In the last decade, several interventions have been approved for men with benign enlargement of the prostate gland. The ever-growing list of options ranges from steam treatment and permanent implants to a drug-coated balloon.
All the new options promise impressive near-term relief of urinary symptoms, but how well these procedures hold up over time — and if clinicians have enough long-term data to recommend one over another, is unclear.
Deciding on the right treatment for benign prostatic hyperplasia (BPH) is a two-step calculation involving assessment of the prostate gland’s size and anatomy to rule out incompatible therapies. Patients must weigh their own personal trade-offs, balancing short-term relief against side effects, the likelihood of a repeat procedure, and use of post-op catheters.
“It’s great to have these choices but at the end of the day it can be overwhelming for providers to stay up-to-date and have the technical skills and resources to use them and be able to effectively communicate all of this in time-constrained settings to patients,” said Kevin Wymer, MD, an assistant professor of urology at Mayo Clinic in Rochester, Minnesota.
BPH occurs in up to 70% in men aged 60-69 years and more than 80% in men older than 70 years. Diagnosis is usually a digital rectal exam, lab studies for urine culture, electrolytes, blood urea nitrogen, and ultrasonography. The American Urological Association (AUA) in May updated guidelines on managing the condition, recommending six minimally-invasive therapies, five of which are approved by the FDA.
While the expanded guidelines offer clinicians a road map, they introduce a layer of complexity. Without direct clinical comparisons between these emerging options, determining which procedure is best for a patient remains an imperfect science.
Samuel Eaton, MD, a urologist at the Minimally Invasive Urology Institute at The Miriam Hospital of Brown University Health in Providence, Rhode Island, said one of the big challenges is a lack of head-to-head evaluations.
“Comparing relative effectiveness winds up being a little bit more based on experience and assessment of the patients vs one that’s clearly better than the other,” he said.
One and Done vs Possible Retreatment
The standard surgical treatment for BPH remains transurethral resection (TURP), which can permanently reduce prostate-related problems. But side effects include retrograde ejaculation and incontinence.
Some less invasive options include UroLift (Teleflex) and Rezum Water Vapor Therapy (Boston Scientific), which both gained moderate recommendations from the AUA with Grade B level evidence. Clinicians should offer these as options to patients with prostates from 30 to 80 cm3 in volume with UroLift available to those without an obstructing median lobe, the guidelines say. Most medical devices go through a clearance process with the FDA, meaning manufacturers have to prove equivalence to another product on the market and do not have to run human tests for safety and efficacy.
UroLift, the first minimally invasive therapy cleared by the FDA in 2013, consists of small permanent implants that compress the prostate tissue. Five-year results of a randomized, blinded, sham-controlled study in 2017 symptoms as measured by the International Prostate Symptom Score (IPSS) improved 36%, quality of life improved 50%, and peak urinary flow rate improved 44%. One-third of men who underwent the procedure required catheterization for about one day.
A little under 14% required a repeat procedure and none sustained erectile or ejaculatory dysfunction. Frequent adverse events included blood in the urine, pain or burning during urination, and pelvic pain, researchers found.
Rezum, cleared in 2015, consists of a handheld device that delivers steam injections into the prostate penetrating the median lobe. It is commonly performed under local anesthesia, and a catheter is typically placed for 3-5 days to manage edema.
Five-year outcomes of a pivotal randomized, sham-controlled trial in 197 individuals published 6 years after clearance found the IPSS was reduced by 48%, quality of life increased by 45%, maximum flow rate improved by 44%, with no reports of related sexual dysfunction. A little over 4% of men required surgical retreatment.
Wymer said minimally invasive options such as UroLift and Rezum are best for patients without significant prostate enlargement or other unique anatomic variants and have normal bladder function and are looking for moderate improvement in symptoms.
The guideline advised that clinicians may offer iTind (Olympus) for patients with prostates between 25 and 75 cm3 without an obstructing median lobe. The device, which FDA cleared in 2020, is composed of a nitinol cage that expands into a three-pronged shape and exerts pressure at the bladder, neck, and prostate lateral lobes, usually left in the urethra for 5-7 days.
Data from a prospective, single-arm follow-up study published in 2023 of 41 patients found prostate scores decreased by 45% 6 years after the procedure. The rate of surgical retreatment after this period was 11%.
Eaton said the key to patient satisfaction is transparency with patients regarding expectations.
“UroLift and iTind work quickly, vs Rezum, which can take weeks to months to see a real benefit,” he said. “Rezum may result in more of a true size reduction of the prostate vs Urolift and iTind.”
The guideline gave a conditional recommendation for Optilume drug-coated balloon (Laborie Medical Technologies), approved by FDA in 2021, based on Grade C level evidence, with data lacking on long-term durability. Observational studies 4 years after patients received the therapy demonstrated a 1.3% surgical retreatment rate with some worsening of IPSS, quality of life scores, and post-void residual bladder volume.
Five-year outcomes of a prospective, single-arm, open label trial published after approval showed functional success was achieved in 58% of 43 patients, and 71.7% did not repeat the intervention. Other studies found most adverse events were mild and resolved within 3 months and did not affect sexual function.
The AquaBeam Robotic System (Procept BioRobotics), which uses an ultrasound guided robotic handpiece to ablate prostate tissue with a high-pressure waterjet, received a moderate recommendation with Grade B level evidence for patients with prostates from 30 to 80 cm3. The treatment was similar to TURP in symptom relief and quality of life through 5 years of follow-up. The risk of requiring medication or surgery due to recurrent symptoms was 51% less for those in in the aquablation arm than for those in the TURP arm.
Eaton noted that patients need to understand the tradeoff between TURP and aquablation and minimally invasive surgical devices, the latter of which have less-immediate side effects but can result in less improvement of symptoms and less durability.
Other Procedures
In addition to the devices, the AUA gave a conditional recommendation for prostate artery embolization for men with prostates ≥ 50 cm. A randomized, open-label study comparing this procedure to TURP found the technical success was approximately 85%-90%. Another study found a rate of treatment recurrence between 20% and 30%.
A 2022 review of six randomized controlled trials comparing embolization to TURP concluded the procedure may provide similar improvement in urologic symptom scores and quality of life, with potential to reduce ejaculatory disorders but likely increasing the need for retreatments.
Future Treatments
Future therapies for BPH include a new generation of prostate stents, including the Zenflow Spring System (Zenflow) and ProVee System (ProVerum), which were approved by the FDA in December 2025. The Urocross Expander System (Prodeon Medical) was cleared in early 2026.
Dean Elterman, MD, an associate professor of urology at the University of Toronto in Toronto, Ontario, Canada, said the new stents bridge the gap between medications and surgery.
“The advantage of these stents is that they can be placed using a flexible cystoscope in an in-office procedure with a local anesthetic,” he said.
Elterman is the co-global principal investigator for study of another investigational BPH treatment, pulsed field ablation, in which electrical pulses are transmitted through prostate tissue. Minimally invasive treatments may be a better choice for men who are unwilling to risk incontinence and other potential side effects.
“Men want to be able to preserve function but also improve their quality of life,” he said.
Wymer reported being a consultant for Boston Scientific and Ab Bio. Eaton reported being a consultant for Boston Scientific. Elterman reported being a clinical investigator for several companies, including Olympus, Laborie, and ALPFA Medical.
Brenda Sandburg is a freelance journalist for Medscape Medical News. She has written about the biopharmaceutical industry and legal issues for the Pink Sheet and American Lawyer Media.
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