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

NCT ID: NCT05150899

Last Updated: 2021-12-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-30
• Study Completion Date: 2022-11-25

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.

Detailed Description

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.

1. history taken about patient pain onset, duration and type with scoring the pain by World Health Organization numerical pain score of 0-10.

2. Ultrasonography done to determine if kidney obstructed and grade of obstruction at the day 1 day 15 and day 30.

3. 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, 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.

4. In case of patient presented by acute renal colic the time of administration of treatment recorded and the time of relief pain recorded.

5. CT scan done to ensure urolithiases if no CT done at the first day and after 30 days.

6. Full labs done especially serum creatinine and serum uric acid.

Conditions

Renal Colic; Ureter Stone

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Tamsulosin Hcl 0.4Mg Cap

Intervention Type: DRUG

alpha blocker

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.

Tamsulosin Hcl 0.4Mg Cap

Intervention Type: DRUG

alpha blocker

fexofenadine 180 mg Oral tablet

Intervention Type: DRUG

antihistaminic

Interventions

Tamsulosin Hcl 0.4Mg Cap

alpha blocker

Intervention Type: DRUG

fexofenadine 180 mg Oral tablet

antihistaminic

Intervention Type: DRUG

Other Intervention Names

tamsule; telefast

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mostafa Kamel Abdel Rahman

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

adel kurkar, MD

Role: PRINCIPAL_INVESTIGATOR

Assiut University

mostafa kamel, demonstrator

Role: PRINCIPAL_INVESTIGATOR

Assiut University

ahmed eltaher, MD

Role: STUDY_CHAIR

Assiut University

ahmed elbadry, MD

Role: STUDY_CHAIR

Assiut University

ahmed abdelhameed, MD

Role: STUDY_CHAIR

Assiut University

rabee gadelkareem, MD

Role: STUDY_CHAIR

Assiut University

hosney behnsawy, MD

Role: STUDY_CHAIR

Assiut University

mohamed zarzour, MD

Role: STUDY_CHAIR

Assiut University

Central Contacts

adel kurkar, MD

Role: CONTACT

Phone: 01098197880

Email: adel.abdelmouteleb@med.aun.edu.eg

References

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.

Reference Type: RESULT

PMID: 22266271 (View on PubMed)

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.

Reference Type: RESULT

PMID: 11756098 (View on PubMed)

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.

Reference Type: RESULT

PMID: 17011944 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23018163 (View on PubMed)

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.

Reference Type: RESULT

PMID: 17102958 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25530364 (View on PubMed)

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.

Reference Type: RESULT

PMID: 2466358 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27908918 (View on PubMed)

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.

Reference Type: RESULT

PMID: 12072644 (View on PubMed)

Other Identifiers

antihistaminic in renal colic

Identifier Type: -

Identifier Source: org_study_id