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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04557202
Enrollment
120
Registered
2020-09-21
Start date
2017-09-01
Completion date
2018-12-01
Last updated
2020-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-stented Ureteroscopic Laser Lithotripsy for Ureteric Stones

Keywords

Uretroscopic lithotripsy, non-stented, alpha1-blocker, LUTS, postoperative pain

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.

Interventions

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.

DRUGPlacebo

Placebo - control group

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

patients were blinded to the type of intervention, as well as the data collector

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Need for dilatationintraoperative 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

MeasureTime frameDescription
Lower urinary tract symptoms LUTsearly postoperative period ( 2 weeks)(frequency, urgency and dysuria) (Yes/NO)
Need for analgesiafirst day postoperativeneed for analgesics for postoperative pain according to the numeric rating scale (yes/no)
Time of operation (min)intraoperative assessmentduration of the procedure in minutes
Feverearly postoperative (2 weeks)elevated body temperature post operative in degree Celsius
hospital stayfrom few hours up to 2 days postoperativeduration in hours
Gross Hematuriafirst day postoperativepost operative hematuria (present or not )

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026