Treatment of Female Stress Urinary Incontinence with Hybrid Fractional Laser, Preliminary Study

Stress urinary incontinence (SUI) is the involuntary loss of urine during activities requiring increased abdominal activation such as sneezing, coughing, jumping, physical exercise and sports. It is the most common form of incontinence, accounting for approximately half of all cases. Urge incontinence accounts for 34% and mixed incontinence for 16% [1,2]. Despite its prevalence, SUI remains underdiagnosed and undertreated [35].


Journal of Gynecology and Women's Health
activities, their confidence, and their daily and social activities. Less than half of those who reported being moderately to extremely bothered (46.6%) had ever talked with a physician about it [9].

Current treatment approaches
There are numerous therapies for SUI. Lifestyle and nonsurgical approaches weight loss, smoking cessation, behavioral therapy, pelvic floor muscle training (PFMT), vaginal devices, electrical stimulation, and biofeedback [10,11].
The gold standard surgical intervention for SUI is the midurethral sling (MUS) using tension-free vaginal tape (TFVT), with a retropubic (RP)or transobturator (TOT) approach [12,13]. The procedure has been extensively studied and demonstrates good efficacy over the long term [14]. However, there is also a significant complication rate, including hemorrhage, bladder perforation, urethral injury, infection, and groin pain, as well as inherent risks from the anesthesia [15,16]. Numerous lawsuits have been filed in several countries against device manufactures and some products have been withdrawn from the market [15].
A recently published retrospective cohort study of 92,246 first-time TFVT, TOT, or RP surgical mesh procedures between April 2007 and March 2015 in England found complication rates in the unconfounded cohort (no concomitant procedures, or such procedures were unlikely to affect outcomes or were rescue procedures associated with the mesh insertion procedure) within 30 days or 5 years of 9.8%. The complication rate within the potentially confounded cohort it was 12.8%. The authors also reported high 30-day readmission rates in both groups (7.1% in unconfounded and 9.7% in confounded cohort) [15].
Another surgical option is the single-incision mini-sling (SIM). Proponents claim it offers a safer, less invasive alternative with faster recovery time, less post-operative pain, and the ability to be performed in an outpatient setting. However, while studies show similar or non-inferior short-term clinical efficacy compared to MUS, there is little long-term data [10,17].

Laser therapy
A newer, non-surgical, minimally invasive option is nonablative laser treatment with Er-YAG laser, which has been used safely for more than a decade in dermatology and aesthetic medicine [18,19]. The photothermal effects lead to collagen remodeling and stimulates neocollagenesis, thus strengthening an important component of pelvic floor supportive structures. Indeed, biopsy studies after Er: YAG laser exposure demonstrate improvement in pelvic muscle tissue thickness and structure as well as increased vascularization, as well as SUI symptoms in pre-and postmenopausal women [7,[20][21][22].
Several studies demonstrate improvement in SUI symptoms with Er: YAG. One of the largest involved 175 patients, 66% of whom had newly diagnosed SUI. After an average of 2.5 Er: YAG distinct laser procedures over 12 months, there was a significant improvement based on the International Consultation on Incontinence Modular Questionnaire (ICIQ) and Incontinence Severity Index (ISI) in 77% of participants regardless of age, with minimal discomfort or pain during the procedure reported [21].
One of the few randomized, controlled trials compared Er: YAG to Kegel exercises found a significant improvement in SUI symptoms at 6 months with the laser group with no change in the control group [22].
Analyses of 2 studies suggest that the best results of Er: YAG laser treatment would occur in younger women with a BMI <23.3; an average birthweight of children of >3.6 kg; a baseline ICIQ-UI of <10; and perineometer squeeze duration at a baseline of 3.51 seconds or higher. The authors also reported that the critical age for Er: YAG laser effect was 47.5 years [23,24].
We previously reported on a longitudinal, prospective study investigating the efficacy of laser photothermal therapy in 42 women with mild-to-severe SUI after 2 sessions of non-ablative Er: YAG laser. The median ICIQ-UI score dropped from 11 at baseline to 3 at 6 months follow-up (P<0.001). The majority of participants (78.6%) reported improvement and 38.1% reported complete remission of SUI at follow up. In addition, 66.7% of participants reported high satisfaction with the procedure, while 81.8% of the 33 sexually active women in the trial reported improved sexual satisfaction. The only adverse effect was mild discomfort during the procedure [25].
More recently, an innovative hybrid laser was introduced that offered another minimally invasive option. This hybrid fractional laser enables delivery of both ablative 2940nm and non-ablative 1470nm wavelengths, either independently or blended, which should improve tissue remodeling while keeping surrounding tissue intact and reducing healing time.
The safety and efficacy of the hybrid fractional laser was assessed in an open-label study of 20 premenopausal women (18 of whom completed the study), mean age 41, with self-reported vaginal laxity. Twelve had SUI symptoms. Participants received 3 laser treatments performed at 4-to 6-week intervals [26].
Three domains on the Female Sexual Function Index (FSFI) were assessed: lubrication, orgasm, and dyspareunia. Eleven subjects were initially classified with female sexual dysfunction (FSD) based on the FSFI score. By 8 months, 73% (n=8) no longer met the FSD criteria. In addition, 80% of participants with mildto-moderate SUI (n=9) demonstrated complete resolution at 1 month follow up based on the ICIQ-UI; 55% (n=5) at 8 months. Mean epithelial thickness increased with evidence of increased denser collagen, increased fibroblasts, and greater vascularity [26].
The objective of this current study was to establish the safety and efficacy of SUI treatments with a hybrid fractional laser combining ablative Er: YAG (2940nm) and non-ablative diode (1470nm) independently adjustable for depth of penetration and density of coverage in the treatment of SUI. Here, we report on the results after 1 treatment and 3 months follow up.

Methods
This pilot, prospective study was performed between November 2017 and February 2018 in Clinica Ginestetica, a private health center in Santiago, Chile.
Inclusion criteria were mild-to-severe SUI, the ability to complete the ICIQ-UI SF, and the ability to provide voluntary written consent. Exclusion criteria were exclusive urge incontinence, severe prolapse, current pregnancy, previous surgery for SUI, severe neurological conditions, vaginal lesions, genitourinary tract infections, abnormal vaginal bleeding, history of photosensitivity disorder or use of photosensitizing drugs, and hematuria.
The degree of SUI, and its impact on quality of life was assessed using the ICIQ-UI SF administered in person by the lead investigator.
A follow-up ICIQ-SF questionnaire was administered 3 months after treatment to assess any improvement of SUI symptoms and quality of life. This assessment was performed via telephone by a non-medical employee. Improvement was defined as an ICIQ SF score lower than baseline regardless of severity stage.
Although it was not the main objective of this study, patient satisfaction with the treatment and sexual life improvement were also reported across an ordinal scale: no satisfaction, low, moderate, or high satisfaction.
The hybrid fractional laser (diVa, Sciton Inc, Palo Alto, CA) was used with ablative 2940nm and non-ablative 1470nm laser wavelengths. The treatment was performed using outpatient clinical settings. Topical anesthetic lidocaine was applied 20 minutes prior to the treatment procedure. Treatment settings for pre-menopausal and postmenopausal subjects are shown in Table 1. Settings for pre-menopausal participants were 1470nm -500um depth (6% density) and 2940nm -300um depth (7% density). Treatment settings for post-menopausal participants were 1470nm-400um depth (4% density), 2940nm-200um depth (7% density). One treatment pass delivered in 360 degrees circumference to vaginal canal and another pass was delivered to the anterior vaginal wall. The results after the initial treatment are reported here (Table 1).

Statistical analysis
Student t-test was used for statistical analysis.

Result
Nineteen female participants were enrolled with a median age of 47.4 years (32-64). Fifteen women had at least 1 vaginal delivery; 3 had at least 1 cesarean delivery; and 1 participant had not delivered any children. Ten participants were premenopausal and 9 were post-menopausal. The mean score on the ICIQ-UI at baseline was 12.7 (8-20 range) (Figure 1). Ten participants (52.6%) also demonstrated urge incontinence. At 3 months follow-up, the ICIQ-UI mean score was 4.7 (0-14), a 68.4% improvement. Five participants (26.3%) demonstrated a 100% improvement. One patient had a higher ICIQ-UI SF score at 3 months and worsening of symptoms at 3 months.  There were no adverse effects, pain, or discomfort reported. The procedure itself took between 10 and 15 minutes. Eighteen of the 19 participants (94.7%) subjectively reported an improvement. Although not a study objective, 80% (n=12) of the 15 women who were sexually active reported improved sexual satisfaction. Of the 19 patients, 17 (89.5%) said they would repeat the treatment and recommend it to others.

Journal of Gynecology and Women's Health Discussion
The results of this study demonstrate that a single treatment with a hybrid fractional laser can improve symptoms of SUI based on the ICIQ-UI with no adverse effects. Treatment was well tolerated by all subjects.
This study demonstrated 94.7% subjectively satisfied improvement in SUI after just 1 treatment session. An earlier study from Pardo et al on the efficacy of 2 sessions with a nonablative Er: YAG laser in 42 women with mild-to-severe SUI demonstrated a 79% improvement. Both studies reported improved sexual satisfaction [25].
This study is, to the author's knowledge, the first to evaluate a hybrid fractional laser in the treatment of SUI only.
An earlier, open-label study of a similar device that included 12 pre-menopausal women with vaginal laxity and SUI also demonstrated a reduction in ICIQ-UI SF scores in 9 participants with mild-to-moderate SUI [26].
Limitations of this study include the lack of a control group; the fact that this was an open label study; the small study population; and the short follow-up time.

Conclusion
A single treatment with a hybrid fractional laser in pre and post-menopausal women appears to provide a quick, safe outpatient procedure for the treatment SUI, with a significant reduction in SUI symptoms. This minimally invasive procedure is comfortable and results in minimal to no bleeding or other adverse effects seen with surgical interventions for SUI. Larger, controlled trials will be needed to validate the findings of this study.