Stent Placement After Ureteroscopy for Kidney Stones
Recruiting in Palo Alto (17 mi)
+8 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Vanderbilt University Medical Center
Disqualifiers: Age < 18, Pregnancy, CKD, others
No Placebo Group
Approved in 5 Jurisdictions
Trial Summary
What is the purpose of this trial?The rationale for this study is to determine if there is a difference in complications among patients undergoing ureteroscopy for renal stones who receive a stent compared to not receiving a stent postoperatively.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Ureteroscopy for kidney stones?
Research shows that ureteroscopy, including both flexible and semi-rigid types, is effective for managing kidney stones, with success rates of up to 90% for smaller stones. It is a reliable and minimally invasive method for treating stones in the urinary tract.
12345Is stent placement after ureteroscopy for kidney stones safe?
Ureteroscopy, including flexible and retrograde approaches, is generally considered safe for treating kidney stones, with most complications being mild. In a large study, complications occurred in 18.9% of procedures, mostly mild, with some related to infection. Another study found minimal complications in transplant patients, indicating the procedure's safety.
678910How does the treatment of ureteroscopy for kidney stones differ from other treatments?
Ureteroscopy is a unique treatment for kidney stones because it involves using a small scope inserted through the urethra and bladder to directly access and remove stones from the ureter or kidney, often without the need for an incision. Unlike other treatments, it can be performed with or without the placement of a ureteral stent (a small tube to keep the ureter open), which is debated for its necessity in uncomplicated cases.
1112131415Eligibility Criteria
This trial is for adults with nonobstructing kidney stones smaller than 1.5cm in total diameter who are undergoing ureteroscopy. It's not for those under 18, pregnant, planning multiple surgeries, or with certain kidney conditions like a solitary kidney or reduced function (eGFR <60 mL/min).Inclusion Criteria
I have a kidney stone smaller than 1.5cm and am getting a ureteroscopy.
Exclusion Criteria
I have one kidney or my kidney function is reduced.
I am under 18 years old.
I have a kidney stone in my ureter.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo ureteroscopy for renal stones, with or without ureteral stent placement
1 day
1 visit (in-person)
Follow-up
Participants are monitored for complications and quality of life post-ureteroscopy
4-8 weeks
2 visits (in-person)
Extended Follow-up
Participants are assessed for long-term complications and quality of life impacts
30 days
Participant Groups
The study aims to see if there's a difference in complications when patients receive a stent after ureteroscopy for kidney stones versus not receiving one at all.
2Treatment groups
Active Control
Group I: Ureteral stent groupActive Control1 Intervention
A ureteral stent will be placed after ureteroscopy.
Group II: No ureteral stent groupActive Control1 Intervention
A ureteral stent will not be placed after ureteroscopy.
Ureteroscopy is already approved in European Union, United States, Canada, Japan, Australia for the following indications:
🇪🇺 Approved in European Union as Ureteroscopy for:
- Renal calculi
- Ureteral calculi
- Upper urinary tract calculi
- Nephrolithiasis
- Ureteral obstruction
🇺🇸 Approved in United States as Ureteroscopy for:
- Kidney stones
- Ureteral stones
- Urinary tract obstruction
- Hematuria
- Ureteral tumors
🇨🇦 Approved in Canada as Ureteroscopy for:
- Renal calculi
- Ureteral calculi
- Upper urinary tract calculi
- Nephrolithiasis
- Ureteral obstruction
🇯🇵 Approved in Japan as Ureteroscopy for:
- Kidney stones
- Ureteral stones
- Urinary tract obstruction
- Hematuria
- Ureteral tumors
🇦🇺 Approved in Australia as Ureteroscopy for:
- Renal calculi
- Ureteral calculi
- Upper urinary tract calculi
- Nephrolithiasis
- Ureteral obstruction
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MontrealMontréal, Canada
Vanderbilt University Medical CenterNashville, TN
Maine Medical CenterPortland, ME
Brigham and Women's HospitalBoston, MA
More Trial Locations
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Who Is Running the Clinical Trial?
Vanderbilt University Medical CenterLead Sponsor
University of California, Los AngelesCollaborator
Brigham and Women's HospitalCollaborator
Penn State HealthCollaborator
Université de MontréalCollaborator
University of California, DavisCollaborator
University of California, San DiegoCollaborator
Indiana UniversityCollaborator
References
Comparison of retrograde flexible ureteroscopy and percutaneous nephrolithotomy in treating intermediatesize renal stones (2-3cm): a meta-analysis and systematic review. [2020]To systematically assess the effectiveness and safety of retrograde flexible ureteroscopy (FURS) versus percutaneous nephrolithotomy (PCNL) in treating intermediate-size renal stones (2-3cm).
Learning curve of semi-rigid ureteroscopy for small calculi: how many cases are necessary? [2023]semi-rigid ureteroscopy is the procedure of choice for the treatment of ureterolithiasis, but it requires a learning curve to be performed safely.
Decreased Recurrence of Urolithiasis After Simultaneous Ureteroscopic Surgery for Ureter and Ipsilateral Renal Calculi: Comparison to Shockwave Lithotripsy for Ureter Calculi Alone. [2022]To compare follow-up outcomes of ureteroscopy (URS) and shockwave lithotripsy (SWL) for ureter calculi in the setting of asymptomatic renal calculi
[Diagnostic and therapeutic advantages of rigid ureteroscopy: retrospective study of 304 cases]. [2019]Uretroscopy has become a common tool for the diagnosis and management of the upper urinary tract. Between April 1994 and Decembre 1999, 304 ureteroscopy procedures were performed. The most common therapeutic procedure was stone manipulation in 299 cases (distal ureter 259 cases, mid-ureter 23 cases, lumber ureter eight cases and staged in nine cases). Procedure was made by a rigid ureteroscope 8.5 Ch or 11.5 Ch. Dorinia was used in 175 cases (57.5%) with or without fragmentation by ultrasound. Therapeutic ureteroscopy was also used to remove a double-J stent that had migrated into the pelvic ureter in one case and in three cases of ureteral tumor. It was used in one case to confine the extrinsic compression of a ureteral stenosis. Median follow up was 12 months (6-36 months). The overall success rate was 87.6%. Results are comparable in men and women (P = 0.8). Success rate was 90% in single lithiasis and 76.2% in case of numerous stones (P = 0.0094). There was a statistically significant difference in success rate between stones 15 mm or under in size (89% stone-free) and those 15 mm (66% stone-free) or larger. In conclusion, rigid ureteroscopy is a minimally invasive and reliable technique for the management of ureteric calculi and for the diagnosis and treatment of other ureteric lesion.
Redefining the limits of flexible ureterorenoscopy. [2022]Flexible ureterorenoscopic holmium laser lithotripsy allows retrograde management of renal calculi that previously needed alternative strategies. This study assesses the influences of stone size, density, and location on treatment outcomes from a large series.
The study of double-J stent free mode of flexible ureteroscopy and laser lithotripsy: a single centre experience. [2023]To evaluate the effectiveness and safety of flexible ureteroscopy in the treatment of kidney and upper ureteral calculi under double-J stent free mode.
Complications of ureteroscopy for stone disease. [2017]Ureteroscopy is one of the most commonly performed surgeries for kidney stones and one of the most commonly performed surgeries by urologists overall. Although generally safe, recognizing and understanding the potential complications of ureteroscopy is paramount. Intraoperative complications discussed in this review include difficult access, bleeding, ureteral false passage, perforation, and avulsion. Postoperative considerations discussed include extravasation, infection, postoperative imaging for silent obstruction, and ureteral stricture. We place special emphasis on the management of ureteral stricture, which can be associated with significant morbidity.
Morbidity of Retrograde Flexible Ureteral Approach for Pyelo-Caliceal Stones - A Retrospective Review of 4500 Procedures. [2020]Introduction: The retrograde flexible ureteroscopic approach is an effective and relatively safe procedure. The aim of this study was to retrospectively evaluate the safety of retrograde flexible ureteroscopic approach in patients with pyelo-caliceal stones on a significant number of cases. Material and method: We retrospectively evaluated 4500 procedures of flexible retrograde ureteroscopic approach for pyelocaliceal lithiasis, operated in two centers. The complications associated with this approach were retrospectively evaluated and data was stratified according to Clavien- Dindo classification. Results: Intraoperative incidents occurred during 5.2% of the procedures. Overall complications occurred in 18.9% of the procedures. Around two thirds of them were septic complications, the use of ureteral access sheath proving to be a protective factor against them. Most of the complications were mild. In 4.8% of the cases in which ureteral access sheath was used, we encountered grade 2 and 3 ureteral wall lesions. Conclusions: Most of the complications associated with retrograde flexible ureteroscopic approach are mild, regardless the type of flexible ureteroscope used. Reduced pressure in the pyelo-caliceal system is important to maintain the complications rate low, both septic and non-septic.
Flexible Ureteroscopy as the New Standard for the Management of Renal Transplant Urolithiasis [2021]Objectives: To determine the safety and efficacy of flexible ureteroscopy in the treatment of transplant urolithiasis. Materials and Methods: We reviewed a single-center series of 2652 patients who underwent surgical treatment for nephrolithiasis at our institution from 2009 to the present day to identify all patients undergoing ureteroscopy for treatment of transplant lithiasis. Results: We identified 18 patients who underwent ureteroscopy for treatment of urolithiasis within the transplanted kidney or ureter. The majority of the procedures were performed using a retrograde approach with flexible ureteroscopy, with one patient undergoing antegrade ureteroscopy and two patients requiring semirigid ureteroscopy. Holmium:yttrium-aluminum-garnet laser lithotripsy was utilized in all but one case, which was performed using basket extraction. There were no intraoperative complications reported. Four patients had small stone fragments on postoperative imaging, three of which were observed. One patient required repeat ureteroscopy for persistent distal ureteral stone. Conclusion: Retrograde ureteroscopy is a feasible, safe, and effective intervention for the treatment of transplant lithiasis. Minimal intraoperative or postoperative complications were reported, and only one patient required additional intervention for residual stone burden.
Improved effectiveness and safety of flexible ureteroscopy for renal calculi ( [2020]We discuss the efficacy and safety of flexible ureteroscopy for renal calculi with a burden of
Routine stenting after ureteroscopy for distal ureteral calculi is unnecessary: results of a randomized controlled trial. [2022]Insertion of a ureteral stent is routinely done after ureteroscopy. Recently, several authors have questioned routine stenting after ureteroscopy for distal ureteral stones. We report our results of a randomized study comparing ureteroscopy with and without placement of stents for distal ureteral stones.
Prestenting improves ureteroscopic stone-free rates. [2022]Although the use of stents after ureteroscopy has been studied extensively, relatively little has been published about stent placement before complicated ureteroscopic procedures. In this study, we examined our experience with stent placement before ureteroscopic management of renal and ureteral stone disease.
The results of ureteral stenting after ureteroscopic lithotripsy for ureteral calculi: a systematic review and meta-analysis. [2022]We evaluated the necessity and adverse effects of routine ureteral stent placement after ureteroscopic lithotripsy for ureteral stones.
Placement of ureteral stent after uncomplicated ureteroscopy: do we really need it? [2022]To investigate the role of stenting after uncomplicated ureteroscopy.
Stenting versus non-stenting following uncomplicated ureteroscopic lithotripsy: Comparsion and evaluation of symptoms. [2018]Currently, ureterorenoscopic (URS) stone fragmentation and removal is the treatment of choice for managing ureteral stones, especially mid and distal ones and is advocated as initial management of ureteric stones. The aim of this work was to evaluate the symptoms, necessity, potential benefits and adverse effects of ureteral stent placement after uncomplicated ureteroscopic lithotripsy.