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1.
Health Care Women Int ; : 1-15, 2020 Oct 08.
Artigo em Inglês | MEDLINE | ID: mdl-33030977

RESUMO

Rapid dissemination of mobile technology provides substantial opportunity for overcoming challenges reaching rural and marginalized populations. We assessed feasibility and acceptability of longitudinal mobile data capture among women undergoing fistula surgery in Uganda (n = 60) in 2014-2015. Participants were followed for 12 months following surgery, with data captured quarterly, followed by interviews at 12 months. Participant retention was high (97%). Most respondents reported no difficulty with mobile data capture (range 93%-100%), and preferred mobile interview (88%-100%). Mobile data capture saved 1000 person-hours of transit and organizational time. Phone-based mobile data collection provided social support. Our results support this method for longitudinal studies among geographically and socially marginalized populations.

2.
Glob Public Health ; : 1-11, 2020 Sep 02.
Artigo em Inglês | MEDLINE | ID: mdl-32878568

RESUMO

Female genital fistula results in severe physical, psychological, and social sequelae. Qualitative research confirms stigma pervasiveness; however, no quantitative instrument exists to measure fistula-related stigma. We adapted an existing HIV-related stigma instrument to fistula-related stigma and assessed its reliability and validity. We recruited 60 Ugandan women seeking genital fistula surgery (December 2014-June 2015). We used exploratory factor analysis to explore the scale's latent structure and evaluated internal consistency reliability with Raykov's ρ statistic. We assessed construct validity through linear regression of stigma with quality of life, depressive symptoms and self-esteem. We retained 15 items across factors 'enacted stigma' and 'internalised stigma' (ρ = 0.960 and ρ = 0.748, respectively). Stigma was inversely associated with all quality of life domains; effect sizes were largest for environmental (enacted stigma, 0.69-point reduction) and psychological (internalised stigma, 0.67-point reduction) domains. Both stigma domains were associated positively with depressive symptoms and inversely with self-esteem, with 0.75 and 1.05-point increases in depressive symptoms and 0.45 and 0.77-point decreases in self-esteem for enacted and internalised stigma, respectively. Results suggest the reliability and validity of the adapted fistula stigma instrument. This instrument may help us understand stigma levels, compare stigma across individuals and communities, prioritise stigma-reduction strategies, and assess intervention impact.

3.
Int J Gynaecol Obstet ; 148 Suppl 1: 42-58, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31943181

RESUMO

BACKGROUND: Female genital fistula is associated with significant physical, psychological, and economic consequences; however, a knowledge and practice gap exists around services adjunct to fistula surgery. OBJECTIVES: To examine rehabilitation and reintegration services provided adjunct to genital fistula surgery, map existing programming and outcomes, and identify areas for additional research. SEARCH STRATEGY: We searched the published and grey literature from January 2000 to June 2019. Two reviewers screened articles and extracted data using standardized methods. SELECTION CRITERIA: Research and programmatic articles describing service provision in addition to female genital fistula surgery were included. DATA COLLECTION AND ANALYSIS: Of 3047 published articles and 2623 unpublished documents identified, 26 and 55, respectively, were analyzed. MAIN RESULTS: Programming identified included combinations of health education, physical therapy, social support, psychosocial counseling, and economic empowerment, largely in sub-Saharan Africa. Improvements were noted in physical and psychosocial health. CONCLUSIONS: Existing literature supports holistic fistula care through adjunct reintegration programming. Improving the evidence base requires implementing robust study designs, increasing reporting detail, and standardizing outcomes across studies. Increased financing for holistic fistula care is critical for developing and supporting programming to ensure positive outcomes.


Assuntos
Fístula Vesicovaginal/reabilitação , África ao Sul do Saara , Feminino , Saúde Holística , Humanos , Modalidades de Fisioterapia , Apoio Social , Resultado do Tratamento , Fístula Vesicovaginal/cirurgia
4.
Cult Health Sex ; 22(3): 352-367, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-31035913

RESUMO

Fistula-related stigma is common. The absence of a unifying conceptual framework prevents a nuanced understanding of the nature of fistula-related stigma, comparison across contexts and the ability to contrast with other stigmas. It also hinders intervention development. We conducted in-depth interviews or focus groups with 60 women who had undergone fistula surgery 6-24 months prior at Mulago Hospital in Kampala, Uganda in 2014. Transcripts were analysed for experiences and consequences of enacted, anticipated and internalised stigma. Narratives revealed experiences with enacted stigma, including gossip, verbal abuse and social exclusion. Women also anticipated and feared stigma in the future. Internalised stigma reports revealed shame and low self-esteem: self-worth reduction, feeling disgraced and envisioning no future. Consequences included social isolation, changes to normal activities, non-disclosure and poor mental health. Refining stigma theory to specific conditions has resulted in a more nuanced understanding of stigma dimensions, manifestations, mechanisms and consequences, permitting comparison across contexts and populations and the development of stigma-reduction interventions. These lessons should be applied to fistula, acknowledging unique features: concealability, the potential for treatment, lack of community awareness and the social consequences of stillbirth. Reducing fistula-related stigma requires timely surgery and supportive care, stigma-reduction interventions and addressing the complex societal structures that perpetuate fistula.

5.
BMJ Open ; 9(10): e027991, 2019 10 15.
Artigo em Inglês | MEDLINE | ID: mdl-31619418

RESUMO

INTRODUCTION: Female genital fistula is a debilitating traumatic injury, largely birth-associated, globally affecting up to 2 million women, mostly in sub-Saharan Africa. Fistula has significant physical, psychological and economic consequences. Women often face challenges in reintegrating and resuming prior roles despite successful surgery. Synthesising the evidence on services adjunct to fistula surgery and their outcomes is important for developing the evidence base for best practices and identifying research priorities. This scoping review seeks to examine the range of rehabilitation and reintegration services provided as adjunct to genital fistula surgery, map the existing programming and outcomes, and identify areas for additional research. METHODS AND ANALYSIS: Our scoping review is informed by existing methodological frameworks and will be conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses-ScR guidelines. The search strategy will be applied to nine biomedical, public health and social science databases. The initial search was completed on 27 September 2018. Grey literature will be identified through targeted Google searches and from organisational websites identified as relevant by the United Nations Population Fund (UNFPA) Campaign to End Fistula. We will iteratively build our search strategy through term harvesting and review, and search reference lists of reports and articles to identify additional studies. Two reviewers will independently screen titles and abstracts, followed by full-text screening of all potentially relevant articles and standardised data extraction. Articles eligible for inclusion will discuss research or programmatic efforts around service provision in adjunct to surgery among females with genital fistula. Data will be presented in summary tables accompanied by narrative description. ETHICS AND DISSEMINATION: Ethics approval is not required for a scoping review. Our results can be used to inform policy, serve as support for funding and development of reintegration programmes and highlight areas for subsequent research. Results will be disseminated at relevant conferences and published in a peer-reviewed journal.


Assuntos
Complicações do Trabalho de Parto/cirurgia , Fístula Vaginal/reabilitação , Fístula Vaginal/cirurgia , Incontinência Fecal/etiologia , Incontinência Fecal/psicologia , Feminino , Humanos , Infertilidade Feminina/etiologia , Infertilidade Feminina/psicologia , Dor/etiologia , Dor/psicologia , Gravidez , Projetos de Pesquisa , Literatura de Revisão como Assunto , Estigma Social , Incontinência Urinária/etiologia , Incontinência Urinária/psicologia , Fístula Vaginal/psicologia
6.
Trop Med Int Health ; 24(1): 53-64, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30372572

RESUMO

OBJECTIVES: To explore trajectories of physical and psychosocial health, and their interrelationship, among women completing fistula repair in Uganda for 1 year post-surgery. METHODS: We recruited a 60-woman longitudinal cohort at surgical hospitalisation from Mulago Hospital in Kampala Uganda (Dec 2014-June 2015) and followed them for 1 year. We collected survey data on physical and psychosocial health at surgery and at 3, 6, 9 and 12 months via mobile phone. Fistula characteristics were abstracted from medical records. All participants provided written informed consent. We present univariate analysis and linear regression results. RESULTS: Across post-surgical follow-up, most women reported improvements in physical and psychosocial health, largely within the first 6 months. By 12 months, urinary incontinence had declined from 98% to 33% and general weakness from 33% to 17%, while excellent to good general health rose from 0% to 60%. Reintegration, self-esteem and quality of life all increased through 6 months and remained stable thereafter. Reported stigma reduced, yet some negative self-perception remained at 12 months (mean 17.8). Psychosocial health was significantly impacted by the report of physical symptoms; at 12 months, physical symptoms were associated with a 21.9 lower mean reintegration score (95% CI -30.1, -12.4). CONCLUSIONS: Our longitudinal cohort experienced dramatic improvements in physical and psychosocial health after surgery. Continuing fistula-related symptoms and the substantial differences in psychosocial health by physical symptoms support additional intervention to support women's recovery or more targeted psychosocial support and reintegration services to ensure that those coping with physical or psychosocial challenges are appropriately supported.


Assuntos
Qualidade de Vida/psicologia , Autoimagem , Estigma Social , Fístula Vaginal/psicologia , Saúde da Mulher , Adaptação Psicológica , Feminino , Humanos , Estudos Longitudinais , Fístula Retovaginal/psicologia , Uganda , Fístula Vaginal/cirurgia , Fístula Vesicovaginal/psicologia
7.
Reprod Health ; 14(1): 109, 2017 Sep 02.
Artigo em Inglês | MEDLINE | ID: mdl-28865473

RESUMO

BACKGROUND: Obstetric fistula is a debilitating and traumatic birth injury affecting 2-3 million women globally, mostly in sub-Saharan Africa and Asia. Affected women suffer physically, psychologically and socioeconomically. International efforts have increased access to surgical treatment, yet attention to a holistic outcome of post-surgical rehabilitation is nascent. We sought to develop and pilot test a measurement instrument to assess post-surgical family and community reintegration. METHODS: We conducted an exploratory sequential mixed-methods study, beginning with 16 in-depth interviews and four focus group discussions with 17 women who underwent fistula surgery within two previous years to inform measure development. The draft instrument was validated in a longitudinal cohort of 60 women recovering from fistula surgery. Qualitative data were analyzed through thematic analysis. Socio-demographic characteristics were described using one-way frequency tables. We used exploratory factor analysis to determine the latent structure of the scale, then tested the fit of a single higher-order latent factor. We evaluated internal consistency and temporal stability reliability through Raykov's ρ and Pearson's correlation coefficient, respectively. We estimated a series of linear regression models to explore associations between the standardized reintegration measure and validated scales representing theoretically related constructs. RESULTS: Themes central to women's experiences following surgery included resuming mobility, increasing social interaction, improved self-esteem, reduction of internalized stigma, resuming work, meeting their own needs and the needs of dependents, meeting other expected and desired roles, and negotiating larger life issues. We expanded the Return to Normal Living Index to reflect these themes. Exploratory factor analysis suggested a four-factor structure, titled 'Mobility and social engagement', 'Meeting family needs', 'Comfort with relationships', and 'General life satisfaction', and goodness of fit statistics supported a higher-order latent variable of 'Reintegration.' Reintegration score correlated significantly with quality of life, depression, self-esteem, stigma, and social support in theoretically expected directions. CONCLUSION: As more women undergo surgical treatment for obstetric fistula, attention to the post-repair period is imperative. This preliminary validation of a reintegration instrument represents a first step toward improving measurement of post-surgical reintegration and has important implications for the evidence base of post-surgical reintegration epidemiology and the development and evaluation of fistula programming.


Assuntos
Parto Obstétrico/efeitos adversos , Apoio Social , Fístula Vaginal/cirurgia , Feminino , Humanos , Modelos Lineares , Qualidade de Vida , Fatores Socioeconômicos , Uganda , Fístula Vaginal/psicologia
8.
Female Pelvic Med Reconstr Surg ; 22(2): e20-1, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-26825410

RESUMO

Vaginal calculi are extremely rare and are most commonly encountered in the setting of an urethrovaginal or vesicovaginal fistula. We present a case of a 72-year-old woman with mixed urinary incontinence and vaginal mesh exposure incidentally found to have a large vaginal calculus. We removed the calculus surgically and analyzed the components. Results demonstrated the presence of ammonium-magnesium phosphate hexahydrate and carbonate apatite.


Assuntos
Cálculos/complicações , Incontinência Urinária/etiologia , Doenças Vaginais/complicações , Idoso , Cálculos/química , Cálculos/diagnóstico , Doença Crônica , Feminino , Humanos , Achados Incidentais , Recidiva , Reoperação , Slings Suburetrais , Telas Cirúrgicas , Incontinência Urinária/cirurgia , Doenças Vaginais/diagnóstico
9.
Reprod Health ; 12: 115, 2015 Dec 18.
Artigo em Inglês | MEDLINE | ID: mdl-26683687

RESUMO

BACKGROUND: Obstetric fistula is a debilitating birth injury that affects an estimated 2-3 million women globally, most in sub-Saharan Africa and Asia. The urinary and/or fecal incontinence associated with fistula affects women physically, psychologically and socioeconomically. Surgical management of fistula is available with clinical success rates ranging from 65-95 %. Previous research on fistula repair outcomes has focused primarily on clinical outcomes without considering the broader goal of successful reintegration into family and community. The objectives for this study are to understand the process of family and community reintegration post fistula surgery and develop a measurement tool to assess long-term success of post-surgical family and community reintegration. METHODS: This study is an exploratory sequential mixed-methods design including a preliminary qualitative component comprising in-depth interviews and focus group discussions to explore reintegration to family and community after fistula surgery. These results will be used to develop a reintegration tool, and the tool will be validated within a small longitudinal cohort (n = 60) that will follow women for 12 months after obstetric fistula surgery. Medical record abstraction will be conducted for patients managed within the fistula unit. Ethical approval for the study has been granted. DISCUSSION: This study will provide information regarding the success of family and community reintegration among women returning home after obstetric fistula surgery. The clinical and research community can utilize the standardized measurement tool in future studies of this patient population.


Assuntos
Fístula Retovaginal/cirurgia , Fístula Vesicovaginal/cirurgia , Adulto , Feminino , Humanos , Estudos Longitudinais , Complicações do Trabalho de Parto , Gravidez , Qualidade de Vida , Recuperação de Função Fisiológica , Fístula Retovaginal/complicações , Fístula Retovaginal/psicologia , Projetos de Pesquisa , Apoio Social , Fatores de Tempo , Resultado do Tratamento , Uganda , Incontinência Urinária/etiologia , Incontinência Urinária/cirurgia , Fístula Vesicovaginal/complicações , Fístula Vesicovaginal/psicologia
10.
Obstet Gynecol ; 122(1): 127-31, 2013 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-23743458

RESUMO

OBJECTIVE: To study the feasibility and acceptability of using video Internet communication to teach and evaluate surgical skills in a low-resource setting. METHODS: This case-controlled study used video Internet communication for surgical skills teaching and evaluation. We randomized intern physicians rotating in the Obstetrics and Gynecology Department at Mulago Hospital at Makerere University in Kampala, Uganda, to the control arm (usual practice) or intervention arm (three video teaching sessions with University of California, San Francisco faculty). We made preintervention and postintervention videos of all interns tying knots using a small video camera and uploaded the files to a file hosting service that offers cloud storage. A blinded faculty member graded all of the videos. Both groups completed a survey at the end of the study. RESULTS: We randomized 18 interns with complete data for eight in the intervention group and seven in the control group. We found score improvement of 50% or more in six of eight (75%) interns in the intervention group compared with one of seven (14%) in the control group (P=.04). Scores declined in five of the seven (71%) controls but in none in the intervention group. Both intervention and control groups used attendings, colleagues, and the Internet as sources for learning about knot-tying. The control group was less likely to practice knot-tying than the intervention group. The trainees and the instructors felt this method of training was enjoyable and helpful. CONCLUSION: Remote teaching in low-resource settings, where faculty time is limited and access to visiting faculty is sporadic, is feasible, effective, and well-accepted by both learner and teacher. LEVEL OF EVIDENCE: II.


Assuntos
Competência Clínica , Educação Médica/métodos , Cirurgia Geral/educação , Gravação de Videoteipe/métodos , Estudos de Casos e Controles , Comunicação , Educação a Distância , Recursos em Saúde , Humanos , Internet , Internato e Residência , Aprendizagem , São Francisco , Uganda
11.
Sex Transm Dis ; 37(12): 745-50, 2010 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-20644497

RESUMO

BACKGROUND: Bacterial vaginosis (BV) is a common vaginal infection caused by a lack of endogenous lactobacilli and overgrowth of pathogens that frequently recurs following antibiotic treatment. METHODS: A phase 2a study assessed colonization efficiency, safety, tolerability, and acceptability of Lactobacillus crispatus CTV-05 (LACTIN-V) administered by a vaginal applicator. Twenty-four women with BV were randomized in a 3:1 ratio of active product to placebo. Participants used LACTIN-V at 2 × 10 colony-forming units (cfu)/dose or placebo for 5 initial consecutive days, followed by a weekly application over 2 weeks. They returned for follow-up on Days 10 and 28. RESULTS: Sixty-one percent of the 18 women randomized to the LACTIN-V group were colonized with L. crispatus CTV-05 at Day 10 or Day 28. Among LACTIN-V users with complete adherence to the study regimen, 78% were colonized at Day 10 or Day 28. Of the 120 adverse events (AEs) that occurred, 108 (90%) and 12 (10%) were of mild and moderate severity, respectively. AEs were evenly distributed between the LACTIN-V and placebo group. Of the total AEs, 93 (78%) were genitourinary in origin. The most common genitourinary AEs included vaginal discharge (46%), abdominal pain (46%), dysuria (21%), pollakiuria (21%), vaginal odor (21%), and genital pruritus (17%). No grade 3 or 4 AEs or serious AEs occurred and no deep epithelial disruption was seen during colposcopic evaluation. The product was well tolerated and accepted. CONCLUSIONS: LACTIN-V colonized well, and was safe and acceptable in women treated for BV.


Assuntos
Lactobacillus/crescimento & desenvolvimento , Aceitação pelo Paciente de Cuidados de Saúde , Probióticos/administração & dosagem , Probióticos/efeitos adversos , Vagina/microbiologia , Vaginose Bacteriana/prevenção & controle , Administração Intravaginal , Adolescente , Adulto , Contagem de Colônia Microbiana , Método Duplo-Cego , Feminino , Humanos , Pessoa de Meia-Idade , Prevenção Secundária , Resultado do Tratamento , Vaginose Bacteriana/microbiologia , Adulto Jovem
12.
Am J Obstet Gynecol ; 203(1): 79.e1-8, 2010 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-20435288

RESUMO

OBJECTIVE: To develop and validate an instrument to assess surgical skills during vaginal surgery. STUDY DESIGN: Trainees from 2 institutions were directly assessed in the operating room by supervising surgeons while performing a vaginal hysterectomy using the new Vaginal Surgical Skills Index, global rating scale, and visual analogue scale. Trainees were assessed again by the same surgeons 4 weeks after the live surgery and by a blinded outside reviewer using a videotape of the case. Internal consistency, interrater and intrarater reliability, and construct validity were evaluated. RESULTS: Two hundred twelve evaluations were analyzed on 76 surgeries from 27 trainees. There was good internal consistency, interrater, and intrarater reliability. Vaginal Surgical Skills Index scores correlated with global rating score and visual analog scale scores. Increasing Vaginal Surgical Skills Index scores significantly correlated with year of training and surgical volume with an estimated increase in score of 0.3 per hysterectomy performed. CONCLUSION: The Vaginal Surgical Skills Index is a feasible, reliable, and valid instrument to assess vaginal surgical skills.


Assuntos
Educação de Pós-Graduação em Medicina/métodos , Ginecologia/educação , Histerectomia Vaginal/educação , Vagina/cirurgia , Competência Clínica , Feminino , Humanos , Variações Dependentes do Observador , Medição da Dor , Estudos Retrospectivos , Estudantes de Medicina , Gravação de Videoteipe
13.
Am J Obstet Gynecol ; 203(1): 81.e1-6, 2010 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-20417494

RESUMO

OBJECTIVE: The aim of this study was to establish minimum cutoff scores on intraoperative assessments of surgical skills to determine surgical competence for vaginal hysterectomy. STUDY DESIGN: Two surgical rating scales, the Global Rating Scale of Operative Performance and the Vaginal Surgical Skills Index, were used to evaluate trainees while performing vaginal hysterectomy. Cutoff scores were determined using the Modified Angoff method. RESULTS: Two hundred twelve evaluations were analyzed on 76 surgeries performed by 27 trainees. Trainees were considered minimally competent to perform vaginal hysterectomy if total absolute scores (95% confidence interval) on Global Rating Scale = 18 (16.5-20.3) and Vaginal Surgical Skills Index = 32 (27.7-35.5). On average, trainees met new cutoffs after performing 21 and 27 vaginal hysterectomies, respectively. With the new cutoffs applied to the same cohort of fourth-year obstetrics and gynecology trainees, all residents achieved competency in performing vaginal hysterectomy by the end of their gynecology rotations. CONCLUSION: Standard-setting methods using cutoff scores may be used to establish competence in vaginal surgery.


Assuntos
Educação de Pós-Graduação em Medicina/métodos , Ginecologia/educação , Histerectomia Vaginal/educação , Avaliação Educacional/métodos , Humanos , Medição da Dor , Estudantes de Medicina
14.
J Reprod Med ; 54(8): 488-92, 2009 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-19769194

RESUMO

OBJECTIVE: To investigate risk factors for advanced pelvic organ prolapse (POP) in Asian women. STUDY DESIGN: This was a case-control study of Asian women referred for POP or incontinence over a 10-year period at San Francisco General Hospital. Details of a structured pelvic examination and demographic information were abstracted from medical records. Cases were women with advanced (beyond the hymenal remnant) POP, while patients with a lesser degree of prolapse served as controls. Categorical variables were analyzed using chi2 or Fisher's exact test (where appropriate), while continuous variables were analyzed with Student's t test. Logistic regression was used for multivariate analysis. RESULTS: One hundred thirty Asian women were identified. Sixty-six women had advanced prolapse of some portion of their vagina. Increasing parity was associated with advanced prolapse of the anterior compartment of the vagina (adjusted OR 1.56, 95% CI 1.22-2.00). Previous hysterectomy appears to be protective of advanced prolapse of the anterior vagina (adjusted OR 0.09, 95% CI 0.01-0.81). CONCLUSION: Similar to the Caucasian population, Asian women with higher parity are at increased risk for prolapse of the anterior compartment of the vagina. However, previous hysterectomy appears to be protective of future prolapse in Asian women.


Assuntos
Grupo com Ancestrais do Continente Asiático , Paridade , Prolapso Uterino/etnologia , Prolapso Uterino/etiologia , Estudos de Casos e Controles , Feminino , Humanos , Histerectomia , Pessoa de Meia-Idade , Razão de Chances , Gravidez , Incontinência Urinária/etnologia
15.
Sex Transm Dis ; 36(9): 564-9, 2009 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-19543144

RESUMO

BACKGROUND: Bacterial vaginosis is a very common vaginal infection. The lack of endogenous lactobacilli and overgrowth of pathogens facilitate numerous gynecological complications. METHODS: A phase I dose-ranging safety trial tested the safety, tolerability, and acceptability of Lactobacillus crispatus CTV-05 (LACTIN-V) administered by vaginal applicator. Twelve healthy volunteers were enrolled in 3 blocks of 4 (5 x 10, 1 x 10, and 2 x 10 cfu/dose). Each block was randomized in a 3:1 ratio of active product to placebo. Participants used study product for 5 consecutive days, returned for follow-up on days 7 and 14, and had phone interviews on days 2 and 35. RESULTS: All 12 participants took 5 doses and completed study follow-up.Overall, 45 adverse events (AEs) occurred, of which 31 (69%) were genitourinary (GU) AEs. GU AEs appeared evenly distributed between the 3 treatment blocks and between LACTIN-V and placebo arms. The most common GU AEs were vaginal discharge in 5 subjects (42%), abdominal pain in 4 subjects (33%), metrorrhagia in 4 subjects (33%), vulvovaginitis in 4 subjects (33%), vaginal candidiasis in 3 subjects (25%), and vaginal odor in 3 subjects (25%). Forty-one (91%) AEs were mild (grade 1) in severity. All 4 moderate AEs (grade 2) were unrelated to product use. No grade 3 or 4 AEs or serious adverse events (SAE) occurred. Laboratory parameters and colposcopy findings were within normal limits or clinically insignificant. The product was well-tolerated and accepted. CONCLUSION: All 3 dose levels of LACTIN-V appeared to be safe and acceptable in healthy volunteers.


Assuntos
Lactobacillus , Probióticos/administração & dosagem , Probióticos/efeitos adversos , Vaginose Bacteriana/microbiologia , Vaginose Bacteriana/prevenção & controle , Administração Intravaginal , Adulto , Relação Dose-Resposta a Droga , Método Duplo-Cego , Esquema de Medicação , Feminino , Humanos , Resultado do Tratamento
16.
Holist Nurs Pract ; 21(1): 26-34, 2007.
Artigo em Inglês | MEDLINE | ID: mdl-17167329

RESUMO

Although the incidence rate of cervical cancer has decreased over the last several years, low-income ethnic minority women remain at increased risk for morbidity and mortality from cervical cancer. We conducted a pilot study to examine the feasibility and acceptability of mindfulness-based stress reduction (MBSR) program among multiethnic low-income women with abnormal Pap smears. Spanish- and English-speaking women recruited through convenience sampling participated in MBSR classes 2 hours each week over 6 consecutive weeks. State anxiety and self-compassion were measured before and after the MBSR program. Focus groups and surveys were used to evaluate the program. Although 51 women were initially recruited, pre- and post-MBSR data were available only for 8 women. There was a significant reduction in anxiety and a trend toward increased self-compassion in this group of women. The participants evaluated the MBSR program very positively. The high attrition rate highlights the challenges of conducting MBSR research with this demographic of women. Potential strategies for improving recruitment and retention of low-income multiethnic women are discussed.


Assuntos
Atitude Frente a Saúde/etnologia , Grupo com Ancestrais do Continente Europeu/psicologia , Hispano-Americanos/psicologia , Teste de Papanicolaou , Pobreza , Estresse Psicológico/prevenção & controle , Esfregaço Vaginal/psicologia , Adulto , Análise de Variância , Ansiedade/prevenção & controle , California , Características Culturais , Feminino , Grupos Focais , Promoção da Saúde/métodos , Humanos , Pessoa de Meia-Idade , Narração , Estresse Psicológico/etnologia , Inquéritos e Questionários
17.
J Clin Endocrinol Metab ; 90(4): 2142-7, 2005 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-15623808

RESUMO

Norplant, a sc contraceptive device, releases levonorgestrel in a sustained fashion. Its effectiveness is offset by irregular bleeding patterns. Because vascular endothelial growth factor (VEGF) is stimulated by synthetic progestogens in vitro and in vivo, we postulated that correlations between this angiogenic factor and uterine bleeding patterns might exist. Twenty-eight women who were exposed to Norplant and 13 control women were prospectively followed for 6-8 months. Bleeding diaries were collected, hysteroscopies were performed, endometrial biopsies were obtained for standardized histological evaluation, and VEGF histochemical immunostaining (H)-scores were assigned. Cluster determination-34 (CD34) staining was also performed to quantify the number of endometrial blood vessels per high-power field. Irregular uterine bleeding was common among women using Norplant devices. Endometrial VEGF H-scores were greater in women using Norplant than in control women. New findings of this study show that vessel density did not correlate with epithelial VEGF H-scores but was highly associated with the intensity of stromal and perivascular VEGF. VEGF expression in the latter regions correlated significantly with hysteroscopic abnormalities and irregular bleeding. The expression of this angiogenic protein, particularly in the stromal and perivascular compartments, correlated with microvascular density, hysteroscopically documented hypervascularity, and uterine bleeding profiles. Irregular bleeding with Norplant use appears to reflect paracrine-mediated effects on vascular function by angiogenic factors, such as VEGF.


Assuntos
Anticoncepcionais Femininos/efeitos adversos , Endométrio/efeitos dos fármacos , Levanogestrel/efeitos adversos , Neovascularização Fisiológica/efeitos dos fármacos , Hemorragia Uterina/induzido quimicamente , Adulto , Endométrio/patologia , Feminino , Humanos , Imuno-Histoquímica , Pessoa de Meia-Idade , Fator A de Crescimento do Endotélio Vascular/análise
18.
Lancet ; 364(9447): 1757-65, 2004.
Artigo em Inglês | MEDLINE | ID: mdl-15541448

RESUMO

BACKGROUND: Vaccination against the most common oncogenic human papillomavirus (HPV) types, HPV-16 and HPV-18, could prevent development of up to 70% of cervical cancers worldwide. We did a randomised, double-blind, controlled trial to assess the efficacy, safety, and immunogenicity of a bivalent HPV-16/18 L1 virus-like particle vaccine for the prevention of incident and persistent infection with these two virus types, associated cervical cytological abnormalities, and precancerous lesions. METHODS: We randomised 1113 women between 15-25 years of age to receive three doses of either the vaccine formulated with AS04 adjuvant or placebo on a 0 month, 1 month, and 6 month schedule in North America and Brazil. Women were assessed for HPV infection by cervical cytology and self-obtained cervicovaginal samples for up to 27 months, and for vaccine safety and immunogenicity. FINDINGS: In the according-to-protocol analyses, vaccine efficacy was 91.6% (95% CI 64.5-98.0) against incident infection and 100% against persistent infection (47.0-100) with HPV-16/18. In the intention-to-treat analyses, vaccine efficacy was 95.1% (63.5-99.3) against persistent cervical infection with HPV-16/18 and 92.9% (70.0-98.3) against cytological abnormalities associated with HPV-16/18 infection. The vaccine was generally safe, well tolerated, and highly immunogenic. INTERPRETATION: The bivalent HPV vaccine was efficacious in prevention of incident and persistent cervical infections with HPV-16 and HPV-18, and associated cytological abnormalities and lesions. Vaccination against such infections could substantially reduce incidence of cervical cancer.


Assuntos
Proteínas Oncogênicas Virais/imunologia , Papillomaviridae/imunologia , Infecções por Papillomavirus/prevenção & controle , Vacinas contra Papillomavirus , Neoplasias do Colo do Útero/prevenção & controle , Vacinas Virais/imunologia , Adolescente , Adulto , Anticorpos Antivirais/sangue , Capsídeo/imunologia , Proteínas do Capsídeo , Neoplasia Intraepitelial Cervical/virologia , Colo do Útero/virologia , Relação Dose-Resposta Imunológica , Método Duplo-Cego , Ensaio de Imunoadsorção Enzimática , Feminino , Humanos , Esquemas de Imunização , Testes de Neutralização , Doenças do Colo do Útero/imunologia , Doenças do Colo do Útero/prevenção & controle , Doenças do Colo do Útero/virologia , Neoplasias do Colo do Útero/virologia , Vacinas Virais/administração & dosagem , Vacinas Virais/efeitos adversos
19.
Int Immunol ; 16(8): 1109-24, 2004 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-15210650

RESUMO

To develop a comprehensive catalogue of phenotypic and functional parameters of human CD4(+) T cell differentiation stages, we have performed microarray gene expression profiling on subpopulations of human thymocytes and circulating naive CD4(+) T cells, including CD3(-)CD4(+)CD8(-) intrathymic T progenitor cells, CD3(int)CD4(+)CD8(+) 'double positive' thymocytes, CD3(high)CD4(+)CD8(-) 'single positive' thymocytes, CD3(+)CD4(+)CD8(-) CD45RA(+)CD62L(+) naive T cells from cord blood and CD3(+)CD4(+)CD8(-) CD45RA(+)CD62L(+) naive T cells from adult blood. These subpopulations were sort-purified to >98% purity and their expressed RNAs were analyzed on Affymetrix Human Genome U133 arrays. Comparison of gene expression signals between these subpopulations and with early passage fetal thymic stromal cultures identify: (i) transcripts that are preferentially expressed in human CD4(+) T cell subpopulations and not in thymic stromal cells; (ii) major shifts in gene expression as progenitor T cells mature into progeny; (iii) preferential expression of transcripts at the progenitor cell stage with plausible relevance to the regulation of expansion and differentiation of these cells; and (iv) preferential expression of potential markers of recent thymic emigrants in naive-phenotype CD4(+) T cells from cord blood. Further evaluation of these findings may lead to a better definition of human thymopoiesis as well as to improved approaches to monitor and to augment the function of this important organ of T cell production.


Assuntos
Antígenos CD/imunologia , Linfócitos T CD4-Positivos/imunologia , Diferenciação Celular/imunologia , Perfilação da Expressão Gênica , Regulação da Expressão Gênica/imunologia , Análise de Sequência com Séries de Oligonucleotídeos , Timo/imunologia , Antígenos CD/genética , Diferenciação Celular/genética , Sangue Fetal/citologia , Sangue Fetal/imunologia , Regulação da Expressão Gênica/genética , Humanos , Timo/citologia
20.
J Am Assoc Gynecol Laparosc ; 11(2): 197-203, 2004 May.
Artigo em Inglês | MEDLINE | ID: mdl-15200775

RESUMO

STUDY OBJECTIVE: To prospectively evaluate the use of gasless laparoscopy techniques in the performance of a traditional Burch colposuspension in women with urodynamically-demonstrated genuine stress incontinence and urethral hypermobility. DESIGN: Multicenter, prospective, single-intervention series (Canadian Task Force Classification II-2). SETTING: Three urogynecologic referral centers. PATIENTS: Fifty-eight women. INTERVENTION: Traditional Burch colposuspension performed utilizing gasless laparoscopic access and conventional surgical instruments. MEASUREMENTS AND MAIN RESULTS: Follow-up was 12 to 38 months. On pad testing, urine loss was significantly reduced, from 6.0 g (CI: 0.55-11.45) to 0.3 g (CI: 0-1.53). Average daily incontinence episodes based on 7-day voiding diaries decreased from 4.7 (CI: 0.87-8.53) to 0.3 (CI: 0-1.58). Q-tip angles were normalized: 49.8 degrees (CI: 40.86-58.74) to 10 degrees (CI: 1.49-18.51). Ninety-five percent of subjects reported resolution of stress incontinence. Three subjects (5%) reported recurrent/persistent genuine stress incontinence: one was operated on during the postpartum period while breastfeeding, and two developed intrinsic sphincteric deficiency postoperatively. Fifty-five percent of subjects underwent other pelvic reconstructive surgery including posterior wall repairs. Average operative time was 60.8 minutes (range, 40-92). The ideal candidate has an unscarred abdominal wall. CONCLUSION: Gasless laparoscopic access was used to effectively perform traditional Burch colposuspension using conventional open surgical instruments. Bladder neck hypermobility was normalized in all subjects, and 95% of subjects reported no further stress incontinence.


Assuntos
Laparoscopia/métodos , Instrumentos Cirúrgicos , Incontinência Urinária por Estresse/cirurgia , Procedimentos Cirúrgicos Urológicos/instrumentação , Adulto , Idoso , Idoso de 80 Anos ou mais , Desenho de Equipamento , Segurança de Equipamentos , Feminino , Seguimentos , Humanos , Pessoa de Meia-Idade , Satisfação do Paciente , Pneumoperitônio Artificial , Estudos Prospectivos , Índice de Gravidade de Doença , Telas Cirúrgicas , Resultado do Tratamento , Incontinência Urinária por Estresse/diagnóstico , Urodinâmica , Procedimentos Cirúrgicos Urológicos/métodos
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