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*Is the new treatment reliable for medical professionals only
?
Low-intensity extracorporeal shock wave is a "regenerative therapy" for erectile dysfunction (ED) that has spread throughout Europe and the United States in recent years, and is said to restore the youthfulness of blood vessels in key areas
.
"A lot of private clinics, beauty salons, spas are in
the United States.
As soon as they buy a piece of equipment, hire a registered nurse or technician, and men use credit cards to make purchases
.
T.
Mike Hsieh, professor of urology and director of the Center for Men's Health at the University of California, San Diego, said
.
The 2022 European Urological Association (EUA) Guidelines for Sexual and Reproductive Health, the North American Society of Sexual Medicine (SMSNA) Position Statement, and the European Society of Sexual Medicine (ESSM) Clinical Recommendations describe this therapy with some caution
.
EUA information suggests that low-intensity extracorporeal shock waves may be useful in patients with mild vasogenic ED, and several single-arm trials have proven beneficial, but data from prospective randomized trials are conflicting and many questions remain unanswered
.
SMSNA and ESSM said they lacked reliable evidence, and the treatment effect and potential risks were unknown
.
Mayo Clinic urologist Gregory Broderick helped develop the SMSNA position statement
.
He said that shock waves may help specific ED patients, but the current indications are not clear, and there are no normative guidance documents
on what equipment to use, how large the pulse sound intensity should be, and how long the course of treatment.
"It's not Indian god oil, and it doesn't have a divine effect
.
"
Photo caption: An American doctor is administering low-intensity extracorporeal shockwave therapy
to men.
/ Screenshot from ABC News
How does the shockwave shake come to life?
In early 2018, Stephen Borgese quit his job as an emergency physician after more than 20 years to open a specialist private practice
in Brynmore, a suburb of Philadelphia.
According to the clinic's official website, only ED patients are served here, and the core treatment method is low-intensity extracorporeal shock wave
.
"We are the first and largest in the region to offer this type of technology
.
"
This is a high-energy two-way sound wave
.
Different from sound waves in the ordinary sense, when the shock wave propagates in the medium, it will cause pressure changes and release energy, resulting in a series of biological effects
in the target organ tissue.
It has a long
history of medical use.
EUA information shows that this technology has long been used to treat kidney stones, arthritis, etc
.
Around the 2010s, studies have found that at lower intensities, shock waves may unblock penile blood vessels, improve blood supply, and rejuvenate patients
.
Like PDE5 inhibitors such as "Viagra", it acts on cavernous bodies, smooth muscle cells, etc
.
The difference is that shock waves can promote the regeneration of penile cavernous nerves, vascular endothelium, smooth muscle, etc
.
, and repair physiological defects or lesions.
This is also the origin of its so-called "regenerative therapy
".
About 1 year after the clinic opened, Stephen Borgese has administered shockwave therapy
to more than 700 men.
A single treatment takes about 10 minutes, and the device probe needs to be attached to each part
of the external genitalia.
According to his statement, in order to be effective, do at least 1 time a week, 12 times for 1 course of treatment, a total of 3,000 US dollars (about 22,000 yuan).
Stephen Borgese said shockwave therapy is safe and effective
.
About 40% of patients can get rid of oral medication after treatment and applaud
as much as they want.
Another 40% of patients were already resistant to drugs, but after treatment and re-medication, the job was ready to use
.
"For years, medical professionals have been looking for a cure
for ED.
Taking medicine and injections only masks the symptoms
.
Shockwaves are not the same, it can cure the root cause
.
In April 2019, registered nurse Helena Milliner said that she joined Infinity, a medical spa clinic specializing in laser hair removal and facial care, to carry out shockwave treatment
.
She described it as a revolutionary "no pill, no surgery, non-invasive" sexual health service
.
Shockwaves have been introduced to China
.
In recent years, a number of people with the identity of "andrologists of third-class hospitals" have posted on the doctor-patient communication platform, saying that their hospitals have introduced relevant technologies and have been used abroad for more than ten years without adverse reports
.
The "Guidelines for the Diagnosis and Treatment of Andrology Diseases in China and Expert Consensus (2016)" compiled by the Andrology Branch of the Chinese Medical Association said that it "is becoming a new treatment
for ED.
" Photo
caption: Stephen Borgese inside his clinic
.
As one of the world's most authoritative sexual medicine organizations, SMSNA has issued two position statements on the clinical use of shock waves in 2019 and 2021
。 Its contents show that low-intensity extracorporeal shock waves are "promising" and there is evidence that it is safe
to use within the scope of studies.
However, the results of the study are controversial and are currently only available to patients
enrolled in clinical trials.
High-quality evidence such as multicentre randomization and double-blinding is needed in the future
.
According to the clinical recommendations issued by ESSM in January 2020, up to that time, there were 11 shockwave RCTs and 5 meta-analyses, with high heterogeneity, low enrollment, and high risk of bias
.
Some studies believe that shock waves are statistically significant in patients with mild and severe ED; Some propose to cooperate with PDE5 inhibitors; There have also been reports of improvement with mild ED+ PDE5 inhibitors +
shockwaves.
The duration of efficacy in different studies varies, some are effective 1-3 months after the completion of treatment, and some are still meaningful
after 5 years of treatment.
"Limited to research
.
The U.
S.
FDA has not approved it for clinical use
.
The shockwave treatments that men can access are all over-label
.
In May 2022, AUA's journal Urological Practice published "Shockwave Therapy for ED: Marketing and Practice Trends in Major Large U.
S
.
Cities.
"
Shock waves are more recognized in Europe
.
In 2013, the EUA developed ED guidelines as an alternative first-line treatment
.
The 2022 sexual and reproductive health guidelines states: "Low-intensity shockwave therapy
is used in patients with mild vascular ED and those with vascular ED who do not respond well to PDE5 inhibitors.
" Alternatively, it may be used as an alternative to first-line therapy for those who do not wish or are candidates for oral vasoactive therapy
, or who are well-informed and wish for a cure.
Notably
, the evidence for this recommendation is rated 'weak'
.
Vascular ED is a subdivision type, accounting for about 80%
of all patients with ED.
Insufficiency of penile arterial or venous blood supply in these patients is manifested by the disappearance of penile erection at night and poor response to intracavernous injection of
vasoactive substances.
Depending on the etiology, ED also includes neurological, anatomical, endocrine, drug-inducing, and psychological
.
"We investigateIt was found that shockwave therapy had long since departed from the society's recommendations
.
Sriram V.
Eleswarapu, author of the aforementioned AUA article, said in an interview that some fundamental problems have not been solved
.
Sriram V.
Eleswarapu and his team conducted surveys
in 8 large cities in the United States.
It was found that 75% of those who provided shockwave therapy were not urologists and sexual medicine doctors, but dermatologists, orthopedics, obstetrician-gynecologists, nurses, etc
.
They are unable to accurately assess the condition before treatment and cannot make effective diagnoses and recommendations
.
Second, treatment lacks standardization
.
A 2019 retrospective meta-analysis showed that the most common course of shockwave therapy was twice weekly for 3 weeks, followed by a break of 3 weeks, followed by twice-weekly treatment for 3 weeks
.
The AUA article found that the most commonly used by various medical institutions is 1 time per week, and 6 times is 1 course of treatment
.
When I arrived at the beauty salon and spa, the treatment was changed
again.
According to Helena Milliner's medical spa, a registered nurse, shockwaves are like facials that can be done once or all the time
.
Thirdly, "do what you want" is also reflected in equipment selection, pulse sound intensity setting and other links
.
The SMSNA statement said that shock waves are divided into focusing type, radial type, etc
.
according to the working principle.
The latter is less expensive and more widely used
.
Its energy coverage area is larger, but the depth of penetration is limited
.
Basic clinical studies have shown that the radial type is not as good as the focused type in inducing tissue healing and improving erection
.
Christopher Love, an Australian urologist who has been practicing medicine for nearly 40 years, demonstrates extracorporeal low-intensity shockwave therapy
at the clinic named after him.
Credit: Dr.
Love Clinic
, Do Men Need to Do It?
"Male hemorrhoids have a long
history.
So far, no panacea
has been found.
Irwin Goldstein, director of the Center for Sexual Medicine at Alvarado Hospital in San Diego, pointed out
.
After the appearance of the blue pill Viagra (Viagra), the guidelines of European and American urology and sexual medicine related societies pointed out that the preferred way to treat ED is oral PDE5 inhibitors, and the evidence level is "strong"
.
But drugs are not effective
per person.
"Do the second monk hit the bell" type of medication, or it is difficult to achieve an effective therapeutic dose
.
Long-term continuous eating, expensive and may increase the risk of
adverse reactions.
Ranjith Ramasamy, assistant professor and director of the Department of Genitourinary Urology at the University of Miami, said that treatment methods have their own shortcomings
.
"Intracavernous injections can be performed a few minutes before sex, and the difficulty is to needle yourself that job, but also to stick it in a specific area
.
Prostheses are expensive, narrow in scope of application, and more niche
.
Marsh
, a massage therapist, started "not tough" in his 40s and has been in his 40s for 14 years
.
He tried a variety of methods with poor
results.
"I'm tall, healthy, and I don't have chronic diseases, just getting worse
.
My wife, who has been married for many years, expressed understanding, but I was uneasy and afraid
.
Having a normal sex life is not just about bed
.
Zhou
Shanjie, deputy chief physician of the Center for Reproductive Medicine at Peking University International Hospital, told the "medical community" that men are dissatisfied with the treatment effect for various
reasons.
Most people are because of treatment options
.
Some have a mismatch
between the effect and the expected value.
China's "Guidelines for the Diagnosis and Treatment of Penile Erectile Dysfunction" shows that the overall effective rate of PDE5 inhibitors is 80%.
Patients who do not respond to oral drugs are injected with intracavernous vasoactive drugs, and the effective rate can reach 85%.
The effectiveness of vacuum erection devices against ED of various etiologies ranges from
27% to 94%.
The effectiveness of shock waves is not surprisingly
good.
EUA reproductive guidelines show that the proportion of treated and satisfied patients ranges from 40% to 80%.
It is not possible to define "satisfactory" because few studies have focused on objective indicators
such as post-treatment penile haemodynamic parameters.
In July 2022, the Journal of Urology published an article saying that men with moderate ED can achieve clinically meaningful improvement
with shockwave therapy.
The evaluation endpoint was an increase in erection scores and an increase
in the number of clappings for love.
"There will always be resistance
to new therapies.
Previously, no one believed that laparoscopic kidneys could be removed and robots could complete prostatectomy, but now this is the norm
.
Urologist Bruce Sloane also performs shockwave therapy for $5,000 for 12 sessions
.
Sometimes, he resorts to another innovative "regenerative therapy," platelet-rich plasma cavernous body injections (PRP) for a single charge of $
1,500.
SMSNA, EUA, etc.
have all stated that PRP is limited to clinical trial settings
.
Bruce Sloane will be candid with men that shockwave therapy is not FDA-approved, is experimental and may not work, but certainly has no serious side effects
.
He noted that men need 5 things to get an erection: blood flow, nerve function, hormones, stimulation, and relaxation
.
"Regenerative therapy" can solve the first two problems
.
In order to regain their strength, men are willing to try everything
.
It's about personal value
.
"Should patients do what they need to do? As a doctor, it is a basic guideline
that treatment is harmless.
But without regulation, without standards, how do we judge harmless? Irwin Goldstein said
.
Acknowledgements: This article has been professionally reviewed by Zhou Shanjie, Chief Physician of the Center for Reproductive Medicine of Peking University International Hospital
?
Low-intensity extracorporeal shock wave is a "regenerative therapy" for erectile dysfunction (ED) that has spread throughout Europe and the United States in recent years, and is said to restore the youthfulness of blood vessels in key areas
.
"A lot of private clinics, beauty salons, spas are in
the United States.
As soon as they buy a piece of equipment, hire a registered nurse or technician, and men use credit cards to make purchases
.
T.
Mike Hsieh, professor of urology and director of the Center for Men's Health at the University of California, San Diego, said
.
The 2022 European Urological Association (EUA) Guidelines for Sexual and Reproductive Health, the North American Society of Sexual Medicine (SMSNA) Position Statement, and the European Society of Sexual Medicine (ESSM) Clinical Recommendations describe this therapy with some caution
.
EUA information suggests that low-intensity extracorporeal shock waves may be useful in patients with mild vasogenic ED, and several single-arm trials have proven beneficial, but data from prospective randomized trials are conflicting and many questions remain unanswered
.
SMSNA and ESSM said they lacked reliable evidence, and the treatment effect and potential risks were unknown
.
Mayo Clinic urologist Gregory Broderick helped develop the SMSNA position statement
.
He said that shock waves may help specific ED patients, but the current indications are not clear, and there are no normative guidance documents
on what equipment to use, how large the pulse sound intensity should be, and how long the course of treatment.
"It's not Indian god oil, and it doesn't have a divine effect
.
"
Photo caption: An American doctor is administering low-intensity extracorporeal shockwave therapy
to men.
/ Screenshot from ABC News
How does the shockwave shake come to life?
In early 2018, Stephen Borgese quit his job as an emergency physician after more than 20 years to open a specialist private practice
in Brynmore, a suburb of Philadelphia.
According to the clinic's official website, only ED patients are served here, and the core treatment method is low-intensity extracorporeal shock wave
.
"We are the first and largest in the region to offer this type of technology
.
"
This is a high-energy two-way sound wave
.
Different from sound waves in the ordinary sense, when the shock wave propagates in the medium, it will cause pressure changes and release energy, resulting in a series of biological effects
in the target organ tissue.
It has a long
history of medical use.
EUA information shows that this technology has long been used to treat kidney stones, arthritis, etc
.
Around the 2010s, studies have found that at lower intensities, shock waves may unblock penile blood vessels, improve blood supply, and rejuvenate patients
.
Like PDE5 inhibitors such as "Viagra", it acts on cavernous bodies, smooth muscle cells, etc
.
The difference is that shock waves can promote the regeneration of penile cavernous nerves, vascular endothelium, smooth muscle, etc
.
, and repair physiological defects or lesions.
This is also the origin of its so-called "regenerative therapy
".
About 1 year after the clinic opened, Stephen Borgese has administered shockwave therapy
to more than 700 men.
A single treatment takes about 10 minutes, and the device probe needs to be attached to each part
of the external genitalia.
According to his statement, in order to be effective, do at least 1 time a week, 12 times for 1 course of treatment, a total of 3,000 US dollars (about 22,000 yuan).
Stephen Borgese said shockwave therapy is safe and effective
.
About 40% of patients can get rid of oral medication after treatment and applaud
as much as they want.
Another 40% of patients were already resistant to drugs, but after treatment and re-medication, the job was ready to use
.
"For years, medical professionals have been looking for a cure
for ED.
Taking medicine and injections only masks the symptoms
.
Shockwaves are not the same, it can cure the root cause
.
In April 2019, registered nurse Helena Milliner said that she joined Infinity, a medical spa clinic specializing in laser hair removal and facial care, to carry out shockwave treatment
.
She described it as a revolutionary "no pill, no surgery, non-invasive" sexual health service
.
Shockwaves have been introduced to China
.
In recent years, a number of people with the identity of "andrologists of third-class hospitals" have posted on the doctor-patient communication platform, saying that their hospitals have introduced relevant technologies and have been used abroad for more than ten years without adverse reports
.
The "Guidelines for the Diagnosis and Treatment of Andrology Diseases in China and Expert Consensus (2016)" compiled by the Andrology Branch of the Chinese Medical Association said that it "is becoming a new treatment
for ED.
" Photo
caption: Stephen Borgese inside his clinic
.
As one of the world's most authoritative sexual medicine organizations, SMSNA has issued two position statements on the clinical use of shock waves in 2019 and 2021
。 Its contents show that low-intensity extracorporeal shock waves are "promising" and there is evidence that it is safe
to use within the scope of studies.
However, the results of the study are controversial and are currently only available to patients
enrolled in clinical trials.
High-quality evidence such as multicentre randomization and double-blinding is needed in the future
.
According to the clinical recommendations issued by ESSM in January 2020, up to that time, there were 11 shockwave RCTs and 5 meta-analyses, with high heterogeneity, low enrollment, and high risk of bias
.
Some studies believe that shock waves are statistically significant in patients with mild and severe ED; Some propose to cooperate with PDE5 inhibitors; There have also been reports of improvement with mild ED+ PDE5 inhibitors +
shockwaves.
The duration of efficacy in different studies varies, some are effective 1-3 months after the completion of treatment, and some are still meaningful
after 5 years of treatment.
"Limited to research
.
The U.
S.
FDA has not approved it for clinical use
.
The shockwave treatments that men can access are all over-label
.
In May 2022, AUA's journal Urological Practice published "Shockwave Therapy for ED: Marketing and Practice Trends in Major Large U.
S
.
Cities.
"
Shock waves are more recognized in Europe
.
In 2013, the EUA developed ED guidelines as an alternative first-line treatment
.
The 2022 sexual and reproductive health guidelines states: "Low-intensity shockwave therapy
is used in patients with mild vascular ED and those with vascular ED who do not respond well to PDE5 inhibitors.
" Alternatively, it may be used as an alternative to first-line therapy for those who do not wish or are candidates for oral vasoactive therapy
, or who are well-informed and wish for a cure.
Notably
, the evidence for this recommendation is rated 'weak'
.
Vascular ED is a subdivision type, accounting for about 80%
of all patients with ED.
Insufficiency of penile arterial or venous blood supply in these patients is manifested by the disappearance of penile erection at night and poor response to intracavernous injection of
vasoactive substances.
Depending on the etiology, ED also includes neurological, anatomical, endocrine, drug-inducing, and psychological
.
"We investigateIt was found that shockwave therapy had long since departed from the society's recommendations
.
Sriram V.
Eleswarapu, author of the aforementioned AUA article, said in an interview that some fundamental problems have not been solved
.
Sriram V.
Eleswarapu and his team conducted surveys
in 8 large cities in the United States.
It was found that 75% of those who provided shockwave therapy were not urologists and sexual medicine doctors, but dermatologists, orthopedics, obstetrician-gynecologists, nurses, etc
.
They are unable to accurately assess the condition before treatment and cannot make effective diagnoses and recommendations
.
Second, treatment lacks standardization
.
A 2019 retrospective meta-analysis showed that the most common course of shockwave therapy was twice weekly for 3 weeks, followed by a break of 3 weeks, followed by twice-weekly treatment for 3 weeks
.
The AUA article found that the most commonly used by various medical institutions is 1 time per week, and 6 times is 1 course of treatment
.
When I arrived at the beauty salon and spa, the treatment was changed
again.
According to Helena Milliner's medical spa, a registered nurse, shockwaves are like facials that can be done once or all the time
.
Thirdly, "do what you want" is also reflected in equipment selection, pulse sound intensity setting and other links
.
The SMSNA statement said that shock waves are divided into focusing type, radial type, etc
.
according to the working principle.
The latter is less expensive and more widely used
.
Its energy coverage area is larger, but the depth of penetration is limited
.
Basic clinical studies have shown that the radial type is not as good as the focused type in inducing tissue healing and improving erection
.
Christopher Love, an Australian urologist who has been practicing medicine for nearly 40 years, demonstrates extracorporeal low-intensity shockwave therapy
at the clinic named after him.
Credit: Dr.
Love Clinic
, Do Men Need to Do It?
"Male hemorrhoids have a long
history.
So far, no panacea
has been found.
Irwin Goldstein, director of the Center for Sexual Medicine at Alvarado Hospital in San Diego, pointed out
.
After the appearance of the blue pill Viagra (Viagra), the guidelines of European and American urology and sexual medicine related societies pointed out that the preferred way to treat ED is oral PDE5 inhibitors, and the evidence level is "strong"
.
But drugs are not effective
per person.
"Do the second monk hit the bell" type of medication, or it is difficult to achieve an effective therapeutic dose
.
Long-term continuous eating, expensive and may increase the risk of
adverse reactions.
Ranjith Ramasamy, assistant professor and director of the Department of Genitourinary Urology at the University of Miami, said that treatment methods have their own shortcomings
.
"Intracavernous injections can be performed a few minutes before sex, and the difficulty is to needle yourself that job, but also to stick it in a specific area
.
Prostheses are expensive, narrow in scope of application, and more niche
.
Marsh
, a massage therapist, started "not tough" in his 40s and has been in his 40s for 14 years
.
He tried a variety of methods with poor
results.
"I'm tall, healthy, and I don't have chronic diseases, just getting worse
.
My wife, who has been married for many years, expressed understanding, but I was uneasy and afraid
.
Having a normal sex life is not just about bed
.
Zhou
Shanjie, deputy chief physician of the Center for Reproductive Medicine at Peking University International Hospital, told the "medical community" that men are dissatisfied with the treatment effect for various
reasons.
Most people are because of treatment options
.
Some have a mismatch
between the effect and the expected value.
China's "Guidelines for the Diagnosis and Treatment of Penile Erectile Dysfunction" shows that the overall effective rate of PDE5 inhibitors is 80%.
Patients who do not respond to oral drugs are injected with intracavernous vasoactive drugs, and the effective rate can reach 85%.
The effectiveness of vacuum erection devices against ED of various etiologies ranges from
27% to 94%.
The effectiveness of shock waves is not surprisingly
good.
EUA reproductive guidelines show that the proportion of treated and satisfied patients ranges from 40% to 80%.
It is not possible to define "satisfactory" because few studies have focused on objective indicators
such as post-treatment penile haemodynamic parameters.
In July 2022, the Journal of Urology published an article saying that men with moderate ED can achieve clinically meaningful improvement
with shockwave therapy.
The evaluation endpoint was an increase in erection scores and an increase
in the number of clappings for love.
"There will always be resistance
to new therapies.
Previously, no one believed that laparoscopic kidneys could be removed and robots could complete prostatectomy, but now this is the norm
.
Urologist Bruce Sloane also performs shockwave therapy for $5,000 for 12 sessions
.
Sometimes, he resorts to another innovative "regenerative therapy," platelet-rich plasma cavernous body injections (PRP) for a single charge of $
1,500.
SMSNA, EUA, etc.
have all stated that PRP is limited to clinical trial settings
.
Bruce Sloane will be candid with men that shockwave therapy is not FDA-approved, is experimental and may not work, but certainly has no serious side effects
.
He noted that men need 5 things to get an erection: blood flow, nerve function, hormones, stimulation, and relaxation
.
"Regenerative therapy" can solve the first two problems
.
In order to regain their strength, men are willing to try everything
.
It's about personal value
.
"Should patients do what they need to do? As a doctor, it is a basic guideline
that treatment is harmless.
But without regulation, without standards, how do we judge harmless? Irwin Goldstein said
.
Acknowledgements: This article has been professionally reviewed by Zhou Shanjie, Chief Physician of the Center for Reproductive Medicine of Peking University International Hospital
Resources:
[1] The'Ugly Side'of ED Care:Sex Medicine Docs Warn of'Restorative'Therapies.
Medpage Today
[2] Restorative Therapies for Erectile Dysfunction:Position Statement From the Sexual Medicine Society of North America(SMSNA).
Sex Med.
2021 Jun; 9(3):100343.
doi:10.
1016/j.
esxm.
2021.
100343.
[3] Shockwave Therapy for Erectile Dysfunction:Does It Work?.
Healthline
[4]'Restorative'treatments for erectile dysfunction aren't proven to work.
Men pay thousands anyway.
Medical Xpress
[5] Shock Wave Therapy for Erectile Dysfunction:Marketing and Practice Trends in Major Metropolitan Areas in the United States.
Urology Pratice.
doi.
org/10.
1097/UPJ.
0000000000000299
[6] Guidelines and expert consensus on the diagnosis and treatment of andrological diseases in China (2016).
Andrology Branch of Chinese Medical Association
