Stent Placement After Ureteroscopy for Kidney Stones

Recruiting at 8 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

103 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{6 7 8 9 10}

How 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. ^{11 12 13 14 15}

Research Team

Ryan Hsi, MD

Principal Investigator

Vanderbilt University Medical Center

Eligibility 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.

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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 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]

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]

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]

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]

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]

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]

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]

References

1. Brazil 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. [2020]

2. Brazil pubmed.ncbi.nlm.nih.gov

Learning curve of semi-rigid ureteroscopy for small calculi: how many cases are necessary? [2023]

3. United States 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. [2022]

4. France pubmed.ncbi.nlm.nih.gov

[Diagnostic and therapeutic advantages of rigid ureteroscopy: retrospective study of 304 cases]. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Redefining the limits of flexible ureterorenoscopy. [2022]

6. England pubmed.ncbi.nlm.nih.gov

The study of double-J stent free mode of flexible ureteroscopy and laser lithotripsy: a single centre experience. [2023]

7. Italy pubmed.ncbi.nlm.nih.gov

Complications of ureteroscopy for stone disease. [2017]

8. Romania pubmed.ncbi.nlm.nih.gov

Morbidity of Retrograde Flexible Ureteral Approach for Pyelo-Caliceal Stones - A Retrospective Review of 4500 Procedures. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Flexible Ureteroscopy as the New Standard for the Management of Renal Transplant Urolithiasis [2021]

10. Canada pubmed.ncbi.nlm.nih.gov

Improved effectiveness and safety of flexible ureteroscopy for renal calculi ( [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Routine stenting after ureteroscopy for distal ureteral calculi is unnecessary: results of a randomized controlled trial. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Prestenting improves ureteroscopic stone-free rates. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

The results of ureteral stenting after ureteroscopic lithotripsy for ureteral calculi: a systematic review and meta-analysis. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Placement of ureteral stent after uncomplicated ureteroscopy: do we really need it? [2022]

15. Serbia pubmed.ncbi.nlm.nih.gov

Stenting versus non-stenting following uncomplicated ureteroscopic lithotripsy: Comparsion and evaluation of symptoms. [2018]