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Men with lower urinary tract symptoms linked to an enlarged prostate report better outcomes from a surgical implant than with a commonly prescribed drug for the condition, according to new data reported on April 7 at the 2024 European Association of Urology Congress in Paris. 

In a trial pitting medication against the implant, marketed as UroLift (Teleflex, Inc; Pleasanton, CA), men who received the intervention experienced greater improvements in urinary symptoms, as well as ejaculatory and erectile function. Experts said the new findings support using the implant as a first-line treatment for benign prostatic hyperplasia (BPH). 

"What we have seen is that in the short term, the surgical treatment, perhaps not unexpectedly, has a substantially greater improvement in symptoms score, a substantially greater improvement in bother score and quality of life score. And the patients on the surgical treatment also have indicated that the expectation as to the treatment outcomes was met better than with the medication," said Claus Roehrborn, MD, the E.E. Fogelson and Greer Garson Fogelson Distinguished Chair in Urology at UT Southwestern Medical Center in Dallas. 

Roehrborn said the study, called IMPACT, was the first nonblinded, randomized controlled trial comparing medication vs the implant procedure, as earlier research included a sham operation. UroLift was approved by the US Food and Drug Administration in 2013.

The IMPACT trial included 88 patients who underwent the procedure, in which implants move the enlarged prostate out of the way to improve urine flow. Another 112 men took 0.4 mg daily of the alpha-blocker tamsulosin.

The average age of men receiving the drug was 61.6 years, compared with 63.8 years for those undergoing the implant.

Both groups were comparable at baseline in terms of lower urinary tract symptoms, rate of urine flow, and urine retention.

Men who received the implant began the study with an average score of 20.6 on the 30-point International Prostate Symptom Score and ended the 3-month trial with a score of 10.3. The medication group had a baseline score of 19.2, which decreased to 16.3 at the 3-month mark, according to the researchers. 

Using another measure, Roehrborn's group found that 76% of men who received the implant reported improvements in urinary symptoms, compared with 60% of those taking medication. In addition, 87% reported that the implant prevented their symptoms from worsening vs 74% of those taking tamsulosin.

Men who received the implant also reported greater improvements in quality of life.

Roehrborn said men who underwent the procedure reported more symptoms, such as burning and blood in the urine, after treatment than did the men taking medication (55.6% vs 17.8%, respectively). However, 90% of symptoms resolved within 2 weeks, he said.

Roehrborn noted that the 3-month follow-up was based on recommendations of the American Urological Association.

William T. Berg, MD, director of the Stony Brook Urology Men's Health Program, in Stony Brook, New York, said BPH guidelines typically recommend that medications be tried first, but the new study offers support to the idea that patients might prefer to start with the implant.

"Now we have ammunition to say, listen, this is better than giving you meds. You're going to do better long-term," Berg said.

Roehrborn said that 30%-40% of patients stop taking alpha-blockers within a year of starting treatment because of side effects or inconvenience. "Compliance is low if the medicine is taken on a long-term basis, so the efficacy is not as good," he said.

Side effects from alpha-blockers can include dizziness, hypertension, gastrointestinal upset, and anejaculation. 

Roehrborn is a consultant to Teleflex. Berg reported no relevant financial conflicts of interest. Teleflex Inc., the manufacturer of the UroLift device, sponsored the study.

Howard Wolinsky is a medical writer in Chicago.