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

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ClinicalTrials.gov Identifier: NCT03912558
Recruitment Status : Recruiting
First Posted : April 11, 2019
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
Butterfly Medical Ltd.

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.


Condition or disease Intervention/treatment Phase
BPH BOO - Bladder Outflow Obstruction Procedure: Butterfly device implantation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : October 23, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Reported device related adverse events [ Time Frame: 12 months post procedure ]
    Assess the rate, nature and severity of device-related adverse events reported

  2. Cystoscopic assessment - inflammation [ Time Frame: 12 months post procedure ]
    Cystoscopic assessment to evaluate lack of local inflammation

  3. Cystoscopic assessment - incrustations [ Time Frame: 12 months post procedure ]
    Cystoscopic assessment to evaluate no incrustations

  4. Cystoscopic assessment - implant coverage [ Time Frame: 12 months post procedure ]
    Cystoscopic assessment to evaluate coverage by mucosa

  5. Device migration [ Time Frame: 12 months post procedure ]
    Rate of migration of the Butterfly device


Secondary Outcome Measures :
  1. Symptoms reduction - IPSS [ Time Frame: Baseline to 12 months post procedure ]
    Improvement in IPSS at 12 months compared to baseline

  2. Symptoms reduction - Qmax [ Time Frame: Baseline to 12 months post procedure ]
    Improvement in Qmax (by uroflowmetry) at 12 months compared to baseline

  3. Sexual quality of life evaluation - erectile dysfunction [ Time Frame: 12 month post procedure ]
    Rate of de-novo sustained erectile dysfunction

  4. Sexual quality of life evaluation - retrograde ejaculation [ Time Frame: 12 month post procedure ]
    Rate of de-novo sustained retrograde ejaculation



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 50 or older
  2. Verified BPH with prostate size of at least 30 grams
  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. Patients not eligible for surgery or refusing surgery

Exclusion Criteria:

  1. Sensitivity to Nickel
  2. Active Prostatitis
  3. Urethral strictures
  4. Prior surgery of prostate (simple or radical)
  5. Currently active bladder tumor
  6. 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. Prior or present urinary stone disease
  16. Patients who are under anticoagulants therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03912558


Contacts
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Contact: Idan Geva +972-50-4043838 idan.geva@butterfly-medical.com
Contact: Irina Kavounovski +972-52-6462215 irina@butterfly-medical.com

Locations
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Israel
Edith Wolfson Medical Center Recruiting
H̱olon, Israel
Contact: Alexander Tsivian, Dr.    +972-3-5028659    atsivian@hotmail.com   
Contact: Gali Boratnic    +972-3-5028408    scurology@wmc.gov.il   
Principal Investigator: Alexander Tsivian, Dr         
Galil Medical Center Recruiting
Nahariya, Israel
Contact: Dov Engelstein, Dr    +972-4-9107734    Dov.Engelstein@naharia.health.gov.il   
Contact: Smadar Basso    +972-4-9107558    SmadarB@gmc.gov.il   
Principal Investigator: Dov Engelstein, Dr.         
Rabin Medical Center Recruiting
Petah tikva, Israel
Contact: Shachar Aharoni, Dr.    +972-3-9376558    shacharA3@clalit.org.il   
Contact: Inbal Grossman       inbalgr3@clalit.org.il   
Principal Investigator: Shachar Aharoni, Dr.         
Ziv Medical Center Recruiting
Tsefat, Israel
Contact: Ran Katz, Dr.    +972-4-6828775    ran.k@ziv.health.gov.il   
Contact: Yara Sefadi    +972-77-6828597    yara.s@ziv.health.gov.il   
Principal Investigator: Ran Katz, Dr.         
Sponsors and Collaborators
Butterfly Medical Ltd.

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Responsible Party: Butterfly Medical Ltd.
ClinicalTrials.gov Identifier: NCT03912558     History of Changes
Other Study ID Numbers: BM-011
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Butterfly Medical Ltd.:
BPH
BOO
Enlarged prostate
LUTS
Urinary obstruction
Retrograde ejaculation
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male