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Prospective, Randomized Trial Comparing Soft and Firm Ureteral Stents

NCT06749652 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-12-27

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate whether ureteral stent type impacts stent-related symptoms and quality of life in patients undergoing ureteroscopy (URS) and stone lithotripsy for ureteral stones. The main questions it aims to answer are:

* Does a soft polymer stent reduce stent-related symptoms compared to a firm polymer stent?
* Does stent type affect intra- and postoperative complications? Researchers will compare patients receiving a soft polymer stent (Universa®, Cook Medical) to those receiving a firm polymer stent (Percuflex®, Boston Scientific) to determine if soft stents improve patient comfort and quality of life while maintaining a similar safety profile.

Participants will:

* Undergo URS and stone lithotripsy for ureteral stones.
* Be randomly assigned to receive either a soft or firm ureteral stent.
* Complete the Ureteral Stent Symptoms Questionnaire (USSQ) upon stent removal, 14 days after URS.

Conditions

  • Urolithiasis

Interventions

DEVICE

firm silicone stent insertion

Insertion of firm silicon ureteral stent (Percuflex Plus)

DEVICE

Soft silicone ureteral stent insertion

Soft silicone ureteral stent insertion

Sponsors & Collaborators

  • Sheba Medical Center

    lead OTHER_GOV

Principal Investigators

  • Nir Kleinmann, M.D. · Sheba Medical Center, Tel-Hashomer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-09
Primary Completion
2024-09-10
Completion
2024-09-10
FDA Device
Yes

Countries

  • Israel

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06749652 on ClinicalTrials.gov