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1.
Trials ; 21(1): 166, 2020 Feb 11.
Artigo em Inglês | MEDLINE | ID: mdl-32046754

RESUMO

BACKGROUND: Urgency is a complaint of sudden, compelling desire to pass urine, which is difficult to defer, caused by involuntary contraction of the detrusor muscle during the bladder-filling stage. To enable detrusor inhibition, electrotherapy resources such as transcutaneous tibial nerve stimulation (TTNS) and parasacral transcutaneous electrical stimulation (PTES) have been used. The objective this study is to publish the study protocol that aims to investigate whether urgency decreases after treatment with both of the techniques. METHODS: This randomized controlled clinical trial will include 99 women, aged more than 18 years old, with urgency (score ≥ 8 in the Overactive Bladder-Validated 8-Question Awareness Tool [OAB-V8]). Women will be randomly allocated into three groups: TTNS, PTES, and placebo. The following questionnaires will be applied: the Anamnesis Record, the Incontinence Questionnaire Overactive Bladder, the King's Health Questionnaire, the 24-Hour Voiding Diary, and the OAB-V8, at four different time points: at baseline prior to the first session, at the 6th session, the 12th session and at follow-up. The current used for the transcutaneous electrical stimulation will be a symmetrical balanced biphasic pulsed current, for 12 sessions, twice a week, for 20 minutes. Qualitative variables will be displayed as frequency and percentage, quantitative variables as mean and standard deviation. Comparison of urgency severity among groups will be performed with a repeated measures ANOVA, considering the effect of the three groups and the four evaluations, and interactions among them. DISCUSSION: The present study aims to contribute evidence for a more in-depth discussion on electrode positioning for electrostimulation used in urgency treatment. It should be emphasized that, based on the possibility of confirming the hypothesis that urgency will decrease in a similar way after both treatments (TTNS and PTES), the PTES will be used as an option for positioning the electrodes alternatively to the tibial nerve region in special populations, such as amputees or people with severe lower limb sensory impairment. TRIAL REGISTRATION: Brazilian Registry of Clinical Trials (ReBEC) ID: RBR-9rf33n, date of registration: 17 May 2018.


Assuntos
Estimulação Elétrica Nervosa Transcutânea/métodos , Bexiga Urinária Hiperativa/terapia , Incontinência Urinária de Urgência/terapia , Adulto , Eletrodos , Feminino , Seguimentos , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Sacro/inervação , Índice de Gravidade de Doença , Nervo Tibial/fisiopatologia , Estimulação Elétrica Nervosa Transcutânea/instrumentação , Resultado do Tratamento , Bexiga Urinária/inervação , Bexiga Urinária/fisiopatologia , Bexiga Urinária Hiperativa/complicações , Bexiga Urinária Hiperativa/fisiopatologia , Incontinência Urinária de Urgência/diagnóstico , Incontinência Urinária de Urgência/etiologia , Incontinência Urinária de Urgência/fisiopatologia
2.
Sci Rep ; 9(1): 6427, 2019 04 23.
Artigo em Inglês | MEDLINE | ID: mdl-31015537

RESUMO

We aimed to compare the efficacy and safety of Multipulse laser vaporesection of the prostate (MPVP) versus plasmakinetic resection of the prostate (PKRP) for treatment of patients with benign prostate obstruction (BPO) in a prospective trial. From January 2016 to April 2017, a total of 144 patients were included in the cohort study, of whom 73 patients underwent MPVP and 71 underwent PKRP. All patients received pre-operative evaluation and followed up at 1, 3, 6 and 12 months postoperatively. Baseline characteristics, perioperative data and postoperative outcomes were compared. Early (within 30 days postoperatively) and late complications were also recorded. Preoperative data, including age, prostate volume, international prostate symptom score (IPSS), International Index of Erectile Function Questionnaires (IIEF-5), the rate of anticoagulants use, Charlson comorbidity index were similar in two groups. Peri-operative parameters, including the rate of transfusion, and decrease in hemoglobin level were comparable. The operative time, the duration of catheterization and length of hospital stay were significantly shorter in the MPVP group. The voiding parameters and the quality-of-life scores (QoL) improved significantly in both groups postoperatively. There was a significantly difference in QoL at 1-year in the MPVP group (p < 0.001), under mixed model analysis with random effect and Bonferroni correction. There were no significant differences in improvement of IPSS, Qmax, IIEF-5, residual prostate volume ratio and PSA level reduction at the 1-year follow-up. MPVP was significantly superior to PKRP in terms of a reduction in overall complication rate (21.9% vs 45.0%, p = 0.004). Both treatments led to comparable symptomatic improvements. MPVP demonstrates satisfactory efficiency, shorter catheterization time and shorter hospital stay. Our data revealed that MPVP may be a promising technique which is safe and favorable alternative for patients with BPO.


Assuntos
Terapia a Laser/métodos , Próstata/cirurgia , Hiperplasia Prostática/cirurgia , Ressecção Transuretral da Próstata/métodos , Idoso , Disuria/diagnóstico , Disuria/etiologia , Disuria/fisiopatologia , Hematúria/diagnóstico , Hematúria/etiologia , Hematúria/fisiopatologia , Humanos , Terapia a Laser/efeitos adversos , Lasers , Tempo de Internação/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Duração da Cirurgia , Tamanho do Órgão , Ereção Peniana/fisiologia , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/fisiopatologia , Estudos Prospectivos , Próstata/patologia , Próstata/fisiopatologia , Hiperplasia Prostática/patologia , Hiperplasia Prostática/fisiopatologia , Inquéritos e Questionários , Ressecção Transuretral da Próstata/efeitos adversos , Resultado do Tratamento , Estreitamento Uretral/diagnóstico , Estreitamento Uretral/etiologia , Estreitamento Uretral/fisiopatologia , Incontinência Urinária de Urgência/diagnóstico , Incontinência Urinária de Urgência/etiologia , Incontinência Urinária de Urgência/fisiopatologia , Micção/fisiologia
3.
J Urol ; 201(5): 967-972, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-31009968

RESUMO

PURPOSE: We performed a clinical feasibility trial to evaluate the safety and efficacy of a fully implanted, primary battery powered, nickel sized and shaped neuromodulation device called the eCoin® for tibial nerve stimulation to treat refractory urgency urinary incontinence. MATERIALS AND METHODS: This prospective, single arm, open label study included 46 participants with refractory urgency urinary incontinence. It was performed at multiple sites in the United States and New Zealand. The device was implanted in the lower leg over the tibial nerve and activated after 4 weeks. Bladder diary data and validated quality of life instruments were collected 3 and 6 months after activation and compared to baseline values. RESULTS: The mean ± SD age of participants was 63.4 ± 11.5 years and 45 (98%) were female. Episodes of urgency urinary incontinence were reduced a relative median of 71% after 3 months of treatment (4.2 vs 1.7 daily episodes at 3 months, p = 0.001). A 50% or greater decrease in reported episodes of urgency urinary incontinence was observed in 32 of 46 participants (69.6%) at 3 months with more than 20% dry at 3 and 6 months. I-QOL (Incontinence Quality of Life) scores improved an average of 25.9 points and 33 of 46 patients (72%) indicated improvement in symptoms. A single serious adverse event secondary to wound care resolved with intravenous antibiotics. CONCLUSIONS: The implantable neuromodulation device was a safe and effective treatment of urgency urinary incontinence associated with overactive bladder syndrome with a significant reduction or resolution of symptoms and no significant safety concerns.


Assuntos
Terapia por Estimulação Elétrica/instrumentação , Terapia por Estimulação Elétrica/métodos , Eletrodos Implantados , Qualidade de Vida , Nervo Tibial , Incontinência Urinária de Urgência/terapia , Idoso , Estudos de Viabilidade , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Níquel , Estudos Prospectivos , Medição de Risco , Resultado do Tratamento , Incontinência Urinária de Urgência/diagnóstico , Incontinência Urinária de Urgência/psicologia
4.
J Am Geriatr Soc ; 67(3): 570-575, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30578542

RESUMO

OBJECTIVES: To estimate the efficacy of vitamin D supplementation to reduce urgency urinary incontinence (UUI) episodes. DESIGN: Pilot, two-arm, randomized trial conducted from 2013 to 2017. Interventions were 12 weeks of weekly oral 50,000 IU vitamin D3 or placebo. SETTING: Academic, university-based outpatient clinic. PARTICIPANTS: Community-dwelling postmenopausal women, 50 years or older, with at least three UUI episodes on 7-day bladder diary and serum vitamin 25-hydroxyvitamin D (25[OH]D) of 30 ng/mL or less. MEASUREMENTS: The primary efficacy estimate was the percentage change in UUI episodes. Secondary estimates included changes in other lower urinary tract symptoms, along with exploratory subgroup analysis by race/ethnicity and obesity. RESULTS: We randomized 56 women (aged 50-84 years; mean = 60.5 ± 8.2 years), 28 to vitamin D and 28 to placebo; 51 completed treatments. Mean serum 25(OH)D at baseline (21.2 ± 5.2 and 18.2 ± 5.6, P = .30) improved to 57.9 ± 16.3 ng/mL with vitamin D3 and 21.9 ± 8.2 ng/mL with placebo (P < .001). UUI episodes per 24-hour day decreased by 43.0% with vitamin D3 compared to 27.6% with placebo (P = .22). Among black women (n = 33), UUI episodes decreased by 63.2% with vitamin D3 compared to 22.9% with placebo (P = .03). Among obese women, UUI episodes decreased by 54.1% with vitamin D compared to 32.7% with placebo (P = .29). For all women, changes in voiding frequency (P = .40), nocturia (P = .40), urgency (P = .90), incontinence severity (P = .81), and overactive bladder symptom severity (P = .47) were not different between arms. CONCLUSIONS: Postmenopausal women with UUI and vitamin D insufficiency demonstrated a greater than 40% decrease in UUI episodes, which did not reach statistical significance compared to placebo, except in the subset of black women. The results of this pilot study support further investigation of vitamin D3 alone or in combination with other treatments for UUI, particularly for women in higher-risk subgroups. J Am Geriatr Soc 67:570-575, 2019.


Assuntos
Prontuários Médicos/estatística & dados numéricos , Bexiga Urinária Hiperativa , Incontinência Urinária de Urgência , Vitamina D/administração & dosagem , Idoso , Suplementos Nutricionais , Feminino , Humanos , Vida Independente , Pessoa de Meia-Idade , Projetos Piloto , Pós-Menopausa/etnologia , Pós-Menopausa/fisiologia , Fatores de Risco , Avaliação de Sintomas/métodos , Resultado do Tratamento , Bexiga Urinária Hiperativa/diagnóstico , Bexiga Urinária Hiperativa/fisiopatologia , Incontinência Urinária de Urgência/diagnóstico , Incontinência Urinária de Urgência/tratamento farmacológico , Incontinência Urinária de Urgência/etiologia , Incontinência Urinária de Urgência/fisiopatologia , Vitamina D/análogos & derivados , Vitamina D/sangue , Vitaminas/administração & dosagem
5.
Am J Obstet Gynecol ; 214(2): 266.e1-266.e9, 2016 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-26348382

RESUMO

BACKGROUND: More than a third of middle-aged or older women suffer from urinary incontinence, but less than half undergo evaluation or treatment for this burdensome condition. With national organizations now including an assessment of incontinence as a quality performance measure, providers and health care organizations have a growing incentive to identify and engage these women who are undiagnosed and untreated. OBJECTIVE: We sought to identify clinical and sociodemographic determinants of patient-provider discussion and treatment of incontinence among ethnically diverse, community-dwelling women. STUDY DESIGN: We conducted an observational cohort study from 2003 through 2012 of 969 women aged 40 years and older enrolled in a Northern California integrated health care delivery system who reported at least weekly incontinence. Clinical severity, type, treatment, and discussion of incontinence were assessed by structured questionnaires. Multivariable regression evaluated predictors of discussion and treatment. RESULTS: Mean age of the 969 participants was 59.9 (±9.7) years, and 55% were racial/ethnic minorities (171 black, 233 Latina, 133 Asian or Native American). Fifty-five percent reported discussing their incontinence with a health care provider, 36% within 1 year of symptom onset, and with only 3% indicating that their provider initiated the discussion. More than half (52%) reported being at least moderately bothered by their incontinence. Of these women, 324 (65%) discussed their incontinence with a clinician, with 200 (40%) doing so within 1 year of symptom onset. In a multivariable analysis, women were less likely to have discussed their incontinence if they had a household income < $30,000/y vs ≥ $120,000/y (adjusted odds ratio [AOR], 0.49, 95% confidence interval [CI], 0.28-0.86) or were diabetic (AOR, 0.71, 95% CI, 0.51-0.99). They were more likely to have discussed incontinence if they had clinically severe incontinence (AOR, 3.09, 95% CI, 1.89-5.07), depression (AOR, 1.71, 95% CI, 1.20-2.44), pelvic organ prolapse (AOR, 1.98, 95% CI, 1.13-3.46), or arthritis (AOR, 1.44, 95% CI, 1.06-1.95). Among the subset of women reporting at least moderate subjective bother from incontinence, black race (AOR, 0.45, 95% CI, 0.25-0.81, vs white race) and income < $30,000/y (AOR, 0.37, 95% CI, 0.17-0.81, vs ≥ $120,000/y) were associated with a reduced likelihood of discussing incontinence. Those with clinically severe incontinence (AOR, 2.93, 95% CI, 1.53-5.61, vs low to moderate incontinence by the Sandvik scale) were more likely to discuss it with a clinician. CONCLUSION: Even in an integrated health care system, lower income was associated with decreased rates of patient-provider discussion of incontinence among women with at least weekly incontinence. Despite being at increased risk of incontinence, diabetic women were also less likely to have discussed incontinence or received care. Findings provide support for systematic screening of women to overcome barriers to evaluation and treatment.


Assuntos
Pobreza/estatística & dados numéricos , Incontinência Urinária por Estresse/epidemiologia , Incontinência Urinária de Urgência/epidemiologia , Negro ou Afro-Americano/estatística & dados numéricos , Idoso , Artrite/epidemiologia , California/epidemiologia , Estudos de Coortes , Comorbidade , Depressão/epidemiologia , Feminino , Humanos , Pessoa de Meia-Idade , Razão de Chances , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Prolapso de Órgão Pélvico/epidemiologia , Índice de Gravidade de Doença , Incontinência Urinária/diagnóstico , Incontinência Urinária/epidemiologia , Incontinência Urinária/terapia , Incontinência Urinária por Estresse/diagnóstico , Incontinência Urinária por Estresse/terapia , Incontinência Urinária de Urgência/diagnóstico , Incontinência Urinária de Urgência/terapia , População Branca/estatística & dados numéricos
6.
Rev. enferm. UERJ ; 22(5): 597-602, sept.-out. 2014. tab
Artigo em Português | LILACS, BDENF | ID: lil-747314

RESUMO

O objetivo deste estudo foi avaliar a eletroestimulação no nervo tibial posterior no tratamento da incontinência urinária de urgência ou mista. Trata-se de uma pesquisa quase experimental com oito pacientes, com diagnóstico de incontinência urinária de urgência ou mista, realizada no Estado de Santa Catarina, em 2010. A avaliação incluiu ficha de avaliação fisioterapêutica, diário miccional e questionário de qualidade de vida - King’s Health Questionnaire. Foram realizados 12 atendimentos de 30 minutos com eletroestimulação no nervo tibial posterior. Os resultados mostram redução na frequência de perdas urinárias diurnas em 62% das pacientes, diminuição da frequência miccional noturna em 37,5% e redução da quantidade das perdas urinárias, de intensa para moderada e de moderada para leve. Não se observou diferença significativa nos escores do questionário de qualidade de vida após o tratamento. Conclui-se que o método estudado apresentou impacto positivo nas pacientes em relação às perdas involuntárias de urina e à quantidade de urina perdida...


The aim of this study was to evaluate electrostimulation of the posterior tibial nerve in treating urgency or mixed urinary incontinence. This quasi-experimental study of eight patients with a diagnosis of urgency or mixed urinary incontinence, was conducted in Santa Catarina State, Brazil, in 2010. The assessment included a physical therapy evaluation form, bladder diary and King’s Health Quality of Life Questionnaire. Twelve 30-minutes procedures of electro-stimulation of the posterior tibial nerve were performed. The results show reduced frequency of daytime urinary incontinence in 62% of the patients, decreased nocturnal urinary frequency in 37.5%, and reduction of urinary leakage from severe to moderate and moderate to mild. No significant difference in quality of life questionnaire scores was observed after treatment. It was concluded that the method studied had positive impact on patients’ involuntary urine loss and the amount of urine lost...


El objetivo de este estudio fue evaluar la electroestimulación del nervio tibial posterior en el tratamiento de la incontinencia urinaria de urgencia o mixta. Se trata de una investigación casi experimental con ocho pacientes, con diagnóstico de incontinencia urinaria de urgencia o mixta, realizada en el Estado de Santa Catarina – Brasil, en 2010. La evaluación incluye ficha de evaluación fisioterapéutica, diario miccional y cuestionario de calidad de vida King’s Health Questionnaire. Se realizaron 12 atenciones de 30 minutos con electroestimulación del nervio tibial posterior. Los resultados muestran reducción en la frecuencia de pérdidas urinarias diurnas en 62% de las pacientes, disminución de la frecuencia miccional nocturna en 37,5% y reducción de la cantidad de orina de las pérdidas urinarias, de intensa a moderada y de moderada a leve. No se observó diferencia significativa en los resultados del cuestionario de calidad de vida después del tratamiento. Se concluye que el método estudiado presentó impacto positivo en las pacientes con relación a las pérdidas involuntarias de orina y a la cantidad de orina perdida...


Assuntos
Humanos , Feminino , Cuidados de Enfermagem , Estimulação Elétrica Nervosa Transcutânea , Incontinência Urinária de Urgência , Incontinência Urinária de Urgência/diagnóstico , Incontinência Urinária de Urgência/prevenção & controle , Incontinência Urinária/terapia , Nervo Tibial , Qualidade de Vida , Brasil , Pesquisa
7.
Neurourol Urodyn ; 32(3): 206-14, 2013 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-22907807

RESUMO

AIMS: To assess the effectiveness of percutaneous tibial nerve stimulation (PTNS) on adult patients with overactive bladder syndrome, using a systematic review of randomized controlled trials (RCTs), clinical controlled trials (CCTs), and prospective observational cohort studies. METHODS: A computer-aided literature search was performed in: PubMed, EMBASE and CENTRAL (2000 to November 15, 2011) to identify RCTs, CCTs, and prospective observational cohort studies. The study had to investigate the effect of PTNS on overactive bladder syndrome. The methodological quality of each study was assessed and a qualitative analysis was performed to establish the levels of evidence. RESULTS: Four RCTs and six prospective observational cohort studies were identified. There is strong evidence for the efficacy of PTNS versus a sham treatment. There is limited evidence that the use of PTNS and tolterodine ER is equally effective. No additional effect of a combination of Stoller afferent nerve stimulation (SANS) and anticholinergic medication compared to SANS alone. Most cohort studies suggested decreased frequency and improvement of incontinence and nocturia. However, the level of evidence was insufficient to make any firm conclusions. Because the total duration of all included trials varied between 6 and 12 weeks, so far there is little information on treatment periods. CONCLUSIONS: PTNS is efficacious for frequency and urgency urinary incontinence. More high quality studies are needed to improve the level of evidence concerning the efficacy of PTNS with regard to urgency and nocturia, to specify patient selection criteria, optimal treatment modalities and long-term effects as well as the effectiveness in more pragmatic trials.


Assuntos
Enurese Noturna/terapia , Nervo Tibial , Estimulação Elétrica Nervosa Transcutânea , Bexiga Urinária Hiperativa/terapia , Bexiga Urinária/inervação , Incontinência Urinária de Urgência/terapia , Adulto , Idoso , Idoso de 80 Anos ou mais , Compostos Benzidrílicos/uso terapêutico , Antagonistas Colinérgicos/uso terapêutico , Ensaios Clínicos como Assunto , Cresóis/uso terapêutico , Medicina Baseada em Evidências , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Enurese Noturna/diagnóstico , Enurese Noturna/fisiopatologia , Fenilpropanolamina/uso terapêutico , Fatores de Tempo , Tartarato de Tolterodina , Estimulação Elétrica Nervosa Transcutânea/efeitos adversos , Resultado do Tratamento , Bexiga Urinária Hiperativa/diagnóstico , Bexiga Urinária Hiperativa/fisiopatologia , Incontinência Urinária de Urgência/diagnóstico , Incontinência Urinária de Urgência/fisiopatologia , Urodinâmica , Adulto Jovem
8.
Neurourol Urodyn ; 32(5): 408-15, 2013 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-23168606

RESUMO

AIMS: To better target a behavioral approach for urge urinary incontinence (UUI) and enhance its efficacy by (1) identifying predictors of response to biofeedback-assisted pelvic muscle training (BFB), and (2) determining factors that mediate response. METHODS: BFB (four biweekly visits) was administered to 183 women > 60 years (mean = 73.6). Before and after intervention, all underwent comprehensive evaluation and videourodynamic testing. Postulated predictors and mediators from four urodynamic domains, specified a priori, were correlated with reduction in UUI frequency. RESULTS: Median UUI frequency decreased from 3.2/day to 1/day (P =0.0001). UUI improved by ≥50% in 55% of subjects and by 100% in 13% of subjects. Frequent UUI predicted poor response (P < 0.01). Of the urodynamic parameters, only high amplitude and briskness of detrusor overactivity (DO) predicted decreased response (P < 0.05 and P < 0.01) and these could be measured only in the 43% of subjects with elicitable DO. Decreased DO elicitability was the only urodynamic variable that changed in concert with improvement and thus was a candidate mediator. Response was neither predicted nor mediated by proprioception/warning, cystometric capacity, detrusor contractility, sphincter strength, or baseline DO elicitability. CONCLUSIONS: Severe DO predicts poor response to BFB. Good response is mediated by reduction in DO elicitability. Other than baseline UUI frequency, there are no other clinically or urodynamically important predictors or mediators of BFB response in this population. BFB may be best for patients with less severe DO. Future research to enhance its efficacy might better focus on the brain than on the lower urinary tract.


Assuntos
Biorretroalimentação Psicológica , Diafragma da Pelve/inervação , Bexiga Urinária Hiperativa/terapia , Incontinência Urinária de Urgência/terapia , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Pessoa de Meia-Idade , Análise Multivariada , Pennsylvania , Estudos Prospectivos , Fatores de Tempo , Resultado do Tratamento , Bexiga Urinária Hiperativa/diagnóstico , Bexiga Urinária Hiperativa/fisiopatologia , Bexiga Urinária Hiperativa/psicologia , Incontinência Urinária de Urgência/diagnóstico , Incontinência Urinária de Urgência/fisiopatologia , Incontinência Urinária de Urgência/psicologia , Urodinâmica
9.
Neurourol Urodyn ; 32(5): 460-6, 2013 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-23023996

RESUMO

AIMS: To test the null hypothesis that a novel disposable "tampon like" electrostimulation device (Pelviva(®)) is no better than unsupervised pelvic floor muscle exercise for treatment of urinary incontinence in women. METHODS: Pre/post-intervention assessor blinded, single center RCT. A total of 123 community dwelling self referred women with symptoms of stress, urge, or mixed incontinence were randomly assigned to one of two 12-week duration treatments: Pelviva(®) used for 30 min a day plus unsupervised pelvic floor muscle exercise or unsupervised exercises alone. Outcome measures included ICIQ-UI (primary), ICIQ FLUTSex and global impression of severity and improvement (secondary) completed at recruitment, after 4 weeks of unsupervised exercise and immediately post-treatment. Diary of exercise frequency/type, overall impression, and usage of device was completed mid- and post-treatment. RESULTS: Pelviva(®) plus exercise produced significantly better outcome than unsupervised exercise alone: 5 points (45%) versus 1 point (10%) for ICIQ-UI (P = 0.014); 67% versus 33% for leak frequency (P = 0.005); 40% versus 20% for leak interference with life (P = 0.018). Incontinence was less bothersome during sex to a greater extent in the Pelviva(®) group (P = 0.026). Women were enthusiastic about the device, found it comfortable/easy to use and experienced no adverse events. CONCLUSIONS: The Pelviva(®) device plus unsupervised exercise is more successful than unsupervised pelvic floor muscle exercise alone in treating urinary incontinence. The device is easy/comfortable to use, there are no apparent adverse incidents, and women can manage their incontinence in the privacy of their own home. The product will be launched 2013.


Assuntos
Equipamentos Descartáveis , Terapia por Estimulação Elétrica/instrumentação , Incontinência Urinária por Estresse/terapia , Incontinência Urinária de Urgência/terapia , Adulto , Terapia por Estimulação Elétrica/efeitos adversos , Inglaterra , Desenho de Equipamento , Feminino , Humanos , Modelos Lineares , Modelos Logísticos , Pessoa de Meia-Idade , Contração Muscular , Satisfação do Paciente , Diafragma da Pelve/fisiopatologia , Qualidade de Vida , Recuperação de Função Fisiológica , Índice de Gravidade de Doença , Comportamento Sexual , Método Simples-Cego , Fatores de Tempo , Resultado do Tratamento , Incontinência Urinária por Estresse/diagnóstico , Incontinência Urinária por Estresse/fisiopatologia , Incontinência Urinária de Urgência/diagnóstico , Incontinência Urinária de Urgência/fisiopatologia
10.
J Urol ; 189(6): 2194-201, 2013 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-23219541

RESUMO

PURPOSE: We report the long-term efficacy and safety of percutaneous tibial nerve stimulation with the Urgent® PC Neuromodulation System for overactive bladder after 3 years of therapy. MATERIALS AND METHODS: Fifty participants in the randomized, double-blind SUmiT (Sham Effectiveness in Treatment of Overactive Bladder Symptoms) Trial who met the primary effectiveness end point after 12 weekly percutaneous tibial nerve stimulation treatments were enrolled in this prospective study to assess long-term outcomes with percutaneous tibial nerve stimulation. STEP (Sustained Therapeutic Effects of Percutaneous Tibial Nerve Stimulation) Study patients were prescribed a fixed schedule 14-week tapering protocol followed by a personal treatment plan aimed at sustaining overactive bladder symptom improvement. Overactive bladder and quality of life questionnaires were completed every 3 months and 3-day voiding diaries were completed every 6 months. RESULTS: A total of 29 patients completed the 36-month protocol and received a median of 1.1 treatments per month after a 14-week treatment tapering protocol. A Bayesian model estimated that 77% (95% CI 64-90) of patients maintained moderate or marked improvement in overactive bladder symptoms at 3 years. Compared to baseline, median voids per day decreased from 12.0 (IQR 10.3-13.7) to 8.7 (IQR 7.3-11.3), nighttime voids per night decreased from 2.7 (IQR 1.7-3.3) to 1.7 (IQR 1.0-2.7) and urge incontinence episodes per day decreased from 3.3 (IQR 0.7-6.0) to 0.3 (IQR 0.0-1.0) (all p <0.0001). All quality of life parameters remained markedly improved from baseline through 3 years (all p <0.0001). One patient experienced 2 mild treatment related adverse events of bleeding at the needle site during followup. CONCLUSIONS: Most STEP participants with an initial positive response to 12 weekly percutaneous tibial nerve stimulation treatments safely sustained overactive bladder symptom improvement to 3 years with an average of 1 treatment per month.


Assuntos
Terapia por Estimulação Elétrica/métodos , Qualidade de Vida , Nervo Tibial , Bexiga Urinária Hiperativa/terapia , Incontinência Urinária de Urgência/terapia , Fatores Etários , Idoso , Método Duplo-Cego , Eletrodos Implantados , Feminino , Seguimentos , Humanos , Assistência de Longa Duração/métodos , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente/estatística & dados numéricos , Estudos Prospectivos , Medição de Risco , Índice de Gravidade de Doença , Fatores Sexuais , Fatores de Tempo , Estimulação Elétrica Nervosa Transcutânea/métodos , Resultado do Tratamento , Bexiga Urinária Hiperativa/diagnóstico , Incontinência Urinária de Urgência/diagnóstico , Urodinâmica
12.
J Wound Ostomy Continence Nurs ; 36(6): 661-70, 2009.
Artigo em Inglês | MEDLINE | ID: mdl-19920749

RESUMO

PURPOSE: The propose of this pilot study was to examine the feasibility of recruiting women into a clinical trial designed to examine the efficacy of acupuncture in treating urge and mixed urinary incontinence (UI) and the feasibility of performing the planned study procedures. We also sought to determine if there was preliminary evidence to suggest that acupuncture may be effective in reducing UI and improving general health-related and disease-specific quality of life and if a sham acupuncture needle is an effective placebo intervention. DESIGN: This pilot study was a double-blinded, randomized, clinical trial. Subjects were randomly assigned to a true or sham (placebo control) acupuncture group. Both true and sham acupuncture treatments were performed twice a week for 6 weeks. All subjects were evaluated at the completion of the 6-week intervention and 4 weeks later. SAMPLE: The sample consisted of 9 women between the ages of 44 and 66 years with urge or mixed urge and stress UI at least twice a week for a minimum of 3 months. MEASURES: Subjects completed a 1-week bladder diary at baseline and at 1 and 4 weeks postacupuncture to assess the impact of acupuncture on incontinence episodes. Quality of life was measured at baseline and at 1 and 4 weeks postacupuncture using the Medical Outcomes Short-Form (general health- related quality of life) and the Incontinence Impact Questionnaire and Urogenital Distress Inventory (incontinence-specific quality of life). RESULTS: It was feasible to recruit subjects and perform the planned study procedures. Subjects randomized to the true acupuncture group had a mean 63.30% (median = 65.99%) reduction in daytime accidents/day at 1 week postacupuncture and 67.47% reduction (median = 75.76%) at 4 weeks postacupuncture. In contrast, the mean reduction in daytime accidents was 18.88% (median = 19.64%) at 1 week and 16.67% (median = 0%) at 4 weeks post-sham acupuncture. There were no significant group differences in changes in the scores on the quality-of-life measures. Subjects' perceptions about whether they had received the true or sham acupuncture were not significantly better than one would expect by chance. CONCLUSIONS: The findings of this pilot study support the need for additional research examining the efficacy of acupuncture in the treatment of UI in women, the feasibility of performing study procedures, and the use of a sham needle as placebo in acupuncture studies.


Assuntos
Terapia por Acupuntura/métodos , Qualidade de Vida , Incontinência Urinária por Estresse/terapia , Incontinência Urinária de Urgência/terapia , Adulto , Idoso , Método Duplo-Cego , Estudos de Viabilidade , Feminino , Seguimentos , Humanos , Satisfação do Paciente , Projetos Piloto , Probabilidade , Valores de Referência , Medição de Risco , Índice de Gravidade de Doença , Estatísticas não Paramétricas , Resultado do Tratamento , Incontinência Urinária por Estresse/diagnóstico , Incontinência Urinária de Urgência/diagnóstico , Urodinâmica
13.
Int Urogynecol J Pelvic Floor Dysfunct ; 20(7): 819-25, 2009 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-19495544

RESUMO

INTRODUCTION AND HYPOTHESIS: This study was conducted to determine whether urgency-free interval (UFI) was effective to evaluate the outcome of overactive bladder (OAB) and the correlation of changes between this parameter and urgency episodes. METHODS: A randomized placebo-controlled trial was conducted involving 73 women with OAB. The interventions for a 12-week period included a vaginal electric stimulation and oxybutynin (2.5 mg) or placebo three times per day. Identical preintervention and postintervention assessments included the measurement of UFI and warning time (WT). The King's Health Questionnaire, Spearman's correlation coefficient (SCC), Kruskal-Wallis, Mann-Whitney U, and Wilcoxon-signed rank tests were used for analysis. RESULTS: A positive and significant correlation between the improvements of WT and UFI was noted in the oxybutynin group (p = 0.009). In all groups, none of the SCC revealed significant correlation between the improvement of UFI and urgency episodes (all p >or= 0.145). CONCLUSIONS: The efficacy of UFI in evaluating treatment outcome of OAB was comparable with that of WT in selected modality.


Assuntos
Terapia por Estimulação Elétrica/métodos , Determinação de Ponto Final , Ácidos Mandélicos/uso terapêutico , Parassimpatolíticos/uso terapêutico , Bexiga Urinária Hiperativa/terapia , Incontinência Urinária de Urgência/fisiopatologia , Adulto , Feminino , Inquéritos Epidemiológicos , Humanos , Incidência , Pessoa de Meia-Idade , Prognóstico , Fatores de Tempo , Resultado do Tratamento , Incontinência Urinária de Urgência/diagnóstico , Incontinência Urinária de Urgência/epidemiologia
15.
Neurourol Urodyn ; 26(2): 213-7, 2007.
Artigo em Inglês | MEDLINE | ID: mdl-17009252

RESUMO

AIMS: To evaluate long-term patient satisfaction of sacral neuromodulation and to correlate satisfaction with incontinence parameters. METHODS: Patients at least 1-year remote from sacral neuromodulation were mailed a questionnaire to evaluate satisfaction and assess incontinence symptoms. RESULTS: Fifty-two patients were consecutively enrolled in the study. Forty-nine questionnaires (94.2%) were returned. The average interval between implantation and questionnaire completion was 27.2 (range 12-52) months. 83.7% of respondents were satisfied and 79.6% of patients would "do it all over again." Compared to dissatisfied subjects during test stimulation, the satisfied patients had a significant decrease in 24-hr pad weight (84.5% vs. 60.6%, P = 0.002) but did not differ in daily pad usage (4.5 fewer pads per day vs. 3.4, P = 0.190). At long-term follow-up, satisfied patients noted significantly greater improvement in their Incontinence Impact Questionnaire score versus dissatisfied patients (mean improvement 53 vs. 10 points, P = 0.0003). Using multiple logistic regression, change in 24-hr pad weight, but not change in average daily pad usage, was correlated with long-term satisfaction. CONCLUSIONS: Eighty-four percent of patients were satisfied with sacral neuromodulation at a mean of 27 months. An 84.5% reduction in 24-hr pad weight correlated with long-term patient satisfaction. In addition to lack of efficacy, device pain was a contributing factor to dissatisfaction.


Assuntos
Terapia por Estimulação Elétrica , Tampões Absorventes para a Incontinência Urinária , Incontinência Urinária de Urgência/terapia , Idoso , Bases de Dados Factuais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Nervos Periféricos/fisiologia , Estudos Prospectivos , Qualidade de Vida , Inquéritos e Questionários , Incontinência Urinária de Urgência/diagnóstico , Incontinência Urinária de Urgência/psicologia
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