Evaluation of Quality of Life in Patients After Placement of a Modified Double J Ureteral Stent
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSt. Luke's Clinical Hospital, Russia
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18 years and older
Patients with kidney stones
Patients with ureteral stones
Disqualifiers
Congenital anomalies of the urinary tract
Urinary tract infections
Upper urinary tract obstruction
Complicated ureteroscopy (e.g., ureteral perforation)
Trial design
Design model
Parallel
Treatments tested in this trial
Ureteric stent insertion
Procedure/SurgeryUreteric 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
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Group I (DJ stent)Active comparator 1 intervention
Group B: Group II (modified DJ stent)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Intraoperative2
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.
Time frame
Postoperative: 1st and 7th day, before stent removalSecondary outcomes
1
Patient's height
The patient's height is measured in centimeters.
Time frame
Preoperative2
Patient's weight
The patient's weight is measured in centimeters.
Time frame
Preoperative3
Body mass index (BMI)
Body mass index (BMI) is a value derived from the mass (weight) and height of a person. BMI = kg/m2
Time frame
Preoperative4
Operative time
total operative time in minutes
Time frame
Intraoperative (measured from start to end of procedure)Sponsors and contacts
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Source ClinicalTrials.gov