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European Journal of Obstetrics,... Mar 2022During menopausal transition, women are frequently affected by vulvovaginal atrophy (VVA), due to the decline of estrogen levels. Resulting symptoms are itching,... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVES
During menopausal transition, women are frequently affected by vulvovaginal atrophy (VVA), due to the decline of estrogen levels. Resulting symptoms are itching, burning, dyspareunia, and vaginal dryness (reported in up to 85%). The aim of this trial was to verify if medical device polycarbophil vaginal (PCV) moisturizer gel is not less effective than hyaluronic acid (HA) gel in treating vaginal dryness.
MATERIAL AND METHODS
This was a multicenter, open label, randomized, parallel group, comparative study with non-inferiority design. Female included were ≥45 to ≤55 years in the menopausal transition, with subjective dryness, any objective sign of VVA, pH > 5, and body mass index of ≥18.5 to ≤36 kg/m. Subjects were randomized to 1 g of PCV gel twice a week for 30 days or 3 g of HA vaginal gel every 3 days for 30 days.
RESULTS
53 subjects (mean age 49.45 ± 2.96 years) were analyzed. Vaginal health index showed an improvement (p < 0.001) in both groups (from 12.54 ± 1.37 to 16.36 ± 2.66 for PCV, from 12.00 ± 1.91 to 16.60 ± 2.50 for HA), but the difference between final means (95%CI: -1.66 to 1.18) evidenced that PCV is non-inferior to HA treatment. Similarly, an improvement was evidenced in vaginal maturation index (p = 0.005 for PCV, ns. for HA), female sexual function index (p < 0.001 for PCV, p < 0.001 for HA), and SF-12 (p < 0.001 for PCV, p < 0.001 for HA), with no difference between groups. Safety was optimal and no adverse events were reported.
CONCLUSIONS
The use of HA gel does not give additional benefits to those that are already provided by the moisturizing PCV.
Topics: Acrylic Resins; Atrophy; Female; Humans; Hyaluronic Acid; Menopause; Middle Aged; Postmenopause; Prospective Studies; Treatment Outcome; Vagina; Vaginal Creams, Foams, and Jellies; Vaginal Diseases; Vulva
PubMed: 35131532
DOI: 10.1016/j.ejogrb.2022.01.021 -
Nutrients Jun 2021Colostrum is the first secretion of mammalian glands during the early period after birth giving. Its components are biologically active and have beneficial effects on...
Colostrum is the first secretion of mammalian glands during the early period after birth giving. Its components are biologically active and have beneficial effects on new-born growth and well-being. Bovine colostrum has the highest concentration of these substances and its supplementation or application may provide health benefits. This systematic review was conducted to update current knowledge on bovine colostrum effects including all administration routes on healthy and sick subjects. Full texts or abstracts of twenty-eight papers as reports of systematic reviews, randomized controlled trials, observational studies and case series were included after searches in Medline, Embase, Cochrane Library and Cinahl databases. The full texts of selected studies were assessed for quality using validated tools and their results were summarized in different categories. Studies were highly heterogeneous as regards to population, intervention, outcome and risk of bias. Bovine colostrum topical application was shown effective on vaginal dryness related symptoms limitation. Its use as food supplement showed interesting effects preventing upper respiratory illness in sportsmen, modulating immune system response and reducing intestinal permeability in healthy and sick subjects. Conflicting results were provided in pediatric population and little evidence is available on its use with older adults. Further studies are mandatory to better understand all factors influencing its activity.
Topics: Adult; Aged; Animals; Cattle; Child; Colostrum; Dietary Supplements; Female; Humans; Male; Nutritional Physiological Phenomena; Pregnancy
PubMed: 34202206
DOI: 10.3390/nu13072194 -
Cureus Jun 2023Introduction The use of virgin coconut oil (VCO) as an over-the-counter (OTC) treatment for vaginal dryness and dyspareunia (VDD) in the general population has increased...
Virgin Coconut Oil in Paste Form as Treatment for Dyspareunia and Vaginal Dryness in Patients With and Without Rheumatic Autoimmune Diseases: An Efficacy and Safety Assessment Pilot Study.
Introduction The use of virgin coconut oil (VCO) as an over-the-counter (OTC) treatment for vaginal dryness and dyspareunia (VDD) in the general population has increased worldwide despite the absence of evidence-based studies supporting its efficacy. The principal objective of our pilot study was to scientifically validate the significant benefits and safety of using intra- and peri-vaginal application of VCO in paste form (VCOPF) for the treatment of VDD in patients with and without rheumatic autoimmune diseases (RAD). Additionally, multiple psychosocial, sexuality, and disease activity variables were also assessed. Methods A survey study of patients with chronic VDD, with and without RAD, treated with a single proprietary brand of VCOPF via the 'CocoRelief' protocol continuously for at least six months in an outpatient rheumatology practice setting. We evaluated the comparison of group characteristics, treatment outcomes, and satisfaction questions by Fisher's exact test or chi-square test for independence for categorical variables and two-sample t-tests for continuous variables. Results Of the 53 respondents, 31 (58%) had an RAD and 22 (42%) did not. Rheumatoid arthritis and primary Sjogren's syndrome comprised 75% of the RAD group. The non-RAD cohort had both a higher baseline mean of intercourse pain (on a scale of 0-5) before VCOPF use (4.4 (SD 1.1) vs 3.9 (SD 1.0) (p = 0.094)) and a higher mean intercourse pain after VCOPF (2.0 (SD 1.3) vs 1.3 (SD 1.1) (p = 0.039)). VDD decreased by 55% in the non-RAD and 66% in the RAD population. Although not statistically significant (p = 0.195), VCOPF was at worst comparable to estrogen-containing therapies (ECT). No adverse events (AE) were documented. Conclusion A high percentage of women with VDD, with and without RAD, needlessly continue to experience quality-of-life-altering physical and psychosocial morbidity due to the underutilization and lack of awareness of VCO-containing therapy. The small sample size, non-blinded, non-randomized, pilot platform, and the use of a non-validated assessment tool represent the principal limiting factors. This study revealed that VCOPF, when used in paste form via the CocoRelief protocol, provided statistically significant long-term VDD-related efficacy not inferior to ECT without AE in patients with and without RAD. VCOPF is, therefore, likely to be a useful, cost-effective alternative in a substantial percentage of patients with and without RAD, particularly in women hesitant to utilize ECT due to cost and/or fear of adverse effects.
PubMed: 37461787
DOI: 10.7759/cureus.40501 -
Diagnostics (Basel, Switzerland) Feb 2022None of the currently available parameters allow for a direct and objective measurement of vaginal moisture. We used a calibrated filter paper strip as a measurement...
None of the currently available parameters allow for a direct and objective measurement of vaginal moisture. We used a calibrated filter paper strip as a measurement tool for the quantification of vaginal fluid, in a similar manner as the ophthalmic “Schirmer test” (used for eye moisture measurement). The study aimed to evaluate the validity of this new, objective tool, to measure vaginal moisture. We compared vaginal moisture measurements using the “modified Schirmer test” in symptomatic women with genitourinary syndrome of menopause to those of women without vaginal dryness. The mean “modified Schirmer test” measurement in the control group was 21.7 mm compared to 3.3 mm in the study group, yielding a statistically significant difference (p < 0.001). Strong correlations were found between “modified Schirmer test” measurements and pH (correlation coefficient −0.714), Vaginal Health Index [VHI (0.775)], and Visual Analogue Score (VAS) of dryness during intercourse (−0.821). Our findings suggest that the “modified Schirmer test” can be used as an objective measurement for the assessment of vaginal fluid level. This test may also prove useful for evaluation of non-hormonal treatments aimed to treat vaginal dryness.
PubMed: 35328126
DOI: 10.3390/diagnostics12030574 -
Urology Journal Apr 2022To study the effect of female sexual abnormalities on the etiology of penile fracture, which is an important urological emergency.
PURPOSE
To study the effect of female sexual abnormalities on the etiology of penile fracture, which is an important urological emergency.
MATERIALS AND METHODS
The sexual function of the partners of patients with penile fracture (study group, n = 90) treated at our clinic and healthy women (control group, n = 90) were evaluated on a voluntary basis. In both groups, sexual function was evaluated with the Female Sexual Function Index (FSFI). Each substance of the FSFI was evaluated separately by comparing both groups and the effect on the development of penile fracture was investigated.
RESULTS
There was no difference in demographic and clinical characteristics between the study and control groups. Evaluation of sexual function with FSFI revealed that the scores of vaginal lubrication, orgasm, satisfaction, and pain subscales were lower in the study group (p < .001). Among these subscales, anorgasmia was determined as the factor with the largest effect on the development of penile fracture (OR = 7.333, 95% CI = 2.666-20.166, p < .001). No correlation was found between the largest dimension of penile fracture and FSFI total and subscale scores in the study group.
CONCLUSION
We believe that female vaginal dryness and dyspareunia in particular are factors which could cause the development of penile fracture during sexual intercourse. The treatment could prevent the development of penile fracture in the male.
Topics: Coitus; Dyspareunia; Female; Humans; Male; Orgasm; Personal Satisfaction; Sexual Behavior; Surveys and Questionnaires
PubMed: 35398882
DOI: 10.22037/uj.v19i.6818 -
Bioengineering (Basel, Switzerland) Oct 2023Genitourinary syndrome of menopause (GSM) and vulvovaginal atrophy (VVA) are the most frequent menopause-related clinical entities and are consistently included in the...
INTRODUCTION
Genitourinary syndrome of menopause (GSM) and vulvovaginal atrophy (VVA) are the most frequent menopause-related clinical entities and are consistently included in the definition of pelvic floor disorders (PFDs). Nonhormonal therapies, such as lubricants and moisturizers, are indicated as first-line treatments, while the "gold standard'' is represented by topical estrogen products; however, in cancer survivors hormonal treatment is not indicated. For this reason, energy-based therapeutic approaches-for instance, through laser technologies-may be employed as alternative options in this kind of patient; however, there are no studies evaluating the efficacy of a pure diode vaginal laser in the treatment of GSM. As a consequence, with our study, we aimed to evaluate outpatient nonablative diode laser treatment in sexually active women, with contraindications, no response, or refusal of local estrogenic therapy.
METHODS
This prospective study included patients with GSM, aged ≥ 18 years old, with contraindications, or refusal of local estrogen therapies. Women were evaluated via the use of their Vaginal Health Index (VHI) scores, which consists of five measures: elasticity, fluid volume, pH, epithelial integrity, and moisture. Moreover, the intensity of VVA symptoms (vaginal burning, vaginal itching, vaginal dryness, dyspareunia, and dysuria) was measured using a 10 cm visual analog scale (VAS), where the left extreme of the scale (score = 0) indicated "absence of symptom" and the right indicated "symptom as bad as it could be" (score = 100). Sexual function was evaluated with the Female Sexual Function Index (FSFI-19) questionnaire. The treatment was performed using a Leonardo Dual diode laser (Biolitec Italia Srl, Milano, Italy). The laser treatment consisted of three sessions, one per month. One month after the third session, the VHI, symptom VAS, and FSFI-19 were re-evaluated. In addition, the Patient Global Impression of Improvement (PGI-I) questionnaire was collected.
RESULTS
Our study enrolled a total of 26 consecutive patients. All patients were either in menopause or under treatment with gonadotropin-releasing hormone (GnRH). None of the patients reported adverse effects after laser treatment. In total, 19 (73.1%) patients referred improvements of their symptoms according to PGI-I scores. All domains of the FSFI-19 questionnaire, significantly improved after the diode laser treatment. The mean VHI score increased by 3.2 points, from 12.2 to 15.4 ( < 0.001). Additionally, we documented a significant improvement in symptoms affecting the VAS score, from 69.2 to 43.5 points ( < 0.001).
CONCLUSION
A diode vaginal laser is an effective and easily tolerated ambulatory procedure for vaginal functional restoration in the treatment of GSM and VVA.
PubMed: 37892888
DOI: 10.3390/bioengineering10101158 -
Cancer Medicine Mar 2023To compare sexual functioning from diagnosis to 5 years post diagnosis among breast cancer survivors (BCS) and women without cancer (controls).
PURPOSE
To compare sexual functioning from diagnosis to 5 years post diagnosis among breast cancer survivors (BCS) and women without cancer (controls).
PATIENTS AND METHODS
Analyses included 118 BCS and 1765 controls from 20 years of the longitudinal Study of Women's Health Across the Nation (SWAN), a multiracial/ethnic cohort of mid-life women assessed approximately annually from 1995 to 2015. Pink SWAN participants reported no cancer at SWAN enrollment and developed (BCS) or did not develop (controls) incident breast cancer after enrollment. Outcomes included: being sexually active or not, intercourse frequency, sexual desire, vaginal dryness, and pain with intercourse. Using longitudinal logistic regression, we compared BCS and controls on prevalence of sexual functioning outcomes with respect to years since diagnosis. In addition, we examined whether menopause transition stage, depressive symptoms, relationship satisfaction, vaginal dryness, or pain with intercourse modified the relation between breast cancer and sexual functioning outcomes.
RESULTS
Adjusting for partner status, both BCS and controls reported similar declines over time in being sexually active, sexual intercourse frequency, and sexual desire. Among sexually active women, more BCS than controls consistently reported vaginal dryness with significant differences between 2 and 4 years post-diagnosis, and pain with intercourse, with statistically significant differences between 0.5 years post-diagnosis to 2 years post-diagnosis. Being post-menopausal and reporting depressive symptoms were significant effect modifiers for pain with intercourse with both variables having positive and stronger associations with pain among the controls than among BCS.
CONCLUSION
Except for more reporting of vaginal dryness and pain with intercourse among BCS, negative changes in sexual function during mid-life were similar in those with and without breast cancer.
Topics: Female; Humans; Breast Neoplasms; Longitudinal Studies; Cancer Survivors; Surveys and Questionnaires; Pain
PubMed: 36440508
DOI: 10.1002/cam4.5433 -
The Journal of Sexual Medicine Oct 2021Tools for diagnosing sexual dysfunction and for tracking outcomes of interest include clinician interviews, physical exam, and patient self-report. Limited work has... (Clinical Trial)
Clinical Trial
BACKGROUND
Tools for diagnosing sexual dysfunction and for tracking outcomes of interest include clinician interviews, physical exam, and patient self-report. Limited work has described relationships among these three sources of information regarding female sexual dysfunction and vulvovaginal health.
AIM
We describe correlations among data collected from clinician interviews, clinical gynecological examination, and patient self-report.
METHODS
Data are from a single-site, single-arm, prospective trial in 100 postmenopausal patients with a history of breast or endometrial cancer who sought treatment for vulvovaginal symptoms. The trial collected a standardized clinical gynecologic exam, clinician-reported outcome (ClinRO) measures of vulvovaginal dryness and pain, and patient-reported outcome (PRO) measures of sexual function, including PROMIS Sexual Function and Satisfaction (SexFS) lubrication, vaginal discomfort, labial discomfort, and clitoral discomfort and Female Sexual Function Index (FSFI) lubrication and pain. We examined polyserial correlations between measures with bootstrapped 95% confidence intervals from the baseline and 12-14-week timepoints.
RESULTS
All of the relationships between the ClinRO variables and the PRO variables were in the expected direction (ie, positive), but the strength of the relationships varied substantially. At 12-14 weeks, there were medium-to-large correlations between ClinRO vaginal dryness and SexFS Lubrication (0.64), ClinRO vulvar dryness and SexFS Lubrication (0.46), ClinRO vulvar discomfort and SexFS Labial Discomfort (0.70), and ClinRO vulvar discomfort and SexFS Clitoral Discomfort (0.43). With one exception, the correlations between the exam variables and the corresponding PRO scores were small (range 0.01-0.27).
STRENGTHS & LIMITATIONS
Our study included a comprehensive, standardized gynecologic exam designed specifically to evaluate sexual dysfunction as well as established PRO measures with significant evidence for validity. A limitation of our findings is that the sample size was relatively small, and our sample was restricted to women who received cancer treatments known to have dramatic effects on vulvovaginal tissue quality.
CONCLUSION
Patient- and clinician-reported vulvovaginal dryness and discomfort were moderately correlated with each other but not with clinical gynecologic exam findings. Understanding the relationships among these different types of data highlights the distinct contributions of each to understand vulvovaginal tissue quality and patient sexual function after cancer. Flynn KE, Lin L, Carter J, et al. Correspondence Between Clinician Ratings of Vulvovaginal Health and Patient-Reported Sexual Function After Cancer. J Sex Med 2021;18:1768-1774.
Topics: Female; Humans; Neoplasms; Patient Reported Outcome Measures; Prospective Studies; Self Report; Sexual Dysfunction, Physiological; Vulvodynia
PubMed: 34446376
DOI: 10.1016/j.jsxm.2021.07.011 -
Maturitas Aug 2022To evaluate whether single measurements of serum estradiol (E), estrone (E) and sex hormone-binding globulin (SHBG) concentration distinguishes between women with and... (Clinical Trial)
Clinical Trial
OBJECTIVES
To evaluate whether single measurements of serum estradiol (E), estrone (E) and sex hormone-binding globulin (SHBG) concentration distinguishes between women with and without menopausal symptom bother.
STUDY DESIGN
We analyzed baseline data from two clinical trials conducted in 2012-2017: MsFLASH 03 (178 peri-/post-menopausal women aged 40-62 years with bothersome vasomotor symptoms, mean age 54) and MsFLASH 05 (181 post-menopausal women aged 45-70 years with moderate-to-severe vulvovaginal symptoms, mean age 61).
MAIN OUTCOME MEASURES
Symptom bother (hot flushes or flashes, night sweats, sweating, aching in muscles and joints, change in sexual desire, vaginal dryness during intercourse, and avoiding intimacy) in the past month was assessed using the Menopause-Specific Quality of Life questionnaire. Using logistic regression, we calculated the area under the receiver operating characteristic curve (AUC) values for E, E, and SHBG concentration in relation to being at least somewhat bothered (symptom bother score ≥3) by each symptom within each trial study population.
RESULTS
AUC values (95% confidence interval) ranged between 0.51 (0.41-0.60) and 0.62 (0.53, 0.72) for MsFLASH 03 and between 0.51 (0.42, 0.59) and 0.64 (0.53, 0.75) for MsFLASH 05. There was little evidence of associations between serum hormone levels and bother by a given menopausal symptom.
CONCLUSION
These findings do not support the clinical utility of a single measurement of serum of E, E, or SHBG concentrations in differentiating between women who are bothered by a given menopausal symptom and those who are not.
Topics: Aged; Estrogens; Female; Hot Flashes; Humans; Menopause; Postmenopause; Quality of Life; Sweating
PubMed: 35489132
DOI: 10.1016/j.maturitas.2022.04.003 -
Lasers in Surgery and Medicine Jul 2021Genitourinary syndrome of menopause (GSM) is a common condition affecting of most postmenopausal women, which greatly impacks the quality of life,and need to treat. This...
BACKGROUND AND OBJECTIVES
Genitourinary syndrome of menopause (GSM) is a common condition affecting of most postmenopausal women, which greatly impacks the quality of life,and need to treat. This prospective multicenter cohort study aimed to compare the efficacy and safety of the fractional carbon dioxide (CO ) laser with that of topical estrogen for vaginal treatment and relieving symptoms of genitourinary syndrome of menopause (GSM).
STUDY DESIGN/MATERIALS AND METHODS
This study included 162 postmenopausal patients who received vaginal laser or topical Estriol cream therapy between January 2017 and May 2019 at eight study centers in China. The degree of GSM-related symptoms (vaginal burning, dryness, and dyspareunia) was evaluated using the Vaginal Health Index score (VHIS) and Visual Analog Scale (VAS) at baseline, 1, 3, 6, and 12 months posttreatment. The primary endpoint was the improvement in vaginal burning, dryness, and dyspareunia at 6 months after treatment. Multivariate logistic regression was used to compare the rate of improvement in the two groups.
RESULTS
At baseline, the laser and control groups showed no significant difference in the mean age, time after menopause, and the VHIS (all P > 0.05). In the laser group, compared with baseline, significant differences were seen in the VHIS after the first or second treatment session and at 1, 3, 6, and 12 months posttreatment (P < 0.01). In the control group, compared with baseline, the VHIS showed significant differences after 1, 3, and 6 months of treatment (P < 0.05). However, there was no significant difference after 3 and 6 months of follow-up between the two groups (P > 0.05). The VHIS scores were significantly higher after 1 month (16.63 ± 2.79 vs. 15.57 ± 2.43) and 12 months (15.72 ± 2.59 vs. 12.12 ± 4.08) of treatment in both the groups (P < 0.05). At 6 months after treatment, both groups showed improvement in vaginal burning, vaginal dryness, and dyspareunia (P > 0.05). The VAS findings at 6 months posttreatment were significantly different when compared with the pretreatment findings (P < 0.001). There were no significant adverse effects in the two groups.
CONCLUSIONS
Fractional CO laser vaginal treatment could be a safe and effective option for treating symptoms of GSM, including vaginal burning, dryness, and dyspareunia. The improvement in symptoms was comparable with that seen with topical estrogen therapy and lasted for at least 6-12 months posttreatment. Lasers Surg. Med. © 2020 Wiley Periodicals LLC.
Topics: Atrophy; Carbon Dioxide; Cohort Studies; Female; Humans; Lasers, Gas; Menopause; Prospective Studies; Quality of Life; Treatment Outcome; Vagina
PubMed: 33211334
DOI: 10.1002/lsm.23346