Effect of Perioperative Selective alpha1-blockers in Non-stented Ureteroscopic Laser Lithotripsy for Ureteric Stones: A Randomized Controlled Trial

Ain Shams University120 enrolled

Overview

To assess the efficacy of peri-operative alpha1 blockers on improving the success rate and decreasing complications of non-stented ureteroscopic laser lithotripsy for ureteric stones.

Objective: To assess the efficacy of peri-operative alpha1 blockers on improving the success rate and decreasing complications of non-stented ureteroscopic laser lithotripsy for ureteric stones. Patients and Methods: A randomized control trial was conducted at two high volume urological centers from September 2017 to December 2018. We enrolled 120 patients with lower ureteric stones. They were randomly divided into two groups. Group A had 58 patients who underwent non-stented ureteroscopy using Ho-YAG laser for stone disintegration and received alpha1-blockers for one week preoperatively and another two weeks postoperatively, while Group B had 62 patients who underwent non-stented ureteroscopy and laser and received placebo.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Non-stented Ureteroscopic Laser Lithotripsy for Ureteric Stones

Interventions

Tamsulosin Oral CapsuleDRUG

To assess the efficacy of peri-operative alpha1 blockers on improving the success rate and decreasing complications of non-stented ureteroscopic laser lithotripsy for ureteric stones.

PlaceboDRUG

Placebo - control group

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patients with single lower ureteric stones of size range between 0.5 and 2 cm Exclusion Criteria: * Patients under the age of 18, pregnant women, or those with urinary tract infections, uncorrected bleeding disorders or coagulopathies, bilateral ureteric stones, single kidney, ureteral stricture, multiple ipsilateral ureteric stones were excluded from our study. Also, any patients who required ureteric stenting were excluded from our study.

Locations (1)

Urology department - ain shams university

Cairo, Egypt

Outcomes

Primary Outcomes

Need for dilatation

( to evaluate whether the ureteroscope will pass easily through the ureter if not , serial ureteric dilatation will be done and documented ) it is a yes or no evaluation

Time frame: intraoperative assessment

Secondary Outcomes

Time of operation (min)

duration of the procedure in minutes

Time frame: intraoperative assessment

Lower urinary tract symptoms "LUTs"

(frequency, urgency and dysuria) (Yes/NO)

Time frame: early postoperative period ( 2 weeks)

Need for analgesia

need for analgesics for postoperative pain according to the numeric rating scale (yes/no)

Time frame: first day postoperative

Gross Hematuria

post operative hematuria (present or not )

Time frame: first day postoperative

Fever

elevated body temperature post operative in degree Celsius

Time frame: early postoperative (2 weeks)

hospital stay

duration in hours

Time frame: from few hours up to 2 days postoperative

Data from ClinicalTrials.gov

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