Ureteral Stents for Kidney Stones
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Wisconsin, Madison
Disqualifiers: Pregnancy, Transplant kidneys, Coagulopathy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This is a prospective randomized controlled trial designed to assess the differences in postoperative symptoms related to placement of a 6Fr Percuflex ureteral stents, 6Fr Tria ureteral stents, 4.8Fr Percuflex ureteral stents, and 4.8Fr Tria ureteral stents after ureteroscopy with laser lithotripsy for treatment of upper tract urinary stones. 272 participants will be enrolled and will be on study for up to approximately 10 weeks.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Ureteral Stents for Kidney Stones?
The research suggests that smaller diameter ureteral stents (like the 4.8Fr Tria ureteral stents) may improve urinary symptoms compared to larger ones, and hydrogel-coated stents are easier to insert and more visible on X-rays without increasing symptoms.
12345How does the ureteral stent treatment for kidney stones differ from other treatments?
Ureteral stents are unique because they are small tubes inserted into the ureter (the duct that carries urine from the kidney to the bladder) to help urine pass more easily, which is different from other treatments like medication or surgery that aim to break down or remove the stones directly.
678910Eligibility Criteria
This trial is for patients with kidney or ureteral stones needing endoscopic treatment and stent placement. It's not for pregnant individuals, those with transplant kidneys, irreversible coagulopathy, known ureteral strictures, planned staged procedures, or pre-surgery stents.Inclusion Criteria
I need a procedure for kidney or ureter stones that involves placing a stent.
Exclusion Criteria
I have a transplanted kidney.
I am scheduled for multiple surgery stages.
I have had a stent placed before undergoing surgery.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Pre-operative
Pre-operative visit to collect baseline data and administer WisQOL
1 week
1 visit (in-person)
Surgery and Initial Post-operative
Participants undergo laser lithotripsy and stent placement, followed by stent removal 1-2 weeks after surgery
1-2 weeks
1 surgery visit, 1 stent removal visit (in-person)
Post-operative Follow-up
Participants are monitored for symptoms and quality of life, including USSQ and WisQOL assessments
3-6 weeks
1 post-operative visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study compares postoperative symptoms from three types of ureteral stents after laser lithotripsy: a smaller 4.8Fr Tria stent and two larger ones - a 6Fr Percuflex and a 6Fr Tria. Participants are randomly assigned to one of these options.
4Treatment groups
Active Control
Group I: 6Fr Percuflex ureteral stentsActive Control1 Intervention
Group II: 4.8Fr Percuflex ureteral stentsActive Control1 Intervention
Group III: 6Fr Tria ureteral stentsActive Control1 Intervention
Group IV: 4.8Fr Tria ureteral stentsActive Control1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Wisconsin School of Medicine and Public HealthMadison, WI
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Who Is Running the Clinical Trial?
University of Wisconsin, MadisonLead Sponsor
References
An in vivo evaluation of a novel spiral cut flexible ureteral stent. [2022]The flow characteristics, ureteral conformance, and histopathologic changes of a novel spiral cut flexible ureteral stent (Percuflex Helical, Boston Scientific, Boston, MA) were evaluated in vivo in an acute and chronic porcine model.
Ureteral stents: impact of diameter and composition on patient symptoms. [2022]We prospectively analyzed three types of ureteral stents to determine the effects of diameter and composition on a patient's symptoms. Twenty stents were placed consecutively in each of the three study groups for the treatment of ureteral obstruction, prior to SWL, or following ureteroscopy: Group I = 6F Percuflex stent, Group II = 6F HydroPlus stent, and Group III = 4.8F HydroPlus stent. All stents were removed in clinic 7 to 10 days after placement. At this time, a confidential questionnaire was completed by the patient addressing the symptoms associated with the indwelling catheter. The 6F hydrogel-coated stents were somewhat easier to insert, especially in high-grade obstructions. Occasional difficulty in seeing the 4.8F stent during fluoroscopy was noted. No statistically significant difference in any of the irritative voiding symptoms-dysuria (P = 0.7998), urgency (P = 0.0928), frequency (P = 0.2646), nocturia (P = 0.2855), hematuria (P = 0.9417), pain (P = 0.4524), or incontinence (P = 0.4524)-was demonstrated. Differences in stent diameter and composition do not appear to affect symptoms. We prefer the hydrogel-coated 6F stent, as it offers advantages in ease of placement and radiographic visibility without increased symptoms.
Effects of Silicone Hydrocoated Double Loop Ureteral Stent on Symptoms and Quality of Life in Patients Undergoing Flexible Ureteroscopy for Kidney Stone: A Randomized Multicenter Clinical Study. [2020]We compared the hydrocoated silicone stent (Coloplast Imajin® hydro) to Percuflex™ Plus stent (Boston Scientific) in terms of patient comfort and quality of life after flexible ureteroscopy for stone disease over a 5-week prospective followup.
Silicone-hydrocoated ureteral stents encrustation and biofilm formation after 3-week dwell time: results of a prospective randomized multicenter clinical study. [2022]To explore the risk of encrustation and biofilm formation for silicone ureteral stents compared to percuflex polymer stents, through a randomized multicenter study.
Impact of differential ureteral stent diameters on clinical outcomes after ureteroscopy intracorporeal lithotripsy: A systematic review and meta-analysis. [2021]In this meta-analysis we assessed whether the diameter of ureteral stents (4.7-5-Fr, 6-Fr) has an impact on the rate of occurrence of urinary tract symptoms and complications after successful URS and intracorporeal lithotripsy. A systematic review was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. A rigorous search for relevant studies published in MEDLINE, Embase, and the Cochrane Controlled Trials Register was conducted to find informative randomized controlled trials. The reference lists of relevant articles were also manually searched and reviewed. The protocol was prospectively registered at PROSPERO (CRD42020202164). All statistical evaluations were performed using RevMan software version 5.3.0. Seven articles comprising 547 patients were included in the meta-analysis. After placement of ureteral stents with different diameters for approximately 1 week, we found that ureteral stents with smaller diameters (4.7-5-Fr) were associated with significant improvements in the main domain scores on the Ureteral Stent Symptom Questionnaire, such as urinary symptoms (mean difference -4.47, 95% confidence interval -5.87 to -3.08; P
Tracheal reaction to three different intraluminal stents in an animal model of tracheomalacia. [2016]Three different internal airway stents were studied in an animal model of tracheomalacia: the Palmaz stent (Johnson & Johnson, Warren, New Jersey) and the NIR stent (Medinol Ltd., Tel Aviv, Israel)--both made of stainless steel in the form of tubular mesh--and the Nitinol stent, made of nickel-titanium formed into a spiral shape. All three stents could be adequately stabilized in the malacic tracheal segment. The Nitinol stent (Medinol Ltd., Tel Aviv, Israel) proved to be less reactive to the tracheal mucosa, demonstrated higher biocompatibility with significantly less granulation tissue formation, and showed superior radial resistance. Extraction of the Nitinol stent also proved to be much smoother. This stent may be the stent of choice in the treatment of tracheo- and bronchomalacia.
Dentinal Tubule Penetration of Tricalcium Silicate Sealers. [2022]The treatments for which mineral trioxide aggregate (MTA)-based materials can be used in dentistry are expanding. Smaller particle size and easier handling properties have allowed the advent of tricalcium silicate sealers including EndoSequence BC Sealer (Brasseler USA, Savannah, GA), QuickSet2 (Avalon Biomed, Bradenton, FL), NeoMTA Plus (Avalon Biomed), and MTA Fillapex (Angelus, Londrina, Brazil). The objective of this study was to measure the tubule penetration with these sealers using continuous wave (CW) and single-cone (SC) obturation techniques.
Fluoride release from orthodontic band cements-a comparison of two in vitro models. [2019]To compare, in vitro, the fluoride release from a conventional glass ionomer cement (Ketac-Cem), a resin-modified glass ionomer cement (3M-Multicure) and a polyacid modified composite (Ultra Band-Lok) using a banded tooth model and a disc model with the same mean cement weight.
Stenting of femoropopliteal lesions using interwoven nitinol stents. [2016]The Supera stent (Abbott Laboratories, Abbott Park, Ill) has a unique biomimetic design allowing axial and longitudinal flexibility and fracture resistance. The aim of this retrospective study was to assess the midterm patency of Supera stents used to treat patients with superficial femoral and popliteal arterial disease by a single practice.
Biocompatibility and pro-mineralization effect of tristrontium aluminate cement for endodontic use. [2022]Label="Background/purpose" NlmCategory="UNASSIGNED">Tristrontium aluminate (S3A) is a hydraulic cement with setting behavior similar to that of mineral trioxide aggregate (MTA). This study examined the biological effects of S3A on mouse dental papilla cells (MDPs) in vitro and on rat exposed pulps in vivo.