Does Tamsulosin Facilitate Semi-rigid Ureteroscopic
Primary Purpose
Ureter Stone
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
rigid ureteroscopy
Sponsored by
About this trial
This is an interventional other trial for Ureter Stone
Eligibility Criteria
Inclusion Criteria:
- Lower ureteral stone.
- Age: 18 - 75 years.
- normal renal function.
- single sided ureteral stone with normal other kideny.
- sign the informed consent.
- Be willing/able to adhere to follow up visits.
Exclusion Criteria:
- Upper and middle ureteral stones.
- renal impairment.
- Age < 18 years or 75 < years.
- female who were pregnant
- bilateral ureteric stone or solitary kidney.
- urinary tract infection need drainage.
Sites / Locations
- Mahmoud Ahmed GaberRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
placebo group
tamsulosin group
Arm Description
people who given placebo to become agroup of comparison with the other group
people who given tamsulosin to know the effect on ureteroscopy and compare with the control group
Outcomes
Primary Outcome Measures
Rate of patients develop spontaneous expulsion of stone
the stone spontaneously expelled without intervension
Number of patients showing dilated ureteric orifice
during ureteroscopy easy introduction in the ureter
Number of patients need dilatation below stone
difficult introduce the ureteroscope and reach the stone
Number of patients need dormia extraction or forceps without disintegration
that is due to dilated ureter so easy remove the stone
Time of operation from introduction of ureteroscope until stone extraction
to know how easy introduction and expulsion of the ureteroscope
Secondary Outcome Measures
Rate of patients developed side effect from tamsulosin
any side effect from alpha blocker
Rate of patients developed complication
any compliction during ureteroscopy such as perforation
Number of patients show failure of ureteroscopy
failed introduction or extraction of stone
Number of patients show residual stone post ureteroscopy
difficulty in expulsion of all stones
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04602403
Brief Title
Does Tamsulosin Facilitate Semi-rigid Ureteroscopic
Official Title
Does Preoperative Tamsulosin Facilitate Semi-rigid Ureteroscopic Management of Lower Ureteric Calculi Prospective, Randomized Double Blind Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2020 (Actual)
Primary Completion Date
October 15, 2021 (Anticipated)
Study Completion Date
October 15, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut 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
Ureteric calculi are one of the most common reasons for frequent Urolithiasis. The estimated prevalence is 8-13% of all calculi.
Medical expulsive therapy (MET) is recommended by the European Association of Urology (EAU) (2013) for 5-10 mm ureteric stones to facilitate stone passage. For MET, alpha blockers, mainly tamsulosin, have shown efficacy in several randomized controlled trials. The underlying pathophysiology of this therapy is supported by the presence and distribution of adrenoreceptors in the ureter. Blocking the action of alpha-1 receptors by pharmacological agents (alpha blockers), such as alfuzosin, terazosin, doxazosin, and, most typically, tamsulosin, results in the relaxation of the ureteric smooth muscle.
Ureteroscopy (URS) is the most commonly performed procedure for the treatment of ureteral calculi, with a high (>90%) stone-free rate after a single treatment. Advancing a rigid ureteroscope into a non-dilated ureter may be difficult and cause complications. Ureteric dilatation may provide access to stones, but not in all cases, and ureteral mucosal injury up to perforation might occur.
Detailed Description
Based on the role of alpha blockers, mainly tamsulosin, in MET of ureteric calculus, the investigator will attempt to extend the use of alpha blockers prior to URS for procedural ease. the investigator will conduct a prospective, randomized double-blind study to evaluate whether alpha blockers facilitate the negotiation of the ureteroscope if administered preoperatively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ureter Stone
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
people who given placebo to become agroup of comparison with the other group
Arm Title
tamsulosin group
Arm Type
Active Comparator
Arm Description
people who given tamsulosin to know the effect on ureteroscopy and compare with the control group
Intervention Type
Procedure
Intervention Name(s)
rigid ureteroscopy
Other Intervention Name(s)
endoscopic treatment of ureteric stone
Intervention Description
endoscopic treatment of ureteric stones by extraction or peumatic desintegration or laser
Primary Outcome Measure Information:
Title
Rate of patients develop spontaneous expulsion of stone
Description
the stone spontaneously expelled without intervension
Time Frame
up to 3 weeks pre operative
Title
Number of patients showing dilated ureteric orifice
Description
during ureteroscopy easy introduction in the ureter
Time Frame
intraoperative
Title
Number of patients need dilatation below stone
Description
difficult introduce the ureteroscope and reach the stone
Time Frame
intraoperative
Title
Number of patients need dormia extraction or forceps without disintegration
Description
that is due to dilated ureter so easy remove the stone
Time Frame
intraoperative
Title
Time of operation from introduction of ureteroscope until stone extraction
Description
to know how easy introduction and expulsion of the ureteroscope
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
Rate of patients developed side effect from tamsulosin
Description
any side effect from alpha blocker
Time Frame
up to 3 weeks pre operative
Title
Rate of patients developed complication
Description
any compliction during ureteroscopy such as perforation
Time Frame
intraoperative
Title
Number of patients show failure of ureteroscopy
Description
failed introduction or extraction of stone
Time Frame
intraoperative
Title
Number of patients show residual stone post ureteroscopy
Description
difficulty in expulsion of all stones
Time Frame
postoperative 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Lower ureteral stone.
Age: 18 - 75 years.
normal renal function.
single sided ureteral stone with normal other kideny.
sign the informed consent.
Be willing/able to adhere to follow up visits.
Exclusion Criteria:
Upper and middle ureteral stones.
renal impairment.
Age < 18 years or 75 < years.
female who were pregnant
bilateral ureteric stone or solitary kidney.
urinary tract infection need drainage.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mahmoud a gaber
Phone
+201129248656
Email
aboshika52@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ahmed m abdel hamed
Organizational Affiliation
Assiut University
Official's Role
Study Director
Facility Information:
Facility Name
Mahmoud Ahmed Gaber
City
Asyūţ
State/Province
Assiut
ZIP/Postal Code
71511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mahmoud a gaber, ph
Phone
+201129248656
Email
aboshika52@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Does Tamsulosin Facilitate Semi-rigid Ureteroscopic
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