Urocross Expander System for Enlarged Prostate

Recruiting at 6 trial locations

Overseen By Clinical Department

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Prodeon Medical, Inc

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Prostate cancer, Neurogenic bladder, others

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

Compensation: Varies

Number of Visits: 4

Duration: 6 months

240 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new device called the Urocross Expander System/Retrieval Sheath. It is designed to help men with an enlarged prostate (BPH) who have trouble urinating. The device works by widening the urinary passage to make it easier to urinate.

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

Yes, you need to stop taking BPH-related medications from the time of enrollment and throughout the study. There is a washout period required before qualifying questionnaires and tests.

Will I have to stop taking my current medications?

Yes, you will need to stop taking your BPH-related medications from the time you enroll in the study and throughout your participation. There is a washout period (time without taking certain medications) required before you can complete the qualifying questionnaires and tests.

What data supports the idea that Urocross Expander System for Enlarged Prostate is an effective treatment?

The available research shows that the Urocross Expander System is designed to help with symptoms caused by an enlarged prostate. The EXPANDER-1 trial focused on its safety and feasibility for treating urinary symptoms due to this condition. Another study tested the system in dogs and found it safe and feasible, suggesting it could work similarly in humans. While the research is promising, it mainly focuses on safety and feasibility rather than direct comparisons with other treatments. ^{1 2 3 4 5}

What data supports the effectiveness of the Urocross Expander System treatment for enlarged prostate?

The EXPANDER-1 trial and a pre-clinical study in dogs suggest that the Urocross Expander System is safe and feasible for treating lower urinary tract symptoms caused by an enlarged prostate. Additionally, similar devices like the UroLume Wallstent have shown effectiveness in treating benign prostatic hyperplasia, indicating potential for the Urocross system. ^{1 2 3 4 5}

What safety data is available for the Urocross Expander System for enlarged prostate?

The EXPANDER-1 trial and a pre-clinical feasibility study in a canine model provide safety data for the Urocross Expander System. The EXPANDER-1 trial focuses on the safety and feasibility of the system for treating lower urinary tract symptoms due to benign prostatic hyperplasia. The pre-clinical study evaluates the safety, feasibility, and tissue response of the first-generation Urocross Expander System. These studies suggest that the system has been evaluated for safety, although specific adverse events or complications are not detailed in the provided abstracts. ^{1 2 6 7 8}

Is the Urocross Expander System safe for treating an enlarged prostate?

The Urocross Expander System, previously known as the XFLO Expander System, has been studied for safety and feasibility in treating lower urinary tract symptoms due to an enlarged prostate. Research indicates it is generally safe, but as with any medical device, there may be risks involved. ^{1 2 6 7 8}

Is the Urocross implant a promising treatment for an enlarged prostate?

Yes, the Urocross implant is a promising treatment for an enlarged prostate. It is designed to help with urinary problems caused by an enlarged prostate by expanding the tissue, which can improve the flow of urine. Studies have shown that it is safe and feasible, making it a potential option for those experiencing these symptoms. ^{1 2 3 5 9}

How is the Urocross Expander System treatment different from other treatments for enlarged prostate?

The Urocross Expander System is unique because it is an implantable device made of nitinol (a flexible metal alloy) that expands and reshapes the prostatic urethra to relieve symptoms of an enlarged prostate, unlike traditional medications or surgeries. ^{1 2 3 5 9}

Research Team

Kevin T. McVary

Principal Investigator

Loyola University

Daniel B. Rukstalis

Principal Investigator

Carilion Clinic

Eligibility Criteria

Men aged 45 or older with symptomatic Benign Prostatic Hyperplasia (BPH), having a prostate size of 30-80 cc, and experiencing reduced urine flow. Participants must not be on BPH medications during the trial and should have no history of certain neurological diseases, prior prostate surgeries, or conditions like urethral strictures that could affect bladder function.

Inclusion Criteria

PVR < 250 mL

PVR < 250 mL.

I have symptoms from an enlarged prostate.

Exclusion Criteria

Biopsy of the prostate within past 8 weeks

I have had an episode of not being able to urinate due to a condition or surgery.

I have had a procedure to improve urine flow from my bladder.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Urocross Expander Implant or undergo a sham procedure

6 months

1 visit (in-person) for procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

2 visits (in-person)

Implant Retrieval

The Urocross Retrieval Sheath is used to retrieve the implant

1 visit

1 visit (in-person)

Treatment Details

Interventions

• Urocross implant

Trial Overview The Expander-2 Trial is testing the Urocross Expander System/Retrieval Sheath against a sham-control to treat symptoms of an enlarged prostate. Men will be randomly assigned to receive either the actual device implantation or a simulated procedure without therapeutic effect.

Participant Groups

Group I: Urocross implant group Experimental Treatment 1 Intervention

The investigational products in this trial are the Urocross Expander Implant as delivered by the Urocross Expander System and the Urocross Retrieval Sheath used to retrieve the implant after 6 months following its implant.

Group II: Sham-control group Placebo Group 1 Intervention

The sham-control in this trial is cystoscopy only.

Who Is Running the Clinical Trial?

Prodeon Medical, Inc

Lead Sponsor

Trials

1

Recruited

240+

Findings from Research

The Urocross Expander System has been shown to be a safe and feasible treatment for lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH), with 39 men successfully receiving implants without complications in a trial.

Improvements in urinary symptoms and quality of life were observed, indicating the device's efficacy, and it appears to have overcome issues seen in earlier prostatic implants, such as encrustation and migration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The EXPANDER-1 trial: introduction of the novel Urocross™ Expander System for treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). Woo, HH., Huang, CP., Huang, WJ., et al.[2022]

The Urocross Expander System was successfully implanted in 8 male canines, leading to a significant increase in urethral width (from 6.9 mm to 10.2 mm) without causing obstruction or retention, indicating its potential efficacy for treating urinary tract symptoms.

The device showed a favorable safety profile, with minimal adverse events and no significant tissue growth, encrustation, or stone formation observed post-retrieval, suggesting it may be a safe option for managing benign prostatic hyperplasia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of a Novel Implant Intended to Expand and Reshape the Prostatic Urethra for the Treatment of Benign Prostatic Hyperplasia: A Pre-Clinical Feasibility Study in the Canine Model. Chughtai, B., Punyala, A., Lata, SS., et al.[2022]

In a study of 78 men with acute urinary retention due to benign prostatic hyperplasia (BPH), 87.1% were able to urinate spontaneously three months after treatment with the Targis System, indicating its efficacy for this condition.

The Targis System is recommended for patients with large prostate volumes (over 35 cc) and poor health, as it provides a viable alternative to traditional surgery (TURP) with a low recurrence rate of urinary retention (7.3% within two years).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transurethral microwave thermotherapy (TUMT) with the Targis System: a single-centre study on 78 patients with acute urinary retention and poor general health. Berger, AP., Niescher, M., Spranger, R., et al.[2019]

The UroLume Wallstent is a new flexible, self-expanding endoprosthesis designed to keep narrowed arteries open after balloon angioplasty, showing promise in treating recurrent urethral strictures, benign prostatic hyperplasia, and detrusor-external sphincter dyssynergia.

Preliminary data indicate that the Wallstent is effective for these conditions with minimal side effects, suggesting it could be a major advancement in urology if long-term results are similarly positive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urologic applications of a permanent, epithelializing urethral endoprosthesis. Oesterling, JE.[2019]

Proper assessment of bladder function and correct fitting are crucial for the effective use of urinary sheaths in managing male urinary incontinence, as incorrect fitting can lead to anxiety and discomfort.

The article highlights the importance of evaluating different urinary sheath systems and the potential issues that may arise during their use, emphasizing the need for ongoing assessment after prescription.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urinary sheaths: assessment, prescription and evaluation. Doherty, W.[2019]

Aquablation and prostatic urethral lift (PUL) procedures for treating benign prostatic hyperplasia (BPH) were associated with significantly higher rates of severe complications compared to transurethral water vapor therapy (TWVT), with 78% of aquablation cases reporting severe events.

Common device malfunctions included rectal perforation in aquablation and issues with PUL implants, highlighting the importance of understanding potential risks associated with these treatments for both patients and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aquablation, Prostatic Urethral Lift, and Transurethral Water Vapor Therapy: A Comparison of Device-Related Adverse Events in a National Registry. Kaplan-Marans, E., Martinez, M., Wood, A., et al.[2023]

A review of the MAUDE database from 2016 to 2023 identified 103 device failures and 165 post-operative complications related to the Urolift procedure, highlighting that while it is minimally invasive, it is not without risks.

Serious complications, including urosepsis, post-operative hemorrhage requiring embolization, and even 11 reported deaths, indicate that careful patient selection and thorough counseling are essential for those considering Urolift for benign prostate enlargement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications and device failures associated with urolift: Findings from the MAUDE database. Juliebø-Jones, P., Somani, BK., Tzelves, L., et al.[2023]

In a study of 283 patients who underwent radical cystectomy for bladder cancer, over 54% experienced at least one adverse event within 90 days post-surgery, with 40% of these being classified as major complications.

The research found a significant association between body mass index (BMI) and the occurrence of adverse events, highlighting the importance of BMI in assessing individual patient risk and improving patient counseling and care quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factor analysis in a contemporary cystectomy cohort using standardized reporting methodology and adverse event criteria. Svatek, RS., Fisher, MB., Matin, SF., et al.[2010]

The Urolume self-expanding flexible endourethral stent was found to be effective in improving symptoms and urinary flow rates in patients with bladder outlet obstruction due to benign prostatic hyperplasia (BPH), with significant improvements noted over a 5-year follow-up period.

Despite a high failure rate attributed to selection and deployment challenges, the Urolume stent was confirmed to be a safe device, with most patients experiencing sustained symptom relief and good quality of life after the first year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term clinical results and quality of life after insertion of a self-expanding flexible endourethral prosthesis. Anjum, MI., Chari, R., Shetty, A., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

The EXPANDER-1 trial: introduction of the novel Urocross™ Expander System for treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). [2022]

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

Characterization of a Novel Implant Intended to Expand and Reshape the Prostatic Urethra for the Treatment of Benign Prostatic Hyperplasia: A Pre-Clinical Feasibility Study in the Canine Model. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Transurethral microwave thermotherapy (TUMT) with the Targis System: a single-centre study on 78 patients with acute urinary retention and poor general health. [2019]

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

Urologic applications of a permanent, epithelializing urethral endoprosthesis. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Urinary sheaths: assessment, prescription and evaluation. [2019]

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

Aquablation, Prostatic Urethral Lift, and Transurethral Water Vapor Therapy: A Comparison of Device-Related Adverse Events in a National Registry. [2023]

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

Complications and device failures associated with urolift: Findings from the MAUDE database. [2023]

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

Risk factor analysis in a contemporary cystectomy cohort using standardized reporting methodology and adverse event criteria. [2010]

9. England pubmed.ncbi.nlm.nih.gov

Long-term clinical results and quality of life after insertion of a self-expanding flexible endourethral prosthesis. [2019]