Clinical data published in the peer-reviewed journal, Prostate Cancer and Prostatic Disease, explains the mechanism of action through which the UroLift^® System provides long-term durability and sustained results for patients with benign prostatic hyperplasia (BPH), also referred to as enlarged prostate.

The UroLift^® System implants provide rapid relief from disruptive lower urinary tract symptoms (LUTS) through a minimally invasive procedure that pulls back enlarged prostate tissue. This study is unique in its combination of 3 different facets of research which include pre-clinical canine tissue, human tissue, and post-market surveillance data. The researchers examined tissue samples from 24 healthy canines and 4 human patients who were implanted with the UroLift^® System to uncover any potential changes attributed to the implants.

They found that the extracted tissues revealed normal-appearing tissue with minimal-mild inflammation and no encrustation, indicating a stable and normal healing response. The data support a long-term biological mechanism of action whereby compression-induced localized tissue remodeling is initiated by the UroLift^® System implant placement and leads to a widened prostatic urethra.

Furthermore, post-market surveillance data of over 770,000 UroLift^® System devices support that the implant is stable and remains fixed after proper deployment and demonstrate low rates of breakage (0.004%) and encrustation (0.006%). The biocompatibility and stability of the UroLift^® System implants appear to be superior to prostatic stents, with studies of prostatic stents showing that up to 47% of men require removal of their implants due to complications associated with migrations and encrustations.¹

The UroLift^® implant pulls the enlarged prostate toward the capsule, thereby mechanically creating an immediate, visible de-obstruction in the prostatic urethra. Researchers describe this “prostate lift” as a distinct mode of action and compared it with not only prostatic stents, but also thermal ablation techniques that induce tissue damage and may result in extended periods of edema, retention/ catheterization, and higher risks of urinary infections and ejaculatory dysfunction.^2-7

“The UroLift^® System is the first mechanical prostatic implant to demonstrate safe and effective treatment of BPH without common issues associated with prior stents. This study describes in detail the unique prostate lift mechanism of action that is the basis of its durable outcomes,” said Dr. Peter Chin, Clinical Associate Professor, Graduate School of Medicine, University of Wollongong, and author on the paper. “Not only are the results seen with the UroLift^® System sustainable, but the implants can provide a superior patient experience during the early recovery period⁴, and rapid symptom relief and preservation of sexual function^*8

Read more on how the UroLift^® System here.

The UroLift System 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 and enlarged prostate up to 100cc. Most common side effects are temporary and include hematuria, dysuria, micturition urgency, pelvic pain, and urge incontinence.⁸ Rare side effects, including bleeding and infection, may lead to a serious outcome and may require intervention. Consult the Instructions for Use (IFU) for more information.

Men treated with the Prostatic Urethral Lift (PUL) procedure (using the UroLift^® System) showed preservation and some improvement of sexual function compared to men being treated with medication for benign prostatic hyperplasia (BPH), according to a comparative analysis study published in the peer-reviewed journal, European Urology Focus, examining the impact of PUL vs. medical therapy on male sexual health.

The comparative analysis “Prostatic Urethral Lift vs. Medical Therapy: Examining the Impact on Sexual Function in Men with BPH,” is the first study to longitudinally compare sexual function outcomes between major PUL studies^1-4 and data from the Medical Therapy of Prostatic Symptoms (MTOPS) trial. Treatment-related changes in sexual function were reported by validated patient questionnaires. 

Researchers demonstrated that the UroLift^® System procedure maintained sexual function among sexually active men in all three domains (erectile function, ejaculatory function, and sexual satisfaction) that were examined. Sexual function at certain timepoints was  improved. This was in contrast to daily treatment with an alpha blocker (doxasozin), 5-alpha-reductase inhibitor (finasteride), either alone or in combination with each other.

Mean percent changes in erectile function, ejaculatory function, and sexual satisfaction from patient reported questionnaires were analyzed to determine improvements in sexual function.

Key findings include:

• Patients experienced improvement in erectile function (17% at 1 year and 21% at 2 years) following the UroLift^® system procedure. PUL was shown to be superior at preserving erectile function compared to medical therapy, specifically: doxazosin at 1 and 2 years, finasteride at 2 and 4 years, and combination therapy at 1 year.
  
  
• Men who received the UroLift^® System also experienced improvements in ejaculatory function over 4 years, with mean percentage changes from baseline in ejaculatory function score reaching 35%, 33%, 14%, and 18% at 1, 2, 3, and 4 years respectively. Conversely, men treated with finasteride or combination therapy experienced a decline in ejaculatory function.
  
  Among the drug therapy groups, combination therapy resulted in the greatest decrease in ejaculatory function, leading to a statistically significant reduction in the mean ejaculatory function score relative to baseline at 1 and 2 years of 17% and 13% respectively.
  
  
• Sexual satisfaction scores among patients treated with the UroLift^® System increased 22%, 21%, 19%, and 28% at 1, 2, 3, and 4 years respectively. In contrast, subjects treated with doxazosin, finasteride, or combination therapy experienced an overall decrease in sexual satisfaction during follow-up. However differences in mean percentage change from baseline were not statistically significant.

This study highlights potential of the UroLift^® System in preserving sexual function in BPH patients, outperforming medications that are prescribed for BPH.

Download our Info Booklet and talk to your patient about theUroLift® System today.

The UroLift^® System 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 and enlarged prostate up to 100cc. Most common side effects are temporary and include hematuria, dysuria, micturition urgency, pelvic pain, and urge incontinence.⁵ Rare side effects, including bleeding and infection, may lead to a serious outcome and may require intervention. Consult the Instructions for Use (IFU) for more information.

A study conducted of 1,000 men over 40 and 1,000 women over 40 with male partners showed that both men and women have many misconceptions about Benign Prostatic Hyperplasia (BPH) treatment options and side effects, as well as the impact of the condition on men’s overall health. These are the findings from Teleflex Interventional Urology surveys.

BPH, also known as enlarged prostate, is non-cancerous and occurs as men age. BPH symptoms can cause loss of productivity, depression, and decreased quality of life. In addition, if left untreated the condition can worsen over time and cause permanent bladder damage.¹ As men age, early intervention can make a huge difference in their long-term quality of life.

Medications are often first-line therapy but are not effective for everyone and in some cases, side effects cause patients to stop using them. Alternative treatments such as the UroLift® System, can offer an alternative to medications for men who are interested in exploring treatment options.

Many men and women were not aware that minimally invasive procedures are available to treat BPH. Of the participants surveyed:

• 50% were aware that medications are available to treat their BPH, but only 6% were aware that minimally invasive procedures like the UroLift^® System procedure or prostatic urethral lift (PUL) are available as treatment options.
• More than 75% of male respondents said that their doctor had not spoken to them about a minimally invasive procedure as an alternative to BPH medication.
• 49% of men surveyed who have BPH are using medication to treat their condition. 48% of these individuals are interested in a solution to get off their BPH medication.
• Over 90% said that they were “very likely” or “somewhat likely” to seek minimally invasive procedures if they carried less risk of impotence or incontinence.

However, men sometimes avoid talking with their doctor about their symptoms because of the perceived side effects of BPH treatment options. Men and women surveyed highlighted their fears with treating BPH:

• 30% of men reported that they are not treating their BPH because the treatment options available are not appealing to them. In other words, they “don’t want to take medication or have surgery.”
• 31% of male respondents and 25% of female respondents with male partners believe BPH treatment options can cause impotence or incontinence.
• Both men and women also have misconceptions about BPH as a precursor to prostate cancer. Although there is no known link between BPH and later prostate cancer², 41% of men and 55% of women surveyed believe that men who have BPH are at a high risk for prostate cancer. In actuality, BPH is a benign condition and unrelated to prostate cancer; however, it can greatly affect a man’s quality of life.

With more education among both men and women about treatment options, physicians can change perspectives of patients who may believe BPH is an inevitable part of aging and help them to seek treatment early and improve their long-term quality of life.

Teleflex is dedicated to developing innovative, minimally invasive and clinically effective devices that address unmet needs in the field of urology. Our focus is on improving the standard of care for patients with BPH using the UroLift® System, a minimally invasive permanent implant system that treats symptoms while preserving sexual function.^3*

Read more on how the UroLift^® System here.

The UroLift System 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 and enlarged prostate up to 100cc. Most common side effects are temporary and include hematuria, dysuria, micturition urgency, pelvic pain, and urge incontinence.³ Rare side effects, including bleeding and infection, may lead to a serious outcome and may require intervention. Consult the Instructions for Use (IFU) for more information.