Cheryl Guttman Krader is a contributor to Dermatology Times, Ophthalmology Times, and Urology Times.
Results of the prospective MedLift study establish the efficacy and safety of the Prostatic Urethral Lift (PUL [UroLift System]) procedure for treatment of symptomatic BPH in men with an enlarged median lobe.
San Francisco-Results of the prospective MedLift study establish the efficacy and safety of the Prostatic Urethral Lift (PUL [UroLift System]) procedure for treatment of symptomatic BPH in men with an enlarged median lobe.
The 1-year clinical trial enrolled 45 men at nine centers. Presenting the findings at the AUA annual meeting in San Francisco, Daniel B. Rukstalis, MD, reported that PUL was associated with high patient satisfaction. Recovery occurred quickly after the procedure, and it led to statistically significant improvements in symptoms and ejaculatory function. Erectile function was preserved.
No patients required medications for BPH after the procedure, and there were no cases of serious device/procedure-related adverse events or de novo sustained erectile or ejaculatory dysfunction.
“After the PUL was initially approved by the FDA, approximately 75% of men with prostates smaller than 80 cc would be considered candidates for this minimally invasive procedure. Based on the results of the MedLift study, we can now say that the PUL is applicable for men with all configurations of the prostate,” said Dr. Rukstalis, professor of urology at Wake Forest Baptist Medical Center, Winston-Salem, NC.
MedLift was conducted as a non-blinded, single-arm FDA Investigational Device Exemption extension of LIFT, the randomized clinical trial that led to FDA approval of the PUL procedure for men with enlarged lateral lobes of the prostate. Except for requiring that men have an obstructive median lobe, the MedLift inclusion criteria were identical to those in LIFT. To be eligible, patients had to be ≥50 years of age, have an International Prostate Symptom Score (IPSS) ≥13, peak flow rate (Qmax) ≤12 mL/s, prostate volume 30 cc to 80 cc, and prostate length 30 mm to 80 mm.
“At baseline, the participants in MedLift were similar to the LIFT patients except the MedLift patients were significantly younger and had significantly more voiding symptoms,” Dr. Rukstalis reported.
Men underwent flexible cystoscopy at baseline and 6 months and completed validated symptom and quality of life questionnaires at follow-up visits through 12 months. The extent of intravesical prostatic protrusionat baseline was categorized as <5 mm, 5-10 mm, and >10 mm using the baseline ultrasound image.
The outcomes evaluations showed that compared with baseline, the AUA Symptom Index score improved 58% at 6 months and 55% at 1 year; quality of life improved 60% at 6 months and 61% at 1 year; BPH Impact Index improved 75% at 6 months and 70% at 1 year; and Qmax improved 90% at 6 months and 108% at 1 year. Ejaculatory function evaluated with the Male Sexual Health Questionnaire improved 27% at 6 months and 39% at 1 year.
Next: Lobe protrusion inconsequentialLobe protrusion inconsequential
There was no statistically significant difference in symptom improvement based on the amount of middle lobe protrusion.
“This was surprising because the literature suggests that the degree of obstruction is related to the extent of middle lobe protrusion. The results would indicate that the PUL procedure can address a variety of presentations of the middle lobe,” Dr. Rukstalis said.
Comparing the results from MedLift and LIFT, Dr. Rukstalis noted that the MedLift patients had greater improvement in symptoms, quality of life, and peak flow.
“Published data from LIFT show that improvement in voiding symptoms was sustained for 5 years. MedLift follow-up is complete at 12 months, but we certainly anticipate that patients with an enlarged median lobe will follow this same pattern,” he said.
Most adverse events experienced by men in MedLift were mild to moderate in severity and resolved within 2 weeks. The most common adverse events were hematuria, dysuria, urgency, and urge incontinence.
“The catheterization rate in MedLift was 80%, which is higher than in LIFT, but the median duration of catheterization was only 1.6 days,” Dr. Rukstalis said.
Data collected at 3 months showed 93% of patients would recommend the procedure.
NeoTract, Inc. provided funding for the study. Dr. Rukstalis is a meeting participant/lecturer for NeoTract. One of Dr. Rukstalis’ co-authors has several disclosures related to pharmaceutical/device companies, including serving as a consultant/adviser for PROCEPT BioRobotics and a consultant/adviser and meeting participant/lecturer for Teleflex.