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

Non-stented Ureteroscopic Laser Lithotripsy for Ureteric Stones Clinical Trial

Official title:

Effect of Perioperative Selective alpha1-blockers in Non-stented Ureteroscopic Laser Lithotripsy for Ureteric Stones

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04557202
• Other study ID #: fwa00001989
• Status: Completed
• Phase: Phase 3
• Start date: September 1, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: September 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 1, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Non-stented Ureteroscopic Laser Lithotripsy for Ureteric Stones
• Ureteral Calculi
• Ureterolithiasis

Intervention

Drug:
• Tamsulosin Oral Capsule
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.
• Placebo
Placebo - control group

Locations

Country	Name	City	State
Egypt	Urology department - ain shams university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	intraoperative assessment
Secondary	Time of operation (min)	duration of the procedure in minutes	intraoperative assessment
Secondary	Lower urinary tract symptoms "LUTs"	(frequency, urgency and dysuria) (Yes/NO)	early postoperative period ( 2 weeks)
Secondary	Need for analgesia	need for analgesics for postoperative pain according to the numeric rating scale (yes/no)	first day postoperative
Secondary	Gross Hematuria	post operative hematuria (present or not )	first day postoperative
Secondary	Fever	elevated body temperature post operative in degree Celsius	early postoperative (2 weeks)
Secondary	hospital stay	duration in hours	from few hours up to 2 days postoperative