Linguistic validation and cognitive assessment of the French version of the Acute Cystitis Symptom Score questionnaire.

INTRODUCTION: The Acute Cystitis Symptom Score (ACSS) questionnaire first developed in Russian and Uzbek languages and now available in many other languages can be used for clinical diagnostics and patient-reported outcome (PRO) in female patients with acute uncomplicated cystitis (AUC). The aim of the current study was the linguistic validation and cognitive assessment of the French version of the ACSS questionnaire according to internationally accepted guidelines. METHODS: After two forward translations from Russian into the French language and backward translation into Russian and Uzbek, the two original languages, the scientific committee (SC) performed a slightly adapted French version, which finally was cognitively assessed by female subjects with different ages and educational levels and medical professionals, such as nurses, physicians, and pharmacists. RESULTS: All comments of the female subjects and professionals were discussed within the SC and after slight, but necessary adaptations, the SC agreed on the final study version of the French ACSS. CONCLUSION: Now, the linguistically validated and cognitively assessed French version of the ACSS can be used for clinical studies and practice.

[Ten questions about bacterial vaginosis]. / La vaginose bactérienne en 10 questions.

The physiopathology of bacterial vaginosis (BV), the ultimate stage of vaginal dysbiosis, has benefited from recent advances in molecular biology, highlighting, among others, the important role of A. vaginae. Certain immunological specificities (variants of TLR4, elevation of IL-1ß, for example) explain the variations in the prevalence of this infection, the poor clinical and cellular inflammatory response and the promoting influence of BV on the acquisition and progression of some sexually transmitted infections. These advances do not fully elucidate the causes of the high rate of recurrences. Some risk factors for relapses of BV have been identified such as tobacco use, stress or hygienic errors have been associated to relapses of BV. However, other paths are beginning to be explored such as the role of sexual transmission, the resistance of certain bacteria associated to BV to nitroimidazoles or the lack of efficacy of conventional treatments on dysbiosis itself. Taking into acount this vaginal dysbiosis appears to be important or even essential to better control the natural history of HPV-hr infection or improve the success rate of IVF, for example. Despite heterogeneous results, the use of probiotics as a complement to conventional treatments (nitroimidazoles, dequalinium chloride) has demonstrated a preventive effect on BV recurrences. Further studies are needed to customize the contribution of probiotics (or synbiotics) according to the individual specificities of the vaginal microbiome.

PRISM study: Comparison of a nystatin-neomycin-polymyxin B combination with miconazole for the empirical treatment of infectious vaginitis.

OBJECTIVE: An empirical treatment of infectious vaginitis is justified because of its multiple etiologies, the frequent uncertainty of clinical diagnosis and limits of microbiological analysis. Our aim was to comparatively investigate nystatin-neomycin-polymyxin B combination (NNP, Polygynax®) and miconazole. PATIENTS AND METHODS: In this European multicenter, double-blind PRISM trial, participating women presenting with infectious vaginitis were randomized to receive one vaginal capsule containing either NNP for 12 days or miconazole for 3 days followed by 9 days of placebo. RESULTS: The clinical success rate was higher in the NNP group (n=302) than the miconazole group (n=309), with a difference between groups close to statistical significance (91.1% vs. 86.7%, P=0.0906). The risk of treatment failure was 36% lower in the NNP group (odds ratio, 0.64; 95% confidence interval, 0.38-1.07). Vaginal burning on Day 2 and vaginal discharge on Day 4 were significantly less intense in the NNP group than in the miconazole group (39.1 vs. 42.3, P=0.031 and 34.6 vs. 37.6, P=0.031, respectively). Adverse drug reactions were reported by 1.2% and 2.1% of patients in the NNP and miconazole group respectively, with the ratio of adverse drug reactions relative to total adverse events significantly higher in the miconazole group (20.3% vs. 6.9%, P=0.022). CONCLUSION: The widespread use of NNP for several decades and its good efficacy and safety profile, as well as the frequent diagnostic uncertainties due to the various pathogens sustain the initiation of this broad-spectrum empirical treatment in infectious vaginitis.

Efficacy and safety of vaginally administered lyophilized Lactobacillus crispatus IP 174178 in the prevention of bacterial vaginosis recurrence.

BACKGROUND: Bacterial vaginosis (BV) is a recurrent disease in women despite treatment by antibiotics. This study investigated the impact of a vaginal probiotic, Lactobacillus crispatus IP174178* (Lc), on the rate of recurrence and time to recurrence. METHODS: A prospective, multi-centre, double blind, randomised phase III trial in women with at least two documented episodes of BV in the previous year (diagnosis confirmed by presence of three Amsel criteria and a Nugent score≥7), and who had been clinically cured (i.e., no Amsel criteria) after oral metronidazole treatment (1g/day×7 days). The patients were randomised to receive vaginal capsules of either Lc or placebo, once a day, for 14 days over the first two menstrual cycles and another 14 days of the same treatment for the following two menstrual cycles. The primary efficacy endpoint was the number of patients with at least one bacteriologically confirmed recurrence of BV. RESULTS: Out of 98 assessable patients (mean age 35.7 years), 78 women were evaluated (20 patients had missing data). During the treatment period, 16/39 patients (41%) had at least one recurrence in the placebo group versus 8/39 patients (20.5%) in the Lc group (P=0.0497). The time to recurrence was longer by 28% in the Lc group (3.75±0.16 months) vs. the placebo group (2.93±0.18 months) (P=0.0298). Tolerability and safety were good in both groups. CONCLUSION: In women with recurrent BV after antibiotics, treatment with Lc IP 174178 administered over four menstrual cycles, could significantly reduce the rate of recurrence and increase the time to recurrence.

[Efficacy of a medical device containing liposomal hyaluronic acid against vulvo-vaginal dryness]. / Efficacité d'un dispositif médical à base d'acide hyaluronique liposomé contre la sécheresse vulvo-vaginale.

OBJECTIVES: Hyaluronic acid (HA) is present in the vulval and vaginal conjonctive tissue. It possesses hydrating and healing properties and is indicated to treat menopause induced vulvo-vaginal atrophy. The goal of this study is to evaluate the efficacy of a medical device containing liposomal HA upon patients of different ages suffering from vulvo-vaginal dryness (VVD). METHODS: Tested product Mucogyne® was applied 3 times a week for 84 days by 47 patients, 28 premenopausal young women (mean age: 32 years old) and 19 post-menopausal women (mean age: 57.5 years old) all suffering from VVD associated to spontaneous pain and dyspareunia. Clinical evaluations and Vaginal Health Index (VHS) were calculated at 0, 1 and 3 months. RESULTS: A significant clinical improvement (P<0.001) occurred at 1 month (-25 % for dryness and -46 % for pain) and at 3 months (respectively -86 and -79 %). VHS was significantly improved (P<0.001) from 30 % at 1 month to 72 % after 3 months. CONCLUSION: Liposomal AH significantly decreases symptoms and clinical signs of VVD at all ages and represents a safe and efficient alternative to topical and/or systemic hormonal therapy after menopause.

Vaginal impact of the oral administration of total freeze-dried culture of LCR 35 in healthy women.

The use of probiotics in the prevention or treatment of some vaginal infections has been the subject of numerous studies. To assess the presence of Lactobacillus casei rhamnosus (LCR35) in the vagina after an oral administration, an open randomised pilot study was conducted on 20 healthy women of child-bearing age. Materials and Methods. 2 groups of 10 women were given a 28-day oral course, that is, at least 108 CFU/day (group 1) or 2 × 108 CFU/day (group 2) of LCR35. Nugent score and vaginal screening for LCR35 were undertaken before and after 28 days of treatment. Results. The mean Nugent score decreased in group 1 (-0,2) as well as in group 2 (-0,3). 10% of women in group 1 versus 40% of women in group 2 were carrying LCR35 at the end of the trial. Conclusion. LCR35, at the minimal dose of 2 × 108 CFU/day, can return the Nugent score to normal in healthy women of child-bearing age, by means of a well-tolerated vaginal temporary presence. Phase III clinical trials will specify the preventive or curative impact of this orally administered strain on a range of vaginal disorders such as bacterial vaginosis or vulvovaginal candidiasis.

[Bacterial vaginosis in 2011: a lot of questions remain]. / La vaginose en 2011 : encore beaucoup d'interrogations.

Bacterial vaginosis is one of the most frequent vaginal affections. It results from a deep imbalance of the vaginal ecosystem whose mechanisms remain mysterious, even if recent progress were accomplished in their comprehension: if the flora implied in the bacterial vaginosis is recognized like polymorphic, it appears that Gardnerella vaginalis plays a major part with two genomically different forms: a commensal form (slightly adhesive to the epithelial cells), and a pathogenic one (strongly adhesive to the epithelial cells); the changes in lactobacilli are also to take into account: L. iners could be a marker of the vaginal flora imbalance whereas L. crispatus is generally met in the normal vaginal flora. These findings could influence the composition of coming probiotics; it is recognized that bacterial vaginosis is involved in the risk of prematurity but molecular quantification of G. vaginalis (and of Atopobium vaginae) is more sensitive for the diagnosis of BV what could improve the detection of high-risk pregnant women. The isolated antibiotic treatments are not very effective on the prevention of recurrences. The rebalancing of the vaginal flora is essential. In this field, the local estrogens showed some effectiveness. The use of probiotics is promising and can be recommended in complement of the antibiotic treatment even if the results of the clinical studies are still too heterogeneous to lead to precise indications.

[The etiologic diversity of vaginitis]. / Diversité étiologique des vaginites.

OBJECTIVE: To establish the different etiologies of vaginitis and, especially, assess the distribution of responsible pathogens through a prospective study. PATIENTS AND METHODS: One hundred and sixty-nine women aged between 18 and 65 years (average age: 33.7 years old), consulting a physician for symptoms of vaginitis, were examined in 21 centers of gynaecology or infectious diseases. The clinical evaluation was completed by bacteriological sample that was tested for infections (including sexually transmitted infections (STIs)). RESULTS: One hundred and eighteen patients (69.8%) had one or several infectious etiologies distributed as follows: 79 (46.7%) candidiasis (3 of which were caused by non albicans Candida), 37 (21.9%) bacterial vaginitis and 16 (9.5%) bacterial vaginosis. To be noticed that there were 38 cases of mixed etiologies out of the 118 infectious etiologies (32.2%), 3 of them were STIs. DISCUSSION AND CONCLUSIONS: Although candidiasis was the most common etiology in this study, it only represented less than 1 out of every two patients. Among the infectious etiologies, 1 out of 3 women presented a bacterial or mixed vaginitis. The etiological diversity of vaginitis leads to consider broad-spectrum treatment as first-line therapy and to prescribe a microbiological analysis in case of failure.

[Chlamydia trachomatis: The enemy of the Fallopian tube]. / Chlamydia trachomatis : l'ennemi de la trompe.

The female prevalence of the genital infections due to Chlamydia trachomatis (Ct) is considered at 1.6%, but reached 3.6% among women from 18 to 24 years. Ct is one of the most implied bacteria in PID, even if it is not possible to quantify exactly the prevalence of chlamydial salpingitis because of the frequency of the asymptomatic forms. The physiopathology of these complications is not completely elucidated. The natural clearance of Ct at the cervical level has been demonstrated but it varies with the bacterial serovar. The period between cervical infection and salpingitis is also vague. However, we know that the risk of salpingitis increases with the time of start-up treatment. In addition, the risk of PID and sequelae increases with the number of cervical infections. The diagnosis can be evocated on a rise in the rate of anti-Ct IgG correlated with a rise in CRP. The diagnosis of certitude rests on the coelioscopy, but endo-vaginal echography or the MRI can direct the diagnosis. The prevention of these complications remains the targeted screening of chlamydial infections in at-risk populations, teenagers in particular. The recent techniques of self-administrated vaginal swabs are, in this respect, a real progress.

Ano-rectal lymphogranuloma venereum: 22 cases reported in a sexually transmited infections center in Paris.

In January 2004 the European Surveillance of Sexually Transmitted Infections Network (ESSTI) issued an international alert regarding an outbreak of Lymphogranuloma venereum (LGV) in Rotterdam in a sexual network of men who have sex with men (MSM). Further to this alert, a retrospective survey was set up by the Institut de Veille Sanitaire and the reference laboratories for N.gonorrhoeae and Chlamydia in France. Our STI clinic in Paris carried out a clinico-biological retrospective study involving 154 MSM screened for anorectal sexually transmitted infections (STIs) between January 2002 and May 2004 and a prospective study between May 2004 and August 2004. Out of 216 swabs of rectal discharge from homosexual or bisexual males, a total of 32 were positive for C. trachomatis (14.8%) (3 patients in 2002, 11 in 2003 and 18 in 2004). C. trachomatis-positive rectal strains were genotyped to detect the specific C. trachomatis serovars and revealed serovars L(2) for 22 patients (respectively 1 in 2002, 9 in 2003 and 12 in 2004). Serum antibody titers for Chlamydia trachomatis were determined among 14 subjects and revealed strongly positive in 13 cases (1/512 to 1/16384) titers of IgG. These 22 patients with clinico-biologically confirmed anorectal lymphogranuloma venereum (ARLGV) were all homosexual men. They ranged from 28 to 52 years (mean age 39.2 years). 12 of 21 (57.1%) subjects with an ARLGV diagnosis were seropositive for human immunodeficiency virus (HIV) (one not done). Although rare, anorectal lymphogranuloma venereum (ARLGV) still exists in France and should not be forgotten in the differential diagnosis of rectal problems in male homosexuals.

[Quality of life with genital herpes]. / Qualité de vie dans l'herpès génital.

Health related quality of life (HRQOL) indicators take into account the personal perception of health, and are proposed as an alternative for efficacy indicators in medical and therapeutic decision-making. They provide, after elaboration and validation of a questionnaire, a standardized assessment of the health status perception. The authors had for aim to review of a variety of HRQOL instruments developed for patients presenting with genital herpes infection. Generic instruments are designed to be applicable in general population and disease-targeted instrument are potentially more sensitive to the characteristics of a specific population. Among HRQOL instruments, we found 4 specific disease-targeted questionnaires developed for patients presenting with genital herpes infection: Genital herpes questionnaire, Herpes research center questionnaire, quality of life with herpes (QLH) scale, and recurrent genital herpes quality of life (RGHQoL).

Kinetics of Chlamydia trachomatis clearance in patients with azithromycin, as assessed by first void urine testing by PCR and transcription-mediated amplification.

METHODS: Test-of-cure of 19 patients with Chlamydia trachomatis genital infection was assessed by daily collection of first void urine for 7 days just after treatment by azithromycin single-dose. RESULTS: Detection by PCR and TMA of C. trachomatis showed a good correlation between both methods. The observation that post-therapy chlamydial nucleic acid detection is associated to bacterial clearance suggests that all the patients were cured.

[Male urethritis]. / Les urétrites masculines.

The incidence of sexually transmitted diseases (STD) is decreasing, but often take on a more subacute form, which may be difficult to detect. Acute gonococcal urethritis, diagnosed by direct examination and culture (with antibiotic susceptibility testing) requires immediate single-dose treatment. Chlamydia trachomatis urethritis is frequent and insidious and may cause a wide range of complications (serological diagnosis with raised IgG). It is sensitive to tetracyclines (for 15 days). Other forms of urethritis are due to Mycoplasmas, Trichomonas and Herpes. The presence of urethritis is a good indicator of high-risk sexual behaviour and warrants proposal of HIV screening.

Phase II study of D.651, an oral vaccine designed to prevent recurrences of vulvovaginal candidiasis.

A vaccine has been prepared with ribosomes of Candida albicans serotypes a and b plus, as adjuvant, membrane proteoglycan from a nonencapsulated Klebsiella pneumoniae. A preliminary phase II trial without placebo control was conducted in 22 women with a history of frequent recurrences of vulvovaginal candidiasis (VVC). Initially, all the patients were treated locally with an antimycotic cream. Beginning at the same time, vaccine was taken orally in capsules containing 0.55 microgram active components. It was administered intermittently over six months, groups of women taking doses of two, three, six or nine capsules. Tolerance was excellent except for mild nausea, probably due to the excipients, in two patients taking nine capsules. Twenty patients completed the study. Only seven of them had a documented recurrence of VVC during the 6 months on vaccine. No recurrence occurred in the eight women taking six or nine capsules per day. Before the study, these 20 patients had had an average of 3.59 attacks of VVC per 6 months. On vaccine, the average rate of recurrence was only 0.55 attacks per 6 months. A multicentre placebo-controlled study of the efficacy of this vaccine is in progress to validate these encouraging preliminary results.