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.

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.

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.

[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.

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).

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.

[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.

Oxytocin during myomectomy: a randomized study.

OBJECTIVE: To evaluate the influence of oxytocin on peroperative blood loss during myomectomy. STUDY DESIGN: From October 1998 to May 2002, 94 patients requiring surgical myomectomy by laparotomy or by the vaginal approach were enrolled in a randomized double blind study. Patients were randomized to two groups. In the first group (47 patients) oxytocin was administered during myomectomy and in the second group (47 patients) a placebo was used. The main outcome measures were peroperative blood loss and rates of blood transfusion and autotransfusion. RESULTS: Peroperative blood loss was no different between the oxytocin group and the placebo group (508 +/- 558 ml versus 451 +/- 336 ml; P=0.55). Rates of autotransfusion and blood transfusion were also similar in both groups. CONCLUSION: Administration of oxytocin during myomectomy did not reduce peroperative blood loss in our study. The benefits of using oxytocin to prevent hemorrhage during myomectomy seem to be limited.

Risk of bladder injury during vaginal hysterectomy in women with a previous cesarean section.

OBJECTIVE: To determine the risk of bladder injury during vaginal hysterectomy in women with a previous cesarean section. STUDY DESIGN: Analysis of selected studies found through a MEDLINE search from 1980 to 2003. RESULTS: Four comparative studies (women with or without a previous cesarean section) were selected and analyzed. Risk of bladder injury was significantly increased in only 1 study. Analysis of cumulative data did not find a significant difference (8 of 430 [1.86%] vs. 11 of 1,227 [0.89%], p = 0.12). CONCLUSION: The risk of bladder injury during vaginal hysterectomy does not seem to be increased in women with a previous cesarean section.

[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.

Postoperative infection and surgical hysteroscopy.

OBJECTIVE: To evaluate the risk of infection after surgical hysteroscopy. DESIGN: Prospective observational study. SETTING: University hospital. PATIENT(S): One thousand nine hundred fifty-two patients requiring operative hysteroscopy during a 10-year period from January 1990 to January 2000. INTERVENTION(S): Two thousand one hundred sixteen operative hysteroscopies were performed: 782 fibroma resections, 422 polyp resections, 623 endometrectomies, 90 uterine septa sections, and 199 lyses of synechiae. MAIN OUTCOME MEASURE(S): Postoperative infectious complications. RESULT(S): Thirty (1.42%) infections occurred. There were 18 (0.85%) cases of endometritis and 12 urinary tract infections. No other severe infectious complications were reported. The risk for early-onset endometritis was higher after lysis of synechiae compared with endometrectomy, fibroma, or polyp resections. However, the risk for early-onset endometritis was similar for endometrectomy, septa, fibroma, or polyp resections. CONCLUSION(S): Infectious risk following surgical hysteroscopy is low. No major infectious complications occurred. Risk for early-onset endometritis was higher after lysis of synechiae compared with other procedures.

Risk of finding an endometrial cancer when atypical hyperplasia was incidentally diagnosed on hysteroscopic resection products.

OBJECTIVE: To evaluate the risk of discovering an endometrial cancer when atypical hyperplasia was diagnosed by histologic examination of hysteroscopic resection products. STUDY DESIGN: A retrospective monocentric study from January 1994 to January 2001. Seventeen patients with atypical hyperplasia were included. Initial endometrial status was provided by operative hysteroscopy resection products. For all patients, there was no hysteroscopical aspect evocative of adenocarcinoma. Histopathological analysis of the hysterectomy pieces precised the final diagnosis. RESULTS: Among the 17 hysterectomy pieces, one adenocarcinoma was diagnosed. Risk for discovering adenocarcinoma when atypical hyperplasia was diagnosed by operative hysteroscopy resection products was 5.9% (1/17). CONCLUSION: Risk of omitting adenocarcinoma when atypical hyperplasia is discovered by hysteroscopy resection pieces is low.

Vaginal myomectomy using posterior colpotomy: feasibility in normal practice.

BACKGROUND: Myomectomy is classically performed via laparotomy. Endoscopic surgery is limited for some indications. Vaginal myomectomy is a surgical procedure that has recently been evaluated. The aim of this study was to evaluate the feasibility, reproducibility and complication rate of vaginal myomectomy via posterior colpotomy. METHODS: A retrospective study was performed from November 1998 to February 2001 in three departments of gynaecology. RESULTS: Forty-five patients were involved, 17 (37.8%) of whom underwent laparoscopy before vaginal myomectomy for evaluation or treatment of a second pelvic disorder. Myomectomy was performed vaginally in 40 (89%) of the 45 patients. Peroperative laparotomy was required in five patients (11%), either because vaginal myomectomy proved impossible (four cases) or because of rectal injury (one case). One patient needed supplementary laparotomy on day 8 for the treatment of a pelvic abscess. CONCLUSION: Posterior vaginal myomectomy seems to be a feasible and reproducible surgical procedure. The success rate of vaginal myomectomy in this study was over 80%. Further randomised studies are needed to compare this procedure with laparotomy and laparoscopy.

Leiomyoma remaining after vaginal hysterectomy for symptomatic leiomyomas. A case report.

BACKGROUND: A remaining leiomyoma, an uncommon postoperative complication of vaginal hysterectomy for symptomatic leiomyomas, occurred. CASE: A second vaginal operation for a remaining leiomyoma was necessary 1 month after a vaginal hysterectomy for a myomatous uterus. CONCLUSION: Checking the pelvic cavity during hysterectomy may avoid this complication.

Acceptance of outpatient flexible hysteroscopy by premenopausal and postmenopausal women.

OBJECTIVE: To compare tolerance for and feasibility of outpatient flexible hysteroscopy in premenopausal and postmenopausal women. STUDY DESIGN: A comparative, prospective study including 475 premenopausal and 216 postmenopausal women who underwent outpatient hysteroscopy without analgesia. RESULTS: Mean pain score was higher in postmenopausal patients (1.55 +/- 0.56 vs. 1.27 +/- 0.38 [P < .0001]). Outpatient flexible hysteroscopy was feasible without analgesia in 471/475 premenopausal (99.2%) and 210/216 postmenopausal women (97.2%) (P = .07). CONCLUSION: Outpatient flexible hysteroscopy was feasible and well tolerated; local anesthesia should be reserved for postmenopausal women.

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.

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.

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

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.