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

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.

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.

Study Overview

• Status: Completed
• Conditions: BPH; BOO - Bladder Outflow Obstruction
• Intervention / Treatment: Procedure: Butterfly device implantation

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.

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Be'er Ya'aqov, Israel
    • Shamir Medical Center
  • Haifa, Israel
    • Bnei Zion
  • Petah tikva, Israel
    • Rabin Medical Center
  • Tsefat, Israel
    • ZIV Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reported device related adverse events	Assess the rate, nature and severity of device-related adverse events reported	12 months post procedure
Cystoscopic assessment - inflammation	Cystoscopic assessment to evaluate lack of local inflammation	12 months post procedure
Cystoscopic assessment - incrustations	Cystoscopic assessment to evaluate no incrustations	12 months post procedure
Cystoscopic assessment - implant coverage	Cystoscopic assessment to evaluate coverage by mucosa	12 months post procedure
Device migration	Rate of migration of the Butterfly device	12 months post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms reduction - IPSS	Improvement in IPSS at 12 months compared to baseline	Baseline to 12 months post procedure
Symptoms reduction - Qmax	Improvement in Qmax (by uroflowmetry) at 12 months compared to baseline	Baseline to 12 months post procedure
Sexual quality of life evaluation - erectile dysfunction	Rate of de-novo sustained erectile dysfunction	12 month post procedure
Sexual quality of life evaluation - retrograde ejaculation	Rate of de-novo sustained retrograde ejaculation	12 month post procedure

Collaborators and Investigators

• Sponsor: Butterfly Medical Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2018
• Primary Completion (Actual): April 1, 2024
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: April 7, 2019
• First Submitted That Met QC Criteria: April 10, 2019
• First Posted (Actual): April 11, 2019

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: August 5, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: LUTS; BPH; Enlarged prostate; BOO; Urinary obstruction; Retrograde ejaculation
• Other Study ID Numbers: BM-011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No