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

St. Luke's Clinical Hospital, Russia

Status: Enrolling

Conditions: Ureteral Double-J Stent; Quality of Life; Urolithiasis

Treatments: Procedure: Ureteric stent insertion

Study type: Interventional

Funder types: Other

Identifiers

NCT07275879

21/4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Group I (DJ stent)

Active Comparator group

Description:

Non-prestented patients who will insert a standard DJ stent after surgery

Treatment:

Procedure: Ureteric stent insertion

Group II (modified DJ stent)

Experimental group

Description:

Non-prestented patients who will insert a modified DJ stent after surgery

Treatment:

Procedure: Ureteric stent insertion