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Recruiting NCT07275879

Evaluation of Quality of Life in Patients After Placement of a Modified Double J Ureteral Stent

No phase Interventional Ureteral Double-J Stent Urolithiasis Quality of Life

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ureteric stent insertion.
Who it may be relevant to
Registry conditions: Ureteral Double-J Stent, Urolithiasis, Quality of Life. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Russia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Evaluation of Quality of Life in Patients After Placement of a Modified Double J Ureteral Stent. Randomized Clinical Trial.

Overview

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.

Detailed description

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.

Interventions

  • 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

Primary outcome measures

  • ureteral reflux [Time frame: Intraoperative]
  • Assessment the Ureteral Stent Symptom Questionnaire (USSQ) [Time frame: Postoperative: 1st and 7th day, before stent removal]
Secondary outcome measures (5)
  • Patient's height [Time frame: Preoperative]
  • Patient's weight [Time frame: Preoperative]
  • Body mass index (BMI) [Time frame: Preoperative]
  • Operative time [Time frame: Intraoperative (measured from start to end of procedure)]
  • Surgery [Time frame: Preoperative]

Eligibility criteria

Inclusion criteria

  • Patients aged 18 years and older
  • Patients with kidney stones
  • Patients with ureteral stones

Exclusion criteria

  • Congenital anomalies of the urinary tract
  • Urinary tract infections
  • Upper urinary tract obstruction
  • Complicated ureteroscopy (e.g., ureteral perforation)
  • Pregnancy
  • Pre-stented patients

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Russia · 1 center
  • St. Luke's Clinical Hospital — Saint Petersburg

Identifiers

NCT: NCT07275879 · 21/4

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗