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
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|
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 (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- Reported device related adverse events [ Time Frame: 12 months post procedure ]Assess the rate, nature and severity of device-related adverse events reported
- Cystoscopic assessment - inflammation [ Time Frame: 12 months post procedure ]Cystoscopic assessment to evaluate lack of local inflammation
- Cystoscopic assessment - incrustations [ Time Frame: 12 months post procedure ]Cystoscopic assessment to evaluate no incrustations
- Cystoscopic assessment - implant coverage [ Time Frame: 12 months post procedure ]Cystoscopic assessment to evaluate coverage by mucosa
- Device migration [ Time Frame: 12 months post procedure ]Rate of migration of the Butterfly device
- Symptoms reduction - IPSS [ Time Frame: Baseline to 12 months post procedure ]Improvement in IPSS at 12 months compared to baseline
- Symptoms reduction - Qmax [ Time Frame: Baseline to 12 months post procedure ]Improvement in Qmax (by uroflowmetry) at 12 months compared to baseline
- Sexual quality of life evaluation - erectile dysfunction [ Time Frame: 12 month post procedure ]Rate of de-novo sustained erectile dysfunction
- Sexual quality of life evaluation - retrograde ejaculation [ Time Frame: 12 month post procedure ]Rate of de-novo sustained retrograde ejaculation
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
|Contact: Idan Gevaemail@example.com|
|Contact: Irina Kavounovskifirstname.lastname@example.org|
|Edith Wolfson Medical Center||Recruiting|
|Contact: Alexander Tsivian, Dr. +972-3-5028659 email@example.com|
|Contact: Gali Boratnic +972-3-5028408 firstname.lastname@example.org|
|Principal Investigator: Alexander Tsivian, Dr|
|Galil Medical Center||Recruiting|
|Contact: Dov Engelstein, Dr +972-4-9107734 Dov.Engelstein@naharia.health.gov.il|
|Contact: Smadar Basso +972-4-9107558 SmadarB@gmc.gov.il|
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|Rabin Medical Center||Recruiting|
|Petah tikva, Israel|
|Contact: Shachar Aharoni, Dr. +972-3-9376558 shacharA3@clalit.org.il|
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|Principal Investigator: Shachar Aharoni, Dr.|
|Ziv Medical Center||Recruiting|
|Contact: Ran Katz, Dr. +972-4-6828775 firstname.lastname@example.org|
|Contact: Yara Sefadi +972-77-6828597 email@example.com|
|Principal Investigator: Ran Katz, Dr.|