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Climacteric
ISSN: 1369-7137 (Print) 1473-0804 (Online) Journal homepage: https://www.tandfonline.com/loi/icmt20
Er:YAG laser in hysterectomized women with
stress urinary incontinence: a VELA retrospective
cohort, non-inferiority study
C. T. Erel, I. Fistonić, M. Gambacciani, Y. Oner & N. Fistonić
To cite this article: C. T. Erel, I. Fistonić, M. Gambacciani, Y. Oner & N. Fistonić (2020) Er:YAG laser in hysterectomized women with stress urinary incontinence: a VELA retrospective cohort, non-inferiority study, Climacteric, 23:sup1, S18-S23, DOI: 10.1080/13697137.2020.1814728
To link to this article: https://doi.org/10.1080/13697137.2020.1814728
© 2020 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group
Published online: 30 Oct 2020.
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SHORT REPORT
Er:YAG laser in hysterectomized women with stress urinary incontinence:
a VELA retrospective cohort, non-inferiority study
C. T. Erela, I. Fistonicb, M. Gambaccianic, Y. Oneraand N. Fistonicd
a
Department of Obstetrics and Gynecology, _Istanbul Cerrahpas¸a University, _Istanbul, Turkey;bInstitute for Women’s Health, Zagreb, Croatia; c
Department of Obstetrics and Gynecology, Pisa University Hospital, Pisa, Italy;dDepartment of Obstetrics and Gynecology, University Hospital Merkur, Zagreb, Croatia
ABSTRACT
Objective: To test whether the erbium-doped yttrium aluminum garnet (Er:YAG) SMOOTHVR
laser treat-ment efficacy on stress urinary incontinence (SUI) in hysterectomized patients is non-inferior to its effi-cacy in non-hysterectomized patients.
Methods: In this real-world, retrospective cohort study performed in Turkey, Croatia and Italy, we enrolled a consecutive sample of 35 hysterectomized and 34 non-hysterectomized patients with SUI. We used the Er:YAG SMOOTHVR
laser (Fotona, Slovenia) with a wave length of 2940 nm. The primary outcome was median reduction of SUI symptoms measured by the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short-Form (ICIQ-SF) with the non-inferiority margin defined as the minimum clinically important difference of ICIQ-SF (d < 2.52 points).
Results: In hysterectomized patients, the ICIQ-SF was reduced by 5 points (95% confidence interval 3–8; p < 0.001), a reduction of 45% (95% confidence interval 36–67%). After adjustment for baseline ICIQ-SF and five covariates, the reduction of symptoms in the hysterectomized group was not inferior to the reduction in the non-hysterectomized group.
Conclusion: The Er:YAG SMOOTHVR
laser treatment seems to improve the symptoms of SUI in hysterec-tomized women not clinically relevantly less than in non-hysterechysterec-tomized women. It seems that the beneficial effect of Er:YAG SMOOTHVR
laser treatment for SUI in hysterectomized women is time-limited.
ARTICLE HISTORY
Received 7 January 2020 Revised 12 August 2020 Accepted 18 August 2020 Published online 30 October 2020
KEYWORDS
Stress urinary incontinence; hysterectomy; Er:YAG SMOOTHVR
laser
Introduction
Hysterectomy is one of the commonest gynecological sur-geries. The incidence of urinary incontinence after
hysterec-tomy is reported roughly as 10%1. It is a controversial issue
whether hysterectomy itself may cause or improve the symp-toms of urinary incontinence. For example, the mean value of Valsalva leak point pressure was significantly lower in the group of patients who had a positive hysterectomy history, and patients in the hysterectomy group were significantly 6.3 times more at risk of severe stress urinary incontinence
(SUI)2,3. Another debatable subject arises from the type of
hysterectomy (total vs. subtotal, abdominal vs. vaginal, open vs. laparoscopic) versus type of induced urinary
incontin-ence4,5. SUI is usually defined as involuntary urinary leakage
by physical efforts6 and can be treated by both non-invasive
and invasive procedures7. Although the patient’s adherence
and the success rate are quite low in non-invasive
proce-dures such as pelvic floor muscle exercise8, invasive
proce-dures such as with transobturator tape and tension-free vaginal tape have quite satisfying success rates, but involve
some serious complications9,10. At the same time, urethral
bulking agents are now an established alternative to mid-urethral slings, with a lower complication rate.
Laser energy induces neocollagenesis, elastogenesis and neoangiogenesis in the vaginal mucosa, supporting a
desta-bilized urethra and bladder neck11,12. Most of studies
regard-ing laser treatment of SUI have been performed usregard-ing the
erbium-doped yttrium aluminum garnet (Er:YAG) SMOOTHVR
system. Its efficacy and safety have been demonstrated by a
randomized controlled trial13 and a number of observational
studies14–22. The Vaginal Er:YAG SMOOTHVR
Laser Academy (VELA) is a recently founded international society focusing
on the efficacy and safety issues of Er:YAG SMOOTHVR
laser treatments, not only in SUI patients but also those with other genital disorders.
In the first collaborative study by VELA, our objective was
to test whether the efficacy of the Er:YAG SMOOTHVR
laser
treatment on SUI, measured by the International
Consultation on Incontinence Questionnaire-Urinary
Incontinence Short-Form (ICIQ-SF), in hysterectomized
patients is non-inferior to its efficacy in non-hysterectomized patients, with the non-inferiority margin defined as the
min-imum clinically important difference of ICIQ-SF (d < 2.52
points)23, and after adjustment for the baseline ICIQ-SF score,
age, body mass index (BMI), parity, number of sessions, and duration of follow-up. Our hypothesis was that the Er:YAG
SMOOTHVR
laser treatment is not clinically relevantly less
CONTACTI. Fistonic ivan.fistonic@zg.t-com.hr Ob/Gyn & Menopause Clinic, Preradoviceva 10, 10000 Zagreb, Croatia
ß 2020 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group
This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited, and is not altered, transformed, or built upon in any way.
2020, VOL. 23, Suppl 1, S18–S23
effective in hysterectomized then in non-hysterectomized patients suffering from SUI.
Methods Study design
This multicenter, real-world, observational, retrospective
cohort study was conducted between April 2018 and May 2019. The patients were enrolled in three
obstetric/gyne-cology clinics: Istanbul Cerrahpas¸a University, Istanbul,
Turkey; Institute for Women’s Health, Zagreb, Croatia; and
Pisa University Hospital, Pisa, Italy. After the intervention, par-ticipants were followed at 6-month intervals. The procedure was explained to all participants in detail, and they all signed the informed consent. All three centers are members of the VELA Society which defined the criteria, procedures, the common informed consent form and instruments for
measur-ing outcomes in routine application of the Er:YAG SMOOTHVR
laser treatment. Numeric codes were assigned to the
partici-pants before the analysis, so that patients’ identities were
known only to their physicians. The study was conducted in accordance with the Declaration of Helsinki of 1975 as
revised in 201324. The Institutional Ethics Committee and
Reviewer Board from the Istanbul Cerrahpas¸a University authorized the protocol (# 52825153-604.01.01-100626). This
observational study was not registered at the
pub-lic repository.
Target population
The target population was composed of 35 hysterectomized and 34 non-hysterectomized women treated with the Er:YAG
SMOOTHVR
laser for SUI. All the patients were submitted to pretreatment evaluation. Diagnosis of SUI was established on the basis of medical history, pelvic examination at rest and during a Valsalva manouver plus cough stress test. All the patients completed the ICIQ-SF. Patients were informed about the laser procedure and its potential adverse effects. All the interventions were performed in outpatient depart-ments. During the intervention, patients were lying in a
nor-mal gynecological lithotomy position and received
no anesthesia.
The exclusion criteria were: any neurologic disease, insu-lin-dependent diabetes mellitus, active urinary tract infection, hematuria, and undiagnosed vaginal bleeding. We enrolled
the total available population by the order of patients’ arrival
for the treatment.
Outcomes
The primary outcome
The primary outcome was the median reduction in SUI symptoms measured by the ICIQ-SF and adjusted for the baseline ICIQ-SF score, age, BMI, parity, number of sessions, and duration of follow-up. We calculated the reduction of symptoms from the baseline ICIQ-SF score to the lowest ICIQ-SF score achieved during the entire follow-up after the
intervention. We defined the non-inferiority margin as the
minimum clinically important difference of ICIQ-SF (d < 2.52
points) as determined by Nystr€om et al.23. The ICIQ-UI Short
Form evaluates the self-reported and subjectively assessed frequency and severity of urinary incontinence and its impact on quality of life. Participants completed questionnaires before and after the intervention, and at check-up examina-tions every 6 months thereafter.
Secondary outcomes
The secondary outcomes were (1) percentage change in ICIQ-SF score after the intervention relative to the baseline
score; (2) ‘maximum improvement time’ (MIT) defined as the
patients’ reported point in the time-line just before the
effi-cacy of the procedure started to decrease, with the time of
intervention as the reference point; (3) ‘total improvement
time’ (TIT), defined as the point in the time-line when the
efficacy disappeared and returned to the state before the procedure, with the time of intervention as the reference point; (4) the percentage of patients experiencing treatment
success, defined as ICIQ-SF 6, which indicates a successful
patient-reported outcome on the Patient Global Impression
of Improvement following surgical treatment of SUI25.
Confounders and other variables
The potential confounders that we controlled as covariates in multivariable analysis of the differences between hysterec-tomized and non-hysterechysterec-tomized women were age, parity and BMI. Additional potential effect-modifying variables that
we controlled as covariates were number of Er:YAG
SMOOTHVR
laser sessions. Other variables used to describe the samples from the target populations were menopausal status, years in menopause, and type of hysterectomy. Pelvic examination, vaginal smear test and ultrasound were per-formed in all the patients.
Intervention
The Er:YAG SMOOTHVR
laser with a wavelength of 2940 nm (SP Dynamis, Fotona, Slovenia) was used with the parameters
previously described17,22. The IncontiLaseVR
intravaginal
appli-cation of ‘smooth’ mode was used with fluence of 10.0 J/
cm2; four pulses per point; pulse duration of 250 ms; spot
size 7 mm, and frequency of 1.6 Hz. The laser sessions were performed at monthly intervals. The total number of sessions was decided by the physicians in accordance with the
manu-facturer’s protocol, which recommends two sessions, but
physicians were free to adapt the number of sessions accord-ing to the vaginal length and width, and severity of atrophic vaginitis. No anesthetics were used.
Statistical analysis
In the main analysis, we claimed non-inferiority if the upper limit of the one-sided 95% confidence interval (CI) of the median reduction of SUI in the hysterectomized group was
within the margin of d < 2.52 ICIQ-SF points from the median reduction in the non-hysterectomized group, after the adjustment for baseline ICIQ-SF score, age, BMI, parity,
number of sessions, and the duration of follow-up.
Introductory analysis of efficacy was performed by the Wilcoxon matched-pairs, signed-rank test within each study group. For the standardized effect size for the change within
each group, we calculated r as r ¼ z/(sqrt(2 n) where z
was the standardized Wilcoxon test statistic and n was the sample size. We calculated crude and adjusted medians (interquartile range; IQR) ICIQ-SF before and after the inter-vention, median reduction and median percentage change of SUI symptoms, median (IQR) of MIT and TIT, and the per-centage of patients achieving treatment success, defined as
the ICIQ-SF 625. We used the multivariable quantile and
Poisson regression only to adjust the medians and CIs for the baseline ICIQ-SF score, age, BMI, parity, number of ses-sions and the duration of follow-up. Except for the CI, we did not statistically compare the two groups on secondary outcomes because we did not have a valid and reliable
non-inferiority margin for these outcomes. We used Klovning’s
stratification26 of urinary incontinence only for descriptive
purposes: very severe (ICIQ-SF score 19–21), severe (13–18),
moderate 6–12, mild 1–5, and as no leakage if it was 0, but
in the analysis we used the original ICIQ-SF values. No data
were missing in any of the outcomes or potential
confounders. We controlled the false-positive rate using the
Benjamini–Hocberg procedure with the false-discovery rate
(FDR) set in advance at < 10%. Statistical significance was
defined as p< 0.05; CIs were calculated at 95%, one-sided in
the non-inferiority test, and two-sided in all other cases. Statistical analysis was performed using the StataCorp. 2019 (Stata Statistical Software: Release 16. College Station, TX: StataCorp LLC).
Results
We enrolled 35 previously hysterectomized women with SUI and 34 women with an intact uterus but having clinically relevant symptoms of SUI. The median (IQR) age of
hysterec-tomized women was 62 (53–66) years with 15/32 (43%)
hav-ing a severe or very severe baseline SUI (Table 1).
Hysterectomized women were markedly older, more often postmenopausal, more often treated with three sessions, and
followed up for a longer time (Table 1). In other
characteris-tics, the two cohorts were comparable.
In the sample of hysterectomized women, the ICIQ-SF score was significantly lowered, from the median (IQR) of 12
(11–15) at baseline to 6 (4–7) points after the treatment
(Wilcoxon matched-pairs signed-rank test, z¼ 5.06; p < 0.001;
r¼ 0.60; FDR < 10%) (Figure 1 and Table 2). This median
Table 1. Characteristics of 35 hysterectomized and 34 non-hysterectomized women.
Hysterectomized (n ¼ 35) Non-hysterectomized (n ¼ 34) Age (years), median (IQR) 62 (53–66) 50 (45–55)
Parity, median (IQR) 2 (1–2) 2 (1–2)
Categorized parity, n (%)
0 2 (6) 2 (6)
1 15 (44) 14 (40)
2 11 (32) 12 (34)
3 6 (18) 7 (20)
Years since menopause, median (IQR) 12 (6–17) 1 (0–7) Menopausal status, n (%)
premenopausal 1 (3) 16 (47)
postmenopausal 34 (97) 18 (53)
BMI (kg/m2), median (IQR) 26 (24–28) 25 (22–28) Categorized BMI, n (%) normal (< 24.9) 15 (43) 17 (50) overweight (25.0–29.9) 19 (54) 15 (44) obese ( 30.0) 1 (3) 2 (6) Type of hysterectomy, n (%) none 0 (0) 34 (100) TAHþ BSO 28 (80) 0 (0.0) TAH 5 (14) 0 (0.0) VTH 1 (3) 0 (0.0) STHþ BSO 1 (3) 0 (0.0)
Number of laser sessions, median (IQR) 3 (2–3) 2 (2–3) Number of laser sessions, n (%)
1 4 (11) 5 (15)
2 7 (20) 18 (53)
3 24 (69) 8 (24)
4 0 (0) 3 (9)
Follow-up (months), median (IQR) 24 (12–24) 17 (10–27)
ICIQ-SF at enrollment 12 (11–15) 14 (9–16)
Categorized ICIQ-SF at enrollment
mild (1–5) 2 (6) 3 (9)
moderate (6–12) 18 (51) 11 (32)
severe (13–18) 13 (37) 15 (44)
very severe (19–21) 2 (6) 5 (15)
Data are presented as number (percentage) of patients if not stated otherwise.
IQR, interquartile range; UI, urinary incontinence; SUI, stress UI; MUI, mixed UI; TAH, total abdominal hysterectomy; BSO, bilateral salpingo-oophorectomy; VTH, vaginal total hysterectomy; BMI, body mass index; ICIQ-SF, International Consultation on Incontinence Questionnaire-Urinary Incontinence Short-Form.
(95% CI) ICIQ lowering by 5 (3–8) points represented a 45%
(95% CI 36–67%) decrease from the baseline values. It was
above the minimum clinically relevant difference of 2.52
ICIQ-SF points. The median (IQR) MIT was 12 (6–18) months,
and TIT was 18 (6–24) months. Overall, 18/35 (51%; 95% CI
34–69%) patients achieved treatment success defined as
ICIQ-SF 6 points on ICIQ-SF.
The lowering of ICIQ-SF was significant and clinically rele-vant in the non-hysterectomized women as well (Wilcoxon
matched-pairs signed-rank test, z ¼ 4.93; p < 0.001; r ¼ 0.60;
FDR< 10%) (Table 2). The median (95% CI) ICIQ-SF lowering
by 7 (3–10) points represented a 64% (95% CI 35–88%)
decrease from the baseline values (Figure 1). The median
(IQR) MIT was 12 (6–17) months, and TIT was 13 (6–17)
months. Overall, 22/34 (65%; 95% CI 46–80%) patients
achieved treatment success defined as ICIQ-SF 6 points.
After the adjustment for the baseline ICIQ-SF, age, BMI, parity, number of sessions and follow-up time, the median
(95% CI) ICIQ-SF reduction after the intervention was 7
(9, 6) in the non-hysterectomized group (Table 2). The
margin of non-inferiority was a ICIQ-SF reduction of4
ICIQ-SF points, calculated as the ICIQ-ICIQ-SF reduction in the
non-hys-terectomized group (D ¼ 7) plus the non-inferiority margin
(d ¼ 2.52). In the hysterectomized group, the adjusted
reduc-tion of ICIQ-SF was 6 (95% CI 7, 5) (Table 2), and the
one-sided 95% CI was5 as well. Therefore, the upper limit
of the one-sided 95% CI of the median ICIQ-SF reduction in the hysterectomized group was within the margin of non-inferiority.
Discussion
Our study supported the hypothesis of non-inferiority of
intravaginal Er:YAG SMOOTHVR
laser treatment efficacy on the symptoms of SUI in hysterectomized women compared to its already proven efficacy in non-hysterectomized patients.
Although many studies have confirmed Er:YAG SMOOTHVR
laser efficacy in the treatment of SUI13–22, as far as we are
aware there are no published data on laser treatment of SUI in hysterectomized women.
There might be some important consequences of hyster-ectomy which might prevent the beneficial effect of laser
treatment for SUI symptoms3,4,27. First, section of
sacrouter-ine and cardinal ligaments, in the course of total hysterec-tomy, may destabilize the pelvic floor. Second, the length of vagina is reduced, and third, the pelvic blood and nerve sup-plies to the bladder become impaired. Additionally, these factors could deteriorate sphincter function, resulting in insufficient improvement in hysterectomized patients treated with laser.
Since the ‘smooth’ mode of the Er:YAG laser is
non-abla-tive and increases the local temperature to the stage that ini-tiates neocollagenosis, neofibrogenesis and neoangiogenesis
in the connective tissue of the vaginal mucosa11,12, it may be
expected that the scar tissue due to the hysterectomy may
weaken the response to the Er:YAG SMOOTHVR
laser. In con-trast, Engin et al. proposed that non-ablative Er:YAG 0 2 4 6 8 10 12 14 16 Before the
intervenon intervenonAer the
Median ICIQ-UI SF score
Hysterectomy No hysterectomy
Figure 1. The median ICIQ-SF scores in hysterectomized and non-hysterectom-ized women before and after the Er:YAG SMOOTHVR
treatment. ICIQ-SF, International Consultation on Incontinence Questionnaire-Urinary Incontinence Short-Form.
Table 2. Treatment outcomes.
Hysterectomized (n ¼ 35) Non-hysterectomized (n ¼ 34)
Baseline interventionAfter the D (95% CI) D% (95% CI) Baseline interventionAfter the D (95% CI) D% (95% CI) Unadjusted analysis Primary outcome ICIQ-SF 12 (11–15) 6 (4–7) 5 (8, 3) 45 (67, 36) 14 (9–16) 4 (1–10) 7 (10, 3) 64 (88, 35) Secondary outcomes MIT (months) 12 (6–18) 12 (6–17) TIT (months) 18 (6–24) 13 (6–17) Treatment successa , n (%) 18 (51) 22 (65) Adjusted analysisb Primary outcome ICIQ-SF 12 (11, 13) 7 (5, 8) 6 (7, 5) 47 (59, 35) 14 (13, 14) 5 (4, 7) 7 (9, 6) 65 (78, 53) Secondary outcomes MIT (months) 10 (8, 12) 14 (12–16) 18 (16, 20) TIT (months) 15 (13, 17) 17 (16, 20)
Treatment successa, % (95% CI) 52 (34, 70) 64 (46, 81) Data are presented as median (IQR) in the unadjusted, and median (two-sided 95% CI) in adjusted analysis if not stated otherwise.
ICIQ-SF, International Consultation on Incontinence Questionnaire-Urinary Incontinence Short-Form; IQR, interquartile range; MIT, maximum improvement time; TIT, total improvement time;D, median of absolute differences from baseline to after the intervention; CI, confidence interval; D%, median of relative differences from baseline to after the intervention relative to the baseline value.
aTreatment success was defined as ICIQ-SF 6 points;bAdjusted for baseline ICIQ-SF score, age, body mass index, parity, number of sessions, and the duration
of follow-up using the quantile regression for ICIQ-SF, MIT and TIT, and Poisson regression for treatment success.
SMOOTHVR
laser treatment improved the scar tissue and
increased the collagen content in acne scar tissue28 beyond
the results of the other dermatological studies29.
Also, in the treatment of burn scars, non-ablative frac-tional erbium lasers create columns of coagulated tissue composed of denatured collagen while leaving the epidermal
layer intact30. Taudorf et al. showed that non-ablative
frac-tional laser provides long-term improvement of mature burn scars. Their post-treatment histology study showed an inter-woven collagen with an overall increased similarity to normal
unaffected skin31. In accordance with these findings, the
Er:YAG SMOOTHVR
laser may improve both the quality and the quantity of scar tissue affecting the upper part of the vagina after hysterectomy.
Our findings are in the accordance with the previously
published data in non-hysterectomized women16–20. Fistonic
and Fistonic clearly showed that age, parity, BMI, and sever-ity of SUI symptoms before the treatment were predictive factors for the efficacy of the Er:YAG laser treatment in
non-hysterectomized women with SUI20. Similarly, in a larger
group of patients with urinary incontinence, it was shown
that women with 3.6 kg/m2 less value in BMI showed better
results from Er:YAG SMOOTHVR
treatment for SUI22. Our study
was not adequately powered for the subgroup analysis of the effect of BMI in the hysterectomized patients, and future studies should address this issue because higher BMI
increases the risk of SUI after hysterectomy3.
Results of this VELA collaborative study further indicate that more laser sessions are associated with a better response. Most of the studies, in non-hysterectomized patients, recommend two or three sessions at a month
apart13–21. Our previous study found that the higher pulse
number in the total sessions per patient was associated with
better improvement22, so the total laser energy expenditure
during the sessions may also be a predictive parameter for the success of Er:YAG laser treatment of urinary incontinence
(p¼ 0.059). MIT and TIT were significantly longer in the
patients in the high-improvement group.
It is reasonable to compare this finding, as more energy stored in the vaginal mucosa induces a better effect.
Although the duration of improvement after the Er:YAG
SMOOTHVR
laser treatment on genitourinary symptoms of menopause was claimed to continue up to 18 months, or
even to 24 months29,32, the patients with SUI were followed
up for a relatively short period of time in most of the stud-ies13–21. In our study, previously hysterectomized patients were followed up for a median of 24 months, and the median time to maximum reduction in ICIQ-SF was around 12 months, while the duration of the response was around 18 months in hysterectomized and 13 months in
non-hyster-ectomized patients after the completion of Er:YAG SMOOTHVR
laser sessions.
However, the beneficial effect of Er:YAG SMOOTHVR
laser treatment on SUI is of limited duration. Therefore, during patient counseling, detailed information about the efficacy and safety of laser treatment for SUI in hysterectomized patients should be given in order to prevent unrealistic
expectations. Periodic examinations and evaluations would reveal the need for further laser treatments.
There are several limitations of our study. The main limita-tion is a lack of randomized control groups not treated with
the Er:YAG SMOOTHVR
laser. This limitation increased the risk of unmeasured confounding effects and therefore poses a threat to the interval validity and generalizability of our find-ings. We could not speculate on the direction or magnitude of the so-caused bias. Second, the small sample size pre-vented a subgroup analysis, multilevel analysis or some other reliable control of the design effect, and affected the preci-sion, reliability and generalizability of our findings, but not necessarily jeopardized the internal validity of the study. Third, we used only subjective, patient-reported outcomes in an open-label study with no control group. This may have increased the risk of measurement bias caused by the pla-cebo effect, which probably acted against the null hypothesis
of no effect of the Er:YAG SMOOTHVR
laser on the symptoms of SUI, but we were not able to determine its magnitude. Fourth, we omitted to control and recode the time from hys-terectomy to the intervention; this may have increased the heterogeneity of our hysterectomized group, while lowering the difference from the non-hysterectomized group. We could not control for the effect of this possible, unmeasured confounder, and future studies should explore the possible moderating effects of the time from hysterectomy on the
efficacy of Er:YAG SMOOTHVR
laser treatment of SUI, and to the severity of SUI itself. Lastl, the physicians were free to change the number of sessions from two, as recommended
by the manufacturer’s protocol, according to the vaginal
length and width, and severity of atrophic vaginitis.
However, the physicians could be biased due to the hyster-ectomy and could have performed additional laser sessions arbitrarily. This possibly unnecessary increase in the number
of sessions may increase the effect of Er:YAG SMOOTHVR
laser treatment in hysterectomized patients. We tried to control this source of bias by adjusting the main analysis for the number of sessions. However, this adjustment could not solve the effects of the possibly arbitrary and unnecessary increase in the number of sessions, but just the effect of their overall larger number. So, future studies should com-pare the two targeted groups with more rigorously defined criteria for the adaptation of the number of sessions.
The uniqueness of our study was the assessment of the
effects of the Er:YAG SMOOTHVR
laser treatment in the popu-lation of hysterectomized women because the real-world data on this subject are missing.
Conclusion
The Er:YAG SMOOTHVR
laser treatment seems to improve the symptoms of SUI in hysterectomized women not clinically relevantly less than in non-hysterectomized women. It seems
that the beneficial effect of Er:YAG SMOOTHVR
laser treatment for SUI in hysterectomized women is time-limited. These results are promising, and therefore prospective, multicenter, randomized, controlled trials are needed with sham and
surgery control groups and more rigorous and objectively defined criteria for adapting the number of sessions.
Potential conflict of interest The authors declare no conflict of interest. The authors alone are responsible for the content and writing of the paper.
Source of fundingNil. The study was funded by the authors.
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