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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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

Первичные конечные точки

• ureteral reflux [Срок оценки: Intraoperative]
• Assessment the Ureteral Stent Symptom Questionnaire (USSQ) [Срок оценки: Postoperative: 1st and 7th day, before stent removal]

Вторичные конечные точки (5)

• Patient's height [Срок оценки: Preoperative]
• Patient's weight [Срок оценки: Preoperative]
• Body mass index (BMI) [Срок оценки: Preoperative]
• Operative time [Срок оценки: Intraoperative (measured from start to end of procedure)]
• Surgery [Срок оценки: Preoperative]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Россия · 1 центр

• St. Luke's Clinical Hospital — Saint Petersburg

Идентификаторы

NCT: NCT07275879 · 21/4

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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