Stent Placement After Ureteroscopy for Kidney Stones

No longer recruiting at 9 trial locations

Overseen By Ryan Hsi, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Age < 18, Pregnancy, CKD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if complications differ for patients who receive a stent (a small tube placed in the ureter) after ureteroscopy, a procedure to remove kidney stones. Some participants will receive the stent, while others will not. The research focuses on individuals with non-blocking kidney stones that are 1.5 cm or smaller. Ideal candidates for this trial are those with these types of kidney stones who plan to undergo ureteroscopy. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance future kidney stone treatments.

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 prior data suggests that stent placement after ureteroscopy is safe?

Research has shown that ureteral stents are often used after ureteroscopy, a procedure that removes kidney stones. These stents keep the tube between the kidney and bladder open. While studies suggest that stents are commonly used, they might not always be necessary.

When used, stents can cause side effects. Some people experience pain on the side of their body or develop urinary tract infections, which affect the urinary system. These side effects occur because the stent alters urine flow.

Overall, ureteral stents are generally safe, but some people might experience side effects. It's important to weigh the benefits and risks when deciding on stent use after a kidney stone procedure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores whether placing a ureteral stent after ureteroscopy for kidney stones is necessary or not. Typically, ureteral stents are used to prevent blockage and ease discomfort post-surgery. However, they can also cause discomfort and complications. This trial seeks to determine if skipping the stent placement can provide the same benefits without the downsides, potentially leading to a more comfortable recovery for patients.

What evidence suggests that this trial's treatments could be effective for kidney stones?

Research has shown that doctors often use ureteral stents after ureteroscopy, a procedure that removes kidney stones. In this trial, participants will be divided into two groups: one will receive a ureteral stent after ureteroscopy, while the other will not. These stents can help if there is an infection, kidney problems, or damage to the ureter (the tube connecting the kidney to the bladder). Studies have found that while stents can be helpful, they might also cause discomfort and other side effects. Some patients might experience less pain and fewer issues without a stent after the procedure. The decision to use a stent usually depends on the specific medical situation and potential risks. ^{1 6 7 8 9}

Who Is on the Research Team?

Ryan Hsi, MD

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Ureteroscopy

Trial Overview 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.

How Is the Trial Designed?

Group I: Ureteral stent group Active Control 1 Intervention

A ureteral stent will be placed after ureteroscopy.

Group II: No ureteral stent group Active Control 1 Intervention

A ureteral stent will not be placed after ureteroscopy.

Ureteroscopy is already approved in European Union, United States, Canada, Japan 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

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

Brigham and Women's Hospital

Collaborator

Trials

1,694

Recruited

14,790,000+

Penn State Health

Collaborator

Trials

2

Recruited

1,200+

Université de Montréal

Collaborator

Trials

223

Recruited

104,000+

University of California, Davis

Collaborator

Trials

958

Recruited

4,816,000+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

Indiana University

Collaborator

Trials

1,063

Recruited

1,182,000+

Published Research Related to This Trial

In a study of 90 patients undergoing ureteroscopic surgery, those who had a stent placed before the procedure achieved significantly higher stone-free rates (67%) compared to those without a stent (47%).

The use of stents before complicated ureteroscopic procedures did not increase the risk of complications, suggesting that prestenting can be a safe and effective strategy to improve outcomes in challenging cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prestenting improves ureteroscopic stone-free rates. Rubenstein, RA., Zhao, LC., Loeb, S., et al.[2022]

Flexible ureteroscopy combined with holmium laser treatment achieved a high success rate of 97.2% for treating renal stones smaller than 2 cm, with a stone-free rate of 94.3% after 8 weeks.

The procedure had a manageable complication rate of 12.9%, with no serious adverse outcomes reported, indicating it is a safe option for patients with small renal calculi.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved effectiveness and safety of flexible ureteroscopy for renal calculi ( Chen, S., Xu, B., Liu, N., et al.[2020]

Percutaneous nephrolithotomy (PCNL) has a higher initial stone-free rate for treating intermediate-size renal stones (2-3 cm) compared to retrograde flexible ureteroscopy (FURS), but FURS can achieve comparable final stone-free rates after additional treatments.

PCNL is associated with a higher rate of intraoperative complications and longer hospital stays, while FURS presents a safer alternative with fewer complications, making it a viable option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of retrograde flexible ureteroscopy and percutaneous nephrolithotomy in treating intermediatesize renal stones (2-3cm): a meta-analysis and systematic review. Zewu, Z., Cui, Y., Feng, Z., et al.[2020]

Flexible ureteroscopy without the use of a double-J stent post-surgery (Post-F group) was shown to be safe and effective for treating kidney and upper ureteral stones, with no stent-related complications observed during follow-up.

While the operation time was similar across all groups, the Pre-F group (with postoperative stenting) experienced a higher incidence of ureteral injuries, indicating that avoiding postoperative stenting may reduce certain complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The study of double-J stent free mode of flexible ureteroscopy and laser lithotripsy: a single centre experience. Xu, M., Han, X., Zhu, J., et al.[2023]

Stenting after uncomplicated ureteroscopy is associated with a higher incidence of dysuria, urinary frequency, and hematuria compared to non-stented patients, indicating potential discomfort and complications from stenting.

There was no significant difference in overall postoperative outcomes such as pain management, urinary tract infections, or stone-free rates between stented and non-stented groups, suggesting that stenting may not provide clear benefits in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placement of ureteral stent after uncomplicated ureteroscopy: do we really need it? Tang, L., Gao, X., Xu, B., et al.[2022]

A systematic review of 16 randomized controlled trials involving 1,573 patients found that routine ureteral stent placement after ureteroscopic lithotripsy does not improve outcomes such as stone-free rates or reduce complications like urinary tract infections.

Patients with ureteral stents experienced significantly more lower urinary tract symptoms and pain compared to those without stents, suggesting that stenting may be unnecessary after uncomplicated procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The results of ureteral stenting after ureteroscopic lithotripsy for ureteral calculi: a systematic review and meta-analysis. Pengfei, S., Yutao, L., Jie, Y., et al.[2022]

In a study of 125 patients undergoing ureteroscopic lithotripsy, all patients achieved a 100% stone-free rate, indicating the effectiveness of the procedure regardless of stent placement.

However, patients with ureteral stents experienced significantly more pain and lower urinary tract symptoms compared to those without stents, suggesting that routine stent placement may not be necessary and could lead to additional discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stenting versus non-stenting following uncomplicated ureteroscopic lithotripsy: Comparsion and evaluation of symptoms. Savić, S., Vukotić, V., Lazić, M., et al.[2018]

Ureteroscopy is a widely performed and generally safe procedure for treating kidney stones, but it is important to be aware of potential intraoperative complications such as bleeding, perforation, and difficult access.

Postoperative complications, particularly ureteral stricture, can lead to significant health issues, highlighting the need for careful management and monitoring after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of ureteroscopy for stone disease. Volkin, D., Shah, O.[2017]

In a study of 4500 retrograde flexible ureteroscopic procedures for kidney stones, overall complications occurred in 18.9% of cases, with most being mild and manageable.

The use of a ureteral access sheath significantly reduced the risk of septic complications, highlighting its protective role during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Morbidity of Retrograde Flexible Ureteral Approach for Pyelo-Caliceal Stones - A Retrospective Review of 4500 Procedures. Geavlete, PA., Mulţescu, R., Geavlete, BF.[2020]

In a study of 789 patients with ureter calculi and asymptomatic renal calculi under 15 mm, ureteroscopy (URS) showed a higher stone-free rate (97.3%) compared to shockwave lithotripsy (SWL) (93.9%).

URS also resulted in better long-term outcomes, with a 2-year intervention-free survival rate of 88.1% and stone-event-free survival of 80.1%, compared to 84.2% and 71.0% for SWL, respectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decreased Recurrence of Urolithiasis After Simultaneous Ureteroscopic Surgery for Ureter and Ipsilateral Renal Calculi: Comparison to Shockwave Lithotripsy for Ureter Calculi Alone. Ito, K., Takahashi, T., Kanno, T., et al.[2022]

A total of 304 ureteroscopy procedures were performed, primarily for stone manipulation, with an overall success rate of 87.6%, indicating that this method is effective for treating ureteric stones.

The success rate was higher for smaller stones (89% for stones 15 mm or under) compared to larger stones (66% for stones over 15 mm), highlighting the importance of stone size in treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Diagnostic and therapeutic advantages of rigid ureteroscopy: retrospective study of 304 cases]. Hajri, M., Ben Amna, M., Achich, A., et al.[2019]

In a study of 185 patients undergoing flexible ureterorenoscopic holmium laser lithotripsy, the overall success rate for stone clearance was 90.7%, with particularly high success (96.5%) for stones sized 20 mm or smaller.

For stones larger than 20 mm, the stone-free rate dropped significantly, with only 58.3% achieving clearance after one treatment, indicating that 20 mm should be considered the maximum size for effective single-treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Redefining the limits of flexible ureterorenoscopy. Hussain, M., Acher, P., Penev, B., et al.[2022]

In a study of 48 patients undergoing ureteroscopy for distal ureteral stones, it was found that stents can be safely omitted without increasing the risk of complications or affecting the success rate, which was 100% in both stented and nonstented groups.

Patients who did not receive stents experienced significantly fewer lower urinary symptoms, such as pain, urgency, and dysuria, suggesting that avoiding stenting may improve patient comfort and could be a cost-effective approach, especially in developing countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Routine stenting after ureteroscopy for distal ureteral calculi is unnecessary: results of a randomized controlled trial. Srivastava, A., Gupta, R., Kumar, A., et al.[2022]

The study evaluated the learning curve for performing semi-rigid ureterorenolithotripsy in 60 procedures on patients with ureterolithiasis up to 1 cm, revealing significant improvements in surgical performance after the first 40 cases.

After completing 40 procedures, there was minimal further improvement in both the quality and efficiency of the surgery, indicating that this is the minimum number of cases needed to safely perform the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Learning curve of semi-rigid ureteroscopy for small calculi: how many cases are necessary? Ilias, D., Passerotti, CC., Pontes Junior, J., et al.[2023]

In a review of 18 patients who underwent flexible ureteroscopy for transplant urolithiasis, the procedure was found to be safe with no intraoperative complications reported.

The use of retrograde ureteroscopy effectively treated transplant lithiasis, with only one patient needing repeat intervention for residual stones, indicating its efficacy in managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flexible Ureteroscopy as the New Standard for the Management of Renal Transplant Urolithiasis Gerber, RC., Best, SL., Hedican, SP., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6365118/

Ureteral stent versus no ureteral stent for ureteroscopy in the ... Ureteral stents are very commonly placed after ureteroscopy and are indicated in the setting of infection, renal failure, ureteral injury, or severe oedema. One ...

2. jmisr.researchcommons.org jmisr.researchcommons.org/cgi/viewcontent.cgi?article=1076&context=home

Ureteric stenting after ureteroscopy... is it a must? Ureteral stents are commonly inserted after URS and are advised for acute oedema, infection, renal failure, or ureteral injury. According to ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10994621/

Comparison of immediate versus post-stenting ... Ureteral stent placement can improve the insertion of the ureteral access sheath and ureteroscope but may be associated with higher morbidity prior to and ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666168324010929

Efficacy and Safety of Semirigid Ureteroscopy Combined ... Ureteral stones are currently treated with holmium:yttrium-aluminum-garnet (Ho:YAG) laser lithotripsy using rigid and flexible ureteroscopes.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03855787

Ureteral Stent Placement After Ureteroscopy for Renal ... A major contributor to patient morbidity after ureteroscopy is the ureteral stent, which is placed at the time of surgery and left in place 1-2 weeks after ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5407333/

Is a ureteral stent required after use of ureteral access sheath ... Postoperative ureteral stenting is not always necessary after using UAS during flexible ureteroscopy in a pre-stented patient.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03713411

Is Urethral Catheter Necessary After Ureteroscopy and DJ ... DJ stent placement has the potential side effects such as flank pain and urinary tract infection (UTI) due to retrograde urine flow. As the bladder pressure ...

8. auanet.org auanet.org/guidelines-and-quality/guidelines/kidney-stones-surgical-management-guideline

Kidney Stones: Surgical Management Guideline Ureteral stent placement is commonly performed following stone interventions. In some cases, stent placement may not be necessary, such as in the case of an ...

9. link.springer.com link.springer.com/article/10.1007/s00345-023-04696-2

Semirigid ureteroscopy and tamsulosin therapy as ... The incidence of primary flexible ureteroscopy failure to reach proximal ureteral or renal stones is about 20–35% [6]. This usually leads to ...