Evaluation of COBAS AMPLICOR (Roche): accuracy in detection of Chlamydia trachomatis and Neisseria gonorrhoeae by coamplification of endocervical specimens.

We evaluated further the accuracy of the COBAS AMPLICOR (Roche) (CA) PCR-based system in detection of Chlamydia trachomatis and Neisseria gonorrhoeae in endocervical specimens. Endocervical specimens collected for any indication for testing for C. trachomatis and N. gonorrhoeae among a university hospital health system population were included. Testing for C. trachomatis was done by two PCR methods, CA and manual microwell AMPLICOR (Roche) (MWA), and by culture; testing for N. gonorrhoeae was done by CA and culture. Discrepancy resolution was performed. Reproducibility testing and hands-on labor time measurements for CA were done. Among 654 C. trachomatis samples, the prevalence of true positivity was 9.2%, and among the 618 N. gonorrhoeae samples, the prevalence of true positivity was 4.4%. For detection of C. trachomatis, the sensitivity, specificity, and negative and positive predictive values were, respectively, as follows for each test: CA, 93.3, 99.7, 99.3, and 96.4%; MWA, 91.7, 99.7, 99.2, and 96.5%; and culture, 65.0, 100, 96.6, and 100%. For detection of N. gonorrhoeae those values were as follows: CA, 96.3, 100, 99.8, and 100%; and culture, 92.6, 100, 99.7, and 100%. Hands-on labor time for each clinical result was estimated to be at 7.5 min. The prevalence of inhibitory specimens was 3.5%, including two positive C. trachomatis samples which would have been missed otherwise. The direct cost of each clinical result with CA was estimated to be $9.09. Our methods include a diverse range of indications for testing among women, using endocervical swabbing samples, 2 M sucrose phosphate transport medium, and discrepancy resolution for comparison. Under our test conditions, the CA system is an accurate, rapid, and cost- and labor-efficient method for detection of C. trachomatis and N. gonorrhoeae.

Comparison of once-daily and twice-daily dosing of 0.75% metronidazole gel in the treatment of bacterial vaginosis.

BACKGROUND AND OBJECTIVES: Bacterial vaginosis is the most common cause of vaginal symptoms in women and has potential complications. Efforts to improve treatment of this disease process are warranted. GOAL OF THIS STUDY: The goal of this study was to compare the safety and efficacy of once-daily intravaginal administration of 0.75% metronidazole gel for 5 days to the established twice-daily regimen in the treatment of bacterial vaginosis. STUDY DESIGN: Nonpregnant women with bacterial vaginosis diagnosed by accepted clinical criteria at 14 geographically diverse general gynecology clinics were enrolled in this prospective, randomized, investigator-blind, parallel study. They were treated with either once-daily or twice-daily 0.75% metronidazole gel 5 g intravaginally for 5 days and were reevaluated at 7 to 12 days and 28 to 35 days after completing treatment. Efficacy was determined by clinical criteria. Adverse drug reactions were monitored. RESULTS: Of the 514 evaluable women enrolled, bacterial vaginosis was cured at the first return visit among evaluable patients in 153 of 199 (77%) of those who received the once-daily and in 157 of 196 (80%) of those who received the twice-daily administration. Bacterial vaginosis was cured among evaluable patients at the final visit in 104 of 180 (58%) of those who received once-daily and 109 of 178 (61%) of those who received the twice-daily regimen. Intent-to-treat analysis showed cure at 1 month in 118 of 207 (57%) of those treated once daily and 129 of 209 (62%) of those treated twice daily. Side effects were mild, and none caused treatment discontinuation. CONCLUSIONS: Once-daily dosing of 0.75% metronidazole gel 5 g for 5 days yields efficacy, safety, and tolerance equivalent to the currently used twice-daily dosing in the treatment of bacterial vaginosis, adding another competitive choice to the available therapeutic options for this condition.

Performance of a commercial polymerase chain reaction test for endocervical Chlamydia trachomatis infection in a university hospital population.

OBJECTIVES: To examine the accuracy of a commercial polymerase chain reaction (PCR) test (Amplicor CTR, Roche Diagnostic Systems, Branchburg NJ) for identification of endocervical chlamydial infections through both laboratory evaluation and among a diverse teaching hospital patient population. METHODS: Testing of reliable threshold inocula and reproducibility were carried out using laboratory stock organisms. Paired endocervical samples from patients with a wide range of indications were tested by PCR and an established culture procedure, and discrepant pairs were further analyzed to determine true results. RESULTS: Laboratory evaluation suggested that one copy of target DNA from a viable organism consistently yielded a positive result, and test reproducibility was very good, with an overall coefficient of variation of 15%. Compared to true results in 1,588 paired clinical samples from 1,489 women with a 10% prevalence of infection, the PCR test and culture yielded respective sensitivities of 87.4% and 78.0%, and negative predictive values of 98.6% and 97.6%. Specificity and positive predictive value for both tests were 100%. Cost per specimen was nearly identical at $18.84 and $18.88 respectively. Polymerase inhibitors and organisms lacking target DNA were not found in false-negative PCR samples. CONCLUSION: This commercial PCR test is accurate, cost-competitive, and much faster than culture for diagnosis of endocervical chlamydia infections in our population of intermediate prevalence of chlamydial infection.

Characterization of the inflammatory cytokines in the vagina during pregnancy and labor and with bacterial vaginosis.

OBJECTIVES: 1) To characterize the presence of interleukin-1 alpha (IL-1 alpha), interleukin-1 beta (IL-1 beta), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-alpha) in the vagina during pregnancy and in labor; 2) to compare the vaginal levels of these inflammatory cytokines between laboring and nonlaboring patients; and 3) to compare the vaginal levels of these cytokines between women with and without bacterial vaginosis (BV). METHODS: Vaginal fluid was obtained by lavage from pregnant women with intact membranes at various gestational ages and during labor at term. These samples were analyzed for specific cytokine levels using standard enzyme-linked immunosorbent assay techniques. A Gram stain, wet mount, and pH were obtained from the vaginal fluid and were used to diagnose BV. The Mann-Whitney U test was used to evaluate the individual cytokine levels between groups, with P < .05 considered statistically significant. RESULTS: There was a wide range of vaginal cytokine levels found in our pregnant population (N = 72). Vaginal levels of IL-1 beta (median 1070 versus 245.7 pg/mL) and IL-6 (9.0 versus 0 pg/mL) were found to be significantly elevated in laboring patients as compared with nonlaboring patients (P = .005 and P = .002, respectively). There were no significant differences in the levels of IL-1 alpha and TNF-alpha between the laboring and nonlaboring women. Interleukin-1 beta was also found to be significantly elevated in the group of patients with BV (3364 versus 245.7 pg/mL; P = .01), particularly those who were nonlaboring (P = .003). In each individual patient, there was a wide variation in the levels of the four different cytokines. CONCLUSIONS: Measurable levels of the inflammatory cytokines IL-1 alpha, IL-1 beta, IL-6, and TNF-alpha were present in the vagina during pregnancy and labor. Vaginal levels of IL-1 beta and IL-6 were found to be significantly elevated in laboring patients as compared with nonlaboring patients. Vaginal levels of IL-1 beta were also significantly elevated in nonlaboring patients with BV.

Colovaginal fistula. Report of a case with failure of transvaginal repair.

BACKGROUND: Spontaneous development of colovaginal fistula is a rare cause of abnormal vaginal discharge in older women and most commonly arises from diverticular disease. Laparotomy for segmental colonic resection is the accepted treatment. The author found no previous reports of attempted transvaginal closure of these fistulae, although such closure of similar fistulae can sometimes be accomplished in patients with Crohn's disease when quiescence is achieved. CASE: An otherwise healthy 69-year-old female developed a colovaginal fistula as a result of diverticular disease. Resolution of all associated inflammatory changes was achieved over four months. A three-layer transvaginal closure of the fistula using the Futh technique was then performed; it was technically successful but broke down one week later. CONCLUSION: Transvaginal closure of a colovaginal fistula, even with intensive preparatory efforts, cannot be recommended on the basis of this attempt.

Bacterial vaginosis in pregnancy: an approach for the 1990s.

It is proposed that clinicians screen all pregnant women at high risk for preterm labor and premature rupture of membranes for bacterial vaginosis, and treat all women when it is diagnosed. This infection is associated with a two to three times increase in preterm labor and delivery, premature rupture of the membranes, and endometritis. Although cause and effect have not been conclusively documented, these associations must be considered in the practice of obstetrics at the present. The paucity of vaginal Lactobacillus spp is pivotal in allowing overgrowth of many other organisms of the vagina. Screening is suggested because 50 percent of bacterial vaginosis is asymptomatic. The diagnosis, which is rapidly made and inexpensive, remains defined by clue cells seen on wet prep, high vaginal pH, and amine odor of the vaginal discharge. Optimal treatment of pregnant women with bacterial vaginosis is via oral or intravaginal metronidazole or clindamycin.

Bacterial vaginosis-associated microflora and effects of topical intravaginal clindamycin.

OBJECTIVES: The goals of this study were as follows: (1) to further define the microbiologic characteristics of bacterial vaginosis in nonpregnant women, (2) to evaluate the in vivo activity of topical intravaginal clindamycin and reference this activity to clinical cure, and (3) to evaluate for clindamycin-related emergence of species. STUDY DESIGN: Vaginal microflora was identified and quantified from 33 women with bacterial vaginosis at enrollment and 4 to 7 days after treatment with placebo or three different dosages of clindamycin administered twice daily for 5 days in a double-blind, randomized trial. RESULTS: Clindamycin eradicated and/or decreased counts of major bacterial vaginosis-associated microflora such as Gardnerella, gram-negative and gram-positive anaerobes, and Mycoplasma hominis; this was correlated with cure in 22 of 24 (92%) women. Altered flora (nonlactobacilli) among some of the women who received clindamycin appeared to be transient and without apparent adverse effects. CONCLUSION: Microbial (and clinical) results support use of clindamycin as effective treatment of bacterial vaginosis.

Bacterial vaginosis: efficacy and safety of intravaginal metronidazole treatment.

OBJECTIVE: We evaluated the effectiveness and safety of intravaginal metronidazole in the treatment of bacterial vaginosis. Demographic data, Gram stain score, and individual clinical diagnostic criteria for bacterial vaginosis were evaluated for association with therapeutic outcome. METHODS: According to accepted diagnostic criteria and blinded Gram stain scoring for quality control, a multicenter, prospective, double-blinded trial of patients randomized to either 0.75% metronidazole gel 5 gm twice daily for 5 days or placebo was undertaken. Therapeutic response after completion of treatment was evaluated by examination at 4 to 16 days and again at 28 to 32 days for patients initially cured. RESULTS: After metronidazole treatment, 38 (78%) of 49 patients were cured initially, compared with 11 (27%) of 41 placebo recipients (p < 0.001). One month after treatment 31 (91%) of 34 in the group initially cured by metronidazole remained cured. Side effects were uncommon and mild. Significant intercenter differences were noted for vaginal discharge assessment but not for other diagnostic criteria. Among patients cured initially with metronidazole, mean Gram stain score was 0.58 among those in whom cure was maintained versus 2.33 for those in whom recurrent bacterial vaginosis developed 1 month after treatment (p = 0.03). Curative metronidazole treatment was found initially in 4 (100%) of 4 patients with sperm present on gram stain compared with 34 (76%) of 45 with sperm absent (p = 0.56) and in 6 (100%) of 6 and 25 (89%) of 28, respectively, at the final visit (p = 1.0). CONCLUSIONS: Intravaginal metronidazole is effective, safe, well-tolerated, durable therapy for bacterial vaginosis. Characterization of vaginal discharge appears to be the most variable among the diagnostic criteria for bacterial vaginosis. Gram stain score may be able to identify patients cured early after therapy who are at risk for later recurrence. Exposure to semen does not appear to affect efficacy of intravaginal metronidazole.

Pelvic inflammatory disease: findings during inpatient treatment of clinically severe, laparoscopy-documented disease.

OBJECTIVES: We evaluated the relationship between clinically severe pelvic inflammatory disease and laparoscopic diagnosis and grading, comparative treatment with clindamycin plus cefamandole or doxycycline, and a management protocol for inpatient pelvic inflammatory disease treatment. STUDY DESIGN: Thirty-three patients who met our clinical criteria for severe pelvic inflammatory disease underwent diagnostic laparoscopy. Pelvic inflammatory disease patients were randomized to double-blind treatment with clindamycin plus cefamandole or doxycycline within our management protocol; postdischarge oral antibiotics were omitted. RESULTS: Laparoscopy confirmed pelvic inflammatory disease in 23 (70%) patients; 10 (44%) had mild pelvic inflammatory disease by laparoscopic grading. Laparoscopic grade alone predicted necessary duration of therapy to response: mild pelvic inflammatory disease, 2.3 +/- 0.5 days; moderate pelvic inflammatory disease, 2.7 +/- 1.5 days; and severe pelvic inflammatory disease, 3.9 +/- 1.5 days (p less than 0.05). Using the management plan presented, response rates for both antibiotic regimens were 100%. CONCLUSIONS: Clinical diagnosis and grading of severe pelvic inflammatory disease has poor specificity. Laparoscopic grading of severity of pelvic inflammatory disease seems accurate. Both clindamycin plus cefamandole and clindamycin plus doxycycline are equally effective regimens for treatment of pelvic inflammatory disease and did not require supplementation after discharge. Our management plan is objective and practical; daily bimanual examination is the most sensitive indicator of persistent disease.

Resolution of resistant vaginal trichomoniasis associated with the use of intravaginal nonoxynol-9.

An otherwise healthy, sexually inactive woman was determined by in vitro susceptibility testing to have vaginal infection by a strain of Trichomonas vaginalis with high-grade metronidazole resistance. Prolonged high-dose oral and intravaginal metronidazole therapy did not resolve the infection, but caused temporary peripheral neuropathy. Tinidazole was ineffective as well. Serendipitous use of topical intravaginal nonoxynol-9 for contraception appeared to resolve the infection. We reviewed reinfection, noncompliance with therapy, and concomitant use of other drugs that degrade the efficacy of metronidazole as possible causes of falsely "resistant" trichomoniasis. The literature suggests that mebendazole, furazolidone, and anisomycin may be effective for treatment of metronidazole-resistant trichomoniasis. This case and previously published laboratory data suggest that intravaginal nonoxynol-9 deserves further study as a treatment for resistant trichomoniasis, though trichomonal coinfection of the patient's urethra, Skene glands, and sexual partner would not likely be resolved by such therapy.

Necrotizing fasciitis in irradiated tissue from diabetic women. A report of two cases.

Two diabetic women with pelvic malignancies developed necrotizing fasciitis within the irradiation fields. Despite aggressive surgical and medical therapy, both died when their health became too unstable for them to tolerate further surgery to resect the residual infection. We attribute their poor outcome to several factors. First, postradiation tissue changes obscured the early clinical findings necessary for a prompt diagnosis and made the identification of adequate surgical margins difficult. Second, diabetic patients have increased susceptibility to this infection. Third, the cumulative effects of radiation, diabetes mellitus and other factors that are common in patients with gynecologic malignancy (advanced age, vascular disease, obesity) favor the development, progression and persistence of necrotizing fasciitis. Radiographic studies were helpful in defining the extent of the infection in one patient.

Bacterial vaginosis: diagnostic and pathogenetic findings during topical clindamycin therapy.

We examined subjective and objective correlates among 67 women with symptomatic bacterial vaginosis before and after treatment with intravaginal clindamycin or placebo. We found no preponderance of any sexual practices among these patients. Nine patients (13.4%) had had hysterectomy. Whereas odor and discharge were the most common symptoms, 30 patients (44.8%) also complained of vulvovaginal irritation. Symptoms correlated poorly with objective therapeutic outcome. On examination the diagnosis would have been missed in seven patients (10.4%) if the clinician relied on presence of an abnormal vaginal discharge to suggest bacterial vaginosis. Vaginal pH greater than 4.5 was found immediately after curative therapy in 59.6% of patients. Mobiluncus spp. morphotypes were 99.0% specific and 52.1% sensitive and proline aminopeptidase activity in vaginal fluid was 84.4% sensitive and 70.2% specific for diagnosis. Our Gram stain criteria yielded no false-negative results, 6.1% false-positive, and frequent indeterminate results after therapy. We found little evidence for sexual transmission of bacterial vaginosis. Recurrence after effective therapy was not predicted by vaginal pH elevation, positive or indeterminate Gram stain result, or positive proline aminopeptidase test.

Bacterial vaginosis: treatment with topical intravaginal clindamycin phosphate.

We tested topical intravaginal clindamycin phosphate at concentrations of 0.1, 1.0, and 2.0% in the treatment of 62 women with symptomatic bacterial vaginosis in a prospective, randomized, double-blind, placebo-controlled trial, and offered open-label treatment with 1.0% clindamycin to patients with persistent disease after blinded treatment. Blinded intravaginal clindamycin phosphate treatment cured bacterial vaginosis in 93.5% (43 of 46) of patients 4-7 days after therapy, compared with 25.0% (four of 16) of patients receiving placebo (P less than .001). One month later, 89.7% (35 of 39) of those who initially responded to clindamycin treatment showed persistent cure. There were no significant side effects.

Failed abdominal sacral colpopexy: observations and recommendations.

Abdominal sacral colpopexy provides effective surgical management of the vagina that has prolapsed after hysterectomy. Recurrences of prolapse after this operation are rare. Three patients are presented who did exhibit recurrent prolapse necessitating another operation. In two patients, the synthetic mesh used for colpopexy had separated from the vagina. In the remaining patient, the posterior vaginal wall had ruptured distal to the attachment of mesh to the vagina. In each patient, the mesh had become completely interpenetrated by tissue. We believe that failures can be minimized by suturing the suspensory mesh to the vagina over as extended an area as possible. Reasons for this belief are addressed, and techniques for achieving such an attachment are described. A meticulous culdoplasty beneath the suspensory mesh is also considered important, as is the use of permanent sutures placed through the full thickness of the vagina in attaching the mesh.

Direct fluorescent antibody testing for endocervical Chlamydia trachomatis: factors affecting accuracy.

Endocervical swabbings obtained after two previous cleansing swabs from 202 women with indications for testing for genital chlamydial infection were evaluated for the presence of Chlamydia trachomatis by culture and two direct fluorescent monoclonal antibody tests. In comparison with culture, the two direct fluorescent antibody tests showed sensitivities of 37.5 and 56.5% and specificities of 97.0 and 99.4% when read by experienced microbiology technologists recently trained in chlamydia direct fluorescent antibody interpretation and blinded to culture results. Overall sensitivities of 69.6 and 78.3% for the direct fluorescent antibody tests were obtained by an expert interpreter during discrepancy analysis. When only direct fluorescent antibody test specimens from the first swab after endocervical cleansing were considered, recently trained interpreters obtained sensitivities of 53.8 and 69.2%, and both direct fluorescent antibody tests were 100% sensitive for the expert interpreter. These data emphasize the critical importance of observer expertise and swab order to the accuracy of chlamydia direct fluorescent antibody tests. Previous studies of these tests are examined to determine how these factors and others may have influenced the outcome.

Necrotizing fasciitis arising from a suprapubic catheter site. A case report.

Necrotizing fasciitis is an unusual complication of gynecologic surgery. A woman developed necrotizing fasciitis at the site of suprapubic urinary catheter placement. The diagnostic criteria for necrotizing fasciitis were fulfilled by the patient, whose predisposition for the disease was undiagnosed diabetes mellitus. This rare complication of suprapubic catheter drainage must be considered in high-risk patients presenting with an inflammation at this site of cutaneous trauma.

Phycomycosis of the vulva.

A necrotic ulcerative lesion of the vulva in a patient with diabetic ketoacidosis initially resembled necrotizing fasciitis. Debridement and histologic examination led to a diagnosis of phycomycosis. The condition responded to surgical debridement without antifungal therapy.

Abdominal sacral colpopexy with Mersilene mesh in the retroperitoneal position in the management of posthysterectomy vaginal vault prolapse and enterocele.

During a 12-year study period from 1972 to 1984, 56 patients underwent abdominal sacral colpopexy with retroperitoneal interposition of a suspensory hammock between a prolapsed vaginal vault and the anterior surface of the sacrum. They were followed from 6 months to 12 1/2 years, and constitute the basis of this report. In most patients, a synthetic mesh was the material interposed. Hysterectomy had previously been performed on 53 patients, and in two patients there was congenital absence of the uterus. Indications for abdominal sacral colpopexy, surgical technique, complications, and results of operation are discussed. Seven additional patients underwent this operation after termination of the defined study period.

Endometrial biopsy, bacteremia, and endocarditis risk.

Although bacterial endocarditis in women at risk because of endocardial lesions frequently follows pregnancy-related pelvic surgery, endometrial biopsy with or without brushing for cytology was not known to be associated with bacteremia or endocarditis risk. Because a patient who developed acute bacterial endocarditis as a result of endometrial biopsy performed without antibiotic prophylaxis was encountered, 50 subsequent patients undergoing endometrial brushing and biopsy were studied and postprocedure bacteremia was found in four, all of whom were premenopausal.