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Treating Vaginal Laxity Using Nonablative Er:YAG Laser: A Retrospective Case Series of Patients From 2.5 Years of Clinical Practice

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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 independent 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 = 20/29) 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 vaginoplasty 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.
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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 womens 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 patientsintroitus. The safety and tolerability of the procedure was
monitored in all patients.
Main Outcome Measure: The study showed an improvement of sexual gratication 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 gratication 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 conrmed 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 Gratication; Quality of Life
INTRODUCTION
Vaginal laxity has long been an underreported problem,
mainly due to the societal stigma associated with womens
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 urogynecologistsperception 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 denition 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 efciency 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 efciency than traditional
noninvasive methods. 2 different laser technologies have been
proposed to treat genitourinary problemsmicroablative frac-
tional CO
2
lasers and Er:YAG lasers. Microablative fractional
CO
2
laser works by creating supercial microablation zones on
the mucosal surfaceas 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 nal treatment
to obtain data on treatment safety and efcacy.
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 efcacy of vaginal tightening was assessed using a sub-
jective patients evaluation of improvement after the laser
treatmenta 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 rst question asking for
information about improvement of sexual gratication 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 differedthat is why the
patients were retrospectively divided into 2 different sub-
groupsgroup 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 nal 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 efcacy assessment, as they have either lled 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 rst 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 uence per one SMOOTH pulse. 2 complete passes
along the length of the vaginal canal were completed in the rst
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 patientsvestibule, 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 efcacy measures (148 patients in totalsome
patients were included in more than one subgroup as they had
been evaluated by more than one efcacy method) were divided
into 3 groups, depending on the efcacy assessment method.
The rst subgroup of patients comprised individuals who
responded to the rst 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 signicant demographic differences between groups.
BMI ¼body mass index.
Table 1. Patient Satisfaction Questionnaire
Patient Satisfaction Questionnaire
Q1. How do you assess improvement of sexual gratication 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 gratication, 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 signicant 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 gratica-
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 gratication 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 patientsintroitus 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 evaluatorsassessments of the pictures were checked for both
groups using the Wilcoxon matched-pairs signed rank test and
were not signicant. 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 signicantly impairs patientssexual 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 efcacy 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 gratication was assessed using a Patient
Satisfaction Questionnaire. The results have shown that 92.7%
of patients in group 1 experienced an improvement of sexual
gratication 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
treatments 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 patients
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
signicant 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 gratication 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 inu-
enced sexual gratication 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 signicance 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 modied 5-point vaginal
laxity scalequestion 2 of the Patient Satisfaction Question-
naire. Patients who answered that question (group 2) had
reported signicantly 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 conrmed in a randomized controlled trial setting.
2 different laser technologies have been used in the treatment
of genitourinary problems connected to pelvic oor dysfunction:
microablative fractional CO
2
lasers and Er:YAG lasers. A
comparative study on the efcacy 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
bers 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 FDAs
generalized warning about vaginal laser procedures, as different
lasers have different mechanisms of action and risk proles. In
contrast to ablative lasers, the laser that we used in our study
vaginal nonablative erbium laser with Fotona SMOOTH
modedoes 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 efcacy 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 gratication after
the laser treatment. Despite the low number of patients in the 3
subgroups evaluated for efcacy, 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-
vethis will, however, need to be conrmed 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 conrm 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 (rst 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 oor
dysfunction affect hundreds of millions of women worldwide.
22
These conditions are interconnected, as their major cause is
weakening of the pelvic oor support. One of the main factors in
pelvic oor 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 rst 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 womens QoL but may
also improve the symptoms or delay the progress of developing
more serious and difcult-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 conrm
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
Conict 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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Sex Med 2020;-:1e9
Er:YAG Laser for Vaginal Laxity 9
... More recently, however, excellent clinical results have been reported for procedures using "SMOOTH" mode Er:YAG laser pulse sequences, characterized by moderate cumulative fluences that are not only below the ablation threshold but also below the patient′s pain threshold [19][20][21][22][23][24][25][26][27][28][29][30][31][32]. The SMOOTH mode Er:YAG laser energy has been found to induce changes in the deeper skin or mucosa, initiating a process of cell activation, production of extracellular matrix, and tissue remodeling, without causing unwanted direct epithelial ablation [33]. ...
... The SMOOTH mode Er:YAG laser energy has been found to induce changes in the deeper skin or mucosa, initiating a process of cell activation, production of extracellular matrix, and tissue remodeling, without causing unwanted direct epithelial ablation [33]. The SMOOTH mode Er:YAG lasers have been, for example, very successfully used for non-ablative laser treatment of vaginal [21][22][23][24][25][26] and oral tissues [27][28][29][30][31][32], and as well for skin tightening [19,20]. ...
... Additionally, as the Er:YAG laser wavelength is limited to its very shallow optical penetration depth, it has been hypothesized that instead of having to rely on the pulse sequence heat-pumping technique, devices with a deeper penetration depth and longer pulse durations may represent a more suitable means for deep thermal remodeling [58]. However, the published clinical results using the smoothresurfacing technique [19][20][21][22][23][24][25][26][27][28][29][30][31][32], suggest that the superficial heat shocking resulting from individual short laser pulses within a SMOOTH sequence may represent an additional, indirect mechanism of action for regenerating epithelial and deeper-lying connective tissues [36][37][38][39][40][41][58][59][60][61][62][63][64][65][66][67], which is complementary to the conventional direct slow stimulation of fibroblasts [68]. ...
Article
Full-text available
Background and Objectives Recently, several minimally invasive gynecological, ENT and esthetic procedures have been introduced that are based on delivering “smooth” sequences of Er:YAG laser pulses to cutaneous or mucosal tissue at moderate cumulative fluences that are not only below the ablation threshold but typically also do not require local anesthesia. To explain the observed clinical results using “smooth‐resurfacing,” it has been suggested that in addition to the direct heat injury to deeper‐lying connective tissues, there is an additional mechanism based on indirect triggering of tissue regeneration through short‐exposure, intense heat shocking of epithelia. The goal of this study is to improve understanding of the complex dynamics of the exposure of tissues to a series of short Er:YAG laser pulses, during which the thermal exposure times transition from extremely short to long durations. Study Design/Materials and Methods A physical model of laser‐tissue interaction was used to calculate the temperature evolution at the irradiated surface and deeper within the tissue, in combination with a chemical model of tissue response based on the recently introduced variable heat shock (VHS) model, which assumes that the tissue damage represents a combined effect of two limiting Arrhenius′ processes, defining cell viability at extremely long and short exposure times. Superficial tissue temperature evolution was measured during smooth‐resurfacing of cutaneous and mucosal tissue, and compared with the model. Two modalities of non‐ablative resurfacing were explored: a standard “sub‐resurfacing” modality with cumulative fluences near the ablation threshold, and the “smooth‐resurfacing” modality with fluences below the patient′s pain threshold. An exemplary skin tightening clinical situation was explored by measuring pain tolerance threshold fluences for treatments on abdominal skin with and without topical anesthesia. The obtained temperature data and pain thresholds were then used to study the influence of Er:YAG laser sequence parameters on the superficial (triggering) and deep (coagulative) tissue response. Results The simulations show that for the sub‐resurfacing modality, the parameter range where no excessive damage to the tissue will occur is very narrow. On the other hand, using pain tolerance as an indicator, the smooth‐resurfacing treatments can be performed more safely and without sacrificing the treatment efficacy. Two preferred smooth‐resurfacing treatment modalities were identified. One involves using optimally long pulse sequence durations (≈1–3 seconds) with an optimal number of pulses (N ≈ 10–30), resulting in a maximal short‐exposure superficial tissue response and moderate coagulation depths. And for deeper coagulation, without significant superficial heat shocking, very long pulse sequences (>5 seconds) with a large number of delivered pulses are to be used in combination with topical anesthesia. Conclusions A comparison of the simulations with the established smooth‐resurfacing clinical protocols in gynecology, ENT, and esthetics suggests that, through clinical experience, the clinical protocols have been optimized for the maximal superficial heat shock triggering effect. Further research is needed to gain a better understanding of the proposed role of heat shock triggering in the clinically observed regeneration of cutaneous, vaginal, and oral tissues following Er:YAG laser smooth‐resurfacing. Lasers Surg. Med. © 2021 The Authors. Lasers in Surgery and Medicine published by Wiley Periodicals LLC.
... Er:YAG laser has proven safe and effective for treating vaginal laxity, stress urinary incontinence, pelvic organ prolapse, and vaginal atrophy [16]. Mitsuyuki et al. [34] reported that 93% of 144 patients receiving an average of 2-3 nonablative Er:YAG laser treatments experienced improvement of their sexual gratification. In addition, a study using Er:YAG laser combined with topical estriol was reported to have more pronounced and longer lasting effect for relieving the symptoms of GSM compared to topical estriol treatment alone [35]. ...
... It is apparent that additional studies are needed to explore the long-term safety and efficacy of various laser therapies for genitourinary symptoms. However, a number of retrospective and prospective trials have showed the safety and efficacy of nonablative, photothermal Er:YAG laser in the treatment of vaginal relaxation syndrome [22,34], and stress and mixed urinary incontinence [36,41,42]. ...
... The present study was conducted during the early period of Er:YAG laser application for the treatment of decreased sexual sensation (study protocol was submitted to our institutional review board last November 2013) when the standard protocol recommendation was to perform only 2 monthly treatments. The current protocol for the treatment of decreased sexual sensation using nonablative Er:YAG laser was a minimum of 3 monthly treatments [34]. Additional treatment sessions, large randomized multi-centered studies with a more diverse set of subjects are warranted to explore the use and utility of this non-invasive treatment on vaginal laxity. ...
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Vaginal laxity, a common cause of decreased sexual sensation, is a common problem affecting the quality of life of women worldwide. Recently, lasers and energy-based devices (EBDs) have been applied in the treatment of this condition. The aim of this study was to compare the efficacy and safety of Er:YAG laser and placebo in treating decreased sexual sensation in Asians. Forty-two patients with decreased sexual sensation were randomized into 2 groups: intervention (laser treatment) and control (placebo treatment). Both groups received two treatments, at 1-month interval. Subjective and objective evaluations were done at baseline, 1-, 3-, and 6-month follow-ups. Pain score and adverse effects were also recorded. In the laser group, there was significant improvement in the patients’ vaginal tightness satisfaction at 1- and 3-month follow-ups (P = 0.002 and 0.004) and also in the patients’ overall satisfaction at 1- and 3-month follow-ups (P = 0.003 and 0.001). Pelvic floor muscle contraction was significantly better in the laser group after the first treatment (P = 0.043). No serious adverse effects were noted. Er:YAG laser provides improvement of sexual sensation for an average of 3 months following treatment. Mild and transient adverse effects such as leukorrhea, dryness, dysuria, vaginal itching, and spot bleeding were noted in the laser group, and these were not significantly different from the control group.
... 58,59 Der Erbium:YAG Laser mit SMOOTH-Modus bietet Programme zur Behandlung von Senkungsbeschwerden und "Loose Vagina" an, die in verschiedenen Ländern ausserhalb der USA zugelassen sind. 60 Publikationen dazu sind aber kaum vorhanden. 60 ...
... 60 Publikationen dazu sind aber kaum vorhanden. 60 ...
... The adverse effect of Er:YAG vaginal laser has been reported as transient edema, vaginal discharge, and no long sequelae was reported. The side effect of observed studies was mild to moderate and seldomly [30][31][32]. No long-term major complications were found during or post-treatment in our study. ...
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The purpose of our study was to investigate the effects of vulvovaginal erbium laser on the genitourinary syndrome of menopause (GSM) and sexual function of postmenopausal women. We conducted a retrospective study of sixty-four postmenopausal women with GSM, and these patients were scheduled for three times of vulvovaginal erbium laser treatment. A baseline and post-treatment vaginal status was assessed by measuring vaginal pH, patients’ subjective vulvovaginal atrophy (VVA) symptoms, which included dryness, dyspareunia, itching, and burning. The urinary response to treatment was assessed using ICIQ-SF, UDI-6, IIQ-7, OABSS, and POPDI-6. Sexual function was evaluated using the Female Sexual Function Index (FSFI) before and after vulvovaginal laser therapy. Patient follow-ups were scheduled for 12 months after treatment. A total of sixty-four patients were enrolled in the study. We observed the significant improvement in the percentage of negative symptoms (dryness/dyspareunia/itching/burning) and in lower urinary tracts symptoms evaluated with ICIQ-SF, UDI-6, IIQ-7, OABSS, and POPDI-6 (P < 0.05). Patients’ overall satisfaction regarding their sexual life, assessed via Female Sexual Function Index (FSFI), showed significant improvement in its six domains of sexual function (P < 0.05). The pH level of vaginal secretions significantly decreased. No long-term complications were found post-treatment. The Er:YAG vaginal laser procedure is associated with a significant improvement in GSM and sexual function of postmenopausal women. Our result demonstrates that it can be a safe and efficacious treatment for patients with GSM without any serious adverse effects up to 1-year post-treatment. The long-term effects of using vulvovaginal laser in the treatment of GSM should be investigated.
... In contrast to CO2 laser creates Er:YAG laser rapid sequential heat pulses, which are transferred into the mucosa. The fast heat pulse does not injure the tissue surface [8]. ...
... VEL uses an Erbium:YAG laser, which has a 2940-nm wavelength absorbed by water. By adjusting the laser's pulse mode, the mucosa can be uniformly heated without heat accumulation on the surface layer [5,6], raising temperatures to 45°C deep in the tissue and 67°C on the surface. The treatment promotes cellular synthesis by improving collagen remodeling and blood flow, and it has been reported to improve urinary incontinence [7][8][9]. ...
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Purpose Stress urinary incontinence (SUI) and mixed urinary incontinence (MUI) lead to poor quality of life. In Japan, urinary incontinence is treated with tension-free vaginal tape (TVT) or transobturator tape (TOT) sling procedures, which involves inserting a synthetic material; however, problems arise with artificial mesh in some instances, requiring new treatment methods. Hence, laser therapy, whereby an erbium-doped yttrium aluminum garnet laser is directed into the vagina and urethra, may be useful. The study aimed to compare the effects of these three treatments. Methods Subjects included patients who received TVT, TOT, or laser therapy (n = 50 each). The 1-h pad test, International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF), and overactive bladder symptom score were used to assess the patients before and 12 months after treatment. For laser therapy, a probe was inserted into the vagina after applying a local anesthetic to the vaginal wall, and irradiation was performed for 20 min at a wavelength of 2940 nm. This treatment was performed three times every alternate month. Results As per the 1-h pad test and ICIQ-SF, the TVT, TOT, and laser therapy groups showed comparable improvements in SUI. For patients with MUI, some in the TVT and TOT groups showed exacerbation; however, all patients in the laser therapy group tended to improve. Conclusions The efficacy of laser therapy for urinary incontinence was confirmed. This is the first study to report on the effect of laser therapy on urinary incontinence in Japanese women.
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Background and objective: Various studies have investigated treatment for vaginal laxity with microablative fractional carbon dioxide CO2 laser in humans; however, this treatment has not yet been studied in an animal model. Herein, we evaluate the therapeutic effects of fractional CO2 laser for tissue remodeling of vaginal mucosa using a porcine model, with the aim of improving vaginal laxity. Study design/materials and methods: The fractional CO2 laser enables minimally invasive and non-incisional procedures. By precisely controlling the laser energy pulses, energy is sent to the vaginal canal and the introitus area to induce thermal denaturation and contraction of collagen. We examined the effects of fractional CO2 laser on a porcine model via clinical observation and ultrasound measurement. Also, thermal lesions were histologically examined via hematoxylin-eosin staining, Masson's trichrome staining, and Elastica van Gieson staining and immunohistochemistry. Results: The three treatment groups, which were determined according to the amount of laser-energy applied (60, 90, and 120 mJ), showed slight thermal denaturation in the vaginal mucosa, but no abnormal reactions, such as excessive hemorrhaging, vesicles, or erythema, were observed. Histologically, we also confirmed that the denatured lamina propria induced by fractional CO2 laser was dose-dependently increased after laser treatment. The treatment groups also showed an increase in collagen and elastic fibers due to neocollagenesis and angiogenesis, and the vaginal walls became firmer and tighter because of increased capillary and vessel formation. Also, use of the fractional CO2 laser increased HSP (heat shock protein) 70 and collagen type I synthesis. Conclusion: Our results show that microablative fractional CO2 laser can produce remodeling of the vaginal connective tissue without causing damage to surrounding tissue, and the process of mucosa remodeling while under wound dressings enables collagen to increase and the vaginal wall to become thick and tightened. Lasers Surg. Med. 50:940-947, 2018. © 2018 Wiley Periodicals, Inc.
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Objectives: To evaluate the long-term efficacy of a second generation of vaginal laser treatment, the vaginal erbium laser, as a non-ablative photothermal therapy for the management of genitourinary syndrome of menopause. Methods: The study was performed using an erbium laser crystal yttrium-aluminum-garnet (XS Fotona Smooth™, Fotona, Ljubljana, Slovenia) with a wavelength of 2940 nm. Postmenopausal women (n = 205) were treated with three laser applications at 30-day intervals. Symptoms were assessed before and after treatment throughout 24 months, using the subjective visual analog scale (VAS) and the objective vaginal health index score (VHIS). In addition, postmenopausal women suffering from stress urinary incontinence were evaluated with the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF). Results: Vaginal erbium laser treatment induced a significant (p < 0.01) decrease in VAS for both vaginal dryness and dyspareunia, as well an increase in VHIS (p < 0.01) up to the 12th month after the last laser treatment. The values returned to levels similar to the baseline after 18 and 24 months. In addition, vaginal erbium laser treatment improved mild-moderate stress urinary incontinence in 114 postmenopausal women. Less than 3% of patients discontinued treatment due to adverse events. Conclusions: These results suggest that vaginal erbium laser may be effective and safe for the treatment of genitourinary syndrome of menopause.
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Introduction To provide evidence that the use of a fractional CO 2 laser in combination with platelet-rich plasma (PRP) locally in the vagina mucous with minimal to moderate atrophy and pelvic floor exercise with perineometer would have effects of greater impact in the 3 layers of vaginal walls, including an important decrease of discomfort during sex. Materials and Methods The study was composed of 2 groups: a study group and a control group. The main consultation purposes were vaginal dryness, dyspareunia, and local irritation. The study group underwent PRP, CO 2 laser, and pelvic exercise, whereas only PRP and pelvic exercise were applied to the control group. We used a special vaginal scanner, which was able to fractionize the laser and could be inserted in the vagina. Both groups were evaluated with a sexual questionnaire and vaginal biopsies. Results An important improvement of vaginal mucous histology and a decrease of discomfort during sex were observed in most patients in the study group compared with the control group. Conclusion Through the local use of vaginal fractional CO 2 laser, PRP, and pelvic floor exercises in women with symptoms of vaginal atrophy, beneficial effects are exerted in the 3 layers of the vagina rather than only the epithelium, as achieved with estrogens. We also observed a significant decrease of discomfort during sex. More data will be needed to better address the use of this new procedure.
Article
Genitourinary syndrome of menopause (GSM) is a common condition affecting up to 50% of postmenopausal women and up to 70% of postmenopausal breast cancer survivors. GSM is a chronic condition with a significant impact on sexual health and quality of life. The mainstay of treatment has been with symptomatic relief using topical emollients or lubricants. Second-line treatment is with topical vaginal estrogens to restore the physiology of the vaginal epithelium. For some, the latter is not suitable or acceptable. Newer treatments with ospemifene and vaginal lasers have now been introduced. The two main types of laser currently used for the treatment of GSM are the fractional microablative CO2 laser and the non-ablative photothermal erbium:YAG laser. We present a study protocol for a multicenter, prospective, non-inferiority, single-blinded, randomized controlled trial comparing the fractional microablative CO2 laser versus the photothermal non-ablative erbium:YAG laser for the management of GSM. We will recruit 88 postmenopausal women across two sites who will be randomized to one of the two laser groups. Participants will all have GSM symptoms and a Vaginal Health Index Score < 15. All participants will receive an active treatment. Each participant will receive three applications of vaginal laser 1 month apart and will be followed up at 1 month, 6 months, and 12 months. Our primary outcomes will look at all changes of GSM symptoms (dryness, dyspareunia, itching, burning, dysuria, frequency, urgency), urinary incontinence (if present), and overall sexual satisfaction. Both subjective and objective means will be used to assess participants. The findings of this trial have the potential to allow clinicians and women suffering from GSM to make an informed decision when opting for a specific laser type. The trial will add to the current growing body of evidence for the safe use of vaginal lasers in GSM as an alternative treatment. We hope this trial will provide robust and long-term data for the safe use of both lasers.
Article
Introduction: Vaginal laxity is increasingly recognized as an important condition, although little is known regarding its prevalence and associated symptoms. Aim: To report the prevalence of self-reported vaginal laxity in women attending a urogynecology clinic and investigate its association with pelvic floor symptoms and female sexual dysfunction. Method: Data were analyzed from 2,621 women who completed the electronic Personal Assessment Questionnaire-Pelvic Floor (ePAQ-PF). Main outcome measure: Response data from ePAQ-PF questionairre. Results: Vaginal laxity was self-reported by 38% of women and significantly associated with parity, symptoms of prolapse, stress urinary incontinence, overactive bladder, reduced vaginal sensation during intercourse, and worse general sex life (P < .0005). Clinical implications: Clinicians should be aware that vaginal laxity is prevalent and has an associated influence and impact on sexual function. Strength & limitations: The main strength of this study is the analysis of prospectively collected data from a large cohort of women using a validated questionnaire. The main limitation is lack of objective data to measure pelvic organ prolapse. Conclusion: Vaginal laxity is a highly prevalent condition that impacts significantly on a woman's sexual health and quality of life. Campbell P, Krychman M, Gray T, et al. Self-reported vaginal laxity-Prevalence, impact, and associated symptoms in women attending a urogynecology clinic. J Sex Med 2018;15:1515-1517.
Article
Nonsurgical vulvovaginal rejuvenation (NVR) is growing in popularity as a treatment for restoration of youthful female genitalia. Numerous radiofrequency (RF) and laser devices have entered the market claiming improvement in vaginal laxity and genitourinary syndrome of menopause. There is a paucity of evidence existing concerning the effectiveness of these devices for both pre- and postmenopausal women with laxity and/or atrophy at the histologic and clinical level. Therefore, the goal of this review is to scrutinize the peer-reviewed data on NVR with RF and laser devices, identify gaps in existing literature, and propose opportunities for further investigation.
Article
Introduction and hypothesis: Vaginal laxity is a poorly understood symptom of pelvic floor dysfunction. The purpose of this study was to investigate associations between the symptom of vaginal laxity and its bother on the one hand, and demographic data, other symptoms, and findings on examination on the other hand. Methods: This was a retrospective observational study at a tertiary urogynecological unit. A total of 337 patients were seen for a standardized interview, clinical examination (ICS POP-Q) and 4D translabial ultrasonography. Stored imaging data were analyzed offline to evaluate functional pelvic floor anatomy and investigate associations with symptoms and other findings. Results: Of the 337 women seen during the study period, 13 were excluded due to missing data, leaving 324. Vaginal laxity was reported by 24% with a mean bother of 5.7. In a univariate analysis, this symptom was associated with younger age, vaginal parity, POP symptoms and bother, clinically and sonographically determined POP and hiatal area on Valsalva maneuver. Conclusions: Vaginal laxity or 'looseness' is common in our urogynecology service at a prevalence of 24%. The associated bother is almost as high as the bother associated with conventional prolapse symptoms. It is associated with younger age, vaginal parity, symptoms of prolapse, prolapse bother and objective prolapse on POP-Q examination and imaging, suggesting that vaginal laxity may be considered a symptom of prolapse. The strongest associations were found with gh + pb and hiatal area on Valsalva maneuver, suggesting that vaginal laxity is a manifestation of levator ani hyperdistensibility.