Butterfly Pivotal Study

Study Overview
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Brief Summary
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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

Official Title
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A Prospective, Randomized, Controlled, Blinded Study to Assess the Safety and Efficacy of the Butterfly Medical Prostatic Retraction Device in BPH Patients

Conditions
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BPH (Benign Prostatic Hyperplasia), Lower Urinary Tract Symptoms (LUTS)

Intervention / Treatment
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* Device: Butterfly Prostatic Retraction Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male patient age 50 to 80 Willing and able to sign informed consent Willing and able to comply with all study assessments Prostate length of 25mm-45mm (from apex of the prostate to the beginning of the bladder neck). Prostate volume 30-90 ml Symptomatic BPH: IPSS ≥ 13; ≥ 1 in the IPSS voiding to sub-score ratio (IPSS-V/S) Exclusion Criteria: Known sensitivity to Nickel. Current urinary retention Urinary stress incontinence (sphincter) Biopsy of the prostate within the last 6 weeks Baseline PSA > 10 ng/mL or confirmed or suspected prostate cancer. Patients with a PSA level above 2.5 ng/mL, in which free PSA is < 25% of total PSA in whom cancer was not ruled out by biopsy. Chronic prostatitis, recurrent prostatitis, chronic pelvic pain syndrome (CPPS), or painful bladder syndrome within the past 12 months Obstructing intraprostatic median lobe (e.g., more than 10mm intravesical prostatic protrusion). Urethral stricture, meatal stenosis, or bladder neck stricture - either current or recurrent. Anatomical anomalies that will not accommodate the retractor, as determined by cystoscopy (e.g., prostatic urethral length to height geometry, absence of bladder neck) Prior surgery or minimal invasive procedure of prostate (brachytherapy and PAE patients are not excluded if they show significant obstruction in urodynamic test and cystoscopy shows no significant fibrosis). Currently active bladder tumor or intravesical instillation. History of other diseases causing voiding dysfunction including urinary retention (e.g., uncontrolled diabetes, diagnosis of neurogenic or atonic bladder, Parkinson's disease, multiple sclerosis, etc.). Suspected Neurogenic or atonic urinary bladder. Suspected Polyuria/Nocturnal Polyuria. Suspected overactive bladder High bladder neck with the absence of lateral lobe encroachment indicating a high likelihood of primary bladder neck obstruction as determined by the Investigator Urethral pathology: diverticula, strictures, tumors, fistula. Acute clinically Significant urinary tract infection. Uncontrolled bleeding disorders. Active stone disease (urinary stone increase in size during the last 3 months/ stone passage during the last 3 months/ presence of cystolithiasis) Taking 5 alpha reductase inhibitors within 6 months of baseline evaluation Taking one of the following within 2 weeks of baseline evaluation: alpha-blockers, imipramine, anticholinergics, Phosphodiesterase-5 Enzyme Inhibitors (Tadalafil) in doses for BPH, Beta-3 adrenergic receptor agonist (Mirabegron), Taking androgens, unless eugonadal state for at least 2 months or greater as documented by the Investigator Taking Gonadotrophin releasing hormone analogues within 12 months of baseline evaluation Taking one of the following within 24 hours of pre-treatment (baseline) evaluation: phenylephrine, or, pseudoephedrine, One of the following baseline test results, taken from a single uroflowmetry reading: Urinary volume void ≤ 125mL (pre-bladder urinary volume of ≥ 150 mL required), Peak urinary flow rate (Qmax) of ≤ 5 ml/second and > 15 mL/second, Post- void residual volume (PVR) > 250 mL Inmates, patient with physical, psychological (such as developmentally delayed adults), or medical impairment that might prevent study completion or would confound study results (including patient questionnaires) in the judgment of the Investigator Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active<br>The active arm patients undergo the Butterfly device procedure. | Device: Butterfly Prostatic Retraction Device<br>* Implantation of the Butterfly device<br>|
| Sham Comparator: Sham Comparator<br>The sham control arm patients undergo a rigid cystoscopy procedure. | Device: Butterfly Prostatic Retraction Device<br>* Implantation of the Butterfly device<br>|
| Other: Cross over<br>Sham arm patient is allowed to crossover and undergo the Butterfly procedure | Device: Butterfly Prostatic Retraction Device<br>* Implantation of the Butterfly device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to month 3 in International Prostate Symptom Score (IPSS) Score. | Analysis will compare the active and control study arms IPSS | 3 month | 
| Change in active arm International Prostate Symptom Score (IPSS) from baseline to 12 months | Analysis will assess the IPSS percent change for the active arm compared to a baseline score | 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BPH, LUTS