Pilot Study to Assess the Safety and Efficacy of Butterfly Medical Prostatic Retraction Device in BPH Patients.

Study Overview
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Brief Summary
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This study evaluates the safety and efficacy of use of the Butterfly Medical's prostatic retraction device in Benign Prostatic Hyperplasia (BPH) Patients. The study follows patients implanted with the Butterfly device for up to 1 year after implantation. Evaluations include recording of safety events and BPH related symptoms by Uroflowmetry tests and International Prostate Symptom Score (IPSS) questionnaires. The study also assess sexual quality of life after implantation of the Butterfly device.

Detailed Description
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Benign prostatic hyperplasia (BPH) is a non-cancerous enlargement of the prostate gland that may restrict the flow of urine from the bladder. BPH is a cellular proliferative process of the prostate, also referred as enlarged prostate. An estimated 50% of men demonstrate histopathologic BPH by age 60 years. This number increases to 90% by age 85 years; thus, increasing gland size is considered a normal part of the aging process. Approximately half of those diagnosed with histopathologic BPH demonstrate moderate-to-severe BPH related symptoms (also known as Lower Urinary Tract Symptoms = LUTS), including urinary frequency, urgency, nocturia (getting up at night during sleep to urinate), decreased or intermittent force of stream, or a sensation of incomplete emptying. Complications occur less commonly but may include acute urinary retention, impaired bladder emptying, or the need for surgery. In current clinical practice, most patients are initially treated with medical therapy, usually with alpha-blockers. A minimally invasive treatment alternative is the use of urethral stents to preserve flow of urine from the bladder. Such stents are also associated with several problems such as encrustation, stone formation, pain, infection, migration and others. Another alternative is the gold standard treatment for managing benign prostatic hyperplasia; the trans urethral resection of prostate (TURP) surgery. Complications associate with TURP procedure include retrograde ejaculation, urinary incontinence, erectile dysfunction, urethral stricture, and others. The Butterfly Medical Prostatic Retraction Device is a definitive device intended for transurethral insertion into the male prostatic urethra diagnosed with Bladder Outlet Obstruction (BOO), caused by an enlarged prostate gland. It is a single use device intended to remain permanently in the prostate urethra, to open the occluded urethral passage. The Butterfly device has a specific shape adjusted to fit the prostatic urethral lumen, and is designed to reside only in the prostate urethra without migration to the urinary bladder or the bulbar urethra. Unlike other forms of treatment, the Butterfly device does not inflict any damage to the bladder neck, preventing irritation or retrograde ejaculation.

Official Title
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Prospective, Open-Label, Non-Comparative, Pilot Study to Assess the Safety and Efficacy of Butterfly Medical Prostatic Retraction Device in Benign Prostatic Hyperplasia (BPH) Patients.

Conditions
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BPH, BOO - Bladder Outflow Obstruction

Intervention / Treatment
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* Procedure: Butterfly device implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 50 or older Verified BPH with prostate size of at least 30 grams or of 25 mm. Signed Informed Consent Failure, intolerance or patient non-compliance of medical treatment Patients suffering from LUTS symptoms of BPH (IPSS >12, Qmax=<13 ml/sec) Patient's voided volume of at least 125 ml in uroflow test Patients not eligible for surgery or refusing surgery Exclusion Criteria: Known sensitivity to Nickel Active Prostatitis Urethral strictures Prior surgery of prostate (simple or radical) Currently active bladder tumor Suspected neurogenic urinary bladder Suspected a-contractile bladder Enlarged median lobe of prostate. Bladder Neck stricture or contracture Urethral pathology: diverticula, strictures, tumors, fistula Clinically Significant urinary tract infection Uncontrolled bleeding disorders Uncontrolled diabetes mellitus Severe medical diseases precluding a minimally invasive procedure Present active urinary stone disease Patients who are under anticoagulants therapy

Ages Eligible for Study
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Minimum Age: 50 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Butterfly device implantation<br>Butterfly device implantation will be performed following initial cystoscopy to evaluate prostate condition and rule out other pathologies. Following implant size selection, the Butterfly implant will be deployed and positioned through the cystoscope over-sheath. After deployment the cystoscope (with its optics) will be re-introduced into the urethra to examine the Butterfly device position. | Procedure: Butterfly device implantation<br>* The Butterfly device will be positioned and deployed with cystoscopy guidance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reported device related adverse events | Assess the rate, nature and severity of device-related adverse events reported | 12 months post procedure | 
| Cystoscopic assessment - inflammation | Cystoscopic assessment to evaluate lack of local inflammation | 12 months post procedure | 
| Cystoscopic assessment - incrustations | Cystoscopic assessment to evaluate no incrustations | 12 months post procedure | 
| Cystoscopic assessment - implant coverage | Cystoscopic assessment to evaluate coverage by mucosa | 12 months post procedure | 
| Device migration | Rate of migration of the Butterfly device | 12 months post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms reduction - IPSS | Improvement in IPSS at 12 months compared to baseline | Baseline to 12 months post procedure | 
| Symptoms reduction - Qmax | Improvement in Qmax (by uroflowmetry) at 12 months compared to baseline | Baseline to 12 months post procedure | 
| Sexual quality of life evaluation - erectile dysfunction | Rate of de-novo sustained erectile dysfunction | 12 month post procedure | 
| Sexual quality of life evaluation - retrograde ejaculation | Rate of de-novo sustained retrograde ejaculation | 12 month post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BPH, BOO, Enlarged prostate, LUTS, Urinary obstruction, Retrograde ejaculation