Prospective, Randomized Trial Comparing Soft and Firm Ureteral Stents

NCT06749652 | Completed FDA Device

• 1 other identifier: 0119-23-SMC
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Urolithiasis; stent-symptoms

Outcome Measures

Primary Outcomes (1)

• the Ureteral stent symptoms questionnaire (USSQ )index score

  The summation of the Ureteral stent symptoms questionnaire (USSQ) individual question scores. The questionnaire includes 32 questions, with a scale of zero to five points each. The USSQ Index score represents the summation of each indivisual question score, with a scale of 0-160, with higher score means the patients is suffering from more severe symptoms.

  14 days after stent insertion

Secondary Outcomes (5)

• Ureteral stent symptoms questionnaire (USSQ) urinary domain score

  14 days after stent insertion

• Ureteral stent symptoms questionnaire (USSQ) pain domain score

  14 days after stent insertion

• Ureteral stent symptoms questionnaire (USSQ) general health domain score

  14 days after stent insertion

• Ureteral stent symptoms questionnaire (USSQ) work performance domain score

  14 days after stent insertion

• Ureteral stent symptoms questionnaire (USSQ) sexual performance domain score

  14 days after stent insertion

Other Outcomes (5)

• Intraoperative lenght

  Upon data collection, at the day of the surgery

• Postoperative complications

  30 days post discharge

• Hospitalization length

  From hospitalization day until discharge days, collected upon patients' discharge, on average of 1 day

Study Arms (2)

Soft silicone stent arm

EXPERIMENTAL

Patients who recieved soft silicone ureteral stent (Universa, Cook medical) at the end of the ureteroscopy

Device: Soft silicone ureteral stent insertion

Firm silicone stent arm

EXPERIMENTAL

Patients who recieved firm silicone ureteral stent (percuflex plux, boston scientificl) at the end of the ureteroscopy

Device: firm silicone stent insertion

Interventions

firm silicone stent insertion DEVICE

Insertion of firm silicon ureteral stent (Percuflex Plus)

Also known as: percuflex plus

Firm silicone stent arm

Soft silicone ureteral stent insertion DEVICE

Soft silicone ureteral stent insertion

Also known as: Universa

Soft silicone stent arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients aged over 18 years
• ureteral stones measuring up to 2cm requiring URS and laser lithotripsy

You may not qualify if:

• pediatric patients
• bilateral stones requiring bilateral URS and laser lithotripsy,
• stone located in the renal pelvis or calyces,
• intra-operative complications of any kind,
• any residual stones during the procedure,
• ureteroscopies in which no stones were treated ("white ureteroscopy").

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, Central District, 5262000, Israel

Location

MeSH Terms

Conditions

Urolithiasis

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Nir Kleinmann, M.D.

  Sheba Medical Center, Tel-Hashomer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urology Resident

Model Details: Parallel model has been used. The randomization allocation sequence (1:1) has been generated using asymptomatic maximal randomization. Patients, data collectors and data analysts were blinded to the allocation. As blinding the surgeons during procedure was not possible, they were not involved in either data collection or analysis.

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: December 27, 2024
• Study Start: July 9, 2023
• Primary Completion: September 10, 2024
• Study Completion: September 10, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Information will be available after the study will be published, for 2 years
• Access Criteria: Upon request to the primary investigator, an anonimized excel sheath will be sent

Locations

IL (1)