Treatment of Female Stress Urinary Incontinence
with Hybrid Fractional Laser, Preliminary Study
Jack Pardo Schanz*, Vicente Sola Dalenz and Isabel Oporto Almiron
Clinica Ginestetica-Laser Rejuvenation Institute, Chile
Submission: August 23, 2018;Published: September 07, 2018
*Corresponding author: Jack Pardo Schanz, Clinica Ginestetica-Laser Rejuvenation Institute, Santiago, Chile, Email:email@example.com
How to cite this article: Jack P S, Vicente S D,Isabel O A. Treatment of Female Stress Urinary Incontinence with Hybrid Fractional Laser, Preliminary
Study. J Gynecol Women’s Health. 2018: 11(3): 555815. DOI: 10.19080/JGWH.2018.11.555815
Background: 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. Despite its prevalence, SUI remains underdiagnosed and undertreated. Current lifestyle and physical therapy treatments have limited success, while surgical options carry with them the risk of significant adverse effects. In recent years, the use of the Er: YAG laser treatment has demonstrated efficacy in alleviating SUI symptoms with minimal adverse effects. A new hybrid fractional laser that enables delivery of both ablative 2940 nm and non-ablative 1470 nm wavelengths, either independently or blended, was recently introduced. This study evaluated its safety and efficacy in SUI.Aim: To determine the knowledge, attitudes and practices of postpatum women with respect to cervical cancer in the health districts of Maroua, northern Cameroon.
Methods: We enrolled 19 women with mild-to-severe SUI in this open-label, non-randomized, prospective pilot trial. Inclusion criteria were mild-to-severe SUI, the ability to complete the Consultation on Incontinence Modular Questionnaire Short Form (ICIQ-SF), and the ability to provide voluntary written consent. The degree of SUI and its impact on quality of life was assessed using the ICIQ-UI SF administered at baseline and again 3 months after treatment. Improvement was defined as an ICIQ-SF score lower than baseline regardless of severity stage. The hybrid fractional laser (diVa, Sciton Inc, Palo Alto, CA) was used with ablative 2940nm and non-ablative 1470nm laser wavelengths in an outpatient setting. One treatment pass delivered in 360 degrees circumference to vaginal canal and second pass to anterior vaginal wall was performed.
Result:The mean score on the ICIQ-UI at baseline was 12.7 (8-20 range). At 3 months follow-up, the ICIQ-UI mean score was 4.7 (0-14), a 68.4% improvement (p< 0.05). Five participants (26.3%) demonstrated a 100% improvement. One patient had a higher ICIQ SF score at 3 months and worsening of symptoms at 3 months. There were no adverse effects, pain, or discomfort reported.
Discussion The results of this pilot 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. We will report the results after a second treatment session.
Keywords:Pelvic floor muscle training; Midurethral sling; Tension-free vaginal tape; Retropubic; Transobturator; Single-incision mini-sling; Female Sexual Function Index
Abbrevations:SUI: Stress urinary incontinence; PFMT: Pelvic Floor Muscle Training; MUS: Midurethral Sling; TFVT: Tension-Free Vaginal Tape; RP: Retropubic; TOT: Transobturator; SIM: single-incision mini-sling; FSFI: Female Sexual Function Index; FSD: Female Sexual Dysfunction; ICIQ-SF: Consultation on Incontinence Modular Questionnaire Short Form; ICIQ: Incontinence Modular Questionnaire; ISI: Incontinence Severity Index
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 [3-5].
Stress urinary incontinence typically occurs as the result of weakened pelvic floor muscles that impair the ability of the urethral sphincter to completely close, leading to urine
loss at lower-than-normal abdominal pressure. The nerves that control the pelvic floor may also be damaged, while the collagen-dependent connective tissues that provide pelvic support may be weakened [6,7]. Risk factors for SUI include obesity, menopausal status, parity, vaginal delivery, pelvic floor disorders, gynecological surgery, smoking, diabetes, and physical and sexual activity .
The condition has a significant impact on women’s quality of life, with one survey of 605 women finding that 77.5% were bothered by their symptoms; 28.8% moderately to extremely. The condition impacted their ability to participate in physical 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 .
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 . 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 .
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) .
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].
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 [7,20-22].
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 .
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 .
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 .
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 .
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
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.
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
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
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).
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.
Figure 2 depicts the mean scores at baseline and follow
up based on menopausal status. Pre-menopausal women
experienced a 58% improvement and post-menopausal women
a 69% improvement (all P< 0.05).
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.
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 .
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 .
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.
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