Does Tamsulosin Facilitate Semi-rigid Ureteroscopic

Ureter Stone Clinical Trial

Official title:

Does Preoperative Tamsulosin Facilitate Semi-rigid Ureteroscopic Management of Lower Ureteric Calculi Prospective, Randomized Double Blind Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04602403
• Other study ID #: tamsulosin and uretroscopy
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2020
• Est. completion date: October 15, 2021

Study information

• Verified date: October 2020
• Source: Assiut University
• Contact: mahmoud a gaber
• Phone: +201129248656
• Email: aboshika52[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Ureteric calculi are one of the most common reasons for frequent Urolithiasis. The estimated prevalence is 8-13% of all calculi.

Medical expulsive therapy (MET) is recommended by the European Association of Urology (EAU) (2013) for 5-10 mm ureteric stones to facilitate stone passage. For MET, alpha blockers, mainly tamsulosin, have shown efficacy in several randomized controlled trials. The underlying pathophysiology of this therapy is supported by the presence and distribution of adrenoreceptors in the ureter. Blocking the action of alpha-1 receptors by pharmacological agents (alpha blockers), such as alfuzosin, terazosin, doxazosin, and, most typically, tamsulosin, results in the relaxation of the ureteric smooth muscle.

Ureteroscopy (URS) is the most commonly performed procedure for the treatment of ureteral calculi, with a high (>90%) stone-free rate after a single treatment. Advancing a rigid ureteroscope into a non-dilated ureter may be difficult and cause complications. Ureteric dilatation may provide access to stones, but not in all cases, and ureteral mucosal injury up to perforation might occur.

Description:

Based on the role of alpha blockers, mainly tamsulosin, in MET of ureteric calculus, the investigator will attempt to extend the use of alpha blockers prior to URS for procedural ease. the investigator will conduct a prospective, randomized double-blind study to evaluate whether alpha blockers facilitate the negotiation of the ureteroscope if administered preoperatively.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 15, 2021
• Est. primary completion date: October 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Lower ureteral stone.

• Age: 18 - 75 years.

• normal renal function.

• single sided ureteral stone with normal other kideny.

• sign the informed consent.

• Be willing/able to adhere to follow up visits.

Exclusion Criteria:

• Upper and middle ureteral stones.

• renal impairment.

• Age < 18 years or 75 < years.

• female who were pregnant

• bilateral ureteric stone or solitary kidney.

• urinary tract infection need drainage.

Related Conditions & MeSH terms

• Ureter Stone
• Ureteral Calculi
• Ureterolithiasis

Intervention

Procedure:
• rigid ureteroscopy
endoscopic treatment of ureteric stones by extraction or peumatic desintegration or laser

Locations

Country	Name	City	State
Egypt	Mahmoud Ahmed Gaber	Asyut	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients develop spontaneous expulsion of stone	the stone spontaneously expelled without intervension	up to 3 weeks pre operative
Primary	Number of patients showing dilated ureteric orifice	during ureteroscopy easy introduction in the ureter	intraoperative
Primary	Number of patients need dilatation below stone	difficult introduce the ureteroscope and reach the stone	intraoperative
Primary	Number of patients need dormia extraction or forceps without disintegration	that is due to dilated ureter so easy remove the stone	intraoperative
Primary	Time of operation from introduction of ureteroscope until stone extraction	to know how easy introduction and expulsion of the ureteroscope	intraoperative
Secondary	Rate of patients developed side effect from tamsulosin	any side effect from alpha blocker	up to 3 weeks pre operative
Secondary	Rate of patients developed complication	any compliction during ureteroscopy such as perforation	intraoperative
Secondary	Number of patients show failure of ureteroscopy	failed introduction or extraction of stone	intraoperative
Secondary	Number of patients show residual stone post ureteroscopy	difficulty in expulsion of all stones	postoperative 4 weeks