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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Urolithiasis; Ureteral Double-J Stent
• Intervention / Treatment: Procedure: Ureteric stent insertion

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dmitriy Sytnik; Phone Number: +7 931 367 78 58; Email: doc.dmitriysytnik@gmail.com
• Study Contact Backup: Name: Yury Mikheev; Phone Number: +79315412190; Email: mikheevyra@gmail.com

Study Locations

• Russia
  • Outside U.S./Canada
    • Saint Petersburg, Outside U.S./Canada, Russia
      • Recruiting
      • St. Luke's Clinical Hospital
      • Contact: Dmitriy Sytnik; Phone Number: +7 931 367 78 58; Email: doc.dmitriysytnik@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group I (DJ stent); Non-prestented patients who will insert a standard DJ stent after surgery	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
Experimental: Group II (modified DJ stent); Non-prestented patients who will insert a modified DJ stent after surgery	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ureteral reflux	Injection of raradiopaque dye using gravity- filling cystogram followed by X-ray imaging. If contrast entered or not entered the ureter and kidney, ureteral reflux was considered positive or not, respectively.	Intraoperative
Assessment the Ureteral Stent Symptom Questionnaire (USSQ)	Ureteral stent symptom questionnaire (USSQ) a psychometrically valid measure to evaluate symptoms and impact on quality of life of ureteral stents. USSQ contains 38 questions and 2 visual analog scales (VAS), allowing assessment of the severity of SRS and their impact on the patient's quality of life. The questions are grouped into 6 domains: Urinary symptoms Pain General health Work performance Sexual matters Additional problems For each domain, a score index is calculated as the sum of the points from all questions in that domain. The scale scores range from 1 to 10, with higher values indicating more severe SRS and lower quality of life.	Postoperative: 1st and 7th day, before stent removal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's height	The patient's height is measured in centimeters.	Preoperative
Patient's weight	The patient's weight is measured in centimeters.	Preoperative
Body mass index (BMI)	Body mass index (BMI) is a value derived from the mass (weight) and height of a person. BMI = kg/m2	Preoperative
Operative time	total operative time in minutes	Intraoperative (measured from start to end of procedure)
Surgery	Type of surgery: ureteroscopy or retrograde intrarenal surgery or stenting	Preoperative

Collaborators and Investigators

• Sponsor: St. Luke's Clinical Hospital, Russia

Study record dates

Study Major Dates

• Study Start (Estimated): December 28, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: December 8, 2025
• First Posted (Actual): December 10, 2025

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urolithiasis
• Other Study ID Numbers: 21/4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We are currently finalizing our data sharing policy. All required individual participant data underlying the reported results will be made available for regulatory purposes immediately upon request, and may be shared with researchers following publication after de-identification, contingent on submission of a methodologically sound proposal and compliance with institutional and national privacy regulations

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No