FloStent for Enlarged Prostate

(RAPID-III Trial)

Recruiting at 20 trial locations

Overseen By Study Manager Study Director, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Rivermark Medical

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

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

Compensation: Varies

Number of Visits: 1

Duration: Procedure day

215 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the FloStent, a device designed to assist men with symptoms of Benign Prostatic Hyperplasia (BPH), an enlarged prostate that causes urinary issues. The study compares the effectiveness and safety of the FloStent against a sham procedure, which does not involve the FloStent. Men with significant urinary symptoms from BPH may be suitable candidates for this trial. Participants will undergo a procedure where the FloStent is either used or not, based on their group assignment. As an unphased trial, this study provides participants the chance to contribute to valuable research that could enhance future BPH treatments.

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 prior data suggests that the FloStent device is safe for treating Benign Prostatic Hyperplasia?

In a previous study, the FloStent device proved safe and effective for treating symptoms of an enlarged prostate, providing significant relief for patients. Research shows that all attempts to implant the FloStent succeeded, with no major safety issues reported. Another study found that participants could stop using catheters immediately after the FloStent procedure, suggesting the treatment is well-tolerated. Overall, the FloStent appears to be a promising option with a good safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

FloStent is unique because it offers a new approach for treating an enlarged prostate, or benign prostatic hyperplasia (BPH). Unlike traditional treatments such as medications that relax or shrink the prostate, or surgical procedures like transurethral resection of the prostate (TURP), FloStent is a minimally invasive implant. It is delivered via a flexible cystoscopy procedure, offering potential benefits like reduced recovery time and lower risk of complications. Researchers are excited because this method could provide relief without the need for more invasive surgery and the accompanying extended recovery period.

What evidence suggests that the FloStent is effective for treating symptoms of an enlarged prostate?

Research has shown that the FloStent, which participants in this trial may receive, is a promising treatment for Benign Prostatic Hyperplasia (BPH), or an enlarged prostate. In a previous study, all 11 participants who relied on catheters stopped using them immediately after receiving the FloStent, indicating significant symptom relief. Another study suggested that FloStent could serve as a good temporary option for men awaiting more invasive procedures like TURP (a surgery to remove part of the prostate). Overall, early findings indicate that FloStent can effectively improve urinary symptoms in men with BPH. ^{1 2 4 6 7}

Who Is on the Research Team?

Study Director, MD

Principal Investigator

Rivermark Medical, Inc.

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• FloStent

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. nature.com nature.com/articles/s41391-025-00984-7

Feasibility and safety study of the Flostent™ system ... This preliminary study indicates that the FloStent™ is a safe and effective treatment option for BPH, providing significant symptom relief and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06849258?term=NCT06849258&rank=1

NCT06849258 | A Clinical Study to Evaluate the Safety and ... 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 ...

3. urotoday.com urotoday.com/recent-abstracts/men-s-health/bph-benign-prostatic-enlargement/163269-first-use-of-the-flostent-tm-for-catheter-dependent-urinary-retention-secondary-to-bph-additional-results-from-the-rapid-i-study.html

First Use of the FloStent™ for Catheter-Dependent Urinary ... All 11 participants achieved catheter-free status immediately post-procedure. Baseline characteristics included mean age 69.0 years, prostate ...

4. urologytimes.com urologytimes.com/view/flostent-device-shows-efficacy-for-acute-urinary-retention-due-to-bph

FloStent device shows efficacy for acute urinary retention ... According to the authors, these findings suggest that FloStent could serve as an effective interim solution for men who are awaiting TURP.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40967370/

First Use of the FloStent™ for Catheter-Dependent Urinary ... Results: All 11 participants achieved catheter-free status immediately post-procedure. Baseline characteristics included mean age 69.0 years, ...

6. urologytimes.com urologytimes.com/view/pivotal-trial-launches-of-flostent-system-for-bph

Pivotal trial launches of FloStent System for BPH A clinical study to evaluate the safety and efficacy of the FloStent in men with benign prostatic hyperplasia symptoms (RAPID-III).

7. researchgate.net researchgate.net/publication/391953346_Feasibility_and_safety_study_of_the_Flostent_system_RAPID-I

Feasibility and safety study of the Flostent™ system (RAPID-I) Results The study enrolled 15 participants with a mean age of 58.1 years. All attempts at implantation were successful. Postoperative ...