Abstract
Abstract
Objective:
About 45% of healthy postmenopausal women have symptoms related to vaginal atrophy that can affect quality of life, including self-esteem and relationships. Initial studies on laser therapy for postmenopausal vaginal atrophy have shown promising results, with reduction of signs of atrophy and improved quality of sexual life. The study was designed to evaluate the viability and efficacy of laser treatment for genitourinary syndrome during menopause.
Materials and Methods:
For this prospective cohort study, women with signs and symptoms of overt urogenital atrophy were enrolled between November 2014 and June 2016, after giving informed consent. A cycle of five treatments of the vagina, at 0, 1, 2, 3, and 6 months was performed using a CO2 laser (Mona Lisa Touch,® Smart Xide DOT, DEKA Laser, Florence, Italy) through a 360°-calibrated probe. Patients were evaluated for reduction of signs and symptoms, and the Gloria Bachman Vaginal Health Index was used to reassess the patients at 3- and 6-month follow ups after the last session of laser therapy. When possible, patients completed the Short Form–12 (SF-2) and Female Sexual Function Index (FSFI) questionnaires at the 6-month follow up, and satisfaction with the therapy was scored on a 5-point Likert scale.
Results:
Forty-five women were recruited, of which 41 (91.1%) were postmenopausal. The average age of the patients was 59.7 years. The average time since menopause was 10.9 years. Twenty-five (55.5%) women were sexually active, and 26 (57.8%) had previous hysterectomies. Thirty-eight patients (84.4%) completed the 6-month follow-up after the fifth laser session. Twenty-seven of 30 patients (90%) with dryness who completed follow-up reported reduction of dryness, and 17 (89.5%) of the 19 patients with dyspareunia who completed follow-up reported reduction of dyspareunia. A visual analogue scale for scoring severity of symptoms and the FSFI and SF-12 questionnaires could not be used for all patients, as many of them were not well-educated and had difficulty answering the questions. There were no side-effects or complications reported, except for a few patients reporting discomfort during probe insertion and some reporting vaginal soreness.
Conclusions:
Vulvovaginal laser therapy appears to be a promising option for managing genitourinary symptoms of menopause. Further randomized controlled trials with long-term follow-up data are needed before routine use of the therapy for this indication.
Introduction
W
The urogenital tract—especially the vagina, urethra, bladder, and trigone and pelvic muscles—are specifically affected by the lack of estrogen. 6 The symptoms of vulvovaginal atrophy include vaginal dryness, irritation, itching, dyspareunia due to poor lubrication, and vaginal bleeding associated with sexual activity. Urinary symptoms include frequency, urgency, nocturia, dysuria, and recurrent urinary-tract infections (UTIs). 7 The signs include pale and dry vaginal mucosa with petechiae formation, disappearance of vaginal rugae, and increase in vaginal pH to 4.5 or more. 1 These changes are often progressive and worsen with time.3,8 The term genitourinary syndrome of menopause to describe these signs and symptoms replaced the term vulvovaginal atrophy after a consensus conference in 2014. 9
These signs and symptoms may be more pronounced in women undergoing treatment for breast cancer because of the hormonal and chemotherapeutic agents used. 1 In a cross-sectional survey, 63% patients undergoing hormonal treatment for breast cancer reported urogenital symptoms. 10
Despite the high prevalence of these problems, many women are reluctant to seek treatment because of embarrassment, lack of awareness of the treatment options, and failure of healthcare professionals to initiate sexual health–related discussions with patients. 3
The various management options include systemic or vaginal estrogens; vaginal lubricants and moisturizers; selective estrogen-receptor modifiers; and the less-studied approaches such as vaginal laser therapy, vaginal dehydroepiandrosterone, and vaginal testosterone. Although vaginal estrogen has been the gold standard treatment for several years, it can be associated with side-effects such as vaginal bleeding, breast pain, and vulvovaginal candidiasis. The lower third of the vagina (bladder and urethra) has fewer estrogen receptors than the upper two-thirds. Hence, estrogen therapy might not be very effective for managing superficial dyspareunia. 11 Use of estrogen therapy is controversial in women with estrogen-dependent neoplasias (breast, endometrium). More data are needed on other therapies to help address the needs of patients that either should not take or who do not want to use estrogen-containing treatments.12,13
CO2 lasers have been used to treat various dermatologic conditions during the past 30 years. Fractional microablation technology reduces healing time and side-effects. 14 Initial studies on laser therapy for postmenopausal vaginal atrophy have shown promising results, with reduction of the signs of atrophy and improvement in the quality of sexual life.14–16 Laser acts by producing supraphysiologic levels of heat, which cause a local heat-shock response and production of several growth factors that cause inflammation. Activation of fibroblasts occurs, leading to increased production of collagen, other extracellular-matrix components, and blood vessels.17,18 Further studies are needed to confirm these findings and to assess the long-term effects of the laser procedure on vaginal tissues. The following study was designed to evaluate the viability and efficacy of laser treatment for genitourinary syndrome of menopause.
Materials and Methods
This was a prospective cohort study in which women with signs and symptoms of overt urogenital atrophy, presenting to the Urogynaecology Clinic in KK Women's and Children's Hospital, Singapore, were enrolled between November 2014 and June 2016, after providing informed consents. CIRB approval was obtained before commencement of the study. Patients with active genital infections, pelvic-organ prolapse of more than grade 2, and history of use of hormone-replacement therapy within the prior 6 months were excluded from enrollment.
A detailed history was obtained from each patient prior to commencement of the laser sessions. A visual analogue scale (VAS) system was used for scoring the severity of vulvovaginal atrophy symptoms from 1 to 10, in which 1 indicates minimal symptoms and 10 indicates severe symptoms (“as bad as it could be”). The Gloria Bachman Vaginal Health Index (VHI) was used for scoring signs of vaginal atrophy. The index consists of the following 5 parameters: (1) vaginal elasticity; (2) fluid volume; (3) pH; (4) epithelial integrity; and (5) moisture. Each parameter is graded from 1 to 5. The vagina is considered to be atrophic if the total score is <15. 19 Patients were asked to complete the Short Form-12 (SF-12) questionnaire and the Female Sexual Function Index (FSFI) questionnaire if they were sexually active at the commencement of the study.
A cycle of five treatments of the vagina, at 0, 1, 2, 3 and 6 months was performed, using a CO 2 laser (Mona Lisa Touch,® Smart Xide DOT, DEKA Laser, Florence, Italy) through a 360°-calibrated probe. The probe is inserted through a circular speculum, making no direct contact with the vaginal mucosa. Many laser emissions need to be made by turning the probe in both directions, while progressively withdrawing the probe from the vaginal apex, to cover the entire vagina. The laser is focused at small spots (called DOTs), which are separated by normal tissue. The depth of laser penetration (SmartStack parameter) and quantity (power, dwell time, and spacing) of heat transferred can be controlled by the software. The settings for the treatment were a DOT power of 40 W, a DOT spacing of 1000 μm, 1000 μs dwell time, and Smart Stack 2 and D-pulse modes.
Patients were evaluated for reductions of symptoms such as vaginal dryness, irritation, itching, dyspareunia, urinary frequency, urgency, and urinary incontinence, and any complications related to the laser therapy at every visit. Any reductions in signs and symptoms of vaginal atrophy and Gloria Bachman VHI scores were reassessed at the 3- and 6-month follow-up visits after the last session of laser therapy. Patients filled in the SF-12 and FSFI questionnaires at the 6-month follow up visit, and their satisfaction with the therapy was scored on a 5-point Likert scale (very satisfied, satisfied, uncertain, dissatisfied, very dissatisfied). Patients whose answers were “satisfied” and “very satisfied” were considered satisfied with the treatment.
Data in Tables 1 and 2 and in the text are presented as mean ± standard deviation and as percentages. Data were analyzed using the SPSS software (SPSS Science, Chicago, IL).
SD, standard deviation; Hx; history.
Two patients defaulted after the first laser session, 1 after the second session, and 4 after the fourth session.
VHI, Vaginal Health Index.
Results
During the study period, 45 women were recruited, of which 41 (91.1%) were postmenopausal. The average age of the patients was 59.7 years (± 9.2 years). The average time since menopause was 10.9 years. Twenty-five (55.5%) women were sexually active and 26 (57.8%) had had previous hysterectomies. Table 1 presents the patients' demographic characteristics. Two patients defaulted after the first laser session, 1 after the second laser session and 4 after the fourth laser session. Thirty-eight patients (84.4%) completed the 6-month follow up after the fifth laser session.
Thirty-four (75.5%) of the patients complained of vaginal dryness at the start of the study, and 27 of the 30 patients (90%) with dryness who completed the follow-up reported reduction of dryness. Twenty-one (46.7%) percent of the patients complained of dyspareunia at the start of the study, and 17 (89.5%) of the 19 patients with dyspareunia who completed the follow-up reported a reduction of dyspareunia. The VAS system for scoring severity of symptoms and the FSFI and SF-12 questionnaires could not be used for all of these patients, as many of were not well-educated and found it difficult to answer the questions.
There were no side-effects or complications reported with the laser treatment, except for a few patients reporting discomfort during probe insertion and some reporting vaginal soreness for 1–2 days after the procedure.
Twenty-six (68.4%) patients reported satisfaction with laser treatment at the 6-months' follow-up visit. Twenty-three patients (60.5%) had improvements in their Gloria Bachmann VHI scores, and this, collectively, was found to be a statistically significant improvement (p < 0.05).
Thirteen patients had histories of breast or endometrial cancer. The average age of these patients was 58.8 years, and 9 (69.2%) of them were sexually active. Eleven (84.6%) of these patients were postmenopausal, and the average duration since menopause was 9.6 years. One of these patients defaulted after the third laser session and another patient defaulted after the fourth session. Seven of the remaining 11 patients (63.6%) had an improvement in Gloria Bachmann VHI score on examination at the 6-months follow up visit. Table 2 presents the patients' outcomes.
Discussion
Since 2008, various studies on the application of CO2 laser for the treatment of vulvovaginal atrophy have been carried out. The treatment is a painless, fast minimally invasive technique with minimal side-effects. Typical treatment sessions last 10–20 minutes, with no requirement for anesthesia. Apart from a warm sensation, most of the patients have not reported any discomfort in clinical trials. A micro-wound pattern is created by the fractional delivery of energy, leaving nearby skin and tissue unharmed, which assists in rapid reepithelialization and healing. The SmartStack feature allows modification of the depth of penetration of the laser beam, to ensure delivery of the laser energy to the lamina propria layer, which is the main target of treatment.19,20
Salvatore et al., in a study of 77 postmenopausal women (mean age: 60.6 ± 6.2 years) who underwent 3 sessions of vaginal CO2 laser 1 month apart, reported significant improvements in sexual function and quality of life at a 12-week follow up visit. 21 In another study on 15 postmenopausal patients, Salvatore et al. reported a 100% reduction of dyspareunia with a significant decrease in intensity at a 12-week follow up. They also reported a significant improvement in VHI scores. 22 Sokol et al. also reported significant reductions in vaginal dryness and dyspareunia, as well as improvements in VHI and FSFI scores, in 24 women undergoing 3 sessions of vaginal CO2 laser treatment at a 1-year follow-up. 23 Significant reductions were also noted in vaginal pain, burning, and itching. 23 Other studies have similarly reported significant reductions in vaginal-atrophy symptoms following laser therapy.24–27
A randomized, double-blinded study on 45 postmenopausal women by Cruz et al. comparing vaginal CO2 laser treatment to local estriol and a combination of both concluded that laser alone or in combination with local estrogen was a good management option for addressing vulvovaginal-atrophy symptoms. The effects of fractional laser treatment have been found to persist for up to 1 year after treatment, whereas the efficacy of topical estrogen treatment was not maintained if it was interrupted. 28 Another randomized trial on 50 postmenopausal women by Sokol et al. comparing efficacy of 3 sessions of 2940-nm erbium:YAG laser (XS Dynamis, Fotona, Slovenia) to topical estriol concluded that both treatments significantly reduced the genitourinary symptoms of menopause, but the effects of laser treatment remained statistically significant up to 18 months' follow-up, whereas those of estriol treatment diminished at 12 months. 29
Athanasiou et al., in a study of 53 postmenopausal women who underwent 3 sessions of laser, found significantly increased Lactobacillus and normal vaginal flora and decreased vaginal pH after completion of the therapeutic protocol. Further randomized controlled studies are required to support these findings, which could be of benefit to women with recurrent UTIs. 30
In a study by Lang, et al., 368 patients who underwent three sessions of CO2 laser therapy for vulvovaginal atrophy were contacted via telephone and asked to complete questionnaires regarding reduction of symptoms, satisfaction with treatment, and side-effects. 31 Eighty six percent of the patients were satisfied with the treatment results, and 78% were satisfied with the cost of the treatment. Patients reported a significant reduction in vaginal dryness and improvement in frequency of intercourse. 31 Other studies have shown that the reduction of vulvovaginal atrophy symptoms was maintained long-term (12–24 months).32,33
Studies on use of laser therapy for treating vulvovaginal atrophy symptoms in breast-cancer survivors have similarly reported significant improvement in VAS scores of symptoms such as vaginal dryness and dyspareunia, and in VHI scores.34–37
Athanasiou et al., in a study of 55 postmenopausal women, suggested that reductions of dryness and dyspareunia with vaginal CO2 laser might be produced in a dose–response manner and an extra fourth or fifth session could improve the efficacy of this treatment. 38 The improvement does not seem to vary with power use of 30 W or 40 W. 39
Several studies on the role of vaginal laser treatment for stress urinary incontinence (SUI) have been conducted. It has been proposed that the synthesis of neocollagen leads to thickening of the vaginal mucosa, which causes better urethral coaptation, leading to a reduction of SUI symptoms. Significant reduction of symptoms, maintained for up to 36 months postprocedure in patients with mild SUI, were found. Further studies are warranted to support these findings.40–44
Vaginal laser therapy has also been found to be a promising option for managing overactive bladder (OAB) symptoms. A study by Perino et al. found a significant decrease in urinary frequency, urgency, and urge incontinence episodes in 30 patients at a 1-month follow-up after the patients had 3 sessions of laser therapy. 45 Similar significant reductions of OAB symptoms have been reported in other studies.24,25,32
A systematic review of studies on laser treatment for genitourinary symptoms of menopause between 2012 and 2017, by Song et al., found that most of the studies were nonrandomized and observational with small sample sizes, ranging from 15 to 175 patients. A total of 761 women had undergone treatment for vaginal-atrophy symptoms and 408 women were treated for urinary incontinence in these studies. Follow-up duration ranged from none to 2 years, and follow-up rates ranged from 45% to 100%. The reviewers concluded that stronger evidence from placebo-controlled randomized trials is needed to support the efficacy and safety of vaginal laser before using it routinely for managing genitourinary symptoms of menopause. 46
The drawbacks of the current study were the lack of randomization and no control group on placebo or treated with vaginal estrogen. Other drawbacks included the small sample size and absence of longer follow-up data (at least 1 year). The strengths included inclusion of a considerable number of women with histories of breast and endometrial cancers. The possible risk of long term complications, such as vaginal scarring, with use of laser therapy needs to be assessed.
Conclusions
Vulvovaginal laser therapy appears to be a promising option for managing genitourinary symptoms of menopause. Further randomized controlled trials with long-term follow-up data are needed before routine use of this laser therapy for this indication.
Footnotes
Acknowledgments
The authors would like to thank Ms. Jolene Peh, clinical coordinator in the department of urogynaecology, at KK Women's and Children's Hospital, for her help with the statistical analysis of the study data.
Author Disclosure Statement
No financial conflicts exist.
