Tamsulosin Assisted Ureteral Access Sheath Insertion
Primary Purpose
Renal Stone, Retrograde Intrarenal Surgery, Urolithiasis
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Tamsulosin
Sponsored by
About this trial
This is an interventional treatment trial for Renal Stone
Eligibility Criteria
Inclusion Criteria:
- renal stone undergoing retrograde intrarenal surgery
Exclusion Criteria:
- not on tamsulosin or other alpha blockers regularly
- ureteral stricture
- concurrent ureteric stone
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1 week of tamsulosin
no additional medication
Arm Description
1 week of tamsulosin tablet 400mcg once a night
Outcomes
Primary Outcome Measures
successful insertion of ureteral access sheath to the upper ureter (above the level of SI joint on fluoroscopy)
Secondary Outcome Measures
grade of ureteric injury after ureteral access sheath removal
post operative complications
stone free rate
need for additional procedures
Full Information
NCT ID
NCT05197088
First Posted
January 9, 2022
Last Updated
January 9, 2022
Sponsor
Sengkang General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05197088
Brief Title
Tamsulosin Assisted Ureteral Access Sheath Insertion
Official Title
Medication Facilitated Ureteral Access Sheath Deployment During Ureteroscopy: the Impact of One Week of Pre-operative Tamsulosin
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 9, 2022 (Anticipated)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sengkang General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Aim is to study if 1 week of pre operative tamsulosin would enable easier insertion of ureteral access sheath in primary retrograde intrarenal surgery for renal stone disease
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Stone, Retrograde Intrarenal Surgery, Urolithiasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1 week of tamsulosin
Arm Type
Experimental
Arm Description
1 week of tamsulosin tablet 400mcg once a night
Arm Title
no additional medication
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Tamsulosin
Intervention Description
1 week of tamsulosin
Primary Outcome Measure Information:
Title
successful insertion of ureteral access sheath to the upper ureter (above the level of SI joint on fluoroscopy)
Time Frame
during operation
Secondary Outcome Measure Information:
Title
grade of ureteric injury after ureteral access sheath removal
Time Frame
during operation
Title
post operative complications
Time Frame
3 months
Title
stone free rate
Time Frame
3 months
Title
need for additional procedures
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
renal stone undergoing retrograde intrarenal surgery
Exclusion Criteria:
not on tamsulosin or other alpha blockers regularly
ureteral stricture
concurrent ureteric stone
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Tamsulosin Assisted Ureteral Access Sheath Insertion
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