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

Renal Colic Clinical Trial

Official title:

Comparative Study Between 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05150899
• Other study ID #: antihistaminic in renal colic
• Status: Not yet recruiting
• Start date: November 30, 2021
• Est. completion date: November 25, 2022

Study information

• Verified date: December 2021
• Source: Assiut University
• Contact: adel kurkar, MD
• Phone: 01098197880
• Email: adel.abdelmouteleb[@]med.aun.edu.eg
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: November 25, 2022
• Est. primary completion date: November 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colic
• Recurrence
• Renal Colic
• Ureter Stone
• Ureteral Calculi
• Ureterolithiasis

Intervention

Drug:
• Tamsulosin Hcl 0.4Mg Cap
alpha blocker
• fexofenadine 180 mg Oral tablet
antihistaminic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & 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. Review. — View Citation

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. — View Citation

Giuliano F, Ückert 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 — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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 — View Citation

Shokeir AA. Renal colic: new concepts related to pathophysiology, diagnosis and treatment. Curr Opin Urol. 2002 Jul;12(4):263-9. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of each treatment in case of patient presented with acute renal colic	(% of patients show relief of the pain).	3 weeks
Primary	Duration of relieve of the symptoms	relieve of renal colic	in 24 hours
Primary	Rate of recurrence of pain and if need analgesic	how many times pain come again	3 weeks
Primary	Numbers of patients showing expulsion of stone	how many people stone expulsed during treatment	3 weeks
Primary	Number of patients underwent URS and duration taken from start of treatment	patient with persistent pain	3 weeks
Primary	Rate of complication from treatment	any side effect from treatment	3 weeks
Primary	Rate of hospital admission and number of admissions.	due to persistent pain	3 weeks
Primary	Rate of drop out from the study due to complication or noncompliance.	patient exit from study	3 weeks