Zenflow Spring System for Enlarged Prostate

Recruiting at 1 trial location

Overseen By Kevin MacDonald

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Zenflow, Inc.

Must not be taking: Anticholinergics, Antispasmodics, Antidepressants, others

Disqualifiers: Prostate cancer, UTI, Prostate surgery, others

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

Compensation: Varies

Number of Visits: 6

Duration: 1 week

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medical device called the Zenflow Spring System, designed to help men with an enlarged prostate (Benign Prostatic Hyperplasia, or BPH) by easing symptoms like frequent urination or a weak urine stream. Researchers aim to determine if this device is safe and effective for those who have not found success with other treatments. Men who have experienced BPH symptoms for a while but haven't found relief with medications might be suitable candidates for this trial. As an unphased trial, this study offers patients a unique opportunity to explore a novel treatment option that could potentially improve their quality of life.

Will I have to stop taking my current medications?

Yes, you may need to stop taking certain medications. Specifically, you must stop taking anticoagulants and antiplatelets at least 3 days before the procedure, coumadin at least 5 days before, and certain other medications like alpha-blockers and anticholinergics within specific timeframes before the evaluation.

What prior data suggests that the Zenflow Spring System is safe for treating enlarged prostate?

Research shows that the Zenflow Spring System is well-tolerated for treating an enlarged prostate. Three years after treatment, patients experienced significant symptom improvements, including a 46% improvement in their International Prostate Symptom Score (IPSS), which measures the impact of symptoms on daily life.

Safety data from other studies also support its use, focusing on the system's ability to relieve symptoms safely without major issues. Patients reported a better quality of life and improved urinary flow, allowing easier urination.

Overall, current findings suggest that the Zenflow Spring System is safe for use in people. However, discussing with a doctor is essential to determine if it's the right fit. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Zenflow Spring System is unique because it offers a minimally invasive approach to treating an enlarged prostate, also known as benign prostatic hyperplasia (BPH). Unlike traditional treatments, which often involve medications like alpha-blockers or surgical procedures such as TURP (transurethral resection of the prostate), the Zenflow Spring System is designed to be less invasive and potentially offer quicker recovery times. Researchers are excited about this treatment because it uses a spring-like implant to gently expand the urethra, improving urine flow without the need for cuts or significant tissue removal. This innovative mechanism could mean fewer side effects and a simpler recovery process for patients.

What evidence suggests that the Zenflow Spring System is effective for relieving symptoms of BPH?

Research has shown that the Zenflow Spring System, which participants in this trial will receive, effectively treats symptoms of Benign Prostatic Hyperplasia (BPH), a condition characterized by an enlarged prostate. Studies found a 46% improvement in the International Prostate Symptom Score (IPSS) after 36 months of treatment. Patients reported feeling 50% better in their daily lives, and the speed of urine flow improved by over 30%. These results suggest that the Zenflow Spring System can significantly reduce BPH symptoms and enhance quality of life. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

Men over 45 with enlarged prostate (BPH) who have an IPSS score >13, a prostate volume of 25-80 cc, and urethral length of 2.5-4.5 cm. Candidates should not be on BPH medications or prefer not to take them and must consent to study requirements. Exclusions include those with urinary flow rate >15 ml/second, prior prostate treatments, certain medications within specific timeframes before the trial, nickel allergy, or life expectancy less than 24 months.

Inclusion Criteria

Baseline IPSS score > 13

My prostate size and urethral length fit the required measurements.

Patient is able and willing to comply with all the assessments of the study

Exclusion Criteria

I am taking medication that affects bladder function.

Any concurrent medical condition or illness that might prevent study completion or would confound study results

I have a condition that could cause difficulty in emptying 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 Zenflow Spring System implant for the treatment of BPH

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Multiple visits over 5 years

Long-term follow-up

Assessment of adverse events and effectiveness of the treatment over an extended period

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Zenflow Spring System

Trial Overview The Zenflow Spring System is being tested for its safety and effectiveness in relieving symptoms caused by BPH. The device aims to improve urinary flow without medication or invasive surgery.

How Is the Trial Designed?

Group I: Treatment Group Experimental Treatment 1 Intervention

Receives intervention with the Zenflow Spring System.

Who Is Running the Clinical Trial?

Zenflow, Inc.

Lead Sponsor

Trials

5

Recruited

440+

Published Research Related to This Trial

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 CoreFlow Soft Stent was successfully used in a study of 19 men with neurogenic diseases to diagnose causes of incomplete bladder emptying (IBE), showing its potential as a simple diagnostic tool.

In patients with prostatic adenoma, 50% were able to urinate with the stent in place, indicating that the adenoma was the cause of IBE, while others required repositioning of the stent to confirm detrusor underactivity as the underlying issue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Temporary stent--CoreFlow Soft Stent--for diagnosis of the causes of incomplete bladder emptying in men with neurological diseases]. Krivoborodov, GG., Mazo, EB., Efremov, NS.[2009]

In a study involving 36 patients with benign prostatic hyperplasia, the Memotherm® urethral stent successfully allowed 34 patients to urinate after implantation, demonstrating its efficacy in relieving urinary retention.

The average follow-up of 24 months showed manageable complications, with only one stent needing removal due to bladder tamponade and another needing exchange due to dislocation, indicating a generally safe profile for this treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Outcome analysis of the urethral stent (Memotherm®)]. Sakamoto, H., Matsuda, A., Arakaki, R., et al.[2012]

Minimally invasive surgical techniques (MIST) for treating benign prostatic hyperplasia (BPH) offer rapid recovery, low complication rates, and can be performed in outpatient settings with local anesthesia, improving patient quality of life.

Technologies such as Aquablation, Rezūm, and UroLift show promise in preserving ejaculation while treating BPH, but long-term safety and efficacy data are still needed to fully evaluate their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Technologies for Treatment of Benign Prostatic Hyperplasia. Elterman, D., Gao, B., Lu, S., et al.[2021]

In a small study of 10 patients with benign prostate hyperplasia (B.P.H.) who had surgical contraindications, a prosthesis was successfully implanted, resulting in a 70% rate of good outcomes over a follow-up period of 4 to 11 months.

The use of this prosthesis may provide a valuable alternative to surgery, potentially reducing the need for indwelling catheters and offering relief for patients who cannot undergo more aggressive treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[First results of our experience with the Fabian's prosthesis]. López Aramburu, MA., Andreu García, A., Arroyo Muñoz, JL., et al.[2006]

Citations

1. urotoday.com urotoday.com/conference-highlights/aua-2025/aua-2025-press-releases/160191-three-year-data-of-zenflow-s-spring-system-demonstrate-durability-of-clinical-benefits-for-patients-suffering-from-bph.html

Three-Year Data of Zenflow's Spring System Demonstrate ... Three-Year Data of Zenflow's Spring System Demonstrate Durability of Clinical Benefits For Patients Suffering from BPH · At 36 months, IPSS was 46% improved ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03595735

Study Details | NCT03595735 | The Zenflow Spring System ... Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH) by patient response to the International Prostate Symptom Score ...

3. medicaldevice-network.com medicaldevice-network.com/news/zenflow-spring-system/

Zenflow announces Spring System data for BPH These studies showed that at the 36-month mark, individuals who received treatment with the Zenflow Spring exhibited a 46% improvement in their ...

4. urologytimes.com urologytimes.com/view/dean-elterman-md-shares-3-year-data-on-zenflow-spring-system-for-bph

Dean Elterman, MD, shares 3-year data on Zenflow Spring ... We saw an improvement in quality of life by at least 50%. We saw an improvement in urinary peak flows by over 30%. We saw a great responder rate ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02786290

The Zenflow Spring System Feasibility and Safety Study This is a First in Human study to assess the feasibility, safety and effectiveness of the Zenflow Spring System in relieving the symptoms of obstructive Benign ...