic

Also known as: telefast

fexofenadine 180 mg in combination of Tamsulosin 0.4mg

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Age from 14 to 70 years old.
• Patient with ureteric stone 5-10 MM.
• Patient with acute renal colic presented to emergency with obstructed kidney with urgent MSCT show stone ureter 5-10 MM and patient come without colic with CT showing lower third stone of the same measurement.

You may not qualify if:

• Age less than 14 or more than 70.
• Chronically diseased patient cardiac that contraindicated to take PD5I or tamsulosin.
• Only functioning kidney.
• CKD Patient.
• Bilateral ureteric stone.
• urinary tract infection.
• severe refractory pain.
• severe hydronephrosis.
• multiple ureteric stones.
• ischemic heart disease, congestive cardiac failure, or complicated hypertension.
• pregnant or lactating mothers.
• patient refuse medical treatment.
• congenital anomalies.
• previous ureteric surgery.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (9)

• 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.

  PMID: 22266271 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.

  PMID: 11756098 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.

  PMID: 17011944 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.

  PMID: 23018163 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.

  PMID: 17102958 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.

  PMID: 25530364 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.

  PMID: 2466358 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.

  PMID: 27908918 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.

  PMID: 12072644 RESULT

MeSH Terms

Conditions

Renal Colic; Ureterolithiasis

Interventions

Tamsulosin; Capsules; fexofenadine; Tablets

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• adel kurkar, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

• mostafa kamel, demonstrator

  Assiut University

  PRINCIPAL INVESTIGATOR

• ahmed eltaher, MD

  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

Central Study Contacts

adel kurkar, MD

CONTACT

01098197880; adel.abdelmouteleb@med.aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 26, 2021
• First Posted: December 9, 2021
• Study Start: November 30, 2021
• Primary Completion: November 25, 2022
• Study Completion: November 25, 2022
• Last Updated: December 9, 2021

Record last verified: 2021-12