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1.  Effects of flexible-dose fesoterodine on overactive bladder symptoms and treatment satisfaction: an open-label study 
To evaluate the efficacy and tolerability of flexible-dose fesoterodine in subjects with overactive bladder (OAB) who were dissatisfied with previous tolterodine treatment.
This was a 12-week, open-label, flexible-dose study of adults with OAB (≥ 8 micturitions and ≥ 3 urgency episodes per 24 h) who had been treated with tolterodine (immediate- or extended-release) for OAB within 2 years of screening and reported dissatisfaction with tolterodine treatment. Subjects received fesoterodine 4 mg once daily for 4 weeks; thereafter, daily dosage was maintained at 4 mg or increased to 8 mg based on the subject’s and physician’s subjective assessment of efficacy and tolerability. Subjects completed 5-day diaries, the Patient Perception of Bladder Condition (PPBC) and the Overactive Bladder Questionnaire (OAB-q) at baseline and week 12 and rated treatment satisfaction at week 12 using the Treatment Satisfaction Question (TSQ). Safety and tolerability were assessed.
Among 516 subjects treated, approximately 50% opted for dose escalation to 8 mg at week 4. Significant improvements from baseline to week 12 were observed in micturitions, urgency urinary incontinence episodes, micturition-related urgency episodes and severe micturition-related urgency episodes per 24 h (all p< 0.0001). Approximately 80% of subjects who responded to the TSQ at week 12 reported satisfaction with treatment; 38% reported being very satisfied. Using the PPBC, 83% of subjects reported improvement at week 12 with 59% reporting improvement ≥ 2 points. Significant improvements from baseline (p< 0.0001) exceeding the minimally important difference (10 points) were observed in OAB-q Symptom Bother and Health-Related Quality of Life (HRQL) scales and all four HRQL domains. Dry mouth (23%) and constipation (5%) were the most common adverse events; no safety issues were identified.
Flexible-dose fesoterodine significantly improved OAB symptoms, HRQL, and rates of treatment satisfaction and was well tolerated in subjects with OAB who were dissatisfied with prior tolterodine therapy.
PMCID: PMC2705818  PMID: 19348029
2.  Darifenacin treatment for overactive bladder in patients who expressed dissatisfaction with prior extended-release antimuscarinic therapy 
Introduction and objective:
Patient perception of overactive bladder (OAB) treatment outcomes can be a useful indicator of benefit and may help drive persistence on treatment, which is known to be poor in OAB. It remains unclear whether OAB patients dissatisfied with one antimuscarinic can achieve satisfaction with another and supporting data are limited. This study investigated patient-reported outcomes and clinical parameters during darifenacin treatment in OAB patients who expressed dissatisfaction with prior extended-release (ER) oxybutynin or tolterodine therapy (administered for ≥ 1 week within the past year).
This open-label study was conducted in darifenacin-naïve OAB patients. Patients received 7.5 mg darifenacin once daily with the possibility of up-titrating to 15 mg after 2 weeks, for up to 12 weeks. Efficacy parameters included the Patient’s Perception of Bladder Condition (PPBC), patient satisfaction with treatment, micturition frequency and number of urgency and urge urinary incontinence (UUI) episodes. Adverse events (AEs) were also recorded.
In total, 497 patients were treated (84.1% women). Darifenacin treatment resulted in statistically significant improvements in PPBC scores, micturition frequency, urgency and UUI episodes from baseline at 12 weeks. The improvements were similar for patients previously treated with oxybutynin ER or tolterodine ER. More than 85% of patients expressed satisfaction with darifenacin. As noted in other studies, the most common AEs were dry mouth and constipation, but these infrequently resulted in treatment discontinuation, which was low overall.
In this study, PPBC score and OAB symptoms were significantly improved, and satisfaction was high during treatment with darifenacin (7.5/15 mg) in patients who were dissatisfied with the previous antimuscarinic treatment.
PMCID: PMC2680263  PMID: 18811599
3.  Prevalence of Chlamydia trachomatis and genital mycoplasmas in asymptomatic women. 
To establish the prevalence of Chlamydia trachomatis, Mycoplasma hominis and Ureaplasma urealyticum in women attending a family planning and a prenatal clinic in Halifax, cervical swabs were obtained at the time of the first visit from 491 women who had no symptoms of genital infection. Among the women attending the family planning clinic M. hominis occurred in combination with C. trachomatis more frequently than expected (p less than 0.05). It occurred in the absence of U. urealyticum in only a few cases (13% of the occurrences in the family planning clinic and 6% of those in the prenatal clinic). C. trachomatis was significantly more prevalent in women under 25 years of age (p less than 0.04). However, mycoplasmas were as prevalent in women over 30 years as in those under 30. There were no significant differences in the infection rates of the organisms by trimester among pregnant women. More research is necessary for a proper understanding of the role of M. hominis and U. urealyticum in genitourinary infections and pregnancy outcomes.
PMCID: PMC1346064  PMID: 4039970
4.  The Prevalence of Vaginal Microorganisms in Pregnant Women with Preterm Labor and Preterm Birth 
Annals of Laboratory Medicine  2012;32(3):194-200.
To investigate the risk factors for vaginal infections and antimicrobial susceptibilities of vaginal microorganisms among women who experienced preterm birth (PTB), we compared the prevalence of vaginal microorganisms between women who experienced preterm labor (PTL) without preterm delivery and spontaneous PTB.
Vaginal swab specimens from 126 pregnant women who experienced PTL were tested for group B streptococcus (GBS), Mycoplasma hominis, Mycoplasma genitalium, Ureaplasma urealyticum, Chlamydia trachomatis, Trichomonas vaginalis, Neisseria gonorrhoeae, Treponema pallidum, herpes simplex virus (HSV) I and II, and bacterial vaginosis. A control group of 91 pregnant women was tested for GBS. Antimicrobial susceptibility tests were performed for GBS, M. hominis, and U. urealyticum.
The overall detection rates for each microorganism were: U. urealyticum, 62.7%; M. hominis, 12.7%; GBS, 7.9%; C. trachomatis, 2.4%; and HSV type II, 0.8%. The colonization rate of GBS in control group was 17.6%. The prevalence of GBS, M. hominis, and U. urealyticum in PTL without preterm delivery and spontaneous PTB were 3.8% and 8.7% (relative risk [RR], 2.26), 3.8% and 17.3% (RR, 4.52), and 53.8% and 60.9% (RR, 1.13), respectively, showing no significant difference between the 2 groups. The detection rate of M. hominis by PCR was higher than that by culture method (11.1% vs. 4.0%, P=0.010). The detection rates of U. urealyticum by PCR and culture method were 16.7% and 57.1%, respectively.
There was no significant difference in the prevalence of GBS, M. hominis, and U. urealyticum between the spontaneous PTB and PTL without preterm delivery groups.
PMCID: PMC3339299  PMID: 22563554
Preterm labor; Preterm birth; Group B streptococcus; Mycoplasma hominis; Ureaplasma urealyticum
5.  Cervical Cytopathological Findings in Korean Women with Chlamydia trachomatis, Mycoplasma hominis, and Ureaplasma urealyticum Infections 
The Scientific World Journal  2014;2014:756713.
This is to investigate the cervical cytological abnormalities associated with Chlamydia trachomatis, Mycoplasma hominis, Mycoplasma genitalium, and Ureaplasma urealyticum infections on routine screen. A total of 714 subjects who had undergone cervical Pap smears and concomitant analyses for cervical infections were included by a retrospective search. The frequencies of reactive cellular change (RCC) and squamous epithelial abnormalities were significantly higher in Chlamydia positive subjects than in uninfected subjects (P < 0.001). Of the 124 subjects tested for M. hominis, M. genitalium, and U. urealyticum, 14 (11%) were positive for M. hominis and 29 (23%) were positive for U. urealyticum. Squamous abnormalities were more frequent in subjects with Ureaplasma infections than in uninfected subjects (24% versus 8%). Taking together these findings, C. trachomatis and U. urealyticum may have a causal role in the development of cervical epithelial changes, including RCC. Thus, extra awareness is warranted in cervical screening of women with Chlamydia or Ureaplasma infections.
PMCID: PMC3910385  PMID: 24526918
6.  High rates of genital mycoplasma infection in the highlands of Papua New Guinea determined both by culture and by a commercial detection kit. 
Journal of Clinical Microbiology  1997;35(1):197-200.
Duplicate vaginal swabs were collected from 100 women, and comparisons were made between an in-house broth-agar culture system and a commercially available kit, the Mycoplasma IST kit (bioMérieux), for the detection of Mycoplasma hominis and Ureaplasma urealyticum. There was good agreement between the two systems for detection of the genital mycoplasmas in terms of sensitivity, with values of > 92% being obtained. In terms of specificity, the mutual comparisons were less favorable, though specificity values of > 72% were obtained. Statistically there was no significant difference in the performance of the two tests (P < 0.1 for both M. hominis and U. urealyticum). While the broth-agar culture system was considerably less expensive than the kit, the Mycoplasma IST kit provided additional information on antibiotic susceptibilities and had the advantages of a shelf life of up to 12 months and not requiring the preparation of culture media. The prevalences of colonization obtained for M. hominis and U. urealyticum were extremely high in this randomly selected group of women from periurban and rural settlements in the Eastern Highlands of Papua New Guinea, being > or = 70% for M. hominis and > or = 78% for U. urealyticum. colonization with both genital mycoplasmas simultaneously was also very common, with > or = 60% of women being colonized by both M. hominis and U. urealyticum.
PMCID: PMC229538  PMID: 8968907
7.  Standard Treatment Regimens for Nongonococcal Urethritis Have Similar but Declining Cure Rates: A Randomized Controlled Trial 
Cure rates for nongonococcal urethritis (NGU), were approximately 80% and there was no significant difference between azithromycin and doxycycline for clinical or microbiologic cure. Chlamydia trachomatis, Ureaplasma urealyticum biovar 2, and idiopathic NGU remained relatively sensitive to standard therapies, but Mycoplasma genitalium was not.
Background. Azithromycin or doxycycline is recommended for nongonococcal urethritis (NGU); recent evidence suggests their efficacy has declined. We compared azithromycin and doxycycline in men with NGU, hypothesizing that azithromycin was more effective than doxycycline.
Methods. From January 2007 to July 2011, English-speaking males ≥16 years, attending a sexually transmitted diseases clinic in Seattle, Washington, with NGU (visible urethral discharge or ≥5 polymorphonuclear leukocytes per high-power field [PMNs/HPF]) were eligible for this double-blind, parallel-group superiority trial. Participants received active azithromycin (1 g) + placebo doxycycline or active doxycycline (100 mg twice daily for 7 days) + placebo azithromycin. Urine was tested for Chlamydia trachomatis (CT), Mycoplasma genitalium (MG), Ureaplasma urealyticum biovar 2 (UU-2), and Trichomonas vaginalis (TV) using nucleic acid amplification tests. Clinical cure (<5 PMNs/HPF with or without urethral symptoms and absence of discharge) and microbiologic cure (negative tests for CT, MG, and/or UU-2) were determined after 3 weeks.
Results. Of 606 men, 304 were randomized to azithromycin and 302 to doxycycline; CT, MG, TV, and UU-2 were detected in 24%, 13%, 2%, and 23%, respectively. In modified intent-to-treat analyses, 172 of 216 (80%; 95% confidence interval [CI], 74%–85%) receiving azithromycin and 157 of 206 (76%; 95% CI, 70%–82%) receiving doxycycline experienced clinical cure (P = .40). In pathogen-specific analyses, clinical cure did not differ by arm, nor did microbiologic cure differ for CT (86% vs 90%, P = .56), MG (40% vs 30%, P = .41), or UU-2 (75% vs 70%, P = .50). No unexpected adverse events occurred.
Conclusions. Clinical and microbiologic cure rates for NGU were somewhat low and there was no significant difference between azithromycin and doxycycline. Mycoplasma genitalium treatment failure was extremely common.
Clinical Trials Registration. NCT00358462.
PMCID: PMC3588116  PMID: 23223595
urethritis; treatment; Mycoplasma genitalium; Chlamydia trachomatis; randomized trial
8.  A Comparative Study on the Efficacy of Solifenacin Succinate in Patients with Urinary Frequency with or without Urgency 
PLoS ONE  2014;9(11):e112063.
Patients with overactive bladder (OAB) often have trouble perceiving urgency because of difficulties in distinguishing between urgency and desire to void. Empirical antimuscarinic treatment of patients with frequency only may be reasonable if conservative management has failed. We compared the efficacy of solifenacin in patients with frequency with or without urgency.
Materials and Methods
This multicenter, 12-week, open-label, comparative, non-inferiority clinical trial assessed whether the solifenacin efficacy for frequency without urgency is non-inferior to its efficacy for frequency with urgency. All patients had micturition frequency ≥8 voids/day with or without urgency. Primary efficacy variable: daily frequency change at 12 weeks relative to baseline. Secondary efficacy variables: change at 12 weeks relative to baseline in Patients' Perception of Bladder Condition (PPBC), OAB Symptom Score (OABSS), and Benefit, Satisfaction, Willingness to continue (BSW) questionnaire.
Of the 286 enrolled patients, 240 (83.9%) completed the study (without urgency n = 115; with urgency n = 125). Full dataset analysis revealed that the groups without and with urgency exhibited significant reductions in daily micturition frequency of −2.49±0.35 (mean ± standard error) and −2.63±0.37, respectively. The lower limit of the 95% two-sided CI of the comparison of the two group means was −1.14, which is smaller than the −0.8 margin of clinical equivalence. The two groups did not differ in improvement in PPBC, OABSS, or BSW scores. Both tolerated the treatment well.
It was not possible to verify that the solifenacin efficacy for frequency alone was non-inferior to its efficacy for OAB. Nevertheless, solifenacin tended to be effective for frequency regardless of urgency.
Trial Registration NCT00979472
PMCID: PMC4234319  PMID: 25401784
9.  Estimating EQ-5D and OAB-5D health state utilities for patients with overactive bladder 
Limited utility data on patients suffering from overactive bladder (OAB) are available in the literature. The objectives of this study were to estimate utility values in patients with OAB using the generic EQ-5D questionnaire and the OAB-5D disease specific questionnaire, to investigate the relationship between utilities and symptoms, and to evaluate the sensitivity of the two instruments to changes in symptom severity.
Analyses were based on pooled data from three large multicenter randomized 12-week placebo-controlled trials (SCORPIO, ARIES, CAPRICORN). Patients completed a micturition diary, EQ-5D and OAB-q (a quality of life questionnaire from which OAB-5D is derived) at baseline and at weeks 4, 8 and 12. Time trade-off tariffs elicited from UK population were applied to obtain utilities from both instruments. Repeated measures regressions were used to estimate EQ-5D and OAB-5D utilities by micturition frequency and incontinence severity level. As a test of sensitivity of the instruments, utility changes from baseline to week 12 were estimated by symptomatic response (improvement, stable or worsening).
The sample included 4427 patients. Mean utilities (± standard deviation) across all visits were 0.82 (±0.21) for EQ-5D and 0.86 (±0.09) for OAB-5D. Correlation between EQ-5D and OAB-5D was 0.34 (p < 0.0001). Both OAB-5D and EQ-5D utilities increased as OAB symptoms improved. Utility values were similar for severe levels of symptoms, but higher with OAB-5D than with EQ-5D for mild cases. Micturitions and incontinence had similar impact on EQ-5D utilities, but micturitions had greater impact on OAB-5D utilities than incontinence. Changes from baseline in OAB-5D utilities differed significantly according to symptomatic response. Changes in EQ-5D utilities were not significantly associated with changes in micturition frequency and weakly associated with changes in incontinence severity among patients with mild symptoms at baseline.
This study showed that both EQ-5D and OAB-5D can detect changes in severity of OAB, especially in severe cases. However, OAB-5D is more sensitive than EQ-5D in measuring differences between treatments in milder cases. Both OAB-5D and EQ-5D–although leading to different results–may be useful to derive utilities from clinical trial data and perform cost-effectiveness analyses.
Trial registration
Clinical Trials NCT00689104, NCT00662909, NCT00912964.
PMCID: PMC3842710  PMID: 24246044
Health-related quality of life; Overactive bladder; EQ-5D; OAB-5D; Quality-adjusted life-years; Utility assessment
10.  Efficacy and safety of Baweidihuang-wan in women with overactive bladder: a randomized, double blind, placebo controlled trial 
The aim of this study was to identify the efficacy and safety of Baweidihuang-wan (BWDH) in women with overactive bladder (OAB) and to investigate whether BWDH is more effective in OAB diagnosed as kidney yang deficiency pattern by the Korean medical pattern identification. The design of this study was a randomized, double blind, placebo controlled trial. One hundred eighty-six women with OAB were randomized to treatment (n=93) or control group (n=93). Participants received BWDH or placebo three times a day for eight weeks. Efficacy was assessed by overactive bladder symptom score and 3-day bladder diary. Subgroup analysis was conducted between kidney yang deficiency pattern and other patterns according to the Korean medical pattern identification. One hundred sixty-four participants completed this trial. The treatment group has improved in OABSS score, Total micturitions per 24 hr, Daytime micturitions per 24 hr, Total count of urgency, and Total urgency score over the control group, but differences were not statistically significant. By a subgroup analysis, OABSS score, total micturitions per 24 hr, total count of urgency and total urgency score improved most in the treatment group with the kidney yang deficiency pattern but this was also not statistically significant. No obvious adverse events were found in the use of BWDH. In conclusion, this trial did not show significant difference between BWDH and placebo in women with OAB. However BWDH tended to improve urinary frequency and urgency in OAB, especially diagnosed as kidney yang deficiency pattern. Further additional research will be needed.
PMCID: PMC4211785  PMID: 25356135
Overactive bladder; herbal medicine; randomized controlled trial
11.  How Dry is “OAB-Dry”?: Perspectives from Patients and Physician Experts 
The Journal of urology  2012;188(5):1811-1815.
Overactive bladder (OAB) is subtyped into OAB-wet and OAB-dry, based on the presence or absence, respectively, of urgency incontinence. In order to better understand patient and physician perspectives on symptoms among women with OAB-wet and OAB-dry, we conducted patient focus groups and interviews with experts in urinary incontinence.
Materials and Methods
Five focus groups totaling 33 patients with OAB symptoms, including three groups of OAB-wet and 2 groups of OAB-dry patients, were conducted. Topics addressed patients’ perceptions of OAB symptoms, treatments, and outcomes. Twelve expert interviews were then conducted in which experts were asked to describe their views on OAB-wet and OAB-dry. Focus groups and expert interviews were transcribed verbatim. Qualitative data analysis was performed using Grounded Theory methodology, as described by Charmaz.
During the focus groups sessions, women screened as OAB-dry shared the knowledge that they would probably leak if no toilet is available. This knowledge was based on a history of leakage episodes in the past. Those few patients with no history of leakage had a clinical picture more consistent with painful bladder syndrome than OAB. Physician expert interviews revealed the belief that many patients labeled as OAB–dry may actually be mild OAB-wet.
Qualitative data from focus groups and interviews with experts suggest that a spectrum exists between very mild OAB-wet and severe OAB-wet. Scientific investigations are needed to determine if urgency without fear of leakage constitutes a unique clinical entity.
PMCID: PMC3571660  PMID: 22999694
focus groups; qualitative research; urge urinary incontinence; grounded theory; overactive bladder
12.  Multiplex PCR Testing Detection of Higher-than-Expected Rates of Cervical Mycoplasma, Ureaplasma, and Trichomonas and Viral Agent Infections in Sexually Active Australian Women▿  
Journal of Clinical Microbiology  2009;47(5):1358-1363.
Knowing the prevalence of potential etiologic agents of nongonococcal and nonchlamydial cervicitis is important for improving the efficacy of empirical treatments for this commonly encountered condition. We describe four multiplex PCRs (mPCRs), designated VDL05, VDL06, VDL07, and VDL09, which facilitate the detection of a wide range of agents either known to be or putatively associated with cervicitis, including cytomegalovirus (CMV), enterovirus (EV), Epstein-Barr virus (EBV), varicella-zoster virus (VZV), herpes simplex virus type 1 (HSV-1), and herpes simplex virus type 2 (HSV-2) (VDL05); Ureaplasma parvum, Ureaplasma urealyticum, Mycoplasma genitalium, and Mycoplasma hominis (VDL06); Chlamydia trachomatis, Trichomonas vaginalis, Treponema pallidum, and group B streptococci (VDL07); and adenovirus species A to E (VDL09). The mPCRs were used to test 233 cervical swabs from 175 women attending a sexual-health clinic in Sydney, Australia, during 2006 and 2007. The agents detected alone or in combination in all cervical swabs (percentage of total swabs) included CMV (6.0), EV (2.1), EBV (2.6), VZV (4.7), HSV-1 (2.6), HSV-2 (0.8), HSV-2 and VZV (0.4), U. parvum (57.0), U. urealyticum (6.1), M. genitalium (1.3), M. hominis (13.7), C. trachomatis (0.4), T. vaginalis (3.4), and group B streptococci (0.4). Adenovirus species A to E and T. pallidum were not detected. These assays are adaptable for routine diagnostic laboratories and provide an opportunity to measure the true prevalence of microorganisms potentially associated with cervicitis and other genital infections.
PMCID: PMC2681846  PMID: 19261782
13.  Fesoterodine for overactive bladder: A review of the literature 
Background: Overactive bladder (OAB) is a chronic condition affecting both men and women, with prevalence increasing with age. Antimuscarinics form the cornerstone of treatment of OAB. Fesoterodine, a nonselective muscarinic-receptor antagonist, was approved by the US Food and Drug Administration in late 2008 for once daily, oral administration in the treatment of OAB to relieve the symptoms of urinary urge incontinence, urgency, and frequency.
Objective: The aim of this review was to provide an overview of the mechanism of action of and clinical trial data for fesoterodine, and to discuss the present status of fesoterodine in the management of OAB.
Methods: The MEDLINE and Google Scholar databases were searched (June 1, 1999–December 1, 2009) using the terms fesoterodine, overactive bladder, and muscarinic antagonists. Full-text articles in English were selected for reference, and articles presenting the mechanism of action, pharmacokinetics, and data from clinical trials were included. The parameters measured were tolerability, efficacy, and health-related quality of life (HRQoL). Trials involving animals and Phase I studies were excluded.
Results: The initial literature search yielded 48 papers. A total of 20 articles fulfilled the inclusion criteria. In two 12-week, randomized, multicenter, Phase III clinical trials involving patients with increased micturition frequency and urgency and/or urinary urge incontinence (n = 836 and 1132 in each trial), both fesoterodine 4 and 8 mg were associated with significantly improved symptoms of OAB (frequency of micturition, urgency, and urge incontinence) compared with placebo (P < 0.05). In a post hoc analysis of pooled data of the Phase III trials, HRQoL improved significantly with both doses. In a 12-week, Phase Illb trial, fesoterodine 4 and 8 mg led to treatment satisfaction in ∼80% of patients (of 516 enrolled) who were initially unsatisfied with their previous treatment.
Conclusion: A review of the literature suggests that fesoterodine is an efficacious and well-tolerated treatment option for patients with OAB.
PMCID: PMC3969610  PMID: 24688149
overactive bladder; fesoterodine; muscarinic antagonists
14.  Human Papillomaviruses and genital co-infections in gynaecological outpatients 
High grade HPV infections and persistence are the strongest risk factors for cervical cancer. Nevertheless other genital microorganisms may be involved in the progression of HPV associated lesions.
Cervical samples were collected to search for human Papillomavirus (HPV), bacteria and yeast infections in gynaecologic outpatients. HPV typing was carried out by PCR and sequencing on cervical brush specimens. Chlamydia trachomatis was identified by strand displacement amplification (SDA) and the other microorganisms were detected by conventional methods.
In this cross-sectional study on 857 enrolled outpatients, statistical analyses revealed a significant association of HPV with C. trachomatis and Ureaplasma urealyticum (at high density) detection, whereas no correlation was found between HPV infection and bacterial vaginosis, Streptococcus agalactiae, yeasts, Trichomonas vaginalis and U. urealyticum. Mycoplasma hominis was isolated only in a few cases both in HPV positive and negative women and no patient was infected with Neisseria gonorrhoeae.
Although bacterial vaginosis was not significantly associated with HPV, it was more common among the HPV positive women. A significant association between HPV and C. trachomatis was found and interestingly also with U. urealyticum but only at a high colonization rate. These data suggest that it may be important to screen for the simultaneous presence of different microorganisms which may have synergistic pathological effects.
PMCID: PMC2656516  PMID: 19216747
15.  The Alabama Preterm Birth Study: Umbilical Cord Blood Ureaplasma urealyticum and Mycoplasma hominis Cultures in Very Preterm Newborns 
To evaluate the frequency of umbilical cord blood infections with Ureaplasma urealyticum and Mycoplasma hominis in preterm 23 to 32 week births and to determine their association with various obstetric conditions, markers of placental inflammation, and newborn outcomes.
Study Design
351 mother/infant dyads with deliveries between 23 and 32 weeks gestational age (GA) who had cord blood cultures for Ureaplasma urealyticum and Mycoplasma hominis had their medical records abstracted, other placental cultures performed, cord IL-6 levels determined, placentas evaluated histologically, and infant outcomes determined.
Ureaplasma urealyticum and/or Mycoplasma hominis were present in 23% of cord blood cultures. Positive cultures were more common in infants of nonwhite women (27.9 vs 16.8%, p = 0.016), in women less than 20 years of age, in those undergoing a spontaneous compared to an indicated preterm delivery (34.7 vs 3.2%, p = 0.0001), and in those delivering at earlier gestational ages. Intrauterine infection and inflammation were more common among infants with a positive Ureaplasma urealyticum and Mycoplasma hominis culture as evidenced by placental cultures for these and other bacteria, elevated cord blood IL-6 levels, and placental histology. Infants with positive cord blood Ureaplasma urealyticum and Mycoplasma hominis cultures were more likely to have neonatal SIRS (41.3 vs 25.7%, p = 0.007, AOR 1.86, 1.08 – 3.21) and probably BPD (26.8 vs 10.1%, p = 0.0001, AOR 1.99, 0.91 – 4.37), but were not significantly different for other neonatal outcomes including RDS, IVH or death.
Ureaplasma urealyticum and Mycoplasma hominis cord blood infections are far more common in spontaneous versus indicated preterm deliveries and are strongly associated with markers of acute placental inflammation. Positive cultures are associated with neonatal systemic inflammatory response syndrome and probably bronchopulmonary dysplasia.
PMCID: PMC2278008  PMID: 18166302
Ureaplasma urealyticum; Mycoplasma hominis; preterm birth; umbilical cord blood; placental histology; neonatal outcome; neonatal systemic inflammatory response syndrome; bronchopulmonary dysplasia
16.  Antimicrobial susceptibility patterns of Ureaplasma species and Mycoplasma hominis in pregnant women 
BMC Infectious Diseases  2014;14:171.
Genital mycoplasmas colonise up to 80% of sexually mature women and may invade the amniotic cavity during pregnancy and cause complications. Tetracyclines and fluoroquinolones are contraindicated in pregnancy and erythromycin is often used to treat patients. However, increasing resistance to common antimicrobial agents is widely reported. The purpose of this study was to investigate antimicrobial susceptibility patterns of genital mycoplasmas in pregnant women.
Self-collected vaginal swabs were obtained from 96 pregnant women attending an antenatal clinic in Gauteng, South Africa. Specimens were screened with the Mycofast Revolution assay for the presence of Ureaplasma species and Mycoplasma hominis. The antimicrobial susceptibility to levofloxacin, moxifloxacin, erythromycin, clindamycin and tetracycline were determined at various breakpoints. A multiplex polymerase chain reaction assay was used to speciate Ureaplasma positive specimens as either U. parvum or U. urealyticum.
Seventy-six percent (73/96) of specimens contained Ureaplasma spp., while 39.7% (29/73) of Ureaplasma positive specimens were also positive for M. hominis. Susceptibilities of Ureaplasma spp. to levofloxacin and moxifloxacin were 59% (26/44) and 98% (43/44) respectively. Mixed isolates (Ureaplasma species and M. hominis) were highly resistant to erythromycin and tetracycline (both 97% resistance). Resistance of Ureaplasma spp. to erythromycin was 80% (35/44) and tetracycline resistance was detected in 73% (32/44) of Ureaplasma spp. Speciation indicated that U. parvum was the predominant Ureaplasma spp. conferring antimicrobial resistance.
Treatment options for genital mycoplasma infections are becoming limited. More elaborative studies are needed to elucidate the diverse antimicrobial susceptibility patterns found in this study when compared to similar studies. To prevent complications in pregnant women, the foetus and the neonate, routine screening for the presence of genital mycoplasmas is recommended. In addition, it is recommended that antimicrobial susceptibility patterns are determined.
PMCID: PMC3976045  PMID: 24679107
Pregnant women; Ureaplasma spp.; Mycoplasma hominis; Antimicrobial susceptibilities
17.  Molecular Detection of Chlamydia trachomatis and Other Sexually Transmitted Bacteria in Semen of Male Partners of Infertile Couples in Tunisia: The Effect on Semen Parameters and Spermatozoa Apoptosis Markers 
PLoS ONE  2014;9(7):e98903.
This study was undertaken to determine the prevalence of Chlamydia trachomatis, Mycoplasmas, and Ureaplasmas in semen samples of the male partners of infertile couples and to investigate whether Chlamydia trachomatis could initiate apoptosis in human spermatozoa. A total of 85 males partners of infertile couples undergoing routine semen analysis according to World Health Organization guidelines were included. Specimens were examined for the presence of Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma hominis, Mycoplasma genitalium, Ureaplasma urealyticum and Ureaplasma parvum by Real time PCR (qPCR). Semen specimens were analysed for the appearance of apoptotic markers (sperm DNA fragmentation, activated caspase 3 levels, mitochondrial membrane potential (ΔΨm)) using flow cytometry. C. trachomatis, N. gonorrhoeae, U. urealyticum, M genitalium were detected in semen samples of 13 (15.2%), 5 (5.8%), 5 (5.8%) and 3 (3.5%) male partners of infertile couples, respectively. M. hominis and U. parvum were detected in semen sample of only one patient (1.1%). The semen of infertile men positive for C. trachomatis showed lower mean of semen count and lower rapid progressive motility (category [a]) of spermatozoa compared to uninfected men with statistically significances (p = 0.02 and p = 0.04, respectively). Flow cytometry analyses demonstrated a significant increase of the mean rate of semen with low ΔΨm and caspase 3 activation of infertile men positive for C. trachomatis compared to uninfected men (p = 0.006 and p = 0.001, respectively). DNA fragmentation was also increased in sperm of infertile men positive for C. trachomatis compared to uninfected men but without statistical significances (p = 0.62). Chlamydial infection was associated to loss of ΔΨm and caspase 3activation. Thus, C. trachomatis infection could be incriminated in apoptosis induction of spermatozoa. These effects may explain the negative direct impact of C. trachomatis infection on sperm fertilizing ability.
PMCID: PMC4096407  PMID: 25019616
18.  Association between Preterm Birth and Vaginal Colonization by Mycoplasmas in Early Pregnancy 
To examine the association between colonization by two newly classified species of genital ureaplasmas (Ureaplasma parvum and U. urealyticum) in early pregnancy and subsequent late abortion or preterm birth at <34 weeks of gestation, four species of genital mycoplasmas—Mycoplasma genitalium, M. hominis, U. parvum, and U. urealyticum—as well as Chlamydia trachomatis and Neisseria gonorrhoeae were examined by PCR-based methods in a prospective cohort study of 877 women with singleton pregnancies at <11 weeks of gestation. Antibiotics were used only in cases in which C. trachomatis and/or N. gonorrhoeae was detected. Multivariate logistic-regression analysis was used to assess independent risk factors after taking maternal low body weight and past history of preterm birth into account. M. genitalium, M. hominis, U. parvum, U. urealyticum, C. trachomatis, and N. gonorrhoeae were detected in 0.8%, 11.2%, 52.0%, 8.7%, 3.2%, and 0.1% of these 877 women, respectively. Twenty-one (2.4%) women experienced late abortion or preterm birth at <34 weeks of gestation. Three factors—detection of U. parvum in the vagina (odds ratio [OR], 3.0; 95% confidence interval [CI], 1.1 to 8.5); use of antibiotics, such as penicillin and cefatrizine, for incidental inflammatory complications before 22 weeks of gestation (OR, 4.2; 95% CI, 1.6 to 10.0); and past history of preterm birth (OR, 10.4; 95% CI, 2.7 to 40.5)—were independently associated with late abortion and preterm birth. In conclusion, vaginal colonization with U. parvum, but not U. urealyticum, is associated with late abortion or early preterm birth.
PMCID: PMC1351938  PMID: 16390947
19.  Detection of Nanobacteria in Patients with Chronic Prostatitis and Vaginitis by Reverse Transcriptase Polymerase Chain Reaction 
Korean Journal of Urology  2011;52(3):194-199.
We aimed to investigate the detection of nanobacteria (NB) from expressed prostatic secretions (EPS) in patients with category III chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) and from vaginal swabs in patients with vaginitis by reverse transcriptase polymerase chain reaction (RT-PCR) and to evaluate the association between NB and Neisseria gonorrhea, Chlamydia trachomatis, Ureaplasma urealyticum (U. urealyticum), Mycoplasma hominis, Trichomonas vaginalis, and Mycoplasma genitalium.
Materials and Methods
A group of 11 men attending a specialized CP/CPPS clinic and a group of 157 women who reported symptoms of lower genital tract infection were enrolled in this study. NB were detected by RT-PCR. A Seeplex Sexually Transmitted Disease Detection assay (Seegene Inc., Seoul, Korea) was used that could detect DNA for 6 types of sexually transmitted pathogens.
In EPS samples, the detection rate of NB in patients with CP/CPPS was 9.1%, and 9 (5.7%) of 157 vaginitis patients showed positive results in RT-PCR for NB in vaginal swabs. Associations observed among the 7 microorganisms included 6 (54.5%) patients who tested positive on EPS and 75 (47.8%) patients who tested positive on vaginal swabs. Five patients with vaginitis were found to have monoinfection of NB (6.7%).
We found that conventional RT-PCR for NB was rapid, simple, low in cost, and easily available for the detection of NB, and that NB may be a possible etiological factor for vaginitis and CP/CPPS. The prevalence of U. urealyticum among the four patients with NB coinfection was 75%; the presence of U. urealyticum might therefore raise suspicion for nanobacterial infection.
PMCID: PMC3065132  PMID: 21461284
Nanoparticles; Prostatitis; Reverse transcriptase polymerase chain reaction; Vaginitis
20.  Genital mycoplasma & Chlamydia trachomatis infections in treatment naïve HIV-1 infected adults 
Background & objectives:
Sexually transmitted infections (STIs) enhance the transmission of human immunodeficiency virus (HIV). Thus, screening for STIs is a routine component of primary HIV care. There are limited data for selective screening guidelines for genital mycoplasmas and Chlamydia trachomatis in HIV-infected adults. The aim of the present study was to determine the frequency of genital infections with Ureaplasma spp., Mycoplasma hominis, M. genitalium and C. trachomatis in treatment naïve asymptomatic HIV-1 - infected adults and study their association with CD4+ T-cell count.
First-void urine samples were collected from 100 treatment-naïve HIV-1-infected adults and 50 healthy volunteers. C. trachomatis and M. genitalium were detected by polymerase chain reaction (PCR). Ureaplasma spp. and M. hominis were detected by both culture and PCR. Circulating CD4+ cell counts of HIV-1-infected patients were determined from peripheral blood by flow-cytometry.
C. trachomatis was detected in 7 per cent of HIV-1-infected adults compared to none in control population. Ureaplasma spp. and M. hominis showed infection rates of 6 and 1 per cent in the HIV group and 2 and 0 per cent in the control group, respectively. None of the individuals from the patient and control groups was tested positive for M. genitalium. A significant association was found between CD4 cell count and detection of C. trachomatis in HIV-infected adults (P = 0.01).
Interpretation & conclusions:
Screening of HIV-infected individuals for C. trachomatis infection could be recommended as a routine component of HIV care. The role of mycoplasmas as co-pathogens of the genitourinary tract in HIV-1 infected patients seems to be unlikely. Further longitudinal studies need to be done to confirm these findings.
PMCID: PMC3284105  PMID: 22310829
CD4 cell counts; Chlamydia trachomatis; genital mycoplasmas; HIV
21.  Lower urinary tract symptoms and falls risk among older women receiving home support: a prospective cohort study 
BMC Geriatrics  2013;13:46.
Although lower urinary tract symptoms have been associated with falls, few studies have been undertaken to understand this relationship in vulnerable community dwelling older adults. The purpose of this study was to describe the relationship over time of falls risk and lower urinary tract symptoms among community based older women receiving home support services.
A prospective cohort study which took place in an urban setting in western Canada. Participants were 100 older women receiving home care or residing in assisted living with home support services and were followed for six months. Demographic characteristics were collected at baseline, with the Timed Up and Go (TUG), International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ-FLUTS), and self-report of falls collected at baseline, 3 and 6 months. Descriptive statistics were used to summarize demographic data. Differences between the three visits were analyzed using the Friedman test with post hoc analysis and associations between variables by the Spearman Rank-Order Correlation Coefficient.
One hundred women initially enrolled; 88 and 75 remained at three months and six months. Mean age = 84.3 years; 91% reported at least one urinary symptom at baseline and 35% reported falling in the six months prior to enrollment; 15.9% reported falling between the baseline and three months and 14.6% between three and six months. Mean TUG scores at each time point indicated falls risk (27.21, 29.18 and 27.76 seconds). Significant correlations between TUG and ICIQ-FLUTS (r = 0.33, p < .001; r = 0.39, p < .001) as well as TUG and overactive bladder scores (r = 0.25, p = .005; r = 0.28, p < .008) were found at baseline and three months, but not six months.
The association of lower urinary tract symptoms and falls risk in this group of vulnerable community dwelling older women at baseline and three months has potential clinical relevance. Lack of correlation at six months may be due loss of less robust participants, illuminating the difficulty in following frailer groups over time. Further studies are needed to understand the contribution of urinary symptoms to falls risk, and clinicians should incorporate continence assessment within falls risk assessment.
PMCID: PMC3658922  PMID: 23672343
Falls; Aged; Incontinence; Older women
22.  Genital flora in pregnancy and its association with intrauterine growth retardation. 
Journal of Clinical Microbiology  1994;32(9):2162-2168.
A study of risk factors for intrauterine growth retardation (IUGR) was conducted among a cohort of 13,914 pregnant women enrolled in the multicenter Vaginal Infections and Prematurity Study. From 23 through 26 weeks of gestational age, cultures of specimens from the vagina and cervix were done for group B streptococci, Neisseria gonorrhoeae, Chlamydia trachomatis, Trichomonas vaginalis, Candida albicans, Gardnerella vaginalis, Mycoplasma hominis, Ureaplasma urealyticum, and anaerobic gram-negative rods belonging to the genera Bacteroides, Porphyromonas, and Prevotella. Newborns who were small for their gestational age were delivered by 1,251 women, and infants of the appropriate weight for their gestational age were delivered by 10,332 women. When controlling for ethnicity and smoking and excluding women treated with antibiotics, the Mantel-Haenszel adjusted relative risk of IUGR was 1.16 for Bacteroides, Prevotella, and Porphyromonas spp. (95% confidence interval [95% CI], 1.01 to 1.33), 1.16 for M. hominis (95% CI, 1.04 to 1.29), 1.20 for U. urealyticum (95% CI, 1.05 to 1.38), and 1.22 for T. vaginalis (95% CI, 1.05 to 1.42). There was also a strong and significant trend for an increasing risk of IUGR with the number of these four microbes recovered. Among women colonized with all four isolates, the adjusted odds ratio of IUGR was 1.79 (95% CI, 1.27 to 2.52) in comparison with women not colonized with any of these microorganisms. Group B streptococci, N. gonorrhoeae, C. trachomatis, and C. albicans were not significantly associated with IUGR. These results suggest that infection is associated with some cases of IUGR and that specific microorganisms, alone or in combination, are involved. Since genital isolates are highly correlated with each other, the relative contribution of each microbe is difficult to determine.
PMCID: PMC263960  PMID: 7814541
23.  Differential vaginal expression of interleukin-1 system cytokines in the presence of Mycoplasma hominis and Ureaplasma urealyticum in pregnant women. 
OBJECTIVE: The genital mycoplasmas, Ureaplasma urealyticum and Mycoplasma hominis, are commonly identified in the vagina of healthy pregnant women. However, these microorganisms are the most common isolates from the amniotic fluids of women in preterm labor. The mechanisms responsible for vaginal colonization and ascent to the uterus remain undetermined. We evaluated the association between U. urealyticum and M. hominis vaginal colonization and the presence of pro-inflammatory and anti-inflammatory interleukin-1 system components in asymptomatic pregnant women of different ethnicities. METHODS: Vaginal specimens, obtained from 224 first trimester pregnant women, were assayed for interleukin-1beta (IL-1beta) and IL-1 receptor antagonist (IL-1ra) concentrations by ELISA. U. urealyticum and M. hominis vaginal colonization were identified by polymerase chain reaction (PCR). RESULTS: Vaginal colonization with M. hominis was identified in 37 (16.5%) women, and was more prevalent in black (18.9%) and Hispanic (20.9%) than in white (4.2%) women (p = 0.01). U. urealyticum was present in 84 (37.5%) women and there was no ethnic disparity in its detection. M. hominis colonization was associated with elevated median vaginal IL-1beta concentrations in both black women (p = 0.02) and Hispanic women (p = 0.04), and was unrelated to vaginal IL-1ra concentrations. In marked contrast, U. urealyticum colonization was associated with elevations in vaginal IL-1ra levels, but not with IL-1beta concentrations, in black women (p = 0.02) and Hispanic women (p < 0.0001) and marginally in white women (p = 0.06). CONCLUSION: M. hominis colonization in healthy pregnant women is associated with localized pro-inflammatory immune activation, while U. urealyticum colonization is associated with immune suppression.
PMCID: PMC1784593  PMID: 15739821
24.  Efficacy and safety of solifenacin succinate 10 mg once Daily: A multicenter, phase III, randomized, double-blind, placebo-controlled, parallel-group trial in patients with overactive bladder 
Background: Solifenacin succinate is an antimuscarinic drug with reported efficacy and tolerability at a recommended starting dose of 5 mg QD in patients with overactive bladder (OAB).
Objective: The objective of this trial was to investigate the efficacy, safety, and tolerability of solifenacin 10 mg QD in patients with OAB.
Methods: In this multicenter, Phase III, double-blind, placebo-controlled, parallel-group trial, patients aged ≥18 years with OAB were randomized at a 1:1 ratio to receive solifenacin 10 mg or placebo QD for 12 weeks. The patients were instructed to complete a micturition diary for the 3 days preceding each scheduled visit (weeks 4, 8, and 12). The primary end point was the change from baseline in the mean number of micturitions per 24 hours; secondary end points included the mean change from baseline in the number of episodes per 24 hours of urgency, incontinence, nocturnal voiding, and nocturia and the mean volume voided per micturition. Tolerability was monitored through adverse events (AEs), vital sign measurements, ECGs, laboratory assessments, and physical examination.
Results: A total of 672 patients were randomized and received ≥1 dose of study drug (solifenacin, n = 340; placebo, n = 332). The mean (SE) decrease from baseline to study end in the number of micturitions per 24 hours was significantly greater in the solifenacin group compared with the placebo group (−3.0 [0.2] vs −1.5 [0.2], respectively; P < 0.001). The mean decrease in the number of episodes of incontinence was significantly greater in the solifenacin group compared with the placebo group (−2.0 [0.2] vs −1.1 [0.2]; P < 0.001), as was the mean decrease in the number of episodes of urgency (−4.1 [0.2] vs −2.1 [0.2]; P < 0.001). Of the patients with ≥1 incontinence episode per 24 hours at baseline, significantly more patients in the solifenacin group achieved complete continence at study end than did patients in the placebo group (119/225 [52.9%] vs 80/237 [33.8%]; P < 0.001). The change from baseline to study end in the mean volume voided per micturition increased significantly in the solifenacin group compared with the placebo group (47.2 vs 2.7 mL; P < 0.001). Most AEs were mild or moderate in intensity. The AEs that were most commonly reported in the solifenacin-treated group were anticholinergic in nature: dry mouth (91 [26.8%] vs 13 patients [3.9%] in the placebo group; P < 0.001); constipation (58 [17.1%] vs 11 [3.3%]; P < 0.001); and blurred vision (12 [3.5%] vs 4 [1.2%]; P < 0.05). Serious AEs (SAEs) were reported for 5 patients in the solifenacin group and 3 patients in the placebo group. In the solifenacin group, 2 patients experienced chest pain, 1 had cellulitis, 1 had dehydration, and 1 had colonic obstruction; only 1 SAE (colonic obstruction) was judged to be possibly related to the study drug. In the placebo group, 1 patient had chest pain, 1 had bacterial meningitis, and 1 had hemopericardium.
Conclusions: This study found that solifenacin 10 mg QD for 12 weeks was associated with significantly reduced symptoms of OAB, including the frequency of micturition, and episodes of urgency and of incontinence. With solifenacin, the volume voided per micturition increased by 47.2 mL, and 53% of patients with ≥1 incontinence episode per 24 hours at baseline achieved complete continence. This efficacy was accompanied by a favorable safety and tolerability profile.
PMCID: PMC3969973  PMID: 24692834
anticholinergic; incontinence; overactive bladder; solifenacin; urgency
25.  Ureaplasma urealyticum, Ureaplasma parvum, Mycoplasma hominis and Mycoplasma genitalium infections and semen quality of infertile men 
Genital ureaplasmas (Ureaplasma urealyticum and Ureaplasma parvum) and mycoplasmas (Mycoplasma genitalium and Mycoplasma hominis) are potentially pathogenic species playing an etiologic role in both genital infections and male infertility. Reports are, however, controversial regarding the effects of these microorganisms infections in the sperm seminological variables. This study aimed at determining the frequency of genital ureplasmas and mycoplasmas in semen specimens collected from infertile men, and at comparing the seminological variables of semen from infected and non-infected men with these microorganisms.
A total of 120 semen samples collected from infertile men were investigated. Semen specimens were examined by in-house PCR-microtiter plate hybridization assay for the presence of genital ureaplasmas and mycoplasmas DNA. Semen analysis was assessed according to the guidelines of the World Health Organization. Standard parametric techniques (t-tests) and nonparametric techniques (Wilcoxon tests) were used for statistical analysis.
The frequency of genital ureaplasmas and mycoplasmas detected in semen samples of infertile men was respectively 19.2% (23/120) and 15.8% (19/120). The frequency of Ureaplasma urealyticum (15%) was higher than that of Mycoplasma hominis (10.8%), Ureaplasma parvum (4.2%) and Mycoplasma genitalium (5%). Mixed species of mycoplasmas and ureaplasmas were detected in 6.7% of semen samples.
Comparison of the parameters of the standard semen analysis between the male partners of the infertile couples with and without genital ureaplasmas and mycoplasmas infection showed that the presence of Mycoplasma hominis DNA in semen samples is associated with low sperm concentration (p = 0.007) and abnormal sperm morphology (p = 0.03) and a negative correlation between sperm concentration and the detection of Mycoplasma genitalium in semen samples of infertile men (p = 0.05). The mean values of seminal volume, pH, vitality, motility and leukocyte count were not significantly related either to the detection of genital mycoplasmas DNA or to the detection of ureaplasmas DNA in semen specimens.
Our results demonstrate that genital mycoplasmas and ureaplasmas seem to be widespread among the male partners of infertile couples in Tunisia. Genital mycoplasmas infections of the male genital tract could negatively influence semen quality. Our results also indicate that PCR-microtiter plate hybridization assay method provides a rapid and effective technique to detect human genital mycoplasmas and ureaplasmas which is useful for etiological and epidemiological studies of these pathogens.
PMCID: PMC2194714  PMID: 17988404

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