Butterfly Device for Lower Urinary Tract Symptoms

Recruiting at 3 trial locations

Overseen By Vardit Segal, Ph.D.

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Butterfly Medical Ltd.

Must not be taking: 5 alpha reductase, Alpha-blockers

Disqualifiers: Prostate cancer, Urinary retention, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

245 Participants Needed

Trial Summary

What is the purpose of this trial?

A prospective, multicenter, blind randomized (2:1) controlled study comparing the International Prostate Symptom Score (IPSS) of the Active arm to the IPSS of the control arm at the 3 months follow-up and active arm IPSS score change from time zero to 12 months. Patients in the active arm undergo Butterfly device treatment. Patients in the control arm undergo a sham rigid cystoscopy procedure

Do I have to stop taking my current medications for the trial?

Yes, you may need to stop certain medications. Specifically, you cannot take 5 alpha reductase inhibitors within 6 months, and certain other medications like alpha-blockers, imipramine, anticholinergics, and others within 2 weeks of the baseline evaluation. Additionally, some medications like phenylephrine or pseudoephedrine must not be taken within 24 hours of the baseline evaluation.

Will I have to stop taking my current medications?

Yes, you may need to stop taking certain medications. The trial requires that you have not taken 5 alpha reductase inhibitors within 6 months, and certain other medications like alpha-blockers, imipramine, and anticholinergics within 2 weeks before the baseline evaluation. Additionally, some medications like phenylephrine or pseudoephedrine should not be taken within 24 hours of the baseline evaluation.

What data supports the idea that Butterfly Device for Lower Urinary Tract Symptoms is an effective treatment?

The available research shows that the Butterfly Device is effective in treating lower urinary tract symptoms by improving urinary flow and quality of life. It is a minimally invasive option that helps to widen the passage in the prostate, which can ease symptoms. Compared to other treatments like prostate artery embolization, the Butterfly Device also aims to improve quality of life with minimal side effects. However, long-term data on its effectiveness and safety are still needed. ^{1 2 3 4 5}

What data supports the effectiveness of the Butterfly Prostatic Retraction Device treatment for lower urinary tract symptoms?

The Butterfly Prostatic Retraction Device is a new implant designed to help with lower urinary tract symptoms by widening the urethra (the tube that carries urine out of the body). Studies have shown it is safe and effective, improving urine flow and quality of life for patients with an enlarged prostate. ^{1 2 3 4 5}

What safety data is available for the Butterfly Device for lower urinary tract symptoms?

The Butterfly Prostatic Retraction Device is a novel transurethral implant designed to treat lower urinary tract symptoms by dilating the prostatic urethra. Safety data from studies indicate that the device has been assessed for its safety, efficacy, and impact on urinary flow, ejaculation, and quality of life. Additionally, a study examined the chronic histological response of prostate tissue to the device in patients with benign prostatic hyperplasia. However, specific adverse events or complications related to the Butterfly Device were not detailed in the provided abstracts. ^{1 2 6 7 8}

Is the Butterfly Device safe for treating lower urinary tract symptoms?

The Butterfly Prostatic Retraction Device has been studied for its safety in treating lower urinary tract symptoms related to benign prostatic hyperplasia (BPH). Research indicates it is a minimally invasive implant designed to improve urinary flow, and studies have focused on its safety and impact on quality of life. ^{1 2 6 7 8}

Is the Butterfly Prostatic Retraction Device a promising treatment for lower urinary tract symptoms?

Yes, the Butterfly Prostatic Retraction Device is a promising treatment. It is a new, minimally invasive option designed to improve urinary flow and quality of life without major side effects. It aims to treat symptoms effectively while minimizing issues like sexual dysfunction. ^{1 2 9 10 11}

How is the Butterfly Prostatic Retraction Device treatment different from other treatments for lower urinary tract symptoms?

The Butterfly Prostatic Retraction Device is unique because it is a minimally invasive implant that dilates the prostatic urethra to relieve symptoms, aiming to minimize side effects and sexual dysfunction compared to traditional surgical and medical therapies. ^{1 2 9 10 11}

Research Team

Adrian Paz, MD

Principal Investigator

Medical director

Eligibility Criteria

Men aged 50-80 with benign prostatic hyperplasia (BPH), experiencing moderate to severe urinary symptoms, and a prostate size of 30-90 ml. Candidates must not have had prior prostate surgery or suffer from conditions like uncontrolled diabetes, neurological disorders, or active bladder issues. They should not be on certain medications for BPH or have a history of prostate cancer.

Inclusion Criteria

My prostate length is between 25mm and 45mm.

My prostate length is between 25mm and 45mm.

My prostate size is between 30 to 90 ml.

Exclusion Criteria

I have had kidney stones grow, pass, or bladder stones in the last 3 months.

I think I have an overactive bladder.

I have had or currently have a narrowing in my urinary passage.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the active arm undergo the Butterfly device procedure, while the control arm undergoes a sham rigid cystoscopy procedure

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with primary assessments at 3 and 12 months

12 months

Crossover

Sham arm patients are allowed to crossover and undergo the Butterfly procedure

Treatment Details

Interventions

• Butterfly Prostatic Retraction Device

Trial Overview The Butterfly Pivotal Study is testing the effectiveness of the Butterfly Prostatic Retraction Device in improving urinary symptoms in men with BPH. Participants are randomly assigned to either receive this device treatment or undergo a sham procedure without actual treatment.

Participant Groups

Group I: Cross over Experimental Treatment 1 Intervention

Sham arm patient is allowed to crossover and undergo the Butterfly procedure

Group II: Active Active Control 1 Intervention

The active arm patients undergo the Butterfly device procedure.

Group III: Sham Comparator Placebo Group 1 Intervention

The sham control arm patients undergo a rigid cystoscopy procedure.

Butterfly Prostatic Retraction Device is already approved in European Union, United States for the following indications:

Approved in European Union as Butterfly Prostatic Retraction Device for:

• Benign Prostatic Hyperplasia (BPH)
• Lower Urinary Tract Symptoms (LUTS)

Approved in United States as Butterfly Prostatic Retraction Device for:

• Benign Prostatic Hyperplasia (BPH)
• Lower Urinary Tract Symptoms (LUTS)

Who Is Running the Clinical Trial?

Butterfly Medical Ltd.

Lead Sponsor

Trials

3

Recruited

400+

Findings from Research

The Butterfly Prostatic Retraction device showed a 25% improvement in urinary flow (Qmax) and a 40% reduction in lower urinary tract symptoms (IPSS) after one year in a study of 64 men with benign prostate hyperplasia.

The device was generally well-tolerated, with most patients experiencing improved quality of life, although some required removal of the device or returned to other treatments, indicating the need for careful patient selection and follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Butterfly: A Novel Minimally Invasive Transurethral Retraction Device for Benign Hypertrophy of the Prostate. Katz, R., Ahmed, MSA., Safadi, A., et al.[2023]

The Butterfly Prostatic Retraction Device showed a favorable safety profile in a study of seven patients, with no significant tissue reactions such as ischemic necrosis or cellular atypia observed after at least one month of implantation.

Four out of six patients experienced a decrease in their International Prostate Symptom Score (IPSS), indicating potential efficacy in alleviating symptoms of benign prostatic hyperplasia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of the histological response to the Butterfly Prostatic Retraction Device in patients with benign prostatic hyperplasia. Katz, R., Sze, C., Punyala, A., et al.[2023]

Prostate artery embolization is an emerging endovascular treatment for lower urinary tract symptoms caused by benign prostatic hypertrophy, showing significant improvements in quality of life with minimal sexual side effects.

This technique is becoming increasingly popular due to its less invasive nature compared to traditional methods, which helps improve patient recovery and reduce complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Is New in Prostate Artery Embolization for Lower Urinary Tract Symptoms? McClure, TD., Ricke, J.[2019]

In a study of 129 patients with post-prostatectomy incontinence, both the adjustable transobturator male system (ATOMS) and the artificial urinary sphincter (AUS) were found to be effective, with similar satisfaction rates (92.2% for ATOMS vs. 88.9% for AUS).

However, the AUS showed a greater improvement in pad test results but had a higher surgical revision rate (22.2% for AUS vs. 6.9% for ATOMS), indicating that while AUS may provide better immediate results, ATOMS may offer better long-term durability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of a Series of Patients with Post-Prostatectomy Incontinence Treated with an Adjustable Transobturator Male System or Artificial Urinary Sphincter. Esquinas, C., Ruiz, S., de Sancha, E., et al.[2021]

Transurethral resection of the prostate (TURP) remains the gold standard surgical treatment for lower urinary tract symptoms (LUTS) caused by benign prostatic obstruction (BPO), demonstrating established efficacy and safety.

New surgical techniques have shown promising functional results for treating LUTS, but there is a lack of long-term data to fully assess their efficacy and safety compared to TURP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Surgical treatment of male lower urinary tract symptoms (LUTS)]. Gratzke, C., Strittmatter, F., Reich, O., et al.[2021]

A review of 2567 reports on various BPH treatment devices showed that over 99% of patients experienced no complications from device malfunctions, indicating a high level of safety across the modalities studied.

The use of morcellators during HoLEP was associated with the highest rate of serious complications, suggesting that urologists should be cautious and choose devices they are most familiar with to minimize risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Device Malfunctions and Complications Associated with Benign Prostatic Hyperplasia Surgery: Review of the Manufacturer and User Facility Device Experience Database. Patel, NH., Uppaluri, N., Iorga, M., et al.[2021]

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 UroLift® System is a new surgical technique for treating lower urinary tract symptoms caused by benign prostatic hyperplasia (BPH) that safely opens the urethra without incisions or thermal injury, showing promising results in a study of 20 patients with a mean age of 74.3 years.

After the procedure, patients experienced significant improvements in symptoms, with a reduction in the International Prostate Symptom Score (IPSS) and an increase in peak urinary flow rate (Qmax), while no major complications or sexual dysfunction were reported, indicating its safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Urolift®, a new minimally invasive treatment for patients with low urinary tract symptoms secondary to BPH. Preliminary results]. Garrido Abad, P., Coloma Del Peso, A., Sinues Ojas, B., et al.[2014]

Recent technologies for treating lower urinary tract symptoms (LUTS) from benign prostatic hyperplasia (BPH) show promise in improving symptoms while minimizing sexual side effects, particularly with prostatic urethral lift and convective water vapor ablation therapy.

Most new therapies are still in early development stages, with phase I and II studies indicating potential benefits, but long-term effectiveness and durability of symptom relief have yet to be established.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New and Emerging Technologies in Treatment of Lower Urinary Tract Symptoms From Benign Prostatic Hyperplasia. Gupta, NK., Gange, SN., McVary, KT.[2020]

The prostatic Urolume Wallstent is a safe and effective minimally invasive treatment for benign prostatic hyperplasia (BPH), as demonstrated in a study involving 100 patients who underwent thorough pre- and postoperative evaluations.

Most patients experienced improved voiding parameters long-term, although some complications such as stent malpositioning and persistent irritative symptoms were noted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of wallstents in patients with benign prostatic hyperplasia. Guazzoni, G., Montorsi, F., Rigatti, P.[2004]

The updated German guidelines provide a comprehensive treatment algorithm for managing lower urinary tract symptoms (LUTS) due to benign prostatic obstruction (BPO), emphasizing the importance of tailoring surgical options to individual patient needs.

Surgical treatments are categorized based on factors like the removal of the obstructing adenoma and the preservation of ejaculatory function, ensuring that the chosen procedure aligns with the patient's anatomical features and overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Surgical treatment options of lower urinary tract symptoms due to benign prostatic obstruction : The German S2e guideline 2023-part 3]. Magistro, G., Abt, SD., Becher, KF., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

The Butterfly: A Novel Minimally Invasive Transurethral Retraction Device for Benign Hypertrophy of the Prostate. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Characterization of the histological response to the Butterfly Prostatic Retraction Device in patients with benign prostatic hyperplasia. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

What Is New in Prostate Artery Embolization for Lower Urinary Tract Symptoms? [2019]

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

Outcomes of a Series of Patients with Post-Prostatectomy Incontinence Treated with an Adjustable Transobturator Male System or Artificial Urinary Sphincter. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

[Surgical treatment of male lower urinary tract symptoms (LUTS)]. [2021]

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

Device Malfunctions and Complications Associated with Benign Prostatic Hyperplasia Surgery: Review of the Manufacturer and User Facility Device Experience Database. [2021]

7. United States 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. [2023]

8. Spain pubmed.ncbi.nlm.nih.gov

[Urolift®, a new minimally invasive treatment for patients with low urinary tract symptoms secondary to BPH. Preliminary results]. [2014]

9. Netherlands pubmed.ncbi.nlm.nih.gov

New and Emerging Technologies in Treatment of Lower Urinary Tract Symptoms From Benign Prostatic Hyperplasia. [2020]

10. Spain pubmed.ncbi.nlm.nih.gov

The use of wallstents in patients with benign prostatic hyperplasia. [2004]

11. Germany pubmed.ncbi.nlm.nih.gov

[Surgical treatment options of lower urinary tract symptoms due to benign prostatic obstruction : The German S2e guideline 2023-part 3]. [2023]