The Efficacy of CO2 Vaginal Laser in the Treatment of Recurrent, Post-Coital and Interstitial Cystitis: A Multicentric Prospective Study.

Background: This multicentric prospective study was carried out at Fondazione Policlinico Universitario Campus Bio Medico and Ospedale di Stato of St. Marino Republic. Between 1 January 2019, and 31 December 2022, all pre- and post-menopausal women diagnosed with recurrent, post-coital, and interstitial cystitis at both centers were included in the study. The main aim of the study was to assess the effectiveness of vaginal CO2 laser treatment, alone or combined with intravesical hyaluronic acid instillations, in managing cystitis symptoms, such as dysuria, pollakiuria, and urgency, across the entire patient cohort. The secondary objective was to investigate the reduction in number of annual cystitis episodes post-treatment. Methods: Each woman underwent three to four sessions of micro-ablative CO2 vaginal laser treatment. A follow-up examination was conducted 12 months after the final laser session (up to December 2023), during which a post-treatment VAS assessment evaluated dysuria, daily pollakiuria, and urgency. The enrolled patients recorded the number of cystitis episodes experienced during the 12-month pre- and post-treatment period. Results: Results indicated the laser's efficacy in reducing the total number of cystitis episodes per year and an improvement in symptoms up to one year post-treatment. Greater efficacy of the CO2 laser treatment, particularly when combined with intravesical hyaluronic acid instillation, was observed in both pre- and post- menopausal women. Conclusions: Fractional CO2 laser therapy represents a safe and efficacious, non-hormonal approach for pre- and post-menopausal women diagnosed with recurrent, post-coital, and interstitial cystitis.

A Qualitative and Quantitative Study to Evaluate the Effectiveness and Safety of Magnetic Stimulation in Women with Urinary Incontinence Symptoms and Pelvic Floor Disorders.

Background and objectives: Involuntary loss of urine owed to dysfunction of the detrusor muscle or muscles of the pelvic floor is known as urinary incontinence (UI). In this study, ultrasound monitoring was employed for the first time to measure the usefulness and safety of electromagnetic stimulation for women with Stress or Urge UI. Materials and Methods: A total of 62 women were enrolled, with a mean age of 55.1 (±14.5); 60% of them were menopausal and presented with urinary incontinence (UI). Eight validated questionnaires were used to evaluate Stress UI, prolapse, overactive bladder urge, faecal incontinence, and quality of life, and the whole study population was tested with ultrasounds at the beginning and at the end of the treatment cycle. The device used was a non-invasive electromagnetic therapeutic system composed of a main unit and an adjustable chair applicator shaped for deep pelvic floor area stimulation. Results: Ultrasound measurements and validated questionnaires revealed a consistent and statistically significant (p < 0.01) improvement of the mean scores when pre- and post-treatment data were considered. Conclusions: Study results showed that the proposed treatment strategy led to a significant improvement in Pelvic Floor Muscle (PFM) tone and strength in patients with UI and pelvic floor disorders, without discomfort or side effects. The demonstration was qualitatively carried out with validated questionnaires and quantitatively with ultrasounds exams. Thus, the "chair" device we used represents valuable and effective support that could be widely employed in the gynaecological field for patients affected by different pathologies.

The efficacy and feasibility of fractional CO2 laser therapy for the treatment of urinary incontinence: a multicentric case-control study.

BACKGROUND: Female urinary incontinence is a significant public health problem. Conservative treatments require high patient compliance, while surgery often leads to more complications and recovery time. Our aim is to evaluate the efficacy of microablative fractional CO2 laser (CO2-laser) therapy in women with urinary incontinence (UI). METHODS: This is a retrospective analysis of prospectively collected data on women with stress urinary incontinence (SUI) and mixed urinary incontinence (MUI) with predominant SUI subjected to four sessions of CO2-laser therapy performed once a month, between February 2017 and October 2017, with a 12-month follow-up. The subjective Visual Analogue Scale (VAS) 0-10 was used to score and variables were evaluated at baseline and at one, six and 12 months after initiation of therapy. Finally, results were compared to a control group. RESULTS: The cohort consisted of 42 women. The proportion of patients with vaginal atrophy among those younger than 55 years was substantially lower (3/23; 13%) than among those older than 55 years (15/19; 78.9%). CO2 laser treatment was associated with a significant improvement in VAS scores recorded one-month, six-months, and one-year, after conclusion of therapy (P<0.001). VAS scores improved significantly in patients with either SUI (26/42; 61.9%) or mixed UI (16/42; 38.1%). No major post treatment complications were registered. Women with vaginal atrophy demonstrated significantly better results (P<0.001). CONCLUSIONS: Results confirm the efficacy and a good safety profile, for CO2 laser treatment in SUI, mostly in women with postmenopausal vaginal atrophy and should be considered as a treatment option for female patients with concomitant SUI and vaginal atrophy.

The Utility of CO2 Laser Treatment of Pelvic Symptoms in Women with Previous Perineal Trauma during Delivery.

This study aimed to examine the impact of fractional CO2 laser treatment of pelvic symptoms in women who have undergone perineal trauma from vaginal delivery. It was a retrospective, monocentric analysis that encompassed all women assessed for pelvic discomfort or signs of vulvovaginal atrophy following vaginal delivery between 2013 and 2018. The severity of symptoms was assessed using the Visual Analogue Scale (VAS). Twenty-seven patients met the inclusion criteria and were sorted into two groups: (1) women who had undergone episiotomies during labor (n = 11); and (2) women who had experienced spontaneous tears during vaginal delivery (n = 16). For women with episiotomies, each treatment and subsequent evaluation consistently showed a significant reduction in dyspareunia intensity. A similar positive trend was observed regarding pain at the introitus (7.5 vs. 6.5 after the first treatment, p = 0.03; 6.5 vs. 3 after the second treatment, p = 0.01; 3 vs. 1 after the third treatment, p = 0.01). Among women experiencing spontaneous perineal tears during delivery, there was a notable decrease in dyspareunia following all treatments (8 vs. 7 after the first treatment, p = 0.01; 8 vs. 4 after the second treatment, p = 0.02; 3 vs. 1 after the third treatment, p = 0.03). The impact of laser treatment did not exhibit significant differences between women who underwent episiotomies and those who experienced spontaneous perineal tears. In conclusion, fractional CO2 laser can be regarded as a non-pharmacological option for managing pelvic floor symptoms in women who encountered perineal trauma during delivery, independently from the nature, spontaneity, or iatrogenesis of the perineal laceration.

Anti-Mullerian Hormone (AMH) and adenomyosis: Mini-review of literature of the last 5 years.

Introduction: Adenomyosis is a form of endometriosis characterized by the presence of endometrial tissue in the myometrium. The correlation between anti-Mullerian hormone (AMH) expression and adenomyosis is unclear. Few studies investigated this possible correlation with promising results. The aim of this mini-review is to illustrate the potential prognostic and therapeutic role of AMH in adenomyosis. Materials and methods: A study protocol was completed conforming to the Preferred Reporting Items for Reviews and Meta-Analyses (PRISMA) guidelines for systematic reviews. We performed an electronic databases search from each database's inception from August 2017 to August 2022 for full-text articles and published abstracts. For database searches, the following main keywords were the following text words: "adenomyosis" or "uterine endometriosis" [Mesh] AND "AMH" or "anti-mullerian hormone". Results: From the literature search, 8 abstracts of studies were retrieved and independently screened for inclusion by three authors. It was found that the most common therapeutic strategies (such as adenomyomectomy and high-intensity focused ultrasound (HIFU) do not alter AMH levels. Moreover, a higher expression of the AMH receptor II was observed in adenomyotic tissue, hence a possible therapeutic use of AMH was hypothesized. Conclusion: The available evidence shows an unclear relationship between adenomyosis and AMH. Probably, women with adenomyosis have lower levels of AMH and the surgical treatment (adenomyomectomy, HIFU) does not alter this characteristic, therefore in all of them, ovarian function is not influenced.

Results of a Five-Year Experience in First Trimester Preeclampsia Screening.

BACKGROUND AND OBJECTIVES: The study aimed to evaluate the ability defining the risk of developing preeclampsia by a screening test carried out in the first trimester (between 11 + 0 and 13 + 6 weeks of gestational age), in order to identify high-risk women requiring more intensive health surveillance. The secondary objective was to evaluate the ability of this test to predict the risk of adverse obstetric outcomes such as fetal growth restriction, intrauterine fetal death, gestational hypertension, HELLP syndrome, placental abruption, and preterm birth. MATERIALS AND METHODS: This was a single-center study, conducted at the Operative Unit of Obstetrics of the State Hospital of the Republic of San Marino. Medical history was collected at the time of enrolment in writing. Subsequently, obstetric outcomes were collected for each enrolled woman, through the analysis of medical records. RESULTS: From October 2014 to May 2019, 589 pregnant women were recruited, of whom, 474 (80.5%) were included in the "low-risk" group, and 115 (19.5%) in the "high-risk" group. At the time of analysis of this population, the obstetric outcomes were available for 498 women (84.5%), while 91 cases (15.5%) were current pregnancies. The PI of the uterine arteries was not significantly different between the two study groups. Otherwise, a significant difference was highlighted for MAP, which is higher in the case of pregnancies at high risk based on the risk factors only, and for PAPP-A, higher in the case of low-risk pregnancies. Regarding the percentage of fetal DNA, according to the most recent literature data, in our series, we report a statistically significant difference of the average between the low and high-risk groups. CONCLUSIONS: In our study, we demonstrate that the multiparametric screening test for early PE performed well in identifying women at high risk of early PE, which certainly has the most severe maternal-fetal outcomes. The data reported that ASA intake at low doses is significantly higher in the population with high-risk tests for both early PE and late PE suggest once again that anamnestic evaluation plays an essential role in women's screening.

CO2-Laser therapy and Genitourinary Syndrome of Menopause: A Systematic Review and Meta-Analysis.

BACKGROUND: Genitourinary syndrome of menopause (GSM) is a widespread condition with a great impact on quality of life and self-image. AIM: We aimed to systematically review the current literature on CO2-Laser therapy efficacy for the treatment of GSM. METHODS: MEDLINE and Embase databases were systematically queried in December 2020 Studies included women with a diagnosis of Vulvo-Vaginal Atrophy (VVA) or GSM without an history of gynaecological and/or breast cancer, pelvic organ prolapse staged higher than 2, pelvic radiotherapy or Sjogren's Syndrome. The quality of the evidence was assessed with the Cochrane risk of bias tool. This study is registered on PROSPERO, number CRD42021238121. OUTCOMES: Effects of CO2-Laser therapy on GSM symptoms assessed through subjective or objective efficacy measurement methods. RESULTS: A total of 803 articles were identified. Of these, 25 studies were included in this review for a total of 1,152 patients. All studies showed a significant reduction in VVA and/or GSM symptoms (dryness, dyspareunia, itching, burning, dysuria). The pooled mean differences for the symptoms were: dryness -5.15 (95% CI:-5.72,-4.58; P < .001; I2:62%; n = 296), dyspareunia -5.27 (95% CI:-5.93,-4.62; P < .001; I2:68%; n = 296), itching -2.75 (95% CI:-4.0,-1.51; P < .001; I2:93%; n = 281), burning -2.66 (95% CI:-3.75, -1.57; P < .001; I2:86%; n = 296) and dysuria -2.14 (95% CI:-3.41,-0.87; P < .001; I2:95%; n = 281). FSFI, WHIS and VMV scores also improved significantly. The pooled mean differences for these scores were: FSFI 10.8 (95% CI:8.41,13.37; P < .001; I2:84%; n = 273), WHIS 8.29 (95% CI:6.16,10.42; P < .001; I2:95%; n = 262) and VMV 30.4 (95% CI:22.38,38.55; P < .001; I2:24%; n = 68). CO2-Laser application showed a beneficial safety profile and no major adverse events were reported. CLINICAL IMPLICATIONS: Vaginal laser treatment resulted in both a statistically and clinically significant improvement in GSM symptoms. FSFI improved significantly in all 8 included studies but it reached a clinically relevant level only in 2 of them. STRENGTHS & LIMITATIONS: The strength of the current meta-analysis is the comprehensive literature search. We reported data from a high number of patients (1,152) and high number of laser applications (more than 3,800). The main limitations are related to the high heterogeneity of the included studies investigating laser effects. Moreover, most of them are single center and nonrandomized studies. CONCLUSION: The data suggest that CO2-Laser is a safe energy-based therapeutic option for the management of VVA and/or GSM symptoms in postmenopausal women; however, the quality of the body of evidence is "very low" or "low". Filippini M, Porcari I, Ruffolo AF, et al., CO2-Laser therapy and Genitourinary Syndrome of Menopause: A Systematic Review and Meta-Analysis. J Sex Med 2022;19:452-470.

First trimester screening for aneuploidy: may combined test and fetal DNA work together?

INTRODUCTION: The purpose of the study was to evaluate the screening performance of combined test (based on the measurement of nuchal translucency, pregnancy-associated plasma protein A, free ß-human chorionic gonadotropin, and maternal age) and fetal DNA screening (NIPS) for trisomies 21 (T21), 18 (T18), and 13 (T13). MATERIAL AND METHODS: Women who accepted screening had a first-trimester combined test (pregnancy-associated plasma protein A, free ß-human chorionic gonadotropin, nuchal translucency interpreted with maternal age) and fetal DNA. RESULTS: Among 302 women screened (including 4 with affected pregnancies), our study demonstrated that DNA screening for trisomies 21, 18, and 13 achieved a detection rate of 100% with a false-positive rate of 0.02%, overcoming the traditional combined test with 75% of sensitivity and 4.7% of false-positive rate. In particular, fetal DNA may be useful in case of intermediate risk, in order to avoid invasive diagnostic procedures such villocentesis and amniocentesis. Because of fetal DNA costs, it can be used in clinical practice as a second step screening in case of intermediate or high risk at combined test. CONCLUSION: Fetal DNA screening may be successfully implemented in routine care, achieving a high detection rate, low false-positive rate, and, consequently, greater safety with fewer invasive diagnostic tests than other methods of screening.

Effects of Fractional CO2 Laser Treatment on Patients Affected by Vulvar Lichen Sclerosus: A Prospective Study.

Background: Fractional carbon dioxide (CO2) lasers are today considered the most effective and efficient treatment for many vulvovaginal disorders, providing mini-invasive procedures without side effects. Previous studies demonstrated the efficacy of fractional CO2 lasers in vulvar lichen sclerosus (VLS), a chronic skin disorder characterized by itching and painful lesions. Complications include pain, sexual and/or urinary dysfunction, with a negative quality of life, and an increased risk of squamous cell carcinoma. A definitive VLS treatment is still lacking. Objectives: This is a prospective, single-center study aimed at evaluating the effect of fractional microablative CO2 laser treatment on women affected by VLS. Materials and methods: Patients with histologically confirmed VLS underwent three fractional microablative CO2 laser treatments, 4 weeks apart, on the genital affected areas. Clinical and VLS-related symptoms, side effects, and patient satisfaction index were assessed and recorded for all the patients using the visual analog scale (VAS). Results: Data from a total of 70 patients were included, paired at different time points and analyzed. VLS-related symptoms and other relevant parameters (pH, vaginal introitus discomfort, dyspareunia, vaginal dryness, itching, and burning) showed a statistically significant improvement (p < 0.001) after the first laser treatment and kept improving after second and third sessions. According to VAS, the two most common symptoms, vaginal introitus discomfort and dyspareunia, went from (mean ± standard deviation) 8.2 ± 2.3 and 8.3 ± 2.2, respectively, at baseline, to 3.6 ± 2.6 and 3.8 ± 2.6, respectively, 1 month after the last treatment. Vaginal dryness, itching, and burning were significantly improved as well. Most patients declared to be very satisfied with the results of the treatment. A total of 62.8% of the women expressed a satisfaction score ≥8 on a scale from 0 to 10. Conclusions: Fractional microablative CO2 laser treatment seems to be safe and effective to treat VLS and improve VLS-related symptoms.

The beneficial effects of fractional CO2 laser treatment on perineal changes during puerperium and breastfeeding period: a multicentric study.

Childbirth is a great change in woman life because of hormonal, physical and psychological alterations that are associated with this process. Dyspareunia and perineal pain are commonly reported symptoms in the postpartum period, mainly due to perineal trauma, lacerations, episiotomy, and forceps or vacuum use at delivery. Among non-pharmacological treatment, a new trend is gaining popularity, which is the energy-based therapy, including fractional micro-ablative CO2 laser. We conducted a multicentric retrospective study to assess the efficacy and the possible side effects of CO2 laser treatment on transient vulvovaginal atrophy and perineal postpartum pain related to puerperium and breastfeeding period. All patients were submitted to 3 or 4 sessions of CO2 laser treatment. As per protocol, an initial, intermediate (after 2 sessions) and final (3 months after the last cycle) evaluation of the symptoms were made, using a VAS (Visual Analogue Scale 0-10). We also compared this group of patients with a control group with no treatment. At the final evaluation, patients showed a significant improvement for dyspareunia (VAS from 7.95 to 3.14, p < 0.0001). A significant improvement was also registered in pain at the vaginal orifice (VAS from 6.94 to 2.05, p = 0.0001), dryness (VAS from 6.6 to 2.9, p = 0.0022), itching (VAS from 4.5 to 1.16, p = 0.0053), heat (VAS from 3 to 0, p = 0.0119) and burning (VAS from 5.5 to 1.6, p = 0.0013) if compared with the control group. Quality of life for the women during the breastfeeding and puerperium is important and training is mandatory to avoid side effects in order to improve the CO2 laser performance.

Postpartum perineal pain: may the vaginal treatment with CO2 laser play a key-role in this challenging issue?

PURPOSE: Pregnancy and childbirth, despite being physiological events, represent a very delicate period in a woman's life, because they expose to important vulvo-perineal traumas. The pelvic pain that follows each delivery, whether spontaneous or surgical (caesarean section), does not end in the first days after birth but, depending on the studies, becomes persistent in a very variable percentage of cases. Therefore, in the present pilot study, we aimed, for the first time in literature, to assess the efficacy of CO2 laser in women affected by perineal postpartum symptoms. MATERIALS AND METHODS: Between February 2013 and June 2018, all women with late postpartum pelvic pain referred to the Department of Obstetrics and Gynecology of San Marino Hospital, were recruited and treated using the CO2 laser for three applications every 4-6 weeks. RESULTS: Between February 2013 and June 2018, according to the inclusion and exclusion criteria, 32 women with late postpartum pelvic pain were recruited in our protocol study. Mean age of patients was 34.1 years. At latest follow-up, our data demonstrated an improvement in symptoms (dyspareunia, pain at introitus, vaginal dryness, itching and vaginal burning) with a mean reduction of this symptom of 70% from baseline. CONCLUSIONS: This study has shown the effectiveness of CO2 laser treatment in postpartum perineal pain. Nevertheless, our results should be considered promising but preliminary. In fact, they need to be tested in larger cohort of patients to confirm its application in clinical practice and to evaluate the long-term duration of this treatment.

Effectiveness of CO2 laser on urogenital syndrome in women with a previous gynecological neoplasia: a multicentric study.

BACKGROUND: Many women diagnosed with gynecological cancers undergo adjuvant therapy, which may lead to transient or permanent menopause that ultimately leads to urogenital syndrome and vulvovaginal atrophy. Studies advise against the use of estrogen in women with a history of hormone-dependent cancer. One alternative is vaginal microablative fractional CO2 laser, which promotes tissue regeneration through the production of collagen and elastic fibers. OBJECTIVE: To evaluate the effectiveness of CO2 laser in the treatment of urogenital syndrome-in particular, symptomatic vulvovaginal atrophy in women who have survived gynecological cancers. METHODS: A retrospective study was carried out, including all patients with a history of gynecological cancers and vulvovaginal atrophy who underwent CO2 laser treatment between November 2012 and February 2018 in four Italian centers. The study was approved by the local ethics committee of each participating institution. The inclusion criteria were women aged between 18 and 75; Eastern Cooperative Oncology Group performance status <2; and history of breast, ovarian, cervical, or uterus cancer. Patients had to have vulvovaginal atrophy and at least one of the following symptoms of urogenital syndrome: vaginal dryness, dyspareunia, vaginal introitus pain, burning, or itching. Three applications were administered at baseline, 30 days, and 60 days. All patients were evaluated before the first laser session, at each session, and 4 weeks after the last session. In particular, patients were asked to indicate the intensity of symptoms before the first session and 4 weeks after the last session, using Visual Analog Scale (VAS) scoring from 0 ('no discomfort') to 10 ('maximum discomfort'). RESULTS: A total of 1213 patients underwent CO2 laser treatment and of these, 1048 were excluded because they did not meet the inclusion criteria in the analysis. Finally, a total of 165 patients were included in the study. The mean age at the time of treatment was 53 years (range 31-73). Dryness improved by 66%, dyspareunia improved by 59%, burning improved by 66%, pain at introitus improved by 54%, and itching improved by 54%. The side effects were evaluated as pain greater than VAS score 6 during and after the treatment period. No side effects were seen in any sessions. CONCLUSIONS: Fractional microablative CO2 laser therapy offers an effective strategy in the management of the symptoms of genitourinary syndrome in post-menopausal women and in survivors of gynecological cancer.

Efficacy of fractional CO2 laser treatment in postmenopausal women with genitourinary syndrome: a multicenter study.

OBJECTIVE: Genitourinary syndrome of menopause (GSM), especially vulvovaginal atrophy (VVA), is one of the most common conditions among women in either natural (4%-47%) or medically induced (23.4%-61.5%) menopause. The aims of this study are to assess the efficacy and effectiveness of CO2 laser in postmenopausal women with clinical signs and symptoms of GSM, in particular VVA, and to evaluate both possible early and late side effects related to this kind of treatment. METHODS: This retrospective, multicenter study was conducted after collecting data from a pre-existing database. We performed three to four CO2 laser treatments on all the women enrolled in this protocol. We used a fractional CO2 laser system (SmartXide VLR, Deka m.e.l.a., Florence, Italy) with a VulvoVaginal Laser Reshaping (VLR) scanning system and appropriate handpieces for the vaginal area. All women before and after the treatment were assessed. The pre- and post-treatment averages of the symptoms, the standard deviation, and the P values were calculated. RESULTS: Six hundred forty-five women who met the inclusion criteria were considered. In all the parameters examined (dyspareunia, vaginal orifice pain, dryness/atrophy, itching, burning, pH) statistically significant data were found between the pretreatment and the post-treatment (dryness: before = 8.30, after = 2.97 [P < 0.0001], dyspareunia: before = 8.70, after = 3.51 [P < 0.0001]; burning: before = 6.12, after = 1.78 [P < 0.0001]; vaginal orifice pain: before = 8.07, after = 2.94 [P < 0.0001]; itching: before = 6.09, after = 1.32 [P < 0.0001]). CONCLUSIONS: Our results show the effectiveness and a good degree of tolerance of treatment with the CO2 laser system in postmenopausal women with GSM.

Fractional CO2 Laser: From Skin Rejuvenation to Vulvo-Vaginal Reshaping.

BACKGROUND: The CO2 laser has become the gold standard treatment in dermatologic surgery for the treatment of a large number of skin and mucosal lesions. The introduction of the fractional micro-ablative technology represented an integration to the ablative resurfacing technique, reducing the healing time and the side effects. OBJECTIVE: Vaginal rejuvenation performed with this technique is a minimally invasive procedure that stimulates internal tissues of the female lower genital tract to regenerate the mucosa, improving tissue trophism and restoring the correct functionality. METHODS: In our experience, 386 menopausal women affected with vulvo-vaginal atrophy (VVA) were treated with three section of fractional micro-ablative CO2 laser. RESULTS: After three treatments, patients reported a complete improvement of the symptoms (59.94% dryness, 56.26% burn, sensation, 48.75% dyspareunia, 56.37% itch, 73.15% soreness, and 48.79% vaginal introitus pain). CONCLUSIONS: Fractional micro-ablative CO2 laser seems to reduce symptoms related to vaginal atrophy. The beneficial effects were reported just after the first session and confirmed 12 months after the last session.