Acceptability and efficacy of vaginal self-sampling for genital infection and bacterial vaginosis: A cross-sectional study.

BACKGROUND & AIM: Screening for genital infection (GI) such as bacterial vaginosis (BV) and yeast infection, for sexually transmitted infection (STI), and for asymptomatic carriage of group B streptococcus (GBS) in pregnant women are common reason for medical appointments. The diagnosis and control of GIs, STIs, and GBS are major issues, for fertility and overall well-being of affected women. Conventional testing is performed using vaginal/cervical classical sampling (VCS); this procedure requires pelvic examination performed by health care professionals which raises concerns among women. Vaginal-self-sampling (VSS), as an alternative to VCS, might capture more women. The aim was first to show non-inferiority of VSS compared with VCS to screen for GIs, STIs, and GBS; second to determine the feasibility of VSS. METHODS: VSS and VCS from 1027 women were collected by health care professionals and simultaneously carried out on each patient. GIs, STIs, and GBS were systematically screened in both paired VSS and VCS samples. Non-inferiority of VSS compared with VCS was assessed using z statistic for binomial proportions. RESULTS: Prevalence of GIs were 39.7% using VSS and 38.1% using VCS (p = 0.0016). Prevalence of STIs was 8.5% (VSS) vs 8.1% (VCS) (p = 0.0087). Prevalence of GBS was 13.4% (VSS) and 11.5% (VCS) (p = 0.0001). Most participants (84%) recommended the use of VSS. CONCLUSIONS: This study shows that VSS was not inferior to VCS for the detection of GIs, STIs, and GBS. This study provides evidence that VSS can be used as a universal specimen for detection of lower genital tract infections in women. STUDY IDENTIFICATION NUMBER: ID-RCB 2014-A01250-4.

[Contraceptive methods after gynecological and breast cancer]. / Contraception après cancer gynécologique et mammaire.

With earlier diagnosis and more effective treatments, more and more women are receiving fertility-preserving cancer therapy. Approximately 10% of breast and gynecological cancers occur in women under 40, and more than 5 000 French women under 45 develop breast cancer each year. While hormonal contraception is contra-indicated for women with a history of breast or endometrial cancer, it seems to have a protective effective in ovarian cancer. Although pregnancy is not contra-indicated after cancer, it must be planned in a timely manner, meaning that appropriate contraception is necessary in the meantime.

Evaluation of the clinical performance of the Abbott RealTime High-Risk HPV for carcinogenic HPV detection.

BACKGROUND: Abbott RealTime (RT) High-Risk (HR) HPV assay is a new qualitative real-time polymerase chain reaction (PCR) based assay for the detection of 14 HR HPV DNA. The assay can differentiate between the infection by HPV 16, HPV 18 and non-HPV 16/18 types through the distinct fluorescent labels on the type specific probes. OBJECTIVES: To evaluate the clinical performance of the Abbott RT HR HPV test, in comparison with biopsy, Hybrid Capture II (HCII), and Linear Array (LA), for detection of high-grade disease (CIN2+). STUDY DESIGN: The study population consisted of 143 women who were included in three referral gynecology clinics in Marseilles (France) between March 2007 and June 2008. The clinical performance of the RT HR HPV assay, performed on the fully automated m2000 system, was compared with HCII and LA. RESULTS: HR HPV positivity rate was similar for all tests (Abbott RT HR HPV and HCII, 62%, and LA 63%). All tests had high sensitivities and negative predictive values for CIN2+ detection (>90%). The agreement between HCII and Abbott RT HR HPV, and between HCII and LA were 93% (k=0.85) and 96% (k=0.91) respectively. As expected, HPV16 or HPV18 positivity was greater in advanced grades of disease, especially in CIN2+ patients: 85% in CIN2+ vs. 33% in

Relevance of HPV mRNA detection in a population of ASCUS plus women using the NucliSENS EasyQ HPV assay.

BACKGROUND: DNA- and mRNA-based assays are the main tools used for detecting human papillomavirus (HPV) nucleic acid in clinical samples. A recent tool, NucliSENS EasyQ HPV, uses a new concept to directly detect the expression of HPV oncogenic factors (E6 and E7) from the most prevalent HPV genotypes in cervical cancer (16, 18, 31, 33 and 45). OBJECTIVES: The primary aim of the study is to assess the accuracy of NucliSENS EasyQ HPV in detecting high-risk (HR) HPV in a population of atypical cells of undetermined significance/low-grade squamous intraepithelial lesion/high-grade squamous lesion (ASCUS/LSIL/HSIL) patients using a clinical cut-off of a cervical dysplasia (CIN2+) histology. The secondary aim is to compare this mRNA-based assay with the DNA-based hybrid capture II (HCII) assay. STUDY DESIGN: The study population comprised 140 women referred for colposcopy and histology. NucliSENS EasyQ HPV test, hybrid capture II (HCII) test and linear array (LA) test were assessed on all samples. All the tests were performed on the samples collected in PreservCyt liquid media for liquid-based cytology (ThinPrep Pap test). RESULTS: The clinical specificity of the NucliSENS EasyQ HPV was 63% for the detection of CIN2+ or HSIL patients, significantly higher than the specificity of HCII and LA (49% and 45%, respectively, p<0.05). Agreement between HCII and NucliSENS EasyQ HPV was fair (k=0.49) and was good between HCII and LA (k=0.88). HPV 16 was the most-detected type (49% with NucliSENS EasyQ HPV and 56% with LA), and HPV 31 was the second most-detected HPV type (31% with NucliSENS EasyQ HPV and 29% with LA). CONCLUSIONS: The NucliSENS EasyQ HPV assay has interesting clinical sensitivity and specificity for the detection of HPV types in CIN2+ patients and shows comparable diagnostic values with the HCII DNA assay. This assay allows simultaneous detection of HPV mRNA and determination of the type of the main prevalent oncogenic virus.

Comparison of the clinical performance of carcinogenic HPV typing of the Linear Array and Papillocheck HPV-screening assay.

BACKGROUND: HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 66 are considered carcinogenic for human beings. DNA-chip technology, Papillocheck HPV-screening (Greiner) and reverse dot blot, Linear Array (LA) (Roche) are tools to assess the distribution of HPV genotypes. OBJECTIVES: The aim of the study was to compare the clinical performance of Papillocheck and LA assays using a clinical cut-off of CIN2+. The secondary aim was to comparatively assess the distribution of HPV types using these two assays. STUDY DESIGN: The study population comprised 239 women referred for colposcopy and histology. Papillocheck, LA, and Hybrid Capture II (HCII) tests were done on all samples. RESULTS: All tests showed good sensitivity and NPV (greater than 90%). None of the comparisons of sensitivities, specificities, PPVs, and NPVs showed statistically relevant differences between tests. High-risk HPV positivity rate was similar for all tests (Papillocheck 75%, LA 77%, and HCII 73%). Agreement between tests was good. The concordance levels between HCII and Papillocheck and between HCII and LA were 93% (k=0.82) and 92% (k=0.80), respectively. Papillocheck and LA tests showed a high overall concordance rate of 96% (k=0.90). HPV16 was the most detected type (45% with Papillocheck, and 47% with LA), and HPV31 was the second most detected type (13% with Papillocheck, and 14% with LA). CONCLUSIONS: The Papillocheck HPV-screening test and LA test have a good clinical sensitivity to detect HPV types in CIN2+ patients. These assays allow, in the same experiment, to detect and determine the virus type. Our study showed that HPV types 16 and 31/33 are the most prevalent.

Stepwise algorithm combining HPV high-risk DNA-based assays and RNA-based assay for high grade CIN in women with abnormal smears referred to colposcopy.

BACKGROUND: The detection of high-risk human papillomavirus (HPV) DNA provides higher sensitivity but lower specificity than cytology for the identification of high-grade cervical intraepithelial neoplasia (CIN). OBJECTIVES: The aim of this study was to combine DNA- and RNA-based assays in order to improve the detection of advanced disease (CIN2+). METHODS: 107 ASCUS+ women were included in Marseilles (France) between March 2007 and June 2008. Up to five tests were carried out on a liquid PreservCyt sample: Hybrid Capture 2 (HCII) (Digene), Papillocheck (Greiner), Abbott RealTime HR HPV (RT HR HPV) (Abbott), Linear Array (Roche), and EasyQ HPV (Biomérieux). RESULTS: 36 (34%) women had CIN2+ histology; among them 6 (6%) had CIN3+ histology. For CIN2+ detection, all tests had comparable sensitivities except EasyQ HPV test: HCII 94%, Papillocheck and LA 92%, RT HR HPV 89%, and NucliSENS EasyQ HPV 75% (P not significant). On the other hand, EasyQ HPV had a higher specificity than the other assays (except RT HR HPV assay). Combining DNA-based and RNA-based assay would allow to reduce the need of colposcopies to be performed among patients HPV positive with DNA-based assay: 32% (7/22) colposcopies not needed in < 30 years old patients, and 29% (14/49) colposcopies not needed in ≥ 30 years patients. CONCLUSIONS: All tests had comparable diagnostic values for CIN2+ detection, but DNA-based tests seemed to be more sensitive and RNA-based assay more specific. The combined use of DNA- and RNA-based assays considerably reduces the number of colposcopies to be performed, and provides better diagnostic accuracy for CIN2+ disease.

Complications of vaginal myomectomy by posterior colpotomy.

OBJECTIVE: To evaluate the morbidity of vaginal myomectomy by posterior colpotomy. STUDY DESIGN: From January 1, 1994, through December 31, 2003, 108 patients in our department underwent a vaginal myomectomy procedure by posterior colpotomy. This study assessed the intra-operative (conversion to laparotomy, organ injury, hemorrhage) and post-operative (hematoma, abscess) complications as well as the risk factors for conversion to laparotomy. RESULTS: There were 27 intra- or post-operative complications (25%), 17 (15.7%) of which concerned conversion to laparotomy necessary for successful myomectomy. One case involved rectal injury (0.9%), three hemorrhages (2.8%), one hematoma (0.9%) and five abscesses (4.7%). The mean weight of fibromas was significantly higher in the group of patients undergoing laparotomy (19 cases) than in the vaginal-myomectomy-only group (89 cases) (270+/-197 g versus 181+/-143 g, p=0.02). Similarly, the fibroma size measured by ultrasound was higher in the laparotomy group than in the vaginal-myomectomy-only group, but this difference was not significant (82.6+/-27.1 mm versus 73.7+/-21.8 mm, p=0.13). CONCLUSIONS: The principal risk of vaginal myomectomy is that it will require conversion to laparotomy. The risk of pelvic abscess also appears greater in myomectomy than in other procedures. However, apart from the risk of conversion to laparotomy, vaginal morbidity is lower with this procedure. Vaginal myomectomy is a useful alternative to laparotomy for specific indications.

Diagnosis of Mullerian anomalies in adults: evaluation of practice.

OBJECTIVE: To evaluate the circumstances associated with the diagnosis of Mullerian anomalies in adults. DESIGN: Retrospective observational study. SETTING: University hospital. PATIENT(S): All patients with Mullerian anomalies referred for evaluation. INTERVENTION(S): All patients underwent radiologic and operative diagnostic workup using ultrasonography, or ultrasonography and hysteroscopy, and in some cases laparoscopy. MAIN OUTCOME MEASURE(S): Clinical symptoms and radiologic investigations leading to the diagnosis. Mode and number of investigations before the diagnosis, and the time since the initial symptoms to the final diagnosis. RESULT(S): One hundred ten patients were diagnosed with Mullerian anomalies: 73 septate uteri, 20 bicornuate uteri, 10 uterine hypoplasia, 4 unicornuate uteri, and 3 with Mayer- Mayer-Rokitansy-Küster-Hauser syndrome. The circumstances leading to the diagnosis were infertility (33.6%), repeat miscarriage (18.2%), ultrasonography during pregnancy (12.7%), pregnancy complications during last trimester (11%), abnormal examination (8.2%), and miscellaneous causes (16.3%). Up 50% of patients complained of gynecologic signs before the appropriate diagnosis. Radiologic diagnosis required two complementary imaging techniques in 62% of patients and more than two in 28%. The correct diagnosis was established in only 40% of cases before hospitalization. Most of the anomalies were initially diagnosed at hysterosalpingography and ultrasonography. The mean time between the first imaging examination and the diagnosis in a specialized department was 6.7 (+/-7.1) months. CONCLUSION(S): The diagnosis of Mullerian anomalies in adults is often made at the time of conception and obstetric complications. There is a tendency toward the use of multiple imaging techniques and this delayed the diagnosis.

Prognostic value of human chorionic gonadotropin changes after methotrexate injection for ectopic pregnancy.

Because early prediction of clinical outcome (one or more injections or surgery) of methotrexate treatment of ectopic pregnancy could ease the intensity of follow-up and patient compliance required, we studied the relationship between the change in hCG levels after methotrexate injection and outcome in 129 consecutive patients. A 20% decline in hCG levels between days 1 and 4 during methotrexate treatment has a positive predictive value of 97%.

[Vaccination against human papillomavirus. Implementation and efficacy against cervical cancer control]. / Les vaccins des papillomavirus humains. Leur place dans la prévention du cancer du col utérin.

The two new HPV vaccines (Gardasil quadrivalent and Cervarix bivalent 16,11) are both effective against HPV types 16 and 18, which are responsible for 70% of cervical cancers, and the quadrivalent vaccine is effective against HPV 6 and 11, responsible for genital warts. Their efficacy is 100% if they are administered before exposure to HPV 16,18. The proven duration of protection against high-grade cervical lesions is currently 5 years, and the need for boosters is unknown. Cervical cancer screening programs must continue, as only 70% of the 15 high-risk HPV types are targeted. The best age for primary vaccination appears to be 11-12 or 14 years, before the outset of sexual activity. Vaccination of older women is less efficacious, and vaccination of males is being discussed. HPV vaccines should be useful in developing countries, if they can be made available. HPV vaccination campaigns require adequate public information.

Prospective evaluation of the Hybrid Capture 2 and AMPLICOR human papillomavirus (HPV) tests for detection of 13 high-risk HPV genotypes in atypical squamous cells of uncertain significance.

The use of high-risk human papillomavirus (hrHPV) testing as an adjunct to cervical cytology in population-based screening programs is currently based on DNA hybridization and PCR assays. The aim of this study was to prospectively assess the diagnostic performance of the Hybrid Capture 2 test (HC2; Digene Corporation) in comparison with that of the recently developed PCR-based AMPLICOR HPV test (Roche Molecular Systems) for the detection of 13 hrHPV types. A reverse line blot hybridization assay (Innogenetics) was used as an internal reference standard in discordant cases. Two hundred seventy-one patients with atypical squamous cells of uncertain significance (ASCUS) in cervical samples underwent hrHPV testing. The chi-square test was performed to compare respective proportions. Totals of 160/271 (59%) and 156/271 (58%) were found to be positive for hrHPV with HC2 and AMPLICOR, respectively. Concordant results were obtained for 235 (86.7%) of the 271 samples (kappa statistic, 0.73 +/- 0.04). Considering types 26, 53, and 66 as oncogenic types, negative predictive values (NPVs) of HC2 and AMPLICOR were 92.8% and 87.8%, respectively (difference was not significant), and their respective accuracies were 94.8% and 91.9% (difference was not significant). Considering types 26, 53, and 66 as not oncogenic, the respective HC2 and AMPLICOR NPVs were 92.8% and 97.4% (difference was not significant), and accuracy was significantly higher for the AMPLICOR assay (95.9% versus 90.8% for HC2) (P<0.05). For ASCUS samples, the NPV was 92.8% for HC2 testing and might be compromised if the copy number of HPV DNA was low. The NPV was 97.4% for the AMPLICOR assay and might be compromised if HPV types 26, 53, and 66 were considered oncogenic. The accuracy of these two assays is good and is compatible with routine clinical use in the triage of ASCUS cases.

In situ methotrexate injection for treatment of recurrent endometriotic cysts.

OBJECTIVE: Ovarian endometrioma recurrence is frequent. Conventional treatment of ovarian endometrioma is by surgical cystectomy. We proposed an alternative medical treatment for recurrent ovarian endometrioma: cyst aspiration followed by in situ methotrexate injection. STUDY DESIGN: From January 2002 to May 2003, 14 patients with recurrent homolateral ovarian endometrioma underwent transvaginal ultrasound guided cyst puncture and aspiration followed by methotrexate injection, whilst under general anasthesia. Recurrence rate during follow up was evaluated. RESULTS: No complication was reported. After a mean follow up of 20+/-5 month (min: 13, max: 29), four recurrences were diagnosed (28.6%). Two asymptomatic recurrences were not treated and two painful recurrences underwent a second cyst drainage with methotrexate injection. CONCLUSIONS: In situ methotrexate injection is a simple, effective and an interesting alternative to surgical treatment in women with recurrent homolateral ovarian endometrioma.

[Impact of surgical access on staging of early borderline and invasive tumors of the ovary]. / Effet de la voie d'abord sur la stadification chirurgicale des lésions ovariennes frontières et des cancers à un stade précoce.

The objectives were to evaluate the impact of the surgical approach on the staging of borderline tumors and early-stage malignancies of the ovary. We retrospectively reviewed cases of borderline and invasive ovarian tumors stages Ia through Ic treated surgically between January 1, 1985 and December 31, 2001. We compared the rates of potentially harmful procedures according to the surgical approach. The quality of surgical staging was assessed by examining each required procedure and by determining a score. The influence of variables related to patient characteristics, preoperative workup, and initial surgery on staging quality was tested by univariate analysis. Variables independently associated with staging quality were entered in a logistic regression model. SPPS 7.5 and STATA 8 software was used for statistical tests. Of 118 patients with borderline tumors, 48 (41 %) underwent laparoscopic surgery, 54 (45 %) laparotomy, and 16 (14 %) laparoscopy converted to laparotomy. Surgery was conservative in 57 % of cases overall ; this proportion was significantly greater with laparoscopy than with laparotomy (p < 0.05) and in younger women (p < 0.001). Intraoperative tumor rupture occurred in 9 % of patients, with no significant difference across surgical approaches (p = 0.1). Bag extraction was used in 19 (40 %) of 48 laparoscopically treated patients. Staging was incomplete in 73 % of patients. By univariate analysis, bilateral adnexectomy and, to a lesser extent, age > 44 years, laparotomy, hysterectomy, and treatment after 1995 predicted at least partial staging. Factors independently associated with at least partial staging in the multivariate model were treatment after 1995, bilateral adnexectomy, and hysterectomy. Of 178 patients with invasive tumors, 34 underwent laparoscopic surgery, 114 laparotomy, and 30 conversion from laparoscopy to laparotomy. The laparotomy group was characterized by significantly older patient age and larger tumors, compared to the laparoscopy group. Staging was often inadequate after initial surgery, most notably with low rates of paraaortic lymphadenectomy (0 % in the laparoscopy group, 18 % in the laparotomy group, and 33 % in the conversion group). Staging is often less complete with laparoscopy than with laparotomy. In patients with invasive cancer, inadequate initial staging is common, most notably when laparoscopy is used. The surgeons training seems of major importance.

Value of laparoscopic assistance for vaginal hysterectomy with prophylactic bilateral oophorectomy.

OBJECTIVE: This study was undertaken to compare morbidity for women undergoing laparoscopy-assisted vaginal hysterectomy with bilateral oophorectomy (LAVHO) and vaginal hysterectomy with bilateral oophorectomy without laparoscopic assistance (VHO). STUDY DESIGN: Between April 1, 2002, and February 1, 2004, a prospective randomized study at Marseille University Hospital (La Conception) included 48 patients who underwent a hysterectomy with prophylactic bilateral oophorectomy for benign uterine conditions. These patients were allocated to 2 groups (LAVHO vs VHO). The study variables were duration of surgery and of hospitalization and surgical and postoperative complications. RESULTS: There was no significant difference in the duration of surgery between the LAVHO and VHO groups (100.2 +/- 27.9 vs 83.9 +/- 34.6, P = .08). The rate of complications was significantly higher in the LAVHO group (13/24 [54.1%] vs 6/24 [25%], P = .039). CONCLUSION: The overall complication rate was higher with LAVHO than VHO. It thus appears that laparoscopic assistance is not useful in performing vaginal hysterectomies with prophylactic bilateral oophorectomies in patients without other related disorders (endometriosis, adhesions, adnexal anomalies).

[The worrying rise in the frequency of cesarean section]. / L'inquiétante augmentation du nombre de césariennes.

The rise in the incidence of Cesarean section over the last thirty years is due to several factors. In particular, maternal age is increasing, parity is declining, and situations potentially requiring Cesarean section are more frequently encountered than before (prematurity, medically assisted procreation, antenatal diagnosis, previous Cesarean section, etc.). Medicolegal pressure is also increasing, and the precautionary principle is leading more and more physicians to propose Cesarean section rather than trial labor. However, although the risks of this form of delivery have decreased, they are still higher than those of vaginal delivery, except in the emergency setting. Moreover, various pathophysiologic studies have demonstrated marked changes in the elevator muscles, nerves and pelvic support after vaginal delivery. The maternal morbidity and mortality of elective caesarean delivery at term, before the onset of labor, appear to be similar to those associated with vaginal birth. However, the maternal risks (particularly placenta praevia, placenta accreta, and uterine rupture) during subsequent pregnancies following Cesarean delivery require careful evaluation. After Cesarean section, the risk of placenta praevia during the next pregnancy is between 1% and 4%. There is subsequently a linear increase, with the risk of placenta praevia reaching nearly 10% after four Cesarean deliveries. The risks and benefits of each form of delivery are extremely difficult to weigh up, and predictors of safe vaginal delivery are lacking.

Immediate complications of tension-free vaginal tape (TVT): results of a French survey.

BACKGROUND: The aim was to evaluate morbidity following operation using tension-free vaginal tape (TVT). METHODS: Between June 2002 and June 2003, a questionnaire was sent to French gynecologists and urologists. Participants reported the number of TVT procedures performed before January 2002, number of minor or major pre- and post-operative complications. RESULTS: The questionnaire was returned by 92 participants (21 urologists and 71 gynecologists) who reported 12,280 TVT procedures (median: 100, minimum: 5, maximum: 2100). Overall, 901 preoperative bladder injuries were reported (7.34%). For 809 patients (6.59%), complete post-operative urinary retention requiring catheterization was noted. There were 26 cases of vaginal defect healing (0.21%). Retropubic or vulvovaginal hematoma was reported for 39 patients (0.32%). Ten major organ injuries were reported (0.08%): one obturator nerve injury, three bowel perforations, four vessel injuries and two ureteral injuries. CONCLUSION: The risk of major complications following the use of tension-free vaginal tape is low. However, these potential complications require experienced surgeons for the practice of tension-free vaginal tape.

Transvaginal sonographic evaluation of cervix length after cervical conization.

OBJECTIVE: The purpose of this study was to evaluate transvaginal sonographic cervical length before and after cervical conization for squamous intraepithelial lesions. METHODS: Between November 2002 and October 2004, all women undergoing conization by either cold-knife conization or a loop electrosurgical excision procedure for squamous intraepithelial lesions were prospectively enrolled in this study. Cervical length was measured by transvaginal sonography (TVS) before and after conization. RESULTS: A total of 48 women were studied before and after a mean of 7 days after conization. Complete excision was achieved in 41 patients, and endocervical margins were involved in 7 patients. Mean TVS cervical length was significantly shorter after than before conization (mean +/- SD, 22.7 +/- 6.9 versus 26.7 +/- 8.1 mm; P < .001). The correlation coefficient between cone specimen length and postoperative length was r = 0.75 (P < .001). Mean TVS cervical lengths were 24.3 +/- 6.7 mm in the group of women who underwent a loop electrosurgical excision procedure and 20.7 +/- 9.4 mm in the group of women who underwent cold-knife conization (P = .13). CONCLUSIONS: Transvaginal sonographic measurement of cervical length after conization is well correlated with cone specimen length.

Influence of clinical and ultrasound factors on the efficacy of misoprostol in first trimester pregnancy failure.

An observational study including 276 patients with early pregnancy failure was performed to evaluate the clinical and ultrasound factors influencing the efficacy of misoprostol in the treatment of first trimester pregnancy failure. Gestational age did not influence the efficacy of this treatment and the success rate was inversely proportional to parity.

[Surgical treatment of female stress urinary incontinence]. / Traitement chirurgical de l'incontinence urinaire d'effort de la femme.

Stress urinary incontinence is frequent in women, and can have a major impact on quality of life. Surgical treatment is the most effective option in many cases. The current reference treatment is urethral stabilization with the use of a free pelvic sling. Surgical management of female stress urinary incontinence is now effective and relatively complication-free.