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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... Sep 2023Safety concerns or contraindications in the use of hormones have resulted in a rise in the use of nutritional medicinal products for the management of menopausal...
OBJECTIVE
Safety concerns or contraindications in the use of hormones have resulted in a rise in the use of nutritional medicinal products for the management of menopausal symptoms. The aim of the present study was to demonstrate the efficacy and safety of Exelvit Menopause®.
PATIENTS AND METHODS
A prospective, open, observational, and multicentre study was performed, including 156 menopausal women. The patients received the nutritional product containing evening primrose oil 50 mg; hop extract 0.127-0.212 mg; saffron Stigmas Extract 0.6 mg; tryptophan 71.25 mg, vitamins B6, D3, K2, B12, and B9 once per day for 12 weeks. The validated menopausal rating score (MRS) was used for recording symptoms.
RESULTS
A decrease in the MRS of all menopausal symptoms was observed after 12 weeks compared to baseline (p < 0. 0001). Overall, hot flashes were reduced by 48.15%, heart discomfort by 33.3%, sleep disturbance by 46.2%, joint and muscular discomfort by 27.8%, depressive mood by 45.0%, irritability by 47.6%, anxiety by 44.4%, physical problems by 36.4%, sexual problems by 30.0%, bladder problems 31.3%, and vaginal dryness by 33.3%.
CONCLUSIONS
The nutritional product Exelvit Menopause® significantly reduced menopausal symptoms.
Topics: Humans; Female; Vitamin B 6; Crocus; Tryptophan; Prospective Studies; Menopause; Biological Products; Vitamins; Plant Extracts
PubMed: 37750646
DOI: 10.26355/eurrev_202309_33578 -
Gynecological Endocrinology : the... Mar 2024Vaginal dryness (VD) represents a significant concern affecting women across diverse life stages, encompassing both pre- and postmenopausal women at any age....
Prospective, multicenter, uncontrolled study on the effectiveness and safety of a hyaluronic acid water-based vaginal lubricant in alleviating vaginal dryness and dyspareunia.
BACKGROUND
Vaginal dryness (VD) represents a significant concern affecting women across diverse life stages, encompassing both pre- and postmenopausal women at any age. Dyspareunia, defined by genital pain that can be experienced before, during, or after intercourse, is often associated with vaginal dryness.
AIM
This study aimed to evaluate the effectiveness and safety of a water-based vaginal lubricant with hyaluronic acid to reduce sexual discomfort associated with vaginal dryness.
METHODS
A prospective, multicenter, uncontrolled clinical investigation was conducted over a three-month period in women aged 18 years or older experiencing pain or difficulty during sexual intercourse for whom the use of a vaginal lubricant was recommended.
RESULTS
Significant improvements were observed in the FSFI scores, indicating enhanced sexual function ( < .001). Vaginal dryness symptoms, including irritation, dryness, itching, and dyspareunia, significantly decreased after product use ( < .001).
CLINICAL IMPLICATIONS
This study contributes to the limited scientific knowledge on the application of lubricants in the context of symptoms associated with VD.
STRENGTHS & LIMITATIONS
In addition to the short study period, inherent limitations of the study design, and lack of placebo control, it is pertinent to acknowledge that some of the pros used in this study were not based on validated questionnaires. However, as far as we know, this study is the only one that analyzes well-being and sexual pleasure as results using a lubricant formulated with hyaluronic acid.
CONCLUSION
This tested vaginal lubricant with hyaluronic acid has demonstrated efficacy in improving vaginal dryness and female sexual function, particularly in reducing pain and improving lubrication during sexual intercourse, and showed a favorable safety profile, with minimal and transient adverse events.
Topics: Female; Humans; Atrophy; Dyspareunia; Hyaluronic Acid; Lubricants; Pain; Prospective Studies; Vagina; Vaginal Diseases; Water
PubMed: 38468593
DOI: 10.1080/09513590.2024.2317268 -
JNCI Cancer Spectrum Oct 2023Sexual health outcomes (SHO), which entail the physical, emotional, mental, and social impacts, are an important consideration for adolescent and young adults (AYA, ages... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Sexual health outcomes (SHO), which entail the physical, emotional, mental, and social impacts, are an important consideration for adolescent and young adults (AYA, ages 15-39) affected by cancer. The objective of this systematic review and meta-analysis is to summarize the current literature and evaluate AYA cancer impact on SHO.
METHODS
EMBASE and MEDLINE were searched from January 1, 2000 to September 28, 2022 to identify epidemiologic studies that used an analytic observational design, included individuals with AYA cancer and non-cancer control participants, and evaluated SHO. Odds ratios and prevalence ratios were calculated; random effects models were used to obtain pooled measures where possible.
RESULTS
Of 2621 articles, 8 were included that investigated 23 SHO in 9038 AYA cancer patients. Based on the sexual response cycle, outcomes were categorized as those occurring among males (desire = 1, arousal = 1, orgasm = 4, other = 3) and females (desire = 2, arousal = 1, orgasm = 2, pain = 6, other = 3). It was feasible to conduct meta-analysis for 3 female SHO and 5 male SHO. There were associations between AYA cancer and 3 SHO: vaginal dryness (pooled odds ratio = 3.94; 95% confidence interval (CI) = 2.02 to 7.70), ejaculatory dysfunction (pooled odds ratio = 3.66; 95% CI = 2.20 to 6.08), and testosterone level (pooled mean difference = -2.56 nmol/liter; 95% CI = -3.46 to -1.66; P = .00001).
CONCLUSION
This study found increased ejaculatory dysfunction and reduced testosterone levels in male AYA cancer patients and increased vaginal dryness in female AYA cancer patients, highlighting the need for sexual health resources in this population.
Topics: Humans; Male; Female; Adolescent; Young Adult; Sexual Behavior; Orgasm; Neoplasms; Testosterone; Outcome Assessment, Health Care
PubMed: 37878813
DOI: 10.1093/jncics/pkad087 -
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 -
Nigerian Journal of Clinical Practice Jul 2023In the postpartum period, changes including pain during intercourse, lack of sexual desire, vaginal dryness, and failure to reach orgasm can affect a woman's sexual... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
In the postpartum period, changes including pain during intercourse, lack of sexual desire, vaginal dryness, and failure to reach orgasm can affect a woman's sexual response cycle.
AIM
This research aimed to determine the effect of midwifery training on postpartum sexual dysfunction among primiparous women.
SUBJECTS AND METHODS
This research using a single-blind randomized controlled experimental and follow-up design. The sample consisted of 70 women, divided equally into training and control groups. Research data were collected using an information form, the Female Sexual Function Index and the Arizona Sexual Experience Scale. In the first phase of our study, 306 primiparous women were interviewed.
RESULTS
The mean Female Sexual Function Index score of the women was 25.18 ± 5.47 and 40.2% reported sexual dysfunction. When comparing the training and control groups before training, the total score average of the ASEX was 10.48 ± 2.13 in the training group and 11.06 ± 3.86 in the control group. The average score in the post-training was higher in the group given education (22.45 ± 2.17) than in the control group (17.08 ± 3.92) and this difference was significant (p = 0.000). It was determined that 42% of the change in the third follow-up scores of pregnant women in the training group could be explained by the education session they received.
CONCLUSION
Our data showed a positive change in the sexual dysfunction scores of women, suggesting the education program was successful.
Topics: Pregnancy; Female; Humans; Single-Blind Method; Educational Status; Sexual Behavior; Coitus; Postpartum Period
PubMed: 37635579
DOI: 10.4103/njcp.njcp_656_22 -
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 -
Annals of Translational Medicine Apr 2024The bladder neck area of the vagina is known as the "zone of critical elasticity" (ZCE). Adequate vaginal elasticity at ZCE is required for the oppositely-acting muscles... (Review)
Review
The bladder neck area of the vagina is known as the "zone of critical elasticity" (ZCE). Adequate vaginal elasticity at ZCE is required for the oppositely-acting muscles to independently close the distal urethra and bladder neck. Scarring at ZCE "tethers" the more powerful posterior muscles to the anterior muscles and the bladder neck is forcibly pulled open, resulting in massive urine loss. This condition is known as "tethered vagina syndrome" (TVS). In developed countries, the main cause of TVS is iatrogenic. Vaginal repairs, vaginal mesh, may cause scarring at ZCE and this directly links the oppositely-acting muscle forces. Over-elevated Burch colposuspensions may stretch the ZCE to the point where its elasticity is lost so the muscles can no longer function independently. The treatment is to dissect the vagina clear of the scarring and to insert a skin graft to the bladder neck to restore ZCE elasticity. In developing countries, extensive trauma to the vagina and bladder from obstructed childbirth can cause obstetric fistulas. In up to 40-50% of these women, there is ongoing massive urine loss after the fistula has been successfully closed. Performing a prophylactical skin graft during fistula closure if there is vaginal tissue deficit is proving to be revolutionary. In women with Goh type 4 fistula (n=45), 46% were cured (full dryness) against an expected 19%. The same operation can produce equally dramatic cures in women who continue to leak urine after successful fistula repair.
PubMed: 38721454
DOI: 10.21037/atm-23-1866 -
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 -
Sleep Medicine: X Dec 2023To examine factors associated with poor sleep quality in community-dwelling midlife women.
OBJECTIVE
To examine factors associated with poor sleep quality in community-dwelling midlife women.
METHODS
Healthy women (aged 45-69 years) of Chinese, Malay and Indian ethnicities attending well-women clinics at the National University Hospital, Singapore, completed the Pittsburgh Sleep Quality Index (PSQI). A PQSI score >5 denoted poor sleep quality. The women filled out validated questionnaires covering menopausal and genito-urinary symptoms, and mental health. Physical performance was measured. Bone mineral density and visceral adiposity were assessed by dual energy X-ray absorptiometry. Binary logistic regression analyses assessed independent factors for poor sleep.
RESULTS
Poor sleep quality was reported in 38.2% of women (n = 1094, mean age: 56.4 ± 6.2 years). Indian women had higher sleep disturbance scores than Chinese women (mean ± SD: 1.33 ± 0.58 vs 1.17 ± 0.49). Malays experienced more daytime dysfunction (0.54 ± 0.60 vs 0.33 ± 0.55) and had a higher overall PSQI score (6.00 ± 3.31 vs 5.02 ± 2.97) than the Chinese. A low education level (aOR: 1.76, 95% CI: 1.01-3.05), feelings of irritability (2.67, 1.56-4.60) and vaginal dryness (1.62, 1.03-2.54) were associated with poor sleep quality in the adjusted multivariable model. Women with moderate to severe disability were ∼3 times (2.99, 1.20-7.44) more likely to experience less than ideal sleep quality, while urinary incontinence (1.53, 1.08-2.17) and breast cancer history (2.77, 1.36-5.64) were also associates of poor sleep quality.
CONCLUSION
Self-reports of education level, irritability, vaginal dryness, disability, urinary incontinence, and breast cancer history were independently related to poor sleep. Ethnic differences suggest the need for targeted interventions among the ethnic groups.
PubMed: 36568060
DOI: 10.1016/j.sleepx.2022.100060