Clinical trial NCT04557202: Effect of Perioperative Selective alpha1-blockers in Non-stented Ureteroscopic Laser Lithotripsy for Ureteric Stones: A Randomized Controlled Trial
Official title: Effect of Perioperative Selective alpha1-blockers in Non-stented Ureteroscopic Laser Lithotripsy for Ureteric Stones
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-stented Ureteroscopic Laser Lithotripsy for Ureteric Stones
Keywords: Uretroscopic lithotripsy
non-stented
alpha1-blocker
LUTS
postoperative pain
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-09-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Need for dilatation
timeFrame: intraoperative assessment
Secondary outcomes:
measure: Time of operation (min)
timeFrame: intraoperative assessment
measure: Lower urinary tract symptoms "LUTs"
timeFrame: early postoperative period ( 2 weeks)
measure: Need for analgesia
timeFrame: first day postoperative
measure: Gross Hematuria
timeFrame: first day postoperative
measure: Fever
timeFrame: early postoperative (2 weeks)
measure: hospital stay
timeFrame: from few hours up to 2 days postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Urology department - ain shams university
Study officials:
References: