Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07275879

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

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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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years and older
  • Patients with kidney stones
  • Patients with ureteral stones
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

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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

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