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

NCT07275879 | Recruiting

• 1 other identifier: 21/4
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ureteral Double-J Stent; Urolithiasis; Quality of Life

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Patient's height

  Preoperative

• Patient's weight

  Preoperative

• Body mass index (BMI)

  Preoperative

• Operative time

  Intraoperative (measured from start to end of procedure)

• Surgery

  Preoperative

Study Arms (2)

Group I (DJ stent)

ACTIVE COMPARATOR

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

Procedure: Ureteric stent insertion

Group II (modified DJ stent)

EXPERIMENTAL

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

Procedure: Ureteric stent insertion

Interventions

Ureteric stent insertion PROCEDURE

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

Group I (DJ stent); Group II (modified DJ stent)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

St. Luke's Clinical Hospital

Saint Petersburg, Outside U.S./Canada, Russia

RECRUITING

MeSH Terms

Conditions

Urolithiasis

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Dmitriy Sytnik

CONTACT

+7 931 367 78 58; doc.dmitriysytnik@gmail.com

Yury Mikheev

CONTACT

+79315412190; mikheevyra@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urologist

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 10, 2025
• Study Start: December 28, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)