ABSTRACT
BACKGROUND: We aimed to evaluate the effects of different therapeutic options to prevent the evolution of vaginal stenosis after pelvic radiotherapy in women with cervical cancer. METHODS: open-label randomized clinical trial of 195 women, stage I-IIIB, aged 18-75 years, using topical estrogen (66), topical testosterone (34), water-based intimate lubricant gel (66), and vaginal dilators (29) to assess the incidence and severity of vaginal stenosis after radiotherapy at UNICAMP-Brazil, from January/2013 to May/2018. The main outcome measure was vaginal stenosis assessed using the Common Terminology Criteria for Adverse Events (CTCAE) scale and percental changes in vaginal volume. The women were evaluated at four different times: shortly after the end of radiotherapy, and four, eight, and 12 months after the beginning of the intervention. Statistical analysis was carried out using Symmetry test, Kruskal-Wallis test and multiple regression. RESULTS: the mean age of women was 46.78 (±13.01) years, 61,03% were premenopausal and 73,84% had stage IIB-IIIB tumors. The mean reduction in vaginal volume in the total group was 25.47%, with similar worsening in the four treatment groups with no statistical difference throughout the intervention period. There was worsening of vaginal stenosis evaluated by CTCAE scale after 1 year in all groups (p < 0.01), except for the users of vaginal dilator (p = 0.37). CONCLUSIONS: there was a reduction in vaginal volume in all treatment groups analyzed, with no significant difference between them. However, women who used vaginal dilators had a lower frequency and severity of vaginal stenosis assessed by the CTCAE scale after one year of treatment. TRIAL REGISTRATION: Brazilian Registry of Clinical Trials, RBR-23w5fv . Registered 10 January 2017 - Retrospectively registered.
Subject(s)
Brachytherapy/adverse effects , Chemoradiotherapy/adverse effects , Radiation Injuries/epidemiology , Uterine Cervical Neoplasms/radiotherapy , Vaginal Diseases/epidemiology , Administration, Topical , Adolescent , Adult , Aged , Brazil/epidemiology , Chemoradiotherapy/methods , Constriction, Pathologic/diagnosis , Constriction, Pathologic/epidemiology , Constriction, Pathologic/etiology , Constriction, Pathologic/prevention & control , Dilatation/instrumentation , Dilatation/methods , Estrogens, Conjugated (USP)/administration & dosage , Female , Humans , Incidence , Middle Aged , Neoplasm Staging , Radiation Injuries/diagnosis , Radiation Injuries/etiology , Radiation Injuries/prevention & control , Severity of Illness Index , Testosterone Propionate/administration & dosage , Treatment Outcome , Uterine Cervical Neoplasms/diagnosis , Uterine Cervical Neoplasms/pathology , Vagina/drug effects , Vagina/pathology , Vagina/radiation effects , Vaginal Diseases/diagnosis , Vaginal Diseases/etiology , Vaginal Diseases/prevention & control , Young AdultABSTRACT
BACKGROUND: Radiotherapy, as a method of treatment of cervical and uterine cancers, may induce severe late-onset vaginal side effects. Unfortunately, little evidence on the management of adverse effects has been presented. This study aimed to evaluate the available interventions which reduce symptoms of vaginitis and vaginal atrophy by improving dyspareunia, mucosal inflammation, vaginal pH and vaginal dryness in women who have undergone brachytherapy or radiotherapy due to uterine or cervical malignancies. MATERIALS AND METHODS: A comprehensive literature search was performed following PRISMA guidelines. The systematic search was conducted using electronic databases, namely Scopus, Web of Science and PubMed, between October and November 2020 to identify randomized controlled trials (RCT) and, prospective randomized studies (PRS). RESULTS: The analyzed population consists of 376 patients with uterine or cervical cancer, treated with hyaluronic acid, vitamin A, vitamin E, alpha-tocopherol acetate and dienestrol. Intervention with HA along with vitamin A and vitamin E revealed advantage in endpoints such as reduced dyspareunia, vaginal mucosal inflammation, vaginal dryness, bleeding, fibrosis and cellular atypia. Administration of alpha-tocopherol acetate reduced vaginal mucosal inflammation and improved vaginal acanthosis, whereas dienestrol resulted in reduced dyspareunia, vaginal caliber and bleeding. CONCLUSIONS: Vaginal suppositories were found to be clinically effective at the management of late-onset vulvovaginal side effects after radiotherapy.
Subject(s)
Brachytherapy , Dyspareunia , Vaginal Diseases , Vaginitis , Atrophy , Brachytherapy/adverse effects , Female , Humans , Vaginal Diseases/etiology , Vaginal Diseases/prevention & control , Vaginitis/drug therapy , Vaginitis/prevention & controlABSTRACT
Endogenous retroviruses (ERVs) are genomic sequences that originated from retroviruses and are present in most eukaryotic genomes. Both beneficial and detrimental functions are attributed to ERVs, but whether ERVs contribute to antiviral immunity is not well understood. Here, we used herpes simplex virus type 2 (HSV-2) infection as a model and found that Toll-like receptor 7 (Tlr7-/-) deficient mice that have high systemic levels of infectious ERVs are protected from intravaginal HSV-2 infection and disease, compared to wildtype C57BL/6 mice. We deleted the endogenous ecotropic murine leukemia virus (Emv2) locus on the Tlr7-/- background (Emv2-/-Tlr7-/-) and found that Emv2-/-Tlr7-/- mice lose protection against HSV-2 infection. Intravaginal application of purified ERVs from Tlr7-/- mice prior to HSV-2 infection delays disease in both wildtype and highly susceptible interferon-alpha receptor-deficient (Ifnar1-/-) mice. However, intravaginal ERV treatment did not protect Emv2-/-Tlr7-/- mice from HSV-2 disease, suggesting that the protective mechanism mediated by exogenous ERV treatment may differ from that of constitutively and systemically expressed ERVs in Tlr7-/- mice. We did not observe enhanced type I interferon (IFN-I) signaling in the vaginal tissues from Tlr7-/- mice, and instead found enrichment in genes associated with extracellular matrix organization. Together, our results revealed that constitutive and/or systemic expression of ERVs protect mice against vaginal HSV-2 infection and delay disease.
Subject(s)
Endogenous Retroviruses/immunology , Herpes Genitalis/immunology , Herpes Genitalis/prevention & control , Herpesvirus 2, Human/immunology , Vaginal Diseases/immunology , Vaginal Diseases/prevention & control , Animals , Endogenous Retroviruses/genetics , Female , Herpes Genitalis/genetics , Herpesvirus 2, Human/genetics , Mice , Mice, Knockout , Vaginal Diseases/geneticsABSTRACT
The prevalence of acute vulvovaginal involvement in toxic epidermal necrolysis can be as high as 70%; up to 28% of female patients will also develop chronic vulvovaginal sequelae. There is little consensus regarding prevention and treatment of the gynecologic sequelae of both Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN). We review acute and chronic sequelae, including erosions, scar formation, chronic skin changes, urethral complications, adenosis, malignant transformation, vulvodynia, and dyspareunia. We provide comprehensive recommendations for acute and long-term vulvovaginal care in adult and pediatric SJS/TEN patients. Treatment should include an ultrapotent topical steroid, followed by a nonirritating barrier cream applied to vulvar and perineal lesions. A steroid should be used intravaginally along with vaginal dilation in all adults (but should be avoided in prepubertal adolescents) with vaginal involvement. Menstrual suppression should be considered in all reproductive age patients until vulvovaginal lesions have healed. Last, referrals for pelvic floor physical therapy and to surgical subspecialties should be offered on a case-by-case basis. This guide summarizes the current available literature combined with expert opinion of both dermatologists and gynecologists who treat a high volume of SJS/TEN patients.
Subject(s)
Stevens-Johnson Syndrome/complications , Vaginal Diseases/etiology , Vaginal Diseases/therapy , Vulvar Diseases/etiology , Vulvar Diseases/therapy , Female , Humans , Practice Guidelines as Topic , Stevens-Johnson Syndrome/diagnosis , Vaginal Diseases/prevention & control , Vulvar Diseases/prevention & controlABSTRACT
OBJECTIVE: Vaginal cuff dehiscence, a severe and potentially detrimental complication, has significantly increased after the introduction of endoscopic hysterectomy. The aim of this systematic review and meta-analysis of the available literature was to identify the incidence of, and possible strategies to prevent, this complication after total laparoscopic hysterectomy and total robotic hysterectomy. DATA SOURCES: PubMed, ClinicalTrials.gov, Scopus, and Web of Science databases were systematically queried to identify all articles reporting either laparoscopic or robot-assisted hysterectomies for benign indications in which vaginal dehiscence was reported as an outcome. Reference lists of the identified studies were manually searched. Only papers written in English were considered. METHODS OF STUDY SELECTION: The Population, Intervention, Comparison, and Outcome framework for the review included (1) population of interest: women who underwent conventional and robot-assisted laparoscopic hysterectomy; (2) interventions: possible methods to prevent vaginal dehiscence; (3) comparison: experimental strategies vs standard treatment or alternative strategy for each item of intervention; and (4) outcome: rate of vaginal dehiscence. Series of subtotal hysterectomies and radical hysterectomies in addition to reports that combined both benign and malignant cases were excluded. The meta-analysis was performed using RevMan version 5.4.1 (Cochrane Training, London, United Kingdom). Two independent reviewers identified all reports comparing 2 or more possible strategies to prevent vaginal dehiscence. TABULATION, INTEGRATION, AND RESULTS: A total of 460 articles were identified. Of these, 20 (6 randomized, 2 prospective, and 12 retrospective) studies were included in this review for a total of 19 392 patients. The incidence of vaginal dehiscence after total laparoscopic hysterectomy ranged between 0.64% and 1.35%. Robotic hysterectomy was associated with a risk of vaginal dehiscence of approximately 1.64%. No study compared early vs delayed resumption of coital activity nor analyzed the role of training in laparoscopic suturing. No study specifically assessed the impact of electrosurgery on the risk of vaginal dehiscence in endoscopic hysterectomies for benign indications. Double-layer and reinforced sutures did not decrease the risk of dehiscence. Barbed sutures reduced the risk of separation compared with nonbarbed closure (0.4% [4/1108] vs 2% [22/1097]; odds ratio [OR] 0.25; 95% confidence interval [CI], 0.11-0.57). However, these data came mainly from retrospective series. Excluding studies on the use of self-anchoring sutures during robotic hysterectomy, there was no significant difference in the risk of dehiscence between barbed and nonbarbed sutures (0.5% [4/890] vs 1.4% [181/776]; OR 0.38; 95% CI, 0.13-1.10). Transvaginal suture of the vault at the end of an endoscopic hysterectomy seemed to increase the risk of dehiscence when compared with laparoscopic closure (2.3% [23/1002] vs 1.16% [11/944]; OR 1.97; 95% CI, 1.00-3.88). CONCLUSION: There is a paucity of high-quality papers evaluating vaginal dehiscence and possible prevention strategies in the current literature. Only 2 effective strategies have been identified in reducing the risk for this complication: the use of barbed sutures and the adoption of a laparoscopic approach to close the vaginal cuff. When restricting the analysis only to laparoscopic cases, the use of barbed sutures does not protect against vaginal cuff separation.
Subject(s)
Hysterectomy/adverse effects , Laparoscopy/adverse effects , Robotic Surgical Procedures/adverse effects , Surgical Wound Dehiscence/prevention & control , Suture Techniques/statistics & numerical data , Vaginal Diseases/prevention & control , Female , Humans , Hysterectomy/methods , Incidence , Laparoscopy/methods , Risk Factors , Robotic Surgical Procedures/methods , Surgical Wound Dehiscence/epidemiology , Surgical Wound Dehiscence/etiology , Treatment Outcome , United Kingdom/epidemiology , Vaginal Diseases/epidemiology , Vaginal Diseases/etiologyABSTRACT
BACKGROUND: Human papillomavirus (HPV) is a common sexually transmitted pathogen and the cause of several cancers and of anogenital warts. With this study, we estimated the trend of hospitalizations for anogenital warts (AGWs) in the Veneto region (Italy) from 2007 to 2018. METHODS: The analysis included all the hospital discharge records of public and accredited private hospitals occurred in Veneto residents in the timespan 2007-2018. The ICD9-CM code 078.11 considered were those associated with condyloma acuminatum and those associated with surgical interventions for vulval/vaginal warts, penile warts anal warts. Annual total and sex- and age-specific hospitalization rates and trends were calculated and correlated with the different HPV vaccine coverage over the study period. RESULTS: We observed an overall reduction of hospitalization rates for AGWs: from 15.0 hospitalizations every 100,000 Veneto residents in years 2007-08 to 10.9 hospitalizations every 100,000 Veneto residents in year 2017-18 (- 37.4%; p < 0.05). Reduction has been caused by a drop in hospitalizations in females - from a rate of 20.4/100,000 in 2007-2008 to a rate of 10.8/100,000 in 2017-18 (AAPC: -7.1; 95%CI: - 10.6;-3.4); while in males, we observed a slight - but not statistically significant - increase in hospitalization rates. CONCLUSION: The marked decline in hospitalization rates for AGWs in Veneto Region is probably attributable to the high coverage rates of HPV vaccination programs implemented since 2008.
Subject(s)
Anus Diseases/prevention & control , Condylomata Acuminata/prevention & control , Hospitalization/trends , Papillomaviridae/immunology , Papillomavirus Infections/prevention & control , Papillomavirus Vaccines/immunology , Penile Diseases/prevention & control , Sexually Transmitted Diseases, Viral/prevention & control , Vaccination , Vaginal Diseases/prevention & control , Vulvar Diseases/prevention & control , Adolescent , Adult , Anus Diseases/virology , Child , Child, Preschool , Cohort Studies , Condylomata Acuminata/epidemiology , Condylomata Acuminata/virology , Cross-Sectional Studies , Female , Humans , Infant , Infant, Newborn , Italy/epidemiology , Male , Middle Aged , Papillomavirus Infections/epidemiology , Papillomavirus Infections/virology , Penile Diseases/virology , Sexually Transmitted Diseases, Viral/epidemiology , Vaginal Diseases/virology , Vulvar Diseases/virology , Young AdultABSTRACT
Vulval skin care is an important part of women's health, and this evaluation aimed to explore vulval care among women attending our sexual health clinic. A questionnaire was completed by 135 women over a five-week period. Forty-three women (32%) washed their vulva two to three times a day, with 93 (69%) using a detergent-containing product. Thirty-eight women (28%) used sanitary products when not menstruating. Ninety-five women (70%) reported at least one previous vulvo-vaginal condition. One hundred and two women (76%) reported being confident in vulval care; however, 60 women (44%) wished to receive more information. The mismatch between women's confidence and knowledge may reflect mixed sources of education used by women. We recommend that sexual health clinics review the information they provide to patients on vulval care.
Subject(s)
Hygiene , Skin Care , Vaginal Diseases/prevention & control , Vulva , Adult , Female , Health Knowledge, Attitudes, Practice , Humans , Sexual Health , Surveys and Questionnaires , Women's HealthABSTRACT
Recent surveys have shown widespread lapses in the procedures used to reduce the risk of transmitting infection via medical devices. Transvaginal ultrasound examination has the potential to transmit vaginal infections, including human papillomavirus. Areas of particular concern are the use of probe covers with high rates of leakage, disinfectants that are not effective against human papillomavirus, and coupling gel from multiple-use containers. We reviewed these issues, and we recommend 4 steps to reduce the risk of transmitting infection. First, during every transvaginal ultrasound exam, the probe should be covered with a sterile, single-use "viral barrier" cover or a condom. Second, sterile, single-use ultrasound gel packets should be used. Third, after every examination, the probe should be cleaned to remove any visible gel or debris. Finally, after cleaning, the probe should undergo high-level disinfection using an agent with proven efficacy against the human papillomavirus, including hydrogen peroxide, hypochlorite, or peracetic acid. Glutaraldehyde, orthophthalaldehyde, phenols, and isopropyl alcohol have virtually no efficacy against the human papillomavirus.
Subject(s)
Disease Transmission, Infectious/prevention & control , Equipment Contamination/prevention & control , Ultrasonography, Prenatal/instrumentation , Vaginal Diseases/microbiology , Vaginal Diseases/prevention & control , Disinfectants , Disinfection/methods , Disposable Equipment , Female , Glutaral , Humans , Infection Control/methods , Papillomavirus Infections/prevention & control , Pregnancy , Sterilization/methods , Ultrasonography, Prenatal/adverse effects , Vaginal Diseases/virology , o-PhthalaldehydeABSTRACT
BACKGROUND: Vacuum and forceps assisted vaginal deliveries are reported to increase the incidence of postpartum infections and maternal readmission to hospital compared to spontaneous vaginal delivery. Prophylactic antibiotics may be prescribed to prevent these infections. However, the benefit of antibiotic prophylaxis for operative vaginal deliveries is still unclear. This is an update of a review last published in 2017. OBJECTIVES: To assess the effectiveness and safety of antibiotic prophylaxis in reducing infectious puerperal morbidities in women undergoing operative vaginal deliveries including vacuum or forceps delivery, or both. SEARCH METHODS: For this update, we searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (5 July 2019), and reference lists of retrieved studies. SELECTION CRITERIA: All randomised controlled trials comparing any prophylactic antibiotic regimens with placebo or no treatment in women undergoing vacuum or forceps deliveries were eligible. Participants were all pregnant women without evidence of infections or other indications for antibiotics of any gestational age. Interventions were any antibiotic prophylaxis (any dosage regimen, any route of administration or at any time during delivery or the puerperium). DATA COLLECTION AND ANALYSIS: Two review authors assessed trial eligibility and risk of bias. Two review authors extracted the data independently using prepared data extraction forms. Any discrepancies were resolved by discussion and a consensus reached through discussion with all review authors. We assessed methodological quality of the two included studies using the GRADE approach. MAIN RESULTS: Two studies, involving 3813 women undergoing either vacuum or forceps deliveries, were included. One study involving 393 women compared the antibiotic intravenous cefotetan after cord clamping compared with no treatment. The other study involving 3420 women compared a single dose of intravenous amoxicillin and clavulanic acid with placebo using 20 mL of intravenous sterile 0.9% saline. The evidence suggests that prophylactic antibiotics reduce superficial perineal wound infection (risk ratio (RR) 0.53, 95% confidence interval (CI) 0.40 to 0.69; women = 3420; 1 study; high-certainty evidence), deep perineal wound infection (RR 0.46, 95% CI 0.31 to 0.69; women = 3420; 1 study; high-certainty evidence) and probably reduce wound breakdown (RR 0.52, 95% CI 0.43 to 0.63; women = 2593; 1 study; moderate-certainty evidence). We are unclear about the effect on organ or space perineal wound infection (RR 0.11, 95% CI 0.01 to 2.05; women = 3420; 1 study) and endometritis (average RR 0.32, 95% CI 0.04 to 2.64; 15/1907 versus 30/1906; women = 3813; 2 studies) based on low-certainty evidence with wide CIs that include no effect. Prophylactic antibiotics probably lower serious infectious complications (RR 0.44, 95% CI 0.22 to 0.89; women = 3420; 1 study; high-certainty evidence). They also have an important effect on reduction of confirmed or suspected maternal infection. The two included studies did not report on fever or urinary tract infection. It is unclear, based on low-certainty evidence, whether prophylactic antibiotics have any impact on maternal adverse reactions (RR 2.00, 95% CI 0.18 to 22.05; women = 2593; 1 study) and maternal length of stay (MD 0.09 days, 95% CI -0.23 to 0.41; women = 393; 1 study) as the CIs were wide and included no effect. Prophylactic antibiotics slightly improve perineal pain and health consequences of perineal pain and probably reduce costs. Prophylactic antibiotics did not have an important effect on dyspareunia (difficult or painful sexual intercourse) or breastfeeding at six weeks. Antibiotic prophylaxis may slightly improve maternal hospital re-admission and maternal health-related quality of life. Neonatal adverse reactions were not reported in any included trials. AUTHORS' CONCLUSIONS: Prophylactic intravenous antibiotics are effective in reducing infectious puerperal morbidities in terms of superficial and deep perineal wound infection or serious infectious complications in women undergoing operative vaginal deliveries without clinical indications for antibiotic administration after delivery. Prophylactic antibiotics slightly improve perineal pain and health consequences of perineal pain, probably reduce the costs, and may slightly reduce the maternal hospital re-admission and health-related quality of life. However, the effect on reduction of endometritis, organ or space perineal wound infection, maternal adverse reactions and maternal length of stay is unclear due to low-certainty evidence. As the evidence was mainly derived from a single multi-centre study conducted in a high-income setting, future well-designed randomised trials in other settings, particularly in low- and middle-income settings, are required to confirm the effect of antibiotic prophylaxis for operative vaginal delivery.
Subject(s)
Antibiotic Prophylaxis , Extraction, Obstetrical/adverse effects , Puerperal Infection/prevention & control , Vaginal Diseases/prevention & control , Amoxicillin-Potassium Clavulanate Combination/therapeutic use , Anti-Bacterial Agents/therapeutic use , Antibiotic Prophylaxis/adverse effects , Cefotetan/therapeutic use , Endometritis/prevention & control , Episiotomy/adverse effects , Female , Humans , Length of Stay , Obstetrical Forceps , Perineum/injuries , Pregnancy , Randomized Controlled Trials as Topic , Surgical Wound Infection/prevention & control , Vacuum Extraction, Obstetrical/adverse effectsABSTRACT
La infección vaginal constituye una de las complicaciones médicas más frecuentes asociadas al embarazo. Se realizó un estudio epidemiológico, observacional, analítico, longitudinal de casos y controles con mujeres embarazadas atendidas en el Policlínico Jimmy Hirzel, Bayamo, Granma, período junio 2016diciembre 2017, con el objetivo de identificar factores de riesgo hipotéticamente relacionados con la aparición de infección vaginal. Los datos se obtuvieron a partir de una encuesta aplicada a las pacientes y su historia clínica, previo consentimiento informado. Se aplicó modelo de riesgo proporcional de Cox para análisis univariado y multivariado, y el Chi cuadrado, con una confiabilidad del 95 por ciento y una probabilidad menor de 0.05. La historia previa de infección de transmisión sexual (OR 2,25), másde tres gestaciones (OR 3,20), los abortos previos (9,88) y el no empleo de preservativos en las relaciones sexuales (OR 5, 35) se constituyeron en los antecedentes gineco-obstétricos relacionados con la aparición de infección vaginal en mujeres embarazadas. El inicio precoz de la vida sexual (OR 2, 25) se constituyó en un factor demográfico y de conducta sexual relacionado con la aparición de infección vaginal en mujeres embarazadas. Haber recibido algún tipo de tratamiento vaginal previo al estudio (OR 1,26), constituyó un factor de riesgo relacionado con los procedimientos externos, aunque no de forma significativa. La presencia de infección de vías urinarias y de diabetes mellitus se constituyeron en factores de riesgo relacionados con la aparición de infección vaginal en mujeres embarazadas(AU)
Vaginal infection is one of the most frequent medical complications associated with pregnancy. An epidemiological, observational, analytical, longitudinal study of cases and controls was carried out with pregnant women attended at the Jimmy Hirzel Polyclinic, Bayamo, Granma, June 2016-December 2017, with the objective of identifying risk factors hypothetically related to the appearance of vaginal infection. The data was obtained from a survey applied to patients and their clinical history, with prior informed consent. Cox proportional risk model was applied for univariate and multivariate analysis, and Chi square, with a 95 percent reliability and a probability lower than 0.05. The previous history of sexually transmitted infection (OR 2.25), more than three pregnancies (OR 3.20), previous abortions (9.88) and the non-use of condoms in sexual relations (OR 5, 35) were constituted in the gynecological-obstetric history related to the appearance of vaginal infection in pregnant women. The early onset of sexual life (OR 2, 25) became a demographic and sexual behavior factor related to the appearance of vaginal infection in pregnant women. Having received some type of vaginal treatment prior to the study (OR 1.26), constituted a risk factor related to external procedures, although not in a significant way. The presence of urinary tract infection and diabetes mellitus constituted risk factors related to the appearance of vaginal infection in pregnant women(EU)
Subject(s)
Humans , Female , Pregnancy , Vaginal Diseases/prevention & control , Vaginosis, Bacterial/complications , Pregnancy Complications, Infectious , Risk Factors , Epidemiologic Studies , Case-Control Studies , Longitudinal StudiesABSTRACT
OBJECTIVE: Nine-valent human papillomavirus (9vHPV) vaccine efficacy against disease and cervical surgeries related to all nine vaccine components was assessed compared with a historic placebo population. This was not assessed in the 9vHPV vaccine efficacy trial since the trial was quadrivalent HPV (qHPV) vaccine-controlled, efficacy was measured for the five HPV types covered only by 9vHPV vaccine (HPV31/33/45/52/58), but not the four types covered by both vaccines (HPV6/11/16/18). METHODS: Three international, randomized, double-blind studies were conducted using the same methodology. In the 9vHPV vaccine study (NCT00543543), 7106 and 7109 women received 9vHPV or qHPV vaccine, respectively. In the historic qHPV vaccine studies (FUTURE I [NCT00092521] and II [NCT00092534]), 8810 and 8812 women received qHPV vaccine or placebo, respectively, based on the same eligibility criteria. Cervical cytological testing was performed regularly. Biopsy or definitive therapy specimens were assessed for HPV DNA. RESULTS: Among women negative for 14 HPV types prior to vaccination, incidence of high-grade cervical disease (9vHPV, nâ¯=â¯2 cases; placebo, nâ¯=â¯141 cases) and cervical surgery (9vHPV, nâ¯=â¯3 cases; placebo, nâ¯=â¯170 cases) related to the nine HPV types was reduced by 98.2% (95% confidence interval [CI], 93.6-99.7) and 97.8% (95% CI, 93.4-99.4), respectively. The 9vHPV vaccine did not prevent disease related to vaccine HPV types detected at baseline, but significantly reduced cervical, vulvar, and vaginal diseases related to other vaccine HPV types. CONCLUSIONS: Effective implementation of the 9vHPV vaccine may substantially reduce the burden of HPV-related diseases and related medical procedures. TRIAL REGISTRATIONS: clinicaltrials.gov: NCT00543543, NCT00092521, NCT00092534.
Subject(s)
Papillomavirus Infections/prevention & control , Papillomavirus Vaccines/administration & dosage , Uterine Cervical Dysplasia/prevention & control , Vaginal Diseases/prevention & control , Vulvar Diseases/prevention & control , Adult , DNA, Viral/isolation & purification , Double-Blind Method , Female , Humans , Papillomaviridae/genetics , Papillomaviridae/immunology , Papillomavirus Infections/pathology , Papillomavirus Vaccines/adverse effects , Papillomavirus Vaccines/immunology , Uterine Cervical Dysplasia/pathology , Uterine Cervical Dysplasia/surgery , Uterine Cervical Dysplasia/virology , Vaginal Diseases/pathology , Vaginal Diseases/virology , Vulvar Diseases/pathology , Vulvar Diseases/virology , Young AdultABSTRACT
BACKGROUND: Radiotherapy treatment for cervical cancer (CC) often induces side effects, including inflammation, dryness, dyspareunia. Considering its key role in the healing process, hyaluronic acid (HA) could be useful for the completion of radiotherapy. OBJECTIVES: The aim of this work was to evaluate the ability of HA to reduce the onset of side effects due to radiotherapy. MATERIALS AND METHODS: In total, 180 women undergoing radiotherapy were randomized into two arms: controls and those treated with vaginal suppositories containing low-molecular-weight HA from day 1 of radiotherapy. The study lasted 5 weeks and was characterized by three visits: at baseline (T0), 15 days later (T1), and at the end of the radiotherapy cycle (T2). The onset of side effects, pain, safety, efficacy, acceptability of treatment, and compliance to the therapy were evaluated. RESULTS: Patients in the control arm reported the onset and worsening of all symptoms with a moderate or severe grade at T2, whereas in the treatment arm almost 90% of patients reported the absence of symptoms or a mild grade. All patients in the treatment arm referred a lower intensity of pain on a visual analog scale compared with the control arm at T2 (6.85 ± 0.94 vs. 1.88 ± 1.02). CONCLUSIONS: HA was able to help vaginal mucosa healing during radiotherapy in patients with CC.
Subject(s)
Hyaluronic Acid/administration & dosage , Uterine Cervical Neoplasms/radiotherapy , Vaginal Diseases/prevention & control , Adult , Aged , Female , Humans , Middle Aged , Neoplasm Staging , Radiation Injuries/prevention & control , Radiotherapy, Adjuvant , Uterine Cervical Neoplasms/therapy , Vaginal Diseases/etiologyABSTRACT
INTRODUCTION AND HYPOTHESIS: A frequent complication following vaginal hysterectomy is the formation of vaginal vault hematoma. The objective of our systematic review was to assess the impact of various interventions in reducing the incidence of vault hematoma or postoperative febrile morbidity following vaginal hysterectomy. METHODS: We carried out a systematic search of Cochrane, MEDLINE, Embase, CINAHL, HTA database, PROSPERO, meta-Register of Controlled Trials (mRCT), PubMed, CENTRAL, Google Scholar, conference abstracts, and a hand search of journals from inception until September 2018. Our search strategy included interventions in women undergoing vaginal hysterectomy with modified vault closure with inclusion of peritoneal edges, vaginal vault drainage, or vaginal packing to reduce the incidence of clinically significant vault hematomas. Two independent reviewers (SR and AD) extracted data using a structured proforma. Meta-analysis was carried out using RevMan 5.3 software. RESULTS: We identified two studies on modified vaginal vault closure incorporating peritoneal edges that reported a significant reduction in vault hematoma incidence. Meta-analysis of two randomized trials on vaginal drains showed no difference in postoperative febrile morbidity secondary to vault hematoma [risk ratio (RR) 0.8, 95% confidence intervals (CI) 0.43-1.50]. Similar results were seen on meta-analysis of four randomized trials on the use of vaginal packing (RR 0.8, 95% CI 0.43-1.50). CONCLUSIONS: Inclusion of peritoneal edges in vaginal vault closure may reduce the incidence of vault hematoma. The routine use of vaginal vault drainage and/or packing has not shown to reduce vault hematoma incidence or postoperative febrile morbidity. We recommend a change of practice to include peritoneal edges in vault closure based on the evidence available in our systematic review.
Subject(s)
Hematoma/prevention & control , Hysterectomy, Vaginal/methods , Postoperative Complications/prevention & control , Vaginal Diseases/prevention & control , Adult , Aged , Aged, 80 and over , Drainage/methods , Female , Hematoma/etiology , Humans , Hysterectomy, Vaginal/adverse effects , Middle Aged , Postoperative Complications/etiology , Risk Factors , Vaginal Diseases/etiology , Young AdultABSTRACT
BACKGROUND: Vaginal dilators (VD) are recommended following vaginal or pelvic radiotherapy for patients with endometrial carcinoma (EC) to prevent vaginal stenosis (VS). The time course of VS is not fully understood and the optimal duration of VD use is unknown. METHODS: We reviewed 243 stage IA-II EC patients who received adjuvant brachytherapy (BT) at an academic tertiary referral center. Patients were instructed to use their VD three times per week for at least 1-year duration. The primary outcome was development of grade ≥ 1 VS using CTCAEv4 criteria during the follow-up period. The log-rank test and multivariable Cox proportional hazards modeling were used to evaluate the effect of VD use (noncompliance vs. standard compliance [up to 1 year] vs. extended compliance [over 1 year]) on VS. RESULTS: The median follow-up was 15.2 months over the 5-year study period. At 15 months, the incidence of VS was 38.8% for noncompliant patients, 33.5% for those with standard compliance, and 21.4% for those with extended compliance (median time to grade ≥ 1 VS was 17.5 months, 26.7 months, and not yet reached for these groups, respectively). On multivariable Cox regression analysis, extended compliance remained a significant predictor of reduced VS risk when compared to both noncompliance (HR 0.38, 95% CI 0.18-0.80, p = 0.012) and standard compliance (HR 0.43, 95% CI 0.20-0.89, p = 0.023). CONCLUSIONS: The risk of VS persists beyond 1 year after BT. Extended VD compliance beyond 1 year may mitigate this risk.
Subject(s)
Brachytherapy , Constriction, Pathologic/prevention & control , Dilatation/instrumentation , Endometrial Neoplasms/radiotherapy , Vaginal Diseases/prevention & control , Adult , Aged , Brachytherapy/adverse effects , Constriction, Pathologic/etiology , Female , Follow-Up Studies , Humans , Middle Aged , Patient Compliance , Radiotherapy Dosage , Treatment Outcome , Vagina/pathology , Vagina/radiation effectsABSTRACT
OBJECTIVE: The aim of the study was to evaluate the effects of nutraceuticals containing equol on vaginal health of postmenopausal women with vulvovaginal symptoms and dyspareunia. METHODS: One hundred twenty-six natural postmenopausal women on +1b +1c (2 and 3-6 y after the final menstrual period, respectively) of the Stages of Reproductive Aging Workshop were enrolled in a nonrandomized trial. Of these, 72 women accepted to use nutraceutical (group A). The remaining 54 women refused the treatment and participated as the control group (group B). Group A was prescribed one tablet daily to take orally, for 8 months. All assessments were made at baseline and at 4 and 8 months. Determination of vaginal maturation index (VMI), evaluation of vaginal pH, and assessment of vaginal atrophy symptoms by the vaginal health index (VHI) were carried out. Dyspareunia score was also measured. RESULTS: Group A had a significant increase in VMI (68â±â5 vs 58â±â8) and improvement of vaginal pH (4.1â±â1.3 vs 5.1â±â1.7) compared with baseline, mainly after 8 months of treatment (Pâ<â0.001). Group A had an improvement of VHI after 4 (13â±â3, Pâ<â0.01) and 8 (16â±â2, Pâ<â0.001) months of nutraceutical intake. Dyspareunia reduced after 8 months (5.1â±â1.3 vs 3.8â±â1.2, Pâ<â0.001) but not after 4 months (4.7â±â1.1, Pâ=â0.06) of treatment. Group B showed no changes from baseline evaluation (Pâ=â0.22). CONCLUSIONS: Nutraceuticals containing equol could be effective in modulating postmenopausal symptoms, particularly vaginal symptoms, and could be well accepted by the women who usually do not wish to use hormone therapy or cannot use it for medical reasons.
Subject(s)
Equol/therapeutic use , Phytoestrogens/therapeutic use , Plant Extracts/therapeutic use , Postmenopause , Vaginal Diseases/prevention & control , Dietary Supplements , Female , Humans , Middle Aged , Treatment Outcome , Vulvar Diseases/prevention & controlSubject(s)
Muscle Hypotonia/therapy , Vagina/physiopathology , Vaginal Diseases/therapy , Adult , Combined Modality Therapy/adverse effects , Female , Humans , Middle Aged , Muscle Hypotonia/diagnosis , Muscle Hypotonia/physiopathology , Muscle Hypotonia/prevention & control , Practice Guidelines as Topic , Pregnancy , Pregnancy Complications/physiopathology , Pregnancy Complications/prevention & control , Pregnancy Complications/surgery , Pregnancy Complications/therapy , Rejuvenation , Terminology as Topic , Vagina/surgery , Vaginal Diseases/diagnosis , Vaginal Diseases/physiopathology , Vaginal Diseases/prevention & controlABSTRACT
BACKGROUND: Vacuum and forceps assisted vaginal deliveries are reported to increase the incidence of postpartum infections and maternal readmission to hospital compared to spontaneous vaginal delivery. Prophylactic antibiotics may be prescribed to prevent these infections. However, the benefit of antibiotic prophylaxis for operative vaginal deliveries is still unclear. OBJECTIVES: To assess the effectiveness and safety of antibiotic prophylaxis in reducing infectious puerperal morbidities in women undergoing operative vaginal deliveries including vacuum or forceps deliveries, or both. SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth's Trials Register (12 July 2017), ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (12 July 2017) and reference lists of retrieved studies. SELECTION CRITERIA: All randomised trials comparing any prophylactic antibiotic regimens with placebo or no treatment in women undergoing vacuum or forceps deliveries were eligible. Participants were all pregnant women without evidence of infections or other indications for antibiotics of any gestational age undergoing vacuum or forceps delivery for any indications. Interventions were any antibiotic prophylaxis (any dosage regimen, any route of administration or at any time during delivery or the puerperium) compared with either placebo or no treatment. DATA COLLECTION AND ANALYSIS: Two review authors assessed trial eligibility and methodological quality. Two review authors extracted the data independently using prepared data extraction forms. Any discrepancies were resolved by discussion and a consensus reached through discussion with all review authors. We assessed methodological quality of the one included trial using the GRADE approach. MAIN RESULTS: One trial, involving 393 women undergoing either vacuum or forceps deliveries, was included. The trial compared the antibiotic intravenous cefotetan after cord clamping compared with no treatment. This trial reported only two out of the nine outcomes specified in this review. Seven women in the group given no antibiotics had endomyometritis and none in prophylactic antibiotic group, the risk reduction was 93% (risk ratio (RR) 0.07; 95% confidence interval (CI) 0.00 to 1.21; low-quality evidence). There was no difference in the length of hospital stay between the two groups (mean difference (MD) 0.09 days; 95% CI -0.23 to 0.41; low-quality evidence). Overall, the risk of bias was judged to be unclear. The quality of the evidence using GRADE was low for both endometritis and maternal length of stay. AUTHORS' CONCLUSIONS: One small trial was identified reporting only two outcomes. Evidence from this single trial suggests that antibiotic prophylaxis may lead to little or no difference in endometritis or maternal length of stay. There were no data on any other outcomes to evaluate the impact of antibiotic prophylaxis after operative vaginal delivery. Future research on antibiotic prophylaxis for operative vaginal delivery is needed to conclude whether it is useful for reducing postpartum morbidity.
Subject(s)
Antibiotic Prophylaxis , Extraction, Obstetrical/adverse effects , Puerperal Infection/prevention & control , Vaginal Diseases/prevention & control , Endometritis/prevention & control , Female , Humans , Obstetrical Forceps , Pregnancy , Randomized Controlled Trials as Topic , Vacuum Extraction, Obstetrical/adverse effectsABSTRACT
Chlamydia trachomatis imposes serious health problems and causes infertility. Because of asymptomatic onset, it often escapes antibiotic treatment. Therefore, vaccines offer a better option for the prevention of unwanted inflammatory sequelae. The existence of serologically distinct serovars of C. trachomatis suggests that a vaccine will need to provide protection against multiple serovars. Chlamydia spp. use a highly conserved type III secretion system (T3SS) composed of structural and effector proteins which is an essential virulence factor. In this study, we expressed the T3SS needle protein of Chlamydia muridarum, TC_0037, an ortholog of C. trachomatis CdsF, in a replication-defective adenoviral vector (AdTC_0037) and evaluated its protective efficacy in an intravaginal Chlamydia muridarum model. For better immune responses, we employed a heterologous prime-boost immunization protocol in which mice were intranasally primed with AdTC_0037 and subcutaneously boosted with recombinant TC_0037 and Toll-like receptor 4 agonist monophosphoryl lipid A mixed in a squalene nanoscale emulsion. We found that immunization with TC_0037 antigen induced specific humoral and T cell responses, decreased Chlamydia loads in the genital tract, and abrogated pathology of upper genital organs. Together, our results suggest that TC_0037, a highly conserved chlamydial T3SS protein, is a good candidate for inclusion in a Chlamydia vaccine.
Subject(s)
Bacterial Proteins , Bacterial Vaccines , Chlamydia Infections , Chlamydia muridarum , Type III Secretion Systems , Administration, Intranasal , Animals , Bacterial Proteins/genetics , Bacterial Proteins/immunology , Bacterial Vaccines/genetics , Bacterial Vaccines/immunology , Chlamydia Infections/immunology , Chlamydia Infections/microbiology , Chlamydia Infections/prevention & control , Chlamydia muridarum/genetics , Chlamydia muridarum/immunology , Disease Models, Animal , Female , Immunization , Mice , Mice, Inbred BALB C , Type III Secretion Systems/genetics , Type III Secretion Systems/immunology , Vaccines, DNA/genetics , Vaccines, DNA/immunology , Vaginal Diseases/immunology , Vaginal Diseases/microbiology , Vaginal Diseases/prevention & controlABSTRACT
Se realizó un estudio descriptivo retrospectivo de tipo transversal en las pacientes embarazadas con diagnóstico de infección vaginal, atendidas en la Sala 1E del Hospital Materno Infantil Fe del Valle Ramos,de Manzanillo en el período de enero del 2011 al 2013, con el objetivo de describir la infección vaginal y su influencia en la morbilidad y mortalidad perinatal. El universo de estudio estuvo constituido por 2145 gestantes y la muestra quedó conformada por 2135 pacientes que cumplieron con los criterios de inclusión propuestos en la investigación. Como fuente primaria de recolección de datos se aplicó un formulario. Se utilizaron variables como: edad, nivel de escolaridad, agente causal, hábitos higiénicos sanitarios y morbilidad y mortalidad perinatal. En el estudio predominaron las gestantes de 15-19 años con nivel de escolaridad preuniversitario terminado, el agente causal más frecuente fue la Candida albicans; los hábitos higiénicos sanitarios fueron inadecuados; los recién nacidos con distrés respiratorio transitorio y la muerte fetal tardía fueron los predominantes(AU)
A retrospective cross-sectional study was conducted in pregnant patients diagnosed with vaginal infection, assisted in Room 1E Maternity Hospital Fe del Valle Ramos from Manzanillo in the period from January 2011 to 2013, with the aim of describing the vaginal infection and its impact on perinatal morbidity and mortality. The study group consisted of 2145 pregnant women and the sample was composed of 2135 patients who met the inclusion criteria proposed in the investigation. As the primary source of data a collection form was applied. There were used variables as age, educational level, causal agent, sanitary habits and perinatal morbidity and mortality. In the study they prevailed pregnant women aged 15-19 with completed pre-university education level, the most common causative agent was Candidaalbicans; hygienic sanitary habits were inadequate, infants with temporary respiratory distress and late fetal death were predominant(EU)
Subject(s)
Humans , Female , Pregnancy , Infant, Newborn , Vaginal Diseases/prevention & control , Pregnancy Complications, Infectious/therapy , Candida albicans/pathogenicity , Respiratory Distress Syndrome, Newborn , Stillbirth , Epidemiology, Descriptive , Cross-Sectional Studies , Retrospective StudiesABSTRACT
OBJECTIVE: Sutures in laparoscopy have been extensively developed in recent years. In this study, we assessed differences between Polysorb™ braided absorbable suture (CL-914) and V-Loc™ barbed suture (V-Loc 180) used in vaginal cuff closure during laparoscopic hysterectomy from various aspects. STUDY DESIGN: This paper presented a prospective cohort study of 490 consecutive women underwent total laparoscopic hysterectomy (TLH) performed between January 2013 and September 2015 applying identical procedure technique, with cuff closure approaches selected by surgeons. Data collected included operative time, estimated blood loss, postoperative changes in body temperature, perioperative routine blood parameters changes, total average hospital stay, and postoperative hospital stay. In addition, short-term (at least 6 months) outcomes of vaginal cuff granulomatous (VCG) between the two suture approaches were compared. RESULTS: Between groups, statistical differences were detected in operative duration, estimated blood loss, total and postoperative hospital stay, WBC, neutrophil counts and Hb in postoperative routine blood parameters; while there were no significant differences in other data (all P>0.05). Postoperative routine blood parameters in each group: compared to preoperative baseline, in Group 1, WBC, N increased (P<0.05), while RBC, Hb decreased (P<0.05). In Group 2, same tendency in WBC, N and Hb was indicated, but RBC increased with no significant difference. In both groups, vaginal cuff healing was well, with no dehiscence. VCG occurred more often in women used CL-914 than women applied V-Loc 180. CONCLUSIONS: V-Loc barbed suture can be used for vaginal cuff closure during TLH due to advantages such as less operative duration and blood loss, shorter postoperative and total hospital stay, and reduced VCG formation six months after TLH.