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Diagnostics (Basel, Switzerland) Feb 2024Polycystic ovary syndrome (PCOS) is a multifactorial, heterogeneous endocrine and metabolic disorder in women. Due to its association with the menstrual cycle and...
Polycystic ovary syndrome (PCOS) is a multifactorial, heterogeneous endocrine and metabolic disorder in women. Due to its association with the menstrual cycle and fertility disorders, the importance of this problem is emphasized especially in patients of reproductive age. Based on a number of analyses, the effect of PCOS on altering the diversity of the microbiome (e.g., intestinal or vaginal) is suggested. Vaginal dysbiosis can result in BV (bacterial vaginosis). The purpose of this study was to assess the prevalence of BV in patients with PCOS, as well as to determine the most reliable diagnostic factors. Retrospective analysis of microbiological findings (2018-2022) of PCOS patients ( = 594) of reproductive age. The present analysis focused on the results of patients with PCOS ( = 380) and vaginal discharge with pH ≥ 4.4 and suspected BV. Biological material was a vaginal swab/vaginal secretion. The most commonly used routine methods for assessing BV were the Amsel analysis and the Nugent scoring system. Patients with PCOS and vaginal fluid pH ≥ 4.4 and suspected BV ( = 380) accounted for 64% of all PCOS patients ( = 594). The relationship between pH and detection of "clue cells" showed significant dependency and increased with leukocytes. The pH measurement also showed dependency on high counts. In addition, the elimination of lactic acid bacteria (LAB) in vaginal secretions was associated with an increase in the number of leukocytes with increasing pH values. A marked increase in was found in more than half (56.8%) of PCOS women ( = 380) with suspected BV. No dependency was observed between the absence of LAB and the diagnosis of BV on a positive culture. Of the = 380 patients with PCOS, 191 (50%) had a Nugent score ≥ 7 positive for BV. No dependency was observed between the number of patients with sp. in vaginal secretions and pH, BV (with clue cells), or elevated leukocyte levels. The LRM was adjusted and the statistical model represented by the following formula was obtained: log(/(1 - )) = -1.18 + 1.24 × Group4.6 + 1.08 × Group4.8 + 1.66 × Group5.4. : Based on the present analysis, BV appears to be more common in patients with PCOS than in the non-PCOS population. Chronic inflammation in PCOS patients and abnormalities in the vaginal microbiome may predispose to the development of BV. In women with PCOS, BV may be one of the unrecognized causes of infertility or complications of pregnancy. Despite the potential link between PCOS and the development of BV, the extent to which this syndrome contributes to vaginal dysbiosis and reproductive complications requires further study.
PubMed: 38396443
DOI: 10.3390/diagnostics14040404 -
Minerva Obstetrics and Gynecology Feb 2024Despite the gold standard treatment for genitourinary syndrome of menopause (GSM) is based on the use of local or systemic estrogen-containing products, the typical...
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.
PubMed: 38358384
DOI: 10.23736/S2724-606X.23.05409-X -
Biomedical Reports Mar 2024Decreasing estrogen levels during the postmenopausal period results in tissue atrophy and physiological changes, such as thinning of the vaginal epithelium, prolapse and...
Decreasing estrogen levels during the postmenopausal period results in tissue atrophy and physiological changes, such as thinning of the vaginal epithelium, prolapse and decreased pelvic floor strength and control. Sexual dysfunction associated with vaginal dryness occurs in postmenopausal patients. The present study (trial no. NCT05654610) was designed as an observational, multicenter, real-world clinical investigation to evaluate the performance and safety of the medical device Halova ovules in decreasing vaginal symptoms associated with vulvovaginal atrophy and sexual dysfunction. A total of 249 female participants were treated with Halova ovules, both in monotherapy and in combination with vaginal lubricants. The primary objective was to evaluate the tolerability of Halova ovules in the management of symptoms associated with perimenopause or genitourinary syndrome of menopause. The evolution of clinical manifestations such as vaginal dryness, dysuria, dyspareunia and endometrial thickness was defined a secondary objective. Halova ovules were rated with 'excellent' clinical performance by 92.74% of participants as a standalone treatment and 95.71% of the study participants when used in association with vaginal lubricants. Sexual dysfunction-associated parameters, such as vaginal dryness and dyspareunia, were reduced by similar percentages in each arm, 82% (monotherapy) and 80% (polytherapy) for vaginal dryness and 72% in monotherapy vs. 48% polytherapy reducing dyspareunia. No adverse reactions associated with treatment with Halova were reported. The medical device demonstrated anti-atrophic activity in the genitourinary tract, resulting in significantly improved symptoms associated with normal sexual functioning.
PubMed: 38312435
DOI: 10.3892/br.2024.1723 -
European Review For Medical and... Jan 2024This study aims to compare the effects of vaginal estrogen and hyaluronic acid on vulvovaginal atrophy. (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
This study aims to compare the effects of vaginal estrogen and hyaluronic acid on vulvovaginal atrophy.
PATIENTS AND METHODS
This randomized controlled study included a total of 300 patients, with 150 patients in each group (Group E and Group H). The VHI score was determined based on a pre-treatment evaluation conducted by a gynecologist. After one month of receiving vaginal estrogen in Group E and vaginal hyaluronic acid in Group H, the patients were re-evaluated by their physicians.
RESULTS
A statistically significant difference was found between the pre- and post-treatment VHI scores in Group E and Group H (p = 0.000; p = 0.000). No statistical difference was found between Group E and Group H in terms of treatment efficacy (p = 0.712). The pre- and post-treatment complaints of dryness, itching, dyspareunia, burning, and dysuria were found to be statistically significant in Group E and Group H (p = 0.000; p = 0.000; p = 0.000; p = 0.000; p = 0.000 in Group E, respectively) (p = 0.000; p = 0.000; p = 0.000; p = 0.000; p = 0.000 in Group H, respectively). No statistical difference was observed regarding dyspareunia, dysuria, and burning complaints (p = 0.632; p = 0.106; p = 0.128, respectively). However, hyaluronic acid was found to be significantly more effective for itching complaints (p = 0.002), while estrogen was found to be significantly more effective for dryness complaints (p = 0.012).
CONCLUSIONS
Hyaluronic acid and estrogen were equally effective in vaginal treatment. Hyaluronic acid may be preferred for patients in whom hormonal therapy is contraindicated or for those who prefer non-hormonal therapy.
Topics: Female; Humans; Hyaluronic Acid; Estradiol; Dyspareunia; Dysuria; Postmenopause; Vagina; Estrogens; Treatment Outcome; Atrophy; Pruritus
PubMed: 38305601
DOI: 10.26355/eurrev_202401_35054 -
Experimental and Therapeutic Medicine Jan 2024Genitourinary symptoms of menopause (GSM) affect ~50% of women after menopause. Recently, CO laser therapy has been used for managing GSM but without high quality...
Genitourinary symptoms of menopause (GSM) affect ~50% of women after menopause. Recently, CO laser therapy has been used for managing GSM but without high quality evidence. The present review assessed the effectiveness of CO laser therapy in the management of GSM. PubMed, Embase, Web of Science, CENTRAL and Scopus databases were searched for randomized controlled trials (RCTs), published up to June 30, 2023, comparing CO laser and sham laser treatments for GSM management. The outcomes of interest included Female Sexual Function Index (FSFI), Vaginal Health Index (VHI) and visual analog scale (VAS) for dyspareunia, dryness, burning, itching and dysuria. A total of seven RCTs were included in the review and meta-analysis, with 6/7 studies using three sessions of laser therapy, 4-8 weeks apart. Meta-analysis demonstrated no statistically significant difference in FSFI [mean difference (MD), -1.48; 95% CI, -5.85, 2.89; I=45%] and VHI scores (MD, -0.18; 95% CI, -1.66, 1.31; I =72%) between laser and control groups. Meta-analysis also demonstrated no statistically significant difference in VAS scores for dyspareunia (MD, -1.63; 95% CI; -4.06, 0.80; I=91%), dryness (MD, -1.30; 95% CI, -3.14, 0.53; I=75%), burning (MD, -0.76; 95% CI, -2.03; 0.51 I=56%), itching (MD, -0.28; 95% CI, -0.95, 0.38; I=0%) and dysuria (MD, 0.15; 95% CI, -0.37, 0.67; I=23%) between the groups. The included RCTs had low risk of bias. In conclusion, meta-analyses of high-quality sham-controlled RCTs indicated that CO may not have any beneficial effect on GSM. Limited data and high heterogeneity in meta-analyses in this area of research are important limitations that need to be addressed by future RCTs.
PubMed: 38223331
DOI: 10.3892/etm.2023.12297 -
Scientific Reports Jan 2024The genitourinary symptom of menopause (GSM) affects up to 65% of women, resulting in symptoms such as vulvovaginal dryness, discomfort, and dysuria, which significantly...
The genitourinary symptom of menopause (GSM) affects up to 65% of women, resulting in symptoms such as vulvovaginal dryness, discomfort, and dysuria, which significantly impacts quality of life. The current assessment methods rely on subjective questionnaires that can be influenced by individual differences, as well as invasive measurements that are time-consuming and not easily accessible. In this study, we explore the potential of a non-invasive and objective assessment tool called diffuse reflectance spectroscopy and imaging (DRSI) to evaluate tissue chromophores, including water, lipid, oxyhemoglobin, and deoxyhemoglobin. These measurements provide information about moisture content, lipid levels, oxygen saturation, and blood fraction, which can serve as surrogate markers for genital estrogen levels. Our findings reveal distinct differences in these chromophores among pre, peri, and postmenopausal subjects. By using lipid and blood fraction tissue chromophores in a K-Nearest Neighbour classifier model, we achieved a prediction accuracy of 65% compared to vaginal maturation index (VMI) that is clinically used to assess estrogen-related hormonal changes. When age was included as the third feature, the accuracy increased to 78%. We believe that by refining the study protocol and configuring the fiber probe to examine tissue chromophores both in the superficial vulva skin for epidermal water content and the deeper layers, DRSI has the potential to provide objective diagnosis and aid in monitoring the treatment outcome of GSM.
Topics: Female; Humans; Pilot Projects; Quality of Life; Menopause; Vagina; Spectrum Analysis; Estrogens; Water; Lipids; Atrophy
PubMed: 38212347
DOI: 10.1038/s41598-023-49655-4 -
Complementary Medicine Research 2024Urogenital atrophy and its sequelae, particularly genital dryness, urological problems, and pain on genital touching, are common medical problems for menopausal women...
INTRODUCTION
Urogenital atrophy and its sequelae, particularly genital dryness, urological problems, and pain on genital touching, are common medical problems for menopausal women and women undergoing antihormonal cancer treatment. To meet the requirements for a nonhormonal local treatment, a compounded herbal preparation was developed as a vaginal ovule (Dioscorea comp. ovulum), and the efficacy and applicability of this herbal treatment were investigated.
METHODS
This was a retrospective chart review of patients' records. The study was approved by the Ethics Committee of the Canton of Zurich (project number BASEC 2016-01982). Between 2007 and 2011, patients with urogenital atrophy and related symptoms, who wanted to initiate herbal treatment, were asked for consent to be interviewed (4-point rating scale) and examined gynecologically with photo documentation of their vaginal discharge. A total of 26 patients met the enrollment criteria and consented to the procedure. The first 8 weeks consisted of a daily application of low-dose Dioscorea comp. ovulum followed by high-dose Dioscorea comp. ovule twice weekly for at least 3 months.
RESULT
A total of 23 patients completed the trial. Of the 19 patients in the subgroup with an atrophic vaginal maturation index (VMI), 16 achieved a eutrophic VMI. Four patients began therapy with hypotrophy. There was a 96% decrease in complaints (22/23). The genital dryness score decreased from 1.80 to 0.25 points, urological problems from 2.38 to 0.85 points, and pain on genital touching from 1.70 to 0.60 points. Application, tolerability, and medical safety of the formula were good.
CONCLUSION
The phytotherapeutic compounded preparation Dioscorea comp. ovule (Dioscorea villosa, Glycine max, Salvia officinalis) is suitable for the treatment of urogenital atrophy and its sequelae.
UNLABELLED
Hintergrund Urogenitale Atrophie und ihre Folgeerscheinungen, insbesondere genitale Trockenheit, urologische Probleme und schmerzhafte genitale Berührungen, sind ein häufiges medizinisches Problem bei menopausalen Frauen und Frauen unter antihormoneller Krebstherapie. Um den Bedarf an einer nicht-hormonellen lokalen Behandlung zu decken, wurde ein pflanzliches Präparat in Form eines Vaginal-Ovulum (Dioscorea comp. Ovulum) entwickelt. Wirksamkeit und Anwendbarkeit dieser pflanzlichen Behandlung werden untersucht.Patientinnen und Methoden Es handelt sich um eine retrospektive Analyse. Das Studienprotokoll wurde von der Ethikkommission des Kantons Zürich genehmigt (Projekt Nummer BASEC 2016-01982). Zwischen 2007 und 2011 wurden geeignete Patientinnen mit urogenitaler Atrophie und assoziierten Beschwerden, die mit einer pflanzlichen Behandlung beginnen wollten, um ihr Einverständnis zu einer Befragung (4-Punkte-Score) und gynäkologischen Untersuchungen mit Fotodokumentation des Vaginalausflusses (Nativpräparat) gebeten. 26 Patientinnen erfüllten die Kriterien und erklärten sich mit dem Verfahren einverstanden.Behandlung Nach einer täglichen Anwendung eines niederdosiertenDioscorea comp. Ovulum folgte eine zweimal wöchentliche Anwendung des höher dosiertenDioscorea comp. Ovulum für mindestens 3 Monate.Ergebnisse Insgesamt 23 Patientinnen schlossen die Studie ab. 16 von 19 Patientinnen in der Untergruppe mit einem atrophen Vaginalen Maturations-Index (VMI) erreichten ein eutrophes Vaginalepithel. Vier Patientinnen begannen mit einer Hypotrophie. Ein Rückgang der Beschwerden wurde bei 96% (22 von 23) erreicht: Trockenheit im Genitalbereich ging von 1,80 auf 0,25 Score-Punkte zurück, urologische Probleme von 2,38 auf 0,85 Score-Punkte und schmerzhafte Berührungen im Genitalbereich von 1,70 auf 0,60 Score-Punkte. Anwendung, Verträglichkeit und medizinische Sicherheit der Magistralrezeptur sind gut.Schlussfolgerung Das phytotherapeutische KombinationspräparatDioscorea comp. Ovulum (Dioscorea villosa L., Glycine Max Merr., Salvia officinalis L.) eignet sich zur Behandlung der urogenitalen Atrophie und ihrer Folgeerscheinungen.PubMed: 38211573
DOI: 10.1159/000536193 -
Journal of Personalized Medicine Dec 2023In the context of the menopausal transition, genitourinary syndrome of menopause (GSM) refers to a range of genitourinary symptoms, from vaginal dryness to dysuria and... (Review)
Review
In the context of the menopausal transition, genitourinary syndrome of menopause (GSM) refers to a range of genitourinary symptoms, from vaginal dryness to dysuria and urinary urgency. While hormonal treatments are standard, their associated side effects have driven the exploration of alternatives like vaginal CO laser. We aimed to evaluate the randomized controlled trials (RCTs) comparing vaginal CO laser treatment for GSM to sham controls. This systematic review sourced four electronic databases until June 2023. The analysis incorporated seven RCTs with 407 women. The CO laser and sham control were comparable for most parameters, including the female sexual function index (FSFI) and visual analogue scale (VAS) for dyspareunia, vaginal health index, pH, and patient satisfaction. However, the CO laser group showed significant improvement in the vaginal assessment scale for GSM symptoms. Sensitivity analyses revealed that parameters like FSFI showed significant differences in favor of CO laser group upon the exclusion of specific studies. In conclusion, vaginal CO laser therapy emerges as a promising alternative for GSM management, especially for most bothersome GSM symptoms; however, the need for further well-designed RCTs remains to validate its broad safety and efficacy.
PubMed: 38138921
DOI: 10.3390/jpm13121694 -
BMC Cancer Nov 2023Vaginal CO laser therapy is a new treatment option for genitourinary syndrome of menopause. Its potential is particularly interesting in breast cancer survivors, where...
BACKGROUND
Vaginal CO laser therapy is a new treatment option for genitourinary syndrome of menopause. Its potential is particularly interesting in breast cancer survivors, where existing treatment options often are insufficient as hormonal treatment is problematic in these women. The objective of this study is to investigate the effectiveness of vaginal laser treatment for alleviation of genitourinary syndrome of menopause in breast cancer survivors treated with adjuvant endocrine therapy. The secondary objective is to explore the importance of repeated vaginal laser treatment and the long-term effects in this patient population.
METHODS
VagLaser consist of three sub-studies; a dose response study, a randomized, participant blinded, placebo-controlled study and a follow-up study. All studies include breast cancer survivors in adjuvant endocrine therapy, and are conducted at the Department of Obstetrics and Gynecology, Randers Regional Hospital, Denmark. The first participant was recruited on 16th of February 2023. Primary outcome is vaginal dryness. Secondary subjective outcomes are vaginal pain, itching, soreness, urinary symptoms and sexual function. Secondary objective outcomes are change in vaginal histology (punch biopsy), change in vaginal and urine microbiota, and change in vaginal pH.
DISCUSSION
More randomized controlled trials, with longer follow-up to explore the optimal treatment regimen and the number of repeat vaginal laser treatments for alleviation the symptoms of genitourinary syndrome of menopause in breast cancer survivors treated with endocrine adjuvant therapy, are needed. This study will be the first to investigate change in vaginal and urine microbiota during vaginal laser therapy in breast cancer survivors.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT06007027 (registered 22 August, 2023).
PROTOCOL VERSION
Version 1, Date 13.11.2023.
Topics: Humans; Female; Breast Neoplasms; Cancer Survivors; Carbon Dioxide; Follow-Up Studies; Laser Therapy; Female Urogenital Diseases; Menopause; Vagina; Urogenital Neoplasms; Treatment Outcome; Randomized Controlled Trials as Topic
PubMed: 38031020
DOI: 10.1186/s12885-023-11656-x -
Medicina (Kaunas, Lithuania) Nov 2023: Signs and symptoms of vulvovaginitis, especially when recurrent, have a significant impact on a woman's quality of life. The aim of this study was to survey... (Observational Study)
Observational Study
Efficacy of a Novel Rigenase and Polyhexanide (Fitostimoline Septagel) Hydrogel Device for the Treatment of Vulvovaginitis Symptoms: Cross-Sectional Analysis of a National Survey and Prospective Observational Study.
: Signs and symptoms of vulvovaginitis, especially when recurrent, have a significant impact on a woman's quality of life. The aim of this study was to survey gynecologists about their habits regarding the treatments of the pathology and to evaluate the efficacy of a novel vaginal hydrogel composed of wheat extracts and polyhexanide aimed at reducing vulvovaginitis symptomatology. : A cross-sectional analysis of a national survey using 155 Italian gynecologists and a prospective, open-label, observational study were carried out in 75 outpatient clinics across Italy. Pre- and postmenopausal women with suspicion of vulvovaginitis due to at least four of the following symptoms (leucoxanthorrhea, bad odor from genitalia, vulvovaginal dryness, petechiae, burning, and pruritus) while waiting for microbiological swab analysis were included and treated with one hydrogel application every 3 days for 1 week. Primary endpoint was the complete resolution of symptomatology. : The pre-study survey reported that, for most clinicians, local or oral treatment (65.7% and 82.8%, respectively) with antibiotics or antifungals is used very often. Therefore, we proceeded to carry out an observational study. Overall, 615 (362 of fertile age and 253 in postmenopause) women were included in this study. At the 28th follow-up examination, complete resolution of symptomatology was achieved in 578/615 (94.1%; < 0.001) within 12.72 ± 6.55 and 13.22 ± 6.33 days for those of fertile age and in postmenopause, respectively ( = 0.342). All of the evaluated symptoms were significantly reduced after treatment ( = 0.001) without differences according to the patient's menopausal status. A slightly significant reduction in ( = 0.040) and ( = 0.049) was found after treatment. No patient reported side effects, adverse reactions, or discontinued therapy. : This pilot study showed that a hydrogel based on Rigenase (wheat extract) and polyhexanide could be a promising treatment for the relief of vulvovaginitis symptoms. However, these results are limited by the absence of a control group. Additional comparative and randomized controlled trials between the hydrogel and other non-antibiotic devices as well as local antibiotic therapy should be performed to increase the validity of the findings.
Topics: Female; Humans; Cross-Sectional Studies; Hydrogels; Prospective Studies; Pilot Projects; Quality of Life; Vulvovaginitis; Anti-Bacterial Agents
PubMed: 38004053
DOI: 10.3390/medicina59112004