Does Tamsulosin Facilitate Semi-rigid Ureteroscopic

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

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.

Study Overview

• Status: Unknown
• Conditions: Ureter Stone
• Intervention / Treatment: Procedure: rigid ureteroscopy

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: mahmoud a gaber; Phone Number: +201129248656; Email: aboshika52@gmail.com

Study Locations

• Egypt
  • Assiut
    • Asyūţ, Assiut, Egypt, 71511
      • Recruiting
      • Mahmoud Ahmed Gaber
      • Contact: mahmoud a gaber, ph; Phone Number: +201129248656; Email: aboshika52@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo group; people who given placebo to become agroup of comparison with the other group	Procedure: rigid ureteroscopy; endoscopic treatment of ureteric stones by extraction or peumatic desintegration or laser; Other Names: endoscopic treatment of ureteric stone
Active Comparator: tamsulosin group; people who given tamsulosin to know the effect on ureteroscopy and compare with the control group	Procedure: rigid ureteroscopy; endoscopic treatment of ureteric stones by extraction or peumatic desintegration or laser; Other Names: endoscopic treatment of ureteric stone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of patients develop spontaneous expulsion of stone	the stone spontaneously expelled without intervension	up to 3 weeks pre operative
Number of patients showing dilated ureteric orifice	during ureteroscopy easy introduction in the ureter	intraoperative
Number of patients need dilatation below stone	difficult introduce the ureteroscope and reach the stone	intraoperative
Number of patients need dormia extraction or forceps without disintegration	that is due to dilated ureter so easy remove the stone	intraoperative
Time of operation from introduction of ureteroscope until stone extraction	to know how easy introduction and expulsion of the ureteroscope	intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of patients developed side effect from tamsulosin	any side effect from alpha blocker	up to 3 weeks pre operative
Rate of patients developed complication	any compliction during ureteroscopy such as perforation	intraoperative
Number of patients show failure of ureteroscopy	failed introduction or extraction of stone	intraoperative
Number of patients show residual stone post ureteroscopy	difficulty in expulsion of all stones	postoperative 4 weeks

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: ahmed m abdel hamed, Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2020
• Primary Completion (Anticipated): October 15, 2021
• Study Completion (Anticipated): October 15, 2021

Study Registration Dates

• First Submitted: October 15, 2020
• First Submitted That Met QC Criteria: October 20, 2020
• First Posted (Actual): October 26, 2020

Study Record Updates

• Last Update Posted (Actual): October 26, 2020
• Last Update Submitted That Met QC Criteria: October 20, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Pathological Conditions, Anatomical; Ureteral Diseases; Urolithiasis; Urinary Calculi; Calculi; Ureteral Calculi; Ureterolithiasis
• Other Study ID Numbers: tamsulosin and uretroscopy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No