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

Phase 3

Completed

• Conditions: Non-stented Ureteroscopic Laser Lithotripsy for Ureteric Stones
• Interventions: Drug: Tamsulosin Oral Capsule; Drug: Placebo

• Registration Number: NCT04557202
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study Start: 2017-09-01
• Primary Completion: 2018-08-01
• Study Completion: 2018-12-01
• Status Verified: 2020-09
• Study First Submitted: 2020-09-16
• Study First Submitted QC: 2020-09-18
• Last Update Submitted: 2020-09-18
• Study First Posted: 2020-09-21
• Last Update Posted: 2020-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• patients with single lower ureteric stones of size range between 0.5 and 2 cm

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Tamsulosin Oral Capsule	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
Group B	Placebo	62 patients who underwent non-stented ureteroscopy and laser and received placebo.

Primary Outcome Measures

Name	Time	Method
Need for dilatation	intraoperative assessment	( 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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Urology department - ain shams university; 🇪🇬 Cairo, Egypt