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Clinical Trials/CTRI/2024/10/075428
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

Sponsor
Vardhman Mahaveer MedicalCollege Safdarjung hospital Department of urology
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Sambit Kar

Vardhaman mahaveer medical college

Study Sites (1)

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