Degradable Ureteral Stent for Ureteral Disease

(URIPRENE Trial)

Recruiting at 4 trial locations

Overseen By Jennifer Cartledge, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Adva-Tec

Must not be taking: Blood thinners

Disqualifiers: Urinary tract infection, Urothelial cancer, Overactive bladder, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 48 hours

87 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude people who are currently taking blood thinners like warfarin. Anti-platelet agents are allowed.

What data supports the effectiveness of the treatment Uriprene® Degradable Temporary Ureteral Stent for ureteral disease?

Research on similar biodegradable ureteral stents in animal models shows they can effectively prevent complications like hydronephrosis (swelling of the kidney due to urine buildup) and avoid issues like calcification, which are common with traditional stents. These stents gradually degrade and are naturally discharged, reducing the need for additional procedures to remove them. ^{1 2 3 4 5}

Is the degradable ureteral stent safe for use in humans?

Research in animal models, like dogs and pigs, shows that biodegradable ureteral stents are generally safe, as they degrade over time without causing calcification (hard mineral deposits) or significant irritation, unlike traditional stents. ^{1 2 3 5 6}

How is the Uriprene® Degradable Temporary Ureteral Stent different from other treatments for ureteral disease?

The Uriprene® Degradable Temporary Ureteral Stent is unique because it is biodegradable, meaning it gradually breaks down and is naturally expelled from the body, eliminating the need for a second procedure to remove it. This reduces the risk of complications like irritation, infection, and calcification that are common with traditional stents, such as the double-J stent. ^{1 2 3 5 7}

What is the purpose of this trial?

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.

Research Team

Mitchell Humphreys, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Inclusion Criteria

I had a successful kidney stone removal surgery without complications.

You need to have a body size that can fit a specific length of ureteral stent as determined by the doctor.

I am between 21 and 80 years old.

Exclusion Criteria

Pregnant or lactating women, or women of childbearing potential who do not employ a reliable method of contraception as judged by the Investigator, and/or are not willing to use reliable contraception for the duration of study participation.

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

Any condition, in the opinion of the investigator, that would deem a subject as ineligible for treatment with the Uriprene® Stent.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Placement of the Uriprene® Degradable Temporary Ureteral Stent following uncomplicated ureteroscopy

48 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including stent degradation and adverse events

90 days

Multiple visits (in-person and virtual)

Treatment Details

Interventions

• Uriprene® Degradable Temporary Ureteral Stent

Trial Overview 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.

Participant Groups

Group I: Placement of ureteral stent post ureteroscopy Experimental Treatment 1 Intervention

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

Uriprene® Degradable Temporary Ureteral Stent is already approved in United States, European Union for the following indications:

Approved in United States as Uriprene for:

• Temporary ureteral stenting following uncomplicated ureteroscopy

Approved in European Union as Uriprene for:

• Temporary ureteral stenting following uncomplicated ureteroscopy

Who Is Running the Clinical Trial?

Adva-Tec

Lead Sponsor

Trials

2

Recruited

100+

Northwest Clinical Research Group

Collaborator

Trials

1

Recruited

90+

Findings from Research

In a study involving 16 female Yorkshire pigs, 90% of the biodegradable Uriprene™ stents completely degraded within 4 weeks, demonstrating their effectiveness and safety as an alternative to traditional polymer stents.

The biodegradable stents provided equivalent drainage and significantly less hydronephrosis compared to biostable stents, indicating they may reduce complications associated with long-term stent use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo evaluation of the third generation biodegradable stent: a novel approach to avoiding the forgotten stent syndrome. Chew, BH., Paterson, RF., Clinkscales, KW., et al.[2013]

In a study involving nine beagles, the use of a biodegradable ureteral stent effectively prevented hydronephrosis and hydroureter in injured ureters, while these complications occurred in all unstented ureters.

The biodegradable stent not only protected renal function but also improved kidney washout times, indicating its potential as a beneficial treatment for ureteral injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Introduction to biodegradable polylactic acid ureteral stent application for treatment of ureteral war injury. Li, G., Wang, ZX., Fu, WJ., et al.[2019]

The biodegradable ureteral stent effectively prevented hydronephrosis and hydroureter in dogs with ureteral injuries, demonstrating its efficacy in treating such injuries.

Unlike the double-J stent, which showed signs of calcification over time, the biodegradable stent completely degraded within 120 days without any calcification, suggesting a safer profile for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of a biodegradable ureteral stent versus the traditional double-J stent for the treatment of ureteral injury: an experimental study. Fu, WJ., Wang, ZX., Li, G., et al.[2016]

The biodegradable antireflux ureteral stent (BDG-ARS) effectively prevented vesicoureteral reflux (VUR) in all tested ureters, indicating its potential for safer urinary tract interventions.

The BDG-ARS demonstrated a controlled and predictable degradation over 3 to 6 weeks without producing obstructive fragments, which may reduce complications associated with traditional ureteral stents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a New Design of Antireflux-biodegradable Ureteral Stent in Animal Model. Soria, F., Morcillo, E., Serrano, A., et al.[2018]

The novel biodegradable ureteral stents began degrading at 1 week and were completely degraded by 4 weeks, showing predictable degradation and good biocompatibility compared to standard biostable stents.

While both stents caused similar levels of hydronephrosis in the first 2 weeks, the biodegradable stents resulted in less hydronephrosis at 3 and 4 weeks, indicating their effectiveness in providing temporary renal drainage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Braided thin-walled biodegradable ureteral stent: preliminary evaluation in a canine model. Zhang, MQ., Zou, T., Huang, YC., et al.[2016]

In a study involving 30 healthy female pigs, a new hybrid metallic ureteral stent significantly reduced the formation of urothelial hyperplasia (21% vs 70%) compared to a standard stent, indicating improved safety and efficacy.

The hybrid stent also demonstrated lower rates of stent migration (6.6% vs 33.3%) and a higher success rate in maintaining ureteral patency after 6 months (86.6% vs 47%), suggesting it is a more effective option for treating ureteral strictures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation in an animal model of a hybrid covered metallic ureteral stent: a new design. Soria, F., Morcillo, E., Pamplona, M., et al.[2013]

The biodegradable ureteral stent, BraidStent-SF-MMC, effectively released mitomycin for the first 12 hours, demonstrating its potential for controlled drug delivery in treating upper urinary tract urothelial carcinoma in a study involving 14 female pigs.

While the stent showed a 67.5% success rate and no systemic toxic effects, complications included ureteral strictures and obstructive fragments, highlighting the need for further refinement in stent design to improve safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Animal model assessment of a new design for a coated mitomycin-eluting biodegradable ureteral stent for intracavitary instillation as an adjuvant therapy in upper urothelial carcinoma. Soria, F., Delacruz, JE., Aznar-Cervantes, SD., et al.[2023]

References

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

In vivo evaluation of the third generation biodegradable stent: a novel approach to avoiding the forgotten stent syndrome. [2013]

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

Introduction to biodegradable polylactic acid ureteral stent application for treatment of ureteral war injury. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Comparison of a biodegradable ureteral stent versus the traditional double-J stent for the treatment of ureteral injury: an experimental study. [2016]

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

Evaluation of a New Design of Antireflux-biodegradable Ureteral Stent in Animal Model. [2018]

5. Australia pubmed.ncbi.nlm.nih.gov

Braided thin-walled biodegradable ureteral stent: preliminary evaluation in a canine model. [2016]

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

Evaluation in an animal model of a hybrid covered metallic ureteral stent: a new design. [2013]

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

Animal model assessment of a new design for a coated mitomycin-eluting biodegradable ureteral stent for intracavitary instillation as an adjuvant therapy in upper urothelial carcinoma. [2023]