Butterfly Device for Lower Urinary Tract Symptoms
Recruiting in Palo Alto (17 mi)
+3 other locations
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Butterfly Medical Ltd.
No Placebo Group
Approved in 2 Jurisdictions
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.
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.
12345What 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.
12678Is 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.
1291011Eligibility 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.
+4 more
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.
+23 more
Participant Groups
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.
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Cross overExperimental Treatment1 Intervention
Sham arm patient is allowed to crossover and undergo the Butterfly procedure
Group II: ActiveActive Control1 Intervention
The active arm patients undergo the Butterfly device procedure.
Group III: Sham ComparatorPlacebo Group1 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)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Houston MethodistHouston, TX
Northwell HealthSyosset, NY
Manhattan Medical ResearchNew York, NY
Summit UrologySalt Lake City, UT
Loading ...
Who Is Running the Clinical Trial?
Butterfly Medical Ltd.Lead Sponsor
References
The Butterfly: A Novel Minimally Invasive Transurethral Retraction Device for Benign Hypertrophy of the Prostate. [2023]The Butterfly Prostatic Retraction device is a novel transurethral implant designed to dilate the prostatic urethra and treat lower urinary tract symptoms. We assessed its safety, efficacy and impact on urinary flow, ejaculation, and quality of life.
Characterization of the histological response to the Butterfly Prostatic Retraction Device in patients with benign prostatic hyperplasia. [2023]The Butterfly Prostatic Retraction Device ("Butterfly") is a permanent nitinol implant for benign prostatic hyperplasia. This study examines the chronic response of prostate tissue to the Butterfly in histological specimens from patients in the Butterfly pilot clinical study.
What Is New in Prostate Artery Embolization for Lower Urinary Tract Symptoms? [2019]Management of lower urinary tract symptoms (LUTS) secondary to benign prostatic hypertrophy (BPH) continues to evolve with techniques becoming less invasive, improving patient convalescence and minimizing side effects. Prostate artery embolization, an endovascular treatment option for men with LUTS secondary to BPH has gained recent interest because of reported improvements in quality of life with minimal sexual side effects. In this brief review, we review the concept of prostate artery embolization, discuss the largest retrospective study and randomized control trial, and discuss complications associated with the procedure.
Outcomes of a Series of Patients with Post-Prostatectomy Incontinence Treated with an Adjustable Transobturator Male System or Artificial Urinary Sphincter. [2021]A prospective evaluation of outcomes in a series of patients with post-prostatectomy incontinence (PPI) treated with two different devices is presented.
[Surgical treatment of male lower urinary tract symptoms (LUTS)]. [2021]Surgical treatment of lower urinary tract symptoms (LUTS) due to benign prostatic obstruction (BPO) comprises a variety of treatment modalities. Transurethral resection of the prostate (TURP) is considered the gold standard. In the last decade various new techniques have emerged with encouraging functional results. However, long-term data are missing in order to evaluate the efficacy and safety. This review aims to describe new widely available techniques and to assess the underlying evidence.
Device Malfunctions and Complications Associated with Benign Prostatic Hyperplasia Surgery: Review of the Manufacturer and User Facility Device Experience Database. [2021]Introduction and Objectives: Multiple surgical therapies for benign prostatic hyperplasia (BPH) have been developed to decrease complications and increase provider efficiency. We investigated contemporary BPH treatment device-related adverse events by searching a publicly available database. Materials and Methods: The Manufacturer and User Facility Device Experience (MAUDE) database was queried for contemporary BPH treatments. All devices were evaluated for malfunction, patient complications, and manufacturer review. The MAUDE adverse event classification system was used to standardize complications. Univariate analysis was performed to identify associations between BPH devices and adverse events. Results: A total of 2567 reports were identified: transurethral resection of the prostate (TURP) 197 (7.67%), holmium laser enucleation of the prostate (HoLEP) 39 (1.52%), GreenLight™ 2315 (90.2%), and UroLift® 16 (0.62%). The most common deviations for each modality included cutting loop detachment during TURP 116 (58.9%), morcellator dysfunction for HoLEP 23 (58.9%), tip fracture/detachment for GreenLight (68.8%), and failure to deploy during UroLift 10 (62.5%). Only 18 (0.7%) patients required medical/surgical management (MAUDE II-IV) due to a device complication. No significant relationship was seen between each modality and complications; however, morcellator use (27.8%) was observed in higher grade complications. Manufacturer review occurred in 61.7% of cases, with 41.3% of reviewed cases finding the operator the cause of the malfunction. Conclusion: Each BPH modality investigated had minimal patient harm with over 99% of patients experiencing no complication after device malfunction. Of note, great care should be taken with morcellator use during HoLEP as it had the greatest number of MAUDE II to IV complications among all devices. Manufacturer review revealed that over 40% of cases were due to misuse by the user. Therefore, urologists should select the modalities they are most familiar with to decrease patient harm and prevent device malfunctions.
Aquablation, Prostatic Urethral Lift, and Transurethral Water Vapor Therapy: A Comparison of Device-Related Adverse Events in a National Registry. [2023]Purpose: Aquablation, prostatic urethral lift (PUL), and transurethral water vapor therapy (TWVT) have demonstrated efficacy for the treatment of benign prostatic hyperplasia (BPH). Our objective was to describe device malfunctions and complications to help guide procedural selection and performance. Materials and Methods: The Manufacturer and User Facility Device Experience (MAUDE) database was examined for reports related to the use of these three procedures for the treatment of BPH between January 1, 2015, and July 1, 2020. Reports were evaluated for device malfunctions and surgical complications using a previously described externally validated classification system developed for the MAUDE database. Chi square analysis was used for statistical comparison between groups. Results: A total of 391 adverse events were reported: aquablation (n = 102), PUL (n = 132), and TWVT (n = 157). There were 79 (78%) severe or life-threatening adverse events for aquablation vs 69 (52%) for PUL vs 24 (15%) for TWVT (p < 0.001). There were 4 cases of rectal perforation with aquablation and 25 cases of the PUL implants needing to be removed or causing a problem with a later procedure. Blood transfusion frequencies were aquablation-32 (31%), PUL-21 (16%), and TWVT-1 (1%). The most common device malfunctions were: aquablation-motion error (n = 8), handpiece fracture/attachment malfunction (n = 8); PUL-device misfire (n = 27), needle fragmentation (n = 21); TWVT-unresolvable error message (n = 19). Conclusions: In a national database, aquablation and PUL had noteworthy complications or device-related malfunctions such as rectal perforation and the improper placement or failed deployment of the PUL implants. Both patients and providers should be aware of potential risks when selecting these novel BPH treatments.
[Urolift®, a new minimally invasive treatment for patients with low urinary tract symptoms secondary to BPH. Preliminary results]. [2014]To report the preliminary results of one of the first series of patients treated with a new simple surgical technique for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) and to evaluate its safety and feasibility.
New and Emerging Technologies in Treatment of Lower Urinary Tract Symptoms From Benign Prostatic Hyperplasia. [2020]Lower urinary tract symptoms (LUTS) from bladder outlet obstruction from benign prostatic hyperplasia (BPH) occur in a large percentage of urologic patients. Treatment of this condition with medical and surgical therapy provides symptom relief but has serious adverse effects and causes sexual dysfunction. New technologies to treat BPH-associated LUTS aim to effectively treat urinary symptoms and minimize side effects and sexual dysfunction.
The use of wallstents in patients with benign prostatic hyperplasia. [2004]This study was conducted to assess the clinical reliability of the prostatic Urolume Wallstent for symptomatic BPH patients. One hundred patients were treated under intravenous sedation or local anesthesia. Pre- and postoperative patient evaluation included scoring of subjective symptoms, physical examination, laboratory analysis, transrectal ultrasonography, uroflowmetry with maximum flow nomograms, intravenous pyelogram and cystourethroscopy. At the long-term follow-up the vast majority of patients showed non-obstructed voiding parameters. The most frequent complications included stent malpositioning and dislocation, and persistent irritative symptomatology. The prostatic UroLume Wallstent is a safe and effective minimally invasive procedure for carefully selected BPH patients.
[Surgical treatment options of lower urinary tract symptoms due to benign prostatic obstruction : The German S2e guideline 2023-part 3]. [2023]Lower urinary tract symptoms (LUTS) due to benign prostatic obstruction (BPO) are one of the most common diagnoses in clinical practice. Bothersome LUTS impact considerably quality of life of men and may cause severe complications without treatment. According to the diagnostic assessment every patient should be treated with an adequate therapy. Management comprises a conservative approach, medication, novel minimally invasive options, and surgical procedures with the aim to remove the obstructing adenoma. The German guideline panel has updated the German guidelines on diagnostic evaluation and management of LUTS due to BPO.