Pilot Study to Assess the Safety and Efficacy of Butterfly Medical Prostatic Retraction Device in Benign Prostatic Hyperplasia (BPH) Patients.
Pilot Study to Assess the Safety and Efficacy of Butterfly Medical Prostatic Retraction Device in Benign Prostatic Hyperplasia (BPH) Patients.
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.
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.
Inclusion Criteria:

 1. Age 50 or older

 2. Verified BPH with prostate size of at least 30 grams or of 25 mm.

 3. Signed Informed Consent

 4. Failure, intolerance or patient non-compliance of medical treatment

 5. Patients suffering from LUTS symptoms of BPH (IPSS >12, Qmax=<13 ml/sec)

 6. Patient's voided volume of at least 125 ml in uroflow test

 7. Patients not eligible for surgery or refusing surgery

 Exclusion Criteria:

 1. Known sensitivity to Nickel

 2. Active Prostatitis

 3. Urethral strictures

 4. Prior surgery of prostate (simple or radical)

 5. Currently active bladder tumor

 6. Suspected neurogenic urinary bladder

 7. Suspected a-contractile bladder

 8. Enlarged median lobe of prostate.

 9. Bladder Neck stricture or contracture

 10. Urethral pathology: diverticula, strictures, tumors, fistula

 11. Clinically Significant urinary tract infection

 12. Uncontrolled bleeding disorders

 13. Uncontrolled diabetes mellitus

 14. Severe medical diseases precluding a minimally invasive procedure

 15. Present active urinary stone disease

 16. Patients who are under anticoagulants therapy