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Non-ablative vaginal erbium YAG laser for the treatment of cystocele

Authors:
  • Juna, Slovenia
  • JUNA clinic Ljubljana

Abstract and Figures

Purpose: the aim of the study was to evaluate the effects of Vaginal Erbium Laser (VEL), a non-ablative solid state erbium-doped yttrium-aluminum-garnet crystal (Er:YAG) laser treatment for reduction of prolapses. Methods: in this prospective cohort study, 61 patients with cystoceles of grades II–IV were submitted to 2-5 treatments with a nonablative VEL laser at 2-month intervals. At baseline and 2, 6 and 12-month followups, prolapses were photographed and graded using the Baden-Walker scale during a physical examination. Patients were interviewed at each follow-up about adverse effects and their satisfaction. Pain during treatment was measured on a 10-point visual analog scale (VAS). Results: at baseline 40 patients presented with grade II cystoceles, 15 with grade III and 6 with grade IV cystoceles. At the final follow-up, the grade of prolapse was reduced by at least one grade in 95% of patients, with 85% of patients presenting with grade 0 or I prolapses and the remaining 15% of patients with grade II prolapses. Most patients were either very satisfied (57%) or satisfied (33%) with the treatment. Treatment discomfort was low (0.5 VAS). No major adverse effects were reported. Conclusions: the results of this pilot study show that the non-ablative VEL treatment may improve cystoceles with minimal patient discomfort and no adverse effects. If these preliminary results will be confirmed in a properly designed, controlled study, then VEL could be considered in selected cases as a minimally-invasive alternative to surgery.
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19
Non-ablative vaginal erbium YAG laser for the treatment of cystocele
Urska Bizjak Ogrinc1, Sabina Sencar1
1 Juna Clinic, Savska cesta 10, 1000 Ljubljana, Slovenia
ABSTRACT
Purpose: the aim of the study was to evaluate the effects
of Vaginal Erbium Laser (VEL), a non-ablative solid
state erbium-doped yttrium-aluminum-garnet crystal
(Er:YAG) laser treatment for reduction of prolapses.
Methods: in this prospective cohort study, 61 patients
with cystoceles of grades II–IV were submitted to 2-5
treatments with a nonablative VEL laser at 2-month
intervals. At baseline and 2, 6 and 12-month follow-
ups, prolapses were photographed and graded using
the Baden-Walker scale during a physical examination.
Patients were interviewed at each follow-up about
adverse effects and their satisfaction. Pain during
treatment was measured on a 10-point visual analog
scale (VAS).
Results: at baseline 40 patients presented with grade
II cystoceles, 15 with grade III and 6 with grade IV
cystoceles. At the nal follow-up, the grade of prolapse
was reduced by at least one grade in 95% of patients,
with 85% of patients presenting with grade 0 or I
prolapses and the remaining 15% of patients with grade
II prolapses. Most patients were either very satised
(57%) or satised (33%) with the treatment. Treatment
discomfort was low (0.5 VAS). No major adverse effects
were reported.
Conclusions: the results of this pilot study show that
the non-ablative VEL treatment may improve cystoceles
with minimal patient discomfort and no adverse effects.
If these preliminary results will be conrmed in a
properly designed, controlled study, then VEL could
be considered in selected cases as a minimally-invasive
alternative to surgery.
Keywords: pelvic organ prolapse, cystocele, Er:YAG,
non-ablative laser, non-surgical treatment
Corresponding author: Urska.Bizjak-Ogrinc@juna.si
Copyright 2017, Partner-Graf srl, Prato
DOI: 10.14660/2385-0868-59
Gyn ae c o l o g y & Obstetrics
Italian Journal of
March 2017 - Vol. 29 - N. 1 - Quarterly - ISSN 2385 - 0868
SOMMARIO
Scopo dello studio: scopo dello studio è stato quello
di valutare gli effetti del trattamento con laser vaginale
non ablativo Erbium (Vaginal Erbium Laser, VEL) nella
riduzione del prolasso genitale.
Metodi: in questo studio di coorte, prospettico, non
controllato, 61 pazienti con cistocele di II–IV grado sono
state sottoposte a trattamento con VEL, eseguendo da 2
a 5 trattamenti, ad intervalli di 2 mesi. La valutazione
del grado di prolasso è stata eseguita secondo la
classicazione di Baden-Walker, sia in condizioni
basali che dopo 2, 6 e 12 mesi, registrando le immagini
fotograche durante la visita, valutando anche
l’incidenza degli effetti collaterali e la soddisfazione
delle pazienti. Il dolore riferito dalle pazienti durante il
trattamento è stato valutato attraverso una scala visuo-
analogica da 0 a 10 (VAS).
Risultati: in condizioni basali 40 pazienti presentavano
un cistocele di II grado, 15 di III grado e 6 di IV grado.
Al follow-up nale, il 95% delle pazienti presentava
una riduzione del prolasso di almeno 1 grado; l’85%
delle pazienti presentava un prolasso di grado 0 o I,
e il rimanente 15% delle pazienti presentavano un
prolasso di II grado. Il dolore indotto dal trattamento è
stato basso (0.5 VAS). La maggior parte delle pazienti è
risultata molto soddisfatta (57%) o soddisfatta (33%) del
trattamento. Non sono stati riscontrati eventi avversi
durante lo studio.
Conclusioni: i risultati di questo studio pilota
suggeriscono che il trattamento con VEL possa
determinare un miglioramento del grado di cistocele,
inducendo minimi effetti collaterali. Se questi risultati
fossero confermati in studi controllati, il trattamento
laser potrebbe essere considerato in casi selezionati una
valida alternativa non invasiva alla chirurgia.
Parole chiave: prolasso genitale, cistocele, Er:YAG, laser
non-ablativo, trattamento non invasivo
It. J. Gynaecol. Obstet.
2017, 29: N. 1
20
Non-ablative laser treatment of cystocele
INTRODUCTION
Pelvic organ prolapse (POP) affects a large
proportion of middle-aged and older women,
with a prevalence of any degree of POP ranging
in different studies from 32% to 98%(1–3). POP is
a complex condition of pelvic floor dysfunction,
with many contributing factors such as vaginal
childbirth, aging, congenital conditions (e.g.
collagen defects), raised intra-abdominal pressure,
etc.(4). Many women with lower stage POP
are asymptomatic, with only 4-10% of women
reporting POP-related symptoms(5–7). Women with
symptomatic POP experience a sensation of vaginal
bulging or a visible bulge protrusion in higher POP
grades, with difficulties in sitting, walking, sexual
intercourse and many other everyday activities(4).
Although POP is not a life-threatening condition,
its symptoms have a severe impact on patients’
quality of life and wellbeing. POP also represents a
significant public health expense, being a frequent
cause for major gynecological surgery(4). Current
management options for POP include conservative
management, such as physical therapy and vaginal
pessaries, as well as various surgical procedures.
Vaginal pessaries have been in use for a long time
because of their low invasiveness(8,9). However,
their use is characterized by a high discontinuation
rate, mainly due to difficulties with inserting/
removing the pessary and side-effects, such as
infections, bleeding and pain(8,9).
Many patients with POP symptoms ultimately
undergo surgical treatment. The lifetime risk of
having prolapse surgery before the age of 80 is 11%,
with almost a third of patients needing repeated
procedures(10). Different surgical techniques are
currently used to treat POP(11). The methods of
choice depend on the type and the severity of
prolapse. In recent decades, transvaginal insertion
of polypropylene mesh implants has been one
of the most popular options, although they are
associated with a high rate of side effects(12).
Prolapse of the bladder into the anterior
vaginal compartment, or cystocele, is the most
frequent type of POP - roughly one third of POP
patients suffer from cystoceles(3). The anterior wall
of the vagina is a very important structure for
pelvic floor support, which provides a hammock-
like support to the upper-lying urethra and the
bladder(13). According to the integral theory of
Petros and Ulmsten, the connective tissue in the
anterior vaginal wall has an important role in
supporting the bladder. Vaginal laxity resulting
from childbirth trauma and aging-related collagen
degradation can cause the loss of support and
contractile strength of the pelvic floor muscles
that attach to the anterior vaginal wall. As a
consequence, stress urinary incontinence and/or
POP arise as typical symptoms of this pelvic floor
dysfunction(14,15).
Collagen is the connective tissue component
that is most responsible for robustness, stability
and plasticity of the vagina. Pulses of laser energy
that temporarily increase the temperature of
collagen can initiate neocollagenesis and improve
collagen structure(16,17). As a result of the laser-
induced temperature increase, intermolecular
cross-links that stabilize the collagen triple-helix
structure are broken, which leads to the shrinkage
of collagen fibrils and an improvement in tissue
firmness, followed by neocollagenesis. VEL
treatment was recently used in different studies
in order to achieve strengthening of the vaginal
wall for the treatment of SUI(18–21) and vaginal
relaxation(18,22).
In the present pilot study, we evaluated the
effects of VEL as a noninvasive, non-surgical
treatment for cystoceles.
MATERIALS AND METHODS
This was a prospective, single-center,
uncontrolled cohort pilot study. It was conducted
between March 2012 and November 2013 and
included 61 women older than 18 years of age.
The study was approved by the Ethical committee
of the Republic of Slovenia and was conducted
in accordance with the Declaration of Helsinki.
No financial incentives were proposed to the
participants.
During the first visit, the eligibility of the
patient was verified, a written informed consent
was obtained and sociodemographic and clinical
characteristics were collected. Inclusion criteria
for participation in the study were: the presence of
POP symptoms, diagnosis of cystocele of grade II
to IV according to the Baden-Walker scale, normal
PAP smear, negative urine culture and integrity of
the vaginal mucosa (without injuries or bleeding)
and voluntary informed consent. Exclusion criteria
were: previous POP surgery, pregnancy, intake of
photosensitive drugs, vaginal bleeding injuries or
infection in the treated area. All the consecutive
patients who presented at our clinic during the
recruitment period and met the inclusion criteria
(and did not meet the exclusion criteria) were
included in the study.
Laser therapy was performed using a 2940 nm
VEL (SP Spectro, Fotona, Slovenia) with SMOOTH
21
Non-ablative laser treatment of cystocele Urska Bizjak Ogrinc et al.
mode setting, which enables non-ablative,
thermal-only operation(18). The parameters were
selected based on extensive preclinical and clinical
studies(23–26). Briefly, Variable Square Pulse (VSP)
technology controls the energy and time duration
(or pulse width) simultaneously, reducing the
power and increasing the pulse duration. The
SMOOTH™ mode, with its sequence of low-
fluence longer-shaped Erbium pulses, distributes
the heat into the mucosa surface, achieving a
controlled, deep thermal effect without ablation.
Therefore, the Erbium SMOOTH™ mode pulses
allow controlled tissue heating in a safe and
harmless ambulatory procedure without ablation
or carbonization of the tissues, practically
avoiding the risk of perforation with accidental
lesions of the urethra, bladder or rectum. Each
laser treatment session consisted of a full vaginal
canal irradiation (using a 360° circular adapter),
followed by additional irradiation of the prolapsed
anterior wall (using a 90° angular adaptor) and
concluded with irradiation of the vestibule area.
Depending on the prolapse severity, multiple
passes of laser irradiation were applied, with
emphasis on the anterior wall irradiation. On
average, we used a total of 8 passes per session,
delivering in this manner around 1500 J of laser
energy to the vaginal mucosa. The VEL procedures
were performed in an outpatient clinical setting,
without any specific preparation, anesthesia, or
post-treatment medications. The treatment time
was approximately 15 minutes and the procedure
did not require any consumables.
Patients received 2-5 treatment sessions with
intervals of 2 months in between the sessions.
This time interval is sufficient to allow the
neocollagenesis initiated by the previous laser
session to proceed(27), and similar intervals were
used in previous studies using VEL(26). The effect of
the previous session can thus be seen and the need
for additional sessions correctly evaluated. At least
two treatments are deemed necessary to provide
long-term results. The total number of sessions
was dependent on the patients’ satisfaction with
the result (lack of symptoms) and the physical
examination after the 2nd session.
At baseline and at each follow-up visit, a
physical examination was conducted, prolapses
were photographed, and the prolapse stage was
determined in a restful and straining (achieved
by coughing) dorsal lithotomy by 2 physicians
according to the Baden-Walker scale(28). The
Baden-Walker scale is fast, simple, and has been
used widely in recent studies on cystocele repair,
with which we wished to compare our results(29).
Follow-up visits were performed at 2, 6 and 12
months after the last VEL procedure.
At each follow up the patients were interviewed
about post-op adverse effects and their level of
satisfaction. Patient satisfaction with the outcome
of treatment was measured on a 4-point scale:
not satisfied, partially satisfied, satisfied or very
satisfied. Pain during the treatment was measured
for every session with a 10-point VAS pain scale.
All the results are reported as the Mean ±
SD of absolute values. Statistical significance
(α=0.05) was calculated with Crosstabs and
the Chi-square test, as well as with one-way
ANOVA and Bonferroni tests in SPSS 17.0 (SPSS
Science, Chicago, IL, USA) and GraphPad Prism
(GraphPad, La Jolla, CA, USA).
RESULTS
In this study 61 patients suffering from pelvic
organ prolapse were included. Their average age
was 54.9 ± 9.1years (range: 29-78 years). Mean
parity was 2.2 ± 0.8: 42 patients had 2 children
(69%), 8 patients had 1 child (13%), 6 patients 3
children (10%), and 3 patients 4 children (5%).
Only 2 patients (3%) were nulliparous. The average
BMI was 25.5 ± 3.1 (range: 19-32). Distribution of
cystocele stages according to the Baden-Walker
(BW) scale at baseline is reported in Table 1.
Twenty patients (33%) had had a hysterectomy,
40 patients (66%) had a concurrent rectocele and 8
patients (13%) had a concurrent uterine prolapse.
No patient had had previous POP surgery. 7% of
the patients underwent two procedures, 60% three,
26% four and 7% underwent five procedures.
There was a significant improvement in
BW grade already after the first laser treatment
(p<0.001). At the time of first follow-up, 48% of the
patients improved to BW grades 0 or 1 (Table 1).
FU-1
(n=61;
2 months)
7 (12%)
22 (36%)
27 (44%)
5 (8%)
1.5
FU-2
(n=61;
6 months)
21 (35%)
28 (46%)
10 (16%)
2 (3%)
0.9
FU-3
(n=52;
12 months)
20 (39%)
24 (46%)
8 (15%)
0.8
Baseline
(n=61)
40 (66%)
15 (24%)
6 (10%)
2.4
BW Grade
0
I
II
III
IV
Average
grade
Table 1.
Distribution of cystocele stages according to the Baden-Walker scale
(BW Grade) at baseline and at three follow-ups
It. J. Gynaecol. Obstet.
2017, 29: N. 1
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Non-ablative laser treatment of cystocele
The differences between average prolapse grades
at baseline and at each follow-up were highly
statistically significant (p<0.001, Fig. 1).
Additional laser treatments brought additional
improvement in BW grade. By the second follow-
up, 81% of patients had improved to a grade 0
or 1 cystocele (Table 1). At the third follow-up,
there were no longer any patients with a cystocele
stage above 2 (Table 1). 39% had normal organ
position (grade 0 cystocele) and a further 46% of
the patients were asymptomatic with a grade 1
cystocele (Table 1).
On average, cystoceles improved by 1.6 grades
(Fig. 2) and 95% of cystoceles improved by at
least one grade. After the final treatment 57% of
the patients were very satisfied with the outcome,
33% were satisfied and 8% were partially satisfied.
Only 1 patient was not satisfied with the outcome
(2%).
Treatment discomfort was very low; the
average pain level on a 10-point VAS scale was
0.49 during the first procedure, 0.22 during the
second and 0.17 during the third procedure. There
were no adverse effects reported.
Many of the patients had concurrent rectoceles
or uterine prolapses at baseline. These prolapses
also improved after the laser treatment of
cystoceles, but as the treatment of cystoceles
was the main objective of our study, these
improvements are not described here.
Baseline cystocele grade had a significant
(p=0.007) effect on the reduction in BW grade at
the final follow-up. The majority of patients with
grade 2 cystoceles at baseline improved to grade
0 (50%) or grade 1 (43%) after laser treatment, but
some 7% remained at grade 2. 20% of the patients
with grade 3 cystoceles at baseline improved
to grade 0 after treatment, 40% improved to
grade 1 and the remaining 40% to grade 2. Of
all the patients diagnosed with the severest POP
(grade 4), a full 83% improved to grade 1 and
the remaining 17% to grade 2. All the patients
diagnosed with either grade 3 or 4 cystoceles
therefore showed improvement after treatment.
There were no statistically significant
differences in improvement between patients
with or without a hysterectomy. For patients that
had undergone hysterectomy, the treatment was
a full success (grade 0 cystocele) in 40% of the
cases. The final diagnosis was grade 1 for 35% and
grade 2 for the remaining 25%. Patients without
a hysterectomy procedure were diagnosed at the
end of treatment with grade 1 cystocele in 51% of
the cases, grade 2 in 12%, while 37% were grade 0.
DISCUSSION
The results of this preliminary pilot study
suggest that the nonablative VEL is an effective
and safe tool for the treatment of cystoceles. In
most of the patients the improvement occurred
after the first treatment, with patients reporting
better prolapse containment inside of the vaginal
canal and less frequent occurrence of the prolapse
falling out of vaginal canal. Further treatments
induced additional improvement in up to 85% of
patients to grade 0 or 1 cystocele. In comparison,
3 years after POP surgery 93% of patients had
grade 0 or 1 cystocele(29). However, VEL has none
of the side effects of POP surgery (fever, urinary
retention, de novo urinary incontinence, mesh
extrusion, mesh retraction, dyspareunia, chronic
pelvic pain)(29).
*** -statistical significance, p<0.001
Figure 1.
Average cystocele stages before VEL treatment and at 3 follow-ups.
The bars show mean POP grade value ± SEM
Figure 2.
Cystocele grade reduction after VEL treatment from baseline to the last
follow-up. Bars present mean values. 13% improved by 3 grades, 44% by 2
grades and 38% by one grade. 5% did not improve.
The average improvement was 1.6 grades
Average POP grade
Baseline 6 months2 months 12 months
Change in POP stage
% of patients
23
Non-ablative laser treatment of cystocele Urska Bizjak Ogrinc et al.
A typical example of prolapse improvement
after laser therapy is shown in Fig. 3, while Fig. 4
presents the improvement of a large (grade 4)
prolapse in a 66-year-old patient.
There were no significant differences in
prolapse improvement with respect to the
patients’ ages or with respect to the number
of procedures applied. The decision about the
number of treatments was based on the level
of improvement observed after the second
procedure. The patients with lower rates of
improvement received additional treatments.
The largest group of patients (60%) received
three procedures; the second largest group (26%)
received four procedures.
Twenty patients included in this study
(33%) had previously undergone hysterectomy.
Although hysterectomy is recognized as a risk
factor for POP(30,31) previous hysterectomy did not
significantly affect the outcome of VEL treatment
Figure 3.
Pelvic organ prolapse in a 63 year old woman (a) before and (b) after 3 laser
treatments
Figure 4.
Reduction of grade 4 prolapse in a 66 year old woman with 4 vaginal
deliveries after the laser therapy: (a) before the therapy, (b) one month after
the first session, (c) one month after the second session, (d) one month
after the third session, (e) 3 months and (f) 6 months after the last (fourth)
session.treatments
in this study. The laser treatment was successful
(post-treatment BW grades 0 or 1) in 75% of post-
hysterectomy patients.
There is a well-established connection
between collagen deficiency and the occurrence
of POP. Lammers et al.(32) compared the
incidence of various collagen disorders between
POP patients and a control group and found a
significantly higher prevalence of other collagen-
related disorders, such as varicose veins, joint
hypermobility and rectal prolapse, in the POP
group. Han et al.(33) have observed abnormal
connective tissue architecture, decreased collagen
expression and increased frailness of the tissue
in patients with POP and SUI. Genetic collagen-
associated disorders have also been associated
with an increased incidence of POP(34).
In this pilot study, we report a novel approach
of treating cystocele using a VEL thermal-only
treatment. The idea comes from pilot studies
of a laser therapy designed for the treatment of
vaginal relaxation syndrome and stress urinary
incontinence that reported improvement of
POP as an additional effect(18). The treatment
uses innovative low-fluence pulse sequences
(SMOOTH™ mode) to achieve precise heating
of the tissue up to 65°C without causing ablation
or damage to the epithelium. Pulses of heat
in the range of 60-65°C have been shown to
achieve immediate shrinkage of collagen, while
maintaining its structure without destruction(16,17).
Besides the immediate shrinkage of collagen,
heat pulsing stimulates the synthesis of new
collagen, as the heat induces a heat-shock healing
response(17,27). Stacking of low-fluence pulse
sequences has been shown in numerical models(35),
as well as animal(36,37) and human studies(38), to be
effective in shrinking the collagen in the dermis
up to a depth of several hundred micrometers,
without causing damage to the epidermis.
The above-mentioned principle was applied
in several studies that aimed to treat different
conditions arising from pelvic floor dysfunction,
such as vaginal relaxation and stress urinary
incontinence (SUI)(18,23–26). Recently, Gambacciani
et al.(20,21) have reported a study using the non-
ablative VEL for the treatment of genitourinary
symptom of menopause, with a significant
decrease in symptoms of SUI in a subset of
incontinent women(20,21).
The overall success rate (post-treatment BW
grade 0 or 1) in our study was 85%. Surgical
methods can achieve higher cure rates, but are also
associated with higher costs and a higher rate of
side effects and re-operation(1,10,29).
It. J. Gynaecol. Obstet.
2017, 29: N. 1
24
Non-ablative laser treatment of cystocele
The most popular method for cystocele
treatment in the past decade has been surgical
insertion of polypropylene meshes(11,12,29). There has
been a lot of controversy regarding polypropylene
meshes following their reclassification by the FDA
into high-risk Class III medical devices due to
numerous side effects(39,40). These developments
have emphasized the lack of effective and safe
therapies for POP. We believe that the minimally
invasive VEL treatment could play an important
role in the future as an intermediate step between
currently available conservative therapies and
surgery. Many of the patients in this study enlisted
due to a fear of surgery or because they already had
undergone previous surgery (e.g. hysterectomy)
and were trying to avoid or postpone re-operation.
The large majority of the patients were satisfied
with the procedure and the results of the therapy.
The follow-up in this study showed that the
results of laser treatment could last at least 12
months. Long-term experiences with the same
Er:YAG modality in aesthetics and dermatology
suggest that the procedure could be safely repeated
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cystoceles with minimal patient discomfort and
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new, safe and effective option to treat cystoceles
as a minimally invasive alternative to surgery in
properly selected patients.
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Non-ablative laser treatment of cystocele Urska Bizjak Ogrinc et al.
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... 24,25 Settings of the lasers varied; however, some authors did not mention the laser settings. [26][27][28][29][30][31][32][33] Table S3 and S4 (see Supplementary material) displays the laser setting details. In the only randomised controlled trial 22 the sham group was treated with the same procedure but with zero intensity settings, without receiving therapeutic irradiation. ...
... One study primarily targeted women with POP. Ogrinc and Sencar performed a cohort study in women with cystocele 29 and reported an anatomical improvement to grade 0 or 1 in 85% and in the remaining 15% to grade II after two to five laser therapy sessions. Lower cystocele grades were associated with a higher success rate. ...
... In 5% of women there was no improvement. 29 We could not identify a formal subjective improvement assessment. Alkhafajy and Alyaseen used three laser applications in 90 women with 'vaginal loosening', later referred to as 'vaginal wall prolapse'but no formal definition is referred to. ...
Article
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Background: LASER therapy is now being proposed for the treatment of pelvic organ prolapse (POP) and urinary incontinence (UI). Objectives: To systematically review the available literature on LASER therapy for POP and UI. Search strategy: Pubmed, Web Of Science and Embase were searched for relevant articles, using a three concept (POP, UI, LASER therapy) search engine composed as (concept 1 OR concept 2) AND concept 3. Selection criteria: Only full text clinical studies in English. Data collection and analysis: Data on patient characteristics, LASER setting, treatment outcome and adverse events were independently collected by two researchers. Due to the lack of methodological uniformity meta-analysis was not possible and results are presented narratively. Main results: Thirty one studies recruiting 1530 adult women met the inclusion criteria. All studies showed significant improvement either on UI, POP or both, however the heterogeneity of LASER settings, application and outcome measures was huge. Only one study was a randomized controlled trial, two studies were controlled cohort studies. All three were on UI and used standardized validated tools. The risk of bias in the RCT was low on all seven domains; the controlled studies had a serious risk of bias. No major adverse events were reported, mild pain and burning sensation were the most common described adverse events. Conclusions: All studies on vaginal and/or urethral LASER application for POP and UI report improvement, but the quality of studies needs to be improved.
... The authors results. The longest follow up was limited to 36 months [17]. That frustrates also us to speak about long-term effects of laser. ...
... Patients received between two and five Er:YAG laser treatment sessions at 2-month intervals. They showed significant improvement even after the first treatment session in prolapse stages and 95% of cystoceles improved by at least one grade without major adverse effects.Follow up of this study was 12 months[17]. Another publication by the same group was able to show that the improvement lasted at least 12 months and for many patients even longer up to 36 months without significant treatment discomfort (average score of0.4 on a 10-point VAS) and with high patient satisfaction (median level of 4 on a scale of 1-5) [18]. ...
... Three studies addressed urge incontinence as a primary endpoint. POP was a primary endpoint in a single study (2), which reported anatomical improvements to grade 0 or 1 in 85% of the subjects and to grade 2 in 15% after two to five LASER therapy sessions. Lower cystocele grades were associated with a higher success rate. ...
... The FotonaSMOOTH V R non-ablative thermal-only Er:YAG technology 1 (Fotona, Ljubljana, Slovenia) has been specially developed for minimally invasive intravaginal treatments. Four different treatment protocols that incorporate non-ablative thermal-only Er:YAG technology have been developed and clinically validated for the following indications: stress urinary incontinence (SUI) 2 , vaginal laxity/vaginal relaxation syndrome 3 , genitourinary syndrome of menopause (GSM)/vulvovaginal atrophy (VVA) 4 , and pelvic organ prolapse (POP) 5 . The non-ablative thermal-only Er:YAG technology works by creating rapid sequential heat pulses that are transferred deeper into mucosa (up to 500 mm), without overheating the tissue surface. ...
Article
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Background: Energy-based devices are becoming a popular option for minimally invasive vaginal procedures. The aim of this study was to obtain information on the frequency of occurrence of adverse effects (AEs) related to vaginal erbium laser (VEL™) treatment. Materials and methods: The global survey was conducted among practitioners using the non-ablative VEL™ (Fotona, Ljubljana, Slovenia). Users were invited to provide the number of patients treated with VEL™ and the number of observed laser-related AEs. Results: The survey was conducted from August 2018 to April 2019. Responses from 535 practitioners were collected, with a total of 113,174 patients treated in the period from 2012 to 2019. Out of 535 respondents, 160 (30%) shared detailed information about the indications they treated in a population of 62,727 patients, whereas 188 (35%) respondents provided information on the frequency of AEs observed in their treated population of 43,095 patients. All observed AEs were mild to moderate, transient and appeared with low frequencies. Conclusions: Minimally invasive thermal-only laser treatment using the non-ablative VEL™ procedures appears to be safe and the incidence of AEs is low.
... An important component of these treatments is the remodeling of existing collagen fibers and the stimulation of new collagen synthesis through fibroblast activation, resulting in a firmer and thicker vaginal wall [2] . Several published clinical studies have shown the effectiveness and safety of VEL in the treatment of stress urinary incontinence (SUI), genitourinary syndrome of menopause (GSM), pelvic organ prolapse (POP), and vaginal laxity [3][4][5][6][7] . All of these studies have reported only mild, transient and rare side effects. ...
Article
Full-text available
Vaginal erbium laser (VEL) treatments with the SMOOTH™ technology are becoming a popular minimally invasive solution for treating various conditions connected to pelvic floor dysfunction. There have thus far been no published data, however, on the impact of these treatments on subsequent (post-laser treatment) vaginal deliveries. A patient survey for patients who gave birth after laser treatment was designed to take into consideration several other factors that could potentially impact vaginal delivery, e.g. infant weight, pregnancy complications, mother’s BMI, etc. The questionnaire was distributed to patients from three international centers – 37 patients responded to the survey. The results showed no impact of vaginal VEL SMOOTH™ treatments on subsequent deliveries. The results indicate that vaginal erbium laser with SMOOTH™ technology is a safe option for treating pre-menopausal women between deliveries. Published in EGO - European Gyncology and Obstetrics ( https://www.egojournal.eu/ )
... The rejuvenation of the mucous tissue following Er:YAG non-ablative vaginal resurfacing has been shown to alleviate symptoms of atrophy Fig. 10 Observed clinical effect on human skin following a single pulse with 2940 nm Er:YAG laser and with 1340 nm Nd:YAP laser, both with a laser pulse duration of t in = 300 μs. The laser spot size of both laser types was approximately 1 mm [42][43][44][45][46][47], stress urinary incontinence [48][49][50][51][52][53][54][55], and vaginal relaxation syndrome [56][57][58][59][60][61]. Similarly, non-ablative resurfacing of soft palate, uvula, and tonsillary regions has been reported to significantly reduce symptoms of chronic snoring-related sleep disorders [23]. ...
Article
Full-text available
According to the standard Arrhenius relation, tissue damage is linearly dependent on the duration of exposure to elevated temperatures and exponentially dependent on the temperature itself. However, recently published measurements of damage threshold temperatures at extremely short exposure times (commonly present during laser treatments) exhibit a shift to temperatures that are higher than what would normally be expected from a single-process Arrhenius model. A novel variable heat shock (VHS) response model was developed that takes into account the observed deviation from the single-process Arrhenius relation, by assuming that the cell viability can be described as the combined effect of two biochemical processes that dominate cell survival characteristics at very short and very long exposure times. The potential implications of the VHS model are explored theoretically through an example of non-ablative laser resurfacing. The VHS model shows that under the appropriate conditions, very high temperature heat shocks can be generated within the superficial epithelium tissue layer without causing irreversible tissue damage. A mechanism of action for tissue regeneration by means of non-ablative resurfacing with the Er:YAG laser is proposed, which involves indirect triggering of tissue regeneration through intense heat shock to the epithelia, in addition to the tissue regeneration mechanism by means of direct thermal injury to deeper lying connective tissues.
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Transvaginal laser therapies are being increasingly used for a variety of indications, particularly genitourinary syndrome of the menopause and stress urinary incontinence. This article reviews the current data pertaining to the place of these devices in current clinical practice. Whilst there has been a rapid increase in the number of publications over the last few years, many of the studies are of small numbers, short duration, and poor quality and are device-sponsored. The evidence suggests that vaginal laser therapy with either the erbium-doped yttrium aluminum garnet laser (FotonaSmooth®) or the CO2 laser (MonaLisa Touch®) is an effective intervention for the relief of symptoms of vulvovaginal atrophy in symptomatic women. The benefits of three laser treatments appear to last for at least 12 months and the procedure is generally well tolerated, with transient minor discomfort being the most common adverse event. Whilst the vaginal laser certainly has the potential to be an alternative treatment to vaginal estrogens for those groups of women, such as breast cancer patients, who cannot take them, there are still many unanswered questions about the role of vaginal laser therapy in clinical practice, particularly in relation to standard conservative management. The place of vaginal laser therapy in other conditions such as stress urinary incontinence is less clear. The outcomes from several ongoing randomized trials should help to answer some of these questions. In the meantime, the use of vaginal laser devices should be confined to clinical trials.
Article
The use of lasers to treat gynaecological and urogynaecological conditions including genitourinary syndrome of the menopause, stress urinary incontinence, vaginal prolapse and other conditions, has become increasingly popular over recent years. Following widespread concerns over the use of mesh for treating stress urinary incontinence and pelvic organ prolapse and potential adverse outcomes from the use of mesh, there has been heightened awareness and debate over the introduction and adoption of new technologies and interventions within the speciality. On July 30th 2018 the United States Food and Drug Administration (FDA) issued a warning against the use of energy based devices (EBDS) including laser to perform "vaginal rejuvenation" or vaginal cosmetic procedures. Numerous review articles and editorials have urged for greater evidence on the efficacy and safety of vaginal lasers This review outlines the evidence to date for the use of lasers in the treatment of gynaecological conditions.
Article
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The study presents an assessment of mechanism of action and a pilot clinical study of efficacy and safety of the Er:YAG laser for the treatment of stress urinary incontinence (SUI). The subject of this study is a treatment of SUI with a 2940 nm Er:YAG laser, operating in a special SMOOTH mode designed to increase temperature of the vaginal mucosa up to maximally 60-65 °C without ablating the epidermis. Numerical modelling of the temperature distribution within mucosa tissue following an irradiation with the SMOOTH mode Er:YAG laser was performed in order to determine the appropriate range of laser parameters. The laser treatment parameters were further confirmed by measuring in vivo temperatures of the vaginal mucosa using a thermal camera. To investigate the clinical efficacy and safety of the SMOOTH mode Er:YAG laser SUI treatment, a pilot clinical study was performed. The study recruited 31 female patients suffering from SUI. Follow-ups were scheduled at 1, 2, and 6 months post treatment. ICIQ-UI questionnaires were collected as a primary trial endpoint. Secondary endpoints included perineometry and residual urine volume measurements at baseline and all follow-ups. Thermal camera measurements have shown the optimal increase in temperature of the vaginal mucosa following treatment of SUI with a SMOOTH mode Er:YAG laser. Primary endpoint, the change in ICIQ-UI score, showed clinically relevant and statistically significant improvement after all follow-ups compared to baseline scores. There was also improvement in the secondary endpoints. Only mild and transient adverse events and no serious adverse events were reported. The results indicate that non-ablative Er:YAG laser therapy is a promising minimally invasive non-surgical option for treating women with SUI symptoms.
Article
Full-text available
Background and objective: Urinary incontinence (UI) is a common disorder that affects women of various ages and impacts all aspects of life. Our aim was to evaluate the non-invasive erbium:yttrium-aluminum-garnet (Er:YAG) laser that exploits its thermal effect and has been used in reconstructive and rejuvenation surgery as a potential treatment strategy for stress UI (SUI) and mixed UI (MUI). Study design/materials and methods: We included 175 women (aged 49.7 ± 10 years) with newly diagnosed SUI (66% of women) and MUI (34%), respectively. Patients were clinically examined and classified by incontinence types (SUI and MUI) and grades (mild, moderate, severe, and very severe) using International Consultation on Incontinence Modular Questionnaire (ICIQ) and assessing Incontinence Severity Index (ISI). Using Er:YAG laser, we performed on average 2.5 ± 0.5 procedures in each woman separated by a 2 month period. At each session, clinical examination was performed, ICIQ and ISI assessed and treatment discomfort measured with visual analog system (VAS) pain scale, and adverse effects and patients' satisfaction were followed. Follow-ups were performed at 2, 6, and 12 months after the treatment. Results: After the treatment, ISI decreased for 2.6 ± 1.0 points in patients diagnosed with mild UI before the treatment, for 3.6 ± 1.4 points in those with moderate UI, for 5.7 ± 1.8 points in those with severe UI and for 8.4 ± 2.6 in those with very severe UI (P < 0.001, paired samples t-test). Altogether, in 77% patients diagnosed with SUI, a significant improvement was found after treatment, while only 34% of women with MUI exhibited no UI at one year follow-up. Age did not affect the outcome. No major adverse effects were noticed in either group. Conclusion: The results of our study, have shown that new non-invasive Er:YAG laser could be regarded as a promising additional treatment strategy for SUI with at least one year lasting positive effects. On the other hand, it does not seem appropriate for treating MUI. Lasers Surg. Med. © 2015 Wiley Periodicals, Inc.
Article
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The aim of this paper is to present a novel laser technology utilizing the erbium YAG laser for various minimally invasive, non-surgical procedures in gynecology. Non-ablative, thermal-only SMOOTH-mode erbium pulses are used to produce vaginal collagen hyperthermia, followed by collagen remodeling and the synthesis of new collagen fibers, resulting in improved vaginal tissue tightness and elasticity. This erbium laser technology is used for treatments of vaginal laxity, stress urinary incontinence, pelvic organ prolapse and vaginal atrophy. In the period from 2010 to 2014, several clinical studies covering all four indications were conducted with the aim to prove the efficacy and safety of this novel technology. An overview is presented of the results of these studies where several objective as well as subjective assessment tools were used. The results have shown that SMOOTH-mode erbium laser seems to be an effective and safe method for treating vaginal laxity, stress urinary incontinence, pelvic organ prolapses and vaginal atrophy.
Article
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To evaluate the long-term efficacy and safety of transobturator four-arm mesh for treating cystoceles. In this prospective study, 105 patients had a cystocele corrected between January 2004 and December 2008. All patients had a symptomatic cystocele of stage ⩾2 according to the Baden-Walker halfway stratification. We used only the transobturator four-arm mesh kit (Surgimesh®, Aspide Medical, France). All surgical procedures were carried out by the same experienced surgeon. The patients' characteristics and surgical variables were recorded prospectively. The anatomical outcome, as measured by a physical examination and postoperative stratification of prolapse, and functional outcome, as assessed by a questionnaire derived from the French equivalents of the Pelvic Floor Distress Inventory, Pelvic Floor Impact Questionnaire and the Pelvic Organ Prolapse-Urinary Incontinence-Sexual Questionnaire, were considered as the primary outcome measures. Peri- and postoperative complications constituted the secondary outcome measures. At 36 months after surgery the anatomical success rate (stage 0 or 1) was 93%. On a functional level, all the scores of quality of life and sexuality were improved. The overall satisfaction score (visual analogue scale) was 71.4%. There were no perioperative adverse events. Mesh erosion was reported in 7.6% and mesh retraction in 5.7% of the patients. If the guidelines and precautions are followed, vaginal prosthetic surgery for genitourinary prolapse has shown long-term benefits. It provides excellent results both anatomically and functionally. However, complications are not negligible and some are specific to prosthetic surgery.
Article
Full-text available
Some of the most common health problems among women that are caused by a deteriorating laxity, elasticity and tightness of mucous membranes are vaginal relaxation (and the associated loss of sexual gratification) and stress urinary incontinence. Recently, two novel minimally invasive, non-ablative Er:YAG laser techniques have been introduced, a vaginal tightening therapy IntimaLase TM and a stress urinary incontinence therapy IncontiLase TM , which show the potential to become an optimal solution for many women suffering from these problems. Both treatment techniques exploit the photothermal effect of a laser beam on mucosa tissue in order to cause its shrinkage without any removal of tissue. The overall impact and burden on the patient's organism is thus minimal, as opposed to more invasive classical or laser surgical procedures. In this paper, a special Er:YAG Pixel Screen technology used in these novel gynecological treatments, and its ablative characteristics, are first analyzed with the aim to establish a range of laser parameters for safe, single-pulse or SMOOTH mode, non-ablative treatment of mucosa tissue. The initial results of multi-center clinical studies of the IntimaLase TM and IncontiLase TM treatments are then presented. All five centers involved in the studies of the IntimaLase TM treatment reported positive results, i.e an improvement in vaginal tightness for a large majority of treated patients, with practically no adverse effects. Similarly, all four studies of the IncontiLase TM treatment showed improvement in stress urinary incontinence (SUI) for a large majority of treated patients. Many patients with mild SUI reported to become free of the symptoms of incontinence following the treatment. There were no adverse effects of this treatment reported in any of the studies. Based on these initial clinical results, the new IntimaLase TM and IncontiLase TM gynecological treatments are promising to become a minimally invasive solution of choice for many women suffering from vaginal relaxation syndrome or stress urinary incontinence.
Article
Objective: To evaluate the efficacy of laser photothermal therapy in a group of Chilean women with SUI. Material and methods: Longitudinal prospective study based on 42 women with mild-to-severe SUI, intervened with non ablative Er:YAG laser, between July 2014 and October 2015, in Santiago, Chile. The therapy efficacy was evaluated through the difference between every patient's scores obtained, before and after treatment, with the International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-SF), at a confidence level of 95%. Also, the patient satisfaction with treatment was reported through an ordinal scale. Results: ICIQ-SF median score was 11 before treatment and 3 after 6 months, with a significant difference per patient (p<0.001). 78.6% (n=33) reported improvement and 38.1% (n=16), a complete healing of SUI at follow up. 66.7% (n=28) reported high satisfaction and 81.8% (n=27) of sexually active women, also reported improvement of sexual gratification. Only mild pain during the procedure was reported as adverse effect. Conclusions: Based on this short-term pilot study, non-ablative Er:YAG laser procedure seems to be a safe and efficacious alternative for patients with SUI. Further controlled studies will help to validate the use of non-ablative Er:YAG for treatment of SUI.
Article
The aim of this study was to evaluate the effects of Vaginal Erbium Laser (VEL) in the treatment of postmenopausal women (PMW) suffering from genitourinary syndrome of menopause (GSM). GSM was assessed in PMW before and after VEL (1 treatment every 30 days, for 3 months; n=45); the results were compared with the effects of a standard treatment for GSM (1 g of vaginal gel containing 50 mcg of Estriol, twice weekly for 3 months; n=25). GSM was evaluated either with subjective (visual analog scale, VAS) and objective (Vaginal Health Index Score, VHIS) measures. In addition, in 19 of these PMW suffering from stress urinary incontinence (SUI), the degree of incontinence was evaluated with the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) before and after VEL treatments. VEL treatment induced a significant decrease of VAS of both vaginal dryness and dyspareunia (p<0.01), with a significant (p<0.01) increase of VHIS. In PMW suffering from mild-moderate SUI, VEL treatment was associated with a significant (p<0.01) improvement of ICIQ-SF scores. The effects were rapid and long lasting, up to the 24th week of the observation period. VEL was well tolerated with less than 3% of patients discontinuing treatment due to adverse events. This pilot study demonstrates that VEL induces a significant improvement of GSM, including vaginal dryness, dyspareunia and mild-moderate SUI. Further studies are needed to explore the role of laser treatments in the management of GSM.
Article
In this study we evaluated the short term effects of vaginal erbium laser (VEL) in the treatment of postmenopausal women (PMW) suffering from genitourinary syndrome of menopause (GSM). Sixty-five PMW were evaluated before and after VEL treatment (1 treatment every 30 days, for 3 months). GSM symptoms were evaluated either with subjective (Visual Analog Scale, VAS) and objective (Vaginal Health Index Score, VHIS) measures. In addition, in 21 of these PMW suffering from mild-moderate stress urinary incontinence (SUI), the degree of incontinence was evaluated with the International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF) before and after VEL treatments. VEL treatment induced a significant decrease of VAS of both vaginal dryness, dyspareunia (P<0.01) and a significant (P<0.01) increase of VHIS). In addition, VEL treatment induced a significant (P<0.01) improvement of ICIQ-SF scores in PMW suffering from SUI. VEL was well tolerated with less than 2 % of patients discontinuing treatment due to adverse events. VEL treatment significantly improves vaginal dryness, dyspareunia and mild-moderate SUI. Larger and long-term studies are needed to investigate the role of laser treatments in the management of GSM.