Active vs. sham treatment
Urologists may be familiar with another Optilume device, the Optilume urethral drug-coated balloon, that is used for urethral strictures.
The devices have similar names, and the underlying technology is similar, but there are major differences, Mr. Schorn said.
The BPH device expands between the lobes of the prostate, creating an anterior commissurotomy. A double-lobe balloon locks the device in place during inflation.
For the PINNACLE trial of the BPH device, which was conducted at 18 sites in the United States and Canada, Steven A. Kaplan, MD, of the Icahn School of Medicine at Mount Sinai, New York, and colleagues enrolled 148 men with symptomatic BPH who were experiencing urinary flow obstruction.
The average age of the patients was 65 years; 100 of them were assigned to undergo active treatment with Optilume BPH. The rest received a sham procedure that mimicked active treatment.
At 3 months, men who received active treatment had an average improvement in the International Prostate Symptom Score of about 11 points. This improvement was maintained at 1 year. Those who received sham treatment experienced an 8-point improvement at 3 months that dissipated over time.
The rate of urine flow increased dramatically with Optilume BPH, the researchers reported.
Five serious adverse events were considered to be possibly related to the device. There were four cases of postprocedural hematuria that required cystoscopic management or extended observation, and one case of urethral false passage that required extended catheterization.
Nonserious adverse events in the men who underwent the Optilume procedure typically resolved in about a month and included hematuria (40%), urinary tract infection (14%), dysuria (9.2%), urge or mixed incontinence (8.2%), mild stress incontinence (7.1%), bladder spasms (6.1%), elevated prostate-specific antigen levels (6.1%), and urinary urgency (6.1%), according to the researchers.
In a subset of participants for whom pharmacokinetic data were available, systemic exposure to paclitaxel was minimal.
Four participants in the Optilume BPH arm (4.1%) reported ejaculatory dysfunction, compared with one man in the sham treatment arm (2.1%). There were no cases of treatment-related erectile dysfunction.
Most patients were treated under deep sedation or general anesthesia, and the average procedure time was 26 minutes.
After the procedure, patients received a Foley catheter, which remained in place for about 2 days, “which is not significantly different from water vapor thermal therapy, holmium laser enucleation of the prostate, or laser photovaporization in similar gland sizes,” Dr. Bole and Petar Bajic, MD, also with Cleveland Clinic, noted in a commentary accompanying the article in The Journal of Urology.
MIST devices can be ideal for patients who prioritize sexual function, but the need for a temporary catheter after the procedure can be a “major postoperative source of patient dissatisfaction,” they acknowledged.
“Consistent with other minimally invasive technologies, the Optilume BPH procedure is a straightforward procedure that can be conducted in an ambulatory or office outpatient setting with pain management at physician and patient discretion,” Dr. Kaplan and his coauthors wrote.
The study was featured on the cover of the journal, which the research team saw as an unusual but welcome spotlight for a treatment for BPH.
“We were thrilled that we got on the cover of The Journal of Urology, which is not a common thing for BPH technology,” Mr. Schorn said.
Urotronic funded the PINNACLE study. Dr. Bole has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.