Charles H. Livengood

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.

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.

Evaluation of COBAS AMPLICOR (Roche): Accuracy in Detection of Chlamydia trachomatis and Neisseria gonorrhoeae by Coamplification of Endocervical Specimens

ABSTRACT We evaluated further the accuracy of the COBAS AMPLICOR (Roche) (CA) PCR-based system in detection of Chlamydia trachomatisand Neisseria gonorrhoeae in endocervical specimens. Endocervical specimens collected for any indication for testing forC. trachomatis and N. gonorrhoeae among a university hospital health system population were included. Testing forC. 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. trachomatissamples, the prevalence of true positivity was 9.2%, and among the 618N. 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. trachomatissamples which would have been missed otherwise. The direct cost of each clinical result with CA was estimated to be

Efficacy of Clindamycin Vaginal Ovule (3-Day Treatment) vs.Clindamycin Vaginal Cream (7-Day Treatment) in Bacterial Vaginosis

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.

Bacterial vaginosis: Diagnostic and pathogenetic findings during topical clindamycin therapy

Objective: To compare the efficacy and safety of a 3-day regimen of clindamycin vaginal ovules with a 7-day regimen of clindamycin vaginal cream for the treatment of bacterial vaginosis (BV) Methods: Women with a clinical diagnosis of BV were treated with a 3-day course of clindamycin ovules or a 7-day course of clindamycin cream administered intravaginally. Three hundred and eighty-four patients received study drug and were included in the evaluable patient population (ovule group, n = 204; cream group, n = 180). Assessments included pelvic examination and diagnostic testing. Primary efficacy endpoints were a resolution of two of three diagnostic criteria at the first follow-up visit and three of three diagnostic criteria at the second. Results: Cure rates in the evaluable patient population were similar between treatment groups: 53.7% (109/204) for the ovule group and 47.8% (85/180) for the cream group (p = 0.2471, 95% CI– 4.1–16.0%). The most commonly reported medical event, vulvovaginal pruritus, had similar incidence in both treatment groups. Conclusions: A 3-day course of clindamycin vaginal ovules is as effective and well-tolerated as a 7-day course of clindamycin vaginal cream in the treatment of BV.

Effectiveness of two tinidazole regimens in treatment of bacterial vaginosis: a randomized controlled trial.

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.

Guidelines for the diagnosis, treatment and prevention of postoperative infections

OBJECTIVE: To assess the effectiveness at 21–30 days after treatment of tinidazole administered orally at 1 g once daily for 5 days and 2 g once daily for 2 days, compared with placebo, in the treatment of bacterial vaginosis, using rigorous U.S. Food and Drug Administration (FDA)–recommended criteria to define cure. METHODS: A total of 235 women at 10 U.S. centers participated in this prospective, randomized, double-blinded, placebo-controlled trial. Presence or absence of all five following criteria was required to define diagnosis or cure of bacterial vaginosis: 1) clue cells were at least 20% of squamous cells in microscopic examination of vaginal fluid; 2) positive potassium hydroxide whiff test; 3) a homogeneous, thin, white-gray vaginal discharge; 4) vaginal pH greater than 4.5; and 5) Nugent score greater than or equal to 4 on Gram-stained vaginal fluid. Compliance, tolerability, and safety were assessed using patient diaries and interviews at 8–10 days and 21–30 days after treatment. Cochran-Mantel-Haenszel statistical analysis with Bonferroni adjustment was used to compare outcomes. RESULTS: Superior efficacy was demonstrated by tinidazole for the 1 g once daily for 5 days regimen (36.8% cured, P<.001, number needed to treat 3.2) and for the 2 g once daily for 2 days regimen (27.4% cured, P<.001, number needed to treat 4.5), when compared with placebo (5.1% cured) in the primary endpoint analysis. Using more traditional criteria for cure, efficacy was greater. Compliance with study therapy and tolerability were comparable in the three treatment groups. CONCLUSION: Both tinidazole regimens studied provided effective treatment for bacterial vaginosis. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00229216 LEVEL OF EVIDENCE: I

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

Bacterial contamination of the operative site is a common occurrence in obstetrics and gynecology. The widespread use of antibiotic prophylaxis has reduced but not eliminated serious postoperative infections. For most operations, a single dose of a limited-spectrum drug has been as effective as a multidose regimen. In the differential diagnosis it is important to consider cellulitis, abscess, necrotizing fasciitis and septic pelvic thrombophlebitis. Abscess and necrotizing fasciitis are expected to require invasive therapy in addition to antibiotics, while cellulitis and septic pelvic thrombophlebitis should respond to medical management alone. Although a postoperative fever is a warning sign of possible infection, it may also be caused by the antibiotics that are given for treatment. The use of prolonged courses of antibiotics once the patient is clinically well is discouraged. While clinical guidelines are provided for use in the diagnosis and management of postoperative infections, these recommendations are intended for general direction and not as an exclusive management plan.

Pelvic inflammatory disease: Findings during inpatienttreatment of clinically severe, laparoscopy-documented disease

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.

Phycomycosis of the vulva

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.