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

BPH Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03912558
• Other study ID #: BM-011
• Status: Recruiting
• Phase: N/A
• Start date: October 23, 2018
• Est. completion date: May 2025

Study information

• Verified date: March 2023
• Source: Butterfly Medical Ltd.
• Contact: Vardit Segal, Ph.D.
• Phone: +972524579178
• Email: vardit[@]butterfly-medical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• BOO - Bladder Outflow Obstruction
• BPH

Intervention

Procedure:
• Butterfly device implantation
The Butterfly device will be positioned and deployed with cystoscopy guidance

Locations

Country	Name	City	State
Israel	Shamir Medical Center	Be'er Ya'aqov
Israel	Bnei Zion	Haifa
Israel	Rabin Medical Center	Petah tikva
Israel	Ziv Medical Center	Tsefat

Sponsors (1)

Lead Sponsor	Collaborator
Butterfly Medical Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reported device related adverse events	Assess the rate, nature and severity of device-related adverse events reported	12 months post procedure
Primary	Cystoscopic assessment - inflammation	Cystoscopic assessment to evaluate lack of local inflammation	12 months post procedure
Primary	Cystoscopic assessment - incrustations	Cystoscopic assessment to evaluate no incrustations	12 months post procedure
Primary	Cystoscopic assessment - implant coverage	Cystoscopic assessment to evaluate coverage by mucosa	12 months post procedure
Primary	Device migration	Rate of migration of the Butterfly device	12 months post procedure
Secondary	Symptoms reduction - IPSS	Improvement in IPSS at 12 months compared to baseline	Baseline to 12 months post procedure
Secondary	Symptoms reduction - Qmax	Improvement in Qmax (by uroflowmetry) at 12 months compared to baseline	Baseline to 12 months post procedure
Secondary	Sexual quality of life evaluation - erectile dysfunction	Rate of de-novo sustained erectile dysfunction	12 month post procedure
Secondary	Sexual quality of life evaluation - retrograde ejaculation	Rate of de-novo sustained retrograde ejaculation	12 month post procedure