Occlusion Balloon vs. Ureteral Catheter for Kidney Stones

Overseen By Blair Gallante, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Pregnancy, Urinary tract anomalies, others

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

Compensation: Varies

Number of Visits: 1

Duration: During procedure

98 Participants Needed

Trial Summary

What is the purpose of this trial?

Occlusion Balloon catheter provides the ability to occlude the exit of the kidney pelvis during percutaneous nephrolithotomy (PCNL) and potentially prevents the migration of stone fragments into the ureter. The necessity for it might be questioned during supine PCNL due to the upward oblique position of the kidney. The objective of the study is to compare the presence of ureteral stone fragments upon completion of supine PCNL with and without using an occlusion balloon catheter (OBC).

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of this treatment for kidney stones?

Research shows that using an occlusion balloon catheter can improve the success of kidney stone removal by preventing stone migration and enhancing the removal process. Additionally, ureteral catheters help in dilating the urinary tract, making it easier to remove stones. ^{1 2 3 4 5}

Is the use of occlusion balloon catheters and ureteral catheters generally safe for humans?

The use of occlusion balloon catheters and ureteral catheters is generally considered safe in humans, as they have been used successfully in procedures to remove kidney stones, enhancing the success of these procedures without significant safety concerns. ^{1 2 3 6 7}

How does the occlusion balloon catheter treatment for kidney stones differ from other treatments?

The occlusion balloon catheter is unique because it helps prevent stone migration and enhances the removal of kidney stones by dilating the ureter and improving access during procedures. This approach can increase the success rate of stone removal compared to traditional methods. ^{1 2 3 4 8}

Research Team

Mantu Gupta, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

Adults over 18 with kidney stones who are scheduled for a type of surgery called PCNL can join. They must be able to consent. Those with urinary tract anomalies, previous related surgeries, or pregnant women cannot participate.

Inclusion Criteria

I have kidney stones and am scheduled for a PCNL procedure.

Able and willing to provide informed consent

Exclusion Criteria

I have had surgery or have a condition affecting my urinary system.

Pregnant women

I can undergo procedures lying face down.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo percutaneous nephrolithotomy (PCNL) with either an occlusion balloon catheter or a 5FR ureteral catheter

During procedure

1 visit (in-person)

Follow-up

Participants are monitored for the presence of ureteral stone fragments and procedural outcomes

4 weeks

Treatment Details

Interventions

• 5FR Ureteral Catheter
• Occlusion Balloon Catheter

Trial Overview The study is testing if using an occlusion balloon catheter during a specific kind of kidney stone surgery (supine PCNL) prevents stone fragments from moving into the ureter better than a standard ureteral catheter.

Participant Groups

Group I: Occlusion Balloon Catheter Active Control 1 Intervention

The occlusion balloon catheter (OBC) is a type of ureteral catheter equipped with a small inflatable balloon at its tip. When inflated, the balloon can help prevent the migration of stone fragments.

Group II: 5FR Ureteral Catheter Active Control 1 Intervention

The 5FR ureteral catheter (5FR-UC) is an open-ended small-caliber tube inserted at the beginning of PCNL to facilitate visualization of the collecting system using fluoroscopy and assist with renal access.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Findings from Research

The use of an occlusion balloon catheter during the percutaneous removal of kidney stones significantly improves the success rate of nephrostomy procedures.

This technique also enhances the effectiveness of stone fragment removal, potentially leading to better patient outcomes in kidney stone treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of occlusion balloon catheter in percutaneous renal stone extraction. Littleton, RH., Cerny, JC., Miles, B.[2019]

The use of an antegrade occlusion balloon catheter in 8 out of 21 patients with proximal ureteral stones effectively prevented stone migration during endoscopic treatment, leading to successful stone removal in all cases.

This technique is particularly beneficial for patients with significant dilation of the proximal collecting system or those who have had previous unsuccessful interventions, enhancing the overall success rate of ureteroscopic procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ureteroscopic treatment of proximal ureter stones with the aid of an antegrade occlusion balloon catheter. Dirim, A., Tekin, MI., Aytekin, C., et al.[2019]

Inserting occlusion balloon catheters before nephrostomy in 60 out of 71 patients improved the success rate of percutaneous renal calculus removal, especially in complex cases like ureteral and infundibular calculi.

Applying hydrostatic pressure overnight in 23 patients with challenging stone conditions led to significant dilation of the renal pelvis, facilitating better access and manipulation of stones during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of retrograde occlusion balloon catheters in percutaneous removal of renal calculi. Beckmann, CF., Roth, RA.[2019]

In a study of 44 patients with ureteral stones, single-stage percutaneous nephrolithotomy was highly effective, achieving success in 42 cases, demonstrating its efficacy as a treatment method.

The use of an occlusion balloon catheter improved the procedure by allowing better visualization for renal puncture, and techniques like mechanical pushing or flushing of stones were successful in 24 out of 30 patients, indicating that these methods can enhance stone removal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upper and midureteral calculi: percutaneous extraction with an occlusion balloon catheter. Beckmann, CF., Roth, RA., Luedke, MD.[2016]

Transrenal ureteral occlusion was performed on 83 ureters in 76 patients, showing that detachable latex balloons were more effective than tissue adhesive, with 69% of balloon occlusions being permanently sealed after one procedure compared to 55% for tissue adhesive.

The average duration of effective occlusion was significantly longer with detachable balloons (19.5 weeks) compared to tissue adhesive (2.5 weeks), and the procedure was generally safe, with only 7% of interventions resulting in complications, most of which were minor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transrenal ureteral occlusion: results and problems. Schild, HH., Günther, R., Thelen, M.[2019]

In a study of 413 patients who underwent peri-operative ureteral catheter placement, 12.1% experienced urologic complications within 30 days, indicating a notable risk associated with the procedure.

The study found that intraoperative difficulty in catheter placement was significantly linked to higher-grade complications, highlighting the importance of technique in minimizing risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications Of Peri-Operative Ureteral Catheter Placement: Experience at A Major Cancer Center. Geskin, AA., Westney, OL., Graber, WJ., et al.[2023]

In a study of 59 patients with upper ureteral stones, a new stone occlusion device was found to be as effective and safe as the established NTrap device during laser lithotripsy, with no complications reported in either group.

Both devices showed identical operation times and success rates, but the new device is more cost-effective, being available at half the price of NTrap, suggesting it could be a viable alternative for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new stone occlusion device for upper ureteral calculi: preliminary clinical outcomes. Feng, CC., Wu, Z., Jiang, HW., et al.[2012]

In a study of 195 patients with proximal ureteric stones, the Stone Cone device significantly reduced the incidence of stone migration during ureteroscopic pneumatic lithotripsy compared to the N-Trap and control groups, leading to a higher stone-free rate of 95.24%.

Both ureteral occlusive devices (Stone Cone and N-Trap) effectively decreased the occurrence of residual stone fragments, ureteral trauma, and the need for additional procedures, but the Stone Cone was notably more effective in preventing stone migration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized prospective controlled study for assessment of different ureteral occlusion devices in prevention of stone migration during pneumatic lithotripsy. Farahat, YA., Elbahnasy, AE., Elashry, OM.[2011]

References

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

Use of occlusion balloon catheter in percutaneous renal stone extraction. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Ureteroscopic treatment of proximal ureter stones with the aid of an antegrade occlusion balloon catheter. [2019]

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

Use of retrograde occlusion balloon catheters in percutaneous removal of renal calculi. [2019]

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

Upper and midureteral calculi: percutaneous extraction with an occlusion balloon catheter. [2016]

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

Transrenal ureteral occlusion: results and problems. [2019]

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

Complications Of Peri-Operative Ureteral Catheter Placement: Experience at A Major Cancer Center. [2023]

7. England pubmed.ncbi.nlm.nih.gov

A new stone occlusion device for upper ureteral calculi: preliminary clinical outcomes. [2012]

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

A randomized prospective controlled study for assessment of different ureteral occlusion devices in prevention of stone migration during pneumatic lithotripsy. [2011]