FloStent for Enlarged Prostate

(RAPID-III Trial)

Recruiting at 18 trial locations

Overseen By Study Manager Study Director, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Rivermark Medical

Disqualifiers: Artificial urinary sphincter, Bladder cancer, Uncontrolled diabetes, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this study is to determine the safety and effectiveness of the FloStent, a medical device used to treat men with symptoms of Benign Prostatic Hyperplasia, compared to sham (procedure without deployment of the FloStent). All participants will undergo a flexible cystoscopy and those randomized to the treatment arm will receive the FloStent, while those randomized to the sham arm will not receive the FloStent.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment FloStent for an enlarged prostate?

The study on the modified prostatic UroLume Wallstent, which is similar to FloStent, showed clinical reliability in treating patients with benign prostatic hyperplasia (enlarged prostate), suggesting that FloStent might also be effective. ^{1 2 3 4 5}

Research Team

Study Director, MD

Principal Investigator

Rivermark Medical, Inc.

Eligibility Criteria

This trial is for men experiencing symptoms from an enlarged prostate, also known as Benign Prostatic Hyperplasia (BPH). Participants should be suitable candidates for the procedure and not have other complicating health issues that would interfere with the study or their safety.

Inclusion Criteria

My prostate size is between 25 to 80 mL.

Peak urinary flow rate (Qmax) greater than 5 mL/sec and less than 13 mL/sec with minimum voided volume greater than 125 mL

Post-void residual (PVR) less than 250 mL

Exclusion Criteria

PSA greater than 10 ng/mL

I have an artificial device in my urinary tract.

I have had surgery or a minimally invasive procedure on my prostate or urethra.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a flexible cystoscopy; those in the treatment arm receive the FloStent, while those in the sham arm do not

Procedure day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with primary and secondary outcomes measured over 12 months

12 months

Treatment Details

Interventions

• FloStent (Stent)

Trial Overview The study is testing the FloStent, a device intended to relieve BPH symptoms. Men in the trial will be randomly assigned to either receive this new stent through a cystoscopy or undergo a sham procedure without actual stent placement.

Participant Groups

Group I: Treatment - FloStent Experimental Treatment 1 Intervention

Flexible cystoscopy procedure with FloStent implant deployed

Group II: Sham Control Placebo Group 1 Intervention

Flexible cystoscopy procedure without FloStent implant deployed

Who Is Running the Clinical Trial?

Rivermark Medical

Lead Sponsor

Trials

1

Recruited

220+

Findings from Research

In a 2-year study involving men aged 50 and older with moderate to severe lower urinary tract symptoms, combination therapy with dutasteride and tamsulosin significantly improved symptoms and urinary flow compared to either medication alone.

While combination therapy was more effective, it also led to a higher incidence of drug-related adverse events, although most patients did not need to stop treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of dutasteride, tamsulosin and combination therapy on lower urinary tract symptoms in men with benign prostatic hyperplasia and prostatic enlargement: 2-year results from the CombAT study. Roehrborn, CG., Siami, P., Barkin, J., et al.[2018]

In a study of 414 patients with benign prostatic hyperplasia (BPH), tamsulosin 0.2 mg was found to be an effective long-term treatment, with 75.2% of patients responding positively by 12 weeks and maintaining improvements over 48 weeks.

The study highlighted that the new lower urinary tract symptoms (LUTS) outcome score (LOS) is a valuable tool for predicting treatment outcomes, as responders continued to show significant clinical improvements, while non-responders had poor results even after switching treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcome of tamsulosin for patients with lower urinary tract symptoms according to the treatment response defined by lower urinary tract symptom outcomes score. Kang, SG., Park, CH., Kim, DK., et al.[2022]

In a 24-month study involving 2,175 patients across five European countries, 70% of previously untreated patients and 42% of previously treated patients experienced significant symptom improvement from pharmacological treatment for benign prostatic enlargement.

The study found low rates of clinical progression and surgery (16% and 5%, respectively) among both untreated and treated groups, indicating that pharmacological treatments are effective and safe in managing lower urinary tract symptoms in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A European Registry Evaluating Symptomatic Effectiveness of Pharmacologically Treated Patients with Lower Urinary Tract Symptoms due to Benign Prostatic Enlargement: Lessons Learned. Tubaro, A., Speakman, M., de la Taille, A., et al.[2021]

Maximal androgen blockade (MAB) significantly improves lower urinary tract symptoms (LUTS) in advanced prostate cancer patients, with noticeable improvements observed as early as 3 months after treatment.

The most significant changes in urinary symptoms and prostate volume occur within the first 3 months of MAB, suggesting that early intervention is crucial for effective symptom management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Improvement of lower urinary tract symptoms in patients with prostate cancer treated with maximal androgen blockade]. Zhong, K., Li, W., Gui, M., et al.[2014]

The modified UroLume Wallstent significantly improved urinary flow rates and reduced residual urine volumes in 135 patients with benign prostatic hyperplasia, indicating its efficacy in relieving bladder outlet obstruction.

Despite the initial success, the study revealed a high complication rate (38%), leading to the abandonment of the stent due to issues like detrusor instability and stent migration, highlighting safety concerns associated with its long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A modified prostatic UroLume Wallstent for healthy patients with symptomatic benign prostatic hyperplasia: a European Multicenter Study. Guazzoni, G., Montorsi, F., Coulange, C., et al.[2019]

References

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

The effects of dutasteride, tamsulosin and combination therapy on lower urinary tract symptoms in men with benign prostatic hyperplasia and prostatic enlargement: 2-year results from the CombAT study. [2018]

2. India pubmed.ncbi.nlm.nih.gov

Long-term outcome of tamsulosin for patients with lower urinary tract symptoms according to the treatment response defined by lower urinary tract symptom outcomes score. [2022]

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

A European Registry Evaluating Symptomatic Effectiveness of Pharmacologically Treated Patients with Lower Urinary Tract Symptoms due to Benign Prostatic Enlargement: Lessons Learned. [2021]

4. China pubmed.ncbi.nlm.nih.gov

[Improvement of lower urinary tract symptoms in patients with prostate cancer treated with maximal androgen blockade]. [2014]

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

A modified prostatic UroLume Wallstent for healthy patients with symptomatic benign prostatic hyperplasia: a European Multicenter Study. [2019]