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A minimally invasive implant procedure led to a 50% improvement in lower urinary tract symptoms due to BPH, which was maintained for a year, results of a randomized trial showed.
San Diego-A minimally invasive implant procedure led to a 50% improvement in lower urinary tract symptoms (LUTS) due to BPH, which was maintained for a year, results of a randomized trial showed.
Men treated with the prostatic urethral lift (UroLift, NeoTract, Inc., Pleasanton, CA) had 88% symptomatic improvement compared with a control group at 90 days. Insertion of the implants led to rapid improvement in urinary flow, which remained almost 60% above baseline a year later, as reported at the AUA annual meeting in San Diego.
The UroLift is currently under FDA review.
“There is rapid and significant symptom improvement, improved urinary flow rate, and preserved sexual function,” said first author Claus G. Roehrborn, MD, chair of urology at the University of Texas Southwestern Medical Center in Dallas. “All primary and secondary endpoints were met, and durability at 1 year was established.”
The procedure was well tolerated with local anesthesia, he added.
The permanent implants consist of a nitinol anchoring tab and a stainless steel urethral end piece, connected by a polyethylene monofilament that is sized according to each patient’s prostate volume and location. During a cystoscopy-guided procedure, the lifts are deployed by means of a hand-held device. Tension on the line between the two attachments lifts the lateral prostatic lobes away from the urethra to relieve obstruction.
The implants were evaluated in a randomized, placebo-controlled trial involving men with LUTS. Eligibility criteria included age ≥50 years, AUA Symptom Index (AUA-SI) ≥13, peak flow rate (Qmax) ≤12 mL/s, prostate volume 30-80 cc, postvoid residual (PVR) volume ≤250 mL, PSA ≤10.0 ng/mL, no active infection, and no obstructive median prostatic lobe.
Investigators at 19 centers in the United States, Canada, and Australia randomized patients 2:1 to the urethral lifts or sham procedures (cystoscopy with a surgical screen and sounds to mimic the implant delivery system). The primary endpoint was reduction in AUA-SI ≥25% compared with the control group at 90 days.
Dr. Roehrborn presented data for 206 patients, who had a mean age of about 66 years, prostate volume of 40-45 cc, AUA-SI of about 23, Qmax 8 mL/s, and PVR of about 85 mL.
The 90-day efficacy results showed that the mean AUA-SI score declined from 22.2 to 11.2 in the urethral lift group compared with a decline from 24.4 to 18.5 in the control group (p<.003). Mean Qmax increased by 4.38 mL/s in the patients who received the implants versus 1.88 mL/s in the control group (p=.005). At 1-year follow-up, mean Qmax remained 4 mL/s above baseline in the urethral lift group.
Quality of life and BPH index scores improved significantly more with the urethral lift group compared with the control group, and the improvements were maintained at 1 year.
Patients randomized to active intervention received an average of 4.9 implants during procedures that had a mean duration of 68 minutes. The most frequent adverse events in the urethral lift group were dysuria (34% vs. 17% of the control group), hematuria (26% vs. 5%), and pelvic pain (19% vs. 9%). Frequency of urge incontinence was similar between the groups (7% vs. 8%).
No patient developed new-onset ejaculatory dysfunction or erectile dysfunction, Dr. Roehrborn said.
Follow-up cystoscopy at 1 year showed no encrustation of lifts in the prostate, but 2.1% of the implants developed encrustation as a result of exposure to the bladder. The implants were removed by forceps without incident.
During the first year after implantation, 5% of patients randomized to the urethral lift underwent additional prostate interventions, including repeat implantation (3.6%), transurethral resection (0.7%), and laser treatment (0.7%).
Dr. Roehrborn is a consultant/adviser for NeoTract, and one of his co-authors is an investigator for the company.UT
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