Butterfly Device for Lower Urinary Tract Symptoms

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called the Butterfly Device for men with bothersome lower urinary tract symptoms due to an enlarged prostate. The goal is to determine if this device can improve urinary symptoms compared to a control group. Participants will receive either the Butterfly Device treatment or a sham procedure (a fake procedure with no real treatment). This trial suits men who have experienced significant prostate-related urinary issues, such as frequent urination or weak stream, for some time. As an unphased trial, it offers a unique opportunity to contribute to pioneering research and potentially benefit from an innovative treatment.

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 prior data suggests that the Butterfly Prostatic Retraction Device is safe for treating lower urinary tract symptoms?

Research has shown that the Butterfly Prostatic Retraction Device is generally easy for patients to handle. Studies indicate that it remains safe to use even up to five years later. Although problems are rare, some individuals might experience temporary issues, such as difficulty emptying their bladder, or might require additional surgery. Most patients do not encounter these issues. Overall, the device appears promising for treating lower urinary tract symptoms with few side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Butterfly Prostatic Retraction Device is unique because it offers a minimally invasive approach to treating lower urinary tract symptoms (LUTS) associated with an enlarged prostate. Unlike traditional surgical methods like transurethral resection of the prostate (TURP), this device aims to reduce symptoms without the need for cutting or removing prostate tissue. Researchers are excited about its potential to provide relief with fewer side effects and a quicker recovery time, making it a promising alternative for patients seeking less invasive treatment options.

What evidence suggests that the Butterfly device is effective for lower urinary tract symptoms?

Research has shown that the Butterfly Prostatic Retraction Device effectively treats symptoms of an enlarged prostate, known as benign prostatic hyperplasia (BPH). In this trial, participants in the active arm will undergo the Butterfly device procedure. Studies have found that it reduces symptoms by about 40%, leading to fewer and less severe issues for patients. Long-term results indicate these benefits last for at least five years, and the device remains safe to use. Overall, the Butterfly device offers a promising option for managing BPH symptoms. ^{1 2 6 7 8}

Who Is on the Research Team?

Adrian Paz, MD

Principal Investigator

Medical director

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

Citations

1. urotoday.com urotoday.com/conference-highlights/aua-2025/aua-2025-press-releases/159871-new-data-highlighting-effectiveness-of-butterfly-medical-s-minimally-invasive-device-for-benign-prostatic-hyperplasia-bph-treatment-to-be-presented-at-aua-2025.html

New Data Highlighting Effectiveness of Butterfly Medical's ... “Our device has demonstrated significant, sustained improvements in lower urinary tract symptoms caused by BPH, with positive trends observed up ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05330520

Long Term Safety and Efficacy of Butterfly Medical Prostatic ... This study evaluates the long term safety and efficacy of use of the Butterfly Medical's prostatic retraction device in Benign Prostatic Hyperplasia (BPH) ...

3. auajournals.org auajournals.org/doi/10.1097/01.JU.0001109776.58983.66.11

IP03-11 5-YEAR FOLLOW-UP OF A MULTICENTER ... Lateral lobe retraction with the Butterfly device demonstrated positive trends in effectiveness up to 5 years with an acceptable safety profile in men with BPH.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36720211/

The Butterfly: A Novel Minimally Invasive Transurethral ... The Butterfly Prostatic Retraction device is a novel transurethral implant designed to dilate the prostatic urethra and treat lower urinary tract symptoms.

5. karger.com karger.com/uin/article/107/4/406/834496/The-Butterfly-A-Novel-Minimally-Invasive

The Butterfly: A Novel Minimally Invasive Transurethral ... 28 patients completed a 1-year follow-up with an intact device. Mean Qmax improved by 2 mL/s (25%), IPSS median drop was 10 points (40%), and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10129019/

The Butterfly: A Novel Minimally Invasive Transurethral ... The Butterfly Prostatic Retraction device is a novel transurethral implant designed to dilate the prostatic urethra and treat lower urinary tract symptoms.

7. urotoday.com urotoday.com/recent-abstracts/endourology-urolithiasis/minimally-invasive-procedures/142240-the-butterfly-a-novel-minimally-invasive-transurethral-retraction-device-for-benign-hypertrophy-of-the-prostate.html

The Butterfly: A Novel Minimally Invasive Transurethral ... We assessed its safety, efficacy and impact on urinary flow, ejaculation, and quality of life. We included 64 men, treated for benign prostate ...

8. clinicaltrial.be clinicaltrial.be/en/details/29628?only_active=0&only_eligible=0&only_recruiting=1&per_page=100

Long Term Safety and Efficacy of Butterfly Medical Prosta... Complications occur less commonly but may include acute urinary retention, impaired bladder emptying, or the need for surgery. The Butterfly ...