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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Non-stented Ureteroscopic Laser Lithotripsy for Ureteric Stones

Intervention / Treatment
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* Drug: Tamsulosin Oral Capsule
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>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 | Drug: Tamsulosin Oral Capsule<br>* 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.<br>|
| Placebo Comparator: Group B<br>62 patients who underwent non-stented ureteroscopy and laser and received placebo. | Drug: Placebo<br>* Placebo - control group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uretroscopic lithotripsy, non-stented, alpha1-blocker, LUTS, postoperative pain