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

NCT ID: NCT03912558

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-29
• Study Completion Date: 2024-04-01

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.

Conditions

BPH; BOO - Bladder Outflow Obstruction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Butterfly device implantation

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.

Group Type: EXPERIMENTAL

Butterfly device implantation

Intervention Type: PROCEDURE

The Butterfly device will be positioned and deployed with cystoscopy guidance

Interventions

Butterfly device implantation

The Butterfly device will be positioned and deployed with cystoscopy guidance

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Butterfly Medical Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shamir Medical Center

Be’er Ya‘aqov, , Israel

Bnei Zion

Haifa, , Israel

Rabin Medical Center

Petah Tikva, , Israel

Ziv Medical Center

Safed, , Israel

Countries

Israel

Other Identifiers

BM-011

Identifier Type: -

Identifier Source: org_study_id