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REVIEW ARTICLE
Received: 2 June 2017 / Accepted: 17 July 2017 / Published online: 2 August 2017
# The International Urogynecological Association 2017
More conservative interventions have been also proposed, articles that met or were presumed to meet criteria were re-
including urethral bulking injections using polyacrylamide trieved as full texts. References of full text articles were also
hydrogel (Bulkamid®), silicone particles, calcium hydroxy- screened to assess for potential eligibility for inclusion.
apatite, ethylene vinyl alcohol, carbon spheres and
dextranomer hyaluronic acid [7, 8]. However, there is limited Literature search and data collection
evidence from high-quality studies around their success rates,
and repeat injections are often required to treat failures and We used MEDLINE (1966–2017), Scopus (2004–2017),
recurrences of SUI. In recent years, laser therapy has been ClinicalTrials.gov (2008–2017) and Cochrane Central
proposed for treating vaginal atrophy, pelvic organ prolapse Register of Controlled Trials (CENTRAL) (1999–2017) data-
(POP) and SUI. The rationale behind this form of treatment is bases, along with reference lists of electronically retrieved
based on collagen reconstruction, which consecutively as- full-text papers. The date of our last search was set at 15
sumes its role in providing vaginal support to pelvic floor May 2017. Search strategies and results are shown in the
structures. More specifically, laser therapy results in con- PRISMA flow diagram (Fig. 1).
trolled heating of the underlying mucosal layers, without Our search strategy in PubMed used the search terms
burning the mucosa [9]. This way, collagen fibrils become (Blasers^[MeSH Terms] OR Blasers^[All Fields] OR
shortened, but no denaturation takes place during the proce- Blaser^[All Fields]) AND incontinence[All Fields]) and the
dure, so their mechanical properties are believed to remain search terms (Berbium^[MeSH Terms] OR Berbium^[All
unaffected. To achieve this effect, the applied temperature Fields]) AND (Burinary incontinence, stress^[MeSH Terms]
should range somewhere between 60 and 70 °C. Available OR (Burinary^[All Fields] AND Bincontinence^[All Fields]
data indicate that this effect lasts due to collagen remodeling 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
and neocolagenesis, which can actually take up to 6 months to incontinence^[All Fields] OR (Bstress^[All Fields] AND
complete [9]. The theoretical advantage of the technique is Burinary^[All Fields] AND Bincontinence^[All Fields])).
that it is painless (no regional anaesthesia is required), mini-
mally invasive, takes only a few minutes and is typically com- Quality assessment
pleted in three therapies over a mean duration of 1 month.
Despite the significant implication for clinical practice We assessed methodological quality of all studies using the
using this form of treatment, there is no consensus regarding Oxford Level of Evidence criteria and the GRADE list [11].
its efficacy in treating SUI. Furthermore, and in view of the
aforementioned issues around the currently used interventions Included outcomes
for treating SUI, evaluation of novel treatment options and
evidence around their safety and efficacy is more essential Subjective and objective outcomes were eligible for inclusion,
than ever. The purpose of our systematic review was to criti- including questionnaires related to quality of life (QoL), pad
cally evaluate evidence on laser treatment for SUI and provide test, Q-tip test and urodynamic tests.
recommendations for clinicians.
Results
Methods
Included studies
Study design
Thirteen studies were included that recruited 818 patients who
We used the Preferred Reporting Items for Systematic underwent laser therapy for SUI [12–23]. We did not identify
Reviews and Meta-Analyses (PRISMA) guidelines to design randomized control trials. The analysed indices were struc-
the systematic review [10]. Eligibility criteria were tured in two tables that briefly present design characteristics
predetermined by the authors. Language and date restrictions of included studies (Table 1) and enrolled patients (Table 2).
were avoided during the literature search. We selected all ob- There was a notable, wide variation in for inclusion and ex-
servational studies (prospective and retrospective) that evalu- clusion criteria in these studies, and we present them separate-
ated the impact of Er YAG and fractional pulsed CO2 laser on ly to emphasise the heterogeneity of the study populations and
patients with SUI that was either clinically or urodynamically the inability to meaningfully pool results or perform meta-
proven. Case reports, review articles and animal studies were analyses.
excluded. The methodological quality of most included studies was
The study selection process took place in three stages. Two low, as they were either individual case–control studies, case
authors ran the initial search. Titles and/or abstracts of all series or poor-quality cohorts (Oxford Level of Evidence 3b
electronic articles were screened to assess eligibility. All and 4). The studies of Gambacciani and Pitsouni were
Int Urogynecol J (2017) 28:1445–1451 1447
exceptions: The first, however, focused mainly on the effect of 36 months following laser therapy [22]. A significant reduc-
vaginal erbium on genitourinary syndrome of menopause in tion of symptoms was observed based on the ICIQ-UI SF
total rather than specifically on UI. 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
Main outcomes < 0.05) [18]. Pitsouni et al. reported significant symptom re-
duction 1 month following therapy based on the ICIQ-
Subjective outcomes (questionnaires and patient-reported FLUTS, ICIQ-UI SF, Urogenital Distress Inventory 6 (UDI-
outcomes) 6) and King’s Health Questionnaire (KHQ) [23]. Tien et al.
presented a 21.9% cure rate and 12.5% improvement rate
Eight studies based their findings on subjective scales com- based on various questionnaires and scales at 6 months fol-
pleted by patients [12–18, 22]. The implemented scales eval- low-up, while the Female Sexual Function Index (FSFI)
uated QoL, clinical improvement and sexual life of patients showed significant improvement after therapy [15].
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 Objective outcomes
23% of patients 3 and 6 months after therapy, respectively
[14]. Similarly, Ogrinc et al. indicated significant improve- Results addressing objective evaluation of SUI improvement
ment after a year follow-up in 77% of patients by evaluating after laser therapy were analysed in seven studies [12, 14, 15,
International Consultation on Incontinence Questionnaire– 18–20, 22]. Among them, three based their results on pad
Urinary Incontinence (ICIQ-UI) and Incontinence Severity weight [14, 15, 22]. Specifically, Gaspar et al. reported a
Index (ISI) [14] scores. González Isaza et al. also observed a 50% decrease in pad weight in 82% and 50% of patients
significant reduction in ICIQ-UI SF scoring at 12, 24 and during the 3- and 6-month evaluation period, respectively
1448
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
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 following application of laser therapy (p = 0.01 and p = 0.04,
a significant reduction in mean pad weight at 3 and 6 months respectively) [12]. Khalafalla et al. conducted flowmetry and
following treatment (p < 0.001) [15]. González Isaza et al. cystometry measurements and evaluated parameters
observed a > 50% decrease in pad weight at 12 months, a concerning urethral pressure in patients with SUI prior to
finding that persisted at 24 and 36 months [22]. Fistonic et al. and 6 months following treatment [20]. Statistically signifi-
found that the angle of the Q-tip test gradually improved dur- cant improvement was noticed in flow rates and voiding time,
ing transition from baseline to 3 and 6 months (p ≤ 0.05) [18]. as well as a significant increase in residual urine volume, in
In their latest study, measurements of residual volume re- first desire and sensation, in strong desire and in maximal
vealed a significant reduction in patients with SUI before urethral pressure [20]. Lappi et al. observed significant thick-
treatment compared with postvoid volume at 1 and 2 months ening of the epithelium (p ≤ 0.05), and significantly improved
1450 Int Urogynecol J (2017) 28:1445–1451
density and number of capillaries after laser therapy (p ≤ 0.05 therapy for treating the genitourinary syndrome [26]. The au-
and p ≤ 0.01, respectively) in pathology analysis of specimens thors concluded that although laser therapy seems to be prom-
[19]. ising, evidence does not allow firm conclusions. In their re-
view, however, the only study included in relation to UI symp-
Adverse effects toms was that of Gambacciani et al. [21].
Eight studies monitored outcomes concerning potential ad- Strengths and weaknesses of our study
verse effects after laser application [12–18, 20]; none reported
significant adverse outcomes. Specifically, Tien et al. and This systematic review is based on meticulous scrutiny of
Fistonic et al. reported no adverse effects [15, 18]. Pardo existing literature through several electronic databases, thus
et al., Ogrinc et al. and Khalafalla et al. reported mild pain at limiting potential article loss. The methodological character-
the time of treatment [16, 17, 20]. Gaspar et al. discussed one istics of the included studies are briefly described, and both
patient with pelvic pain and two with dysuria that receded subjective and objective methods of SUI severity assessment
following completion of treatment [14]. Fistonic et al. detect- are presented in depth.
ed mild symptoms of irritation and sense of elevated temper- Several limitations prohibit firm conclusions, as the avail-
ature during therapy, as well as slight oedema of the treated able evidence is particularly poor due to methodological
area and vaginal discharge, which lasted for a maximum of flaws, which render the studies prone to selection, attrition
48 h [12, 13]. 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-
Discussion ment modalities for SUI.
Conflicts of interest Stergios Doumouchtsis has received travel grants 13. Fistonic N, Fistonic I, Lukanovic A, Findri Gustek S, Sorta Bilajac
and sponsorship to attend conferences from Speciality European Pharma. Turina I, Franic D. First assessment of short-term efficacy of Er:
He has also received speaker Honorarium from Astellas. The other au- YAG laser treatment on stress urinary incontinence in women: pro-
thors have no conflict of interest to report. spective cohort study. Clim : J Int Menopause Soc. 2015;18(Suppl
1):37–42. doi:10.3109/13697137.2015.1071126.
14. Gaspar A, Brandi H. Non-ablative erbium YAG laser for the treat-
ment of type III stress urinary incontinence (intrinsic sphincter de-
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