An interventional study of Ureteric stent insertion in Ureteral Double-J Stent, Urolithiasis and Quality of Life, sponsored by St. Luke's Clinical Hospital, Russia. Recruiting at 1 site in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-10.
Sponsored by St. Luke's Clinical Hospital, Russia · Not applicable, Interventional, and Treatment
Double-J (DJ) stents are commonly inserted after ureteroscopy. There are several complications associated with the presence of DJ stent: urinary tract infection, stent encrustation, stent migration, and stent-related symptoms (SRS).
SRS occur in up to 80% of patients and include pain, hematuria, and dysuria, all of which negatively impact the patient's quality of life.
Physicians proposed the distal end of the ureteral stents might involve in SRS by over-simulating the trigone of bladder. The design of the distal end, made with a thinner loop than that of a standard DJ stent, is intended to mitigate SRS and reduce urine reflux.
Study Design:
Prospective, randomized, open-label, controlled trial with two parallel arms.
Study Center:
Department of Urology, St. Luke's Clinical Hospital, St. Petersburg, Russia
Study Population:
All patients should not be prestented and should have no ureteral obstruction. 40 patients, divided into four equal groups of 20 people each:
Group I (standard DJ stent):
Group II (modified DJ stent)
Procedure for evaluation:
After surgery ( RIRS, ureteroscopy) reflux is assessed (gravity-filling cystogram). After stenting, the presence of post-stent reflux is assessed.
In the postoperative period, patients complete the USSQ (1st day, 7th day and before stent removal).
Statistics method:
The results are presented as the median and interquartile range (IQR) for continuous variables, and as frequencies (n with percentage %) for categorical variables. Statistical comparisons of all primary and secondary outcome measures between different treatment groups were conducted using the Mann-Whitney U test for continuous data. Meanwhile, categorical variables were analyzed using either Pearson's chi-square (χ²) test or Fisher's exact test, where appropriate. Thenthreshold for statistical significance was established at 5%, implying that a p-value less than 0.05 (p \< 0.05) was considered statistically significant for all tests performed.
253 studies on the registry are indexed under Urolithiasis; 67 are open to participants now.
This study's planned enrollment of 40 is below the median of 100 across 182 interventional studies indexed under Urolithiasis.
Browse Urolithiasis studies →St. Luke's Clinical Hospital, Russia is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Non-prestented patients who will insert a standard DJ stent after surgery
Procedure: Ureteric stent insertion
Non-prestented patients who will insert a modified DJ stent after surgery
Procedure: Ureteric stent insertion
Ureteric stent insertion is the procedure to place a thin, flexible plastic tube that is temporarily in the ureter to help urine drain. They are placed with cystoscopic and X-ray guidances in an operating room setting
ureteral reflux
Injection of raradiopaque dye using gravity- filling cystogram followed by X-ray imaging. If contrast entered or not entered the ureter and kidney, ureteral reflux was considered positive or not, respectively.
Time frame: Intraoperative
Assessment the Ureteral Stent Symptom Questionnaire (USSQ)
Ureteral stent symptom questionnaire (USSQ) a psychometrically valid measure to evaluate symptoms and impact on quality of life of ureteral stents. USSQ contains 38 questions and 2 visual analog scales (VAS), allowing assessment of the severity of SRS and their impact on the patient's quality of life. The questions are grouped into 6 domains: Urinary symptoms Pain General health Work performance Sexual matters Additional problems For each domain, a score index is calculated as the sum of the points from all questions in that domain. The scale scores range from 1 to 10, with higher values indicating more severe SRS and lower quality of life.
Time frame: Postoperative: 1st and 7th day, before stent removal
Patient's height
The patient's height is measured in centimeters.
Time frame: Preoperative
Patient's weight
The patient's weight is measured in centimeters.
Time frame: Preoperative
Body mass index (BMI)
Body mass index (BMI) is a value derived from the mass (weight) and height of a person. BMI = kg/m2
Time frame: Preoperative
Operative time
total operative time in minutes
Time frame: Intraoperative (measured from start to end of procedure)
Surgery
Type of surgery: ureteroscopy or retrograde intrarenal surgery or stenting
Time frame: Preoperative
Plan to share: No — We are currently finalizing our data sharing policy. All required individual participant data underlying the reported results will be made available for regulatory purposes immediately upon request, and may be shared with researchers following publication after de-identification, contingent on submission of a methodologically sound proposal and compliance with institutional and national privacy regulations
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St. Luke's Clinical Hospital, Russia