UroLift System (NeoTract Inc.) for treatment of benign prostatic hyperplasia

HAYES, Inc.
Record ID 32017000044
English
Authors' objectives: Current surgical treatment of benign prostatic hyperplasia (BPH) involves a transurethral resection of the prostate (TURP) requiring general or spinal anesthesia and inpatient hospitalization. TURP is associated with measureable complications, including sexual dysfunction, ejaculatory dysfunction, erectile dysfunction, urinary incontinence, bladder neck contractures, urethral stricture, and septic shock. Less invasive techniques that can be performed as outpatient procedures have been developed in an attempt to reduce associated complications and preserve sexual function. Description of Technology: The UroLift System is a minimally invasive, prostatic urethral lift (PUL) system that provides anterolateral mechanical traction of the lateral lobes of the prostate, opening the urethral lumen, and reducing urinary obstruction. The UroLift System is generally implanted by an urologist in an outpatient setting. The delivery device contains a preloaded implant that deploys, self-adjusts, tensions, and trims a permanent tensioning suture. The suture runs from the urethra to the outer prostatic capsule and serves to compress the lateral lobe of the prostate. Implants are delivered bilaterally to separate the encroaching lobes. Four to 5 implants are typically inserted, but this varies with the size and shape of the prostate. Patient Population: The UroLift System is intended for the treatment of symptoms due to urinary outflow obstruction secondary to BPH in men >= 50 years of age. The UroLift may be used to treat prostate glands measuring < 80 milliliters (mL) in size in the United States and < 100 mL in Europe and Australia. Clinical Alternatives: Treatment for early BPH includes watchful waiting and pharmacologic treatment with alpha (?)-1 blockers, 5-?- reductase inhibitors, antimuscarinics, or phosphodiesterase-5 inhibitors (PDE5i). Surgical treatments include TURP, photoselective vaporization of the prostate with a potassium titanyl phosphate or thulium laser, enucleation with a holmium laser, transurethral microwave therapy, transurethral needle ablation, and prostatic arterial embolization. Emerging therapies include drugs that inhibit fibrosis, such as antagonists of transforming growth factor beta (?)1; transurethral or transrectal injection of botulinum toxin or anhydrous ethanol; self-expanding prostatic stents; convective water vapor; histotripsy (therapeutic ultrasonography); aquablation (transurethral delivery of high-pressure water that fractionates prostatic tissue); and 2 injectable proteins, NX-1207 and PRX302.
Details
Project Status: Completed
Year Published: 2016
English language abstract: An English language summary is available
Publication Type: Not Assigned
Country: United States
MeSH Terms
  • Humans
  • Male
  • Prostatic Hyperplasia
Contact
Organisation Name: HAYES, Inc.
Contact Address: 157 S. Broad Street, Suite 200, Lansdale, PA 19446, USA. Tel: 215 855 0615; Fax: 215 855 5218
Contact Name: saleinfo@hayesinc.com
Contact Email: saleinfo@hayesinc.com
Copyright: 2014 Winifred S. Hayes, Inc
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