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NCT05197088 Clinical Trial

Tamsulosin Assisted Ureteral Access Sheath Insertion

Urolithiasis Clinical Trial

Official title:
Medication Facilitated Ureteral Access Sheath Deployment During Ureteroscopy: the Impact of One Week of Pre-operative Tamsulosin

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05197088
Other study ID # 2019/2156
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date January 9, 2022
Est. completion date July 31, 2023

Study information
Verified date January 2022
Source Sengkang General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 110
Est. completion date July 31, 2023
Est. primary completion date March 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - renal stone undergoing retrograde intrarenal surgery Exclusion Criteria: - not on tamsulosin or other alpha blockers regularly - ureteral stricture - concurrent ureteric stone

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Tamsulosin
1 week of tamsulosin

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Sengkang General Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary successful insertion of ureteral access sheath to the upper ureter (above the level of SI joint on fluoroscopy) during operation
Secondary grade of ureteric injury after ureteral access sheath removal during operation
Secondary post operative complications 3 months
Secondary stone free rate 3 months
Secondary need for additional procedures 3 months
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