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FDA Approves New Device for Enlarged Prostate Treatment

This topic can be found at:
https://sigforum.com/eve/forums/a/tpc/f/320601935/m/2240013205

July 27, 2023, 02:04 PM
ZSMICHAEL
FDA Approves New Device for Enlarged Prostate Treatment
Another option for BPH. I would like to see more data in a year or two, but it seems promising.

The US Food and Drug Administration has approved a new catheter designed to treat urinary tract symptoms of an enlarged prostate, also known as benign prostate hyperplasia (BPH).

Designed and marketed by Urotronic (Plymouth, Minnesota), the Optilume BPH Catheter System employs mechanical dilation to relieve obstruction of the prostate and then delivers paclitaxel to aid in prostate healing. The device is used in an outpatient setting and is less invasive than other procedures.

"There's nothing else like Optilume BPH that's currently available, it's the only treatment option that requires no cutting, burning, steaming, or implants," said Urotronic President and CEO David Perry in a press release.

Two randomized trials, EVEREST-1 and PINNACLE, both showed that the Optilume BPH system improved urinary flow rate and decreased the amount of urine stored in the bladder following urination. Men who used the OPTILUME device were able to ejaculate normally and reported no sexual difficulties.

"Optilume BPH is the next generation of minimally invasive technology, creating a new drug device space among BPH therapies," said Steven A. Kaplan, MD, professor of urology at the Icahn School of Medicine at Mount Sinai in New York City, in the press release. Kaplan led the EVEREST-1 and PINNACLE studies, which Urotronic funded.

More than 80% of men older than age 70 have an enlarged prostate, based on autopsy analyses.

LINK: https://www.medscape.com/viewa...id5685042&uac=65325S
July 27, 2023, 02:13 PM
kkina
Whoa, it would be nice to get off the Flomax.



ACCU-STRUT FOR MINI-14
"Pen & Sword as one."
July 27, 2023, 02:19 PM
parabellum
My urethra is a one-way street.
July 27, 2023, 02:27 PM
medic451
quote:
Originally posted by parabellum:
My urethra is a one-way street.

Someday it may just be a bike path… Big Grin



"I won't be wronged, I won't be insulted, and I won't be laid a hand on. I don't do these things to other people and I require the same from them."
- John Wayne in "The Shootist"
July 27, 2023, 02:47 PM
Mark in Michigan
Nobody goes near my junk with 'a device'...


Best regards,
Mark in Michigan
July 27, 2023, 05:10 PM
tatortodd
quote:
minimally invasive technology
Urologists and proctologists have a warped view of minimally invasive.

Their definition: We're going to jam a catheter up your wiener, once we get to your prostate we're going to pump up a mechanical dilator until you think you're going to die, and we promise one day you'll heal enough to be able to have sex.

My definition: I keep my pants on and you stay on your side of the room. The only thing invasive are the questions.



Ego is the anesthesia that deadens the pain of stupidity

DISCLAIMER: These are the author's own personal views and do not represent the views of the author's employer.
July 27, 2023, 05:50 PM
nhracecraft
Nope...The FDA does not have a particularly good track record re: approval of 'devices', or anything else for that matter as of late! Sorry, Hard Pass!


____________________________________________________________

If Some is Good, and More is Better.....then Too Much, is Just Enough !!
Trump 47....Making America Great Again!
"May Almighty God bless the United States of America" - parabellum 7/26/20
Live Free or Die!
July 27, 2023, 06:19 PM
cparktd
I’d give it a go before letting them send a roto-rooter up…



Endeavor to persevere.
July 27, 2023, 07:21 PM
sdy
I have an enlarged prostate. three times the average size.

Have been on a drug called finasteride for a year. (shrinks the prostate) PSA dropped from 5.0 to 1.2

My urologist said it doesn't work for everyone, but when it does work it is usually very effective

He thought my PSA may continue to drop some.
July 27, 2023, 07:24 PM
gjgalligan
quote:
Originally posted by parabellum:
My urethra is a one-way street.


Only until it becomes completely road blocked......


Integrity is doing the right thing, even when nobody is looking.
July 27, 2023, 08:19 PM
wcb6092
Wonder what the long term effect of having paclitaxel injected into your prostate is?

Paclitaxel is a type of chemotherapy called a taxane. Taxanes interfere with structures in a cell called microtubules that help move chromosomes during mitosis (cell division). Paclitaxel stops the growth of cancer cells and other dividing cells by blocking cell division.

"Designed and marketed by Urotronic (Plymouth, Minnesota), the Optilume BPH Catheter System employs mechanical dilation to relieve obstruction of the prostate and then delivers paclitaxel to aid in prostate healing. The device is used in an outpatient setting and is less invasive than other procedures."


_________________________
July 27, 2023, 08:20 PM
cas
I dunno, I keep picturing a bicycle pump and one of those skinny balloons they make balloon animals out of. Eek
July 27, 2023, 08:34 PM
bald1
They don't mention the required implements for the procedure.... DAMN!







Certifiable member of the gun toting, septuagenarian, bucket list workin', crazed retiree, bald is beautiful club!
USN (RET), COTEP #192
July 27, 2023, 09:49 PM
Sig2340
quote:
Originally posted by medic451:
quote:
Originally posted by parabellum:
My urethra is a one-way street.

Someday it may just be a bike path… Big Grin


Or a Subway.





Nice is overrated

"It's every freedom-loving individual's duty to lie to the government."
Airsoftguy, June 29, 2018
July 27, 2023, 09:55 PM
grumpy1
Sounds very promising. So far I am managing it well with flomax every other day and saw palmetto daily. I just have to be careful not to drink too much caffeine as it diminishes the effect of the medication.
July 28, 2023, 10:34 AM
sjtill
I have two urologists--one for my bladder cancer, and one for my kidney stones and BPH.
The bladder cancer specialist told me every 5 years or so a new BPH procedure is approved when the long-term results of the last one prove disappointing. Once Medicare approves a new procedure, that becomes king of the hill for a while until it's replaced by the next one.
UroLift was hot, now it's not.
Rezume is hot now, like superheated steam injected into your urethra with needles hot. Somehow I can't get excited about that one.
I guess I'm just going to have to drink less coffee and carbonated drinks to decrease the urgency and frequency.


_________________________
“Remember, remember the fifth of November!"
July 28, 2023, 11:53 AM
egregore
quote:
the Optilume BPH Catheter System employs mechanical dilation to relieve obstruction of the prostate

It should have been Peter Rooter.
July 28, 2023, 12:07 PM
ZSMICHAEL
quote:
UroLift was hot, now it's not.

^^^^^^^^^^^^^^
Maybe the new device will get the terribly annoying Urolift commercial off television.