What side effects are associated with this type of intervention?

Common side effects of treatments for ureteral disease, including degradable stents like the ADVA-Tec Uriprene® Degradable Temporary Ureteral Stent, typically include discomfort, urinary frequency, urgency, hematuria, and infection. While degradable stents aim to minimize long-term issues, they may still cause initial discomfort, urinary symptoms, and potential for incomplete degradation, which can lead to obstruction or infection. Severe complications are rare but can include significant pain, stent migration, and ureteral injury.

What prior FDA approvals exist?

Ureteral stents are commonly used to maintain ureteral patency in cases of obstruction. Traditional stents made from materials such as silicone or polyurethane require removal after a certain period. Degradable stents, like the ADVA-Tec Uriprene® Degradable Temporary Ureteral Stent, are designed to maintain patency and then degrade over time, potentially eliminating the need for a second procedure to remove the stent. While specific FDA approvals for degradable ureteral stents are not detailed, the development of such stents represents an advancement in reducing patient discomfort and the need for additional interventions.

What other types of research exist?

Promising alternatives to the ADVA-Tec Uriprene® Degradable Temporary Ureteral Stent for ureteral disease patients include: 1) Biodegradable stents made from materials like polylactic acid (PLA) that gradually dissolve, reducing the need for a second procedure to remove the stent. 2) Drug-eluting stents that release medications to prevent infection and reduce inflammation, potentially improving patient comfort and outcomes. 3) Smart stents equipped with sensors to monitor ureteral patency and detect complications early, allowing for timely medical intervention.

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Ureteral Stent

Degradable Ureteral Stent for Ureteral Disease (URIPRENE Trial)

Q: What is the mechanism of action of this treatment?

Common treatments for ureteral disease include the use of ureteral stents, which are designed to maintain ureteral patency and ensure urine flow from the kidney to the bladder. The ADVA-Tec Uriprene® Degradable Temporary Ureteral Stent, for example, works by providing temporary support to the ureter, preventing obstruction and allowing for healing or resolution of the underlying condition. Over time, this stent degrades and is naturally eliminated from the body, reducing the need for a second procedure to remove it. This mechanism is particularly beneficial for patients as it minimizes the risk of long-term complications, reduces the need for additional surgeries, and improves overall patient comfort and outcomes.

N/A

Recruiting

Led By Mitchell Humphreys, MD

Research Sponsored by Adva-Tec

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects with unilateral ureteral or renal stones who have undergone a successful, uncomplicated ureteroscopy (UURS).

Subjects who are >21, <80 years of age; inclusive of males and females.

Must not have

Subject has a known significant concomitant illness with a life expectancy of <1 year.

Subjects with known/diagnosed overactive bladder (OAB).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a dissolvable tube that helps urine flow from the kidney to the bladder. It targets patients who need temporary assistance with urine drainage. The tube keeps the passage open and then dissolves on its own, avoiding another procedure.

Who is the study for?

This trial is for adults aged 21-80 with unilateral ureteral or renal stones who've had a successful, uncomplicated ureteroscopy. They must be able to fit one of the specified stent sizes and not have urinary tract abnormalities, active infections, severe kidney dysfunction, or certain other medical conditions. Women must use reliable contraception.

What is being tested?

The Uriprene® Degradable Temporary Ureteral Stent's safety and performance are being tested in this non-randomized study across multiple centers. The stent is designed for patients following an uncomplicated procedure to remove kidney stones.

What are the potential side effects?

While specific side effects aren't listed here, typical risks may include discomfort during insertion or removal of the stent, potential irritation while it's in place, urinary symptoms like frequency or urgency, and possible infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I had a successful kidney stone removal surgery without complications.

Select...

I am between 21 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a serious illness and am expected to live less than a year.

Select...

I have been diagnosed with an overactive bladder.

Select...

I have a tear in my ureter.

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I have cancer in my bladder, ureter, or kidney.

Select...

I have large kidney stones that fill the kidney.

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I have only one kidney.

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I have a bleeding disorder or am currently on blood thinners like warfarin.

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I still have kidney stones in my ureter or they haven't fully broken down.

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I have a history of urinary tract abnormalities.

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I have been diagnosed with urge urinary incontinence.

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I have a current urinary tract infection.

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I have a blockage in my ureter.

Select...

I have an abnormal connection between my ureter and another organ.

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My ureter is being squeezed by something outside of it.

Select...

I have issues with bladder control or blockage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Effectiveness Endpoint defined as the presence of the stent during the first 48 hours

Primary Safety Endpoint defined as assessment of adverse events through 90 days

Secondary study objectives

Overall Clinical Success

Technical success of the device

Pharmaceutical Preparations

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Placement of ureteral stent post ureteroscopyExperimental Treatment1 Intervention

Subjects with unilateral ureteral or renal stone fragments who have undergone an uncomplicated ureteroscopy (UURS)

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for ureteral disease include the use of ureteral stents, which are designed to maintain ureteral patency and ensure urine flow from the kidney to the bladder. The ADVA-Tec Uriprene® Degradable Temporary Ureteral Stent, for example, works by providing temporary support to the ureter, preventing obstruction and allowing for healing or resolution of the underlying condition. Over time, this stent degrades and is naturally eliminated from the body, reducing the need for a second procedure to remove it. This mechanism is particularly beneficial for patients as it minimizes the risk of long-term complications, reduces the need for additional surgeries, and improves overall patient comfort and outcomes.

Potentially useful materials for biodegradable ureteric stents.