Clinical trial NCT06749652: Prospective, Randomized Trial Comparing Soft and Firm Ureteral Stents
Official title: Soft Vs. Firm Ureteral Stents: Symptoms Improvement Without Affecting Outcomes- a Prospective, Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urolithiasis
Keywords: Urolithiasis
stent-symptoms
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2024-12-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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").

Primary outcomes:
measure: the Ureteral stent symptoms questionnaire (USSQ )index score
timeFrame: 14 days after stent insertion
Secondary outcomes:
measure: Ureteral stent symptoms questionnaire (USSQ) urinary domain score
timeFrame: 14 days after stent insertion
measure: Ureteral stent symptoms questionnaire (USSQ) pain domain score
timeFrame: 14 days after stent insertion
measure: Ureteral stent symptoms questionnaire (USSQ) general health domain score
timeFrame: 14 days after stent insertion
measure: Ureteral stent symptoms questionnaire (USSQ) work performance domain score
timeFrame: 14 days after stent insertion
measure: Ureteral stent symptoms questionnaire (USSQ) sexual performance domain score
timeFrame: 14 days after stent insertion
Other outcomes:
measure: Intraoperative lenght
timeFrame: Upon data collection, at the day of the surgery
measure: Postoperative complications
timeFrame: 30 days post discharge
measure: Hospitalization length
timeFrame: From hospitalization day until discharge days, collected upon patients' discharge, on average of 1 day
measure: Emergency department visits
timeFrame: From discharge day to 30 days post discharge
measure: Number of Re-hospitalizations
timeFrame: From surgery discharge day to 30 days post discharge
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
state: Hamerkaz
Study officials:
affiliation: Sheba Medical Center, Tel-Hashomer
name: Nir Kleinmann, M.D.
role: STUDY_DIRECTOR
References: