Change in Peak Systolic Velocity of Cavernous Artery in Response to Low Intensity Shock Waves Therapy in Diabetic Polyneuropathy Patients with Erectile Dysfunction: A Randomized Controlled Trial

Journal of Environmental Treatment Techniques

2020, Volume 8, Issue 4, Pages: 1434-1438

J. Environ. Treat. Tech.

ISSN: 2309-1185

Journal web link: http://www.jett.dormaj.com

https://doi.org/10.47277/JETT/8(4)1438

Change in Peak Systolic Velocity of Cavernous

Artery in Response to Low Intensity Shock Waves

Therapy in Diabetic Polyneuropathy Patients with

Erectile Dysfunction: A Randomized Controlled

Trial

Abdelrazak A Ahmed *, Wael S Shendy , Moataz M Elsemary , Mahmoud S Asal , Omar M

Elsoghier ³

Department of Physical Therapy for neuromuscular Disorders and their Surgeries, Faculty for Physical Therapy, South valley University, Egypt

Department of Basic Science, Faculty for Physical Therapy, South valley University, Egypt

Department of Urolog, Faculty of Medicine,South valley University Egypt

Received: 06/01/2020

Accepted: 13/04/2020

Published: 20/09/2020

Abstract

Although several reports have documented the subjective improvement of erectile function after low-intensity extracorporeal

shockwave therapy (LI-ESWT) in patients with vasculogenic erectile dysfunction (ED), objective assessment data of penile

hemodynamics are lacking. The aim of this research is to detect the Change in peak systolic velocity of cavernous artery in response to

low intensity shock waves therapy in diabetic patients with erectile dysfunction. This study is a randomized controlled trial. Overall

forty male individuals with mean age (48.6±5.52 years)who have erectile dysfunction after diabetes were equally divided into two

separate groups. 1st Group received low intensity extracorporeal shock wave therapy (ESWT). 2nd Group received shame therapy by

put head of shock wave while machine is turned off. 1st Group received low intensity extracorporeal shock wave with the following

parameters: - 3000 SWs (energy intensity of 0.09mJ/mm2) to each of five different sites of application: three areas along the penile

shaft and two areas at the crural level for six weeks as a total period of treatment. Measurements of peak systolic velocity by penile

duplex were performed before the treatment and after 3months. There were change in peak systolic velocity of the right and left

cavernous arteries were low at baseline, indicating arterial insufficiency. After treatment, PSV significantly in the two groups;

however, the post-treatment PSV was significantly higher in the SW group compared to the PFE group (p < 0.001, for both

arteries).LIESWT is lead to significant changes in patients suffering from erectile dysfunction after diabetes as evidenced by increase

in the peak systolic volume of the both right and left cavernous arteries of the shock wave group.

Keywords: Peak systolic velocity, Low intensity shock wave therapy, Erectile Dysfunction and Diabetic patients

primary hemodynamic events controlled by the central or

Introduction¹

peripheral neural networks that promote an erectile response

will impair erectile function so both the endothelium-

dependent and neural mechanisms that mediate relaxation of

the smooth muscle of the corpus cavernosa impaired in

diabetic patients with ED[4].ED is one of the most-frequent

complications of diabetes mellitus (DM), which leads to a

marked decrease in the quality of life and is usually treatment

is difficult because of a combination of microangiopathy and

peripheral diabetic neuropathy, which adversely affect the

mechanism of erection[5].ED in men with diabetes has also

been associated with increased age, poor glycemic control,

smoking, increased alcohol intake, depression, use of specific

type of medications and micro-vascular diabetic

complications[6].It has been proven that ED and coronary

artery disease (CAD) share pathways. Endothelial dysfunction

is one of the basic mechanisms has effect in the

pathophysiology of vasulogenic ED, which develops as a

result of decrease in the synthesis and bioavailability of nitric

oxide (NO) and subsequent atherosclerosis. Atherosclerosis

leads to an impairment of the blood flow required for normal

erection [7].Chronic progressive impotence related directly to

Erectile dysfunction (ED) is defined as the continuous

inability to obtain and maintain an erection sufficient to allow

satisfactory sexual intercourse. Although ED is a benign

disorder, it may affect physical and psychosocial health and

may have a significant impact on the quality of life (QoL) of

sufferers and their partners [1].According to the underlying

causes, ED can be classified as psychogical, endocrinological,

neurological, and vascular. Vascular erectile dysfunction (ED)

is defined as inability to obtain or keep an erection firm

enough for sexual performance due to diseases such as

diabetes mellitus and atherosclerotic vascular occlusive

disease [2].The onset of ED usually occurred within the first

0 years of diagnosis of type 1 and type 2diabetes in > 50% of

men affected by ED[3].The etiology of ED in diabetic patients

can be vascular or neurogenic and any disruption of the

Corresponding author: Abdelrazak Abdelnaeim Ahmed

Mahmoud,Assistant Lecturer at the Department of Physical Therapy

for Neuromuscular Disorders and their Surgeries, Faculty for Physical

Therapy,

South

valley

University.Address:

Qena,

Egypt.Email:dr_abdelrzak_pt@yahoo.com

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Journal of Environmental Treatment Techniques

2020, Volume 8, Issue 4, Pages: 1434-1438

diabetes is the most frequent form. This form of impotence

occurs years after the diagnosis of the patient. This form is

progressive, irreversible and is accepted as a natural result

any time. The patients were randomly assigned into 2 equal

groups (control group and study group) with the use of a

computer-based randomization program. No subject dropped

out from the study after randomization. The patients were

blinded about which group they were allocated.

(neuropathic, vascular or both) of the diabetes [8].Patients

with diabetic and neuropathic ED have been noted to have

similar frequencies of somatic and autonomic neuropathies,

suggesting that neuropathy contributes significantly to

diabetic ED [9].Low-intensity extracorporeal SW therapy (Li-

ESWT) was used both in vitro and in vivo studies and the

results shown that shock wave energy can stimulate

angiogenesis. The idea of application of Li-ESWT to the penis

came from animal studies in which Li-ESWT was applied to

the myocardium of pigs, where it has been found that there

was an improvement in ischemia that induced myocardial

dysfunction [10].Low-intensity extracorporeal SW therapy

2.6 Ethical approval

The research has complied with all the relevant national

regulations and institutional policies and has followed the

tenets of the Declaration of Helsinki and the Consolidated

Standards of Reporting Trials and has been approved by the

institutional review board at Faculty of Physical Therapy,

Cairo University. No.P.T.REC/012/001983.

.7 Procedures

(LIESWT) of the penis would improve penile blood flow and

.7.1 Assessment device

endothelial function by stimulating angiogenesis in the

corpora [11]Consequently, it will be of importance to do a

randomized controlled trial using valid and reliable measures

to investigate the effect of Li-ESWT in treatment of erectile

function in diabetic polyneuropathic patients.

The equipment used in the measurement on this research

was the Penile color-coded duplex scanning machine

ultrasound with 8.4MHZ linear vascular probe (VF 15-3

trasducer, ACSON X 300 SIEMENS ultrasound) that used to

get an unbiased assessment of the penile haemodynamics.

(

Materials and Methods

2.7.2 Treatment devices

.1 Design of the study

The therapeutic equipment and tools used on this research

were Shock wave device; ESWT device (MASTERPULS

MP200, StorzMedical, Tägerwilen, Switzerland),

The study was designed as a prospective, randomized,

controlled trial. It was performed between July2018 and

January 2020.

.3 Procedures

.2 Participants

3.3.1 Assessment procedures

The study was carried out on forty outpatient male

Penile color-coded duplex scanning (Color-coded Duplex

individuals with mean age (48.6±5.52 years) who have

erectile dysfunction after diabetes. Their age was ranging

from 35 to 60 years. They were selected from South valley

University hospitals. The body mass index (BMI) of those

individuals not more than 32they were diagnosed with type 2

diabetes with secondary complication of erectile dysfunction.

These individuals reported no other pathological conditions

lead to erectile dysfunction. They showed the necessary

cooperation needed to enable the investigator to secure the

required data. Patients were equally divided into two separate

groups. 1st Group (the study group) received the low intensity

extracorporeal shock wave therapy (ESWT). 2nd Group

scanner Transducer: 5-10 MHz)

- Patient’s position: supine

- Probe position: placed on the back of the penis

- Transversal scanning to assess the echo structure and

dimensions of the cavernous bodies.

- Longitudinal scanning to identify the cavernous arteries,

their patency and their hemodynamic through these

parameters. (I) Peak systolic volume for right cavernous

artery and (II) peak systolic volume for left cavernous artery.

Treatment Procedure: The 1st group received low intensity

shock wave while the 2nd group received shame therapy.

Shock wave therapy application:The patient was placed in

supine lying position receive low intensity extracorporeal

shock wave with the following parameters: - 3000 SWs

(energy intensity of 0.09 mJ/mm2) to each of five different

areas: three along the shaft of penis and two at the crural level

[12].The protocol consists of 6 treatment sessions, once per

week. The shock waves delivered through the applicator

covering the corpora cavernosa of the penis along the penile

shaft and the crura.Before the experiment, recording of the

peak systolic velocity of right and left cavernous arteries for

every individual were done in both groups. Treatment of

ESWT application was applied one session every week for six

weeks after which the second (final) penile duplex parameter

(PSV) recording was taken. The pre and post experimental

measurements were performed during the same time of the

day to decrease the variability. The step-by-step procedure for

data recording was identical to that followed during pre-

experimental measurement of the penile duplex parameter

(peak systolic velocity) taken before the treatment as an initial

record and then after six weeks as a second last record in the

two groups.

(control group) received only shame therapy.

.3 Inclusive criteria

All patients had the following characteristics; their ages

ranged between 35 and 60years, they had the body mass index

BMI) of those individuals not more than 32 they were

(

diagnosed with type 2 diabetes with secondary complication

of erectile dysfunctionthe diagnosis was confirmed by using

penile duplex. All patients take their medications described by

their andrologyist physicians.

.4 Exclusive criteria

Patients with a history of past radical prostatectomy or

extensive pelvic surgery, recovering from cancer in the past 5

years, any unstable medical, psychiatric disorder, spinal cord

injury and another neurological disease, penile anatomical

abnormalities, clinically significant chronic hematological

disease, patients with untreated hypogonadism and

cardiovascular conditions that prevent sexual activity (heart

attack, stroke or life-threatening arrhythmia within the

previous 6 months were excluded.

.5 Randomization

Every individual was informed about the nature, purpose,

benefits of the research and their right to withdraw or refuse at

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2020, Volume 8, Issue 4, Pages: 1434-1438

allstatistical testes was set at P < 0.05. with using the

statistical package for social studies (SPSS) version 23 and

window ( IBM SPSS, CHICAGO IL USA) for data analysis.

.3.3 Informed consent

Informed consent has been obtained from all individuals

included in this study

Results

.1 Demographic characteristics

Table 1 showed demographic characteristics of both

groups. There was no significant difference between both

groups in the mean age, weight, height and body mass index

(

p<0.05). The mean values of peak systolic velocity for right

Figure 1: Application of shock wave therapy (Faculty of physical

therapy south valley university2019)

and left cavernousarteriesshowed a statistically significant

improvement (p < 0.05) With in both groups (A and B). The

post-treatment comparison of both groups revealed

statistically significant increase in the mean values of peak

systolic velocity for right and cavernousarteries in favor of

group (A) (Table 2).

Discussion

This study demonstrated the positive effect of Li-ESWT

on erectile function in patients with ED caused by diabetic

polyneuropathy three months after treatment. Li-ESWT

induced a significant increase of of penile hemodynamics,

evidenced by a significant rise of PSV. Generally, the

treatment was safe and well-tolerated, with no serious adverse

events.In the current study, all patients were confirmed to

have diabetic polyneuropathy. Doppler assessment before

treatment indicated arterial insufficiency (a PSV < 25 cm/s) in

less than half of the patients.This observation indicates that

neurogenic, rather than a vasculogenic element, is operating

as a cause of ED in the current series. In fact, DM-related ED

Figure 2: Application of shock wave therapy (Faculty of physical

therapy south valley university 2019)

.3.2 Statistical analysis

Data collected were admitted into a personal computer to

analyze the statistics; the statistical analysis was conducted by

using t-test to compare the patient characteristics of both

groups. TheShapiro-wilk test revealed that the data were

normally distributed for all dependant variables.Levrne,s test

was conducted to test the homogeneity between groups. To

compare the mean values of peak systolic velocity between

both groups and before and after the treatment in both groups

use paired t test. Level of significance of significance for

a multifactorial process that involves vascular and

neurogenic causes in addition to endothelial dysfunction and

nitric-oxide system disturbance [13]. However, diabetic

neuropathy is believed to be a major contributing factor in the

mechanism of ED in patients with type-2 DM [14].

Table 1: Participants characteristics

Study group

±SD

Control group

x±SD

t- value

p- value

Age (years)

48.6±5.52

84.52±8.98

167.53±3.58

25.2±2.46

47.5+5.68

85.4±8.89

169.8±6.73

26.2±2.46

0.56

0.080

0.814

0.232

0.993

0.937

0.355

0.827

Weight (kg)

Height (cm)

Body mass indexkg/m

Mean; SD, Standard deviation; p-value, Level of significance.

Table 2: Mean peak systolic velocity for right and left cavernous arteries for patient’s pre and post treatment of both groups

Pre treatment

Study group

Post treatment

Study group

Control group

±SD

Control group

±SD

x̅ ±SD

P value

±SD

P value

PSV OF

RTcavernous

artery cm/sec

PSV OF

26.58+6.94

26.2+6.06

0.989

36.24+6.76

26.7+5.70

0.001*

LTcavernous

25.59+6.65

26.60+5.75

0.896

34.80+6.53

26.38+5.68

0.001*

artery cm/sec

푋: Mean, SD: Standard deviation, PSV: peak systolic velocity, level of significance:* Significant

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Journal of Environmental Treatment Techniques

2020, Volume 8, Issue 4, Pages: 1434-1438

The neurogenic element in DM exerts its effect by

inefficient nerve signaling to the corpora cavernosa. This

functional alteration results in the reduction in nitric oxide

patients increase peak systolic velocities of right and left

cavernous arteries which result in improved erectile

functions.

(NO) load in the smooth muscles [15]. The mechanism of

action of Li-ESWT is still hypothetical. Physically,

shockwaves exert two effects, mechanical stress due to

exposure to highpeak pressure waves and cavitations bubbles

formed in liquids. These bubbles result from the vaporization

of theliquid. Consequently, these cavities collapse when

exposed to highpressure causing local trauma and

neovascularization[16]. In vitro and in vivo studies confirmed

the process of neovascularization in response to shockwave,

which is believed to be a principal therapeutic mechanism in

the treatment of ED[17]. Other mechanisms are hypothesized,

including NO induction [18], nerve regeneration, andstem cell

proliferation[19]. In diabetic rat mode, Li-ESWT was found to

affect penile neural tissue with the enhancement of neuronal

NO synthase positive cells[20].Tepekoylu C et al. [21]found

that low-intensity SW has shear stress and induces changes in

membrane permeability, which leads to activation of signaling

cascades, thus, improve angiogenesis,modulation of the

inflammatory response,release of nitric oxide,and targeting of

endothelial progenitor cells and stem cells to the active

organs. Fode, M et al. [22] stated that two proposed

mechanisms whereby LIESWT improve erectile function:

Shear stress and endothelium disruption by growth and

implosion of cavitations bubbles in the vessels, which result in

neo angiogenesis and endothelial and neuronal nitric oxide

synthesisSchuh et al. [23] investigated the effects of ex

vivoshockwave treatment of nerves on subsequent Schwann

cell cultures from these nerves and found consistently higher

purity, proliferation rate, and expression of regenerative

phenotype-associated markers (p75 neurotrophic factor

receptor, glial fibrillary acidic protein, c-Jun) in pretreated

Schwann cell cultures. Hence, these studies suggest an effect

of shockwave therapy on nerve regeneration, which could be

established by supporting Schwann cell proliferation.Assaly

R, et al., [24] stated that the effect of LIST on EF was

examined in an animal model. Shock wave therapyenhance

nerve stimulated erection in diabetic rats, increase the smooth

muscle- collagen ratio, increased the endothelial content of

penile tissue and up-regulated the expression of growth

factors. Qiu, X et al. [25]. Found that LIESWT are good for

penile tissue regenerating by mesenchymal stem cells

activation andnerve regeneration (via Schwann cells

activation), and vessels, with the consequent release of pro-

angiogenetic growth factors. In addition, LIESWT also

enhance erectile function via nitric oxide/cGMP-

nondependent mechanisms.Rizk et al. [26]included

randomized controlled trials, meta-analyses, and select single-

arm studies on the use of Li-ESWT in the treatment of at least

mild ED, with some data supporting efficacy in moderate-to-

severe ED also demonstrated some benefit in specific subsets

of men with vasculogenic ED (including patients with DM).

Kalyvianakis et al. [27] assessed the efficacy and safety of 6-

and 12-treatment sessions within a 6-week treatment period

and also investigated the effect of repeat treatment after a 6-

month period in a 2-phase study in patients with vasculogenic

ED. The results demonstrated that re-treating patients after 6

Months could further improve EF without side effects. In

addition, it was demonstrated that 12 sessions can be

delivered within 6 weeks without a 3-week break period with

similar clinical outcome. After discussion of the results and

according to reports of the previous investigators in fields

related to this study, it can be claimed that the application of

LI-ESWT in erectile dysfunction in diabetic polyneuropahty

Limitations

The study was limited by emotional state of the patients,

and the psychological condition of the patients at the time of

performance which might affect the results, also, other

limitation are small sample size and possible errors in

measuring penile haemodynamics. So, more extensive studies

assigning the efficacy of ESWT on the erectile function in

diabetic polyneuropathy patients with larger sample are

needed. Follow-up studies would be of great interest to detect

the long-term effect of ESWT and the recurrence of erectile

dysfunction.

Conclusion

Application of ESWT in erectile dysfunction in diabetic

patients improve peak systolic velocity for both right and left

cavernous arteries. This study demonstrated that using the

ESWT is beneficial in treating diabetic patients suffering from

erectile dysfunction by improving peak systolic velocity in

right and left cavernous arteries.

Acknowledgment

We would like to represent our gratitude to our patients

for participation in this study.

Ethical issue

Authors are aware of, and comply with, best practice in

publication ethics specifically with regard to authorship

(avoidance of guest authorship), dual submission,

manipulation of figures, competing interests and compliance

with policies on research ethics. Authors adhere to publication

requirements that submitted work is original and has not been

published elsewhere in any language.

Competing interests

The present study was performed in absence of any

conflict of interest which was declared by the authors.

Authors’ contribution

AA, WS, ME, OE and MS conceived of the study,

designed the study protocol and drafted the manuscript. WE

are the corresponding author and supervisor of the research.

AA helped us in drafting the revised manuscript and

substantively helped us to revise the manuscript. All authors

have reviewed the final version of the manuscript and approve

it for publication.

Disclosure statement

No author has any financial interest or received any

financial benefit from this research.

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