Prospective, Randomized Trial Comparing Soft and Firm Ureteral Stents

Not Applicable

Completed

• Conditions: Urolithiasis

• Registration Number: NCT06749652
• Lead Sponsor: Sheba Medical Center

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.

Detailed Description

Study Design and Patient Selection

1. Study Period and Ethical Approval:

* Conducted between July 2023 and July 2024 following institutional review board approval (SMC 0119-23).

* Informed consent obtained from all participants.

* Adhered to the Declaration of Helsinki.

2. Stent Types and Randomization:

* Soft stent: Universa® (Cook Medical).

* Firm stent: Percuflex™ Plus (Boston Scientific).

* Randomization in a 1:1 ratio using asymptomatic maximal randomization.

Surgical Technique and Intervention Operative Team included three fellowship-trained endourologists.

Procedure Details:

* Ureteroscopy performed using standard 6.5/8.5Fr semi-rigid ureteroscope.

* Lithotripsy performed using a 120W Holmium:YAG laser (0.3 Joule, 40 Hertz, dusting technique).

Stent Placement was performed using a 0.038 Inch glide wire. 6Fr stents used, either soft or firm polymer material, according to randomization.

Proximal stent curls positioned in the upper calyx/renal pelvis; distal curls in the bladder.

Postoperative Care Stent removal was scheduled 2 weeks post-procedure, ans performed using a flexible cystoscope in the outpatient clinic.

Symptoms assesed using the Ureteral Stent Symptoms Questionnaire (USSQ) that was completed at the stent removal visit.

Statistical Analysis

1. Sample Size Calculation:

* Based on a 3-point difference in USSQ index score between groups.

* Assumed 5% type I error and 80% power.

* Adjusted for a 10% dropout rate; target sample size: 140 patients.

2. Data Blinding:

* Patients, data collectors, and analysts blinded to allocation.

* Since blinding the surgeons to stent type was impossible, surgeons were not involved in data collection or analysis.

3. Analysis Methods:

* Continuous variables: Mann-Whitney U test; median and IQR.

* Categorical variables: Pearson's chi-square or Fisher's exact test; frequencies and proportions.

* Multivariate linear regression for USSQ index and urinary domain scores.

* Statistical significance set at p\<0.05.

* Analyses conducted using IBM SPSS v26.

This protocol ensures a rigorous and reproducible methodology for evaluating the impact of stent type on patient-reported outcomes following ureteroscopy and lithotripsy.

Study Timeline

• Study Start: 2023-07-09
• Primary Completion: 2024-09-10
• Study Completion: 2024-09-10
• Status Verified: 2024-12
• Study First Submitted: 2024-12-15
• Study First Submitted QC: 2024-12-24
• Last Update Submitted: 2024-12-24
• Study First Posted: 2024-12-27
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

• 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").

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
the Ureteral stent symptoms questionnaire (USSQ )index score	14 days after stent insertion	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.

Secondary Outcome Measures

Name	Time	Method
Ureteral stent symptoms questionnaire (USSQ) urinary domain score	14 days after stent insertion	There are total of 5 different domains in the Ureteral stent symptoms questionnaire (USSQ): urinary synptoms, pain, general health, occupational and sexual distress. The summation of the score of each domain represents a secondary outcome. The urinary domain has 10 questions, each in a scale of zero to five, to a total of 0-50. Higher score means the patient experience more severe urinary symptoms.
Ureteral stent symptoms questionnaire (USSQ) pain domain score	14 days after stent insertion	There are total of 5 different domains in the Ureteral stent symptoms questionnaire (USSQ): urinary synptoms, pain, general health, occupational and sexual distress. The summation of the score of each domain represents a secondary outcome. The pain domain has 7 questions, each in a scale of zero to five, to a total of 0-35. Higher score means the patient experience more severe pain.
Ureteral stent symptoms questionnaire (USSQ) general health domain score	14 days after stent insertion	There are total of 5 different domains in the Ureteral stent symptoms questionnaire (USSQ): urinary synptoms, pain, general health, occupational and sexual distress. The summation of the score of each domain represents a secondary outcome. The general health domain has 6 questions, each in a scale of zero to five, to a total of 0-30. Higher score means the stent affecting the patients general health in a more prominent way.
Ureteral stent symptoms questionnaire (USSQ) work performance domain score	14 days after stent insertion	There are total of 5 different domains in the Ureteral stent symptoms questionnaire (USSQ): urinary synptoms, pain, general health, occupational and sexual distress. The summation of the score of each domain represents a secondary outcome. The work performance domain has 6 questions, each in a scale of zero to five, to a total of 0-30. Higher score means the stent affecting the patients work performance in a more prominent way.
Ureteral stent symptoms questionnaire (USSQ) sexual performance domain score	14 days after stent insertion	There are total of 5 different domains in the Ureteral stent symptoms questionnaire (USSQ): urinary synptoms, pain, general health, occupational and sexual distress. The summation of the score of each domain represents a secondary outcome. The sexual performance domain has three questions, each in a scale of zero to five, to a total of 0-15. Higher score means the stent affecting the patients sexual performance in a more prominent way.

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Ramat Gan, Hamerkaz, Israel