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Radiofrequency energy in the treatment of erectile dysfunction – a novel cohort pilot study on safety, applicability, and short-term efficacy



Collagen is an essential component of the structures involved in the erectile mechanism and as such, impaired collagen may hinder it. Because Radiofrequency (RF) energy has been shown to renew and restore spatial structural arrangement of collagen fibers, treatment of ED with RF could lead to anatomical and physiological changes at the penile tissue level and could lead to improvement in the erectile mechanism. We conducted this study to assess the effect of RF treatment on erection quality. We evaluated the safety, applicability, and efficacy of a self-applied, handheld, low-intensity radiofrequency device (Vertica®) in men with moderate and mild-to-moderate organic ED. The treatment protocol consisted of 12 treatments (twice a week during the 1st month, and once a week during the 2nd month), each participant treated himself individually. Treatment outcomes were evaluated using the International Index of Erectile Function (IIEF-15), Erection Hardness Scale (EHS), Erectile Dysfunction Index of Treatment Satisfaction (EDITS), Benefit, Satisfaction & Willingness to continue (BSW), Quality of Erection Questionnaire (QEQ), Sexual Quality of Life (SQOL) questionnaires and specific questions addressing side-effects and ease of use. Twenty-eight out of 32 men (mean age 59.5.7 ± 9.8, range: 41-78y) completed a one-month follow-up after treatment. Mean IIEF-15 (43.7. ±7.8 vs 60.9 ± 10.8, p < 0.01), IIEF-Erection Function domain (IIEF-EF) (16.8 ± 3.1 vs. 24.4 ± 4.4, p < 0.001), and EHS scores (2.2 ± 0.8 vs. 3.2 ± 0.5, p = 0.01) were all significantly improved. Fifty percent of patients achieved normal EF parameters (IIEF-EF score ≥ 25). High mean scores were achieved in the EDITS (76.8 ± 20.3), BSW (4.83 ± 1.1), QEQ (73.4 ± 23.8), and SQOL (67 ± 29.4) questionnaires. No side effects were reported and participants rated the device as very comfortable, simple, and easy to operate.
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Radiofrequency energy in the treatment of erectile
dysfunction a novel cohort pilot study on safety,
applicability, and short-term ecacy
Ilan Gruenwald ( )
Boaz Appel
Arik Shechter
Rambam Healthcare Campus
Alexander Greestein
Keywords: Radiofrequency, erectile dysfunction, treatment, home-use
Posted Date: February 6th, 2023
License: This work is licensed under a Creative Commons Attribution 4.0 International License.
Read Full License
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Collagen is an essential component of the structures involved in the erectile mechanism and as such,
impaired collagen may hinder it. Because Radiofrequency (RF) energy has been shown to renew and
restore spatial structural arrangement of collagen bers, treatment of ED with RF could lead to
anatomical and physiological changes at the penile tissue level and could lead to improvement in the
erectile mechanism. We conducted this study to assess the effect of RF treatment on erection quality. We
evaluated the safety, applicability, and ecacy of a self-applied, handheld, low-intensity radiofrequency
device (Vertica®) in men with moderate and mild-to-moderate organic ED. The treatment protocol
consisted of 12 treatments (twice a week during the 1st month, and once a week during the 2nd month),
each participant treated himself individually. Treatment outcomes were evaluated using the International
Index of Erectile Function (IIEF-15), Erection Hardness Scale (EHS), Erectile Dysfunction Index of
Treatment Satisfaction (EDITS), Benet, Satisfaction & Willingness to continue (BSW), Quality of Erection
Questionnaire (QEQ), Sexual Quality of Life (SQOL) questionnaires and specic questions addressing
side-effects and ease of use. Twenty-eight out of 32 men (mean age 59.5.7 ± 9.8, range: 41-78y)
completed a one-month follow-up after treatment. Mean IIEF-15 (43.7. ±7.8 vs 60.9 ± 10.8, p < 0.01), IIEF-
Erection Function domain (IIEF-EF) (16.8 ± 3.1 vs. 24.4 ± 4.4, p < 0.001), and EHS scores (2.2 ± 0.8 vs. 3.2 
± 0.5, p = 0.01) were all signicantly improved. Fifty percent of patients achieved normal EF parameters
(IIEF-EF score  25). High mean scores were achieved in the EDITS (76.8 ± 20.3), BSW (4.83 ± 1.1), QEQ
(73.4 ± 23.8), and SQOL (67 ± 29.4) questionnaires. No side effects were reported and participants rated
the device as very comfortable, simple, and easy to operate.
Erectile dysfunction (ED) is dened as the consistent or recurrent inability to attain and/or maintain a
penile erection sucient for sexual satisfaction[1]. The worldwide prevalence of ED is estimated to be up
to about 80% in adults, and increases with age [2].
The quest for an ED treatment modality that would provide a rehabilitative or curative impact for ED and
would put an end to coupling the treatment to sexual activity is still ongoing. Most contemporary
treatments (e.g., oral medications, intracorporal injections, or use of a vacuum-constriction device) require
timing treatment before any expected sexual activity, negatively affecting the spontaneity of any sexual
activity and leading to a less satisfying relationship [3].
In the recent years, applying external energy to the penis emerged as a new concept of treatment to
improve erection quality. Such treatment is not applied prior to sexual activity, and therefore eliminates
the need to time and schedule ahead the use of medications before sexual activity and intercourse,
consequently restoring spontaneity to sex life. Low-Intensity Shockwave Therapy (LI-ESWT) which results
in micro-anatomical and physiological changes at the level of the cavernosal tissue is one form of such
treatment modality [4]. Radiofrequency (RF) energy has been shown to renew collagen and to restore their
spatial structural arrangement in various tissue bers due to its heating effect [5]. Collagen layers are
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present abundantly in the tunica albuginea (TA), and in the corpora cavernosa. We hypothesise that
applying RF to penile tissues may trigger remodeling of the collagen in those tissues that are involved in
the erectile mechanism. In addition, hyperthermia may promote upregulation of nitric oxide synthase
involved in the erectile mechanism.[6] These mechanisms triggered by RF may act synergistically to
improve the quality of erection. We conducted our study to evaluate the safety, applicability, and ecacy
of a self-applied RF handheld device for the treatment of ED.
Study population:
Men 40–85 years old with mild or mild-to-moderate organic ED (IIEF-EF scores between11-20) with an ED
duration of 6 months and a stable relationship for at least three months comprised the study population.
The diagnosis of organic ED was based on a medical and sexual history. The study protocol was
reviewed and approved by the local institutional review board and each participant gave his written
informed consent to participate in this study.
Patients using phosphodiesterase type 5 inhibitors (PDE5i) treatment were not excluded and were
instructed to adhere to their routine pattern of treatment during the whole study period. Excluded were
men with any penile dermatologic disease or lesion, micropenis, history of penile carcinoma, penile
piercing, penile prosthesis, Peyronie’s disease, documented urethral stricture, sensory disorders, and any
known allergy to aqueous gel.
Device: The Vertica® (Ohhmed, Israel), is a computerized hand-held device that generates pulses of RF
energy delivered at a frequency of 1Mhz. into the penis via 3 couples of electrodes, creating an internal
thermal heating effect. (Photo 1). The temperature in the corpora cavernosa and the surrounding TA
reaches 41–43ºC. The level of energy is fully controlled by the patient, increasing, or decreasing it via the
+ and - buttons on the control panel of the device (Photo 2) according to the heat sensation on the penis.
The Vertica® (Ohhmed, Tiberius, Israel) consists of two parts. One is a handheld ring into which the penis
is placed. The ring component contains a circle of electrodes that deliver the RF energy in a
predetermined digitally revolving order to the corpora cavernosa, encompassing the penis without
covering the urethra or the neurovascular bundle area, as the electrodes in the these areas (12 and six
o'clock) are inactive and do not deliver RF energy, The second part is a pad that contains 3 electrodes that
are used for RF energy delivery and is placed at the perineal area, covering the crural region of the penis
while sparing the urethral area (Photo 3).
As a safety measure, all the electrodes have a built-in thermistor that is set to immediately stop the
energy discharge whenever the skin temperature level on the skin reaches 40ºC. As an additional safety
measure in order to deliver the RF energy, the patient is required to press the "treatment" button
continuously for operating the device, thus in any situation in which the patient feels any discomfort, he
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can immediately shut the energy delivery off by simply removing the nger from the "treatment" button
(Photo 2).
The study was conducted between 2018–2019. Patients attending the neuro-urology unit complaining of
ED were recruited. None of them received incentives of any form. The device was supplied by the
manufacturer (Ohhmed, Tiberius, Israel). All men received a short explanation on the operation of the
device. After applying an aqua gel on the penile shaft, the penis is placed into the electrode ring of the
handheld piece and the perineal electrode pad is placed at the perineal area. During the treatment
session, to cover the whole penile pendulous part, the patient slowly slides the Vertica® from the base of
the penis, along the shaft to the distal part (the corona sulcus line), applying the preferred intensity of RF
by self-controlling the heat level at the penis. Each treatment session starts with the lowest intensity level
and the patient then gradually increases it until he reaches his individually comfortable heat intensity.
Each participant treated himself individually with the Vertica® device at the Neuro-Urology unit, Rambam
Medical Center, initially under the guidance of the investigator until complete adequate operation by the
patient was achieved. This took no more than 2 sessions. Treatment protocol was based on the dermal
treatment protocols. The patient was then left alone in a private room for continuing self-treatment. The
treatment protocol consisted of 12 treatments (twice a week during the 1st month, and once a week
during the 2nd month). Each treatment session duration at the clinic was 30 minutes,15 minutes with the
ring part, and additional 15 minutes with both the ring and pad.
Baseline status and outcomes were evaluated before treatment and one month after completion of all 12
treatment sessions, using IIEF-15, IIEF-EF, Erection Hardness Scale (EHS). For evaluation of their status
post treatment, Erectile Dysfunction Index of Treatment Satisfaction (EDITS), Satisfaction Willingness to
continue (BSW), Quality of Erection Questionnaire (QEQ) and Sexual Quality of Life (SQOL)
questionnaires. All questionnaires used in the study were professionally translated to Hebrew. These
questionnaires are accepted and used by the urological community clinical and research tools in Israel.
As outcome measure of success we used the strict criteria for minimal clinical signicant improvement of
quality of erections, dened by the MCID (Minimal Clinical Important Difference) of the IIEF-EF [7]
Specic questions addressing safety and side-effects (pain, fever, burning, discomfort, urinary disorders)
and ease of use were handed each session. The International Prostate Symptom Score (IPSS) was used
to evaluate any possible deleterious effect on micturition. Patients on PDE5i treatment were constantly
and actively followed up for conrming their use of PDE5i during the whole study duration, and all the
evaluations at baseline and at follow-up reected the patients' erectile function while using the
In addition, the rst 10 participants underwent a penile Flow Mediated Dilatation (FMD) study. This is a
modied plethysmography measure at the penile level, done in the accid state. The technique includes a
rapid cessation of a 3–5 minutes’ ischemic period (achieved by using a designated strain gauge). This
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technique aims to assess arterial elasticity representing penile endothelial function and was performed at
baseline and 1 month after the last (12th) treatment [8] [9].
Statistical analysis:
For analysis of sample size for an 80% power with a 5% level of signicance, we used a sample size
calculator for comparing paired differences in IIEF-EF for mean score changes of 4.0 ± 4.0 resulting in a
need for 10 participants. Calculating the sample size assessment for our 28 participants, a power of 95%
was reached.
Descriptive statistics in terms of mean, standard deviation, median and percentage were calculated to all
parameters in the study. Wilcoxon Signed Ranks Test was used to test the differences between IIEF − 15
for IIEF-EF at baseline vs. one-month after ending treatment.
Repeated measure model was demonstrated to test the changes of IIEF-EF at baseline vs. one-month
after ending treatment when controlling for combined treatment, age < 60, age  60 and for ED duration
at 3 categories: <12 months, 18–24 months and > 30 months.
SPSS version 28 was used for all statistical analysis. The statistical signicance level was set as p <
Thirty-two men were recruited. Four of the 32 participants were withdrawn from results analysis due to
protocol violation, not due to side effects related to the treatment: one due to separation from his steady
partner, one due to COVID-19 restrictions, one due to evaluation of a new incidental pathologic nding in
the lungs, and one due to unexpected personal issues necessitating traveling abroad.
Twenty-eight out of 32 men with ED (mean age 59.5 ± 9.8, range: 41-78y), completed the entire treatment
protocol and one-month follow-up. Their average ED duration was 41.4 ± 30.6: range 6 to 120 months.
Overall, a statistically signicant improvement was demonstrated in the IIEF-15 (43.7 ± 7.8 vs 60.9 ± 10.8,
p < 0.01), IIEF-EF (16.8 ± 3.1 vs. 24.4 ± 4.4, p < 0.01). (Table1). Fourteen out of twenty-eight (50%) reached
normal EF parameters (IIEF-EF score 25). only 3 patients did not meet the MCID criteria and were
considered failures.
EHS scores (2.2 ± 0.8 vs. 3.2 ± 0.5, p < 0.001) when comparing baseline parameters to one month after
ending treatment. 25/28 improved their erections according to the IIEF-EF MCID criteria. (Table1). At
baseline, 13 (46.4%) reported an EHS of 3, 8 (28.5%) reported an EHS 2 and 7 (25%) reported EHS 1.
Following treatment,19 (67.8%) reported an EHS of 3, 7 (25%) reported EHS score of 4 and 2 patients
reported and EHS 2 (7.1%). None of the patients reported an EHS of 1, (Graph 1).
Sexual desire domain was the only domain of the IIEF-15 that did not improve signicantly (7.59 ± 1.46
vs. 8.08 ± 1.29; p = 0.23) (Table1).
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Since 8/28 patients were using PDE5is, we compared IIEF-EF scores according to use (n = 8) and non-use
(n = 20) of PDE5Is. Mean IIEF-EF scores increased signicantly in both groups, (fom 17.45 ± 2.64 to 25.1 
± 4.54, p < 0.001), and from (16.29 ± 3.40 to 24.0 ± 4.47 p = 0.005)) respectively, without a statistically
signicant difference between the two groups (p = 0.13) (Graph 2).
When analyzing IIEF-EF scores of the participants according to age groups, the young (< 60) and old (
60) age group. IIEF-EF scores improved signicantly in both age groups (16.47 ± 2.99 to 24.4 ± 5.35; p < 
0.001) and (18.0 ± 2.48 vs. 25.33 ± 3.17, p < 0.001.) respectively, Without a statistically signicant
difference between the two age groups (P = 0.69).
When analyzing IIEF-EF scores of the participants according to ED duration;<12 months, 13–24 months
and > 25 months, a statistically signicant improvement was demonstrated in all three ED duration
groups (18.8 ± 2.38 vs 27.2 ± 3.83, p < 0.004, 17.8 ± 2.95 vs 26.4 ± 4.21, p = 0.015, and 15.9 ± 2.77 vs
23.42 ± 4.96, p < 0.001), respectively without a statistically signicant difference between the three ED
duration groups. (p = 0.84).
High scores were achieved in the EDITS (76.8 ± 20.3), BSW (4.83 ± 1.1), QEQ (73.4 ± 23.8) and SQOL (67 ± 
29.4), questionnaires (Table1).
Quantied endothelial function improved signicantly in all 3 FMD parameters; baseline ow, max ow
and area under the curve (blood volume) by 53%, 124% and 125%, respectively (Table1).
No signicant deleterious effect of the treatment on lower urinary tract symptoms was demonstrated by
the IPSS questionnaire (9.40 ± 7.48 vs. 8.49 ± 6.8, p = 0.6).
Twelve participants reported re-appearance or improved morning erections, without being directly asked
about it. No side effects such as pain, fever, burning sensation, local pressure, discomfort and dysuria
were reported, nor any dropouts due to side effects occurred. Participants rated the device as very
comfortable and easy to operate.
In this proof-of-concept study, we were able to conrm that RF treatment for ED is effective, safe and
easily applicable. We demonstrated statistically signicant improvement in all IIEF-15 domains, except
for the sexual desire domain. The improvement in erectile function was prominently emphasized by the
EHS scores, as at baseline only 46.4% reported an EHS score of 3 (penis is hard enough for penetration
but not completely hard) while following treatment 67.8% reported an EHS score 3 and an additional 25%
an EHS score of 4 (Penis is completely hard and fully rigid) while none reported an EHS score of 1 (Graph.
Our interest in applying RF as external physical energy to the penis for the treatment of ED evolved from
the documented benecial results of LI-ESWT applied to the penis for ED treatment [4][10]. RF, which is
routinely used in medicine, is a type of electric current between two electrodes.[11] When applied at low
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frequencies, it causes interactions between charged molecules and ions and creates heat within the
tissue. The heat causes collagen bers to undergo structural changes, resulting in the remolding of new
collagen and elastin bers[12] [13]. This type of low-intensity RF is currently used in the dermatology eld
to improve skin laxity and treat cellulite and wrinkles[14] These treatments are based on several
laboratory research studies showing a statistically signicant increase in collagen types I and III,
consisting of newly synthesized collagen found in the histology of the human skin following RF
treatment .[15]. Zelickson et al, using a bovine tendon histological and ultrastructural model of an RF
application, documented dermal remodeling with new collagen regeneration[16]. In addition,
rearrangements of collagen tissue were found in vaginal wall biopsies before and after RF application in
postmenopausal women who were treated for stress urinary incontinence [17].
The rationale for improving erection quality by altering collagen characteristics is based on the fact that
during erection, the increase in intracavernosal pressure depends, among others, on the integrity and
function of the bro-elastic components (collagen and elastin) within the sinusoids and within the TA[18].
Collagen types I and III are mainly present in the TA, interlaced with elastin bers, and involved in the
compression of the emissary veins. In addition, the corpora cavernosa contains an evident amount of
collagen type IV[19]
Collagen IV is the major structural scaffold of the intracavernosal pillars which have an important role in
maintaining the cylindrical shape, strength, and rigidity of the penis during erection, and they also
signicantly contribute to the regulation of the intracorporal pressure during erection [20][21] Collagen
type IV also constitutes the scaffold of the basal membranes in the corpora cavernosa tissue, providing
more exibility and support to the vessels[22]. It is important to note that in recent years the basal
membrane area has also been recognized as an important regulator of cell behavior, probably serving as
an extracellular microenvironment sensor for endothelial cells[23]. At the penile level, the basal membrane
may play a role in tissue and organ morphogenesis and angiogenesis. Collagen type IV is ideally suited
for the incorporation of laminins, molecules that interact with receptors and regulate multiple cellular
activities and signaling pathways [22]. Therefore, our assumption is that remodeling these components in
both corpora and TA by application of low-intensity RF may improve and restore erectile quality.
Remodeling collagen by applying RF energy is a biological process that lasts approximately three months
[23]. We documented favorable results as early as 4 weeks, which merit further discussion. However,
similar early results were also reported following treatment of ED by other external energy sources such
as LISWT[24]. According to Ciampa et al., the peak expression of the neovascularization response
following LI-ESWT occurs as early as 4 weeks after treatment, which may be related to the nitric oxide
(NO) mechanism.[25] Cavernosal NO activity may be enhanced by the direct effect of the higher
temperature leading to vasodilation and increased blood ow, consequently leading to increases in penile
PO2. High oxygen tension arterial levels promote the activation eNOs and nNOs (mediators involved in
the erectile mechanism)[25, 26, 27].
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Activation of these enzymes by increased temperature was demonstrated in several laboratory studies;
Ilangovan et al. demonstrated that eNOs is induced in cultured endothelial cells when exposed to mild
heat (42oC), and concluded that induced heat may upregulate NO synthase in cardiac cells [6]. Harris et
al, in a Bovine aortic endothelial cells model, reported that incubation of cells for 1 h at 42oC was
associated with increased eNOs activity, agonist-stimulated NO release, and a decreased vasoconstrictor
response [27]. The penile hemodynamic changes in our study were veried objectively by penile FMD in
all three measured parameters. Furthermore, our FMD results after RF treatment are in concert with data
presented by Mamede et al using Duplex ultrasound and showing that RF energy improves hemodynamic
parameters [28].
We expect to achieve a sustained effect of ED improvement similar to the reported dermal RF protocols
[16], which is explained by vascular changes leading to physiological variations. The adventitial tissue
that surrounds the penile arterioles responds to arterial "injury" by activating its resident progenitor cells
and induces the process of collagenesis and angiogenesis [29–31]. The repeated heat caused by RF to
the penis applied during the protocol we used, may induce the same “injury” effect and promote the
remodeling of vascular cavernosal body components. In addition, Korshunov et al reported that the local
heat dissipated by RF energy triggers endothelial cell interaction with medial and adventitial cells and
may contribute to vascular remodeling[32]
Another possible mechanism for the early RF effects is the fact that heating by RF is volumetric, and a
reverse thermal gradient is created, causing small amounts of transudate to accumulate in the
extracellular matrix. A mild perivascular inltrate after RF treatment has already been documented [33]
[16]. This natural inammatory process could by itself trigger angiogenesis and collagenesis, but we can
assume that some of the uid remains in the extracellular matrix. Following repeated exposures to RF
treatment, accumulation of extracellular uid contributes to better compression of the draining venules
against the TA inner wall during the following events of increased intracorporal pressure, clinically
expressed as improved erections.
We used questionnaires for outcome assessments because some data such as severity and frequency of
sexual function is better assessed in real life settings using patient reported outcomes (PROs), avoiding
elaborated laboratory-based diagnostic testing [34]. Therefore, evaluation was done primarily based on
PROs, leaving out nocturnal penile tumescence test, omitting a PDE5i washout period and allowing the
participants to continue their routine sexual activity pattern. IIEF-15 served only in the initial evaluation of
the patients as an additional tool for exclusion/inclusion of the patients. Nevertheless, due to the
innovative nature of our study, and to have a better understanding of the underlying hemodynamic
changes induced by RF treatment, we decided to apply the FMD test in a cohort of ten participants before
and one month after completion of all RF sessions.
To the best of our knowledge, this is the rst study in the English literature in which a benecial effect of
RF on ED was proven by using the contemporary ED evaluation protocols. However, our study served
merely as a proof-of-concept trial. The small number of patients, lack of a sham-controlled group and
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short-term follow-up are its main limitations. Because collagen type III is present in the brous plaques of
Peyronie's Disease as well as in the normal tunical tissue, a link between RF therapy and Peyronie's merits
further research.[32]
Further randomized sham-controlled studies are essential to verify our preliminary results. In order to
dene the ideal treatment protocol and the most favorable levels of energy for optimal results.
To our knowledge, this is the rst clinical trial on RF treatment for ED published in the english literature. In
this pilot study we evaluated a RF energy-based treatment for ED. Its innovation lies in the pioneering use
of RF energy for treatment of ED, by employing an innovative handheld, individually operated device
specically designed for home-use. We demonstrated the applicability, safety, and short-term ecacy of
this novel self-use device in improving ED. Our preliminary results are promising but still call for
multicenter, long-term, randomized and sham-controlled studies to better dene its ecacy and to explore
the characteristics of the patient who will benet most from it.
Ilan Gruenwald: designed the protocol, participated in executing the study protocol data extraction and
evaluation, reviewing and editing the manuscript.
Boaz Appel: designed the protocol, participated in executing the study protocol data extraction and
evaluation, reviewing and editing the manuscript.
Arik Shechter: designed the protocol, participated in executing the study protocol data extraction and
evaluation, reviewing and editing the manuscript.
Alexander Greenstein: designed the protocol, participated in executing the study protocol data extraction
and evaluation, reviewing and editing the manuscript.
This study was funded by Ohhmed. Tiberius, Israel. The sponsor was not involved in the preparation of
the study protocol, data acquisition and analysis nor in the construction of the manuscript or its
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Table 1 is available in the Supplementary Files section.
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Figure 1
Erection Hardness Scores according to visits
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Figure 2
IIEF-EF scores in the PDE5i's treated and non-treated groups
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Figure 3
Vertica® front view
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Figure 4
Vertica® rear view
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Vertica® User panel
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Figure 6
Vertica®: Ring and Pad
Supplementary Files
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Radiofrequency (RF) treatment appears to be involved in production of new collagen fibrils and the improvement of existing collagen structures; however, the molecular bases of the effect of non-invasive RF on the skin tissue have not been fully elucidated. This study reports the effects of RF associated or not with hydrolyzed collagen (HC) in the skin tissue. Wistar rats were randomly divided into four groups, according to the treatment received: control group (G1, n = 5), no treatment; subjects in group G2 (n = 5) were treated with HC; and capacitive RF was applied to the back of each subject in G3 (n = 5) and RF associated with HC in G4 (n = 5). Biopsies were taken 30 days after treatment and then were histologically processed and studied for inflammatory cell counting, collagen content, and morphometry. In addition, FGF2, CD105, and COX-2 expression was assessed by immunohistochemical staining. The most relevant changes were the increase in cellularity and accumulation of intercellular substance in RF-treated animals (G3 and G4). The greatest dermis thickness rate was observed in G4, followed by G3 and G2 (p < 0.05). RF-treated skins (G3 and G4) exhibited a significant overexpression of FGF2 (p < 0.0001) and increased microvessel density (p < 0.0001) in comparison with G1 and G2. Moreover, the amount of COX-2 was significantly higher (p < 0.0001) in dermis of RF-treated areas compared to G1 and G2, and demonstrated differences in G3 (RF) compared to G4 (RF + HC) (p < 0.0001). Our results suggests that RF treatment associated or not with HC induces FGF2 overexpression, promotes neoangiogenesis and modulates the COX-2 expression, subsequently promotes neocollagenesis, and increased thickness rate of dermis.
Full-text available
Basement membranes are delicate, nanoscale and pliable sheets of extracellular matrices that often act as linings or partitions in organisms. Previously considered as passive scaffolds segregating polarized cells, such as epithelial or endothelial cells, from the underlying mesenchyme, basement membranes have now reached the center stage of biology. They play a multitude of roles from blood filtration to muscle homeostasis, from storing growth factors and cytokines to controlling angiogenesis and tumor growth, from maintaining skin integrity and neuromuscular structure to affecting adipogenesis and fibrosis. Here, we will address developmental, structural and biochemical aspects of basement membranes and discuss some of the pathogenetic mechanisms causing diseases linked to abnormal basement membranes.
Erectile dysfunction (ED) is defined as the inability to achieve or maintain penile erection sufficient to permit satisfactory sexual activity. The prevalence increases with age. Basic and clinical research is identifying the neurovascular and humoral control of the mechanisms. The initial evaluation should differentiate erectile dysfunction from premature ejaculation and loss of libido. Myocardial insufficiency, hypogonadism and peripheral neuropathy should be looked for. Initial laboratory investigations should be restricted to identifying previously undetected medical illness that may directly contribute to erectile dysfunction. Discussing the available options with the couple is an important aspect. If erectile dysfunction is secondary to other treatable disorders these should be treated simultaneously. When other diseases that require intervention are ruled out and if there are no contraindications, therapy may be initiated with a phosphodiesterase inhibitor. In selected cases, psychosexual therapy may be beneficial. If phosphodiesterase inhibitors are contraindicated, vacuum constriction devices may be tried. Further options include intracavernosal injection, intraurethral instillation, penile revascularization and prosthesis. The availability of effective and well-tolerated oral medications has dramatically changed the clinical approach to erectile dysfunction. Pharmacotherapy is the preferred cost-effective first-line therapy in the vast majority of patients. A stepped-care approach is followed in the primary care and family practice settings. Appropriate urological, endocrine and psychiatric referrals, and shared decision-making with the couple will enable effective treatment of men with erectile dysfunction.
Introduction: Low-intensity shockwave therapy (LISWT) has been investigated for the treatment of uroandrological disorders including erectile dysfunction (ED), Peyronie's disease (PD) and chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) with controversial findings. Aim: To review the evidence on LISWT for ED, PD, and CP/CPPS and provide clinical recommendations on behalf of the European Society of Sexual Medicine. Methods: Medline and Embase databases were searched for randomized clinical trials (RCTs), meta-analyses and open-label prospective or retrospective studies investigating the effect of LISWT on ED, PD, or CP/CPPS. Outcomes: The panel provided statements on clinically relevant questions concerning LISWT: (i) treatment efficacy, (ii) treatment protocol, (iii) clinical indications, and (iv) safety. The level of evidence was provided according to the Oxford 2011 criteria and graded using the Oxford Centre for Evidence-Based Medicine recommendations. Results: 11 RCTs and 5 meta-analyses investigated LISWT for ED. RCTs provided controversial results on the efficacy of LISWT and were affected by high heterogeneity and the small number of patients included. Pooled-data analysis showed an overall positive effect in terms of erectile function improvement but reported small estimates and included a largely heterogeneous cohort of patients. 4 RCTs and 1 meta-analysis assessed LISWT for PD. All trials showed positive findings in terms of pain relief but no effect on penile curvature and plaque size. Inclusion criteria vary widely among studies, and further investigation is needed. 5 RCTs investigated LISWT for CP/CPPS. Data showed a possible effect on pain relief, although there is no evidence supporting that pain relief was maintained or any improvement in pain over time. Clinical implications: LISWT needs to be further investigated in the context of sexual medicine and is almost but not yet ready for clinical practice. Strengths and limitations: All studies have been evaluated by a panel of experts providing recommendations for clinical practice. Conclusions: LISWT is a safe and well-tolerated procedure but its efficacy for the treatment of ED is doubtful and deserves more investigation. Patients reporting pain associated with PD may benefit from LISWT, although no effect is expected on disease progression. LISWT is not a primary treatment for CP/CPPS, but it may be considered as an option to relieve pain. Capogrosso P, Frey A, Jensen CFS, et al. Low-Intensity Shock Wave Therapy in Sexual Medicine-Clinical Recommendations from the European Society of Sexual Medicine (ESSM). J Sex Med 2019;16:1490-1505.
Objective: To evaluate the global prevalence of erectile dysfunction (ED); as well as its association with physiological and pathological ageing by examining the relationship between ED and cardiovascular disease (CVD), benign prostatic hyperplasia (BPH), and dementia. We also aimed to characterise discrepancies caused by the use of different ED screening tools. Methods: The Excerpta Medica dataBASE (EMBASE) and Medical Literature Analysis and Retrieval System Online (MEDLINE) were searched to find population-based studies investigating the prevalence of ED and the association between ED and CVD, BPH, and dementia in the general population. Results: The global prevalence of ED was 3-76.5%. ED was associated with increasing age. Use of the International Index of Erectile Function (IIEF) and Massachusetts Male Aging Study (MMAS)-derived questionnaire identified a high prevalence of ED in young men. ED was positively associated with CVD. Men with ED have an increased risk of all-cause mortality odds ratio (OR) 1.26 (95% confidence interval [CI] 1.01-1.57), as well as CVD mortality OR 1.43 (95% CI 1.00-2.05). Men with ED are 1.33-6.24-times more likely to have BPH then men without ED, and 1.68-times more likely to develop dementia than men without ED. Conclusion: ED screening tools in population-based studies are a major source of discrepancy. Non-validated questionnaires may be less sensitive than the IIEF and MMAS-derived questionnaire. ED constitutes a large burden on society given its high prevalence and impact on quality of life, and is also a risk factor for CVD, dementia, and all-cause mortality.
This introductory manuscript aims to familiarize the concept of the ability of certain forces or energies applied on the penis. This concept is described and discussed in more detail for three optional applicative energies; shock wave energy via mechano-transduction, ultrasound energy via its theoretical unique effect on the cellular membrane, specifically cyclic separation of the two phospholipid layers, creating biochemical, functional and structural tissue changes. Radio frequency energy via its heating effect is proven to induce immediate changes on collagen strucures and on realignment of collagen fibers, as well as induction of local vasodilation. Applying any of these energies on the erectile tissue may potentially affect biochemical processes, which through different mechanisms lead to a beneficial clinical effect on erectile function.
Objective: The aim of this study was to evaluate the effects of non-ablative, monopolar transcutaneous temperature controlled radiofrequency (TTCRF) technology in the treatment of postmenopausal women suffering from genuine stress urinary incontinence (SUI) related to menopause and to evaluate histological changes vaginally associated with the treatment. Materials and methods: Subjective and objective symptoms of SUI were assessed in study subjects before and after TTCRF, (1 treatment every 30 days, for 3 months; n=10) and compared with the effects of a placebo treatment on a control group of demographically similar women (n =10). SUI was subjectively evaluated with subjective Urogenital Distress Inventory (UDI-6) and with the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) before and after TTCRF treatments and objectively with cough stress test. Vaginal health was evaluated with the Vaginal Health Index (VHI) score and visual analogue score (VAS) for dyspareunia and dryness. Punch biopsies were obtained at the urethra-vesical junction in the anterior compartment, before and at the end of the treatment protocol. Basic and histochemical staining methods were used. Results: In subjects suffering SUI, TTCRF treatment was associated with a significant (p<0.01) improvement of ICIQ-SF and UDI-6 scores. Seven of 10 patients (70%) had a negative cough stress test after the treatment protocol. Improvements were maintained up to the 12th week of follow-up. The results were supported by the positive histologic changes seen vaginally in women suffering from postmenopausal vaginal atrophy. TTCRF was well tolerated with no complications reported in study patients. Conclusion: TTCRF treatment in postmenopausal women suffering from SUI showed significant improvement in both objective and subjective symptoms. Vaginal health scores also improved as did VAS for dryness and dyspareunia. We feel these improvements were related to histological changes related to improvement in vaginal atrophy that were not observed in placebo patients.
Introduction: Definitions of sexual dysfunctions in women and men are critical in facilitating research and enabling clinicians to communicate accurately. Aims: To present the new set of definitions of all forms of sexual dysfunction in women and men adopted by the Fourth International Consultation on Sexual Medicine (ICSM) held in 2015. Methods: Classification systems, including the International Classification of Diseases, 10th Edition and the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, and systems that focus on only specific types of sexual dysfunctions (eg, the International Society for Sexual Medicine definition for premature ejaculation) were reviewed. Main Outcome Measures: Evidence-based definitions were retained, gaps in definitions were identified, and outdated definitions were updated or discarded. Where evidence was insufficient or absent, expert opinion was used. Some definitions were self-evident and termed clinical principles. Results: The evidence to support the various classification systems was carefully evaluated. A more comprehensive analysis of this evidence can be found in two other articles in this journal that consider the incidence and prevalence and the risk factors for sexual dysfunction in men and women. These data were used to shape the definitions for sexual dysfunction that have been recommended by the 2015 ICSM. Conclusion: The definitions that have been adopted are those that are most strongly supported by the literature at this time or are considered clinical principles or consensus of experts' opinions. As more research and clinical studies are conducted, there likely will be modifications of at least some definitions.
The demand for noninvasive methods of facial and body rejuvenation has experienced exponential growth over the last decade. There is a particular interest in safe and effective ways to decrease skin laxity and smooth irregular body contours and texture without downtime. These noninvasive treatments are being sought after because less time for recovery means less time lost from work and social endeavors. Radiofrequency (RF) treatments are traditionally titrated to be nonablative and are optimal for those wishing to avoid recovery time. Not only is there minimal recovery but also a high level of safety with aesthetic RF treatments.
Background: Fine lines and rhytides are clinically evident signs of photodamage. Traditionally, ablative and nonablative lasers have been used for nonsurgical facial rejuvenation, but their side effects and downtime have limited their use. Objective: Radiofrequency (RF) is novel nonablative technology originally used to target photodamage. It differs from lasers in that it uses an electric current rather than a light source. It is frequently used in dermatology to treat skin laxity, rhytides, acne vulgaris and scarring, and cellulite. The goal of this review is to summarize the various types of RF devices and their uses and to determine the evidence-based efficacy of these devices. Materials and methods: This article reviews the current literature on RF, its uses and clinical effectiveness, and a practical guide for application of the assorted RF devices. Results and conclusion: Results have been favorable for the different clinical uses of RF, but many studies are nonrandomized, noncomparative trials that use subjective means of evaluation. Overall, nonablative RF is a safe, tolerable, and effective tool for skin rejuvenation and cellulite treatment that produces modest results. RF should serve as an alternative but not as an equivalent substitute to surgery.