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BMJ Open Jul 2021Menopause is a physiological and progressive phenomenon secondary to decreased ovarian follicular reserve. These changes have consequences: vaginal dryness, dyspareunia,...
INTRODUCTION
Menopause is a physiological and progressive phenomenon secondary to decreased ovarian follicular reserve. These changes have consequences: vaginal dryness, dyspareunia, discomfort, burning and irritation, vulvovaginal pruritus, dysuria and increased frequency of genitourinary infections. The therapy more suitable for vaginal symptoms in postmenopause yet is the use of a topical hormone. However, the prescription of topical oestrogens should also be avoided in women with a history of breast cancer, oestrogen-sensitive tumours and thromboembolism, emphasising the necessity of alternative treatments. Recently, physical methods, such as laser and radiofrequency (RF), in their non-ablative, ablative and microablative forms have been used in the vaginal mucosa to promote neocolagenesis and neoelastogenesis. This randomised study aims to compare the efficiency of microablative fractional RF (MAFRF) treatment with vaginal oestrogens and no treatment.
METHODS AND ANALYSES
This randomised, controlled clinical intervention trial with an open label design comparing the treatment of MAFRF with vaginal oestrogens and no treatment. Four important moments were considered to evaluate treatment results (T0, T1, T2 and T3). The primary outcome includes vulvovaginal atrophy (vaginal pain, burning, itching, dryness, dyspareunia and dysuria), and the secondary outcomes will be sexual function, vaginal health (epithelial integrity, vaginal elasticity, moisture, fluid volume and vaginal pH) and quality of life.
ETHICS AND DISSEMINATION
Due to the nature of the study, we obtained approval from the ethics committee. All participants must sign an informed consent form before randomisation. The results of this study will be published in peer-reviewed journals. The data collected will also be available in a public repository of data.
TRIAL REGISTRATION NUMBER
RBR-94DX93.
Topics: Atrophy; Dyspareunia; Female; Humans; Lasers, Gas; Menopause; Quality of Life; Randomized Controlled Trials as Topic; Vagina; Vaginal Diseases
PubMed: 34226218
DOI: 10.1136/bmjopen-2020-046372 -
Evidence-based Complementary and... 2021This survey was designed and conducted with an aim to present data on sexual desire and activity in Chinese women.
OBJECTIVE
This survey was designed and conducted with an aim to present data on sexual desire and activity in Chinese women.
METHODS
Between October 2013 and December 2013, we surveyed 3000 women (aged 40-65 years) at Beijing No. 2 Hospital and the Yuetan Community Health Service Center using a questionnaire. The primary outcomes included determination of sexual desire in the past 4 weeks, reasons for stopping sexual activity, and postmenopausal syndrome. The secondary outcome was determination of factors for low sexual desire.
RESULTS
A total of 2400 women (mean age 54.33 ± 6.25 years; mean menopausal age 50.11 ± 3.31 years) returned the questionnaire, with 58% of women reporting lowered sexual desire and 39.3% reporting stoppage of sexual activity. Compared with the postmenopausal group, the incidence of anxiety, depressive, somatic, and vasomotor symptoms was higher in the perimenopausal group. Muscle and joint pain (45.8%) and vaginal pruritus (21.5%) were the most commonly reported menopausal and vulvovaginal symptoms, respectively. The odds of decrease in sexual desire were significantly higher with older age, menopause, presence of gynecological disease, menopausal depression symptoms, menopausal vasomotor symptoms, and vulvovaginal atrophy; only cesarean delivery (odds ratio = 0.887, =0.018) was associated with lesser reduction in sexual desire compared with the aforementioned factors.
CONCLUSION
This survey showed that a high proportion of Chinese middle-aged and old women have lowered sexual desire and activity. Lack of sexual desire is associated with multiple factors and affects the quality of life of women.
PubMed: 34122604
DOI: 10.1155/2021/6649242 -
Journal of Pain Research 2021Compared to low concentrations of local anesthetics with opioids for labor epidural analgesia, very high concentrations of local anesthetics are associated with an...
A Systematic Review and Meta-Analysis of Randomized Controlled Trials of Labor Epidural Analgesia Using Moderately High Concentrations of Plain Local Anesthetics versus Low Concentrations of Local Anesthetics with Opioids.
PURPOSE
Compared to low concentrations of local anesthetics with opioids for labor epidural analgesia, very high concentrations of local anesthetics are associated with an increased risk of assisted vaginal delivery. We aimed to investigate if moderately high concentrations of plain local anesthetics are also associated with this risk.
METHODS
We searched for published randomized controlled trials that compared moderately high concentrations of plain local anesthetics (>0.1% but ≤0.125% bupivacaine, >0.1% but ≤0.125% levobupivacaine, or >0.17% but ≤0.2% ropivacaine) to low concentrations of local anesthetics (≤0.1% bupivacaine, ≤0.1% levobupivacaine, or ≤0.17% ropivacaine) with opioids for labor analgesia. Meta-analyses were performed to compare the risk of assisted vaginal delivery and other perinatal outcomes between these two groups.
RESULTS
We identified nine randomized controlled trials with a total of 1334 participants. Meta-analysis of these nine trials showed no differences in the risks of assisted vaginal delivery (odds ratio [OR] = 1.18; 95% confidence interval [CI], 0.93-1.49) or Cesarean delivery (OR = 0.96; 95% CI, 0.71-1.29) between the two groups. The incidence of motor block was higher in the group of moderately high concentrations (OR = 4.05; 95% CI, 2.19-7.48), while the incidence of pruritus was lower (OR = 0.07; 95% CI, 0.03-0.16).
CONCLUSION
This systematic review and meta-analysis suggests that the current evidence is inadequate to support that moderately high concentrations of plain local anesthetics increase the risk of assisted vaginal delivery compared to low concentrations of local anesthetics with opioids.
PubMed: 34054305
DOI: 10.2147/JPR.S305838 -
The Journal of International Medical... May 2021To assess the efficacy, acceptability, and tolerability of a vaginal cream based on plant extracts for treating signs and symptoms of vulvovaginitis (VV) (Zelesse... (Observational Study)
Observational Study
OBJECTIVE
To assess the efficacy, acceptability, and tolerability of a vaginal cream based on plant extracts for treating signs and symptoms of vulvovaginitis (VV) (Zelesse cream®), either as monotherapy (non-infectious VV) or adjuvant to antimicrobial therapy (infectious VV).
METHODS
This prospective, observational, multicenter study included women who attended outpatient offices for VV. The severity of signs (vaginal discharge, erythema, and edema) and symptoms (pruritus, burning, and dysuria) was assessed before and after 15±5 days of daily treatment with Zelesse cream on a 4-point scale (18-point global score).
RESULTS
The study included 58 women aged 43.0±13.2 years, including 42 who were treated with Zelesse cream only and 16 who used Zelesse cream as adjuvant to antimicrobial therapy. All participants showed significantly reduced scores and absolute prevalence of individual signs and symptoms in both groups. Similarly, the median signs/symptoms decreased by 4.0 and 8.0 points in women using Zelesse only and those using Zelesse plus antimicrobial therapy, respectively. This product was well tolerated and had high acceptability.
CONCLUSIONS
Zelesse cream relieves signs and symptoms of VV, either as monotherapy in non-infectious VV or as adjuvant to antimicrobial therapy in infectious VV. Future randomized, placebo-controlled trials with larger sample sizes are warranted.
Topics: Administration, Intravaginal; Adult; Female; Humans; Middle Aged; Ointments; Prospective Studies; Treatment Outcome; Vaginal Creams, Foams, and Jellies; Vulvovaginitis
PubMed: 33983051
DOI: 10.1177/03000605211013226 -
Obstetrics and Gynecology Jun 2021To evaluate the histologic response rate of high-grade squamous intraepithelial lesions (HSIL) of the cervix after topical application of 5% imiquimod cream. (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
To evaluate the histologic response rate of high-grade squamous intraepithelial lesions (HSIL) of the cervix after topical application of 5% imiquimod cream.
METHODS
In this phase II trial, women with cervical HSIL (cervical intraepithelial neoplasia [CIN] 2-3) were randomly assigned to 250 mg of 5% imiquimod cream applied to the cervix weekly for 12 weeks, followed by loop electrosurgical excision procedure (LEEP) without preceding treatment. The sample size was calculated based on the HSIL regression rates previously reported by Grimm et al. The primary outcome was rate of histologic regression (to CIN 1 or less) in LEEP specimens. Prespecified secondary endpoints included surgical margin status and adverse events. Outcomes were stratified by human papillomavirus type and lesion grade (CIN 2 or CIN 3). Results were reported according to per protocol (PP) and intention-to-treat (ITT) analyses.
RESULTS
Ninety women were enrolled: 49 in the experimental group and 41 in the control group. In the PP population, histologic regression was observed in 23 of 38 participants (61%) in the experimental group compared with 9 of 40 (23%) in the control group (P=.001). Surgical margins were negative for HSIL in 36 of 38 participants (95%) in the experimental group and 28 of 40 (70%) in the control group (P=.004). In the ITT population, rates of histologic regression also were significantly higher in the experimental group. Rates of adverse events in the experimental group were 74% (28/38) in the PP population and 78% (35/45) in the ITT population. Adverse events were mild, with abdominal pain being the most common. Three patients in the experimental group had grade 2 adverse events, including vaginal ulcer, vaginal pruritus with local edema, and moderate pelvic pain.
CONCLUSION
Weekly topical treatment with imiquimod is effective in promoting regression of cervical HSIL.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, NCT03233412.
Topics: Administration, Topical; Adult; Antineoplastic Agents; Combined Modality Therapy; Electrosurgery; Female; Humans; Imiquimod; Intention to Treat Analysis; Margins of Excision; Middle Aged; Neoplasm Grading; Papillomavirus Infections; Squamous Intraepithelial Lesions of the Cervix; Uterine Cervical Neoplasms; Young Adult; Uterine Cervical Dysplasia
PubMed: 33957649
DOI: 10.1097/AOG.0000000000004384 -
Gels (Basel, Switzerland) Jan 2021Condyloma acuminata is an infectious disease caused by the human papilloma virus (HPV) and one of the most common sexually transmitted infections. It is manifested as...
Condyloma acuminata is an infectious disease caused by the human papilloma virus (HPV) and one of the most common sexually transmitted infections. It is manifested as warts that frequently cause pain, pruritus, burning, and occasional bleeding. Treatment (physical, chemical, or surgical) can result in erosion, scars, or ulcers, implying inflammatory processes causing pain. In this work, a biocompatible topical hydrogel containing 2% ketorolac tromethamine was developed to manage the painful inflammatory processes occurring upon the removal of anogenital condylomas. The hydrogel was physically, mechanically, and morphologically characterized: it showed adequate characteristics for a topical formulation. Up to 73% of ketorolac in the gel can be released following a one-phase exponential model. Upon application on human skin and vaginal mucosa, ketorolac can permeate through both of these and it can be retained within both tissues, particularly on vaginal mucosa. Another advantage is that no systemic side effects should be expected after application of the gel. The hydrogel showed itself to be well tolerated in vivo when applied on humans, and it did not cause any visible irritation. Finally, ketorolac hydrogel showed 53% anti-inflammatory activity, suggesting that it is a stable and suitable formulation for the treatment of inflammatory processes, such as those occurring upon chemical or surgical removal of anogenital warts.
PubMed: 33498627
DOI: 10.3390/gels7010008 -
Case Reports in Women's Health Oct 2020A 31-year-old woman, gravida 3 para 1, at 10 weeks of gestation presented to a vulvar specialty clinic with a 6-month history of vulvar pruritus that had not responded...
A 31-year-old woman, gravida 3 para 1, at 10 weeks of gestation presented to a vulvar specialty clinic with a 6-month history of vulvar pruritus that had not responded to the treatment prescribed by her referring gynecologist. Examination was consistent with vaginitis and vulvar lichen simplex chronicus. Fungal cultures ultimately revealed and . The organisms were eradicated with oral fluconazole and intravaginal terazole. Few cases of isolation of in humans have been reported. Both immunosupressed and immuno-competent hosts have been identified, with the most common sites of isolation being the genitourinary and gastrointestinal tracts. Asymptomatic colonization and superficial disease have been noted; no invasive cases of have been described. Even fewer cases of infection during pregnancy have been reported, and symptomatic vulvovaginal disease has been described only once prior to this case report.
PubMed: 32983910
DOI: 10.1016/j.crwh.2020.e00254 -
Acta Obstetricia Et Gynecologica... Feb 2021Intrahepatic cholestasis of pregnancy (ICP) is a pregnancy-specific liver disease characterized by pruritus and abnormal liver function tests and it has been associated... (Comparative Study)
Comparative Study
INTRODUCTION
Intrahepatic cholestasis of pregnancy (ICP) is a pregnancy-specific liver disease characterized by pruritus and abnormal liver function tests and it has been associated with intrauterine fetal distress and stillbirth. We compared two guidelines of the management of ICP: one mandating induction at 38 weeks of gestation (Rigshospitalet and Hvidovre Hospital before 2012) and another separating ICP into mild and severe forms, and only women with severe ICP were recommended for induction at 38 weeks (Hvidovre Hospital after 2012).
MATERIAL AND METHODS
We performed a historical cohort study at two Copenhagen Hospitals from 2004 to 2015. We included 62 937 women with singleton deliveries at Rigshospitalet and 71 015 at Hvidovre Hospital, of whom 971 women (1.5%) and 998 women (1.4%) were diagnosed with ICP at Rigshospitalet and Hvidovre Hospital, respectively. Data were retrieved from a local medical database. For the analysis of induction and comparison of obstetrical outcomes we only included pregnancies with an ICP diagnosis and excluded women with other medical conditions that could mandate induction. Main outcome measures were induction and cesarean section rates, asphyxia and stillbirth.
RESULTS
We found no changes in the rate of spontaneous labor, cesarean section and induction over the years at Rigshospitalet (P = .17) and Hvidovre Hospital (P = .38). For women with intended vaginal delivery we found no change in the final mode of delivery over the years at Rigshospitalet (P = .28) and Hvidovre Hospital (P = .57).
CONCLUSIONS
The two approaches to the management of mild ICP regarding the timing of induction are comparable. Women with mild ICP and their clinicians should be encouraged to engage in shared decision-making when discussing timing of induction.
Topics: Adult; Asphyxia Neonatorum; Cesarean Section; Cholestasis, Intrahepatic; Cohort Studies; Delivery, Obstetric; Denmark; Female; Humans; Labor, Induced; Practice Guidelines as Topic; Pregnancy; Pregnancy Complications; Severity of Illness Index; Stillbirth
PubMed: 32970824
DOI: 10.1111/aogs.13998 -
European Review For Medical and... Jul 2020The aim of the study is to evaluate the efficacy and safety of hydroxytyrosol for the prevention of the vulvar vaginal candida infections recurrence. (Observational Study)
Observational Study
Efficacy and safety of oral administration of a product based on hydroxytyrosol as preventive therapy for recurrent vulvo-vaginal candidosis: a prospective observational pilot study.
OBJECTIVE
The aim of the study is to evaluate the efficacy and safety of hydroxytyrosol for the prevention of the vulvar vaginal candida infections recurrence.
PATIENTS AND METHODS
This study is a prospective observational pilot study. Eligible subjects were at least 18 years old, with at least 4 documented episodes of vulvovaginal candidiasis in the last 12 months. Patients were instructed to therapy (2 tabs daily for the first month and then 1 tab daily for 2 other months). Each capsule consists of hydroxytyrosol (HT) and other components: tea tree oil, tabebuia, juglans regia, and copper. Clinical and microbiological assessments took place at baseline and 12 weeks after. The impact on Quality of Life (QoL) was evaluated with the SF-36 and the Patient Global Impression of Improvement (PGI-I) after 3 months of treatment was calculated.
RESULTS
Sixty patients were enrolled in the study. In the last 1 year the mean number of previous infections was 5.83 ± 2.76. Forty-nine patients (83%) did not have candida episodes during 3 months of treatment. A significant reduction in clinical symptoms, vaginal signs, such as pruritus, burning and vulvar erythema (< 0.0001). The SF-36 showed a significant change (55.67±8.43 vs. 84.56±11.56, p < 0.0001) and the total success at PGI-I was reported in 54 patients (90%).
CONCLUSIONS
The HT-based product is effective and safe in preventing recurrent candida episodes and improves the quality of life and sexual function of treated women.
Topics: Administration, Oral; Adult; Antifungal Agents; Candidiasis, Vulvovaginal; Copper; Drug Combinations; Female; Humans; Middle Aged; Phenylethyl Alcohol; Pilot Projects; Plant Extracts; Prospective Studies; Quality of Life; Reinfection; Sexual Behavior; Time Factors; Treatment Outcome
PubMed: 32706082
DOI: 10.26355/eurrev_202007_21911 -
Contraception: X 2020The objective was to evaluate the contraceptive effectiveness, safety, and acceptability of a novel vaginal pH regulator over seven cycles of use.
OBJECTIVE
The objective was to evaluate the contraceptive effectiveness, safety, and acceptability of a novel vaginal pH regulator over seven cycles of use.
STUDY DESIGN
A single-arm, open-label, phase 3 study was conducted across 112 sites in the United States in sexually active 18-35-year-old women at risk of pregnancy. Women administered the study treatment ≤ 1 h before each episode of intercourse. Women recorded use of study drug, coital information, and any symptoms experienced in electronic diaries. The primary outcome was the seven-cycle cumulative pregnancy rate as calculated using the Kaplan-Meier methodology; secondary outcomes included safety. Overall satisfaction was assessed via written questionnaires.
RESULTS
A total of 1384 women were enrolled in the study from July 2017 to November 2018. Mean age was 27.7 ± 4.4 years; most women were white (69.0%). The seven-cycle cumulative pregnancy percentage was 13.7% [95% confidence interval (CI): 10.0%-17.5%], meeting the prespecified primary endpoint of having the upper bound 95% CI ≤ 21%. Most common adverse events (AEs) occurring in ≥ 2% of women were vulvovaginal burning sensation, vulvovaginal pruritus, urinary tract infection, vulvovaginal pain, mycotic infection, bacterial vaginosis, and nasopharyngitis. Of 1330 women who used the study drug at least once, fewer than 2% of women discontinued due to any AEs, and < 1% of women discontinued due to genitourinary symptoms. Overall, > 80% of women reported being "very satisfied" or "satisfied" with study treatment.
CONCLUSIONS
In this phase 3 study, the novel vaginal pH regulator demonstrated 86.3% contraceptive effectiveness, was safe and well tolerated, and was highly acceptable.
IMPLICATIONS
This novel vaginal pH regulator is a safe, nonhormonal, woman-controlled method of contraception that expands women's options.
PubMed: 32685920
DOI: 10.1016/j.conx.2020.100031