Soft Vs. Firm Ureteral Stents: Symptoms Improvement Without Affecting Outcomes- a Prospective, Randomized Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Urolithiasis
- Sponsor
- Sheba Medical Center
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- the Ureteral stent symptoms questionnaire (USSQ )index score
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Dr. Orel Hemo
Urology Resident
Sheba Medical Center
Eligibility Criteria
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").
Outcomes
Primary Outcomes
the Ureteral stent symptoms questionnaire (USSQ )index score
Time Frame: 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 Outcomes
- 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)