Evaluation of Quality of Life in Patients After Placement of a Modified Double J Ureteral Stent
NCT ID: NCT07275879
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2025-12-28
2026-04-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group I (DJ stent)
Non-prestented patients who will insert a standard DJ stent after surgery
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
Group II (modified DJ stent)
Non-prestented patients who will insert a modified DJ stent after surgery
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Patients with kidney stones
* Patients with ureteral stones
Exclusion Criteria
* Urinary tract infections
* Upper urinary tract obstruction
* Complicated ureteroscopy (e.g., ureteral perforation)
* Pregnancy
* Pre-stented patients
18 Years
ALL
No
Sponsors
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St. Luke's Clinical Hospital, Russia
OTHER
Responsible Party
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Mikheev Yury
Urologist
Locations
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St. Luke's Clinical Hospital
Saint Petersburg, Outside U.S./Canada, Russia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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21/4
Identifier Type: -
Identifier Source: org_study_id
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