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. Does the UroLift System have NICE guidance?
Yes. In January 2014, the National Institute for Health and Care Excellence (NICE) issued an Interventional Procedure Guidance (IPG) approving the UroLift prostatic urethral lift implant for use by UK doctors. In September 2015, NICE acknowledged the UroLift System saves the NHS money compared to the most commonly used surgical intervention and has unique benefits including preservation of sexual function, improved quality of life, reduced recovery time and the ability to treat high risk patients. Additionally, the UroLift System is CE marked in Europe and FDA cleared in the USA. In the UK, the UroLift® System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50.
5. Where is the UroLift System currently being used?
The UroLift System is commercially available in the United States, Canada, Australia, United Kingdom, Germany, Sweden, Denmark, Norway, Finland, Ireland, Italy, Spain, Netherlands, France, Switzerland, Austria, Turkey and Saudi Arabia.
6. What prostate size does this work on?
In Europe, the UroLift System is indicated to treat prostates up to 100 cc.
7. Is the treatment permanent?
The UroLift Implant is a permanent implant, and the treatment is intended to be permanent. 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 the 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 randomised 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 three years. Over 600 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, the UroLift treatment typically requires lighter anaesthesia (either local anaesthesia and oral sedation or intravenous conscious sedation) than TURP or laser (typically general anaesthesia). Bleeding is much less than TURP, with a 0% transfusion rate to date for UroLift vs. 5%-7% for TURP. Postoperative catheterisation 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 published data, there has been 0% incidence of de novo, sustained erectile dysfunction or ejaculatory dysfunction.1
13. What long-term data is there on UroLift?
Roehrborn et al (2015) reported the 3-year results of the largest randomised study, and Chin et al (2012) reported 3-year results of a multi-center study. Other publications report results at 1 or 2 years. 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 haematuria, 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 UroLift System should not be used if the prostate volume is greater than 100 cc. 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 firstname.lastname@example.org.
1. Roehrborn et al. Can J Urology 2015 3-Year LIFT Study
2. McNicholas et al. European Urology 2013
3. Chin et al. Urology 2012
4. Barkin et al, Canadian J of Urology 2013
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 Guidelines for Management of BPH 2010
11. Roehrborn CG et al. AUA Guidelines for Management of BPH 2003
12. Stucki et al. Abstract, AUA 2013 Meeting, San Diego
13. Elshal et al. Abstract, AUA 2013 Meeting, San Diego