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1.
J Urol ; 203(1): 185-192, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31347955

RESUMO

PURPOSE: Sacral neuromodulation is a guideline recommended treatment of urinary dysfunction and fecal incontinence in patients in whom conservative treatments have failed. Historically sacral neuromodulation has been delivered using a nonrechargeable device with an average life span of 4.4 years. Surgery is required to replace the implanted neurostimulator due to battery depletion. Implantation of a long-lived implanted neurostimulator can eliminate the need for replacement surgeries, potentially reducing patient surgical risks and health care costs. The Axonics r-SNM System™ is a miniaturized, rechargeable sacral neuromodulation system designed to deliver therapy for at least 15 years. The ARTISAN-SNM (Axonics® Sacral Neuromodulation System for Urinary Urgency Incontinence Treatment) study is a pivotal study using rechargeable sacral neuromodulation therapy to treat urinary urgency incontinence. Six-month results are presented. MATERIALS AND METHODS: A total of 129 eligible patients with urinary urgency incontinence were treated. All participants were implanted with a tined lead and the rechargeable sacral neuromodulation system in a nonstaged procedure. Efficacy data were collected using a 3-day bladder diary, the validated ICIQ-OABqol (International Consultation on Incontinence Questionnaire Overactive Bladder quality of life) questionnaire and a participant satisfaction questionnaire. Therapy responders were identified as participants with a 50% or greater reduction in urinary urgency incontinence episodes compared to baseline. We performed an as-treated analysis in all implanted participants. RESULTS: At 6 months 90% of participants were therapy responders. The mean ± SE number of urinary urgency incontinence episodes per day was reduced from 5.6 ± 0.3 at baseline to 1.3 ± 0.2. Participants experienced a clinically meaningful 34-point improvement on the ICIQ-OABqol questionnaire. There were no serious device related adverse events. CONCLUSIONS: The Axonics r-SNM System is safe and effective with 90% of participants experiencing clinically and statistically significant improvements in urinary urgency incontinence symptoms.


Assuntos
Neuroestimuladores Implantáveis , Incontinência Urinária de Urgência/terapia , Adulto , Idoso , Idoso de 80 Anos ou mais , Fontes de Energia Elétrica , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Qualidade de Vida , Sacro , Incontinência Urinária de Urgência/fisiopatologia
2.
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
3.
Ann Intern Med ; 170(7): 465-479, 2019 04 02.
Artigo em Inglês | MEDLINE | ID: mdl-30884526

RESUMO

Background: Urinary incontinence (UI), a common malady in women, most often is classified as stress, urgency, or mixed. Purpose: To compare the effectiveness of pharmacologic and nonpharmacologic interventions to improve or cure stress, urgency, or mixed UI in nonpregnant women. Data Sources: MEDLINE, Cochrane Central Register of Controlled Trials (Wiley), Cochrane Database of Systematic Reviews (Wiley), EMBASE (Elsevier), CINAHL (EBSCO), and PsycINFO (American Psychological Association) from inception through 10 August 2018. Study Selection: 84 randomized trials that evaluated 14 categories of interventions and reported categorical cure or improvement outcomes. Data Extraction: 1 researcher extracted study characteristics, results, and study-level risk of bias, with verification by another independent researcher. The research team collaborated to assess strength of evidence (SoE) across studies. Data Synthesis: 84 studies reported cure or improvement outcomes (32 in stress UI, 16 in urgency UI, 4 in mixed UI, and 32 in any or unspecified UI type). The most commonly evaluated active intervention types included behavioral therapies, anticholinergics, and neuromodulation. Network meta-analysis showed that all interventions, except hormones and periurethral bulking agents (variable SoE), were more effective than no treatment in achieving at least 1 favorable UI outcome. Among treatments used specifically for stress UI, behavioral therapy was more effective than either α-agonists or hormones in achieving cure or improvement (moderate SoE); α-agonists were more effective than hormones in achieving improvement (moderate SoE); and neuromodulation was more effective than no treatment for cure, improvement, and satisfaction (high SoE). Among treatments used specifically for urgency UI, behavioral therapy was statistically significantly more effective than anticholinergics in achieving cure or improvement (high SoE), both neuromodulation and onabotulinum toxin A (BTX) were more effective than no treatment (high SoE), and BTX may have been more effective than neuromodulation in achieving cure (low SoE). Limitation: Scarce direct (head-to-head trial) evidence and population heterogeneity based on UI type, UI severity, and history of prior treatment. Conclusion: Most nonpharmacologic and pharmacologic interventions are more likely than no treatment to improve UI outcomes. Behavioral therapy, alone or in combination with other interventions, is generally more effective than pharmacologic therapies alone in treating both stress and urgency UI. Primary Funding Source: Patient-Centered Outcomes Research Institute. (PROSPERO: CRD42017069903).


Assuntos
Incontinência Urinária por Estresse/terapia , Incontinência Urinária de Urgência/terapia , Terapia Comportamental , Antagonistas Colinérgicos/uso terapêutico , Terapia por Estimulação Elétrica , Estrogênios/uso terapêutico , Terapia por Exercício , Feminino , Humanos , Terapia de Campo Magnético , Meta-Análise em Rede
4.
Cochrane Database Syst Rev ; 2: CD012668, 2019 02 28.
Artigo em Inglês | MEDLINE | ID: mdl-30816997

RESUMO

BACKGROUND: Urinary incontinence in women is associated with poor quality of life and difficulties in social, psychological and sexual functioning. The condition may affect up to 15% of middle-aged or older women in the general population. Conservative treatments such as lifestyle interventions, bladder training and pelvic floor muscle training (used either alone or in combination with other interventions) are the initial approaches to the management of urinary incontinence. Many women are interested in additional treatments such as yoga, a system of philosophy, lifestyle and physical practice that originated in ancient India. OBJECTIVES: To assess the effects of yoga for treating urinary incontinence in women. SEARCH METHODS: We searched the Cochrane Incontinence and Cochrane Complementary Medicine Specialised Registers. We searched the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) and ClinicalTrials.gov to identify any ongoing or unpublished studies. We handsearched Proceedings of the International Congress on Complementary Medicine Research and the European Congress for Integrative Medicine. We searched the NHS Economic Evaluation Database for economic studies, and supplemented this search with searches for economics studies in MEDLINE and Embase from 2015 onwards. Database searches are up-to-date as of 21 June 2018. SELECTION CRITERIA: Randomised controlled trials in women diagnosed with urinary incontinence in which one group was allocated to treatment with yoga. DATA COLLECTION AND ANALYSIS: Two review authors independently screened titles and abstracts of all retrieved articles, selected studies for inclusion, extracted data, assessed risk of bias and evaluated the certainty of the evidence for each reported outcome. Any disagreements were resolved by consensus. We planned to combine clinically comparable studies in Review Manager 5 using random-effects meta-analysis and to carry out sensitivity and subgroup analyses. We planned to create a table listing economic studies on yoga for incontinence but not carry out any analyses on these studies. MAIN RESULTS: We included two studies (involving a total of 49 women). Each study compared yoga to a different comparator, therefore we were unable to combine the data in a meta-analysis. A third study that has been completed but not yet fully reported is awaiting assessment.One included study was a six-week study comparing yoga to a waiting list in 19 women with either urgency urinary incontinence or stress urinary incontinence. We judged the certainty of the evidence for all reported outcomes as very low due to performance bias, detection bias, and imprecision. The number of women reporting cure was not reported. We are uncertain whether yoga results in satisfaction with cure or improvement of incontinence (risk ratio (RR) 6.33, 95% confidence interval (CI) 1.44 to 27.88; an increase of 592 from 111 per 1000, 95% CI 160 to 1000). We are uncertain whether there is a difference between yoga and waiting list in condition-specific quality of life as measured on the Incontinence Impact Questionnaire Short Form (mean difference (MD) 1.74, 95% CI -33.02 to 36.50); the number of micturitions (MD -0.77, 95% CI -2.13 to 0.59); the number of incontinence episodes (MD -1.57, 95% CI -2.83 to -0.31); or the bothersomeness of incontinence as measured on the Urogenital Distress Inventory 6 (MD -0.90, 95% CI -1.46 to -0.34). There was no evidence of a difference in the number of women who experienced at least one adverse event (risk difference 0%, 95% CI -38% to 38%; no difference from 222 per 1000, 95% CI 380 fewer to 380 more).The second included study was an eight-week study in 30 women with urgency urinary incontinence that compared mindfulness-based stress reduction (MBSR) to an active control intervention of yoga classes. The study was unblinded, and there was high attrition from both study arms for all outcome assessments. We judged the certainty of the evidence for all reported outcomes as very low due to performance bias, attrition bias, imprecision and indirectness. The number of women reporting cure was not reported. We are uncertain whether women in the yoga group were less likely to report improvement in incontinence at eight weeks compared to women in the MBSR group (RR 0.09, 95% CI 0.01 to 1.43; a decrease of 419 from 461 per 1000, 95% CI 5 to 660). We are uncertain about the effect of MBSR compared to yoga on reports of cure or improvement in incontinence, improvement in condition-specific quality of life measured on the Overactive Bladder Health-Related Quality of Life Scale, reduction in incontinence episodes or reduction in bothersomeness of incontinence as measured on the Overactive Bladder Symptom and Quality of Life-Short Form at eight weeks. The study did not report on adverse effects. AUTHORS' CONCLUSIONS: We identified few trials on yoga for incontinence, and the existing trials were small and at high risk of bias. In addition, we did not find any studies of economic outcomes related to yoga for urinary incontinence. Due to the lack of evidence to answer the review question, we are uncertain whether yoga is useful for women with urinary incontinence. Additional, well-conducted trials with larger sample sizes are needed.


Assuntos
Incontinência Urinária por Estresse/terapia , Incontinência Urinária de Urgência/terapia , Ioga , Adulto , Idoso , Feminino , Humanos , Pessoa de Meia-Idade , Atenção Plena/métodos , Estresse Psicológico/terapia , Resultado do Tratamento , Listas de Espera , Adulto Jovem
6.
Int Urogynecol J ; 30(5): 705-710, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30306193

RESUMO

INTRODUCTION AND HYPOTHESIS: To identify the association between the symptom severity and outcome of conservative management for OAB, SUI and MUI. Conservative treatments are recommended for overactive bladder (OAB), stress urinary incontinence (SUI) and mixed incontinence (MUI). It is unclear whether disease severity affects treatment outcome. METHODS: Patients receiving conservative management were reviewed. Disease-specific questionnaires (OAB-q SF, ICIQ-UI SF) and bladder diaries recorded baseline symptoms. Success was defined by Patient Global Impression of Improvement questionnaire (PGI-I) response of "very much better" or "much better". Non-parametric statistical tests and logistic regression were used. RESULTS: In 50 OAB patients success was associated with lower symptom severity [30 (0-80) vs. 80 (23-100), p = 0.0001], fewer urgency episodes [4 (0-12) vs. 6 (0-11), p = 0.032] and lower ICIQ-UI SF [5.5 (0-20) vs. 15 (0-21), p = 0.002], but higher QoL [67 (20-101) vs. 24 (6-58), p = 0.0001]. In 50 MUI patients, variables were fewer urgency episodes [3 (0-10) vs. 6 (0-16), p = 0.004] and lower ICIQ-UI [11 (1-18) vs. 15 (5-21), p = 0.03]. In 40 SUI patients, variables were fewer incontinence episodes [1 (0-4) vs. 2 (0-5), p = 0.05] and lower ICIQ-UI [11 (6-16) vs. 13.5 (11-19), p = 0.003]. Multiple regression confirmed OAB-q QoL [odds ratio (OR) 1.10 (95% confidence intervals 1.04, 1.1)] for OAB, urgency episodes [OR 0.74 (0.56, 0.98)] and ICIQ-UI [OR 0.83 (0.71, 0.98] for MUI and ICIQ-UI [OR 0.57 (0.40, 0.83)] for SUI. CONCLUSIONS: Milder baseline disease severity was associated with successful outcome. There is potential for triage at initial assessment to second-line interventions for women unlikely to achieve success.


Assuntos
Tratamento Conservador/métodos , Índice de Gravidade de Doença , Bexiga Urinária Hiperativa/terapia , Incontinência Urinária por Estresse/terapia , Incontinência Urinária de Urgência/terapia , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Pessoa de Meia-Idade , Qualidade de Vida , Inquéritos e Questionários , Resultado do Tratamento
7.
Gynecol Endocrinol ; 35(2): 155-159, 2019 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-30324854

RESUMO

The aim of this study was to assess the effectiveness and safety of Ospemifene in the improvement of urgency component in women affected by mixed urinary incontinence (MUI) who underwent surgery with mid-urethral sling (MUS). Eighty-one patients with MUI underwent surgical intervention with MUS were enrolled. After surgical intervention 38 patients received Ospemifene 60 mg one tablet daily per os for 12 weeks. Physical examination, 3-day voiding diary, urodynamic testing were performed at the start and the follow-up after 12 weeks in the Trans-Obturator-Tape (TOT)-Alone group and TOT-Ospemifene. Patients completed the Overactive Bladder Symptom and Health-Related Quality of Life Short-Form (OAB-Q SF), International Consultation on Incontinence Questionnaire (ICIQ-UI-SF), and King' s Health Questionnaire (KHQ). A significant difference between the two groups was observed in peak flow (ml/s), in first voiding desire (ml), in maximum cystometric capacity (ml), and in detrusor pressure at peak flow (cmH2O) at urodynamic evaluation. A significative difference between the two groups at voiding diary was observed in the mean number of voids, urgent micturition episodes/24 h, urge urinary incontinence, and in nocturia events. The OAB-Q symptoms and OAB-Q (HRQL) scores after 12 weeks showed a significative difference between the two groups. Ospemifene is an effective potential therapy after MUSs in women with MUI improving urgency symptoms and quality of life.


Assuntos
Moduladores Seletivos de Receptor Estrogênico/uso terapêutico , Slings Suburetrais , Tamoxifeno/análogos & derivados , Incontinência Urinária por Estresse/terapia , Incontinência Urinária de Urgência/terapia , Procedimentos Cirúrgicos Urológicos , Idoso , Terapia Combinada , Feminino , Humanos , Pessoa de Meia-Idade , Medidas de Resultados Relatados pelo Paciente , Qualidade de Vida , Tamoxifeno/uso terapêutico , Incontinência Urinária por Estresse/complicações , Incontinência Urinária por Estresse/fisiopatologia , Incontinência Urinária de Urgência/complicações , Incontinência Urinária de Urgência/fisiopatologia , Urodinâmica
8.
Obstet Gynecol ; 132(6): 1337-1345, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30399090

RESUMO

Sacral nerve stimulation delivers nonpainful electrical pulses to the sacral nerves that modulate the reflexes that control the bladder, bowels, and pelvic floor musculature. This relatively simple procedure was generated to improve and restore function in patients with a variety of pelvic floor disorders. Currently this therapy is approved for use in patients with urgency urinary incontinence, urinary urgency-frequency, nonobstructive urinary retention, and fecal incontinence. This review includes the history of this treatment modality, explains the mechanism of action, and describes the procedure for implantation of this device. Additionally, advancements in this treatment over the past two decades and landmark literature to date regarding sacral nerve stimulation are reviewed. Current literature regarding off-label uses of this treatment modality for a variety of pelvic floor disorders is also discussed.


Assuntos
Terapia por Estimulação Elétrica , Incontinência Fecal/terapia , Plexo Lombossacral , Bexiga Urinária Hiperativa/terapia , Incontinência Urinária de Urgência/terapia , Retenção Urinária/terapia , Humanos , Neuroestimuladores Implantáveis , Implantação de Prótese/métodos
9.
Int J Surg ; 60: 141-148, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30415088

RESUMO

BACKGROUND & AIM: Both intradetrusor OnabotulinumtoxinA (BTX) and Sacral neuromodulation (SNM) as third-line therapies for urgency urinary incontinence (UUI) are increasingly being utilized. However, there are differences in preference between patients and medical personnel in clinical practice. This meta-analysis was designed to compare BTX versus SNM in treatment of UUI. METHODS: We searched the Cochrane Library, PubMed, EMBASE and Web of Science from January 1, 1992 to April 22, 2018. Mean differences (MDs) and risk ratio (RR) with its 95% confidence intervals (CIs) were estimated to compare the outcomes of the groups. All the MDs were after subtracting OnabotulinumtoxinA data from Sacral neuromodulation data. RRs were acquired from comparing OnabotulinumtoxinA data to Sacral neuromodulation data. Two reviewers assessed trial quality and extracted data independently. All statistical analyses were performed using standard statistical procedures provided in Review Manager 5.2. This work has been reported in line with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and AMSTAR (Assessing the methodological quality of systematic reviews) Guidelines. RESULTS: Seven randomized controlled trials and two retrospective studies (N = 1649 participants) were identified for the present analysis. In change from baseline in UUI episodes (UUIE) per day, comparing BTX groups with SNM groups, the effects were observed through 1, 2, 4, 5 and 6 month, with pooled MDs of -0.62, -0.55, -0.38, -1.02 and -0.50 respectively. In UUIE reduction post treatment, the pooled RRs of complete UUIE reductions through 4 and 6 months respectively were 5.13 and 6.63. Significant results were observed through overall times in more than 75% UUIE reduction. No significance was found in more than 50% UUIE reduction. Significant results were observed in urinary tract infection. More treatment satisfaction were found in BTX groups than that in SNM groups (RR 1.14, 95% CI 1.01-1.29; P = 0.004). CONCLUSIONS: Generally, BTX seems superior to SNM in treatment of UUI but inferior regarding safety. Patients receiving BTX experienced a higher treatment satisfaction.


Assuntos
Toxinas Botulínicas Tipo A/administração & dosagem , Fármacos Neuromusculares/administração & dosagem , Estimulação Elétrica Nervosa Transcutânea/métodos , Incontinência Urinária de Urgência/terapia , Toxinas Botulínicas Tipo A/efeitos adversos , Humanos , Plexo Lombossacral , Fármacos Neuromusculares/efeitos adversos , Satisfação do Paciente/estatística & dados numéricos , Ensaios Clínicos Controlados Aleatórios como Assunto , Estimulação Elétrica Nervosa Transcutânea/efeitos adversos , Resultado do Tratamento , Infecções Urinárias/epidemiologia , Infecções Urinárias/etiologia
10.
Investig Clin Urol ; 59(4): 246-251, 2018 07.
Artigo em Inglês | MEDLINE | ID: mdl-29984339

RESUMO

Purpose: Intravesical electrical stimulation treatment (IVES) has been successfully used to treat neurogenic bladder. We report the results of an observational study regarding the use of IVES for women with overactive bladder syndrome (OAB) and/or urgency urinary incontinence (UUI). Materials and Methods: IVES was performed in women with OAB (defined by frequency ≥8/day, nocturia ≥2/night, or ≥3 episodes of UUI on 3-day voiding diary) who failed prior medical therapy. Subjects underwent 4 weeks of treatment with an 8-Fr Detruset™ IVES catheter. Primary outcome was Patient Global Impression of Improvement (PGI-I) at 3 months. Secondary outcomes included Visual Analog Scale (VAS), Short Form OAB Questionnaire (OAB-q SF), Pelvic Floor Distress Inventory (PFDI), Pelvic Floor Impact Questionnaire (PFIQ), reduction in frequency and UUI on voiding diary, and adverse effects. Analysis was done with paired t-tests and Wilcoxon signed rank tests. Results: Seventeen subjects completed the study. At 4 weeks post-treatment, 15 improved on PGI-I (11 subjects: 'a little better', 2: 'much better', 2: 'very much better'). There were significant improvements in symptom bother and health-related quality of life as measured by OAB-q SF and pelvic organ prolapse and urinary distress as measured by PFDI. Frequency decreased from 10.3±4.3 at baseline to 8.9±2.3 (p=0.04) at 3 months. No pain was reported during treatment. There was one urinary tract infection during the study period. No other adverse events were reported. Conclusions: IVES appears to be a safe and effective novel treatment for OAB. Larger comparative studies are needed to investigate its potential for long-term treatment.


Assuntos
Terapia por Estimulação Elétrica/métodos , Bexiga Urinária Hiperativa/terapia , Incontinência Urinária de Urgência/terapia , Adulto , Idoso , Feminino , Humanos , Pessoa de Meia-Idade , Prolapso de Órgão Pélvico/complicações , Qualidade de Vida , Resultado do Tratamento , Bexiga Urinária Hiperativa/complicações , Incontinência Urinária de Urgência/complicações
11.
J Urol ; 200(2): 382-388, 2018 08.
Artigo em Inglês | MEDLINE | ID: mdl-29630979

RESUMO

PURPOSE: The mechanism of sacral neuromodulation is poorly understood. We compared brain activity during urgency before and after sacral neuromodulation in women with overactive bladder and according to the response to treatment. MATERIALS AND METHODS: Women with refractory overactive bladder who elected sacral neuromodulation were invited to undergo functional magnetic resonance imaging before and after treatment. During imaging the bladder was filled until urgency was experienced. Regions of interest were identified a priori and brain activity in these regions of interest was compared before and after treatment as well as according to the treatment response. Whole brain exploratory analysis with an uncorrected voxel level threshold of p <0.001 was also performed to identify additional brain regions which changed after sacral neuromodulation. RESULTS: Of the 12 women who underwent a pretreatment functional magnetic resonance imaging examination 7 were successfully treated with sacral neuromodulation and underwent a posttreatment examination. After sacral neuromodulation brain activity decreased in the left anterior cingulate cortex, the bilateral insula, the left dorsolateral prefrontal cortex and the bilateral orbitofrontal cortex (each p <0.05). No new brain regions showed increased activity after sacral neuromodulation. Pretreatment brain activity levels in the bilateral anterior cingulate cortex, the right insula, the bilateral dorsolateral prefrontal cortex, the right orbitofrontal cortex, the right supplementary motor area and the right sensorimotor cortex were higher in women who underwent successful treatment (each p <0.05). CONCLUSIONS: Brain activity during urgency changes after successful sacral neuromodulation. Sacral neuromodulation may be more effective in women with higher levels of pretreatment brain activity during urgency.


Assuntos
Encéfalo/fisiopatologia , Terapia por Estimulação Elétrica/métodos , Plexo Lombossacral/fisiopatologia , Bexiga Urinaria Neurogênica/complicações , Bexiga Urinária Hiperativa/complicações , Incontinência Urinária de Urgência/terapia , Idoso , Encéfalo/diagnóstico por imagem , Terapia por Estimulação Elétrica/instrumentação , Feminino , Neuroimagem Funcional/métodos , Humanos , Neuroestimuladores Implantáveis , Imagem por Ressonância Magnética/métodos , Pessoa de Meia-Idade , Período Pós-Operatório , Período Pré-Operatório , Resultado do Tratamento , Incontinência Urinária de Urgência/etiologia , Incontinência Urinária de Urgência/fisiopatologia
12.
Neurourol Urodyn ; 37(8): 2597-2605, 2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-29672906

RESUMO

AIMS: Urgency urinary incontinence (UUI) is a major problem for seniors. The underlying mechanisms of disease and therapy are unknown. We sought structural brain abnormalities that might underlie the functional differences previously observed by functional Magnetic Resonance Imaging in UUI patients versus controls, or among UUI responders versus non-responders to therapy-and thereby reveal potential disease mechanisms and therapeutic targets. METHODS: Secondary study of a trial of biofeedback-assisted pelvic floor muscle training (BFB) in 60 women (>60 yrs) with UUI, plus 11 age-matched continent controls. Brain structural abnormalities were investigated using: (1) white-matter hyperintensities (WMH); (2) diffusion tensor imaging (DTI) to reveal white-matter pathways with impaired integrity; and (3) voxel-based morphometry (VBM) to show regions of atrophy or hypertrophy. RESULTS: WMH burden was greater in UUI patients than controls (globally and in superior longitudinal fasciculus and cingulum), suggesting a possible causal connection. WMH burden was unexpectedly greater in responders than non-responders to BFB, and appeared to increase in non-responders but not in responders. DTI revealed even worse integrity of the cingulum than was apparent by WMH. VBM showed parahippocampal atrophy in UUI. CONCLUSIONS: Many women with UUI have white-matter damage that interferes with pathways critical to bladder control; they can be taught by techniques like BFB to exert stronger control over the bladder. For others, in whom abnormalities of key brain areas are less marked, UUI's cause may reside elsewhere, and therapy targeting these brain centers may be less effective than therapy targeting the bladder or other brain centers.


Assuntos
Encéfalo/diagnóstico por imagem , Bexiga Urinária/fisiopatologia , Incontinência Urinária de Urgência/diagnóstico por imagem , Substância Branca/diagnóstico por imagem , Idoso , Idoso de 80 Anos ou mais , Biorretroalimentação Psicológica/métodos , Estudos de Casos e Controles , Imagem de Tensor de Difusão , Feminino , Neuroimagem Funcional , Giro do Cíngulo/diagnóstico por imagem , Humanos , Imagem por Ressonância Magnética , Pessoa de Meia-Idade , Vias Neurais/diagnóstico por imagem , Diafragma da Pelve , Prognóstico , Incontinência Urinária de Urgência/fisiopatologia , Incontinência Urinária de Urgência/terapia
13.
Int Urol Nephrol ; 50(5): 825-832, 2018 May.
Artigo em Inglês | MEDLINE | ID: mdl-29532309

RESUMO

AIMS: To evaluate whether baseline symptoms and outcomes are influenced by gender in a matched cohort undergoing neuromodulation. METHODS: Patients in our prospective neuromodulation database that had a tined lead placed were reviewed. Those that had implantable pulse generator (IPG) placed were matched on age and urologic diagnosis. History, voiding diaries, satisfaction, Interstitial Cystitis Symptom/Problem Index (ICSIPI), and overactive bladder symptom severity (OABq ss)/health-related quality of life (HRQOL) preimplant and over 3 years were evaluated using descriptive statistics, repeated measures, and matched pair GEE or mixed analyses. RESULTS: Of 590 patients in the database, more women than men received an IPG (450/488; 92.2 vs. 84/102; 82.4%; p = 0.0011). Eighty matched pairs (n = 160; 81% ≥ 50 years old; 56.25% had urgency/frequency with urge incontinence-UI) were identified and evaluated. On voiding diaries, volume/void was greater in women only at baseline (p = 0.040); both groups improved over time (p < 0.0001). Urinary frequency improved in both women and men (p = 0.0010; p = 0.0025). Over 3 years, UI episodes/day improved only in men (p = 0.017) and UI severity improved only in women (p < 0.0001). ICSIPI, OABq ss, and HRQOL scores improved similarly in both groups (p < 0.0001 for all measures in both groups), and although more women were satisfied at 3 months (p = 0.027), groups did not differ at other time points. CONCLUSIONS: More women undergo neuromodulation and have initial success and subsequent IPG implantation. UI episodes improved only in men, and UI severity improved only in women. Both women and men experienced similar levels of symptom improvement on other measures.


Assuntos
Terapia por Estimulação Elétrica , Fatores Sexuais , Bexiga Urinária Hiperativa/terapia , Incontinência Urinária de Urgência/terapia , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Neuroestimuladores Implantáveis , Plexo Lombossacral , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Qualidade de Vida , Inquéritos e Questionários , Bexiga Urinária Hiperativa/complicações , Bexiga Urinária Hiperativa/fisiopatologia , Incontinência Urinária de Urgência/etiologia , Micção , Urina
14.
Eur Urol ; 74(1): 66-73, 2018 07.
Artigo em Inglês | MEDLINE | ID: mdl-29482936

RESUMO

BACKGROUND: Urgency urinary incontinence (UUI) is a chronic condition for which sacral neuromodulation (SNM) (InterStim/Medtronic) and onabotulinumtoxinA (BTX) (BotoxA/Allergan) are utilized. These therapies have not been compared over extended time. OBJECTIVE: To compare UUI episodes (UUIE) over 24 mo following SNM or BTX. DESIGN, SETTING, AND PARTICIPANTS: Multicenter, open-label, randomized, extension trial (February 2012-July 2016) at nine US medical centers involving 386 women with ≥6 UUIE over 3 d inadequately managed by medications. Participants were clinical responders to treatment: ≥50% reduction in UUIEs after SNM placement or 1 mo post BTX. INTERVENTION: SNM (n=194) versus 200 U BTX (n=192). SNM reprogrammings occurred throughout the 24 mo. After 6 mo, two additional BTX injections were allowed. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Primary outcome: change in mean daily UUIE over 24 mo. SECONDARY OUTCOMES: no UUIE, ≥75% and ≥50% UUIE reduction; Overactive Bladder Questionnaire Short Form; Urinary Distress Inventory short form; Incontinence Impact Questionnaire; Patient Global Impression of Improvement; Overactive Bladder Satisfaction of Treatment Questionnaire; and adverse events (AEs). Primary analysis used a linear mixed model. RESULTS AND LIMITATIONS: Outcome data were available for 260/298 (87%) clinical responders. No difference in decreased mean UUIE was found over 24 mo (-3.88 vs -3.50 episodes/d,95% confidence interval [CI]=-0.14-0.89; p=0.15), with no differences in UUI resolution, ≥75% or ≥50% UUIE reduction. BTX group maintained higher satisfaction (mean difference=-9.14, 95% CI=-14.38--3.90; p<0.001), treatment endorsement (mean difference=-12.16, 95% CI=-17.7--6.63; p<0.001) through 24 mo. Other secondary measures did not differ. Recurrent urinary tract infections (UTIs) were higher after BTX (24% vs 10%; p<0.01), 6% required intermittent catheterization post second injection. SNM revision and removals occurred in 3% and 9% patients, respectively. CONCLUSIONS: Both treatments offered sustainable UUI improvement, and higher BTX dosing had low clean intermittent catheterization rates, but with UTI risk. SNM revision/removal rates were low due to standardized lead placement with strict treatment response definitions. PATIENT SUMMARY: We compared a large group of US women with severe urgency urinary incontinence (UUI) who received sacral neuromodulation (InterStim) or onabotulinumtoxinA (Botox A) therapy during a 2-yr period. We found that both therapies had similar success in reducing UUI symptoms, and adverse events were low. However, women in the BotoxA group had higher satisfaction and endorsement with their treatment, but with a higher chance of a urinary tract infection. We conclude that both therapies offer sustained reduction in daily incontinence over 2 yr.


Assuntos
Toxinas Botulínicas Tipo A/administração & dosagem , Terapia por Estimulação Elétrica , Fármacos Neuromusculares/administração & dosagem , Incontinência Urinária de Urgência/terapia , Idoso , Toxinas Botulínicas Tipo A/efeitos adversos , Pesquisa Comparativa da Efetividade , Terapia por Estimulação Elétrica/efeitos adversos , Eletrodos Implantados , Feminino , Humanos , Pessoa de Meia-Idade , Fármacos Neuromusculares/efeitos adversos , Sacro , Resultado do Tratamento , Incontinência Urinária de Urgência/tratamento farmacológico , Infecções Urinárias/induzido quimicamente
15.
Am J Obstet Gynecol ; 218(1): 111.e1-111.e9, 2018 01.
Artigo em Inglês | MEDLINE | ID: mdl-29031894

RESUMO

BACKGROUND: Women with refractory urgency urinary incontinence (ie, unresponsive to behavioral and pharmacological interventions) are treated with onabotulinumtoxinA or sacral neuromodulation. OBJECTIVE: The objective of the study was to compare treatment efficacy and adverse events in women <65 and ≥65 years old treated with onabotulinumtoxinA or sacral neuromodulation. STUDY DESIGN: This study was a planned secondary analysis of a multicenter, randomized trial that enrolled community-dwelling women with refractory urgency urinary incontinence to onabotulinumtoxinA or sacral neuromodulation treatments. The primary outcome was a change in mean daily urgency urinary incontinence episodes on a bladder diary over 6 months. Secondary outcomes included ≥75% urgency urinary incontinence episode reduction, change in symptom severity/quality of life, treatment satisfaction, and treatment-related adverse events. RESULTS: Both age groups experienced improvement in mean urgency urinary incontinence episodes per day following each treatment. There was no evidence that mean daily urgency urinary incontinence episode reduction differed between age groups for onabotulinumtoxinA (adjusted coefficient, -0.127, 95% confidence interval, -1.233 to 0.979; P = .821) or sacral neuromodulation (adjusted coefficient, -0.698, 95% confidence interval, -1.832 to 0.437; P = .227). Among those treated with onabotulinumtoxinA, women <65 years had 3.3-fold greater odds of ≥75% resolution than women ≥65 years (95% confidence interval, 1.56 -7.02). Women <65 years had a greater reduction in Overactive Bladder Questionnaire Short Form symptom bother scores compared with women ≥65 years by 7.49 points (95% confidence interval, -3.23 to -11.74), regardless of treatment group. There was no difference between quality of life improvement by age. Women ≥65 years had more urinary tract infections following onabotulinumtoxinA and sacral neuromodulation (odds ratio, 1.9, 95% confidence interval, 1.2-3.3). There was no evidence of age differences in sacral neuromodulation revision/removal or catheterization following onabotulinumtoxinA treatment. CONCLUSION: Younger women experienced greater absolute continence, symptom improvement, and fewer urinary tract infections; both older and younger women had beneficial urgency urinary incontinence episode reduction, similar rates of other treatment adverse events, and improved quality of life.


Assuntos
Inibidores da Liberação da Acetilcolina/uso terapêutico , Toxinas Botulínicas Tipo A/uso terapêutico , Sacro/inervação , Estimulação Elétrica Nervosa Transcutânea , Incontinência Urinária de Urgência/terapia , Fatores Etários , Idoso , Feminino , Humanos , Degeneração do Disco Intervertebral/epidemiologia , Qualidade de Vida , Infecções Urinárias/epidemiologia
16.
J Urol ; 199(4): 1023-1031, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-29111381

RESUMO

PURPOSE: We described and compared the frequency and type of lower urinary tract symptoms reported by men and women at the time that they were recruited from urology and urogynecology clinics into the Symptoms of Lower Urinary Tract Dysfunction Research Network multicenter, prospective, observational cohort study. MATERIALS AND METHODS: At 6 research sites treatment seeking men and women were enrolled who reported any lower urinary tract symptoms at a frequency more than rarely during the last month on the LUTS (Lower Urinary Tract Symptoms) Tool. At baseline the study participants underwent a standardized clinical evaluation and completed validated questionnaires. Urological tests were performed, including pelvic/rectal examination, post-void residual urine measurement and urinalysis. RESULTS: A total of 545 women and 519 men were enrolled in the study. Mean ± SD age was 58.8 ± 14.1 years. At baseline nocturia, frequency and a sensation of incomplete emptying were similar in men and women but men experienced more voiding symptoms (90% vs 85%, p = 0.007) and women reported more urgency (85% vs 66%, p <0.001). Women also reported more of any type of urinary incontinence than men (82% vs 51% p <0.001), which was mixed incontinence in 57%. Only 1% of men reported stress incontinence but they had other urinary incontinence, including post-void dribbling in 44% and urgency incontinence in 46%. Older participants had higher odds of reporting symptoms of nocturia and urgency. CONCLUSIONS: In this large, treatment seeking cohort of men and women lower urinary tract symptoms varied widely by gender and age. Men reported more voiding symptoms and nonstress or urgency urinary incontinence while women reported more incontinence overall and urgency. Older participants had greater odds of urgency and nocturia.


Assuntos
Noctúria/epidemiologia , Incontinência Urinária por Estresse/epidemiologia , Incontinência Urinária de Urgência/epidemiologia , Fatores Etários , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Noctúria/diagnóstico , Noctúria/terapia , Estudos Prospectivos , Fatores Sexuais , Inquéritos e Questionários/estatística & dados numéricos , Incontinência Urinária por Estresse/diagnóstico , Incontinência Urinária por Estresse/terapia , Incontinência Urinária de Urgência/diagnóstico , Incontinência Urinária de Urgência/terapia
17.
J Urol ; 199(1): 229-236, 2018 01.
Artigo em Inglês | MEDLINE | ID: mdl-28709886

RESUMO

PURPOSE: We evaluated the therapeutic success rate, changes in quality of life and safety of sacral neuromodulation 5 years after InterStim™ implantation. Included in study were subjects with bothersome symptoms of overactive bladder, including urinary urge incontinence and/or urgency-frequency, in whom at least 1 anticholinergic medication failed and 1 medication had not been tried. MATERIALS AND METHODS: Therapeutic success was defined as a urinary urge incontinence or urgency-frequency response of 50% or greater improvement in average leaks or voids per day, or return to normal voiding, defined as fewer than 8 voids per day. Quality of life was evaluated by ICIQ-OABqol (International Consultation on Incontinence Modular Questionnaire). Safety was evaluated through adverse events. RESULTS: Of the 340 subjects who completed the test stimulation 272 had an implant, of whom 91% were female. Mean age was 57 years. At baseline 202 subjects with urinary urge incontinence had a mean ± SD of 3.1 ± 2.7 leaks per day and 189 with urgency-frequency had a mean of 12.6 ± 4.5 voids per day. The 5-year therapeutic success rate was 67% (95% CI 60-74) using modified completers analysis and 82% (95% CI 76-88) using completers analysis. Subjects with urinary urge incontinence had a mean reduction from baseline of 2.0 ± 2.2 leaks per day and subjects with urgency-frequency had a mean reduction of 5.4 ± 4.3 voids per day (each completers analysis p <0.0001). Subjects showed improvement in all ICIQ-OABqol measures (p <0.0001). The most common device related adverse events were an undesirable change in stimulation in 60 of the 272 subjects (22%), implant site pain in 40 (15%) and therapeutic product ineffectiveness in 36 (13%). CONCLUSIONS: This multicenter study shows that sacral neuromodulation had sustained efficacy and quality of life improvements, and an acceptable safety profile through 5 years in subjects with overactive bladder.


Assuntos
Terapia por Estimulação Elétrica/métodos , Plexo Lombossacral/fisiopatologia , Dor Pós-Operatória/epidemiologia , Bexiga Urinária Hiperativa/terapia , Incontinência Urinária de Urgência/terapia , Terapia por Estimulação Elétrica/instrumentação , Eletrodos Implantados/efeitos adversos , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Dor Pós-Operatória/etiologia , Estudos Prospectivos , Qualidade de Vida , Fatores de Tempo , Resultado do Tratamento , Bexiga Urinária Hiperativa/fisiopatologia , Incontinência Urinária de Urgência/fisiopatologia
18.
Low Urin Tract Symptoms ; 10(3): 266-270, 2018 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-28627109

RESUMO

OBJECTIVE: Urinary incontinence (UI) is one of the most common urinary system diseases that mostly affects women but also men. We evaluated the therapeutic efficacy of functional magnetic stimulation (FMS) as potential UI treatment with improvements in the pelvic floor musculature, urodynamic tests and quality of life. METHODS: A total of 20 UI patients (10 females and 10 men, mean age 64, 14 years), including 10 with stress UI, four with urgency UI and six with mixed UI, were treated with FMS (20 min/session) twice a week for 3 weeks. The patients' impressions, records in urinary diaries, and scores of three life stress questionnaires (overactive bladder symptom questionnaire [OAB-q], urogenital distress inventory questionnaire-short form [UDI-6], incontinence impact questionnaire-short form [IIQ-7]) were performed pre- and post-treatment. RESULTS: Significant reductions (P < 0.01) of micturition number and nocturia after magnetic treatment were evidenced. The urodynamic tests recorded a significant increase in cystometric capacity (147 ± 51.3%), in maximum urethral closure pressure (110 ± 34%), in urethral functional length (99.8 ± 51.8%), and in pressure transmission ratio (147 ± 51.3%) values compared with the baseline values. CONCLUSIONS: These preliminary findings suggest that FMS with Magneto STYM (twice weekly for 3 weeks) improves the UI and may be an effective treatment for this urogenital disease.


Assuntos
Terapia de Campo Magnético , Incontinência Urinária por Estresse/terapia , Incontinência Urinária de Urgência/terapia , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Imãs , Masculino , Pessoa de Meia-Idade , Noctúria/etiologia , Diafragma da Pelve/fisiopatologia , Qualidade de Vida , Estudos Retrospectivos , Uretra/fisiopatologia , Incontinência Urinária por Estresse/fisiopatologia , Incontinência Urinária de Urgência/fisiopatologia , Micção , Urodinâmica
19.
Female Pelvic Med Reconstr Surg ; 24(4): 267-271, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-28914707

RESUMO

OBJECTIVES: The aim of this prospective, randomized, multicenter, single-blind, 4 × 4 crossover study was to estimate the effect of 4 InterStim cycling settings (continuous, 16 seconds on/8 seconds off, 10 minutes on/10 minutes off, and 30 minutes on/23.5 hours off) on efficacy, Global Response Assessment, and safety. METHODS: Eligible women implanted for at least 3 months for urgency urinary incontinence (UI) were enrolled, and daily diaries were collected. General linear mixed models were used to estimate the cycling effect on efficacy. Quality of life measured by Global Response Assessment (subjects' perception of effectiveness) and safety were summarized. RESULTS: Primary efficacy analysis was based on the first 24 subjects who completed unique randomization sequences. Mean age was 64 years, and mean implant duration was 2.8 years. Results showed no significant cycling (P = 0.3773) or period (P = 0.0800) effect on UI. There was a statistically significant interaction between cycling and period (P = 0.0032). In the first period, subjects on 10 minutes on/10 minutes off had significantly fewer UI episodes compared with subjects on 16 seconds on/8 seconds off (P = 0.0026); this difference was not observed in any other period or sensitivity analyses. No cycling effect was found on urgency or pad usage. When programmed to 10 minutes on/10 minutes off, 54% of subjects felt their incontinence symptoms improved compared with when they entered the study, followed by 42% on 30 minutes on/23.5 hours off, 38% on 16 seconds on/8 seconds off, and 29% on continuous. Safety was similar across cycling settings. CONCLUSIONS: The results suggest that patients with overactive bladder who have been implanted with sacral neuromodulation devices and are receiving substantial benefit may perceive further optimization by switching to cycling settings.


Assuntos
Terapia por Estimulação Elétrica/métodos , Neuroestimuladores Implantáveis , Incontinência Urinária de Urgência/terapia , Idoso , Estudos Cross-Over , Estudos de Viabilidade , Feminino , Humanos , Pessoa de Meia-Idade , Estudos Prospectivos , Qualidade de Vida , Sacro/inervação , Método Simples-Cego , Inquéritos e Questionários , Incontinência Urinária de Urgência/psicologia
20.
Neurourol Urodyn ; 37(3): 1060-1067, 2018 03.
Artigo em Inglês | MEDLINE | ID: mdl-28892221

RESUMO

BACKGROUND: Overactive bladder is a chronic condition affecting lower urinary tract function that has a significant negative impact on QoL. OBJECTIVE: Evaluation of the BlueWind implantable tibial nerve system performance and safety in refractory OAB. DESIGN, SETTING, AND PARTICIPANTS INTERVENTION: A 6-month multi-center prospective intervention study. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Objective assessment was done by voiding diary parameters including voids/day, volume voided/day, urgency assessment, leaking episodes/day, pads used/day, leak severity, and clinical success defined as a ≥50% reduction in the number of leaks/day or number of voids/day or number of episodes with degree of urgency >2 or a return to <8 voids/day on a 3 Day diary. Subjective assessment was based on OAB-q including HRQL and symptom severity score. Safety was evaluated by adverse event (AE) analysis. RESULTS AND LIMITATIONS: Thirty-four of the 36 implanted subjects completed the study. One subject withdrew voluntarily and one developed inflammation necessitating removal of the system. In the remaining subjects, 71% experienced clinical success at 6 months. Leaks/day, leak severity, and pad changes/day decreased significantly over time with 27.6% of urge incontinence subjects that became "dry." Voids/day, degree of urgency, volume/void, pads changed improved significantly. All quality of life aspects (concern, coping, sleep, and social) improved as well as symptom severity scores measured by the OAB-q. Adverse events included: implant site pain (13.9%), suspected infection (22.2%), and procedural wound complications (8.3%). CONCLUSIONS: The BlueWind implantable tibial nerve stimulator is a safe, minimally invasive system that affords OAB patients significant improvements. PATIENT SUMMARY: The performance and safety of the BlueWind RENOVA™ implantable tibial nerve neuromodulator for OAB was tested. Our preliminary results demonstrate that the system has a low risk safety profile and may be considered an effective treatment option for OAB management.


Assuntos
Terapia por Estimulação Elétrica/instrumentação , Neuroestimuladores Implantáveis , Qualidade de Vida , Nervo Tibial/fisiopatologia , Bexiga Urinária Hiperativa/terapia , Incontinência Urinária de Urgência/terapia , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Resultado do Tratamento , Bexiga Urinária Hiperativa/fisiopatologia , Incontinência Urinária de Urgência/fisiopatologia , Micção/fisiologia
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