LAS VEGAS — A novel, non-ablative intervention for lower urinary tract symptoms (LUTS) produced rapid, durable symptom relief with no adverse effect on sexual function, long-term results from prospective study showed.

Five years after treatment with the Optilume BPH catheter system, urinary flow rate (Qmax) improved by 63% and post-void residual volume (PVR) remained substantially lower than baseline. The average International Prostate Symptom Score (IPSS) decreased by 51%, and only one patient (out of 80) had surgical retreatment.

Sexual function scores remained unchanged from baseline throughout follow-up, reported Steven Kaplan, MD, of Mount Sinai Health System in New York City, at the American Urological Association (AUA) meeting.

“Optilume BPH provided immediate and sustained improvement over 5 years,” said Kaplan. “Optilume BPH represents a compelling and durable option for the minimally invasive treatment of LUTS secondary to BPH [benign prostatic hyperplasia].”

Before reporting 5-year data from the EVEREST trial, Kaplan polled the audience of urologists on their current use of medication to treat BPH/LUTS. A substantial proportion of the standing-room-only crowd raised their hands when asked if they prescribed as many as three drugs for a patient.

Kaplan noted a recent survey showing that as many as a third of patients with BPH/LUTS receive three drugs for symptom management. He also pointed out that many patients undergoing minimally invasive treatment for BPH/LUTS still require medication.

“Three drugs for a quality-of-life [QoL] condition? That’s crazy,” he said. “Maybe we’re going about this all wrong. Maybe we need to look at it differently.”

The Optilume system represents an alternative approach to other minimally invasive interventions that focus on removing prostate tissue to improve urinary flow and improve prostate symptoms. Instead, the system uses a catheter to inflate a paclitaxel-coated balloon that dilates the natural space between the prostate lobes, creating an anterior commissurotomy that maintains separation between the lobes. The paclitaxel is released in a rapid but controlled manner to prevent a hyperplastic response and maintain patency to facilitate better urinary flow through the urethra.

The catheter system was evaluated in a multicenter prospective study conducted in six Latin American countries. Investigators enrolled a total of 80 patients with symptomatic BPH/LUTS. The primary outcomes were change in urinary flow and improvement in LUTS symptoms as measured by the IPSS.

The 80 patients had a mean age of 65 and moderate-size prostates (mean volume 35.9 cc). Baseline IPSS averaged 22.3 (severe), Qmax 10.9 mL/s, and PVR 63.1 mL. Other baseline measures included a BPH-II score of 6.9 (mild) and an IIEF erectile function score of 17.6 (mild/moderate).

Follow-up assessments at 5 years showed that mean Qmax had increased to 17.8 mL/s, PVR had decreased by 10.7 mL, and mean IPSS had decreased to 11. The improvements occurred almost immediately after treatment and then exhibited minimal change throughout follow-up.

Three patients had additional treatment for BPH/LUTS. One patient had surgical retreatment (1.3%) and the other two opted to initiate medical therapy. Erectile and ejaculatory function exhibited little variation over time.

Other reports at the AUA provided long-term follow-up data that reflected the accumulating experience with other minimally invasive treatments for BPH/LUTS.

Aquablation

Pooled data from five large studies of the Aquablation water ablation system showed that patients treated with the device had sustained symptom reduction and continual improvement in QoL over 12 months, reported Dean Elterman, MD, of the University of Toronto. The five studies involved a total of 528 patients who had large prostates (mean volume 71.7 mL). Comparison of baseline and 12-month outcomes showed substantial improvement in:

• IPSS: 21.5 vs 6.6
• IPSS QoL (lower is better): 4.7 vs 1.4
• Qmax: 8.1 vs 20.5 mL/s
• PVR: 105.7 vs 53.1 mL
• Voided volume: 197.5 vs 271.9 mL

The findings added to those reported last month at the European Association of Urology meeting from a comparison of Aquablation and laser enucleation of the prostate (LEP) for BPH/LUTS in men with large prostates. Three months after treatment, the two interventions achieved similar symptomatic improvement. LEP was associated with greater reduction in prostate volume and improvement in Qmax, whereas patients treated with Aquablation had substantially less post-treatment ejaculatory dysfunction and stress urinary incontinence.

Rezum

Three-year outcomes showed sustained improvement in symptoms and QoL with the Rezum water vapor thermal therapy, also reported by Elterman. The analysis included 712 men whose baseline prostate volume averaged 74.1 mL. Follow-up data showed improvement in multiple parameters:

• IPSS: 22 vs 9.8
• IPSS-QoL: 4.5 vs 1.9
• BPH-II: 7.7 vs 2.7
• PVR: 134.9 vs 38.5 mL
• Qmax: 8.6 vs 12.1 mL/s (15 mL/s at 24 months)

Erectile and ejaculatory function did not change significantly from baseline to 3 years, said Elterman.

Rezum vs UroLift

Previous reports have documented improvement in symptoms and QoL for up to 5 years with the Rezum system and UroLift, an implant system that relieves BPH/LUTS symptoms by lifting the prostate from the urethra to reduce pressure and flow restriction. Charlotte Quinn, MD, of Norfolk and Norwich University Hospitals in England, reported rates of surgical retreatment associated with the two interventions after 8 years of follow-up.

The analysis included 401 patients treated with UroLift and 69 treated with Rezum. Overall, patients treated with UroLift had substantially more reoperations (16.5% vs 9.9%). The difference emerged during the first 24 months (10.5% vs 7.25%) and increased at 60 months (15.2% vs 9.9%), although the difference did not achieve statistical significance (P=0.204). The 8-year data for UroLift only showed a reoperation rate 15.9%, which did not differ significantly from 5 years.

For perspective, Quinn noted that transurethral resection of the prostate has a reoperation rate of 10-15% over 5-8 years and Holmium laser enucleation has rates of 0-5% over the same time period.

Ongoing monitoring of re-operation rates is needed to get an accurate determination of clinical experience with different interventions for BPH/LUTS, said Quinn.

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