Laser procedure for female urinary stress incontinence: A review of the literature

25 décembre 2017

Auteurs : C. Conté, T. Jauffret, S. Vieillefosse, J.F. Hermieu, X. Deffieux
Référence : Prog Urol, 2017, 17, 27, 1076-1083



Female stress urinary incontinence (SUI) is a lower urinary tract dysfunction defined as involuntary loss of urine on effort or physical exertion (e.g., sporting activities), or on sneezing or coughing [1, 2]. With an estimated prevalence of 4-35% among adult women [3], SUI is thought to have a complex and multifactorial pathophysiology that relates to general weakening of the pelvic musculature and of collagen-dependent tissues involved in pelvic support [4]. Major risk factors for female SUI include pregnancy, vaginal delivery, parity, age, postmenopausal status and obesity [5]. Gynecological surgery for prolapse, hysterectomy and other gynecological procedures double the risk of SUI [6].

Initial non-surgical management includes behavioral therapy, pelvic floor muscle training and continence pessaries. Pelvic floor muscle training seems to be efficient, but studies show discordant results and the long-term benefits are unclear. Further clinical studies are needed. [7]. Surgical procedures (midurethral slings) are more effective and tension-free vaginal tape (TVT) has been considered the gold standard in SUI [4]. In France, TVT and TOT are recommended for the surgical management of female SUI [8, 9]. However, midurethral slings are associated with side effects such as bladder perforation, urethral injury, bladder outlet obstruction and mesh exposure [10]. Therefore, less invasive procedures should be developed. Laser photothermal heating results in denaturation of collagen, which shortens along the longitudinal axis, resulting in collagen remodeling and collagen neogenesis. The treated tissue may then become enriched with new collagen, making it tighter [11, 12]. This tensioning of the anterior vaginal wall may explain the therapeutic effect of the laser procedure on SUI. Collagen is an important component of pelvic floor support structures. An increase in temperature breaks up intermolecular cross-links and stabilizes the collagen triple-helix structure, thus resulting in the shortening of collagen fibers. In order to achieve a shrinkage of collagen, without destroying its fibrillar structure, and stimulation of neocollagenesis, the temperature must be between 60°C and 65°C [13]. The idea is that laser-mediated heat pulsing of the pelvic floor tissue could be an effective non-surgical method for treating female SUI. Microscopic studies showed significant changes after Er:YAG laser in the main structural components of the vaginal wall mucosa. Studies of vaginal biopsy specimens before the exposure showed degenerative and atrophic changes in the stratified squamous epithelium, disorganization of fibrillar structures of the intercellular matrix, and microcirculatory disorders. Studies after Er:YAG laser exposure showed signs of neocollagenogenesis and elastogenesis, foci of neoangiogenesis, reduction of epithelial degeneration and atrophy, and an increase of the fibroblast population [14]. Erbium YAG laser technology is already used in dermatology and esthetic medicine and to treat vaginal tissue in some indications (human papilloma virus infections, cervical ectropion, vulvar intraepithelial neoplasia, dystrophic lesions, melanosis). IncontiLase® is a minimally invasive, non-surgical and non-ablative Er:YAG laser therapy for the treatment of SUI. Thermoablative fractional CO2 laser (TACO2L) is a transvaginal laser used in the treatment of SUI.

Patients' increasing interest in these new technologies emphasizes the importance of this study, which may help physicians to inform their patients correctly. The aim of the current study was to analyze the literature concerning the efficacy, complications and place of laser phototherapy in the treatment of SUI.


Studies that focused on the use, efficacy and safety of laser procedures in the treatment of female SUI, as an alternative to more invasive traditional surgical procedures, were included. Review articles, conference abstracts, letters, and animal studies were excluded. We searched the PubMed/Medline database for relevant trials using the following keywords: "female" "stress urinary incontinence" AND "laser" or "phototherapy". Only articles in French or English were analyzed. We excluded studies whose main objective was not the assessment of laser treatment of urinary incontinence. Three of these were reviews or editorials about indications for laser therapy in gynecology; and the others were about the use of laser treatment for vaginal atrophy associated with the menopause [4]; mesh exposure [12]; the biological effects of lasers [7] and surgical management of SUI [15] (See flowchart in Figure 1). Of the 47 published studies identified; all seven that were relevant and concerned laser treatment of SUI were prospective; non-randomized and single-center. No randomized trial focused on laser treatment for SUI. The level of evidence of all studies was 4; according to the CEBM classification. Relevant studies are presented in Table 1.

Figure 1
Figure 1. 



Inclusion and exclusion criteria

The inclusion criteria for recruitment were similar between studies: SUI, normal cell cytology, negative urine culture, no injuries or bleeding in the vaginal canal, introitus and vestibule. In two studies, patients with mixed urinary incontinence were included (34% in Ogrinc et al. [12] and 40% in Tien et al. [11]) Exclusion criteria differed between studies. In two studies by Fistonic et al. [15, 16], patients with insulin-dependent diabetes mellitus or body mass index >30kg/m2 were excluded. Patients with severe prolapse, severe neurological conditions associated with incontinence and neurogenic bladder were excluded from three studies [13, 14, 15]. Previous surgery for a treated condition was an exclusion criterion in one study [17]. Urge urinary incontinence and pregnancy were common exclusion criteria.

Laser procedure

Proposed as a first-line therapy for SUI in all studies, laser treatment of the vagina wall consisted of three steps varying in laser intensity and exposure time. Patients were discharged immediately afterwards.

Most studies used a 2940nm Er:YAG laser (XS Dynamis, Fotona, Slovenia) in a non-ablative, thermal-only smooth mode modality [12, 13, 14, 15, 16, 17]. Vaginal temperature was reported in only two studies and ranged from 60 to 65°C [15, 16]. In one study [15], temperature was measured with a thermal camera to assess heating of the mucosal tissue. Local anesthesia was used in two studies during the procedure [17, 18], four studies did not use anesthesia at all [15, 16, 19, 20] and no data were available in one study [21]. Laser treatment is performed with a special accessory called a G-set, which is composed of two hand pieces (R11 with a 360°-circular adapter and PS03 with a 90°-angular adapter), and a laser speculum. Each laser treatment consists of three steps. The laser procedure is well described in most of the studies, but there are significant variations between studies regarding total energy delivered and number of passes in each step. The first step consists of irradiation of the full circumference of the vaginal canal with the R11 360° circular adapter. In the second step, the anterior vaginal wall is irradiated with the PS03 90° angular adapter. In the last and third step, the laser speculum is removed and laser energy is delivered to the mucosa of the vestibule and introitus. The total energy deposited ranged between 1000J and 3000J in the studies; no information about energy dose was given by Tien et al. [18]. With the Er:YAG laser, fluence can be chosen by physicians and total energy delivered directly controlled. In the study by Pardo et al. [13], all postmenopausal women with vaginal atrophy and no hormonal replacement therapy were treated with local estrogen (estriol) before treatment. Patients were advised to avoid sexual intercourse for at least 3 days after the treatment in the study by Pardo et al. [13] and for at least 15 days in the study by Fistonic et al. [14, 15]. Two laser treatment sessions were used by Ogrinc et al. [19] and Pardo et al. [17], at respective intervals of 4-6weeks and 21-28 days. Ogrinc et al. [12] also performed a third procedure 6months after the first (109 patients, 62%).

In a study conducted in Colombia [21], a thermoablative fractional CO2 laser (TACO2L) was used (SmartXide2 V2LR fractional microablative CO2 laser system MonoLisa TouchTM; Deka, Florence, Italy) at the urethrovesical junction, but the method used to determine the location of this urethrovesical junction is not described. The authors noted that "the same laser device parameters were used in all patients", but the parameters are not described.

In a study conducted in Argentina [20], 22 patients received two Er:YAG laser sessions with a 3-week interval, delivering non-ablative laser pulses inside the whole length of the urethra [20]. Preoperative care included vitamin C for 3months and prophylactic antibiotic 2h before the intervention.

In all studies, patients provided written inform consent and patient participation was not remunerated. An ethics committee approved all studies. One study was partially funded by Dynamic Medical Technologies Inc. [18]. In another study, some of the authors were employees of Fotona, the manufacturer of lasers used in the study [15].

Primary outcome

The difference between the pre-operative and post-operative ICIQ-UI-SF scores was statistically significantly different in all studies (Table 1). In the literature, anchor-based minimal important differences for ICIQ-UI-SF ranged from −4.5 to −5.7 at 12months and from −3.1 to −4.3 at 24months [22]. The only study that had adequate follow-up was that of González et al. [21], with a follow-up of 36months and a difference of −7.58 (P <0.001). Four studies show significant differences for ICIQ-UI-SF, but with a follow-up of 6months only. In 42 patients with mild to severe SUI, Pardo et al. [17] used the ICIQ-UI-SF score as primary outcome. The improvement noted in 78% of patients was not related to age or to the number of vaginal deliveries. The patient satisfaction rate was 66%. Nevertheless, only 38% of all patients reported complete healing at follow-up (no SUI symptoms). No improvement was reported for 7 patients and in 2 cases a worsening of symptoms was observed. Fistonic et al. [15] reported significant average decreases in ICIQ-UI-SF score: 6.3 points after 1 month (P <0.001), 5.3 points after 2 months (P <0.01) and 5.1 points after 6months (P <0.05). Ten of 31 patients (32%) had an ICIQ-UI-SF score of zero, and the score was only available at 1-month follow-up. Another study reported similar results: a significant 46% decrease in ICIQ-UI-SF score at 2 and 6months of follow-up (95% CI, 33-67%, P <0.01) and better outcomes in younger patients (<39years; 100% versus 8%, P <0.001) and normal weight patients (67% versus 25%, P <0.001) [16]. Only 18/47 patients (38%) had an ICIQ-UI-SF score equal to zero at the last follow-up.

Ogrinc et al. [19] reported a significant decrease in incontinence severity index in all women (P <0.001) at one-year follow-up. The ICIQ-UI-SF score was significantly dependent on the type of incontinence diagnosed before therapy: the procedure cured 77% of women with SUI and 34% of women with mixed urinary incontinence. In 38 patients (22%), urinary incontinence worsened after treatment.

Tien et al. [18] used as primary outcome the efficacy of the IncontiLase® procedure, assessed using pad weights and urodynamic values. An objective "cure" was defined by a pad weight≤1g after the 20-min pad test at 6 months after treatment; "improvement" was defined as follows: a ≤50% decrease in pad weight at 6 months. Significant improvement in pad weights was noted at the follow-up visits (P <0.001): 14g at baseline versus 3g at 6months follow-up. Nevertheless, failure was observed in 6 of 28 patients (21%). Urodynamic values did not vary.

González Isaza et al. assessed the efficacy of a thermoablative fractional CO2 laser (TACO2L) as a treatment of mild SUI in postmenopausal women [18]. This study was conducted in Colombia, in 161 women over 36 months of follow-up. However, the lost to follow-up rate is not provided in the published manuscript. Improvement in ICIQ-UI-SF score was observed at 12months (14.34 vs. 7.09, P <0.001), 24months (14.34 vs. 7.49, P <0.001), and 36months (14.34 vs. 6.76, P <0.001). Significant changes were recorded in the 1-h pad-weight test from 9.89 at baseline to 3.52, 3.55 and 3.72 at 12, 24, and 36months respectively (all P <0.001). The efficacy associated with laser treatment was sustained up to the last follow-up (3years). At the end of treatment, 32% of patients reported having moderate urinary incontinence.

In a study by Gaspar et al., 10/22 patients (46%) were cured (ICIQ-UI-SF=0) and five (23%) were improved (1- or 2-stage reduction in ICIQ-UI-SF score compared to baseline); failure was noted in 7 patients (32%) at 6months. Furthermore, clinical improvement, assessed using the 1-h pad-weight test, was noted at 6months in 11 patients (50%). However, no statistical analysis was reported in this study.

Secondary outcomes

Fistonic et al. [15] found a statistically significant decrease in post-void residual urine volume at 1 month and 2 months of follow-up, compared with the baseline measurement, but not at 6months, indicating the improvement of voiding efficiency following treatment. Using validated questionnaires, Tien et al. [18] found that laser treatment improved lower urinary tract symptoms, health-related quality of life, and the sexual function of both partners. In the study by Pardo et al. [13], 81.8% of sexually active women reported improvement of sexual gratification.

Histological findings

In a study of the thermoablative fractional CO2 laser (TACO2L), punch biopsies were obtained at the urethrovesical junction in the anterior compartment of the vaginal mucosa before and at the end of treatment [18]. The biopsies were stained with hematoxylin and eosin for histological analysis at baseline, and at 6 weeks and 6months after treatment. Histological examination revealed:

thicker vaginal epithelium;
higher population of intermediate and shedding superficial cells and underlying connective tissue with papillae indenting the epithelium-connective tissue junction.

The authors reported that the stroma showed "features indicating structural recovery in all patients at 6 weeks".

Adverse events

The procedure was well tolerated in all studies and only mild pain during treatment was reported (Table 2). Fistonic et al. [15, 16] reported that all patients experienced a sensation of warmth or teasing during the procedure, and in the following days increased vaginal discharge and slight vulvar edema. In three studies, a visual analog scale was used to evaluate pain. Transient vulvar edema was infrequent. Another side effect was a change in the type of incontinence: Ogrinc et al. [19] reported transient urge urinary incontinence as a complication in 6.3% patients after the first procedure and again in 4% after the second procedure; and one case of de novo urgency was reported in another study [16]. In the study by Gaspar et al., two patients (9%) reported dysuria, which disappeared within 24h after the procedure. Three studies [17, 18, 21] reported no side effects, but gave no information about their measurement.


Laser therapy was designed to provide a less invasive treatment for SUI in women than the current gold standard, which is placement of a midurethral sling via either the retropubic or the transobturator route. However, questions have been raised about the effectiveness and safety of laser treatment.

We found no consistent study, no randomized control trial of laser treatment of SUI, but only cohort studies with short-term follow-up and no control group. All results pointed to short-term improvement of SUI, assessed by means of the ICIQ-UI-SF or pad weights. Improvement of SUI after a laser procedure was reported in between 62% and 78% of cases. We found no study that compared laser treatment with surgery such as TVT or with pelvic floor muscle training or placebo. For comparison, in a recent randomized clinical trial, the objective cure rate for TVT and TVT-0 was, respectively, 84.7% and 86.2%, with a follow-up of five years [23]. The benefits of the TVT operation last for 17 years, with a high satisfaction rate and no serious long-term tape-induced adverse effects [24]. However, patients who are treated with TVT have more severe SUI and laser therapy seems to be relevant for moderate SUI. When compared with a control group, women with SUI who underwent pelvic floor muscle training were eight times more likely to be cured (56.1% vs. 6%) or seventeen times more likely to experience cure or improvement (55% vs. 3.2%) [25]. Urethral bulking agents have been considered as an alternative in patients unsuitable for more invasive procedures in a context of severe sphincter deficiency and for those willing to accept the need for repeat injections [26], and yield objective success rates ranging from 25.4% to 73.3%. Urodynamic values were evaluated in only one study [18], but no statistically significant difference was noted in terms of detrusor activity or maximum urethral closure pressure after the laser procedure. We cannot draw conclusions about the efficacy of laser therapy in patients with sphincter deficiency, in which the laser procedure does not seem to be an alternative. The role of laser therapy in the management of SUI is still unclear and remains to be defined.

In laser therapy, the photothermal effect of a laser beam causes mucosal tissue to shrink, without any removal of tissue, and induces neocollagenesis following heat treatment, which generates new collagen fibers [27]. We may wonder about the long-term effect of this treatment and about the need for repeat procedures to sustain the beneficial effect.

All the studies of laser therapy were limited by a short-term follow-up, loss to follow-up, and a small sample size. Fistonic et al. [15] reported that, 6months after laser intervention, only 14 patients (43%) remained in the study, while 17 (57%) were lost to follow-up. More than half of the patients were no longer evaluated at 6 months, which limits results and the power of the study. The longest follow-up was 36 months [18] and the largest sample size was 175 patients [19], but with SUI and mixed urinary incontinence. Studies monitored only short-term outcomes, so the results should not be generalized to longer time periods. In two studies [15, 16], the improvement of ICIQ-UI-SF score was greatest at the first follow-up and slightly smaller at each subsequent follow-up (3 and 6months). This might be an argument in favor of repeating the procedure in order to fortify the effect. Ogrinc et al. [19] reported that the beneficial outcome persisted as much as one year after the last procedure. The results in population sub-groups differ between the studies: in two studies [17, 19], age and number of vaginal deliveries did not affect the outcome, whereas Fistonic et al. [16] reported that there were better outcomes in younger patients. In one study [19], the final outcome was significantly worse in women diagnosed with mixed urinary incontinence before therapy. Only one study [17] excluded patients with previous surgery and there is no information in other studies about previous surgery, as TVT, and we conclude that the laser procedure was the first-line treatment for SUI in all studies. We found no data concerning the results of the TVT procedure after laser treatment (efficacy, side effects such as mesh exposure). Despite the scarcity of data on adverse events, laser treatment seems to be safe. No explicit data on dyspareunia were found, but two studies reported good results regarding sexual symptoms [17, 18], with high or moderate improvement of sexual gratification.

In two studies [15, 18] there were conflicts of interest, as some co-authors were employees of Fotona, the manufacturer of the laser used in the studies.

We believe that, given the recent rise in interest in alternative, less invasive treatment options for SUI, further studies should be performed to confirm the effectiveness and safety of laser therapy and to understand which patient group stands to gain the most from this therapy. Finally, laser therapy might be a good alternative to surgical management of SUI for patients with mild SUI or who have had a negative experience with previous surgery, but to date there are no published controlled studies of this procedure.


The efficacy of vaginal laser therapy in SUI has not been assessed in comparative studies. More rigorous and adequately powered trials are required to assess the relative benefits and adverse event profile of laser procedures, as compared with other minimally invasive procedures for SUI treatment.

Disclosure of interest

The authors declare that they have no competing interest.

Table 1 - Summary of the studies.
Author, year  C Country  Study design  Level of evidence  No. women  Mean or median age (y/o)  Mean BMI (kg/m2 Main exclusion criteria  Type of UI  Primary outcome  Follow-up  Loss of follow-up  Procedure/No. sessions (interval between 2 sessions)  Mean or median ICIQ-UI-SF score at baseline  Mean or median ICIQ-UI-SF score at last follow-up  Results 
González Isaza et al., 2017  Colombia  Prospective, non-randomized, monocentric  161  53.3  NP  Previous surgery or POP stage>1 or recurrent urinary tract infection or BMI>35kg/m2  Mild SUI  ICIQ-UI-SF &1h pad test  36 months  NP  CO2 laser/4 (30-45 days) & yearly (12, 24 & 36 months)  14.34  6.76  Improvement in ICIQ-UI-SF: 6.76 vs. 14.34 (P <0.001) Improvement in 1h pad test: 3.7 vs. 9.8 (P <0.001) 
Gaspar et al., 2017  Argentina  Prospective, non-randomized, monocentric  22  57.9  27.3  Antihypertensive medication and alpha blockers  Type III SUI (ISD)  ICIQ-UI-SF&1h pad test  6 months  0/22 (0%) at 6 months  Er. Yag laser intra urethral/2 (3 weeks)  18  ICIQ-SF: 10 patients (46%) were cured
1h pad test: improvement in 11 patients (50%) at 6 months 
Pardo et al., 2016  Chile  Prospective, non-randomized, monocentric  42  46.5  NP  Previous surgery
SUI +MUI  ICIQ-UI-SF  3-6 (5 months)  0/42 (0%) at 3-6 months  Er. Yag laser/2 (21-28 days)  11  Improvement in ICIQ-UI-SF: 3 vs. 11 (P <0.001)
Tien et al., 2016  Taiwan  Prospective, non-randomized, monocentric  35  43.3  24  Non-sexually active  SUI  Pad test & Urodynamic values  3 and 6 months  3/35 (9%) at 3months  Er. Yag laser/1  NP  NP  Improvement in pad weight: 3.1 vs. 14 (P <0.001)
Cure and improvement rate) in 78.6%
Urodynamic values did not differ 
Fistonic et al., 2016  Croatia  Prospective, non-randomized, monocentric  31  46.6  23.2  BMI>30
SUI  ICIQ-UI-SF  1, 2 and 6 months  17/31 (57%) at 6months  Er. Yag laser/1  12.9  7.8  Improvement in ICIQ-UI-SF: 7.8 vs 12.9 (P <0.05) 
Ogrinc et al., 2015  Slovenia  Prospective, non-randomized, monocentric  175  49.7  NP  UUI  SUI or MUI  ICIQ-UI-SF&ISI  2, 6 and12 months  NP  Er. Yag laser/3 (4-6 weeks & 6 months)  NP  NP  Improvement in 62.3% (P <0.001) 
Fistonic et al., 2015  Croatia  Prospective, non-randomized, monocentric  73  47  23  BMI>35kg/m2
SUI  ICIQ-UI-SF  1 and 2-6months  28/73 (38%) at 2-6months  Er. Yag laser/1  12  Improvement in 72.3% 

Légende :
APFQ: Australian pelvic floor questionnaire; BMI: Body Masse Index; ICIQ-UI-SF: International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form; ISD: intrinsic sphincteric deficiency (defined as follows: Valsalva leak point pressure<60cmH2O); ISI: Incontinence Severity Index; MUI: mixed urinary incontinence; n: number; NP: not provided; POP: pelvic organ prolapse; SUI: stress urinary incontinence; UUI: urinary urge incontinence; MUI: mixed urinary incontinence.

Table 2 - Post-procedure adverse events associated with the treatment of stress urinary incontinence using a laser procedure.
Author, year  N. women  Last follow-up (months)  Increased vaginal discharge in the next few days  Pelvic pain  Worsening of SUI symptoms  Transient UUI  Bladder outlet obstruction symptoms  Dyspareunia 
González Isaza et al., 2017  161  36  NP 
Gaspar et al., 2017  22  NP  1 (4%)a  2 (8%)a 
Pardo et al., 2016  42  NP  "Mild pain in some patient" 
Tien et al., 2016  35  NP 
Fistonic et al., 2016  31  Most  5% 
Ogrinc et al., 2015  175  12  NP  11 (6%) 
Fistonic et al., 2015  73  Most  2 (5%)  2 (4%)  1 (1%) 

Légende :
n: number; NP: not provided; SUI: stress urinary incontinence; UUI: urge urinary incontinence.

Transient (disappeared within 24hours).


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