Prevalence of female genital tuberculosis, its risk factors and associated clinical features among the women of Andaman Islands, India: a community-based study.

OBJECTIVE: There is scarcity of information on the prevalence of female genital tuberculosis (FGTB) in the community. The present study was carried out to estimate the prevalence of FGTB, its risk factors and associated clinical features. STUDY DESIGN: Community-based cross-sectional survey. METHODS: This study was carried during October 2011 and May 2014 in the Andaman Islands. A total of 13,300 women aged 20-59 years were primarily screened using a structured questionnaire. About 721 (5.4%) were found initially eligible for screening for genital tuberculosis by clinical examination and specimen collection for laboratory tests but only 460 (63.8%) expressed their willingness. Endometrial specimens were collected from 405 (88%) subjects. The association of the potential risk factors with genital tuberculosis was tested by Chi-squared test. A similar analysis was performed to identify clinical features associated with genital tuberculosis. RESULTS: The estimated prevalence of FGTB was 45.1 cases per 100,000 women (95% confidence interval [CI]: 16.6-98.1). Infertility and oligomenorrhoea were identified as clinical features associated with FGTB. Past history of tuberculosis and history of close contact with tuberculosis cases were identified as risk factors. CONCLUSIONS: This study shows the prevalence of FGTB among the female population of the Andaman Islands. Though the estimated prevalence was close to the expected prevalence, but as only 63.8% of the eligible women could be adequately screened, a much higher prevalence of FGTB could not be ruled out. Infertility, oligomenorrhoea, past history of tuberculosis and contact with tuberculosis case were identified as factors associated with genital tuberculosis.

Female Genital Tuberculosis.

Female genital tuberculosis (FGTB) is an important cause of morbidity and infertility worldwide. Mycobacterium tuberculosis most commonly spreads to the genital tract from a focus elsewhere in the body and affects the bilateral fallopian tubes and/or endometrium. Many patients with FGTB have indolent disease and are only diagnosed after evaluation for infertility. Women may present with menstrual irregularities, lower abdominal or pelvic pain, or abnormal vaginal discharge. Given the low sensitivity of diagnostic tests, various composite reference standards are used to diagnose FGTB, including some combination of endoscopic findings, microbiological or molecular testing, and histopathological evidence in gynecological specimens. Early treatment with a standard regimen of a 2-month intensive phase with isoniazid, rifampin, ethambutol, and pyrazinamide, followed by a 4-month continuation phase with isoniazid and rifampin, is recommended to prevent irreversible organ damage. However, even with treatment, FGTB can lead to infertility or pregnancy-related complications, and stigma is pervasive.

Insight into diagnosis of female genital tuberculosis.

INTRODUCTION: Female genital tuberculosis (TB) is a common form of extrapulmonary TB (EPTB) with varied clinical presentations, i.e. infertility, pelvic pain, and menstrual irregularities. Diagnosis of female genital TB is challenging predominantly due to paucibacillary nature of specimens and inconclusive results obtained by most of the routine laboratory tests. AREAS COVERED: This review has briefly summarized the epidemiology, clinical features, and transmission of female genital TB. Commonly used laboratory tests include bacteriological examination (smear/culture), tuberculin skin testing, interferon-γ release assays, imaging, laparoscopy/hysteroscopy, and histopathological/cytological observations. Furthermore, utility of nucleic acid amplification tests (NAATs), like loop-mediated isothermal amplification, PCR, multiplex-PCR, nested PCR, real-time PCR, and GeneXpert® could significantly improve the detection of female genital TB. EXPERT OPINION: Currently, there is no single test available for the efficient diagnosis of female genital TB, rather a combination of tests is being employed, which yields moderate diagnostic accuracy. The latest modalities developed for diagnosing pulmonary TB and other clinical EPTB forms, i.e. aptamer-linked immobilized sorbent assay, immuno-PCR (I-PCR), analysis of circulating cell-free DNA by NAATs, and identification of Mycobacterium tuberculosis biomarkers within extracellular vesicles of bodily fluids by I-PCR/nanoparticle-based I-PCR, may also be exploited to further improve the diagnosis of female genital TB.

Detection of genital tuberculosis among women with infertility using best clinical practices in India: An implementation study.

BACKGROUND: Diagnosis of genital tuberculosis (TB) as a cause of infertility still remains a diagnostic dilemma for clinicians, as no standard guidelines exist. The recently proposed best practices for genital TB diagnosis have not been evaluated yet in India. OBJECTIVES: To implement best practices to diagnose and treat likely genital TB as a cause of infertility. METHODS: Between April 2016 and June 2018, consenting women seen at a tertiary hospital infertility clinic were assessed by thorough TB related clinical history, ultrasonography, tuberculin skin test (TST), and ESR. Those with suspected genital TB underwent laparohysteroscopy. Clinical and laboratory characteristics were compared between likely (microbiologically confirmed or probable TB) and unlikely (possible and no genital TB) genital TB. Fertility outcome was assessed among women initiated on anti-TB treatment (ATT). RESULTS: Of 185 women seeking infertility care, likely genital TB was identified among 29 (15.7%) women, with 6 (21%) confirmed and 23 (79%) probable genital TB. Compared to unlikely genital TB cases, the likely genital TB group were found to have past history of TB (p < 0.001); positive TST (p = 0.002) and elevated ESR (p = 0.001). Among the likely genital TB group, all 6 confirmed genital TB were started on ATT and 2 (33.3%) conceived. Of 5 probable genital TB started on ATT, 3 (60%) conceived. CONCLUSION: Approximately 1/6th of women seeking infertility care met the criteria for likely genital TB. Conception among over-half of treated probable genital TB cases provides preliminary evidence that best clinical practices can be utilized, but needs further confirmatory studies.

Evaluation of endometrial polymerase chain reaction in diagnosis of female genital tuberculosis

Background: Genital tuberculosis also known as tuberculous pelvic inflammatory disease can affect any age group, most common being reproductive women of 20-40 years. Clinical diagnosis of genital tuberculosis is a big challenge as the disease is either asymptomatic or has varied presentations. Conventional methods for diagnosis including AFB smear, endometrial histopathology and culture have limitations of low detection rate because of paucibacillary nature of disease. Laparoscopy generally detects macroscopic changes such as peritubal adhesions, tubercles and tubo-ovarian mass but it fails to diagnose disease at early stage. The objective of this study was to evaluate efficacy of TB DNA PCR in diagnosis of genital tuberculosis.Methods: A total of 127 patients (between 2013-2016) who presented in gynecologic OPD with symptoms suggestive of tuberculosis were included in the study. All patients were subjected to endometrial histopathology and TB DNA PCR of endometrial tissue and peritoneal fluid. Since there is no gold standard test available for diagnosis of genital tuberculosis, a diagnostic criteria was adopted in the study based on laparoscopic findings, clinical history and other investigations. Patients were divided in two groups. Group A included patients positive of tuberculosis based on diagnostic criteria. Group B included patients negative for tuberculosis based on diagnostic criteria.Results: In our study sensitivity of endometrial PCR, peritoneal PCR and endometrial histopathology were 73.8%,17.8% and 10.7% respectively. Endometrial histopathology and peritoneal fluid PCR was found to be highly specific (100%) while endometrial PCR was found to be 93% specific. Endometrial PCR although has highest sensitivity and specificity amongst the groups evaluated but high false negative rate was its major limitation.Conclusions: No single test fulfills all criteria to emerge as sole diagnostic test, hence a high degree of suspicion with a detailed history and investigating with a variety of tests is all that is required to diagnose geniatal tuberculosis.

Evaluating PCR, culture & histopathology in the diagnosis of female genital tuberculosis.

Background & objectives: Genital tuberculosis (GTB) is one of the major causes for severe tubal disease leading to infertility. Unlike pulmonary tuberculosis, the clinical diagnosis of GTB is difficult because in majority of cases the disease is either asymptomatic or has varied clinical presentation. Routine laboratory values are of little value in the diagnosis. An absolute diagnosis cannot be made from characteristic features in hysterosalpingogram (HSG) or laparoscopy. Due to the paucibacillary nature of GTB, diagnosis by mycobacterial culture and histopathological examination (HPE) have limitations and low detection rate. The objective of this study was to evaluate the efficacy of PCR technique, culture and histopathological examination in the diagnosis of GTB in female infertility. Methods: This study included 72 infertile women who met the inclusion and exclusion criteria. After a detailed history and clinical examination all patients were subjected to investigations including pelvic sonogram, HSG and laparoscopy. Endometrial samples from were allocated for AFB smear, culture and HPE examination. Only 49 samples were available for PCR using IS 6110 and TRC4 primers. In seven patients peritoneal fluid was also taken for culture and PCR. Based on the clinical profile and laparoscopic findings, a diagnostic criteria was derived to suspect GTB. Specific diagnostic tests were evaluated against this diagnostic criterion. Results: Laparoscopy was suggestive of tuberculosis in 59.7 per cent of cases, AFB smear was positive in 8.3 per cent, culture was positive in 5.6 per cent, HPE positive in 6.9 per cent and PCR was positive in 36.7 per cent of cases. Based on the diagnostic criteria, GTB was suspected in 28 of the 49 cases. On evaluating against the diagnostic criteria, the sensitivity of PCR, HPE and culture were 57.1, 10.7, 7.14 per cent respectively. The concordance of results between the clinical criteria and specific diagnostic tests were analysed by Kappa measure of agreement. The culture and HPE showed mild agreement with the clinical criteria, whereas PCR showed a moderate agreement. PCR was positive in Two of the 21 cases in whom GTB was not suspected. False positive PCR in these two cases were ruled out by multiple areas of sampling and re-sampling in one case. The PCR results were negative in 12 of the 28 cases. PCR using TRC4 primers had a higher sensitivity (46.4%) than IS 6110 primers (25%) in detecting clinically suspected GTB. Interpretation & conclusions: Our results showed that conventional methods of diagnosis namely, HPE, AFB smear and culture have low sensitivity. PCR was found to be useful in diagnosing early disease as well as confirming diagnosis in clinically suspected cases. False negative PCR was an important limitation in this study.