UROLIFT with MEDIAN LOBES

Ken,

I talked to Urolift rep today .  She said the Urolift procedure for Obstructive median lobe has been done on about 60 people worldwide as of 8-8-2018.  She said it is important to distinguish between enlarged median lobe and obstructive enlarged median lobe, a good question for your Urologist.  Apparently an enlarged median lobe by itself does not cause failure of Urolift or other procedures unless it is obstructive.  I'm not sure if obstructive means the, ball valve effect, but that is probably one of the causes of obstruction.

I called Steven Gange in Salt Lake City, Utah, who appears in a video on the Urolift web site.  He has not done it yet but was making a list of patients who want it for his training from Urolift.  Apparantly doctors who want training from Urolift have to get a list of patients who want it, and will get it while the training crew, from Urolift, is there . 

I also called a Doctor in the California, who is a Urolift Center of Excellence.  They have not done the median lobe procedure and had not made a list of patients for the training. 

The Urolift rep sent me the following paper:

LBA15

MULTI-CENTER PROSPECTIVE STUDY OF THE PROSTATIC

URETHRAL LIFT FOR OBSTRUCTIVE MEDIAN LOBE: THE

MEDLIFT STUDY, AN EXTENSION OF THE LIFT RANDOMIZED

STUDY

Daniel Rukstalis*, Winston Salem, NC; Douglas Grier, Edmonds, WA;

Sean Stroup, San Diego, CA; Ronald Tutrone, Towson, MD; Euclid De

Souza, Omaha, NE; Sheldon Freedman, Las Vegas, NV;

Richard David, Sherman Oaks, CA; Jed Kamientsky, New York, NY;

Gregg Eure, Virginia Beach, VA

INTRODUCTION AND OBJECTIVES: Presence of an

obstructive median lobe (OML) has historically limited treatment options

for men suffering from lower urinary tract symptoms (LUTS) due to

benign prostatic hyperplasia (BPH). Recently, the FDA indicated the

Prostatic Urethral Lift (PUL) for the treatment of OML based on the

results of the MedLift clinical trial (NCT02625545), presented herein.

MedLift was conducted as an FDA Investigational Device Exemption

extension of the LIFT randomized study, studying PUL for lateral lobes

(LL) of the prostate.

METHODS: Inclusion criteria were identical to the L.I.F.T. study

with the exception of requiring an OML: at least 50 years, AUASI ! 13,

peak flow rate (Qmax) " 12 ml/s and prostate volume no greater than

80cc. The primary endpoint was assessed at 6 months, compared to

L.I.F.T. study results, and followed to 12 months with assessment of

LUTS, quality of life, Qmax, and sexual function.

RESULTS: When compared to the lateral lobe only patients, the

OML patients symptoms responded at least as well at every time point.

For the median lobe patients, AUASI change at 1, 3, 6, and 12 months

was at least a 13.5 point improvement and significantly better than

baseline at every time point (p < 0.0001). Quality of life score and BPH

Impact Index were similarly improved (>60% and >70%, respectively at

3, 6, and 12 months). Qmax improvement ranged from 95-124%

throughout follow up. At 1 month, 65% subjects reported !80 on the

Quality of Recovery scale, 80% reported being 00much00 or 00very much

better,00 and 89% would recommend the procedure. There were no reports

of de novo, sustained erectile or ejaculatory dysfunction. Erectile

function as measured by IIEF-5 remained stable and ejaculatory function

(MSHQ-EjD score) was significantly improved throughout follow up

(p < 0.001).

CONCLUSIONS: Median prostatic lobe obstruction can be

treated with PUL implants safely and effectively and is a new FDA

indication for this therapy.

Source of Funding: NeoTract, Inc.