Application of Perioperative Pain Management in the Perioperative Nursing of Labia Minora Plasty and its Effect on the Rehabilitation of Patients.

Objective: The objective of this study is to investigate effective pain management strategies for women undergoing labiaplasty surgery. By focusing on pain relief, patient rehabilitation, and satisfaction improvement, we aim to enhance the overall patient experience and outcomes of this common gynecological plastic surgery. Methods: A total of 126 individuals diagnosed with labia minora hypertrophy and who underwent plastic surgery on their labia minora within the period of July 2020 to July 2023 were chosen as the participants for this study. They were divided into an observation group and a comparison group, each consisting of 63 cases, based on the different nursing methods. The comparison group was treated with routine perioperative nursing after labia minora surgery, and the observation group was treated with perioperative pain nursing management based on the comparison group. Postoperative pain score, comfort score, incision healing time, first urination time, night Pittsburgh Sleep Quality Index (PSQI) score, complications, and satisfaction were compared between the two groups. All data were established in an Excel database, and statistical analysis was performed using SPSS26.0. Statistical methods used include descriptive analysis, t tests, and Chi-square tests. Results: The mean incision healing time of the observation group was 3.90±0.61 days, and that of the control group was 3.62±0.64 days. The mean incision healing time of the observation group was significantly different from that of the control group (P < .05). VRS scores and PSQI scores were significantly lower in both groups 1 week aftercare compared with 1 day before care, indicating improvements in pain and sleep quality. The improvement degree of VRS score and PSQI score in the observation group was significantly different (P < .05). The number of incision infections, hematoma, flap necrosis, skin scar, delayed healing, and total complication rate were 3 in the observation group and 11 in the comparison group, indicating that the complication rate in the observation group was significantly lower than that in the comparison group. The comparison difference was statistically significant (P < .05). Through the Chi-square test, the nursing satisfaction and perineal aesthetic effect satisfaction of the observation group were significantly higher than those of the comparison group, and the difference was statistically significant (P < .05). Conclusions: The implementation of perioperative pain nursing management has been shown to effectively alleviate pain in patients diagnosed with labia minora hypertrophy. This approach not only enhances treatment comfort but also significantly reduces the occurrence of postoperative complications. Additionally, it accelerates the healing process of incisions, improves the quality of incision healing, and enhances patient satisfaction with both the aesthetic outcome of the perineal area and the quality of nursing care provided.

Safety and efficacy of a class II medical device based on highly purified and standardized plant extracts in the management of post-menopausal patients with vulvar and vaginal atrophy: a single-center prospective observational study.

BACKGROUND: Despite the gold standard treatment for genitourinary syndrome of menopause (GSM) is based on the use of local or systemic estrogen-containing products, the typical long-term side effects of hormonal treatments and, most importantly, the contraindications in patients with history of breast and endometrial neoplasms do limit in some extent its use. As hyaluronic acid and some highly purified botanicals have clearly demonstrated their anti-inflammatory and mucosa-protecting properties, we have tested, in women with GSM, a class II vaginal medical device containing hyaluronate gel and a mucoadhesive active enriched with purified alkylamides from Zanthoxylum bungeanum, triterpenes from Centella asiatica and high molecular weight polysaccharides from Tamarindus indica. METHODS: Our single-center, open-label, prospective and observational study was conducted on 50 menopausal women enrolled at the Department of Maternal-Fetal Medicine at Umberto I Polyclinic Hospital in Rome, Italy. Gel administration lasted 150 days and was performed daily for the first 12 days and every 48 hours for the remaining 138 days. Clinical evaluations were performed at baseline and after 12, 57 and 150 days. Besides product safety, main outcomes of our study were: 1) vaginal health (by Vaginal Health Index score [VHI]); 2) sexual quality of life (by Female Sexual Distress Scale [FSDS]); and 3) percentage of women declaring regular sexual activity. RESULTS: The product was safe with no specific adverse events reported. It significantly improved VHI (about 5% after 57 days and 8% after 150 days), FSDS (about 7% after 57 days and 10% after 150 days), and sexual activity (about 20% after 150 days). It also reduced dryness, dyspareunia, burning, itching, and dysuria incidence, respectively by about 18%, 14%, 14%, 27% and 11% after 150 days. CONCLUSIONS: In women with GSM, the intravaginal administration of a hyaluronate-based gel enriched with purified botanical actives endowed with anti-inflammatory and mucosal-protecting properties, reduced painful sensation during sexual acts and increased regular sexual activity.

Plurigin Ovules and Plurigin Solution in the Treatment of Vulvovaginal Atrophy in Menopausal Women: A Retrospective Monocentric Observational Study.

Background and Objectives: Vulvovaginal atrophy (VVA) is a condition that affects a large number of women and can significantly impact their quality of life. While several treatments are currently available for VVA, there are potential risks associated with their use. Non-hormonal medical devices have been developed to treat VVA, offering a potential alternative to traditional hormone-based therapies. This study aimed to evaluate the safety and efficacy of the combined treatment with two medical devices, Plurigin Ovules and Plurigin Solution, used as an adjuvant in the treatment of VVA. Materials and Methods: This is a retrospective, observational study. Data were collected from medical records of all patients who received the combination treatment of both medical devices as part of normal clinical practice for the treatment of VVA. The performance of the medical devices was analyzed using the THIN Prep. A comprehensive physical examination and gynecological evaluation were conducted before the initiation of treatment (day 0), as well as at follow-up 1 (day 90), follow-up 2 (day 180), and follow-up 3 (day 270). Data analysis included descriptive analysis and statistical tests. Results: The study included 76 women (mean age: 59 years). At follow-up 3, 61% of the respondents demonstrated improved THIN Prep results and symptom resolution (p < 0.001; CI [0.5003, 0.7197]). Moreover, the percentage of patients reporting dyspareunia, burning, and irritation decreased over the course of the study, with the majority of patients reporting no symptoms at follow-up 3. Conclusions: The use of Plurigin Ovules plus Plurigin Solution may be an effective treatment option for VVA, improving vaginal health, alleviating symptoms, and improving sexual function, leading to improved quality of life for women suffering from this condition. However, the study has limitations, such as its retrospective nature, and further studies are needed to confirm the efficacy and safety of these devices.

New developments in the management of vulvovaginal atrophy: a comprehensive overview.

INTRODUCTION: Proper recognition and individualized therapy of vulvovaginal atrophy (VVA) is paramount. AREAS COVERED: Assessment of VVA should be performed using several questionnaires in combination with wet mount microscopy to determine Vaginal Cell Maturation Index (VCMI) and infections. PubMed searches were carried out between 1 march 2022 and 15 October 2022.Low dose vaginal estriol seems safe, efficient, and could be used in patients with contraindications for steroid hormones such as women with a history of breast cancer, and should therefore be considered as first choice hormonal treatment, when non-hormonal treatments fail. New estrogens, androgens, and several Selective Estrogen Receptor Modulators (SERMs) are being developed and tested. Intravaginal Hyaluronic Acid (HA) or Vit D can help women who can't or don't want to use hormones. EXPERT OPINION: Proper treatment is not possible without a correct and full diagnosis, including microscopy of the vaginal fluid. Low dose vaginal estrogen treatment, especially with estriol, is very efficient and is preferred in most women with VVA. Oral ospemifene and vaginal dihydroepiandrosterone (DHEA) are now considered efficient and safe alternative therapies for VVA. More safety data are waited for several SERMs and for a newly introduced estrogen: estetrol (E4), although so far no major side effects were seen from these drugs. Indications for laser treatments are questionable.

Conjugate treatment with high concentration normobaric oxygen and hyaluronic acid for vaginal atrophy: a prospective study.

OBJECTIVE: Vulvovaginal atrophy is a condition closely related to low circulating estrogen levels, with post-menopause being the main cause. However, patients of childbearing age may also present with these symptoms due to treatments that reduce estrogen production. Local estrogen therapy is the causal treatment of local symptoms, but it is not always accepted and is often abandoned by patients. In recent years, alternative therapies have been proposed: fractional CO2 laser or the conjugate treatment with normobaric oxygen and hyaluronic acid, the latter being the subject of this study. The study aimed to evaluate the effectiveness of conjugate topical treatment with normobaric oxygen and hyaluronic acid. PATIENTS AND METHODS: 50 patients were evaluated and treated with 5 applications of 15 minutes each, every 15 days, with Caressflow®. All patients presented at least one of the symptoms related to vulvovaginal atrophy: dryness, burning, and dyspareunia. In all cases, vulvoscopy, colposcopy, and cervicovaginal cytology were performed. The patients were interviewed with an analogic scale (VAS) concerning the severity of symptoms before and after the treatment. Colposcopy and PAP-smear were assessed by mean of Vaginal Health Index Score (VHI) at baseline and at the end of the treatment. RESULTS: All patients completed the treatment scheme and presented with a significant improvement in subjective symptoms. The colposcopy and PAP-smear performed 10 days after the end of the last treatment showed a significant improvement in the appearance and elasticity of the vaginal epithelium and the cytological picture, which showed, in the sample taken after treatment, hyaluronic acid vesicles within the cell cytoplasm. CONCLUSIONS: This study corroborates the data presented in the latest published papers on the effectiveness of treatment with normobaric O2 and hyaluronic acid on vaginal atrophy. Efficacy has been confirmed both in terms of subjective symptoms reported by the patients and objective improvement at colposcopy and PAP-smear cytology.

Shaping birth: variation in the birth canal and the importance of inclusive obstetric care.

Regional variation in pelvic morphology and childbirth has long occurred alongside traditional labour support and an understanding of possible normal courses of childbirth for each population. The process of migration and globalization has broken down these links, while a European model of 'normal' labour has become widespread. The description of 'normal' childbirth provided within obstetrics and midwifery textbooks, in fact, is modelled on a specific pelvic morphology that is common in European women. There is mounting evidence, however, that this model is not representative of women's diversity, especially for women of non-white ethnicities. The human birth canal is very variable in shape, both within and among human populations, and differences in pelvic shapes have been associated with differences in the mechanism of labour. Normalizing a white-centred model of female anatomy and of childbirth can disadvantage women of non-European ancestry. Because they are less likely to fit within this model, pelvic shape and labour pattern in non-white women are more likely to be considered 'abnormal', potentially leading to increased rates of labour intervention. To ensure that maternal care is inclusive and as safe as possible for all women, obstetric and midwifery training need to incorporate women's diversity. This article is part of the theme issue 'Multidisciplinary perspectives on social support and maternal-child health'.

Outcomes After Central Wedge Labiaplasty Performed Under General Versus Local Anesthesia.

PURPOSE: Interest in labiaplasty as a way to alter and improve genital appearance has been on the rise. Labiaplasty procedures can be performed in the office setting under local anesthesia. However, these procedures are often performed under general anesthesia for patient comfort and to facilitate the operative technique and to potentially improve outcomes. Outcomes after labiaplasty performed under general anesthesia as compared with that performed under local anesthesia in the office setting have not been well-defined. This article aimed to compare outcomes after central wedge labiaplasty performed under general anesthesia versus that performed under local anesthesia. METHODS: A retrospective chart review identified patients who underwent central wedge labiaplasty performed by a single surgeon from 2011 to 2019. Demographic, clinical, and operative information were reviewed and recorded. Outcomes were assessed by evaluating postoperative complications and the need for revision surgery. RESULTS: Thirty-two women with a mean age of 32.8 ± 11.2 years and a mean body mass index of 22.0 ± 3.5 kg/m2 underwent central wedge or extended central wedge labiaplasty during the study period. Ten (31.2%) labiaplasties were performed under local anesthesia in an office setting, and 22 (68.8%) were performed under general anesthesia. Demographic, clinical, and operative characteristics were comparable between labiaplasties performed under local anesthesia and those performed under general anesthesia. Postoperative asymmetry and wound dehiscence were the most common complications. Outcomes after labiaplasty performed under general anesthesia were comparable to those performed under local anesthesia, with regard to asymmetry (27.3% vs 10.0%; P = 0.387), dehiscence (27.3% vs 40.0%; P = 0.683), scarring (4.5% vs 0.0%; P = 1.000), and the need for revision surgery (31.8% vs 40.0%; P = 0.703), respectively. There were no cases of infection, hematoma, decreased sensation, or dyspareunia. CONCLUSIONS: Postoperative asymmetry and dehiscence were the most common complications after labiaplasty performed under general or local anesthesia. Outcomes after labiaplasty performed under general anesthesia were comparable to those performed under local anesthesia. Further studies are needed to assess outcomes after labiaplasty performed under general anesthesia versus that performed under local anesthesia.

Efficacy and safety of a new vaginal gel for the treatment of symptoms associated with vulvovaginal atrophy in postmenopausal women: A double-blind randomized placebo-controlled study.

OBJECTIVE: The aim of the present randomized placebo-controlled single-center study was to assess the efficacy and safety of a new vaginal gel (Meclon Idra - Alfasigma) in the treatment of vulvovaginal atrophy (VVA). The gel is composed of sea buckthorn (Hippophaë rhamnoides) oil, aloe vera, 18ß-glycyrrhetic acid, hyaluronic acid and glycogen. The study assessed whether the gel can reduce VVA symptoms (vaginal dryness, itching, burning sensation) and improve sexual function in postmenopausal women over 12 weeks. STUDY DESIGN: Postmenopausal women (n° = 60) reporting VVA symptoms were recruited and randomized in a 1:1 ratio to the gel or placebo. Active vaginal gel or placebo was applied for 14 days and then twice a week for 90 consecutive days. MAIN OUTCOME MEASURE: The Vaginal Health Index (VHI), including vaginal pH, was used to assess changes in objective signs, whereas the self-reported Female Sexual Function Index (FSFI) was used to investigate sexual function. RESULTS: Meclon Idra was effective in reducing vaginal pain, dyspareunia and vaginal pH, with the VHI showing significant improvement at day 90 (P < .0001), and in reducing each VVA symptom (vaginal dryness, vaginal itching, burning sensation) at weeks 2 and 4, and the end of the study (P < .0001). The analysis of FSFI scores showed, after the end of treatment, an improvement of sexual function in the active-treatment group, with a statistically significant increase (P < 0.001) in all domains scores and total score (P < 0.001). CONCLUSIONS: The present single-center randomized clinical trial demonstrated the efficacy, tolerability and safety of 12-week treatment with a new vaginal gel in postmenopausal women with symptoms associated with VVA. Based on this trial, the gel seems to be a valid choice as a single, local agent for relieving VVA symptoms and improving sexual function, and to have good compliance. This trial is registered prospectively with the Clinical Trials Registry - India, number CTRI/2019/05/01911.

Multidisciplinary management of patients with pubic osteomyelitis, a rare but serious complication after surgery and radiation therapy for advanced gynaecological cancer.

Pubic osteomyelitis is a rare and often late-onset complication of radiation therapy and surgery for vulvar and vaginal carcinoma. It typically presents with vulvar pain, fever, vaginal discharge and/or gait disorders. Pubic osteomyelitis is often accompanied by fistulas or wound dehiscence in the pelvic area. Its accurate diagnosis and treatment are challenging and require a multidisciplinary team effort. In our patients, multiple combined surgical procedures, long-term antibiotic treatment and days to weeks of hospital admission were necessary to treat pubic osteomyelitis. We emphasise the importance of timely and adequate diagnosis and multidisciplinary approach resulting in a course of treatment that is as effective as possible, limiting the impact on quality of life, which is generally high in this group of patients.

A Systematic Review of Nonsurgical Vulvovaginal Restoration Devices: An Evidence-Based Examination of Safety and Efficacy.

BACKGROUND: The efficacy and safety of vulvovaginal restoration devices were called into question in a U.S. Food and Drug Administration statement on July 30, 2018, claiming that women are being harmed by laser and other energy-based devices. The goal of this systematic literature review was to assess existing data, determine gaps in evidence, and propose opportunities for continued investigation pertaining to laser and energy-based vaginal restoration techniques. METHODS: A review of literature using PubMed, Cochrane Library databases, Embase, MEDLINE, and the Cumulative Index to Nursing and Allied Health Literature was conducted on January 9, 2019, and articles up to this point were considered. For inclusion, studies had to be available or translated in English and relate to clinical medicine, direct patient care, and nonsurgical energy-based vulvovaginal procedures. RESULTS: The authors found five level I studies, 19 level II studies, four level III studies, and 46 level IV studies that used 15 different devices. Various degrees of improvement of symptoms were reported in all studies. Adverse events/side effects were noted in two of the 13 radiofrequency device studies, 15 of the 23 erbium:yttrium-aluminum-garnet device studies, and 17 of the 37 carbon dioxide device studies. The majority of adverse events were considered mild. CONCLUSIONS: The majority of studies resulted in mild to no adverse side effects. However, there is a large gap in level I evidence. As a result, the authors emphasize the necessity of supplemental data surrounding this subject and suggest that additional randomized sham-controlled studies be conducted to further investigate vulvovaginal restoration devices in an effort to address women's health issues.

At-Home Transvaginal Device Following Fractional Carbon Dioxide Laser Treatment for Genitourinary Syndrome of Menopause.

BACKGROUND: Device-based therapeutic approaches have been developed to treat women’s genitourinary post-menopausal symptoms. Fractional carbon dioxide laser resurfacing (FxCO2) has been demonstrated to be safe and effective in the treatment of GSM symptoms, however the results begin to wane by 12-months post-treatment. OBJECTIVE: This study aims at assessing the application of an at-home transvaginal red and infrared light device as a maintenance treatment commencing 12 months following FxCO2 laser treatment for genitourinary syndrome of menopause (GSM). STUDY DESIGN: Subjects completing 12-month follow-up after three fractional CO2 laser vulvovaginal treatments received an at-home device and monitored for GSM symptoms with long-term follow-up to 12 months (2 years post-laser). METHODS: 10 post-menopausal subjects completing 12-months follow-up after three FxCO2 vulvovaginal treatments for GSM were treated with an at-home red and infrared LED device. Treatment consisted of intravaginal application three times per week, and subjects were followed to 1, 3, 6, and 12 months. Subjects completed the vaginal assessment scale subject satisfaction, and QUID to assess for vulvovaginal and stress urinary incontinence (SUI) symptoms. RESULTS: Vulvovaginal symptoms measured by VAS were mean 89% improved at 12-month follow-up after FxCO2 and maintained at 73% improved over baseline (2 years post-laser) following an additional 12 months of at-home transvaginal light therapy (P<0.05). VAS symptoms gradually increased over the 12 months maintenance period by a mean of 17% (P<0.05). Mean subject satisfaction was 0 at baseline, 1.86 at 1 year following FxCO2, and 1.00 after an additional 1 year of at-home light therapy. SUI symptoms as measured by QUID were mean 81% improved at 12-month follow-up after FxCO2and maintained at 38% improved over baseline (2 years post-laser) following an additional 12-months of at-home light therapy (P<0.05). SUI symptoms gradually increased by a mean of 43% over the 12-month maintenance period (P<0.05). CONCLUSIONS: At-home transvaginal red and near infrared light therapy commencing at 12 months post-FxCO2 vulvovaginal treatment in a post-menopausal population maintained statistically significant improvements in vulvovaginal and SUI symptoms over the additional12-month period (2 years post-laser); however, a gradual return of symptoms suggests that laser re-treatment or combination withhormone therapy may be necessary to maintain optimal outcomes.J Drugs Dermatol. 2020;19(11):1076-1079. doi:10.36849/JDD.2020.1012.

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.

Vulvar diseases: Approach to the patient.

Patients with vulvar dermatoses often delay seeking medical treatment because of anxiety and embarrassment. Moreover, women frequently self-treat with various home remedies and see multiple clinicians before presenting to a dermatologist. Despite serving as the primary providers for patients with vulvovaginal symptoms, gynecologists typically receive limited training in the causes and management of these conditions. Dermatologists are experts in the evaluation and management of cutaneous disease and should be the caretakers of all skin, including the genitalia. Vulvar disorders are underrecognized by dermatologists for numerous reasons: inadequate training, lack of comfort with both interview and examination techniques, and unfamiliarity with normal anatomic variations. The first article in this continuing medical education series on vulvar dermatoses reviews the fundamentals, approach, and techniques that can be used to ensure a successful visit for both patient and provider.

A medical device containing purified bovine colostrum (Monurelle Biogel) in the treatment of vulvovaginal atrophy in postmenopausal women: Retrospective analysis of urinary symptoms, sexual function, and quality of life.

OBJECTIVE: This study assessed the effectiveness and safety of a medical device containing purified bovine colostrum (Monurelle Biogel; Zambon, Bresso, Italy) in improving vulvovaginal atrophy (VVA), sexual function, urinary symptoms, and quality of life (QoL) in postmenopausal women. METHODS: In all, 172 postmenopausal women with VVA were included in the study. All women were treated with vaginal Monurelle Biogel daily for 12 weeks. Patients underwent clinical examinations, completed a 3-day voiding diary, and had VVA graded using the Vaginal Health Index (VHI) at baseline and 12 weeks. Patients also completed the Female Sexual Function Index (FSFI), overactive bladder questionnaire (OAB-Q), and the Urogenital Distress Inventory (UDI-6), among others. RESULTS: After 12 weeks, there were significant increases in mean (± SD) VHI (12.53 ± 3.67 vs. 19.31 ± 3.49; P < .0001), the number of patients engaging in regular sexual activity 102 (59.3%) vs. 144 (83.7%), and in the total FSFI score (21.64 ± 2.99 vs. 28.16 ± 1.93; P < .0001) compared with baseline. In addition, there were significant reductions in the mean number of 24-hour voids (9.57 ± 2.12 vs. 7.13 ± 1.22; P < .0001), urgent micturition episodes per 24 hours (1.75 ± 0.76 vs. 1.14 ± 0.87; P = .001), nocturia episodes (1.58 ± 0.85 vs. 0.97 ± 1.18; P = .0002), and urinary incontinence episodes per 24 hours (0.74 ± 0.59 vs. 0.28 ± 0.52; P = .003). Finally, after 12 weeks treatment, there were significant differences in UDI-6 (7.85 ± 0.81 vs. 5.56 ± 1.40), OAB-Q symptom (53.60 ± 12.57 vs. 22.08 ± 9.63), and OAB-Q health-related QoL (21.75 ± 8.51 vs. 69.34 ± 14.59) scores compared with baseline (P < .0001 for all). The Patient Impression of Global Improvement scale revealed global improvement in 143 women (83.14%). CONCLUSIONS: Monurelle Biogel is an effective treatment for VVA in postmenopausal women, improving sexual life, urinary symptoms, and QoL.

Treatment to External Labia and Vaginal Canal With CO2 Laser for Symptoms of Vulvovaginal Atrophy in Postmenopausal Women.

Background: Increasingly, women have sought alternatives to traditional options (lubricants, estrogen products, and hormone replacement therapy) for unwelcome vaginal changes of menopause. Objectives: This study evaluated whether a series of three monthly fractional CO2 laser treatments significantly improves and maintains vaginal health indices of elasticity, fluid volume, pH level, epithelial integrity, and moisture. Self-reported symptoms of vaginal atrophy were also measured. Biopsy samples after a series of three treatments were evaluated for histological changes to vaginal canal tissue. Methods: Forty postmenopausal women were treated extravaginally and internally with a fractional CO2 laser. Objective measurements of vaginal health index, as well as subjective measurements of symptoms of vulvovaginal atrophy (VVA), urinary incontinence, and sexual function were reported at baseline. Follow-up evaluations were at one, three, six, and 12 months after the third treatment. Results: Vaginal health index improved significantly after the first treatment and was maintained with mean improvement of 9.6 ± 3.3 (P < 0.001) and 9.5 ± 3.3 (P < 0.001) at the 6- and 12-month follow ups, respectively. Vaginal symptoms of dryness, itching, and dyspareunia improved significantly (P < 0.05) at all evaluations. Histological findings showed increased collagen and elastin staining, as well as a thicker epithelium with an increased number of cell layers and a better degree of surface maturation. Conclusions: Fractional CO2 laser treatments were well tolerated and were associated with improvement in vaginal health and amelioration of symptoms of VVA. Histological changes in the epithelium and lamina propria, caused by fractional CO2 laser treatments, correlated with clinical restoration of vaginal hydration and pH to premenopausal levels.

IUGA committee opinion: laser-based vaginal devices for treatment of stress urinary incontinence, genitourinary syndrome of menopause, and vaginal laxity.

This committee opinion reviews the laser-based vaginal devices for treatment of genitourinary syndrome of menopause, vaginal laxity, and stress urinary incontinence. The United States Food and Drug Administration has issued a warning for unsubstantiated advertising and use of energy-based devices. Well-designed case-control studies are required to further investigate the potential benefits, harm, and efficacy of laser therapy in the treatment of genitourinary syndrome of menopause, vaginal laxity, and stress urinary incontinence. The therapeutic advantages of nonsurgical laser-based devices in urogynecology can only be recommended after robust clinical trials have demonstrated their long-term complication profile, safety, and efficacy.

Vaginal natural oxygenation device (VNOD) for concomitant administration of hyaluronic acid and topical hyperbaric oxygen to treat vulvo-vaginal atrophy: a pilot study.

OBJECTIVE: This is a pilot study to evaluate the effectiveness of concomitant administration of hyaluronic acid and topical hyperbaric oxygen therapy (THOT) by a specifically designed medical device (vaginal natural oxygenation device, VNOD) in improving the symptomatology of postmenopausal patients with vulvo-vaginal atrophy (VVA). PATIENTS AND METHODS: Women with diagnosis of severe VVA from September 2017 to May 2018 were included. Five biweekly administration of THOT and concomitant of hyaluronic acid were performed with a specifically designed medical device. In each occasion, the intensity of patient's symptoms (well-being such as absence of dyspareunia, vaginal dryness, vulvar and/or vaginal itching; vaginal burning; presence of fluid) was determined with a graduated scale from 1 to 6 and the vaginal elasticity and the vaginal wall epithelium appearance were also determined with a graduated scale from 1 to 5. The change in all parameters from baseline to end of therapy was evaluated. RESULTS: Twenty-five patients were considered for the final analysis. A significant improvement in well-being (0.3 vs. 5.1, p < 0.001), vaginal burning (0.2 vs. 5.1, p < 0.001), presence of fluid (0.6 vs. 4.9, p < 0.001), vaginal epithelium appearance (1.8 vs. 4.7, p < 0.001), and vaginal elasticity (1.1 vs. 3.8, p < 0.001) was observed between the first and the last therapy session. All the patients reported a recovery of their sexuality at the end of the five treatment sessions. CONCLUSIONS: In this pilot study, the use of VNOD seems to be a valid treatment of VVA, resulting in a completely natural type of therapy well accepted by patients with immediate therapeutic effects and without side effects; these findings must be confirmed in a well-designed randomized controlled trial.

Efficacy of intravaginal dehydroepiandrosterone (DHEA) on moderate to severe dyspareunia and vaginal dryness, symptoms of vulvovaginal atrophy, and of the genitourinary syndrome of menopause.

OBJECTIVE: The aim of this study is to confirm the local beneficial effects of intravaginal dehydroepiandrosterone (DHEA, Prasterone) on moderate to severe dyspareunia or pain at sexual activity, the most frequent symptom of vulvovaginal atrophy due to menopause or genitourinary syndrome of menopause (GSM). METHODS: In a prospective, randomized, double-blind, and placebo-controlled phase III clinical trial, the effect of daily intravaginal 0.50% DHEA (6.5 mg) (Prasterone, EndoCeutics) was examined on four coprimary objectives, namely percentage of parabasal cells, percentage or superficial cells, vaginal pH, and moderate to severe pain at sexual activity (dyspareunia) identified by the women as their most bothersome vulvovaginal atrophy symptom. The intent-to-treat population included 157 and 325 women in the placebo and DHEA-treated groups, respectively. RESULTS: After daily intravaginal administration of 0.50% DHEA for 12 weeks, when compared to baseline by the analysis of covariance test, the percentage of parabasal cells decreased by 27.7% over placebo (P < 0.0001), whereas the percentage of superficial cells increased by 8.44% over placebo (P < 0.0001), vaginal pH decreased by 0.66 pH unit over placebo (P < 0.0001), and pain at sexual activity decreased by 1.42 severity score unit from baseline or 0.36 unit over placebo (P = 0.0002). On the other hand, moderate to severe vaginal dryness present in 84.0% of women improved at 12 weeks by 1.44 severity score unit compared to baseline, or 0.27 unit over placebo (P = 0.004). At gynecological evaluation, vaginal secretions, epithelial integrity, epithelial surface thickness, and color all improved by 86% to 121% over the placebo effect (P < 0.0001 for all comparisons with placebo). Serum steroid levels remained well within the normal postmenopausal values according to the involved mechanisms of intracrinology. The only side effect reasonably related to treatment is vaginal discharge due to melting of the vehicle at body temperature and this was reported in about 6% of the participants. CONCLUSIONS: The daily intravaginal administration of 0.50% (6.5 mg) DHEA (Prasterone) has shown clinically and highly statistically significant effects on the four coprimary parameters suggested by the US Food and Drug Administration. The strictly local action of Prasterone is in line with the absence of significant drug-related adverse events, thus showing the high benefit-to-risk ratio of this treatment based upon the novel understanding of the physiology of sex steroids in women.