Back to resultsEffect of Perioperative Selective alpha1-blockers in Non-stented Ureteroscopic Laser Lithotripsy for Ureteric Stones: A Randomized Controlled Trial
Primary Purpose
Non-stented Ureteroscopic Laser Lithotripsy for Ureteric Stones
Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Tamsulosin Oral Capsule
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Non-stented Ureteroscopic Laser Lithotripsy for Ureteric Stones focused on measuring Uretroscopic lithotripsy, non-stented, alpha1-blocker, LUTS, postoperative pain
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.
Sites / Locations
- Urology department - ain shams university
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Group A
Group B
Arm Description
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
62 patients who underwent non-stented ureteroscopy and laser and received placebo.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Time of operation (min)
duration of the procedure in minutes
Lower urinary tract symptoms "LUTs"
(frequency, urgency and dysuria) (Yes/NO)
Need for analgesia
need for analgesics for postoperative pain according to the numeric rating scale (yes/no)
Gross Hematuria
post operative hematuria (present or not )
Fever
elevated body temperature post operative in degree Celsius
hospital stay
duration in hours
Full Information
NCT ID
NCT04557202
First Posted
September 16, 2020
Last Updated
September 18, 2020
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT04557202
Brief Title
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
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
August 1, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-stented Ureteroscopic Laser Lithotripsy for Ureteric Stones
Keywords
Uretroscopic lithotripsy, non-stented, alpha1-blocker, LUTS, postoperative pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Masking Description
patients were blinded to the type of intervention, as well as the data collector
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
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
Arm Title
Group B
Arm Type
Placebo Comparator
Arm Description
62 patients who underwent non-stented ureteroscopy and laser and received placebo.
Intervention Type
Drug
Intervention Name(s)
Tamsulosin Oral Capsule
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo - control group
Primary Outcome Measure Information:
Title
Need for dilatation
Description
( 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
Time Frame
intraoperative assessment
Secondary Outcome Measure Information:
Title
Time of operation (min)
Description
duration of the procedure in minutes
Time Frame
intraoperative assessment
Title
Lower urinary tract symptoms "LUTs"
Description
(frequency, urgency and dysuria) (Yes/NO)
Time Frame
early postoperative period ( 2 weeks)
Title
Need for analgesia
Description
need for analgesics for postoperative pain according to the numeric rating scale (yes/no)
Time Frame
first day postoperative
Title
Gross Hematuria
Description
post operative hematuria (present or not )
Time Frame
first day postoperative
Title
Fever
Description
elevated body temperature post operative in degree Celsius
Time Frame
early postoperative (2 weeks)
Title
hospital stay
Description
duration in hours
Time Frame
from few hours up to 2 days postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Urology department - ain shams university
City
Cairo
ZIP/Postal Code
11361
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of Perioperative Selective alpha1-blockers in Non-stented Ureteroscopic Laser Lithotripsy for Ureteric Stones: A Randomized Controlled Trial
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