LASER treatment in gynaecology -A randomized controlled trial in women with symptomatic lichen sclerosus.

OBJECTIVE: Aim of our study was to evaluate the therapeutic effect of laser treatment in vulvar lichen sclerosus, mainly the reduction of existing symptoms as itching, burning and pain. We asked about the different outcome by using different application doses. STUDY DESIGN: We conducted a prospective randomized double-blind dose-controlled trial in our dysplasia unit specializing vulvar disorders. 67patients with active LS were included. LS was confirmed by biopsy or by the validated CSS (clinical scoring system of vulvar LS). Computer generated randomization resulted in two groups, each group received a different application dose.(LDG- low dose group, NDG- normal dose group) During the study period of 18 weeks all participants received three laser applications in three subsequent sessions of three weeks. Two follow-ups six and twelve weeks after the first application was performed. At every visit, the participants filled in the VAS (visual analogue scale) for recording the actual vulvar symptoms as itching burning or pain on a range from 0 to 10. RESULTS: Before treatment the mean VAS-Score was 4.3 (STD ± 2.4) in the NDG and 5.1(±2.6) in the LDG. After 18 weeks, the mean reduction was -2.4 (±2.3) for NDG and -2.7 (±2.8) for LDG. Four patients (two of each group) reported more pain after than before treatment. Both groups show significant lower VAS-Scores 18 weeks after the treatment than before therapy (p < 0.0001). The reduction of symptoms after 18 weeks between NDG and LDG was not significant (p = 0.6244). CONCLUSION: Laser treatment with the microablative CO2 laser leads to a significant improvement for symptoms of LS. A higher dosage of laser radiation shows no benefit concerning the symptoms. We have not observed any serious adverse events during this study.

Efficacy of topical progesterone versus topical clobetasol propionate in patients with vulvar Lichen sclerosus - A double-blind randomized phase II pilot study.

BACKGROUND: Lichen sclerosus (LS) is a chronic inflammatory skin disease that mostly affects the anogenital region of women and lowers patients' quality of life. Current standard treatment of LS is topical steroids. OBJECTIVE: To evaluate the efficacy of topical progesterone 8% ointment and compare to standard therapy with topical clobetasol propionate 0.05% in premenopausal women presenting with previously untreated early onset LS. STUDY DESIGN: Randomized, double-blind, 2-arm, single center superiority trial in premenopausal women with histologically confirmed vulvar LS who were randomized in a 1:1 ratio to receive clobetasol propionate 0.05% ointment or progesterone 8% ointment. The primary outcome was the clinical severity LS score after 12 weeks, which consists of six clinical features assessed by the physician. Secondary outcomes were the symptom severity LS score, which consists of three symptoms rated by the patient, the Short Form SF-12 physical and mental health scores, and adverse events. Response to medication was assessed by biopsy at the end of the treatment to evaluate inflammatory parameters. RESULTS: Overall, 105 women were screened, 102 underwent vulvar biopsy and 37 received a histologically confirmed diagnosis of LS and were randomized: 17 to progesterone and 20 to clobetasol propionate. At 12 weeks, the mean clinical LS scores improved from 4.6 (SD 2.0) to 4.5 (SD 1.7) in the progesterone arm, and from 4.6 (SD 2.8) to 2.9 (SD 2.2) in the clobetasol propionate arm (difference in favor of clobetasol 1.61; 95% CI 0.44 to 2.77, p = 0.009), and the mean symptom severity LS scores improved from 4.5 (SD 3.8) to 3.1 (SD 3.0) in the progesterone arm, and from 4.7 (SD 2.8) to 1.9 (SD 1.8) in the clobetasol propionate arm (difference in favor of clobetasol 1.32; 95% CI -0.25 to 2.89, p = 0.095). LS was in complete remission in 6 out of 10 patients (60%) with available biopsy in the progesterone arm, and in 13 out of 16 patients (81.3%) in the clobetasol propionate arm (odds ratio in favor of clobetasol 0.35; 95% CI 0.06 to 2.06, p = 0.234). No drug-related serious adverse event occurred during the trial. CONCLUSIONS: Topical progesterone 8% ointment is inferior to standard therapy with topical clobetasol propionate 0.05% in previously untreated premenopausal women with vulvar LS after 12 weeks treatment.

Group B streptococcal colonization in elderly women.

BACKGROUND: In non-pregnant adults, the incidence of invasive Group B Streptococcus (GBS) disease is continuously increasing. Elderly and immunocompromised persons are at increased risk of infection. GBS commonly colonizes the vaginal tract, though data on colonization in the elderly are scarce. It is unknown whether the prevalence of GBS colonization is increasing in parallel to the observed rise of invasive infection. We conducted a three-year (2017-2019) prospective observational cross-sectional study in two teaching hospitals in Switzerland to determine the rate of GBS vaginal colonization in women over 60 years and i) to compare the proportions of known risk factors associated with invasive GBS diseases in colonized versus non-colonized women and ii) to evaluate the presence of GBS clusters with specific phenotypic and genotypic patterns in this population. METHODS: GBS screening was performed by using vaginal swabs collected during routine examination from women willing to participate in the study and to complete a questionnaire for risk factors. Isolates were characterized for antibiotic resistance profile, serotype and sequence type (ST). RESULTS: The GBS positivity rate in the elderly was 17% (44/255 positive samples), and similar to the one previously reported in pregnant women (around 20%). We could not find any association between participants' characteristics, previously published risk factors and GBS colonization. All strains were susceptible to penicillin, 22% (8/36) were not susceptible to erythromycin, 14% (5/36) were not susceptible to clindamycin and 8% (3/36) showed inducible clindamycin resistance. Both M and L phenotypes were each detected in one isolate. The most prevalent serotypes were III (33%, 12/36) and V (31%, 11/36). ST1 and ST19 accounted for 11% of isolates each (4/36); ST175 for 8% (3/36); and ST23, ST249 and ST297 for 6% each (2/36). Significantly higher rates of resistance to macrolides and clindamycin were associated with the ST1 genetic background of ST1. CONCLUSIONS: Our findings indicate a similar colonization rate for pregnant and elderly women. TRIAL REGISTRATION: Current Controlled Trial ISRCTN15468519 ; 06/01/2017.

[Management of Pelvic Inflammatory Disease]. / Diagnostik und Therapie der Adnexitis (Pelvic Inflammatory Disease).

Management of Pelvic Inflammatory Disease Abstract. Pelvic inflammatory disease (PID) is a common medical problem, but the diagnosis of PID can be challenging because the clinical manifestations may mimic those of other pelvic and abdominal processes. As PID might cause late complications such as infertility or chronic pelvic pain, it is of prime importance that the diagnosis of PID is made promptly to assure the early onset of an adequate antibiotic therapy. Where uncomplicated PID usually has a favorable course, complicated forms with tubo-ovarian abscess generally require surgical exploration.

Clinical scoring system for vulvar lichen sclerosus.

INTRODUCTION: Vulvar lichen sclerosus (LS) is a chronic inflammatory and mutilating disease, which goes often undetected for years. Advanced disease severely affects quality of life like sexual disorders and is also associated with an increased risk of vulvar cancer. AIM: To develop and validate a patient-administered symptom score and a physician-administered clinical score for the diagnosis and evaluation of vulvar LS. METHODS: We included 24 patients with established LS diagnosis and 49 with other vulvar disease. The physician-administered score was based on six clinical features and the patient-administered score was a symptom-based four-item composite score. We determined inter-item correlations and internal consistency of both scores, and estimated sensitivities, specificities, likelihood ratios, and posttest probabilities for different cutoffs of the physician-administered score. MAIN OUTCOME MEASURES: Characteristics of patients with and without LS were compared using χ(2) and unpaired t-test as required. We then determined Cronbach's alpha as a measure of the overall consistency of scores and calculated positive and negative likelihoods. RESULTS: Lack of redundancy of items (correlation coefficients < 0.90) and internal consistency (Cronbach's α ≥ 0.70) suggested that final composite scores were valid and yielded excellent power to rule in LS. CONCLUSION: Scores may be useful for assessing symptoms of vulvar disorders, to ease diagnosis of LS and to evaluate treatment response over time.

Off-label use of misoprostol for labor induction: a nation-wide survey in Switzerland.

OBJECTIVE: Off-label use of drugs is frequent in obstetrical practice. No data however are available about nation-wide off-label use in obstetrics regarding frequency and patient information. The objective of our study was to assess the clinical practice of off-label use of misoprostol for labor induction. STUDY DESIGN: We performed a prospective nation-wide survey study by means of a validated questionnaire in three languages in Switzerland. All registered obstetricians/gynaecologists in Switzerland were included. Of 1100 subjects, 725 (66%) answered the questionnaire; 69 subjects were excluded because they were not actively practicing OB/GYN, resulting in a total of 656 questionnaires included in the analysis. RESULTS: A total of 512 out of 656 obstetricians/gynaecologists (78%) use misoprostol for labor induction. The most frequent administration route of misoprostol is intravaginal (86%), in a single dose of 50µg (94%), at a dose interval range from 4 to 6h (85%). Among the users of misoprostol, 314 (61%) answered that they do not inform their patients about the off-label use of the medication. Among the non-users of misoprostol, the main reason for non-use is absent license for obstetric indications (48%) and non-availability (14%). If misoprostol were to be licensed for this indication, and commercially available, 69% of current non-users would use it. Non-users of misoprotol use prostaglandin E2 vaginal gel, ovules or slow-release vaginal insert, and oxytocin for labor induction. CONCLUSION: Misoprostol is the single most commonly used drug for labor induction in Switzerland, although it is not licensed and although there are effective, licensed alternative drugs available. A minority of practitioners inform the patients about the off-label use.

Out of Eastern Africa: defibulation and sexual function in woman with female genital mutilation.

INTRODUCTION: Female genital mutilation (FGM) is defined by the World Health Organization (WHO) as all procedures that involve partial or total removal of the female external genitalia and/or injury to the female genital organs for cultural or any other non-therapeutic reasons. AIM: Aim of this study was to determine sexual function before and after defibulation using a CO(2) laser in migrant women who had undergone FGM in the past. MAIN OUTCOME MEASURES: Female Sexual Function Index (FSFI) before and 6 months after defibulation. METHODS: Patients were asked to fill the FSFI before surgery and at 6 months follow-up. Defibulation took place under general anesthetic using a CO(2) laser. RESULTS: Eighteen patients underwent defibulation in a standardized manner and filled in the FSFI completely. Female sexual function improves after surgical defibulation in the domains desire, arousal, satisfaction, and pain whereas lubrification and orgasm remained unchanged. CONCLUSION: Defibulation using CO(2) laser may improve some aspects of sexual function in patients who undergo defibulation but not all.

Impact of hormone replacement therapy on the histologic subtype of breast cancer.

OBJECTIVE: Postmenopausal hormone replacement therapy (HRT) is associated with an increase in breast cancer risk, which correlates to the duration of HRT use. We wanted to investigate a possible association between HRT use and the risk of a histologic subtype of breast cancer. PATIENTS AND METHODS: From 1995 until 2004, 497 cases of primary ductal, lobular or ductulolobular breast cancer in postmenopausal women were diagnosed at the Department of Gynecology and Obstetrics, University Hospital Basel, Switzerland. The data was derived from patient's records. HRT ever use was defined as HRT use for > or =6 months. RESULTS: Of the 99 cases of lobular cancer 72.7% were invasive lobular cancers, 21.2% were invasive ductulolobular cancers and 6.1% were lobular cancers in situ. Of the 398 cases of ductal cancer, 90.5% were invasive ductal cancers and 9.5% were ductal cancers in situ. Totally 144 women were HRT ever users, and 341 women were HRT never users. HRT status could not be defined in 12 women. HRT ever use was associated with an increased risk for lobular cancer (OR 1.67; 95% CI 1.02-2.73). Also, menopause due to bilateral oophorectomy was associated with an increased risk for lobular cancer (OR 2.42; 95% CI 1.06-5.54). CONCLUSIONS: There is evidence that HRT as well as menopause due to bilateral oophorectomy may be associated with an increased risk for lobular cancer. This association is of major clinical relevance, since lobular breast cancer is more difficult to diagnose clinically and radiologically than ductal breast cancer.