Urocross Expander System for Enlarged Prostate

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of the Urocross implant for men with symptoms of an enlarged prostate, known as Benign Prostatic Hyperplasia (BPH). Participants will either receive the Urocross implant or undergo a sham procedure, which involves only a basic internal examination without treatment. Ideal candidates are men experiencing BPH symptoms, such as difficulty urinating, who are willing to stop their current BPH medications during the study. The trial aims to determine if the Urocross implant can safely improve symptoms compared to no treatment. As an unphased trial, it offers participants the chance to contribute to understanding a potential new treatment for BPH.

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 prior data suggests that the Urocross Expander System is safe for treating Benign Prostatic Hyperplasia?

Research shows that the Urocross Expander System is generally safe for treating an enlarged prostate. Studies have found that most people handle the procedure well. In earlier research, patients experienced only mild side effects, such as temporary discomfort after the implant procedure. Animal studies also support the system's safety, confirming its general safety.

While the safety data is encouraging, all medical devices can have risks. Consider these risks when deciding to join a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Urocross implant for treating an enlarged prostate because it offers a minimally invasive option with a unique delivery and retrieval system. Unlike traditional treatments like medication or surgery, the Urocross implant is inserted and later retrieved using a specialized sheath, potentially reducing recovery time and side effects. This method could provide relief without the need for ongoing medication or invasive surgery, making it a promising alternative for many patients.

What evidence suggests that the Urocross Expander System is effective for treating Benign Prostatic Hyperplasia?

Research has shown that the Urocross implant, which participants in this trial may receive, may help treat Benign Prostatic Hyperplasia (BPH), a condition characterized by an enlarged prostate. Early results indicate that patients experienced significant improvement in urinary symptoms, as measured by a standard test, within just three months. Some studies even found that symptoms improved as soon as two weeks after receiving the implant. The Urocross Expander System safely widens the prostatic urethra (the tube through which urine passes) from about 6.9 mm to 10.2 mm, improving urine flow. These findings suggest that the Urocross implant could effectively ease symptoms for those with an enlarged prostate. Meanwhile, the sham-control group in this trial will undergo cystoscopy only, serving as a comparator to evaluate the effectiveness of the Urocross implant. ^{1 3 5 6 7}

Who Is on the Research Team?

Kevin T. McVary

Principal Investigator

Loyola University

Daniel B. Rukstalis

Principal Investigator

Carilion Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05400980

Expander-2 Trial: Randomized Study to Evaluate Safety & ... The primary efficacy endpoint is Change from Baseline in Total International Prostate Symptom Score (IPSS) at 3 months post-procedure. The IPSS items range in ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35641601/

introduction of the novel Urocross™ Expander System for ... Conclusions: Preliminary results demonstrate that the Urocross Expander System is a feasible and safe procedure for treating BPH/LUTS. A strong ...

3. prodeonmedical.com prodeonmedical.com/interim-results-of-the-expander-1-clinical-study/

Interim results of the EXPANDER-1 Clinical Study In addition, the XFLO Expander System was demonstrated to be effective at providing immediate symptom relief (2 weeks post-implant) with 40% ...

4. withpower.com withpower.com/trial/phase-prostatic-hyperplasia-5-2022-b3828

Urocross Expander System for Enlarged Prostate ... Urocross implant will have tolerable side effects & efficacy for patients with Benign Prostatic Hyperplasia and Enlarged Prostate. Learn more about the study.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0090429521009948

Characterization of a Novel Implant Intended to Expand ... All implants were successfully deployed in the prostatic urethra. Urethral width was increased (6.9 ± 1.8 mm to 10.2 ± 0.6 mm, P = .012) and preserved through ...

6. urotoday.com urotoday.com/recent-abstracts/men-s-health/bph-benign-prostatic-enlargement/137664-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.html

The EXPANDER-1 trial: introduction of the novel Urocross ... Preliminary results demonstrate that the Urocross Expander System is a feasible and safe procedure for treating BPH/LUTS. A strong signal of ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9385491/

The EXPANDER-1 trial: introduction of the novel Urocross ... Preliminary results demonstrate that the Urocross Expander System is a feasible and safe procedure for treating BPH/LUTS.