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2.
Adv Ther ; 37(2): 637-643, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31875299

RESUMO

Recently rechargeable devices have been introduced for sacral neuromodulation (SNM) with conditional safety for full-body magnetic resonance imaging (MRI). Currently a recharge-free SNM device represents the standard implant; however, it is only approved for MRI head scans. As further new technologies with broader MRI capabilities are emerging, the advantages as well as disadvantages of both rechargeable versus recharge-free devices will be briefly discussed in this commentary from the perspective of patients, healthcare professionals, and providers.

3.
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
4.
Adv Urol ; 2019: 2757862, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31065264

RESUMO

A risk factor model for urinary tract infections in patients with adult neurogenic lower urinary tract dysfunction performing clean intermittent catheterisation was developed; it consists of four domains, namely, (1) general (systemic) conditions in the patient, (2) individual urinary tract conditions in the patient, (3) routine aspects related to the patient, and (4) factors related to intermittent catheters per se. The conceptual model primarily concerns patients with spinal cord injury, spina bifida, multiple sclerosis, or cauda equina where intermittent catheterisation is a normal part of the bladder management. On basis of several literature searches and author consensus in case of lacking evidence, the model intends to provide an overview of the risk factors involved in urinary tract infections, with specific emphasis to describe those that in daily practice can be handled and modified by the clinician and so come to the benefit of the individual catheter user in terms of fewer urinary tract infections.

5.
Urology ; 128: 107-111, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30890419

RESUMO

OBJECTIVE: To examine the utility of the Neurogenic Bladder Symptom Score (NBSS) in adults with cerebral palsy (CP). METHODS: Patients participated in a structured intake which included bladder management. Patients (or caregivers, if patients unable) completed NBSS and SF-Qualiveen twice over a 2-week period. Validity was determined using Cronbach's alpha and correlation testing between NBSS, intake, and SF-Qualiveen. Reliability was determined using test-retest method and intraclass correlation coefficients. RESULTS: Fifty-four patients were included. Thirty-six patients (67%) used a wheelchair; 35 patients (66%) required a caregiver to complete questionnaires. Median NBSS subdomain scores were 12 of 29 for incontinence, 9 of 22 for storage and/or voiding, 2 of 23 for consequences and 1 of 4 for quality of life (QOL). Lower scores reflect fewer symptoms. Reliability was high (intraclass correlation coefficients = 0.90). There was a moderate correlation (R = 0.70) between NBSS QOL and SF-Qualiveen. Bladder management method, as determined by the NBSS, was indwelling catheter in 4, intermittent catheterization in 6, voiding into a toilet in 33, and missing in 11. Importantly, there was no option for voiding into a diaper, which was common in this population. CONCLUSION: For adults with CP, the NBSS has high reliability and statistically, it demonstrated appropriate validity, but it has limitations. Its face validity is questionable given that diapers were not an option. The validity of caregiver completion needs further assessment. The NBSS may have a floor effect for detecting urinary consequences or QOL, reflected by consistently low scores in these subdomains. The development of a specific urinary symptom and/or QOL tool for adults with CP is needed.


Assuntos
Paralisia Cerebral/complicações , Qualidade de Vida , Bexiga Urinaria Neurogênica/diagnóstico , Micção/fisiologia , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Índice de Gravidade de Doença , Inquéritos e Questionários , Bexiga Urinaria Neurogênica/etiologia , Bexiga Urinaria Neurogênica/fisiopatologia
6.
Neurourol Urodyn ; 38(2): 668-676, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30499226

RESUMO

AIM: To systematically review the qualitative literature on neurogenic bladder management to better understand the relevant psychosocial issues. METHODS: We used two reviewers to systematically review EMBASE, CINAHL, and PsycINFO for qualitative studies that included a neurogenic bladder patient population and were relevant to bladder management. We used a meta-ethnography technique to summarize and synthesize the data. RESULTS: We found 13 studies that were relevant. When choosing a bladder management technique (three studies), there were two major themes (bladder management decision makers, and characteristics and risks) that impacted the process. For studies evaluating life with a urinary catheter (five about intermittent catheters, and five about indwelling catheters), relevant themes could be arranged into three consecutive periods: First, a changed life (the initial stage of selecting and using a catheter: coping, teaching and technical challenges, and control and independence). Second, learning to live with a catheter (the practical skill and knowledge that goes into using a catheter: knowledge, adjustments, and normalization). Third, a new life (the acceptance and integration of a catheter into a person's life: problems and benefits, unpredictability, travel and social activities, intimacy and relationships, and dealing with negative emotions). Themes were generally consistent across studies. Conclusions Several important themes were identified from the existing qualitative literature; these can provide insight into how neurogenic bladder patients select a bladder management method, and how physicians can optimize their counseling and the long-term management of these patients.

8.
Artigo em Inglês | MEDLINE | ID: mdl-30393569

RESUMO

Study design: Revision, review, and presentation of the International Spinal Cord Injury (SCI) Urodynamic Basic Data Set (version 2.0). Objectives: Describe the revision and review and present the dataset. Setting: International. Methods: The first version of the dataset was revised according to new knowledge and suggestions. The review included International SCI Data Sets Committee, American Spinal Injury Association (ASIA) board, International Spinal Cord Society (ISCoS) executive and scientific committees, major organizations, and interested individuals. The dataset was also on ASIA and ISCoS websites. All replies were answered and appropriate adjustments made. Finally, the dataset was endorsed by ASIA board, and ISCoS executive and scientific committees. Results: Among revisions are adoptions of new terminology by the International Continence Society. The variable "Detrusor function" has been divided into "Detrusor function during filling cystometry" and "Detrusor function during voiding". The response categories have been adjusted, deleting 'Not applicable' for the variables "Detrusor leak point pressure during filling cystometry", "Cystometric bladder capacity during filling cystometry" and "Urethral function during voiding". The cutoff-value for low bladder compliance has been modified from 10 mL/cm H2O to 20 mL/cm H2O. Conclusions: The International SCI Urodynamic Basic Data Set (version 2.0) with its complete syllabus is available from http://www.iscos.org.uk/international-sci-data-sets.

9.
Artigo em Inglês | MEDLINE | ID: mdl-30002915

RESUMO

Study design: Revision, review, and presentation of the International Spinal Cord Injury (SCI) Lower Urinary Tract (LUT) Function Basic Data Set (version 2.0). Objectives: Describe the revision and review and present the data set. Setting: International. Methods: The first version of the data set was revised according to new knowledge and suggestions. The review included International SCI Data Sets Committee, American Spinal Injury Association (ASIA) board, International Spinal Cord Society (ISCoS) executive and scientific committees, major organizations, and interested individuals. The data set was also on ASIA and ISCoS websites. All replies were answered and appropriate adjustments made. Finally, the data set was endorsed by ASIA board, and ISCoS executive and scientific committees. Results: Among revisions are adoptions of new terminology by the International Continence Society. For most variables, advice for collection of information from pediatric patients stated. For the variable 'Bladder emptying', is in the data collection form to the response category 'Normal voiding' expanded. 'Sacral Anterior Root Stimulator' is deleted as response category. For the variable 'Any involuntary urine leakage (incontinence) within the last 4 weeks' 'last 4 weeks' has replaced 'last 3 months'. The response categories have been adjusted to: 'Daily', 'Once or more per week (but not daily)', 'Less than once per week', 'Never', 'Not applicable' and 'Unknown'. For the variable 'Any drugs for the urinary tract within the last four weeks' 'last four weeks' has replaced 'last year'. Conclusions: The International SCI LUT Function Basic Data Set (version 2.0) with its complete syllabus is available from http://www.iscos.org.uk/international-sci-data-sets.

10.
Female Pelvic Med Reconstr Surg ; 24(4): e23-e25, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29894327

RESUMO

Fistulas are defined as abnormal connections between 2 organ, vessels, or structures. They can often present in the genitourinary tract as a result of iatrogenic injury during pelvic surgery. A 46-year-old female presents many years after a hysterectomy for persistent vaginal leakage with concern for a vesicovaginal fistula. Computed tomography urogram, intravenous retrograde pyelogram, and cystoscopy were negative for vesicovaginal fistula; however, a vaginal sinus tract was noted and further explored. This case report will describe the use of both laparoscopy and concomitant vaginoscopy to diagnose and, ultimately, surgically excise a salpingovaginal fistula.


Assuntos
Doenças das Tubas Uterinas/diagnóstico , Salpingectomia/métodos , Fístula Vaginal/diagnóstico , Doenças das Tubas Uterinas/etiologia , Doenças das Tubas Uterinas/cirurgia , Feminino , Humanos , Histerectomia/efeitos adversos , Pessoa de Meia-Idade , Prolapso , Fístula Vaginal/etiologia , Fístula Vaginal/cirurgia
11.
Exp Neurol ; 306: 169-176, 2018 08.
Artigo em Inglês | MEDLINE | ID: mdl-29753647

RESUMO

Loss of control over voiding following spinal cord injury (SCI) impacts autonomy, participation and dignity, and can cause life-threatening complications. The importance of SCI bowel and bladder dysfunction warrants significantly more attention from researchers in the field. To address this gap, key SCI clinicians, researchers, government and private funding organizations met to share knowledge and examine emerging approaches. This report reviews recommendations from this effort to identify and prioritize near-term treatment, investigational and translational approaches to addressing the pressing needs of people with SCI.


Assuntos
Gerenciamento Clínico , Intestino Neurogênico/etiologia , Intestino Neurogênico/terapia , Traumatismos da Medula Espinal/complicações , Traumatismos da Medula Espinal/reabilitação , Pesquisa Médica Translacional , Bexiga Urinaria Neurogênica/etiologia , Bexiga Urinaria Neurogênica/terapia , Animais , Humanos
12.
Curr Med Res Opin ; 34(10): 1771-1776, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-29458265

RESUMO

OBJECTIVE: Previous randomized controlled trials have reported a 6.1-6.9% incidence of clean intermittent catheterization (CIC) following treatment with onabotulinumtoxinA in non-neurogenic overactive bladder (OAB) patients who were inadequately managed by ≥1 anticholinergic. A multi-center retrospective chart review assessed the real-world rate of voiding dysfunction requiring catheterization. METHODS: Patients received onabotulinumtoxinA 100 U (approved dose) administered by experienced injectors between January 2013 and June 2015. Patients using CIC or an indwelling catheter for ≥24 hours for voiding dysfunction prior to onabotulinumtoxinA injections were excluded. The primary outcome was post-treatment CIC (lasting >24 hours; per individual physician's clinical judgment considering patient's voiding symptoms, post-void residual [PVR] urine volumes and patient bother). Potential baseline predictors of CIC (history of pelvic prolapse, cystocele, diabetes, PVR urine volume and age) were assessed using multivariable logistic regression. RESULTS: Overall, 299 patients received their first treatment with onabotulinumtoxinA 100 U. Mean age was 66.4 years; 98.3% were female. The incidence of CIC was 2.7% in the total study population after the first treatment with onabotulinumtoxinA. The de novo CIC rate in treatments 2 and 3 combined was similarly low (3.2%). None of the evaluated baseline characteristics were significant predictors of CIC initiation due to the low CIC incidence. CONCLUSIONS: This real-world study of non-neurogenic OAB patients treated with onabotulinumtoxinA suggests that the CIC rate is lower than the rates reported in previous studies. There were no significant correlations between baseline predictors and CIC initiation, although statistical significance may not have been reached because of the low incidence of CIC.


Assuntos
Toxinas Botulínicas Tipo A , Cateterismo Uretral Intermitente , Bexiga Urinária Hiperativa/tratamento farmacológico , Retenção Urinária , Idoso , Toxinas Botulínicas Tipo A/administração & dosagem , Toxinas Botulínicas Tipo A/efeitos adversos , Antagonistas Colinérgicos/administração & dosagem , Antagonistas Colinérgicos/efeitos adversos , Feminino , Humanos , Incidência , Injeções , Cateterismo Uretral Intermitente/métodos , Cateterismo Uretral Intermitente/estatística & dados numéricos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Estados Unidos/epidemiologia , Retenção Urinária/induzido quimicamente , Retenção Urinária/epidemiologia , Retenção Urinária/terapia
13.
J Neurotrauma ; 2018 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-29108476

RESUMO

During the last few years, the international community debated urinary tract infection and re-use of catheters when managing neurogenic lower urinary tract dysfunction (NLUTD) among individuals with spinal cord injury (SCI). In this respect, the 2014 Cochrane review by Prieto and colleagues, "Intermittent catheterisation for long-term bladder management," became one of the leading documents that captured the minds and attention of clinicians around the world. Although numerous countries had switched to single-use catheters for management of NLUTD following SCI, the opinion that was expressed in the 2014 Cochrane review had a strong influence on healthcare providers and agencies to recommend re-use of catheters. However, many clinicians have expressed concern regarding the conclusions in the 2014 Cochrane review by Prieto and colleagues. We therefore conducted an independent appraisal of the data and analyses presented in the review. Our appraisal identified crucial discrepancies of data extraction and analyses within the review. In appraisal to that of Prieto and colleagues' review, our analysis revealed a trend to favor single over multiple use of catheters. After addressing our concerns to Cochrane's acting Editor-in-Chief, the most recent version of the 2014 Cochrane review was withdrawn from publication.

14.
Artigo em Inglês | MEDLINE | ID: mdl-30774176

RESUMO

A nonsurgical laser procedure is being developed for treatment of female stress urinary incontinence (SUI). Previous studies in porcine vaginal tissues, ex vivo, as well as computer simulations, showed the feasibility of using near-infrared laser energy delivered through a transvaginal contact cooling probe to thermally remodel endopelvic fascia, while preserving the vaginal wall from thermal damage. This study explores optical properties of vaginal tissue in cadavers as an intermediate step towards future pre-clinical and clinical studies. Optical clearing of tissue using glycerol resulted in a 15-17% increase in optical transmission after 11 min at room temperature (and a calculated 32.5% increase at body temperature). Subsurface thermal lesions were created using power of 4.6 - 6.4 W, 5.2-mm spot, and 30 s irradiation time, resulting in partial preservation of vaginal wall to 0.8 - 1.1 mm depth.

15.
Neurourol Urodyn ; 36(4): 915-926, 2017 04.
Artigo em Inglês | MEDLINE | ID: mdl-28345769

RESUMO

AIMS: Antibiotic prophylaxis before urodynamic testing (UDS) is widely utilized to prevent urinary tract infection (UTI) with only limited guidance. The Society of Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction (SUFU) convened a Best Practice Policy Panel to formulate recommendations on the urodynamic antibiotic prophylaxis in the non-index patient. METHODS: Recommendations are based on a literature review and the Panel's expert opinion, with all recommendations graded using the Oxford grading system. RESULTS: All patients should be screened for symptoms of UTI and undergo dipstick urinalysis. If the clinician suspects a UTI, the UDS should be postponed until it has been treated. The first choice for prophylaxis is a single oral dose of trimethoprim-sulfamethoxazole before UDS, with alternative antibiotics chosen in case of allergy or intolerance. Individuals who do NOT require routine antibiotic prophylaxis include those without known relevant genitourinary anomalies, diabetics, those with prior genitourinary surgery, a history of recurrent UTI, post-menopausal women, recently hospitalized patients, patients with cardiac valvular disease, nutritional deficiencies or obesity. Identified risk factors that increase the potential for UTI following UDS and for which the panel recommends peri-procedure antibiotics include: known relevant neurogenic lower urinary tract dysfunction, elevated PVR, asymptomatic bacteriuria, immunosuppression, age over 70, and patients with any indwelling catheter, external urinary collection device, or performing intermittent catheterization. Patients with orthopedic implants have a separate risk stratification. CONCLUSIONS: These recommendations can assist urodynamic providers in the appropriate use of antibiotics for UDS testing. Clinical judgment of the provider must always be considered.


Assuntos
Antibioticoprofilaxia , Técnicas de Diagnóstico Urológico/efeitos adversos , Infecções Urinárias/etiologia , Infecções Urinárias/prevenção & controle , Antibioticoprofilaxia/efeitos adversos , Humanos , Guias de Prática Clínica como Assunto , Urodinâmica
16.
J Biomed Opt ; 22(1): 18002, 2017 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-28301637

RESUMO

Near-infrared laser energy in conjunction with applied tissue cooling is being investigated for thermal remodeling of the endopelvic fascia during minimally invasive treatment of female stress urinary incontinence. Previous computer simulations of light transport, heat transfer, and tissue thermal damage have shown that a transvaginal approach is more feasible than a transurethral approach. However, results were suboptimal, and some undesirable thermal insult to the vaginal wall was still predicted. This study uses experiments and computer simulations to explore whether application of an optical clearing agent (OCA) can further improve optical penetration depth and completely preserve the vaginal wall during subsurface treatment of the endopelvic fascia. Several different mixtures of OCA's were tested, and 100% glycerol was found to be the optimal agent. Optical transmission studies, optical coherence tomography, reflection spectroscopy, and computer simulations [including Monte Carlo (MC) light transport, heat transfer, and Arrhenius integral model of thermal damage] using glycerol were performed. The OCA produced a 61% increase in optical transmission through porcine vaginal wall at 37°C after 30 min. The MC model showed improved energy deposition in endopelvic fascia using glycerol. Without OCA, 62%, 37%, and 1% of energy was deposited in vaginal wall, endopelvic fascia, and urethral wall, respectively, compared with 50%, 49%, and 1% using OCA. Use of OCA also resulted in 0.5-mm increase in treatment depth, allowing potential thermal tissue remodeling at a depth of 3 mm with complete preservation of the vaginal wall.


Assuntos
Terapia a Laser/métodos , Incontinência Urinária por Estresse/cirurgia , Vagina/cirurgia , Feminino , Humanos , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Resultado do Tratamento
17.
BJU Int ; 119(6): 926-932, 2017 06.
Artigo em Inglês | MEDLINE | ID: mdl-28139068

RESUMO

OBJECTIVE: To examine whether response to first treatment with onabotulinumtoxinA is predictive of long-term treatment outcome in patients with neurogenic detrusor overactivity (NDO). PATIENTS AND METHODS: Patients with NDO who were enrolled in a 3-year extension study (after a 52-week phase III study) received onabotulinumtoxinA 'as needed', based on fulfilment of prespecified retreatment criteria. This post hoc analysis included patients who received only the 200-U dose during the phase III and extension studies. Data on mean percent reduction from baseline in urinary incontinence (UI) episodes at week 6 after the first treatment were analysed, and the patients were stratified into three response groups: <50% (group 1; n = 33), 50-74% (group 2; n = 23), and 75-100% (group 3; n = 139). The following were assessed: change from baseline in mean percent UI reduction; proportions of patients who achieved ≥50% and 100% UI reduction after each subsequent treatment, and patients who achieved ≥50% UI reduction after all subsequent treatments; change from baseline in Incontinence Quality of Life (I-QOL) total summary score; and the proportion of patients who achieved or exceeded the minimally important difference (MID; +11 points) in I-QOL score. Adverse events (AEs) were also assessed. RESULTS: The majority of the patients (83.1%; 162/195) experienced a ≥50% UI reduction after onabotulinumtoxinA treatment 1. Baseline characteristics were largely similar across the groups. After treatment 1, the mean percent reduction in UI remained consistent in subsequent treatments 2-6 for patients in response group 2 (range: 64.5-83.5%) and group 3 (range: 79.4-88.0%), but increased for those in the low response group (range: 36.3-60.3%). After treatment 1, the proportion of patients who achieved ≥50% reduction in UI episodes was consistent with subsequent treatments 2-6 in group 2 (range: 75.0-100%) and group 3 (range: 87.3-97.1%), but increased in the low response group (range: 48.3-72.7%). Even among those who achieved a low response after treatment 1, 37.9% of patients achieved ≥50% UI reduction in all subsequent treatments. Improvements in I-QOL scores in groups 2 and 3 were consistently 2-3 times the MID. In the low response group, at least 50% of the patients achieved or exceeded the MID with treatments 2-6. AEs were similar across all response groups and consistent across repeated treatments. CONCLUSION: Patients with NDO with a ≥50% UI reduction after their first onabotulinumtoxinA treatment continued to experience consistent improvements in UI and quality of life with subsequent treatments over the duration of 4 years. A <50% UI reduction after first treatment did not necessarily predict low response with subsequent treatments. Thus, these results underscore the importance of attempting at least a second treatment with onabotulinumtoxinA before deeming patients unsuitable for onabotulinumtoxinA therapy.


Assuntos
Toxinas Botulínicas Tipo A/administração & dosagem , Bexiga Urinária Hiperativa/tratamento farmacológico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Qualidade de Vida , Fatores de Tempo , Resultado do Tratamento
18.
Spinal Cord Ser Cases ; 3: 17098, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-29423301

RESUMO

Introduction: The International Standards for the Neurological Classification of Spinal Cord Injury (ISNCSCI) is a measure for motor-sensory dysfunction following spinal cord injury (SCI) but does not assess the autonomic nervous system dysfunction. The International Standards to document remaining Autonomic Dysfunction after Spinal Cord Injury (ISAFSCI) has been recommended to study autonomic dysfunction in such patients. We present a case presentation to demonstrate how to use the ISAFSCI and ISCoS urodynamics data set in persons with SCIs. Case presentation: A 24-year-old caucasian male presents with T4 ASIA SCI. We followed the patient over the course of 18 months. We present his clinical picture at different stages and how to apply ISAFSCI and ISCoS urodynamic data set to this patient. Discussion: The ISAFSCI and ISCoS urodynamics data sets are important tools in the repertoire of the clinician assessing autonomic dysfunction in persons with SCIs. They allow efficient clinical assessment of patients and standard communication between clinical care providers.

19.
Lasers Surg Med ; 49(2): 198-205, 2017 02.
Artigo em Inglês | MEDLINE | ID: mdl-26900038

RESUMO

BACKGROUND AND OBJECTIVES: A non-surgical method is being developed for treating female stress urinary incontinence by laser thermal remodeling of subsurface tissues with applied surface tissue cooling. Computer simulations of light transport, heat transfer, and thermal damage in tissue were performed, comparing transvaginal and transurethral approaches. STUDY DESIGN/MATERIALS AND METHODS: Monte Carlo (MC) simulations provided spatial distributions of absorbed photons in the tissue layers (vaginal wall, endopelvic fascia, and urethral wall). Optical properties (n,µa ,µs ,g) were assigned to each tissue at λ = 1064 nm. A 5-mm-diameter laser beam and incident power of 5 W for 15 seconds was used, based on previous experiments. MC output was converted into absorbed energy, serving as input for finite element heat transfer simulations of tissue temperatures over time. Convective heat transfer was simulated with contact probe cooling temperature set at 0°C. Variables used for thermal simulations (κ,c,ρ) were assigned to each tissue layer. MATLAB code was used for Arrhenius integral thermal damage calculations. A temperature matrix was constructed from ANSYS output, and finite sum was incorporated to approximate Arrhenius integral calculations. Tissue damage properties (Ea ,A) were used to compute Arrhenius sums. RESULTS: For the transvaginal approach, 37% of energy was absorbed in the endopelvic fascia target layer with 0.8% deposited beyond it. Peak temperature was 71°C, the treatment zone was 0.8-mm-diameter, and 2.4 mm of the 2.7-mm-thick vaginal wall was preserved. For transurethral approach, 18% energy was absorbed in endopelvic fascia with 0.3% deposited beyond the layer. Peak temperature was 80°C, treatment zone was 2.0-mm-diameter, and 0.6 mm of 2.4-mm-thick urethral wall was preserved. CONCLUSIONS: Computer simulations suggest that transvaginal approach is more feasible than transurethral approach. Lasers Surg. Med. 49:198-205, 2017. © 2016 Wiley Periodicals, Inc.


Assuntos
Terapia a Laser/métodos , Incontinência Urinária por Estresse/terapia , Simulação por Computador , Fáscia/efeitos da radiação , Feminino , Humanos , Modelos Biológicos , Método de Monte Carlo , Uretra/efeitos da radiação , Vagina/efeitos da radiação
20.
Neurourol Urodyn ; 36(2): 368-375, 2017 02.
Artigo em Inglês | MEDLINE | ID: mdl-26607743

RESUMO

AIMS: To present final efficacy/safety results from a prospective, long-term extension trial of onabotulinumtoxinA for urinary incontinence (UI) due to neurogenic detrusor overactivity (NDO); patients received treatment for up to 4 years. METHODS: Patients who completed a 52-week, phase III trial of onabotulinumtoxinA for NDO were eligible to enter a 3-year, multicenter, open-label extension study of intradetrusor onabotulinumtoxinA (200U or 300U). Patients were treated "as needed" based on their request and fulfillment of prespecified qualification criteria (≥12 weeks since previous treatment and a UI episode threshold). Assessments included change from study baseline in UI episodes/day (primary efficacy measure), volume/void, and Incontinence Quality of Life (I-QOL) total score (week 6); duration of effect; adverse events (AEs); and initiation of de novo clean intermittent catheterization (CIC). Data are presented for up to six treatments. RESULTS: OnabotulinumtoxinA 200U consistently reduced UI episodes/day; reductions from baseline ranged from -3.2 to -4.1 across six treatments. Volume/void consistently increased, nearly doubling after treatment. I-QOL improvements were consistently greater than twice the minimally important difference (+11 points). Overall median duration of effect was 9.0 months (200U). Results were similar for onabotulinumtoxinA 300U. Most common AEs were urinary tract infections and urinary retention. De novo CIC rates were 29.5, 3.4, and 6.0% (200U), and 43.0, 15.0, and 4.8% (300U) for treatments 1-3, respectively; de novo CIC rates were 0% for treatments 4-6. CONCLUSIONS: OnabotulinumtoxinA treatments consistently improve UI, volume/void, and QOL in patients with UI due to NDO in this 4-year study, with no new safety signals. Neurourol. Urodynam. 36:368-375, 2017. © 2015 The Authors. Neurourology and Urodynamics Published by Wiley Periodicals, Inc.


Assuntos
Inibidores da Liberação da Acetilcolina/uso terapêutico , Toxinas Botulínicas Tipo A/uso terapêutico , Bexiga Urinaria Neurogênica/tratamento farmacológico , Bexiga Urinária Hiperativa/diagnóstico por imagem , Incontinência Urinária/tratamento farmacológico , Inibidores da Liberação da Acetilcolina/efeitos adversos , Adulto , Toxinas Botulínicas Tipo A/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Qualidade de Vida , Resultado do Tratamento
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