have you ever heard of Shockwave therapy
for erectile dysfunction well I'm Dr
Reena Malik urologist and pelvic surgeon
and today I'm going to talk all about
what we know up until 2023 about
Shockwave therapy for erectile
dysfunction so there is new data
emerging all the time about Shockwave
therapy I made a prior video and so this
is an update on kind of where the data
is today to start off we're going to
talk about what shock waves are shock
waves are essentially sound waves that
can carry energy propagate through a
medium which is usually gel and transfer
to tissue now shock waves have different
kind of waves the specific type of wave
that you see in low intensity shock wave
therapy which is the one that is highly
studied for artile dysfunction has a
very characteristic waveform it has a
high peak pressure which is achieved
very rapidly and then there's a
subsequent pressure Decay and these
particular shock waves have three parts
of them first there is a short pulse
followed by a rapid increase to maximum
positive pressure followed by a
prolonged period of negative pressure
there are three types of Shockwave
generators electrohydraulic
electromagnetic and piso electric and
each of these uses a different method to
generate the shock waves the
electrohydraulic lithotriptor has two
electrodes where there's high voltage
applied and there's a spark that's
generate in between them this causes a
high amplitude wave that's in a
spherical shape that's then focused by a
reflector on the other hand
electromagnetic waves use a high voltage
electric pulse that causes this metal
membrane to move away from a coil this
causes the pulse itself and then the
shock wave is focused by an acoustic
lens or reflector and lastly the piso
electric lithotriptor uses special
crystals they're shaped like a sphere
that rapidly expand when you apply an
electrical pulse this then creates a
pressure wave and the spherical shape of
the crystals then causes the focused
shock wave so a lot of you ask me what
are the names of these lithotriptors and
how do I know that the one that the
person who's discussing shock wave with
me is actually the right one there are
three electromagnetic machines available
one is called duolith sd1 made by stores
medical another one is called Aries made
by dorier Medtech and the last one is
called Renova made by the Dux system for
piso electric there's only one option
it's the piso Wave 2 well you may have
heard of some other companies some other
brands some other machines that people
are using and what exactly are these
well a lot of them use radial shock
waves so how do radial shock waves
differ from these focused shock waves
that you're getting from low intensity
shock wave therapy the radial shock
waves are actually pressure waves that
have maximum pressures that are 100
times lower as well as pulse durations
that are 100 times longer which means
that they have a shorter and longer
pulse wave rather than a very focused
and more intense shock wave therefore
they tend to penetrate the tissue at a
much shallower depth of penetration
which is is usually about Less Than 3 cm
compared to the low intensity shock wave
therapy which is penetrating about 10 to
12 CM because of these different types
of shock waves radial shock wave therapy
is classified as an FDA class one device
meaning that it does not require any
medical supervision however the low
intensity shock wve therapy is a Class 2
medical device and this actually
requires supervision by a medical
professional and because of this radial
shock waves are very commonly used
because there's no require reement for
medical supervision also there's been
very little peer-reviewed published
literature on the efficacy of radial
shock waves there are some small studies
that say they work effectively however
the majority of the data that we're
looking at is in this low intensity
shock wave space I would encourage you
if you are looking to get Shockwave
treatment to look for one of those
machines that I mentioned earlier so how
do shock waves work well they create
damage in one of two ways the first way
is directly they create mechanical
stress on the tissues because of that
high int it shock and two indirectly
because they create a sort of turbulent
flow in the blood vessels this turbulent
flow causes the body to react and
respond to it like there's some trauma
going on this causes the body to
increase the amount of growth factors
specifically vegf or vascular
endothelial growth factor which causes
more blood vessels to be grown a term
called angiogenesis it also causes
recruitment of what we call stem cells
or other early types of cells which then
differentiate to create more blood
vessels and repair damage tissues that
cause erectile dysfunction it may also
increase the production of nitric oxide
in those tissues and if you're new here
nitric oxide is the ignition for
erections if you don't have sufficient
nitric oxide you can't have an erection
there's also some animal studies that
show it may play a role in nerve
regeneration because it clears up some
debris and scarring in the nerves and
also recruits cells like Swan cells
which are important in nerve regrowth so
what do we know about Shockwave therapy
well we know that there have been
several randomized control trials
meaning that they had patients have
shockwave therapy and another group not
have shock wve therapy and then they
compared their outcomes they've done it
with no treatment versus a sham
treatment they got something that
sounded like a shock wave but it really
wasn't a shock wave and they've also
done metaanalyses and systematic reviews
looking at the outcomes of all of these
studies together and when reviewing all
of the literature on shock wve therap we
found that men who have vascular genic
ed meaning having erectile dysfunction
because they have poor blood flow to the
penis like high blood pressure from
smoking other things like that
particularly those who are still
responsive to medical treatment me they
still get an erection when taking
something like selenop or tadalfil or
brand named Calis or Viagra and they're
still able to get an erection with
medication however also in patients who
have moderate erectile dysfunction it
seems to be mean they may have just
recently stopped responding to oral
medication or they still occasionally
respond to oral medications so when we
look at the data when you compare
Shockwave to Sham therapy we found
pretty much solid evidence that it does
improve erectile function based on the
erectile hardness score which is a
fourpoint score which people can use to
kind of explain how hard their erection
gets zero meaning they get no erection
at all and four meaning that they're
completely firm and rigid and they've
even looked at something called the Peak
systolic velocity on ultrasound of the
penis what that means is that the speed
of the blood flowing through the
arteries to the penis increases after
shock wve therapy the other important
thing is that in these studies they've
shown no obvious side effects associated
with treatment so when I last made a
video about Shockwave therapy I told you
guys that we had oneyear data meaning
that Shockwave after one year showed
that about 50% of people with mild to
moderate erectile dysfunction had
stained improvements in erectile
function at that time point so now we
have some small numbers of patients at 2
years and 5 years in this study they
followed about 156 patients who had
erectile dysfunction of those patients
in the initial study at 1 month they saw
64% have success meaning that they
achieved a clinically meaningful
difference in their erectile function
after receiving shock wave therapy
however at 2 years postoperatively of
those remaining 64% only
53% continued to have an improvement in
erectile function that's only 34% of the
entire cohort interestingly when they
broke these patients down and they took
out the patients who had diabetes and
severe erectile dysfunction 0% of those
saw any Improvement at 2 years however
when they took out those patients 76% of
the remaining patients did have a
successful outcome at 2 years another
study at 5 years only followed up about
30 patients over those 5 years they
found that erectile function continued
to deteriorate but tended to Plateau at
about 40% meaning that 40% of patients
had some clinical efficacy at 48 to 60
months after completion of the shock
wave therapy the other important thing
was that there was no penl pain or
deformity in these patients at 5 years
meaning that it is safe also there's
been a few small studies looking at
shock wve therapy for patients who've
had nerve injuries specifically during
radical prostatectomy for prostate
cancer or radical cystectomy for bladder
cancer and the numbers of patients have
ranged anywhere from 19 to 128 patients
and in many of these studies they've
seen some improvements however it's not
met the definition for clinically
significant meaning you see a little bit
of improvement but it may not mean that
much to you as a patient and so the
thought is that in these patients shock
wve therapy may be beneficial as an
adjunctive treatment meaning you can
take it with medication or with other
treatments to obtain better erectile
function so taking all this together
together Shockwave therapy seems to be
most beneficial for patients who have
mild to moderate erectile dysfunction
ideally not diabetic it may be best for
patients who want to optimize their
response to medications or for those
whove recently lost response to
medication and need something additional
to help with erectile function and again
I think the big important take-home from
all this is that there has been no
significant short or long-term side
effects associated with the treatment so
why are people not recommending ing this
as a treatment why is Insurance not
covering it well at this point in time
very few associations around the country
and around the world actually advocate
for the use of shock wve therapy for
example in metaanalyses of these studies
when you look at a number of these
studies you can find that the duration
of treatment and the number of shocks
per session and the machines used are
very very different for example when
looking at 14 studies they found that
shocks per session range between 1,500
shocks to 5,000 shocks and that the
length of treatment varied anywhere from
6 weeks to 9 weeks so it's hard to
compare the results of these studies to
each other also there has been no
significant long-term data and we still
don't know is there a value in adding a
maintenance maybe after a year should
you get another round of shock wve
therapy and how long should that be does
it need to be another six weeks does it
need to be 3 weeks does it need to be a
week we don't know another issue is that
many of these studies were not powered
appropriately meaning that in order to
see a difference from Placebo or from a
sham trial you will expect that Placebo
effects are high in that arm just like
we've talked about before on this
channel placebo effect is very powerful
in most erectile dysfunction trials
Placebo effects are about 25% so you
need to power a study appropriately so
you can accommodate for that placebo
effect and say okay I know that placebo
effect is going to be this much I also
know that I need to get this significant
change between the placebo group and the
clinical trial group to see that there
is an actual difference and that that
difference is Meaningful that's not just
statistics and so if the studies are not
powered appropriately you have to take
those studies results with a grain of
salt and lastly a lot of the studies
have included multiple patient
populations or have not focused in on
the specific degree of severity of the
erectile dysfunction to identify which
patient populations this is going to be
best for so where does this treatment
actually fit in is it in patients who
are just starting to get erectile
dysfunction is it patients who have
failed medical therapy who is it best
for and where are we going to put it in
in the guidelines so the sexual medicine
Society of North America has created a
position statement about these
treatments and they say quote the
emergence of restorative therapies such
as low intensity shock wve therapy stem
cell therapies and platelet rich plasma
therapy represents a new frontier of
investigative therapies for erectile
dysfunction at the moment however the
cumulative body of clinical trials for
restorative therapies is large ly
incomplete and many questions remain
unanswered the society however
recognizes the need for adequately
powered multi-center randomized sham
Placebo controlled trials in
well-characterized patient populations
to ensure that efficacy and safety are
demonstrated for any novel Ed therapy
the society agrees with the regulatory
agency pathway of approval including
safety and efficacy studies to achieve
goals in diverse patient populations
without FDA approval the use of any
novel therapy is considered off label to
date there is an absence of robust
clinical trial data supporting
restorative therapies efficacy in humans
although relative safety has been
established for stem cell therapy and
low intensity shock wave therapy
furthermore the precise treatment
parameters for low intensity shock wve
therapy such as energy settings dosing
frequency of use and duration of therapy
among others remains to be fully
elucidated so bottom line I think that
shock with therapy is really exciting
and has a place in the treatment for
erectile dysfunction however because
it's not yet covered by Insurance it can
be very financially costly and if you
don't do your research you may end up
spending a lot of money and you may not
benefit from the therapy so it's
important to know if you're going to
investigate into shock wof therapy that
you know which type of generator is
being used and if you are a candidate
for this treatment do you have mild to
moderate vasculogenic erectile
dysfunction because if you don't at this
point we don't know if it's going to
help you of course many studies are
underway and hopefully we will have
answers soon as always I hope you guys
enjoyed this video if you did please
share this Channel with your friends and
as always remember to take care of
yourself because you're worth it
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