1. What is the UroLift® System?
The UroLift® System is a new minimally invasive device designed to treat lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). It is comprised of a UroLift Delivery Device and a UroLift Implant. Each UroLift Implant consists of a nitinol capsular tab, PET suture and a stainless steel urethral end piece.
2. How does the UroLift System work?
The UroLift System relieves prostate obstruction and opens the urethra directly by retracting the obstructing prostatic lobes without cutting, heating, or removing prostate tissue. The Delivery Device transurethrally pushes aside the obstructive prostate lobes like opening window curtains. Small permanent UroLift Implants are deployed, holding the lobes in the retracted position, and thus opening the urethra while leaving the prostate intact.
3. Who are the right patients for the UroLift System?
BPH patients who are looking for an alternative to drugs or major surgery are candidates for the UroLift System. These may be patients who are considering or scheduled for a TURP/Laser treatment, or are unhappy with or have stopped taking medications. The UroLift System is appropriate for patients seeking a minimally invasive treatment and are concerned about preserving their sexual function and their quality of life, postoperatively.
4. Is the UroLift System FDA approved?
NeoTract, Inc. received FDA De Novo approval for the UroLift System on September 13, 2013 and is commercially available. It is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men 50 years of age or older.
5. Where is the UroLift System currently being used?
The UroLift System is commercially available in the United States, Canada, Australia, United Kingdom, Germany, Italy, Spain, Netherlands, France, Switzerland, Austria, Turkey and Saudi Arabia.
6. What prostate size does this work on?
In the United States, the UroLift System is approved to treat prostates up to 80cc in size. In Europe and Australia the identical device is indicated to treat prostates up to 100cc.
7. Is the treatment permanent?
The UroLift Implant is a permanent implant, and the treatment is intended to be permanent. FDA de novo approval was based on review of studies at 2 years and 1 year. Clinical data will continue to be published as studies continue to 5 years. The UroLift System does not preclude UroLift System retreatment or other BPH treatments, should that be desired at some time in the future.
8. Does the implant cause encrustation?
The UroLift Implant is made of three materials: a nitinol capsular tab, a stainless steel urethral endpiece, and PET suture. Properly placed implants will invaginate within the prostatic tissue. In the LIFT clinical study, patients were followed up with cystoscopy at 1 year. No evidence of encrustation was found on implants delivered within the prostate.1
9. How can the prostate really be compressible?
The prostatic capsule is firm fibromuscular tissue, but the gland tissue is comprised of a series of ducts, like a sponge, which makes it compressible. The gland tissue is compressed using the UroLift delivery device, and the delivered implant then holds the urethra open by tethering the compressed geometry to the firm prostate capsule.
10. Can I remove an implant if I need or want to?
Using traditional cystoscopic techniques, you can simply remove a urethral end piece with cystoscopic grasping forceps and replace the implant as needed.
11. How do I know it works? What clinical data is available on the UroLift System?
The safety and efficacy of the UroLift System has been shown in numerous studies, including a randomized double-blinded study conducted primarily in the USA1, a European retrospective
registry,2 and open label studies conducted in the UK, Germany, Netherlands, Spain, Italy, France and Australia.3,4,5,6,7 Improvement in urinary symptoms, as seen through reduction in IPSS (International Prostate Symptom Score), has been consistent across the various studies, showing rapid relief within two weeks and sustained effect to two years. Over 450 patient-years of data have been presented in peer-reviewed publications to date.8 See Clinical Results for more information.
12. What are the benefits of the UroLift System over traditional TURP or laser procedures?
The UroLift System treatment has consistently demonstrated an excellent safety profile. Perioperatively, UroLift typically requires lighter anesthesia (either local anesthesia and oral sedation or intravenous conscious sedation) than TURP or laser (typically general anesthesia). Bleeding is much less than TURP, with a 0% transfusion rate to date for UroLift vs. 5%-7% for TURP. Postoperative catheterization has been shown to be 30%-35% (compared to standard protocol for TURP) with a mean duration of 0.9 days (compared to 1-5 days for TURP).1,3,9,10,11,12,13
An additional unique benefit of the UroLift System is the preservation of sexual function. In all studies to date, there has been 0% incidence of de novo, sustained erectile dysfunction or ejaculatory dysfunction.1
13. What long-term data is there on UroLift?
Chin et al (2012) published data on patients to 3 years, whereas other publications to date report data to 1 year. Ongoing protocols are following patients to 5 years.
14. What are the side effects?
In our clinical studies to date, the most common adverse events reported included hematuria, dysuria, micturition urgency, pelvic pain, and urge incontinence. Most symptoms were mild to moderate in severity and resolved within two to four weeks after the procedure.
15. Are there any contraindications?
The primary contraindication to UroLift is an obstructive or protruding median lobe of the prostate. Additional contraindications can be found in the UroLift System Instructions for Use.
16. How do I learn more about UroLift?
If you are interested in talking to us about bringing UroLift into your practice, please contact us at email@example.com.
1. Roehrborn et al., Journal of Urology 2013 LIFT Study
2. McNicholas et al., European Urology 2013
3.Chin et al., Urology 2012
4 Barkin et al., Canadian J of Urology 2012
5 Woo et al., J Sex Med 2012
6 Woo et al., BJU International 2011
7 Delongchamps et al., Progres en urologie 2012
8 Data on file at NeoTract
9 Oelke et al., Guidelines, EAU 2011
10 McVary KT et al., AUA Guideline for Management of BPH 2010
11 Roehrborn CG et al., AUA Guideline for Management of BPH 2003
12 Stucki et al., Abstract, AUA 2013 Meeting, San Diego
13 Elshalet al., Abstract, AUA 2013 Meeting, San Diego
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