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1.
BJU Int ; 132(6): 606-607, 2023 12.
Artigo em Inglês | MEDLINE | ID: mdl-38011914
2.
Health Technol Assess ; 26(23): 1-172, 2022 05.
Artigo em Inglês | MEDLINE | ID: mdl-35535708

RESUMO

BACKGROUND: Daily, low-dose antibiotic prophylaxis is the current standard care for women with recurrent urinary tract infection. Emerging antimicrobial resistance is a global health concern, prompting research interest in non-antibiotic agents such as methenamine hippurate, but comparative data on their efficacy and safety are lacking. OBJECTIVE: To assess the clinical effectiveness and cost-effectiveness of methenamine hippurate (Hiprex®; Mylan NV, Canonsburg, PA, USA) compared with current standard care (antibiotic prophylaxis) for recurrent urinary tract infection prevention in adult women. DESIGN: Multicentre, pragmatic, open-label, randomised, non-inferiority trial of 12 months' treatment with the allocated intervention, including an early, embedded qualitative study and a 6-month post-treatment observation phase. The predefined non-inferiority margin was one urinary tract infection per person-year. SETTING: Eight UK NHS secondary care sites. PARTICIPANTS: A total of 240 adult women with recurrent urinary tract infection requiring preventative treatment participated in the trial. INTERVENTIONS: A central randomisation system allocated participants 1 : 1 to the experimental (methenamine hippurate: 1 g twice daily) or control (once-daily low-dose antibiotics: 50/100 mg of nitrofurantoin, 100 mg of trimethoprim or 250 mg of cefalexin) arm. Crossover between treatment arms was permitted. MAIN OUTCOME MEASURES: The primary clinical outcome was incidence of symptomatic antibiotic-treated urinary tract infection during the 12-month treatment period. Cost-effectiveness was assessed by incremental cost per quality-adjusted life-year gained, extrapolated over the patient's expected lifetime using a Markov cohort model. Secondary outcomes included post-treatment urinary tract infections, total antibiotic use, microbiologically proven urinary tract infections, antimicrobial resistance, bacteriuria, hospitalisations and treatment satisfaction. RESULTS: Primary modified intention-to-treat analysis comprised 205 (85%) randomised participants [102/120 (85%) participants in the antibiotics arm and 103/120 (86%) participants in the methenamine hippurate arm] with at least 6 months' data available. During treatment, the incidence rate of symptomatic, antibiotic-treated urinary tract infections decreased substantially in both arms to 1.38 episodes per person-year (95% confidence interval 1.05 to 1.72 episodes per person-year) for methenamine hippurate and 0.89 episodes per person year (95% confidence interval 0.65 to 1.12 episodes per person-year) for antibiotics (absolute difference 0.49; 90% confidence interval 0.15 to 0.84). This absolute difference did not exceed the predefined, strict, non-inferiority limit of one urinary tract infection per person-year. On average, methenamine hippurate was less costly and more effective than antibiotics in terms of quality-adjusted life-years gained; however, this finding was not consistent over the longer term. The urinary tract infection incidence rate 6 months after treatment completion was 1.72 episodes per year in the methenamine hippurate arm and 1.19 in the antibiotics arm. During treatment, 52% of urine samples taken during symptomatic urinary tract infections were microbiologically confirmed and higher proportions of participants taking daily antibiotics (46/64; 72%) demonstrated antibiotic resistance in Escherichia coli cultured from perineal swabs than participants in the methenamine hippurate arm (39/70; 56%) (p-value = 0.05). Urine cultures revealed that during treatment higher proportions of participants and samples from the antibiotic arm grew E. coli resistant to trimethoprim/co-trimoxazole and cephalosporins, respectively. Conversely, post treatment, higher proportions of participants in the methenamine hippurate arm (9/45; 20%) demonstrated multidrug resistance in E. coli isolated from perineal swabs than participants in the antibiotic arm (2/39; 5%) (p = 0.06). All other secondary outcomes and adverse events were similar in both arms. LIMITATIONS: This trial could not define whether or not one particular antibiotic was more beneficial, and progressive data loss hampered economic evaluation. CONCLUSIONS: This large, randomised, pragmatic trial in a routine NHS setting has clearly shown that methenamine hippurate is not inferior to current standard care (daily low-dose antibiotics) in preventing recurrent urinary tract infections in women. The results suggest that antimicrobial resistance is proportionally higher in women taking prophylactic antibiotics. RECOMMENDATIONS FOR RESEARCH: Future research should include evaluation of other non-antibiotic preventative treatments in well-defined homogeneous patient groups, preferably with the comparator of daily antibiotics. TRIAL REGISTRATION: This trial is registered as ISRCTN70219762 and EudraCT 2015-003487-36. FUNDING: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 23. See the NIHR Journals Library website for further project information.


Women with recurrent urine infections often require preventative treatment to reduce the frequency of infection episodes. Daily low-dose antibiotic medication is a guideline-recommended treatment option for these women. There is increasing concern globally regarding antibiotic-resistant infections, which has led researchers to look at alternative treatments. This trial was conducted to find out whether or not taking an alternative treatment that is not an antibiotic [i.e. methenamine hippurate (Hiprex®; Mylan NV, Canonsburg, PA, USA)] was as effective as the standard daily low-dose antibiotics. A total of 240 women from across the UK took part in the trial. They were divided equally into two groups; half of the women were given methenamine hippurate and the other half were given standard low-dose antibiotics. Both treatments were prescribed to be taken every day for 1 year. To make a fair comparison, people were put into the two groups at random using a computer program. Aspects of the trial that could be improved were identified through telephone interviews with patients and recruiting staff. Feedback from these telephone interviews helped to ensure the successful conduct of the trial. Patients were followed up for 18 months, comprising the 12 months when they were taking treatment and a 6-month follow-up phase after they had finished treatment. We found that the non-antibiotic option of methenamine hippurate was no worse than the current standard treatment of daily antibiotics in preventing urinary tract infection episodes in adult women. For both treatments, patients expressed high levels of satisfaction. One advantage of the methenamine hippurate treatment was that infecting bacteria were slightly less likely to develop resistance to antibiotics. We also evaluated health-care costs of both treatments and found that methenamine hippurate seemed worthwhile to the NHS in the short term, but there was uncertainty over longer-term costs and benefits. These results will help patients with repeated urinary tract infections to decide on treatment options, particularly if they want to avoid prolonged courses of preventative antibiotics.


Assuntos
Antibioticoprofilaxia , Infecções Urinárias , Adulto , Antibacterianos/efeitos adversos , Análise Custo-Benefício , Escherichia coli , Feminino , Hipuratos , Humanos , Masculino , Metenamina/análogos & derivados , Trimetoprima , Infecções Urinárias/tratamento farmacológico , Infecções Urinárias/prevenção & controle
3.
Eur Urol Focus ; 8(6): 1736-1750, 2022 11.
Artigo em Inglês | MEDLINE | ID: mdl-35430159

RESUMO

CONTEXT: The degree of change in erectile (EF) and ejaculatory function (EjF) according to validated questionnaires following anterior urethroplasty and different techniques is unclear. OBJECTIVE: To investigate the evidence on EF and EjF evaluated via validated questionnaires following anterior urethroplasty. EVIDENCE ACQUISITION: A systematic review (PROSPERO ID: CRD42021229797) of the literature was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist. The PubMed and CENTRAL databases were searched on February 1, 2021, with an updated search performed on December 1, 2021. Studies evaluating EF and/or EjF using validated questionnaires in men aged ≥18 yr following anterior urethroplasty were included. EVIDENCE SYNTHESIS: Overall, 29 studies (two randomised and 27 nonrandomised) were included. The questionnaire most commonly used to evaluate EF and EjF was the International Index of Erectile Function (IIEF) and Male Sexual Health Questionnaire (MSHQ), respectively. The incidence of postoperative erectile dysfunction (ED) was 0-38% and the mean change in EF score according to the IIEF ranged from -4.0 to 2.5. The incidence of postoperative ejaculatory dysfunction (EjD) was 7.7-67% and the mean change in EjF score according to the MSHQ-EjD was 0.7-7.0. Meta-analyses revealed a mean difference of -0.87 (95% confidence interval [CI] -1.50 to -0.23; p = 0.008) in IIEF-EF score and 1.77 (95% CI 0.61-2.93; p = 0.003) in MSHQ-EjF score following anterior urethroplasty. CONCLUSIONS: EF and EjF may be affected following anterior urethroplasty and men should be counselled appropriately. Owing to the variation in questionnaires and cutoff scores used, EF and EjF outcomes following different urethroplasty techniques are heterogeneous, with limited data from randomised controlled trials. An agreement on questionnaires and cutoff scores should be established to allow consistent reporting. Future research should aim to investigate best approaches for minimising sexual dysfunction. PATIENT SUMMARY: Surgical repair of the urethra (urethroplasty) used to treat narrowing of the urethra (urethral stricture) may affect erectile and ejaculatory function. Different questionnaires and definitions are used to evaluate sexual function, so it is hard to compare data. The degree of disruption can be affected by different techniques and the severity of disease.


Assuntos
Masculino , Humanos
4.
BMJ ; 376: e068229, 2022 03 09.
Artigo em Inglês | MEDLINE | ID: mdl-35264408

RESUMO

OBJECTIVE: To test and compare the efficacy of methenamine hippurate for prevention of recurrent urinary tract infections with the current standard prophylaxis of daily low dose antibiotics. DESIGN: Multicentre, open label, randomised, non-inferiority trial. SETTING: Eight centres in the UK, recruiting from June 2016 to June 2018. PARTICIPANTS: Women aged ≥18 years with recurrent urinary tract infections, requiring prophylactic treatment. INTERVENTIONS: Random assignment (1:1, using permuted blocks of variable length via a web based system) to receive antibiotic prophylaxis or methenamine hippurate for 12 months. Treatment allocation was not masked and crossover between arms was allowed. MAIN OUTCOME MEASURE: Absolute difference in incidence of symptomatic, antibiotic treated, urinary tract infections during treatment. A patient and public involvement group predefined the non-inferiority margin as one episode of urinary tract infection per person year. Analyses performed in a modified intention-to-treat population comprised all participants observed for at least six months. RESULTS: Participants were randomly assigned to antibiotic prophylaxis (n=120) or methenamine hippurate (n=120). The modified intention-to-treat analysis comprised 205 (85%) participants (antibiotics, n=102 (85%); methenamine hippurate, n=103 (86%)). Incidence of antibiotic treated urinary tract infections during the 12 month treatment period was 0.89 episodes per person year (95% confidence interval 0.65 to 1.12) in the antibiotics group and 1.38 (1.05 to 1.72) in the methenamine hippurate group, with an absolute difference of 0.49 (90% confidence interval 0.15 to 0.84) confirming non-inferiority. Adverse reactions were reported by 34/142 (24%) in the antibiotic group and 35/127 (28%) in the methenamine group and most reactions were mild. CONCLUSION: Non-antibiotic prophylactic treatment with methenamine hippurate might be appropriate for women with a history of recurrent episodes of urinary tract infections, informed by patient preferences and antibiotic stewardship initiatives, given the demonstration of non-inferiority to daily antibiotic prophylaxis seen in this trial. TRIAL REGISTRATION: ISRCTN70219762.


Assuntos
Antibacterianos/administração & dosagem , Antibioticoprofilaxia , Hipuratos/administração & dosagem , Metenamina/análogos & derivados , Infecções Urinárias/prevenção & controle , Adolescente , Adulto , Feminino , Humanos , Metenamina/administração & dosagem , Pessoa de Meia-Idade , Recidiva , Resultado do Tratamento , Infecções Urinárias/microbiologia , Adulto Jovem
6.
BJU Int ; 128(4): 451-459, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-33249744

RESUMO

OBJECTIVE: To present the long-term adjuvant radiotherapy outcomes of patients with pN3 squamous cell carcinoma of the penis (SCCp) treated at two UK centres. PATIENTS AND METHODS: We conducted a retrospective audit of all pN3 SCCp patients, deemed suitable for adjuvant therapy by a specialist multidisciplinary team at St George's and Leeds Hospitals, who received adjuvant radiotherapy. Primary outcomes were recurrence-free survival (RFS), cancer-specific survival (CSS) and overall survival (OS). Secondary outcomes were time to adjuvant treatment, frequency of in-field recurrence, site and side of recurrence, and dose and schedule of radiotherapy. RESULTS: A total of 146 patients were included: 121 completed radiotherapy, 4 did not complete radiotherapy and 21 did not start it. The median (interquartile range [IQR]) age was 59 (54-70)years. The 5-year RFS was 51%, CSS was 51% and OS was 44%. Adjuvant radiotherapy was started at a median (IQR) of 75 (48-106) days. A dose of 45 Gy in 20 fractions was most commonly used. Of the 125 patients who started adjuvant treatment, 55 relapsed. Of these relapses, 30 occurred in an inguinal or pelvic nodal station and 26 of the 30 were in a radiation field. Relapses in 18 of the 55 cases were in visceral sites only and seven were in both nodal (non-irradiated sites) and visceral sites. Doses of <50 Gy were used more commonly before 2013 and higher doses (>50 Gy) were more commonly used after 2013. CONCLUSIONS: Application of a standard radiotherapy protocol within a centralized supra-network setting has achieved survival outcomes that would appear better than those previously documented for either radiotherapy or chemotherapy in a cohort with solely pN3 disease. The addition of adjuvant chemotherapy may improve these outcomes further. These data suggest that adjuvant radiotherapy has a role to play in the management of men with pN3 SCCp.


Assuntos
Carcinoma de Células Escamosas/radioterapia , Neoplasias Penianas/radioterapia , Idoso , Carcinoma de Células Escamosas/patologia , Humanos , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Neoplasias Penianas/patologia , Radioterapia Adjuvante , Estudos Retrospectivos , Fatores de Tempo
7.
BJU Int ; 126(6): 651-652, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-33270971
9.
BJU Int ; 126(4): 411-415, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32649792

RESUMO

'When I use a word' Humpty Dumpty said, in a rather scornful tone, 'it means just what I choose it to mean, neither more nor less'. 'The question is' said Alice 'whether you can make words mean so many different things'. Through the Looking-Glass, Lewis Carroll, 1872.


Assuntos
Compreensão , Consentimento Livre e Esclarecido/legislação & jurisprudência , Competência Mental/legislação & jurisprudência , Complicações Pós-Operatórias/etiologia , Vasectomia/efeitos adversos , Humanos , Masculino , Reino Unido , Vasectomia/legislação & jurisprudência
11.
BMJ Simul Technol Enhanc Learn ; 5(3): 151-154, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-35514940

RESUMO

Objective: Education and training of surgeons has traditionally focused on the development of individual knowledge, technical skills and decision making. Knowledge about endoscopic instruments is one of the core elements of urological training. We assessed the precourse knowledge of newly appointed urology trainees and the impact of boot camp in improving their knowledge. Methods: Newly appointed specialty trainees in urology took part in a pilot 5-day urology simulation boot camp (USBC). The aim of the USBC was to improve their confidence, procedural performance and non-technical skills, with one of the modules looking at the trainees' knowledge about common endoscopic instruments in urology. Delegates were first asked to identify and assemble the instruments, followed by one-to-one teaching about the instruments. An Objective Structured Assessment Tool was used to assess their knowledge in the identification and assembly of the cystoscope, resectoscope and optical urethrotome, before and at the end of the course. Results: Data of two successive boot camps were collected to assess knowledge of instruments of newly appointed urology trainees. Majority of the trainees had good precourse knowledge of the cystoscopy kit, with 84% able to correctly identify the parts. Seventy-six per cent of candidates were able to identify the resectoscope equipment, but only approximately a third of trainees were able to correctly identify the urethrotome kit. The assembly of cystoscope, resectoscope and urethrotome was performed correctly in 74%, 42% and 32% at baseline and 94%, 90% and 77% postcourse, respectively. Overall performance improved significantly in the postcourse assessment (<0.001). Conclusion: This urology boot camp has addressed gaps in trainees' core equipment knowledge and guided them to improve their knowledge with respect to identification and assembly of cystoscope, resectoscope and urethrotome.

12.
Trials ; 19(1): 616, 2018 Nov 09.
Artigo em Inglês | MEDLINE | ID: mdl-30413181

RESUMO

BACKGROUND: At least half of all adult women will experience infective cystitis (urinary tract infection: UTI) at least once in their life and many suffer from repeated episodes. Recurrent urinary tract infection (rUTI) in adult women is usually treated with long-term, low-dose antibiotics and current national and international guidelines recommend this as the 'gold standard' preventative treatment. Although they are reasonably effective, long-term antibiotics can result in bacteria becoming resistant not only to the prescribed antibiotic but to other antimicrobial agents. The problem of antimicrobial resistance is recognised as a global threat and the recent drive for antibiotic stewardship has emphasised the need for careful consideration prior to prescribing antibiotics. This has led clinicians and patients alike to explore potential non-antibiotic options for recurrent UTI prevention. DESIGN /METHODS: This is a multicentre, pragmatic, patient-randomised, non-inferiority trial comparing a non-antibiotic preventative treatment for rUTI in women, methenamine hippurate, against the current standard of daily low-dose antibiotics. Women who require preventative treatment for rUTI are the target population. This group is comprised of those with a diagnosis of rUTI, defined as three episodes in 1 year or two episodes in 6 months, and those with a single severe infection requiring hospitalisation. Participants will be recruited from secondary care urology / urogynaecology departments in the UK following referral with rUTI. Participants will be followed up during a 12-month period of treatment and in the subsequent 6 months following completion of the prophylactic medication. Outcomes will be assessed from patient recorded symptoms, quality of life questionnaires and microbiological examination of urine and perineal swabs. The primary outcome is the incidence of symptomatic antibiotic-treated UTI self-reported by participants during the 12-month period of preventative treatment. Health economic outcomes will also be assessed to define the cost-effectiveness of both treatments. A qualitative study will be conducted in the first 8 months of the trial to explore with participants/non-participants' and recruiting clinicians' views on trial processes and identify potential barriers to recruitment, reasons for participating and non-participation and for dropping out of the study. DISCUSSION: The study was commissioned and funded by the National Institute for Health Research (NIHR) and approved under the Medicines and Healthcare products Regulatory Agency (MHRA) notification scheme as a 'Type A' study. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number (ISRCTN), registry number: ISRCTN70219762 . Registered on 31 May 2016.


Assuntos
Antibioticoprofilaxia , Ensaios Clínicos Pragmáticos como Assunto , Infecções Urinárias/tratamento farmacológico , Adulto , Idoso , Viés , Segurança Computacional , Feminino , Hipuratos/uso terapêutico , Humanos , Metenamina/análogos & derivados , Metenamina/uso terapêutico , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Avaliação de Resultados em Cuidados de Saúde , Recidiva , Projetos de Pesquisa , Tamanho da Amostra , Padrão de Cuidado
13.
Exp Cell Res ; 369(2): 284-294, 2018 08 15.
Artigo em Inglês | MEDLINE | ID: mdl-29842880

RESUMO

Identification of transcription factors expressed by differentiated cells is informative not only of tissue-specific pathways, but to help identify master regulators for cellular reprogramming. If applied, such an approach could generate healthy autologous tissue-specific cells for clinical use where cells from the homologous tissue are unavailable due to disease. Normal human epithelial cells of buccal and urothelial derivation maintained in identical culture conditions that lacked significant instructive or permissive signaling cues were found to display inherent similarities and differences of phenotype. Investigation of transcription factors implicated in driving urothelial-type differentiation revealed buccal epithelial cells to have minimal or absent expression of PPARG, GATA3 and FOXA1 genes. Retroviral overexpression of protein coding sequences for GATA3 or PPARy1 in buccal epithelial cells resulted in nuclear immunolocalisation of the respective proteins, with both transductions also inducing expression of the urothelial differentiation-associated claudin 3 tight junction protein. PPARG1 overexpression alone entrained expression of nuclear FOXA1 and GATA3 proteins, providing objective evidence of its upstream positioning in a transcription factor network and identifying it as a candidate factor for urothelial-type transdifferentiation or reprogramming.


Assuntos
Mucosa Bucal/citologia , Mucosa Bucal/metabolismo , Fatores de Transcrição/metabolismo , Urotélio/citologia , Urotélio/metabolismo , Diferenciação Celular , Transdiferenciação Celular , Células Cultivadas , Reprogramação Celular , Células Epiteliais/citologia , Células Epiteliais/metabolismo , Fator de Transcrição GATA3/genética , Fator de Transcrição GATA3/metabolismo , Fator 3-alfa Nuclear de Hepatócito/genética , Fator 3-alfa Nuclear de Hepatócito/metabolismo , Humanos , PPAR gama/genética , PPAR gama/metabolismo , Fenótipo , Engenharia Tecidual , Fatores de Transcrição/genética , Uroplaquinas/genética , Uroplaquinas/metabolismo
14.
Mol Carcinog ; 57(5): 606-618, 2018 05.
Artigo em Inglês | MEDLINE | ID: mdl-29323757

RESUMO

Extra-hepatic metabolism of xenobiotics by epithelial tissues has evolved as a self-defence mechanism but has potential to contribute to the local activation of carcinogens. Bladder epithelium (urothelium) is bathed in excreted urinary toxicants and pro-carcinogens. This study reveals how differentiation affects cytochrome P450 (CYP) activity and the role of NADPH:P450 oxidoreductase (POR). CYP1A1 and CYP1B1 transcripts were inducible in normal human urothelial (NHU) cells maintained in both undifferentiated and functional barrier-forming differentiated states in vitro. However, ethoxyresorufin O-deethylation (EROD) activity, the generation of reactive BaP metabolites and BaP-DNA adducts, were predominantly detected in differentiated NHU cell cultures. This gain-of-function was attributable to the expression of POR, an essential electron donor for all CYPs, which was significantly upregulated as part of urothelial differentiation. Immunohistology of muscle-invasive bladder cancer (MIBC) revealed significant overall suppression of POR expression. Stratification of MIBC biopsies into "luminal" and "basal" groups, based on GATA3 and cytokeratin 5/6 labeling, showed POR over-expression by a subgroup of the differentiated luminal tumors. In bladder cancer cell lines, CYP1-activity was undetectable/low in basal PORlo T24 and SCaBER cells and higher in the luminal POR over-expressing RT4 and RT112 cells than in differentiated NHU cells, indicating that CYP-function is related to differentiation status in bladder cancers. This study establishes POR as a predictive biomarker of metabolic potential. This has implications in bladder carcinogenesis for the hepatic versus local activation of carcinogens and as a functional predictor of the potential for MIBC to respond to prodrug therapies.


Assuntos
Citocromo P-450 CYP1A1/genética , Citocromo P-450 CYP1B1/genética , Sistema Enzimático do Citocromo P-450/metabolismo , Neoplasias da Bexiga Urinária/metabolismo , Idoso , Idoso de 80 Anos ou mais , Diferenciação Celular , Linhagem Celular Tumoral , Regulação para Baixo , Feminino , Regulação Neoplásica da Expressão Gênica , Humanos , Masculino , Pessoa de Meia-Idade , Análise Serial de Tecidos , Neoplasias da Bexiga Urinária/genética , Urotélio/citologia , Urotélio/metabolismo , Xenobióticos/farmacologia
15.
J Sex Med ; 15(2): 167-175, 2018 02.
Artigo em Inglês | MEDLINE | ID: mdl-29306609

RESUMO

BACKGROUND: Current treatments for erectile dysfunction (ED) have some limitations. AIM: This study evaluated the efficacy and tolerability of MED2005, a 0.2% glyceryl trinitrate topical gel, formulated into an enhanced absorption topical delivery system (DermaSys), administered on demand, in the treatment of ED. METHODS: This randomized, double-blinded, placebo-controlled, phase II crossover trial involved 232 men with ED (231 treated, 230 assessed for efficacy) and their partners. After a 4-week run-in period, patients were randomized to 1 of 2 treatment sequences, MED2005-placebo or placebo-MED2005. Each treatment was given for 4 weeks, separated by a 1-week washout interval. Efficacy was assessed by the International Index of Erectile Function (IIEF), the Sexual Encounter Profile, a Global Assessment Questionnaire (GAQ), and specific questions about the onset and offset of action and treatment preferences (patients and partners). OUTCOMES: The primary outcome measure was the IIEF erectile function domain (IIEF-EF) score. Other efficacy assessments were secondary outcomes. RESULTS: The mean baseline IIEF-EF score was 17.1 (SD = 5.7), and this increased to 19.6 (SD = 7.5) after MED2005 treatment and 18.5 (SD = 6.7) after placebo (P = .0132). Overall, 23.1% of patients showed a clinically relevant (≥4-point) increase in IIEF-EF scores after treatment with MED2005 only compared with 14.5% who responded after MED2005 and placebo, 14.0% who responded after placebo only, and 48.4% who did not respond after either treatment (P = .0272). MED2005 also was associated with significant improvements compared with placebo in the other IIEF domains, and this was consistent with patients' and partners' responses to the GAQ. For all assessments, significant effects of MED2005 were seen primarily in patients with mild ED. The start of erection was noticed within 5 and 10 minutes in 44.2% and 69.5%, respectively, of all intercourse attempts with MED2005. Patients and partners showed significant preferences for MED2005 over placebo. The most commonly reported adverse events during MED2005 treatment were headache (patients, n = 18 [7.9%]; partners, n = 3 [1.3%]) and nasopharyngitis (patients, n = 13 [5.7%]; partners, n = 2 [0.9%]). CLINICAL IMPLICATIONS: These findings suggest that topical glyceryl trinitrate could be a useful treatment option in ED. STRENGTHS AND LIMITATIONS: Strengths of this study include the use of a validated outcome measure. Limitations include the use of only 1 dosage. CONCLUSION: Further studies are warranted to investigate the efficacy of topical glyceryl trinitrate to include higher doses, thereby improving clinical significance, especially in cases of moderate and severe ED. Ralph DJ, Eardley I, Taubel J, et al. Efficacy and Safety of MED2005, a Topical Glyceryl Trinitrate Formulation, in the Treatment of Erectile Dysfunction: A Randomized Crossover Study. J Sex Med 2018;15:167-175.


Assuntos
Disfunção Erétil/tratamento farmacológico , Nitroglicerina/administração & dosagem , Ereção Peniana/efeitos dos fármacos , Adulto , Idoso , Coito , Estudos Cross-Over , Método Duplo-Cego , Humanos , Masculino , Pessoa de Meia-Idade , Comportamento Sexual/efeitos dos fármacos , Parceiros Sexuais , Inquéritos e Questionários , Resultado do Tratamento , Adulto Jovem
16.
J Sex Med ; 14(8): 975-976, 2017 08.
Artigo em Inglês | MEDLINE | ID: mdl-28760256
17.
J Sex Med ; 14(4): 475-485, 2017 04.
Artigo em Inglês | MEDLINE | ID: mdl-28364975

RESUMO

INTRODUCTION: This review was designed to make recommendations on future educational needs, principles of curricular development, and how the International Society for Sexual Medicine (ISSM) should address the need to enhance and promote human sexuality education around the world. AIM: To explore the ways in which graduate and postgraduate medical education in human sexuality has evolved and is currently delivered. METHODS: We reviewed existing literature concerning sexuality education, curriculum development, learning strategies, educational formats, evaluation of programs, evaluation of students, and faculty development. We reviewed literature relating to four main areas: (i) the current status of the international regulation of training in sexual medicine; (ii) the current delivery of education and training in sexual medicine; (iii) resident and postgraduate education in sexual medicine surgery; and (iv) education and training for allied health professionals. RESULTS: The main findings in these four areas are as follows. Sexual medicine has grown considerably as a specialty during the past 20 years, with many drivers being identified. However, the regulatory aspects of training, assessment, and certification are currently in the early stages of development and are in many ways lagging behind the scientific and clinical knowledge in the field. However, there are examples of the development of curricula with accompanying assessments that have attempted to set standards of education and training that might underlie the delivery of high-quality care to patients in sexual medicine. The development of competence assessment has been applied to surgical training in sexual medicine, and there is increasing interest in simulation as a means of enhancing technical skills training. Although the focus of curriculum development has largely been the medical profession, there is early interest in the development of standards for training and education of allied health professionals. CONCLUSION: Organizations of professionals in sexual health, such as the ISSM, have an opportunity, and indeed a responsibility, to provide and disseminate learning opportunities, curricula, and standards of training for doctors and allied health professionals in sexual medicine. Eardley I, Reisman Y, Goldstein S, et al. Existing and Future Educational Needs in Graduate and Postgraduate Education. J Sex Med 2017;14:475-485.


Assuntos
Educação Médica Continuada/tendências , Educação Sexual/tendências , Sexologia/educação , Currículo , Educação Médica/tendências , Educação de Pós-Graduação em Medicina , Humanos , Disfunções Sexuais Fisiológicas/diagnóstico , Disfunções Sexuais Fisiológicas/terapia , Disfunções Sexuais Psicogênicas/diagnóstico , Disfunções Sexuais Psicogênicas/terapia , Sociedades Médicas
19.
PLoS One ; 11(7): e0157864, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27391962

RESUMO

The aim of this work was to investigate the microbial causes, incidence, duration, risk factors and clinical implications of bacteraemia occurring during transurethral resection of the prostate (TURP) surgery to better inform prophylaxis strategies. An ethically approved, prospective, cohort study of patients undergoing TURP was conducted. Clinical information and follow-up details were collected using standardized data collection sheets. Blood was obtained for culture at 6 different time points peri-procedure. Standard of care antibiotic prophylaxis was given prior to surgery. Bacteriuria was assessed in a pre-procedure urine sample. Histopathology from all prostate chips was assessed for inflammation and malignancy. 73 patients were consented and 276 blood samples obtained. No patients developed symptomatic bacteraemia during the procedure, 17 patients developed asymptomatic bacteraemia (23.2%). Enterococcus faecalis and Pseudomonas aeruginosa were the most common organisms cultured. 10 minutes after the start of the TURP, the odds ratio (OR) of developing bacteraemia was 5.38 (CI 0.97-29.87 p = 0.05), and 20 minutes after the start of the procedure, the OR was 6.46 (CI 1.12-37.24, p = 0.03), compared to before the procedure. We also found an association between the development of intra-operative bacteraemia and recent antibiotic use (OR 4.34, CI 1.14-16.62, p = 0.032), the presence of a urinary catheter (OR 4.92, CI 1.13-21.51, p = 0.034) and a malignant histology (OR 4.90, CI 1.30-18.46, p = 0.019). There was no statistical relationship between pre-operative urine culture results and blood culture results. This study shows that asymptomatic bacteraemia is commonly caused by TURP and occurs in spite of antibiotic prophylaxis. Our findings challenge the commonly held view that urine is the primary source of bacteraemia in TURP-associated sepsis and raise the possibility of occult prostatic infection as a cause of bacteraemia. More work will be needed to determine the significance of transient bacteraemia in relation to more serious complications like infective endocarditis and malignancy.


Assuntos
Bacteriemia/tratamento farmacológico , Hiperplasia Prostática/complicações , Ressecção Transuretral da Próstata/efeitos adversos , Idoso , Estudos de Casos e Controles , Endocardite/complicações , Humanos , Complicações Intraoperatórias , Masculino , Pessoa de Meia-Idade , Razão de Chances , Estudos Prospectivos , Próstata/cirurgia , Hiperplasia Prostática/cirurgia , Fatores de Risco , Sepse/complicações
20.
J Sex Med ; 13(7): 1013-26, 2016 07.
Artigo em Inglês | MEDLINE | ID: mdl-27318019

RESUMO

INTRODUCTION: This article explores the evolution and current delivery of undergraduate medical education in human sexuality. AIM: To make recommendations regarding future educational needs, principles of curricular development, and how the International Society for Sexual Medicine (ISSM) should address the need to enhance and promote human sexuality education around the world. METHODS: The existing literature was reviewed for sexuality education, curriculum development, learning strategies, educational formats, evaluation of programs, evaluation of students, and faculty development. MAIN OUTCOME MEASURES: The prevailing theme of most publications in this vein is that sexuality education in undergraduate medical education is currently not adequate to prepare students for future practice. RESULTS: We identified components of the principles of attitudes, knowledge, and skills that should be contained in a comprehensive curriculum for undergraduate medical education in human sexuality. Management of sexual dysfunction; lesbian, gay, bisexual, and transgender health care; sexuality across genders and lifespan; understanding of non-normative sexual practices; sexually transmitted infections and HIV, contraception; abortion; sexual coercion and violence; and legal aspects were identified as topics meriting particular attention. CONCLUSION: Curricula should be integrated throughout medical school and based on principles of adult learning. Methods of teaching should be multimodal and evaluations of student performance are critical. To realize much of what needs to be done, faculty development is critical. Thus, the ISSM can play a key role in the provision and dissemination of learning opportunities and materials, it can promote educational programs around the world, and it can articulate a universal curriculum with modules that can be adopted. The ISSM can create chapters, review documents, slide decks, small group and roleplay topics, and video-recorded materials and make all this material easily available. An expert consensus conference would be needed to realize these recommendations and fulfill them.


Assuntos
Educação de Graduação em Medicina/métodos , Medicina Reprodutiva/educação , Educação Sexual/métodos , Comportamento Sexual , Adulto , Atitude do Pessoal de Saúde , Currículo , Feminino , Humanos , Saúde Reprodutiva , Faculdades de Medicina/estatística & dados numéricos , Adulto Jovem
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