CTRI/2024/10/075428
Not yet recruiting
Phase 3
ASSESSMENT OF PATIENT REPORTED OUTCOME MEASURES IN EARLY VERSUS LATE DOUBLE J STENT REMOVAL POST-URETEROSCOPIC LITHOTRIPSY
Vardhman Mahaveer MedicalCollege Safdarjung hospital Department of urology1 site in 1 country64 target enrollmentStarted: October 29, 2024Last updated:
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Vardhman Mahaveer MedicalCollege Safdarjung hospital Department of urology
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- USSQ score
Overview
Brief Summary
Purpose of this study is recruit post URSL patients in two groups as per their DJ stent removal status in early (1 week) or late (3 week) phase and then assess their patient related outcomes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Adults aged 18 years or older undergoing URSL with DJ stent placement who provide informed consent for participation.
Exclusion Criteria
- •Pregnant women.
- •Non-functional kidneys.
- •Known allergic reactions to materials used in stents.
- •Unable to complete the USSQ due to cognitive impairments.
- •Positive urine culture report.
- •Iatrogenic injury
- •Incomplete stone clearance.
Outcomes
Primary Outcomes
USSQ score
Time Frame: 1, 2, 3, 4 week
UTI
Time Frame: 1, 2, 3, 4 week
Secondary Outcomes
- To evaluate the incidence of urinary tract infections and stent-related complications in relation to the timing of stent removal.(1, 2, 3, 4 week)
Investigators
Dr Sambit Kar
Vardhaman mahaveer medical college
Study Sites (1)
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