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A Systematic Review on Vaginal Laser Therapy for Treating Stress Urinary

Incontinence: Do We Have Enough Evidence?

Article  in  Obstetrical and Gynecological Survey · January 2018

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Int Urogynecol J (2017) 28:1445–1451
DOI 10.1007/s00192-017-3437-x
REVIEW ARTICLE
A systematic review on vaginal laser therapy for treating stress
urinary incontinence: Do we have enough evidence?
Vasilios Pergialiotis 1 & Anastasia Prodromidou 1 & Despina N. Perrea 1 &
Stergios K. Doumouchtsis 1,2
Received: 2 June 2017 / Accepted: 17 July 2017 / Published online: 2 August 2017
# The International Urogynecological Association 2017
Abstract
Introduction and hypothesis Current treatment strategies for
stress urinary incontinence (SUI) raise concerns about safety
and efficacy. The purpose of this systematic review was to
present available evidence related to vaginal laser therapy as
a treatment option for SUI.
Methods We searched the MEDLINE (1966–2017), Scopus
(2004–2017), Clinicaltrials.gov (2008–2017) and Cochrane
Central Register of Controlled Trials (CENTRAL) (1999–
2017) databases for relevant studies in this field. We aimed
to include all observational studies (prospective and retrospec-
tive, randomized and nonrandomized) that reported outcomes
on vaginal laser therapy as a treatment option for SUI.
Results Thirteen studies were included that recruited 818 pa-
tients who underwent laser therapy for SUI. The methodolog-
ical quality of most included studies was low, as they were
either individual case–control studies, case series or poor-
quality cohorts (Oxford Level of Evidence 3b and 4).
According to the existing evidence, laser therapy may be a
useful, minimally invasive approach for treating SUI.
However, the methodological limitations of included studies
render them prone to significant bias, limiting their scientific
integrity.
Electronic supplementary material The online version of this article
(doi:10.1007/s00192-017-3437-x) contains supplementary material,
which is available to authorized users.
* Vasilios Pergialiotis
pergialiotis@yahoo.com
1
Laboratory of Experimental Surgery and Surgical Research N.S.
Christeas, 6, Danaidon str, 15232 Chalandri, Greece
2
Department of Urogynaecology and Pelvic Floor Reconstructive
Surgery, St. George’s Hospital, London, UK
Conclusions As the demand for minimally invasive ap-
proaches for treating SUI increases, it is expected that more
patients will seek alternative treatments over current standards
(midurethral slings). Given the limitations of the existing stud-
ies, it seems that conducting future trials is necessary to elu-
cidate this field.
Keywords Sui . Laser . Erbium . Incontinence . Systematic
review
Introduction
Urinary incontinence (UI) is a common problem, with an esti-
mated prevalence of 50% in the female population worldwide
[1]. By definition, stress urinary incontinence (SUI) is the in-
voluntary loss of urine on effort, sneezing and coughing [2].
Treatment of incontinence is often delayed, as most patients do
not report their symptoms to their physician [3]. Various treat-
ment options have been proposed for SUI ranging from con-
servative approaches, such as pelvic floor exercises, to surgical
treatments [4]. Midurethral slings (MUS) are the mainstay of
surgical treatment and are usually inserted when conservative
treatment measures fail to improve symptoms [5]. However, in
recent years, MUS surgery has been widely criticized, as it is
accompanied by both early and late complications, including
bladder injury, voiding dysfunction, obstruction, extrusion,
pain and mesh erosion [6]. Consequently, concerns about the
safety of mesh devices were raised by women experiencing
complications. Some women adversely affected by these im-
plants have experienced serious complications. Various organi-
zations, including the US Food and Drug Administration
(FDA) and professional societies, have published reports to
address these concerns and provide recommendations for prac-
tice around the use of synthetic meshes.
1446
More conservative interventions have been also proposed,
including urethral bulking injections using polyacrylamide
hydrogel (Bulkamid®), silicone particles, calcium hydroxy-
apatite, ethylene vinyl alcohol, carbon spheres and
dextranomer hyaluronic acid [7, 8]. However, there is limited
evidence from high-quality studies around their success rates,
and repeat injections are often required to treat failures and
recurrences of SUI. In recent years, laser therapy has been
proposed for treating vaginal atrophy, pelvic organ prolapse
(POP) and SUI. The rationale behind this form of treatment is
based on collagen reconstruction, which consecutively as-
sumes its role in providing vaginal support to pelvic floor
structures. More specifically, laser therapy results in con-
trolled heating of the underlying mucosal layers, without
burning the mucosa [9]. This way, collagen fibrils become
shortened, but no denaturation takes place during the proce-
dure, so their mechanical properties are believed to remain
unaffected. To achieve this effect, the applied temperature
should range somewhere between 60 and 70 °C. Available
data indicate that this effect lasts due to collagen remodeling
and neocolagenesis, which can actually take up to 6 months to
complete [9]. The theoretical advantage of the technique is
that it is painless (no regional anaesthesia is required), mini-
mally invasive, takes only a few minutes and is typically com-
pleted in three therapies over a mean duration of 1 month.
Despite the significant implication for clinical practice
using this form of treatment, there is no consensus regarding
its efficacy in treating SUI. Furthermore, and in view of the
aforementioned issues around the currently used interventions
for treating SUI, evaluation of novel treatment options and
evidence around their safety and efficacy is more essential
than ever. The purpose of our systematic review was to criti-
cally evaluate evidence on laser treatment for SUI and provide
recommendations for clinicians.
Methods
Study design
We used the Preferred Reporting Items for Systematic
Reviews and Meta-Analyses (PRISMA) guidelines to design
the systematic review [10]. Eligibility criteria were
predetermined by the authors. Language and date restrictions
were avoided during the literature search. We selected all ob-
servational studies (prospective and retrospective) that evalu-
ated the impact of Er YAG and fractional pulsed CO2 laser on
patients with SUI that was either clinically or urodynamically
proven. Case reports, review articles and animal studies were
excluded.
The study selection process took place in three stages. Two
authors ran the initial search. Titles and/or abstracts of all
electronic articles were screened to assess eligibility. All
Int Urogynecol J (2017) 28:1445–1451
articles that met or were presumed to meet criteria were re-
trieved as full texts. References of full text articles were also
screened to assess for potential eligibility for inclusion.
Literature search and data collection
We used MEDLINE (1966–2017), Scopus (2004–2017),
ClinicalTrials.gov (2008–2017) and Cochrane Central
Register of Controlled Trials (CENTRAL) (1999–2017) data-
bases, along with reference lists of electronically retrieved
full-text papers. The date of our last search was set at 15
May 2017. Search strategies and results are shown in the
PRISMA flow diagram (Fig. 1).
Our search strategy in PubMed used the search terms
(Blasers^[MeSH Terms] OR Blasers^[All Fields] OR
Blaser^[All Fields]) AND incontinence[All Fields]) and the
search terms (Berbium^[MeSH Terms] OR Berbium^[All
Fields]) AND (Burinary incontinence, stress^[MeSH Terms]
OR (Burinary^[All Fields] AND Bincontinence^[All Fields]
A N D Bs t r e s s ^[ A l l F i e l d s ] ) O R Bs t r e s s u r i n a r y
incontinence^[All Fields] OR (Bstress^[All Fields] AND
Burinary^[All Fields] AND Bincontinence^[All Fields])).
Quality assessment
We assessed methodological quality of all studies using the
Oxford Level of Evidence criteria and the GRADE list [11].
Included outcomes
Subjective and objective outcomes were eligible for inclusion,
including questionnaires related to quality of life (QoL), pad
test, Q-tip test and urodynamic tests.
Results
Included studies
Thirteen studies were included that recruited 818 patients who
underwent laser therapy for SUI [12–23]. We did not identify
randomized control trials. The analysed indices were struc-
tured in two tables that briefly present design characteristics
of included studies (Table 1) and enrolled patients (Table 2).
There was a notable, wide variation in for inclusion and ex-
clusion criteria in these studies, and we present them separate-
ly to emphasise the heterogeneity of the study populations and
the inability to meaningfully pool results or perform meta-
analyses.
The methodological quality of most included studies was
low, as they were either individual case–control studies, case
series or poor-quality cohorts (Oxford Level of Evidence 3b
and 4). The studies of Gambacciani and Pitsouni were
Int Urogynecol J (2017) 28:1445–1451
Fig. 1 Search strategy
exceptions: The first, however, focused mainly on the effect of
vaginal erbium on genitourinary syndrome of menopause in
total rather than specifically on UI.
Main outcomes
Subjective outcomes (questionnaires and patient-reported
outcomes)
Eight studies based their findings on subjective scales com-
pleted by patients [12–18, 22]. The implemented scales eval-
uated QoL, clinical improvement and sexual life of patients
prior to and following treatment. Gaspar et al. reported cure at
3 and 6 months’ follow-up in 64% and 46% of patients, re-
spectively, whereas improvement was observed in 18% and
23% of patients 3 and 6 months after therapy, respectively
[14]. Similarly, Ogrinc et al. indicated significant improve-
ment after a year follow-up in 77% of patients by evaluating
International Consultation on Incontinence Questionnaire–
Urinary Incontinence (ICIQ-UI) and Incontinence Severity
Index (ISI) [14] scores. González Isaza et al. also observed a
significant reduction in ICIQ-UI SF scoring at 12, 24 and
1447
36 months following laser therapy [22]. A significant reduc-
tion of symptoms was observed based on the ICIQ-UI SF
score at 6 months follow-up in three studies [12, 13, 18].
Fistonic et al. reported a significant increment in Pelvic
Organ Prolapse/Urinary Incontinence Sexual Questionnaire
(PISQ-12) scores 1, 3 and 6 months following therapy (p
< 0.05) [18]. Pitsouni et al. reported significant symptom re-
duction 1 month following therapy based on the ICIQ-
FLUTS, ICIQ-UI SF, Urogenital Distress Inventory 6 (UDI-
6) and King’s Health Questionnaire (KHQ) [23]. Tien et al.
presented a 21.9% cure rate and 12.5% improvement rate
based on various questionnaires and scales at 6 months fol-
low-up, while the Female Sexual Function Index (FSFI)
showed significant improvement after therapy [15].
Objective outcomes
Results addressing objective evaluation of SUI improvement
after laser therapy were analysed in seven studies [12, 14, 15,
18–20, 22]. Among them, three based their results on pad
weight [14, 15, 22]. Specifically, Gaspar et al. reported a
50% decrease in pad weight in 82% and 50% of patients
during the 3- and 6-month evaluation period, respectively
 1448

Table 1 Methodologic criteria of included studies

Date; Author No. Type of Laser Evaluation* Therapy mode Assessed parameters

2017; González Isaza 161 Fractional CO2 laser system 12–24-36 - Histological examination of main structural
(MonaLisa Touch™;Deka, Florence, Italy) components of the vaginal wall mucosa,
ICIQ-UI SF, 1-h pad-weight test
2017; Lapii 98 Er:YAG laser (SP Spectro, Fotona, Slovenia SMOOTH 1.5–2 3260 ± 368 pulses Histological examination of main structural
Mode components of the vaginal wall mucosa
2017; Gaspar 22 Er:YAG laser (SP Spectro, Fotona, Slovenia) -SMOOTH 3–6 2 mm spot size, 6.0 J/cm2, 1.4 Hz ICIQ-UI SF, 1-h pad-weight test
mode
2017; Tien 35 Fotona 3–6 N/A Urodynamic studies, pad testing, LUTS, and
Dynamis Er:YAG laser (2940 nm) system sexual function questionnaires
(XS Dynamis,
Fotona, Slovenia SMOOTH mode
2016; Pitsouni 53 CO2 Laser (SmartXide2 V2LR, Monalisa Touch, DEKA) 1 D-pulse mode, dot power, 40 W, 400 μs, dot ICIQ-FLUTS, ICIQ-UI SF, UDI-6, KHQ
spacing 1000 μm
2016; Fistonic 31 2940 nm Er:YAG 1 to 6 300 μs pulses each 50 msec ICIQ-UI-SF, perineometry and residual urine
laser (XS Dynamis, Fotona, Slovenia)-SMOOTH mode volume
2016; Pardo 42 2940 nm Er:YAG laser (Fotona SmoothTM XS, Fotona, 3–6 6 J/cm2 ICIQ-UI-SF, patient’s satisfaction with the
Ljubljana, Slovenia) 1.6 Hz treatment and sexual life improvement
2015; Gambacciani 45 2940-nm Er:YAG 1–3-6 6 J/cm2 ICIQ-UI SF
laser (XS Dynamis, Fotona, Slovenia) 1.6 Hz
SMOOTH mode
2015; Fistonic 73 2940-nm Er:YAG laser, (XS Dynamis, Fotona, Slovenia) 2 to 6 2500–3000 J ICIQ-UI-SF and perineometry
SMOOTH mode
2015; Elbia 50 IncontiLaseTM procedure 6 N/A Uroflowmetry, voiding cystometry
Fotona, Slovenia
2015; Ogrinc 175 2940 nm Er:YAG laser (SP Spectro, Fotona, Slovenia) 2–6-12 10.0 J/cm2 Clinical examination, ICIQ and ISI
set in smooth mode 1.6 Hz
2013; Salvatore 34 Fractional CO2 laser 30–40 days VAS for various symptoms of vaginal atrophy
(e.g UI)
2012; Fistonic 39 2940 nm Er:YAG laser (XS Dynamis, Fotona, Slovenia) 1–3-6 30 J ICIQ-UI SF, Q-tip test, PISQ-12, perineometry

ICIQ-UI SF International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form, FLUTS female lower urinary tract symptoms, UDI-6 Urogenital Distress Inventory 6, KHQ King’s
Health Questionnaire, VAS visual analogue scale, PISQ-12 Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, ISI Incontinence Severity Index
Int Urogynecol J (2017) 28:1445–1451
Int Urogynecol J (2017) 28:1445–1451 1449

Table 2 Characteristics of enrolled women

Date; Author Inclusion/exclusion criteria

2017; González Isaza Patients with mild SUI and no evidence of prolapse (POP-Q) stage >I in the anterior compartment, no previous surgery,
absence of recurrent lower urinary tract infection or obesity (BMI >35 kg/m2)
2017;Lapii SUI under conditions of colpoptosis (degree 0–1–2, POP-Q system)
2017; Gaspar VLPP 20–60 cm H2O (type III SUI); no intake of antihypertensive medication or alpha blockers (e.g. prazosin, terazosin, etc);
no prior pelvic radiotherapy or surgery
2017; Tien Sexually active; without undiagnosed abnormal vaginal bleeding
2016; Pitsouni Postmenopausal women; at least one moderate to severe symptom of genitourinary syndrome of menopause; maturation index
in cervical smear <5; vaginal pH >4.5; did not receive hormone therapy within the previus 6 months; no lubricants or vaginal
moisturizers the last month; no active genital infections; no prolapse POP-Q stage >2
2016; Fistonic SUI; history of vaginal delivery; normal cell cytology; negative urine culture; a vaginal canal, introitus and vestibule free of
injuries and bleeding; no severe prolapse or damage to rectovaginal fascia; no urge incontinence; no severe neurological
conditions; no neurogenic bladder; no insulin-dependent DM; no actual urinary tract infection; no genitourinary tract
infections or injury; no age ≤ 18 or >70 years; no pregnancy; no interval < 24 weeks after vaginal delivery; without BMI
>30; without hematuria; without abnormal vaginal bleeding; no intake of photosensitive drugs
2016; Pardo Mild to severe SUI; voluntary completion of interviews and written informed consent; no urge incontinence; no severe prolapse;
no pregnancy, no previous surgery for treated condition; no severe neurological conditions; no vaginal lesions; no
genitourinary tract infections; no hematuria; no undiagnosed abnormal vaginal bleeding; no history of photosensitivity
disorder or intake of photosensitive drugs
2015; Gambacciani Genitourinary syndrome of menopause; postmenopausal; normal cell cytology of vaginal lesions, active or recent (30 days)
scars of genitourinary tract infections; abnormal uterine bleeding; use of lubricants or any other local preparations within
30 days prior to the study; photosensitivity disorder or use of photosensitising drugs; genital prolapse (grade II–III according
to the POP-Q system classification); serious or chronic condition that could interfere with study compliance; treatment with
hormones or other medicines to relieve menopausal symptoms in the 12 months before the study
2015; Fistonic SUI; history of vaginal delivery; normal cell cytology; negative urine culture; vaginal canal, introitus and vestibule free of
injuries and bleeding; no severe prolapse and damage of rectovaginal fascia; no UUI; no severe neurological conditions; no
neurogenic bladder; no insulin-dependent DM; no actual UTI; no genitourinary tract infections or injury; age ≥18 or
<70 years; no pregnancy; no interval < 24 weeks after vaginal delivery; BMI ≤30; no hematuria; no abnormal vaginal
bleeding; no intake of photosensitive drugs
2015; Elbia No UTI; no UUI or MUI; severe SUI; no neurological conditions or pelvic muscle diseases; no pregnancy; age ≤70 years; no
severe prolapse; no genitourinary tract infections or injury; not menstruating; no pregnancy; no undiagnosed abnormal
vaginal bleeding; no intake of photosensitive drugs
2015; Ogrinc UI clinically confirmed; no pure UUI; normal cell cytology; negative urine culture; vaginal canal, introitus and vestibule free of
injuries and bleeding; no pregnancy; no genitourinary tract infections; no injured or abnormal vaginal; no intake of
photosensitive drugs
2013; Salvatore Postmenopausal; no estrogen administration 6 months prior to therapy; symptoms and discomfort related to vaginal laxity;
vaginal dryness; dyspareunia; irritation or burning pain; no POP grade ≥ II; no genitourinary tract infections or injury; no
clinically relevant systemic disorders; no primary pelvic reconstructive surgery; able to understand and follow study
instructions
2012; Fistonic Mild and moderate SUI; history of vaginal delivery; normal cell cytology; negative urine culture; vaginal canal, introitus and
vestibule free of injuries and bleeding; no severe SUI; no severe prolapse and damage of rectovaginal fascia; no genitourinary
tract infections or injury; age ≤70 years; no pregnancy; no abnormal vaginal bleeding; no intake of photosensitive drugs

SUI stress urinary incontinence, POP-Q Pelvic Organ Prolapse Quantification system, BMI body mass index, VLPP vascular leak-point pressure, UUI
urge urinary incontinence, UTI urinary tract infection, MUI mixed urinary incontinence

[14]. Similar results were reported by Tien et al. demonstrating
a significant reduction in mean pad weight at 3 and 6 months
following treatment (p < 0.001) [15]. González Isaza et al.
observed a > 50% decrease in pad weight at 12 months, a
finding that persisted at 24 and 36 months [22]. Fistonic et al.
found that the angle of the Q-tip test gradually improved dur-
ing transition from baseline to 3 and 6 months (p ≤ 0.05) [18].
In their latest study, measurements of residual volume re-
vealed a significant reduction in patients with SUI before
treatment compared with postvoid volume at 1 and 2 months
following application of laser therapy (p = 0.01 and p = 0.04,
respectively) [12]. Khalafalla et al. conducted flowmetry and
cystometry measurements and evaluated parameters
concerning urethral pressure in patients with SUI prior to
and 6 months following treatment [20]. Statistically signifi-
cant improvement was noticed in flow rates and voiding time,
as well as a significant increase in residual urine volume, in
first desire and sensation, in strong desire and in maximal
urethral pressure [20]. Lappi et al. observed significant thick-
ening of the epithelium (p ≤ 0.05), and significantly improved
1450
density and number of capillaries after laser therapy (p ≤ 0.05
and p ≤ 0.01, respectively) in pathology analysis of specimens
[19].
Adverse effects
Eight studies monitored outcomes concerning potential ad-
verse effects after laser application [12–18, 20]; none reported
significant adverse outcomes. Specifically, Tien et al. and
Fistonic et al. reported no adverse effects [15, 18]. Pardo
et al., Ogrinc et al. and Khalafalla et al. reported mild pain at
the time of treatment [16, 17, 20]. Gaspar et al. discussed one
patient with pelvic pain and two with dysuria that receded
following completion of treatment [14]. Fistonic et al. detect-
ed mild symptoms of irritation and sense of elevated temper-
ature during therapy, as well as slight oedema of the treated
area and vaginal discharge, which lasted for a maximum of
48 h [12, 13].
Discussion
According to the findings of our systematic review, laser ther-
apy may be a useful, minimally invasive approach for treating
SUI. To date, however, evidence does not allow firm conclu-
sions, as none of the included studies compared this form of
treatment to clinically proven alternatives, including pelvic
floor exercises and/or midurethral slings. As laser therapy
gains ground in treating vaginal atrophy, it is expected that
many women will seek potential treatment of incontinence
symptoms with this form of treatment. However, the lack of
substantial evidence prohibits the institution of this mode of
treatment into clinical practice.
Relevance with other studies
Twelve years ago, Sotomayor et al. were the first to examine
the safety of radiofrequency energy (RF) tissue
microremodeling in women with SUI [24]. A radiofrequency
probe was inserted into the urethra with the patient under
conscious sedation with midazolam and fentanyl IV. The re-
searchers concluded that this seems to be a promising, mini-
mally invasive tool for treating SUI, which significantly im-
proved patient QoL. Since then, several studies have been
published investigating the promising effects of laser therapy
for treating the genitourinary syndrome of menopause. In their
previous systematic review, Salvatore et al. suggested that
pulsed CO2 laser may benefit patients with the disease, as
clinical and histological data support this hypothesis.
Despite their recommendation for future randomized trials,
to date, evidence remains extremely limited [25]. Recently,
Arunkalaivanan et al. published a review that summarised
current evidence related to the beneficial effect of laser
Int Urogynecol J (2017) 28:1445–1451
therapy for treating the genitourinary syndrome [26]. The au-
thors concluded that although laser therapy seems to be prom-
ising, evidence does not allow firm conclusions. In their re-
view, however, the only study included in relation to UI symp-
toms was that of Gambacciani et al. [21].
Strengths and weaknesses of our study
This systematic review is based on meticulous scrutiny of
existing literature through several electronic databases, thus
limiting potential article loss. The methodological character-
istics of the included studies are briefly described, and both
subjective and objective methods of SUI severity assessment
are presented in depth.
Several limitations prohibit firm conclusions, as the avail-
able evidence is particularly poor due to methodological
flaws, which render the studies prone to selection, attrition
and statistical biases. Furthermore, the lack of control group
in all studies but one renders it impossible to make direct
comparison with either a control group or other proven treat-
ment modalities for SUI.
Clinical implications and suggestions for future research
Current evidence does not justify the routine use of vaginal
laser therapy as a minimally invasive treatment for SUI.
However, results of studies included in our systematic review
are quite promising. It is our belief that future studies are
needed that will compare the efficacy of laser therapy to that
of other interventions, including midurethral slings, urethral
bulking agents and pelvic floor exercises. These studies
should base their findings not only on patient satisfaction
but also include urodynamic evaluation to enhance their sci-
entific merit, increasing our understanding of whether laser
therapy actually benefits women with SUI and identifying
the underlying mechanism that is potentially corrected.
Conclusion
Vaginal laser therapy seems to be a promising method for
treating SUI. However, available evidence is drawn from stud-
ies at significant risk of bias due to low-quality research meth-
odology. Randomised trials are needed to allow us to draw
firm conclusions, as it is expected that in women will increas-
ingly frequently seek minimally invasive treatment modalities
for SUI.
Compliance with ethical standards
Funding The authors did not receive funding for the present paper.
Int Urogynecol J (2017) 28:1445–1451
Conflicts of interest Stergios Doumouchtsis has received travel grants
and sponsorship to attend conferences from Speciality European Pharma.
He has also received speaker Honorarium from Astellas. The other au-
thors have no conflict of interest to report.
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