INTRODUCTION:Optical coherent tomography (OCT) is an emerging non-invasive imaging technology with significant potential in fields of medicine where invasive biopsy is limited or impractical. In ophthalmology, where retinal biopsy is not possible, OCT has become a standard of care for monitoring physiologic and pathologic changes. Similarly, OCT holds promise for improving women's healthcare, particularly in areas where biopsies are not routinely performed due to anatomical, ethical, or patient comfort considerations. Genitourinary syndrome of menopause (GSM) is one such condition where OCT may provide significant clinical value. However, ethical and practical limitations often restrict the ability to perform repeated or even sporadic vaginal wall biopsies. As a result, the efficacy of new treatment modalities largely assessed through subjective patient-reported outcomes, leading to inconsistent and controversial data that hinder progress in the field. This review outlines a collaborative effort by scientists and clinicians at the University of California, Irvine, to develop a novel, non-invasive "optical biopsy" tool for external genital assessment. A dedicated system integrated within a vaginal probe was developed to combine energy-based treatment with real-time OCT imaging. The new system successfully detected differences in vaginal epithelial thickness (VET) and blood vessel density (BVD) across women of different age groups, and between different segments of the vaginal wall. The system was used to measure VET and BVD changes before and after treatment with Fractional-Pixel CO2 laser. Beyond GSM, this technology is now being applied to other vulvovaginal conditions, including vulvar lichen sclerosus (VLS). The ability to perform non-invasive real-time monitoring of tissue structure and function is a critical step forward in women's health, offering new opportunities for diagnosis, treatment, monitoring, and ultimately improving clinical outcomes.

Monitoring the vaginal health changes is crucial in evaluating the treatment effectiveness for patients with genitourinary syndrome of menopause (GSM). Here we developed a multifunctional OCT/OCTA/OCE system to offer comprehensive analysis of vaginal tissue.

The first published reports on the use of laser for cervical pathology date back to 1973. Technical advancements in flexible and rigid laser fibers revolutionized video laser laparoscopy in the 1990s. Fractionated lasers have been used to treat vulvovaginal symptoms associated with genitourinary syndrome of menopause, lichen sclerosus, and urinary incontinence. Review of available data suggests that fractionated lasers can improve both subjective and objective signs of vaginal atrophy and lichen sclerosus, but the evidence is weak because most of the trials are underpowered, are at risk for bias, and lack long-term follow-up. There is no strong evidence to support fractionated laser therapy for urinary incontinence or low-level laser therapy for chronic pelvic pain. Although short-term, single-arm trials suggest benefit of fractionated laser therapy for genitourinary syndrome of menopause, lichen sclerosus, and urinary incontinence, additional adequately powered, prospective, randomized, and longer-term comparative trials are needed before lasers can be recommended for these specific conditions. The purpose of this Clinical Expert Series is to review basic laser biophysics and the mechanism of action for modern fractionated lasers as relevant to the gynecologist. We also summarize safety and effectiveness data for lasers used for some of the most commonly studied gynecologic conditions: the vulvovaginal atrophy component of genitourinary syndrome of menopause, lichen sclerosus, and urinary incontinence.

Fractional-pixel CO2 laser therapy shows promise for treating the genitourinary syndrome of menopause (GSM). Nevertheless, it remains controversial in the field of female pelvic medicine. This is due to the inherent difficulties in obtaining noninvasive biopsies to evaluate the treatment's efficacy and safety objectively. To address this challenge, we developed a noninvasive intravaginal optical coherence tomography (OCT)/OCT angiography (OCTA) endoscopic system, whose probe features a shape identical to the laser treatment probe. This system can provide high-resolution OCT images to identify the microstructure of vaginal tissue and visualize the vasculature network in vivo. We conducted clinical research on 25 post-menopausal patients with GSM. OCT/OCTA scans were acquired at four different locations of the vagina (distal anterior, distal posterior, proximal anterior, and proximal posterior) during the whole laser treatment session. A U-Net deep learning model was applied to segment the vaginal epithelium for assessing vaginal epithelial thickness (VET). Blood vessel density and VET were quantified to monitor the efficacy of fractional-pixel CO2 laser therapy. Statistical correlation analyses between these metrics and other clinical scores were conducted, validating the utility of our system. This OCT/OCTA endoscopic system has great potential to serve as a noninvasive biopsy tool in gynecological studies to screen, evaluate, and guide laser treatment for GSM.

BackgroundLasers and energy-based technologies have been developed for genitourinary applications over the past several decades. AimsThis consensus article aims to categorize the published articles and clinical trial data that culminated in protocol development of technology for genitourinary applications, and to develop consistent parameters in future clinical trials. Materials and MethodsThe published articles and clinical trials data on lasers and energy-based devices applied to genitourinary conditions were categorized according to device and condition and consensus developed on protocols and parameters. ResultsThe devices in genitourinary applications were classified as fractional lasers, radiofrequency and high-intensity focused electromagnetic field therapy. The consensus of the protocols and parameters based upon the published clinical trials of their application to the vaginal and urologic conditions associated with genitourinary syndrome of menopause was developed and organized according to device and condition. DiscussionThe status of FDA clearances and future pathways are discussed. ConclusionsThis consensus article categorizes and presents the protocols and practices for the main classes of lasers and energy-based devices for genitourinary applications in future clinical trials.

Genitourinary syndrome of menopause (GSM) negatively affects more than half of postmenopausal women. Energy-based therapy has been explored as a minimally invasive treatment for GSM; however, its mechanism of action and efficacy is controversial. Here, we report on a pilot imaging study conducted on a small group of menopause patients undergoing laser treatment. Intravaginal optical coherence tomography (OCT) endoscope was used to quantitatively monitor the changes in the vaginal epithelial thickness (VET) during fractional-pixel CO2 laser treatment. Eleven patients with natural menopause and one surgically induced menopause patient were recruited in this clinical study. Following the laser treatment, 6 out of 11 natural menopause patient showed increase in both proximal and distal VET, while two natural menopause patient showed increase in VET in only one side of vaginal tract. Furthermore, the patient group that showed increased VET had thinner baseline VET compared to the patients that showed decrease in VET after laser treatment. These results demonstrate the potential utility of intravaginal OCT endoscope in evaluating the vaginal tissue integrity and tailoring vaginal laser treatment on a per-person basis, with the potential to monitor other treatment procedures.

Despite the emerging market in fractional-pixel CO2 lasers to treat Genitourinary Syndrome of Menopause (GSM) in menopausal women, the effect of the laser treatment on vaginal tissue remains poorly understood. We developed an intravaginal OCT endoscope that can obtain structural and vascular information simultaneously during the vaginal laser procedure. Based on the monitoring and statistical analysis of the Vaginal Epithelial Thickness (VET) and Blood Vessel Density (BVD) along with the treatment for months, laser treatment shows a positive impact on vaginal health. This system can serve as a noninvasive biopsy tool in gynecological studies.

Objective Optical coherence tomography is a noninvasive technology that visualizes tissue microstructure with high spatial resolution. We designed a novel vaginal system that demonstrates a clear distinction between vaginal tissues planes. In this study, we sought to compare vaginal tomographic images of premenopausal, perimenopausal, and postmenopausal women, demonstrate feasibility of tracking vaginal tissue changes after treatment with fractional-pixel CO2 laser therapy, and obtain a histologic correlation of these findings. Methods Enrolled subjects underwent imaging and were divided into 3 groups based on menopausal status. Women with genitourinary syndrome of menopause who received fractional-pixel CO2 laser therapy were assessed before and after treatment. A cadaveric vagina was used to obtain tomographic and histologic images to assess for accuracy. Our primary outcome was mean vaginal epithelial thickness. Statistical analysis was performed using analysis of variance and t tests, respectively. Results Among 6 women, the mean vaginal epithelial thickness decreased with menopause (P < 0.01). Although change in epithelial thickness after fractional-pixel CO2 laser treatment varied between the 2 subjects evaluated, it increased significantly for the subject who reported improvement of vaginal symptoms (P < 0.01). Using a cadaveric specimen, optical biopsy was correlated to an hematoxylin and eosin-stained biopsy of the same vaginal site. Conclusions This study establishes feasibility of optical coherence tomography in providing an optical biopsy of the vaginal epithelium and lamina propria. In addition, it demonstrates vaginal changes as women enter menopause. This report is the initial phase of a longitudinal cohort study to evaluate changes in vaginal microstructure after energy-based treatment.

Despite the emerging market in energy-based devices to treat Genitourinary Syndrome of Menopause (GSM) in menopausal women, the exact effect of the laser on vaginal tissue remains poorly understood. We developed a point-of-care intravaginal endoscope that can obtain simultaneous information on structural and vascular information during the vaginal laser procedure. We evaluated the capability of assessing the treatment outcome by investigating patients receiving the CO2 fractional laser treatment. Our study supports the hypothesis that the treatment effect highly depends on the initial tissue parameters such as epithelium thickness and vascular density.

Lasers in Surgery and MedicineVolume 51, Issue 4 p. 315-317 Guest Editorial Energy-based treatment for gynecologic conditions including genitourinary syndrome of menopause: Consensus, controversies, recommendations, and FDA clearance Yona Tadir MD, Corresponding Author Yona Tadir MD ytadir@gmail.com Beckman Laser Institute and Medical Clinic, University of California, Irvine, California Correspondence to: Yona Tadir, MD, Beckman Laser Institute and Medical Clinic, University of California, Irvine, California. E-mail: ytadir@gmail.comSearch for more papers by this authorCheryl Iglesia MD, Cheryl Iglesia MD Departments of Obstetrics, Gynecology and Urology, Georgetown University School of Medicine, Washington, District of Columbia; Section of Female Pelvic Medicine and Re-constructive Surgery, MedStar Washington Hospital Center, Washington, District of ColumbiaSearch for more papers by this authorMacrene Alexiades MD, PhD, Macrene Alexiades MD, PhD Department of Dermatology, Yale University School of Medicine, New Haven, Connecticut Siggrou Hospital, University of Athens, Athens, Greece Dermatology and Laser Surgery Center of New York, New York, New YorkSearch for more papers by this authorG Willy Davila MD, G Willy Davila MD Women's and Children's Center, Female Pelvic Medicine and Re-constructive Surgery, Holy Cross Medical Center, Fort Lauderdale, FloridaSearch for more papers by this authorNathan Guerette MD, Nathan Guerette MD The Female Pelvic Medicine Institute, Division of Female Pelvic Medicine and Reconstructive Surgery, Virginia Commonwealth University, North Chesterfield, VirginiaSearch for more papers by this authorAdrian Gaspar MD, Adrian Gaspar MD Department of Gynecology, Uroclinica, Mendoza, Argentina Department of Laser Surgery, Palmares Hospital, Mendoza, ArgentinaSearch for more papers by this author Yona Tadir MD, Corresponding Author Yona Tadir MD ytadir@gmail.com Beckman Laser Institute and Medical Clinic, University of California, Irvine, California Correspondence to: Yona Tadir, MD, Beckman Laser Institute and Medical Clinic, University of California, Irvine, California. E-mail: ytadir@gmail.comSearch for more papers by this authorCheryl Iglesia MD, Cheryl Iglesia MD Departments of Obstetrics, Gynecology and Urology, Georgetown University School of Medicine, Washington, District of Columbia; Section of Female Pelvic Medicine and Re-constructive Surgery, MedStar Washington Hospital Center, Washington, District of ColumbiaSearch for more papers by this authorMacrene Alexiades MD, PhD, Macrene Alexiades MD, PhD Department of Dermatology, Yale University School of Medicine, New Haven, Connecticut Siggrou Hospital, University of Athens, Athens, Greece Dermatology and Laser Surgery Center of New York, New York, New YorkSearch for more papers by this authorG Willy Davila MD, G Willy Davila MD Women's and Children's Center, Female Pelvic Medicine and Re-constructive Surgery, Holy Cross Medical Center, Fort Lauderdale, FloridaSearch for more papers by this authorNathan Guerette MD, Nathan Guerette MD The Female Pelvic Medicine Institute, Division of Female Pelvic Medicine and Reconstructive Surgery, Virginia Commonwealth University, North Chesterfield, VirginiaSearch for more papers by this authorAdrian Gaspar MD, Adrian Gaspar MD Department of Gynecology, Uroclinica, Mendoza, Argentina Department of Laser Surgery, Palmares Hospital, Mendoza, ArgentinaSearch for more papers by this author First published: 08 November 2018 https://doi.org/10.1002/lsm.23031Citations: 8 Conflict of Interest Disclosure: Yona Tadir consulted with Alma Lasers. Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat No abstract is available for this article.Citing Literature Volume51, Issue4April 2019Pages 315-317 This article also appears in:24 Hours of LSM Marathon RelatedInformation

Gynecologist and plastic surgeons pioneered the application of lasers in medicine and surgery almost 5 decades ago, initially used to treat cervical and vaginal pathologies. Ever since, energy-based devices have been deployed to treat pelvic pathologies and improve fertility. Recent technological developments triggered an unprecedented wave of publications, assessing the efficacy of fractional laser, and radiofrequency on the vaginal wall in reversing natural aging processes. Studies have shown that a certain degree of thermal energy deposited on the vaginal wall stimulates proliferation of the glycogen-enriched epithelium, neovascularization, and collagen formation in the lamina propria, and improves natural lubrication and control of urination. This review aimed to review such data and to guide future research. A unique assembly of experts from around the globe, compiled and edited this manuscript based on a thorough literature review and personal experience. Lasers Surg. Med. 49:137-159, 2017. © 2017 Wiley Periodicals, Inc.

Objective: To evaluate the efficacy and safety of 3 months of vaginal mifepristone treatment on leiomyoma volume and related symptoms.Design: Prospective, open-label, two tertiary centers, phase II clinical trial.Setting: Two tertiary medical centers in Israel.Patient(s): Thirty-three enrolled women, ages 30-53 years, diagnosed with symptomatic uterine fibroids.Intervention(s): Patients received 10 mg mifepristone vaginally daily for 3 months.Main Outcome Measure(s): Reduction in uterine leiomyoma volume. Improvement in symptoms related to uterine fibroids was assessed with the use of the "Uterine Fibroid Symptoms Quality of Life Questionnaire" (UFS-QoL). The number of bleeding days, safety, and tolerability were secondary measures.Result(s): Mifepristone treatment significantly reduced leiomyoma volume from 135.3 +/- 22.9 cc at enrollment to 101.2 +/- 22.4 cc after 3 months of treatment. The UFS-QoL Score significantly decreased from 20.7 +/- 0.7 at enrollment to 14.0 +/- 0.8 after 3 months of treatment. The number of bleeding days significantly decreased by 3.5 days. Endometrial biopsies showed no evidence of endometrial hyperplasia or cellular atypia. There were no major side effects during the course of the study, and treatment was well tolerated.Conclusion(s): Vaginal mifepristone may offer an effective treatment option for women with symptomatic uterine leiomyoma and can improve the patients' quality of life. (C) 2014 by American Society for Reproductive Medicine.

With the increasing demand of Laparoscopic surgery, many departments are considering the development of surgical skills centers. The authors describe their hospitaLs endoscopic training program which includes a theoretical curriculum and an inexpensive laparoscopic simulator The system is designed in order to improve basic skills of laparoscopic surgery. Other systems available elsewhere are discussed.