Clinical trial NCT03912558: Pilot Study to Assess the Safety and Efficacy of Butterfly Medical Prostatic Retraction Device in BPH Patients.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: BPH
BOO - Bladder Outflow Obstruction
Keywords: BPH
BOO
Enlarged prostate
LUTS
Urinary obstruction
Retrograde ejaculation
Lead sponsor: Butterfly Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2019-04-11
Enrollment: 92
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Reported device related adverse events
timeFrame: 12 months post procedure
measure: Cystoscopic assessment - inflammation
timeFrame: 12 months post procedure
measure: Cystoscopic assessment - incrustations
timeFrame: 12 months post procedure
measure: Cystoscopic assessment - implant coverage
timeFrame: 12 months post procedure
measure: Device migration
timeFrame: 12 months post procedure
Secondary outcomes:
measure: Symptoms reduction - IPSS
timeFrame: Baseline to 12 months post procedure
measure: Symptoms reduction - Qmax
timeFrame: Baseline to 12 months post procedure
measure: Sexual quality of life evaluation - erectile dysfunction
timeFrame: 12 month post procedure
measure: Sexual quality of life evaluation - retrograde ejaculation
timeFrame: 12 month post procedure
Other outcomes:
Locations:
city: Be'er Ya'aqov
country: Israel
facility: Shamir Medical Center
city: Haifa
country: Israel
facility: Bnei Zion
city: Petah tikva
country: Israel
facility: Rabin Medical Center
city: Tsefat
country: Israel
facility: Ziv Medical Center
Study officials:
References: