BOO - Bladder Outflow Obstruction, BPH
Conditions
Keywords
BPH, BOO, Enlarged prostate, LUTS, Urinary obstruction, Retrograde ejaculation
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.
Interventions
PROCEDUREButterfly device implantation
The Butterfly device will be positioned and deployed with cystoscopy guidance
Sponsors
Butterfly Medical Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device migration | 12 months post procedure | Rate of migration of the Butterfly device |
| Reported device related adverse events | 12 months post procedure | Assess the rate, nature and severity of device-related adverse events reported |
| Cystoscopic assessment - inflammation | 12 months post procedure | Cystoscopic assessment to evaluate lack of local inflammation |
| Cystoscopic assessment - incrustations | 12 months post procedure | Cystoscopic assessment to evaluate no incrustations |
| Cystoscopic assessment - implant coverage | 12 months post procedure | Cystoscopic assessment to evaluate coverage by mucosa |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms reduction - Qmax | Baseline to 12 months post procedure | Improvement in Qmax (by uroflowmetry) at 12 months compared to baseline |
| Sexual quality of life evaluation - erectile dysfunction | 12 month post procedure | Rate of de-novo sustained erectile dysfunction |
| Sexual quality of life evaluation - retrograde ejaculation | 12 month post procedure | Rate of de-novo sustained retrograde ejaculation |
| Symptoms reduction - IPSS | Baseline to 12 months post procedure | Improvement in IPSS at 12 months compared to baseline |
Countries
Israel
Outcome results
None listed