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ORIGINAL RESEARCH & REVIEWS
Treating Vaginal Laxity Using Nonablative Er:YAG Laser: A
Retrospective Case Series of Patients From 2.5 Years of Clinical
Practice
Midori Mitsuyuki, MD,
1
Ula
Stok, MSc,
2,3
Irena Hreljac, PhD,
4
Kikue Yoda, MS,
5
and Zdenko Vi
zintin, Msc
4
ABSTRACT
Introduction: Vaginal laxity drastically impairs women’s quality of life, suggesting there is a need for effective
noninvasive treatments.
Aim: The aim was to retrospectively assess the effectiveness and safety of a nonablative Er:YAG IntimaLase laser
procedure for vaginal laxity in patients treated in our clinical practice during a 2.5-year period.
Methods: Laser treatment for vaginal laxity was performed using an intravaginal nonablative Er:YAG laser.
Effectiveness was assessed using a Patient Satisfaction Questionnaire and also by independent evaluation of before
and after treatment photographs of the patients’introitus. The safety and tolerability of the procedure was
monitored in all patients.
Main Outcome Measure: The study showed an improvement of sexual gratification and improvement of
vaginal tightness, as assessed by patients. The tightness of the introitus was also improved, as assessed by in-
dependent evaluators.
Results: As assessed by the Patient Satisfaction Questionnaire, we show that 92.7% of patients experienced
improvement of sexual gratification after IntimaLase laser treatment. The results of the visual evaluation of the
grade of laxity improvement in the introitus area, when open introitus photos were evaluated, show that 69%
(n ¼20/29) of patients had an improvement of laxity. Nonablative Er:YAG treatment seems to be an effective
and safe treatment for vaginal laxity. As it is a noninvasive procedure, it should be considered before any vag-
inoplasty surgery. The study included all the patients treated in clinical practice and observed very few adverse
effects. The results were comparable with other published data. Because it is a retrospective study, there is a lack
of a control group.
Conclusion: The results have confirmed that patients suffering from vaginal laxity can be effectively treated using
the nonablative Er:YAG IntimaLase procedure without adverse effects. Mitsuyuki M,
Stok U, Hreljac I.
Treating Vaginal Laxity Using Nonablative Er:YAG Laser: A Retrospective Case Series of Patients From
2.5 Years of Clinical Practice. Sex Med 2020;XX:XXXeXXX.
Copyright 2020, The Authors. Published by Elsevier Inc. on behalf of the International Society for Sexual Medicine.
This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Key Words: Vaginal Laxity; ER:YAG Laser; Sexual Gratification; Quality of Life
INTRODUCTION
Vaginal laxity has long been an underreported problem,
mainly due to the societal stigma associated with women’s
sexuality. As vaginal laxity has not been historically recognized as
a treatable condition, there are still no existing objective criteria
or standardized questionnaires for determining the impact of
vaginal laxity on sexual function in women. The prevalence of
vaginal laxity has started to be systematically addressed only
recently, with 2 studies showing that 28e40% of surveyed
women (patients in urogynecological clinics) suffered from a
degree of vaginal laxity that negatively affects their quality of life
(QoL).
1,2
In the study by Dietz et al,
2
the women rated the
Received August 20, 2019. Accepted January 1, 2020.
1
Midori Beauty Clinic Hiroo, Tokyo, Japan;
2
University Medical Centre Ljubljana, Department of Rheumatology, Ljubl-
jana, Slovenia;
3
University of Ljubljana, Faculty of Pharmacy, Ljubljana, Slovenia;
4
Fotona d.o.o., Ljubljana, Slovenia;
5
Haltek, Tokyo, Japan
Copyright ª2020, The Authors. Published by Elsevier Inc. on behalf of
the International Society for Sexual Medicine. This is an open access
article under the CC BY-NC-ND license (http://creativecommons.org/
licenses/by-nc-nd/4.0/).
https://doi.org/10.1016/j.esxm.2020.01.001
Sex Med 2020;-:1e91
problem a score of 5.7 on a 0-10 Visual Analog Scale (VAS)
scale. In the study by Campbell et al,
1
48% of surveyed women
reported symptoms of vaginal laxity and almost 90% of these
women reported vaginal laxity as a presenting a problem. Phy-
sicians have also started to recognize vaginal laxity as a bother-
some symptom in their patientsePauls et al
3
published a survey
of urogynecologists’perception of vaginal laxity issues. The study
included answers from 563 urogynecologists spanning 6 conti-
nents. A vast majority (87%) of the surveyed physicians agreed
that vaginal laxity is underreported by their patients; 57%
thought that it is a bothersome QoL condition that impacts
relationship happiness; and 95% felt that vaginal laxity impacts
sexual function. A majority of respondents recommended Kegel
muscle training (75.5%), while surgical repair was offered by
54% of respondents, with North American doctors more in-
clined to perform surgeries than their counterparts on other
continents. Despite these results showing an awareness of the
problem, there is still no standardized definition of vaginal laxity,
or guidelines for diagnosis and treatment. Because vaginal laxity
is a QoL issue but is not life-threatening, noninvasive methods
are the main treatment of choice both for patients and doctors.
Traditional noninvasive methods include physical therapy and
Kegel exercises, which have limited efficiency due to poor patient
compliance. Invasive surgical methods have been proven effec-
tive. Vaginoplasty is a joint term for surgical tightening of the
vaginal canal that involves different surgical procedures aimed to
decrease the diameter of the vaginal canal and reduce excessive
vulvar tissue. These procedures include excision of redundant
vaginal tissues, muscular tightening by imbrication of the median
levator ani muscles, remodeling of the perineal body, and exci-
sion of surplus skin.
4
However, there is reluctance in offering
surgical treatments for QoL problems, such as vaginal laxity.
In the last decade, new energy deviceebased therapies have
become available, including radiofrequency, high-focused ultra-
sound, and different laser therapies.
5,6
These methods are
minimally invasive and offer better efficiency than traditional
noninvasive methods. 2 different laser technologies have been
proposed to treat genitourinary problems—microablative frac-
tional CO
2
lasers and Er:YAG lasers. Microablative fractional
CO
2
laser works by creating superficial microablation zones on
the mucosal surface—as a result, a healing response is triggered,
resulting in new collagen formation. Nonablative Er:YAG laser
works by creating rapid sequential heat pulses, which are com-
pounded and transferred deeper into the mucosa. The fast heat
pulsing results in tightening of the mucosa and stimulation of
new collagen formation, without injuring the tissue surface.
Er:YAG laser incorporating Fotona SMOOTH technology
effectively restores tissue quality, but it works in a nonablative
manner, leaving the surface intact. In this way, the risk of un-
wanted side effects, especially after multiple repeated treatments,
is greatly reduced. For the aforementioned reasons, we have
chosen the nonablative Er:YAG IntimaLase treatment as our
noninvasive treatment of choice for vaginal laxity patients.
In the present study, we report on a retrospective case series of
patients treated in our clinic, which included patients with
vaginal laxity from our clinical practice who received the Inti-
maLase treatment during a 2.5-year period.
PARTICIPANTS AND METHODS
This study is a retrospective case series, based on a chart review
of patients treated in our clinic in Tokyo. A total of 364 patients
suffering from vaginal laxity were treated in our clinic using a
nonablative Er:YAG treatment protocoleIntimaLase (XS
Dynamis, Fotona, Slovenia) between October 2013 and
February 2016.
All treated women had complained about symptoms of vaginal
looseness, which negatively impacted their QoL. They were older
than 18 years, with normal cell cytology (Papanicolaou smear),
negative for urinary infections, with a vaginal canal and introitus
free of injuries. Pregnant women and active users of photosen-
sitive drugs or women having any genitourinary infection and/or
injury were deemed ineligible for the treatment.
All patients were provided with detailed information about the
treatment. Telephone follow-ups were scheduled for all patients
after 48 hours and at 3 and 12 months after the final treatment
to obtain data on treatment safety and efficacy.
Informed consent for inclusion of their data into the retro-
spective case series was obtained from all individual participants
included in the study, and ethical approval was obtained for this
retrospective study.
The efficacy of vaginal tightening was assessed using a sub-
jective patient’s evaluation of improvement after the laser
treatment—a Patient Satisfaction Questionnaire (Table 1); the
patients completed question 1 at the follow-up 3 months after
the treatment (question 1), whereas they answered question 2
before the treatment and at every telephone follow-up. The
questionnaire comprised 2 questions: the first question asking for
information about improvement of sexual gratification after the
laser treatment and the second question about the sensation of
the degree of the tightness of the vagina after the laser treatment
(see Table 1). The numbers of patients who answered both
questions of the questionnaire greatly differed—that is why the
patients were retrospectively divided into 2 different sub-
groups—group 1 including patients who answered question 1
and group 2 including patients who answered question 2. The
analysis was performed using anonymized data retrieved from
patient charts.
Effectiveness of the treatment on the tightening of the
introitus was also determined in a subgroup of patients (group 3)
that had introitus pictures taken before and after the procedure.
The evaluation was carried out by blinded analysis of standard-
ized photographs of open introitus that were taken before the
treatment and 12 months after the final treatment. All the
photographs were taken by the lead investigator. The camera
Sex Med 2020;-:1e9
2Mitsuyuki et al
used was a RICOH CX5 digital camera with 10 megapixel
resolution.
2 independent evaluators were given a pair of before and after
photos for each patient and were asked to (i) determine whether
a photo was taken before or after the treatment and (ii) evaluate
the level of improvement on a Likert scale (0: no change, 1: mild,
2: moderate, 3: excellent change).
Hundred forty-eight women were included in the retrospec-
tive efficacy assessment, as they have either filled out one or both
questions of the Patient Satisfaction Questionnaire (group 1 and
2) or had photographs evaluated by blinded reviewers (group 3).
All statistical analysis was performed using GraphPad Prism
statistical software.
The safety and tolerability of the treatment were monitored in
all treated patients (N ¼364). The tolerability of the procedure
was assessed by measuring patient discomfort data on a 0-10
VAS scale. Safety was measured by monitoring and documenting
side effects during and after the procedure.
The IntimaLase treatment protocol was performed using a
2,940 nm Er:YAG laser using a unique nonablative Fotona
SMOOTH mode (XS Dynamis, Fotona, Slovenia). In this
SMOOTH modality, one pulse sequence comprises a train of
several micropulses, resulting in a gradual temperature increase in
the vaginal mucosa, enabling controlled heating of the lamina
propria to a range between 45 and 65C, which is the optimal
temperature range for collagen remodeling. The IntimaLase
protocol consists of 2 steps. In the first step, a full-beam hand-
piece (R11) was used together with a circular intravaginal
adapter, which delivers a 360laser beam to the whole circum-
ference of the vaginal canal. The whole length of the vagina was
treated by sequentially moving the handpiece outward by 5 mm
until the entrance to the vaginal canal had been reached.
250 joules of energy was delivered per pass, corresponding to 3 J/
cm
2
of fluence per one SMOOTH pulse. 2 complete passes
along the length of the vaginal canal were completed in the first
step. In the second step, a fractional handpiece (PS03) was used
to deliver laser pulses to the entrance of the vaginal canal. 3
passes of the whole vestibule and introitus area were completed
in this step, each pass depositing around 10 J of laser energy. The
patients received 2-3 IntimaLase sessions with 30 days interval
between the sessions.
Before the treatment, topical anesthesia (10% lidocaine cream)
was applied to the introitus and the distal portion of the vaginal
canal. The anesthetic was left for 10 minutes and then wiped off.
Before the laser treatment, the patients’vestibule, introitus, and
the vaginal canal were washed with physiological solution and
carefully dried off. After the procedure, the patients were advised
to avoid sexual intercourse for at least 3 days. Other post-
operative precautions were not necessary.
RESULTS
In the period between October 2013 and February 2016, 364
patients underwent a noninvasive Er:YAG laser treatment with
the aim to reduce symptoms of vaginal laxity (IntimaLase,
Fotona, Slovenia). Demographic characteristics of the patients
are summarized in Table 2. Patients who were evaluated using
one or more efficacy measures (148 patients in total—some
patients were included in more than one subgroup as they had
been evaluated by more than one efficacy method) were divided
into 3 groups, depending on the efficacy assessment method.
The first subgroup of patients comprised individuals who
responded to the first question of the Patient Satisfaction
Table 2. Demographic data on patients involved in the study
Group demographics Total Group 1 Group 2 Group 3
Number of patients 364 144 11 29
Mean age (95% CI) 42.8 (41.7e43.8) 44.7 (43.2e46.3) 42.9 (37.1e48.6) 43.5 (40.1e46.7)
Mean BMI (95% CI) 20.2 (19.9e20.4) 20.5 (20.1e20.9) 19.8 (18.2e21.3) 19.5 (18.8e20.2)
Parity (95% CI) 1.40 (1.3e1.5) 1.53 (1.4e1.7) 1.55 (0.7e2.3) 1.52 (1.1e1.9)
% menopause patients 19.5 18.8 18.2 20.7
Three hundred sixty-four patients in total underwent IntimaLase procedure in our clinic. Group 1 included patients who have answered the question 1 of the
Patient Satisfaction Questionnaire, group 2 included patients who have answered question 2, and group 3 included patients who were included into visual
evaluation of improvement laxity at the introitus. There were no significant demographic differences between groups.
BMI ¼body mass index.
Table 1. Patient Satisfaction Questionnaire
Patient Satisfaction Questionnaire
Q1. How do you assess improvement of sexual gratification after
laser treatment?
0¼No sexual relations since treatment
1¼No improvement
2¼Noticeable improvement
3¼Large improvement
Q2. How do you assess the tightness of your vagina?
1¼very loose
2¼loose
3¼normal
4¼tight
5¼very tight
Question 1 was used to assess improvement of sexual gratification, whereas
question 2 was used to assess vaginal tightness by patients who have
undergone the IntimaLase procedure.
Sex Med 2020;-:1e9
Er:YAG Laser for Vaginal Laxity 3
Questionnaire (see Table 1) at their 3-month follow-up
(n ¼144); the second, a much smaller subgroup included the
patients who responded to the second question before treatment,
at the 3-month follow-up and at the 12-month follow-up
(n ¼11); and the third subgroup included patients who were
evaluated using the independent blinded evaluation of before and
after pictures of the open introitus (n ¼29). There were no
statistically significant differences between the groups in any of
the collected demographic parameters (analysis was performed
using the Kruskal-Wallis one-way analysis of variance with
multiple comparisons test).
Group 1 included 144 patients who answered question 1 at
the follow-up 3 months after the treatment. Thirty-four patients
were excluded from the analysis of group 1, as they had marked
0 on the questionnaire, indicating that they had no sexual re-
lations since the treatment. Of the remaining patients, 32.7%
(n ¼36/110) reported a large improvement of sexual gratifica-
tion after the laser treatment, 60% (n ¼66/110) reported
noticeable improvement, and only 7% (n ¼8/110) reported no
improvement. Together, 92.7% (n ¼102/110) of patients in
group 1 claimed improvement of sexual gratification after the
laser treatment (Figure 1).
Group 2 (n ¼11, except at the 12-month follow-up, where
n¼10) (Table 3) consisted of a small subgroup of 11 patients
who also responded to the second question, which asked them to
estimate the degree of their vaginal tightness before the treatment
and at each follow-up at 3 and 12 months after treatment. At the
second follow-up at 12 months, 60% (n ¼6/10) of patients in
group 2 evaluated their vaginal canal to be tight or very tight,
whereas before the treatment, none of the patients considered
their vaginal canal to be tight or very tight (Figure 2,Table 3).
Of the patients in group 2, 36.4% (n ¼4/11) reported their
vaginal canal to be very loose before the treatment; however,
none of the patients considered it loose anymore at the follow-
ups 3 months and 12 months after the treatment (Figure 2,
Table 3).
Group 3 consisted of a subgroup of patients (n ¼29) who
were also evaluated using the objective visual evaluations of the
grade of laxity evaluated by 2 independent reviewers on the basis
of the patients’introitus photographs taken before and 3 months
after treatment (Figure 3). The objective visual assessments had
shown improvements in laxity at the introitus after IntimaLase
treatment. The results of the visual evaluation of the grade of
laxity improvement in the introitus area have shown that when
open introitus photos were evaluated, 69% (n ¼20/29) of pa-
tients had an improvement of laxity. The differences between the
2 evaluators’assessments of the pictures were checked for both
groups using the Wilcoxon matched-pairs signed rank test and
were not significant. Figure 4 shows examples of the assessed
photographs from 2 patients.
Tolerability and safety of the treatment were evaluated for all
treated patients (n ¼364). Treatment-associated pain was esti-
mated on average as 1 on a VAS 0-10 scale. All patients expe-
rienced transient edema after the treatment, which receded after
1e2 days. Stronger vaginal discharge was reported by 40% of
patients, while transient urge incontinence was reported by 3%
of patients. All adverse effects were mild and transient.
DISCUSSION
Vaginal laxity significantly impairs patients’sexual function
and reduces their QoL.
3
Recently, different studies suggested
promising short-term results with treating vaginal laxity using
energy-based devices such as lasers and low-dose radio-
frequency.
5,6
In the present study, we aimed to retrospectively
extract and analyze the safety and efficacy data of the nonablative
Er:YAG IntimaLase treatments performed in our clinical practice
during a 2.5-year period. The results of our retrospective case
series indicate that the nonablative Er:YAG laser produced
favorable results without serious adverse effects.
The effect on sexual gratification was assessed using a Patient
Satisfaction Questionnaire. The results have shown that 92.7%
of patients in group 1 experienced an improvement of sexual
gratification after receiving IntimaLase laser treatment. Our re-
sults are in accordance with previously published studies; Gaviria
and Lanz
7
have shown improvement in vaginal laxity, high pa-
tient satisfaction, and also calculated the duration of the
Figure 1. Patients' improvement in sexual satisfaction after the
vaginal laser tightening as assessed by question 1 from the Patient
Satisfaction Questionnaire. The numbers represent percentages of
sexually active patients in group 1 (n ¼110) by estimated levels of
improvement. Thirty-three percent of patients (n ¼36) reported
large improvement, 60% of patients (n ¼66) reported noticeable
improvement, and 7.3% of patients (n ¼8) reported no
improvement.
Sex Med 2020;-:1e9
4Mitsuyuki et al
treatment’s effects in a retrospective study with a 3-year follow-
up period.
8
Pardo and Dalenz
9
evaluated sexual satisfaction
before and after the IntimaLase treatment and also the patient’s
satisfaction with the procedure. They found that the mean level
of improvement in sexual satisfaction was 70% and the mean
level of satisfaction with the laser vaginal tightening procedure
was 75%. All the aforementioned studies have shown a
significant improvement of symptoms without adverse effects
even after repeated treatments and prolonged periods of time.
8,10
Our results strongly indicate that the laser treatment improved
the sexual gratification of the treated patients; however, it was
recorded only using a self-reported questionnaire. Owing to the
absence of a control group, other factors that might have influ-
enced sexual gratification in women may have been overlooked.
Table 3. Assessment of vaginal laxity in group 2 (n ¼11 patients who answered question 2 of the Patient Satisfaction Questionnaire)
before and at the 3- and 12-month follow-ups
Patient no. Before
3 months
FU 12 months FU
1245
2234
3344
4122
5333
6234
723
8234
9122
10 1 3 5
11 1 2 3
Average (95% CI) 1.82 (1.31e2.32) 2.91 (2.44e3.38) 3.60 (2.83e4.37)
P-value (FU vs before) 0.029*0.0006
†
ANOVA ¼analysis of variance; FU ¼follow-up.
Increasing numbers denote increasing sensation of vaginal tightness (see Table 1). Statistical significance was determined using the Kruskal-Wallis one-way
ANOVA with multiple comparisons test.
*P<.05.
†
P<.001.
Figure 2. Distribution of the group 2 patient population (n ¼11) by the estimated levels of vaginal tightness as assessed by question 2 of
the Patient Satisfaction Questionnaire.The columns represent results taken before and at follow-ups 3 and 12 months after the IntimaLase
vaginal laser treatment. Before treatment, 36.4% of patients (n ¼4) reported their vagina to be very loose, whereas 45.5% of patients
(N ¼5) reported their vagina as loose. At both follow-ups, none of the patients reported their vagina as very loose. At the 12-month follow-
up, 80% of patients reported their vagina as either normal, tight, or very tight.
Sex Med 2020;-:1e9
Er:YAG Laser for Vaginal Laxity 5
These may include higher motivation for sexual intercourse of
the patients and their partners because of the received treatment
and selection bias of patients who are motivated to change their
sexual life, as these patients would be highly motivated to come
for treatment and expect improvement.)
Vaginal laxity was estimated using a modified 5-point vaginal
laxity scale—question 2 of the Patient Satisfaction Question-
naire. Patients who answered that question (group 2) had
reported significantly improved symptoms of vaginal laxity at the
3- and 12-month follow-ups after receiving the IntimaLase
treatment. None of the patients in group 2 had categorized their
vagina as very loose at the 1-year follow-up. All patients in group
2 reported an improvement of vaginal laxity. The results of our
retrospective case series are in accordance with other studies,
where the improvement of vaginal laxity symptoms assessed by
patients was in a range of 80e95%.
7e9,11,12
This level of
effectiveness is comparable with that of surgical procedures.
4
The visual evaluations of laxity, which were performed using
independent blind evaluation of before and after photographs of
the introitus, showed an improvement of laxity in 69% of the
evaluated patients (group 3). These results are also in accordance
with the other aforementioned studies.
All 364 treated patients were asked about tolerability and side
effects, which were mild and rare.
Although our results indicate a high effectiveness of the Inti-
maLase treatment for treating vaginal laxity, these would have to
be further confirmed in a randomized controlled trial setting.
2 different laser technologies have been used in the treatment
of genitourinary problems connected to pelvic floor dysfunction:
microablative fractional CO
2
lasers and Er:YAG lasers. A
comparative study on the efficacy of CO
2
vs Er:YAG treatments
has not yet been performed, although there is an ongoing ran-
domized controlled trial to compare the effectiveness of these 2
lasers on the treatments of genitourinary syndrome of meno-
pause/vaginal atrophy.
13
Both technologies have separately
shown to be effective for the treatment of genitourinary condi-
tions. Microablative fractional CO
2
laser, which produces laser
light in the wavelength of 10.6 mm, works by creating micro-
ablation zones on the surface of the mucosa. In these zones,
microscopic punctures with coagulated edges are created; these
stimulate the regenerative response in the skin/mucosal surface,
increasing the synthesis of collagen, the formation of new vessels,
and tightening of the tissue.
14
Even though CO
2
treatments have
been shown effective in treating some genitourinary conditions,
there is concern about the side effects of long-term repetitive
microwounding of the mucosa, as the laser treatments need to be
repeated to maintain symptom free results. There were several
reported cases of pain and burning sensation lasting up to 5 days
after fractional CO
2
laser treatment.
15
Contrary to fractional microablative CO
2
laser, nonablative
Er:YAG laser with Fotona SMOOTH technology does not
injure the tissue surface. Delivering the energy in SMOOTH
pulses heats the epithelial surface up to 500 mm deep into the
mucosa, while at the same time prevents overheating of the
surface because of the optimal spacing between the
Figure 3. Results of objective visual estimation of improvement of the tightness of the introitus after the IntimaLase treatment. Mea-
surements were based on pictures of open introitus in the patient group 3 (n ¼29). The numbers represent the estimated percentage of
patients as per levels of improvement, as estimated by 2 independent reviewers on the basis of before and after (12-month follow-up)
treatment photographs of the open introitus. The lines on the graphs represent the average of both reviewers' estimate. On average,
the change in laxity at the introitus was estimated as excellent in 8.6% of patients, as moderate in 32.8% of patients, and as mild in 27.6%
of patients. No change in laxity was estimated in 31% of the patients' photographs.
Sex Med 2020;-:1e9
6Mitsuyuki et al
micropulses.
12,16
The treatment results in shrinkage of collagen
fibers and the induction of neocollagenesis.
17,18
This distinction is important to understand in light of the Food
and Drug Administration (FDA) warning letter of July 2018,
which was sent to 7 energy-based device manufacturers that
market lasers and other energy-based devices, such as radio-
frequency, for indications of vaginal rejuvenation. The FDA
warning letter resulted in an increased level of skepticism for all
such treatments internationally, even in countries where they have
been approved for clinical use. We disagree with the FDA’s
generalized warning about vaginal laser procedures, as different
lasers have different mechanisms of action and risk profiles. In
contrast to ablative lasers, the laser that we used in our study—
vaginal nonablative erbium laser with Fotona SMOOTH
mode—does not physically harm the tissue surface but creates only
controlled heating of the mucosal surface. It therefore does not
pose any of the safety risks that are connected with tissue ablation,
such as scarring or infection. The safety data from our study and all
other cited clinical trials have shown that all adverse effects are of a
mild and transient nature. Over the past years, nonablative
Er:YAG laser with SMOOTH technology has been used to safely
and effectively treat various genitourinary conditions, such as stress
and mixed urinary incontinence, genitourinary syndrome of
menopause, and pelvic organ prolapse, as well as vaginal
laxity.
7e12,16e21
The limitations of our study include the small number of
patients in subgroups (group 2 and 3) that estimated efficacy in
improving vaginal laxity; this is due to cultural reasons, as many
Japanese patients are reluctant to respond to such questions. A
somewhat larger (n ¼144) subgroup of patients answered the
question regarding the improvement of sexual gratification after
the laser treatment. Despite the low number of patients in the 3
subgroups evaluated for efficacy, they have included different
assessment methods, which have shown consistent improvement
in all analyzed groups, comparable with published data. Our
results give us an indication that the treatment is highly effecti-
ve—this will, however, need to be confirmed in further pro-
spective controlled trials.
The major limitation of this study is that it is not a ran-
domized controlled trial, but a retrospective case-series, without a
control group or a comparator In order to confirm the effect of
the non-ablative vaginal Er:YAG laser on vaginal laxity with the
highest level of clinical evidence, randomized controlled trials
should be performed.
Figure 4. Examples of photographs used in objective estimation of laxity of the introital area before and after treatment (group 3,
N¼29). Images show the vulvar area of 2 patients (first patient: A and B; second patient: C and D) before nonablative Er:YAG laser
treatment (A) (C) and 12 months after the second treatment (B) (D) in open introitus view.
Sex Med 2020;-:1e9
Er:YAG Laser for Vaginal Laxity 7
Conditions related to age- and childbirth-related pelvic floor
dysfunction affect hundreds of millions of women worldwide.
22
These conditions are interconnected, as their major cause is
weakening of the pelvic floor support. One of the main factors in
pelvic floor dysfunction is the laxity in the vagina and its sup-
porting ligaments due to increasing age and vaginal childbirth.
Dietz et al
2
have found strong concurrence of vaginal laxity with
early pelvic prolapse stages, and even proposed that vaginal laxity
may be the first stage in the development of pelvic organ pro-
lapse. Hence, we can speculate that the treatment of this both-
ersome condition may not only improve women’s QoL but may
also improve the symptoms or delay the progress of developing
more serious and difficult-to-treat conditions.
CONCLUSIONS
Vaginal laxity is detrimental to quality of life and may be an
early or a concurrent symptom in more conditions related to
pelvic dysfunction. Our data indicates that Er:YAG laser treat-
ment is an effective and safe method for treating vaginal laxity
symptoms, with our results being comparable to other published
studies. Randomized controlled trials are necessary to confirm
these results with highest level of clinical evidence.
Corresponding Author: Zdenko Vizintin, MSc, Fotona, 1000
Ljubljana, Slovenia, Tel: þ386 1 5009100; Fax: þ386 1 5009
206; E-mail: zdenko.vizintin@fotona.com
Conflict of Interest: Irena Hreljac and Zdenko Vizintin are
currently employed by Fotona d.o.o., a medical laser company
and manufacturer of the laser used in the study.
Funding: None.
STATEMENT OF AUTHORSHIP
Category 1
(a) Conception and Design
Midori Mitsuyuki; Kikue Yoda; Zdenko Vi
zintin
(b) Acquisition of Data
Zdenko Vi
zintin; Midori Mitsuyuki
(c) Analysis and Interpretation of Data
Midori Mitsuyuki; Ula
Stok
Category 2
(a) Drafting the Article
Ula
Stok
(b) Revising It for Intellectual Content
Irena Hreljac; Midori Mitsuyuki; Zdenko Vi
zintin; Kikue Yoda
Category 3
(a) Final Approval of the Completed Article
Midori Mitsuyuki; Zdenko Vi
zintin
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