Actively Recruiting
Evaluation of Quality of Life After Placement of a Modified Double-J Ureteral Stent Randomized Clinical Trial
Led by St. Luke's Clinical Hospital, Russia · Updated on 2025-12-10
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the quality of life in patients who receive a modified Double-J ureteral stent after surgery for kidney or ureteral stones. The study focuses on complications often linked to standard Double-J stents, such as urinary tract infections, stent encrustation, migration, and stent-related symptoms (SRS) including pain, blood in urine, and discomfort, which affect patients' daily life. The modified stent has a thinner loop at the distal end designed to reduce these symptoms by lessening bladder irritation and urine reflux. The trial is a prospective, randomized, open-label controlled study with two groups: one receiving the standard Double-J stent and the other receiving the modified version. Both groups include patients who have not had previous stenting and have no ureteral obstruction. After surgery such as retrograde intrarenal surgery (RIRS) or ureteroscopy, the presence of urine reflux is assessed, and stents are placed under cystoscopic and X-ray guidance. Patients fill out the Ureteral Stent Symptom Questionnaire (USSQ) on the first and seventh days post-operation and before stent removal to track symptoms. Participants will undergo evaluations before surgery including height, weight, and body mass index measurements. Operative time is recorded during the procedure. Urine reflux is assessed intraoperatively. Researchers will monitor symptom changes through questionnaires after surgery and before stent removal to compare the impact of both stent types on quality of life. The study will use statistical tests to analyze symptom severity and reflux occurrence. The total duration and follow-up align with these postoperative assessments.
CONDITIONS
Brief Title
Evaluation of Quality of Life in Patients After Placement of a Modified Double J Ureteral Stent
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years and older
- Patients with kidney stones
- Patients with ureteral stones
You will not qualify if you...
- Congenital anomalies of the urinary tract
- Urinary tract infections
- Upper urinary tract obstruction
- Complicated ureteroscopy (e.g., ureteral perforation)
- Pregnancy
- Pre-stented patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of stent placement until removal
Participants will have a ureteric stent inserted after surgery (RIRS or ureteroscopy) to help urine drain. Two types of stents are used: a standard double-J stent or a modified double-J stent.
3 postoperative visits (1st day, 7th day, and before stent removal) to complete the Ureteral Stent Symptom Questionnaire (USSQ) and assess reflux
Trial Site Locations
Total: 1 location
1
St. Luke's Clinical Hospital
Saint Petersburg, Outside U.S./Canada, Russia
Actively Recruiting
Research Team
D
Dmitriy Sytnik
Y
Yury Mikheev
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here