Zenflow Spring System for Enlarged Prostate

Recruiting at1 trial location

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Zenflow, Inc.

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

Disqualifiers: Prostate cancer, UTI, Prostate surgery, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of the Zenflow Spring System, a device designed to help men with an enlarged prostate urinate more easily. The spring is placed in the urinary tract to keep it open, reducing symptoms with minimal side effects. The target group is men who suffer from urinary problems due to an enlarged prostate.

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.

How does the Zenflow Spring System treatment for enlarged prostate differ from other treatments?

The Zenflow Spring System is unique because it is a minimally invasive treatment designed to provide rapid symptom relief for benign prostatic hyperplasia (BPH) with low complication rates, and it can be performed in an outpatient setting with local anesthesia, preserving ejaculation. ^{1 2 3 4 5}

Research Team

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Zenflow Spring System (Device)

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. Spain pubmed.ncbi.nlm.nih.gov

[First results of our experience with the Fabian's prosthesis]. [2006]

2. 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]

3. Japan pubmed.ncbi.nlm.nih.gov

[Outcome analysis of the urethral stent (Memotherm®)]. [2012]

4. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Temporary stent--CoreFlow Soft Stent--for diagnosis of the causes of incomplete bladder emptying in men with neurological diseases]. [2009]

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

New Technologies for Treatment of Benign Prostatic Hyperplasia. [2021]