Evaluation of Quality of Life in Patients After Placement of a Modified Double J Ureteral Stent. Randomized Clinical Trial.
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- St. Luke's Clinical Hospital, Russia
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- ureteral reflux
Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
ureteral reflux
Time Frame: Intraoperative
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.
Assessment the Ureteral Stent Symptom Questionnaire (USSQ)
Time Frame: Postoperative: 1st and 7th day, before stent removal
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.
Secondary Outcomes
- 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)
Investigators
Mikheev Yury
Urologist
St. Luke's Clinical Hospital, Russia