Key points

Introduction: nature of the problem

Traditional treatment options for male lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) include watchful waiting with lifestyle management, medical therapy, and interventional procedures. Each approach is associated with positive and negative attributes and represents an important tool for the practicing urologist. Despite the number and variety of approaches, there still exists a large population of men who are underserved by these standard options and desire a therapy that has fewer side effects and offers faster recovery compared with standard surgery, yet is more effective and less burdensome than lifelong medical therapy.

Shortcomings of traditional therapies limit the population of patients to which they can be applied. The least disruptive of the treatment approaches is watchful waiting with lifestyle management. Although this approach exposes patients to minimal iatrogenic risk, it is generally limited to patients with mild or moderate symptom frequency and severity and low bother due to the symptoms. Medications are associated with modest symptom relief (3.5–7.5 International Prostate Symptom Score [IPSS] improvement compared with 0–5.7 for placebo) but carry the burden of daily, lifetime dosing and not insignificant side effects. As many as 25% of men on drug therapy are dissatisfied and discontinue treatment. The most invasive treatment option is surgical therapy, whereby tissue is removed either by transurethral resection of the prostate (TURP) or ablative laser procedures (vaporization or enucleation). TURP, the gold standard surgery, results in 14.9 IPSS improvement at 1 year. This substantial improvement in symptoms can be associated with significant postoperative morbidity, however, as complications from TURP include urinary incontinence (3%), urethral stricture (7%), erectile dysfunction (10%), and ejaculatory dysfunction (65%). Catheterization after TURP is expected, and patients are counseled to expect 4 to 6 weeks of worsened irritative symptoms. Laser therapy demonstrates superior control of bleeding to TURP but is similar in effectiveness, anesthesia requirement, and complication rates.

Existing minimally invasive thermotherapies such as transurethral microwave therapy (TUMT), transurethral needle ablation (TUNA), and steam injection (REZUM) induce tissue damage and necrosis by different heat sources. Their effectiveness is superior to medications but inferior to TURP (10.2 and 9.1 point improvement in IPSS at 1 year for TUMT and TUNA, respectively). Because of the thermal injury, there is a healing response, tissue inflammation, and irritative voiding symptoms in most patients during the first few months after treatment. After the procedure, patients experience routine catheterization, a 20% to 25% risk of acute urinary retention, and irritative voiding symptoms that last for 4 to 6 weeks. The 3 TUMT patient groups in the Coretherm pivotal study underwent 14, 18, and 20 days mean posttreatment indwelling catheter time. Further, TUMT therapies have been associated with a greater than 20% retrograde ejaculation rate. Lower power alternatives were developed to minimize adverse effects, but effectiveness was greatly compromised as well. Retreatment rates for thermal ablation techniques have been disappointing, reaching as high as 20% to 50% by 3 years. Because of limitations with the technologies and the difficult patient experience after the procedure, the number of minimally invasive thermotherapy procedures among Medicare beneficiaries increased gradually to modest levels of 37,637 in 2005 and then have precipitously declined.

The prostatic urethral lift (PUL) is a nonthermal technology to treat patients who want superior efficacy with minimal risk. With the high prevalence of patients who discontinue medications and the declining number who pursue surgical or minimally invasive therapy, there is a significant population of suffering men who are inadequately treated by the currently available treatment options. The PUL procedure uses a mechanical approach, and the mechanism of action is to pin the lateral lobes out of the way and thereby reduce obstruction. By not requiring biological response to tissue removal or thermal injury, PUL can offer a more rapid recovery, freedom from urinary catheterization, and the opportunity to achieve significant symptom relief with low morbidity.