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1.
Neurourol Urodyn ; 37(8): 2932-2937, 2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-29953660

RESUMO

BACKGROUND AND AIMS: Stakeholders from around the world came together to address the unmet needs of underactive bladder (UAB) at the 3rd International Congress for Underactive Bladder. METHODS: The main recommendation from the regulatory working group is a need for a meeting of UAB stakeholders and regulatory agencies including the FDA to discuss guidance for regulatory trial design for devices, drugs, and/or biologics for UAB. RESULTS: The following issues to be discussed and agreed upon for UAB trials: 1) Appropriate inclusion and exclusion criteria. 2) Should residual urine volume be the primary outcome parameter and how often should it be measured? 3) Are there secondary measures that should have a place in UAB trials, such as change in the number of catheterizations, quality of life measures, etc.? 4) Use and format of bladder voiding and catheterization diary for trials. 5) Define role and technique of urodynamics in UAB trials. Are urodynamics required to monitor, and possibly exclude, individuals with high pressure voiding induced by bladder prokinetic therapies? 6) Development and use of UAB questionnaires. DISCUSSION AND CONCLUSION: The UAB regulatory working group recognizes the path forward should include engaging the FDA and other regulatory organizations that may harmonize and formalize guidance for regulatory trial designs for therapeutics for UAB.


Assuntos
Avaliação da Tecnologia Biomédica/métodos , Bexiga Inativa/terapia , Betanecol/uso terapêutico , Ensaios Clínicos como Assunto , Terapia por Estimulação Elétrica , Humanos , Agonistas Muscarínicos/uso terapêutico , Qualidade de Vida , Projetos de Pesquisa , Inquéritos e Questionários , Resultado do Tratamento , Estados Unidos , United States Food and Drug Administration , Bexiga Inativa/psicologia , Cateterismo Urinário/estatística & dados numéricos , Urodinâmica
2.
J Urol ; 197(6): 1480-1486, 2017 06.
Artigo em Inglês | MEDLINE | ID: mdl-28049010

RESUMO

PURPOSE: We compared 2-year urinary incontinence and urgency scores of older women who attended a 2-hour bladder health class vs those who viewed a 20-minute abbreviated class video for the purpose of urinary incontinence prevention. MATERIALS AND METHODS: A randomized, 2-arm, parallel design study was done to test the superiority of the 20-minute video over the 2-hour class. Outcomes at baseline, and 3, 12 and 24 months were the scores on questions 1 to 3 of ICIQ-SF (International Consultation on Incontinence Short Form) as the primary outcome and on IUSS (Indevus Urgency Severity Scale). Intent to treat analysis was done to compare the change from baseline in each intervention group across time and also with each other. Multiple imputation was used for missing data. RESULTS: A total of 647 women participated in the study. Mean age was 63 years and approximately 28% of the participants were African American, primarily from an urban setting. The 2 arms were balanced on body mass index at baseline, age, race/ethnicity, education, employment status, income and marital status. No differences in primary or secondary outcomes were demonstrated between the 2 groups from baseline to the 3, 12 or 24-month visits. CONCLUSIONS: The absence of significant differences in the outcome measures of ICIQ-SF and IUSS between the 2-hour class and the 20-minute video groups demonstrates that the 2 interventions were comparable. As urinary incontinence and urgency tend to rise annually in older women, instruction in bladder health self-care provided through either the 2-hour class or the 20-minute video format is a useful intervention to prevent urinary incontinence in older women.


Assuntos
Sintomas do Trato Urinário Inferior/prevenção & controle , Educação de Pacientes como Assunto , Incontinência Urinária/prevenção & controle , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Pessoa de Meia-Idade , Educação de Pacientes como Assunto/métodos , Gravação em Vídeo
3.
Can J Urol ; 26(4): 9803-9805, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-31469633
5.
Int Urol Nephrol ; 54(11): 2767-2774, 2022 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-35909146

RESUMO

PURPOSE: Because of many unanswered questions regarding men's health, a literature review was performed to better understand the role of testosterone and testosterone replacement therapy (TRT) in the management of hypogonadism and aging related prostate gland diseases (ARPGD) including prostate cancer (PCa) and benign prostatic hyperplasia (BPH) with lower urinary tract symptoms (LUTS). METHODS: The PubMed database was screened for pertinent peer reviewed articles published during the last four decades that culminated in the positions and recommendations in this paper. RESULTS: Hypogonadism seriously impacts men's health, and the diagnosis remains controversial. The incidence of ARPGD is projected to increase worldwide and treatment still has significant limitations. There is compelling evidence that lower, not higher, testosterone levels trigger the development of PCa and BPH through androgen receptor over-expression. TRT was found to be safe and effective in treating hypogonadism including in PCa survivors and those harboring PCa. There is also evidence that TRT might reduce the incidence and prevalence of ARPGD. CONCLUSIONS AND RECOMMENDATIONS: This review synthesizes a wide-ranging compendium of basic science and clinical research that strongly encourages altering the present approach to diagnosing and treating men with hypogonadism and ARPGD. These findings underscore the importance of avoiding significant testosterone decline and support the use of TRT. Ten recommendations are offered as a framework for the way forward. It is now time for clinicians, payers, researchers, funding agencies, professional associations, and patient advocacy groups to embrace this new paradigm to increase longevity and improve the quality of life.


Assuntos
Hipogonadismo , Hiperplasia Prostática , Humanos , Hipogonadismo/tratamento farmacológico , Masculino , Saúde do Homem , Hiperplasia Prostática/tratamento farmacológico , Qualidade de Vida , Receptores Androgênicos , Testosterona/uso terapêutico
6.
Int Urol Nephrol ; 53(7): 1331-1338, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-33840007

RESUMO

We report on the first regulatory approved clinical trial of a prospective open-label physician-initiated study assessing the safety and efficacy of intradetrusor injected Autologous Muscle Derived Cells (AMDC) treatment for underactive bladder (UAB). 20 non-neurogenic UAB patients were treated. Approximately 50-250 mg of quadriceps femoris muscle was collected using a spirotome 8-gauge needle. The muscle biopsy samples were sent to Cook MyoSite (Pittsburgh, PA) for processing, isolation, and propagation of cells. Research patients received approximately 30 intradetrusor injections of 0.5 mL delivered to the bladder, for a total of 15 mL and 125 million AMDC, performed utilizing a flexible cystoscope under direct vision using topical local anesthesia. Follow-up assessments included adverse events and efficacy via voiding diary and urodynamic testing at 1, 3, 6 and 12 months post-injection. An optional second injection was offered at the end of the 6 months visit. 20 patients received the first injection and all 20 patients requested and received a second injection. Median patient age was 65 years old (range 41-82 years). There were 16 male (80%) and 4 female (20%) patients. Etiology included 7 men (35%) with persistent urinary retention after transurethral resection of the prostate for benign prostatic hyperplasia and 13 patients (65%) with idiopathic chronic urinary retention. At the primary outcome time point of 12 months, 11/19 patients (58%) reported a global response assessment (GRA) ≥ 5, showing slight to marked improvement in their UAB symptoms, compared to 6/20 (30%) patients at 3 months post-injection. No serious procedure or treatment-related adverse events occurred. Noted improvements included: decreased post void residual urine volume, increased voiding efficiency, and decreased catheter use. Intradetrusor-injected AMDC as a treatment for UAB was successfully completed in a 20-patient trial without serious adverse event and with signal of efficacy. Cellular therapy may be a promising novel treatment for catheter-dependent chronic urinary retention. A multicenter controlled trial is needed to further assess the promise of regenerative medicine in the treatment of lower urinary tract dysfunction.


Assuntos
Transplante de Células/métodos , Músculo Esquelético/citologia , Bexiga Inativa/cirurgia , Administração Intravesical , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Resultado do Tratamento
7.
N Engl J Med ; 356(21): 2143-55, 2007 May 24.
Artigo em Inglês | MEDLINE | ID: mdl-17517855

RESUMO

BACKGROUND: Many surgical procedures are available for women with urinary stress incontinence, yet few randomized clinical trials have been conducted to provide a basis for treatment recommendations. METHODS: We performed a multicenter, randomized clinical trial comparing two procedures--the pubovaginal sling, using autologous rectus fascia, and the Burch colposuspension--among women with stress incontinence. Women were eligible for the study if they had predominant symptoms associated with the condition, a positive stress test, and urethral hypermobility. The primary outcomes were success in terms of overall urinary-incontinence measures, which required a negative pad test, no urinary incontinence (as recorded in a 3-day diary), a negative cough and Valsalva stress test, no self-reported symptoms, and no retreatment for the condition, and success in terms of measures of stress incontinence specifically, which required only the latter three criteria. We also assessed postoperative urge incontinence, voiding dysfunction, and adverse events. RESULTS: A total of 655 women were randomly assigned to study groups: 326 to undergo the sling procedure and 329 to undergo the Burch procedure; 520 women (79%) completed the outcome assessment. At 24 months, success rates were higher for women who underwent the sling procedure than for those who underwent the Burch procedure, for both the overall category of success (47% vs. 38%, P=0.01) and the category specific to stress incontinence (66% vs. 49%, P<0.001). However, more women who underwent the sling procedure had urinary tract infections, difficulty voiding, and postoperative urge incontinence. CONCLUSIONS: The autologous fascial sling results in a higher rate of successful treatment of stress incontinence but also greater morbidity than the Burch colposuspension. (ClinicalTrials.gov number, NCT00064662 [ClinicalTrials.gov] .).


Assuntos
Complicações Pós-Operatórias/epidemiologia , Incontinência Urinária por Estresse/cirurgia , Procedimentos Cirúrgicos Urológicos/métodos , Feminino , Humanos , Pessoa de Meia-Idade , Satisfação do Paciente , Reoperação , Falha de Tratamento , Incontinência Urinária de Urgência/epidemiologia , Incontinência Urinária de Urgência/etiologia , Retenção Urinária/epidemiologia , Retenção Urinária/etiologia , Infecções Urinárias/epidemiologia , Infecções Urinárias/etiologia
8.
J Urol ; 184(2): 702-7, 2010 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-20639040

RESUMO

PURPOSE: Restoring bladder and bowel function in spina bifida by creation of a skin-central nervous system-bladder reflex arc via lumbar to sacral nerve rerouting has a reported success rate of 87% in China. We report 1-year results of the first North American trial on nerve rerouting. MATERIALS AND METHODS: Nine subjects were enrolled in the study. Intradural lumbar to sacral nerve rerouting was performed. Subjects underwent urodynamic testing with stimulation of the cutaneous dermatome and careful neurological followup. Adverse events were closely monitored along with changes in bowel and bladder function. RESULTS: At 1 year 7 patients (78%) had a reproducible increase in bladder pressure with stimulation of the dermatome. Two patients were able to stop catheterization and all safely stopped antimuscarinics. No patient achieved complete urinary continence. The majority of subjects reported improved bowel function. One patient was continent of stool at baseline and 4 were continent at 1 year. Of the patients 89% had variable weakness of lower extremity muscle groups at 1 month. One child had persistent foot drop and the remainder returned to baseline by 12 months. CONCLUSIONS: At 1 year a novel reflex arc with stimulation of the appropriate dermatome was seen in the majority of subjects. Improvements in voiding and bowel function were noted. Lower extremity weakness was mostly self-limited, except in 1 subject with a persistent foot drop. More patients and longer followup are needed to assess the risk/benefit ratio of this novel procedure.


Assuntos
Plexo Lombossacral/cirurgia , Transferência de Nervo , Disrafismo Espinal/complicações , Raízes Nervosas Espinhais/cirurgia , Bexiga Urinaria Neurogênica/etiologia , Bexiga Urinaria Neurogênica/cirurgia , Adolescente , Adulto , Criança , Feminino , Humanos , Masculino , Resultado do Tratamento , Adulto Jovem
9.
Int Neurourol J ; 24(1): 3-11, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-32252181

RESUMO

There is a significant need for research and understanding of underactive bladder (UAB). The International Congress of Urologic Research and Education on Aging UnderActive Bladder (CURE-UAB) was organized by Doctors Michael Chancellor and Ananias Diokno in order to address these concerns. CURE-UAB was supported, in part, by the US National Institute of Aging and National Institute of Diabetes Digestive and Kidney. Since 2014, there have been 5 successful CURE-UAB congresses. They have brought together diverse stakeholders in the UAB field to identify areas of major scientific challenge and initiated a call to action among the medical community. In this review, we will highlight current and novel treatments under development for UAB and the progress and impact from the CURE-UAB initiative.

10.
J Urol ; 179(3): 1024-30, 2008 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-18206917

RESUMO

PURPOSE: We identified baseline demographic and clinical factors associated with treatment failure after surgical treatment of stress urinary incontinence. MATERIALS AND METHODS: Data were obtained from 655 women randomized to Burch colposuspension or autologous rectus sling. Of those, 543 (83%) had stress failure status assessed at 24 months (269 Burch, 274 sling). Stress failure (261) was defined as self-report of stress urinary incontinence by the Medical, Epidemiological, and Social Aspects of Aging questionnaire, positive stress test or re-treatment for stress urinary incontinence. Nonstress failure (66) was defined as positive 24-hour pad test (more than 15 ml) or any incontinent episodes by 3-day voiding diary with none of the 3 criteria for stress failure. Subjects not meeting any failure criteria were considered a treatment success (185). Adjusting for surgical treatment group and clinical site, logistic regression models were developed to predict the probability of treatment failure. RESULTS: Severity of urge incontinence symptoms (p = 0.041), prolapse stage (p = 0.013), and being postmenopausal without hormone therapy (p = 0.023) were significant predictors for stress failure. Odds of nonstress failure quadrupled for every 10-point increase in Medical, Epidemiological, and Social Aspects of Aging questionnaire urge score (OR 3.93 CI 1.45, 10.65) and decreased more than 2 times for every 10-point increase in stress score (OR 0.36, CI 0.16, 0.84). The associations of risk factors and failure remained similar regardless of surgical group. CONCLUSIONS: Two years after surgery, risk factors for stress failure are similar after Burch and sling procedures and include greater baseline urge incontinence symptoms, more advanced prolapse, and menopausal not on hormone replacement therapy. Higher urge scores predicted failure by nonstress specific outcomes.


Assuntos
Incontinência Urinária por Estresse/cirurgia , Adulto , Feminino , Humanos , Pessoa de Meia-Idade , Prognóstico , Fatores de Risco , Slings Suburetrais , Falha de Tratamento
11.
Obstet Gynecol ; 111(4): 899-907, 2008 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-18378749

RESUMO

OBJECTIVE: To estimate costs for incontinence management, health-related quality of life, and willingness to pay for incontinence improvement in women electing surgery for stress urinary incontinence. METHODS: A total of 655 incontinent women enrolled in the Stress Incontinence Surgical Treatment Efficacy Trial, a randomized surgical trial. Baseline out-of-pocket costs for incontinence management were calculated by multiplying self-report of resources used (supplies, laundry, dry cleaning) by national resource costs (USD2,006). Health-related quality of life was estimated with the Health Utilities Index Mark 3. Participants estimated willingness to pay for 100% improvement in incontinence. Potential predictors of these outcomes were examined by using multivariable linear regression. RESULTS: Mean age was 52+/-10 years, and mean number of weekly incontinence episodes was 22+/-21. Mean and median (25%, 75% interquartile range) estimated personal costs for incontinence management among all women were USD14+/-USD24 and USD8 (interquartile range USD3, USD18) per week, and 617 (94%) women reported any cost. Costs increased significantly with incontinence frequency and mixed compared with stress incontinence. The mean and median Health Utilities Index Mark 3 scores were 0.73+/-0.25 and 0.84 (interquartile range 0.63, 0.92). Women were willing to pay a mean of USD118+/-USD132 per month for complete resolution of incontinence, and willingness to pay increased significantly with greater expected incontinence improvement, household income, and incontinent episode frequency. CONCLUSION: Urinary incontinence is associated with substantial costs. Women spent nearly USD750 per year out of pocket for incontinence management, had a significant decrement in quality of life, and were willing to pay nearly USD1,400 per year for cure.


Assuntos
Efeitos Psicossociais da Doença , Incontinência Urinária por Estresse/economia , Incontinência Urinária por Estresse/cirurgia , Adulto , Estudos Transversais , Procedimentos Cirúrgicos Eletivos/economia , Feminino , Humanos , Modelos Lineares , Pessoa de Meia-Idade , Análise de Componente Principal , Qualidade de Vida , Estados Unidos , Procedimentos Cirúrgicos Urológicos/economia
12.
Int J Med Sci ; 5(2): 62-7, 2008 Mar 24.
Artigo em Inglês | MEDLINE | ID: mdl-18392145

RESUMO

PURPOSE: To evaluate the safety and efficacy of oral Apatone (Vitamin C and Vitamin K3) administration in the treatment of prostate cancer in patients who failed standard therapy. MATERIALS AND METHODS: Seventeen patients with 2 successive rises in PSA after failure of standard local therapy were treated with (5,000 mg of VC and 50 mg of VK3 each day) for a period of 12 weeks. Prostate Specific Antigen (PSA) levels, PSA velocity (PSAV) and PSA doubling times (PSADT) were calculated before and during treatment at 6 week intervals. Following the initial 12 week trial, 15 of 17 patients opted to continue treatment for an additional period ranging from 6 to 24 months. PSA values were followed for these patients. RESULTS: At the conclusion of the 12 week treatment period, PSAV decreased and PSADT increased in 13 of 17 patients (p < or = 0.05). There were no dose-limiting adverse effects. Of the 15 patients who continued on Apatone after 12 weeks, only 1 death occurred after 14 months of treatment. CONCLUSION: Apatone showed promise in delaying biochemical progression in this group of end stage prostate cancer patients.


Assuntos
Ácido Ascórbico/uso terapêutico , Neoplasias da Próstata/tratamento farmacológico , Vitamina K 3/uso terapêutico , Administração Oral , Idoso , Ácido Ascórbico/administração & dosagem , Quimioterapia Combinada , Humanos , Masculino , Pessoa de Meia-Idade , Terapia de Salvação , Vitamina K 3/administração & dosagem
13.
J Altern Complement Med ; 14(1): 53-60, 2008.
Artigo em Inglês | MEDLINE | ID: mdl-18199015

RESUMO

INTRODUCTION: In the United States, more than 1 million women and men are affected with interstitial cystititis (IC), which is a clinical syndrome involving urinary urgency, frequency, and pelvic pain. A review of the literature revealed that there are no studies showing the effect of guided imagery in women with IC. The purpose of this clinical investigation was to explore the effect of guided imagery on pelvic pain and urinary symptoms in women with IC symptoms. METHODOLOGY: Thirty (30) women with diagnosed IC were randomized into 2 equal groups. One group (treatment) listened to a 25-minute guided imagery compact disc (CD), that was created specifically for women with pelvic pain and IC, twice a day for 8 weeks. The control group rested for 25 minutes twice daily for 8 weeks. Because no guided imagery CDs specifically for women with IC were found on the commercial market, the authors created a script and recorded the CD specifically for women with IC and pelvic pain. The focus of this guided imagery CD was on healing the bladder, relaxing the pelvic-floor muscles, and quieting the nerves specifically involved in IC. Baseline and end-of-study assessment questionnaires (Interstitial Cystitis Symptom Index & Problem Index [IC-SIPI], IC Self-Efficacy Scale, a visual analogue [VAS] scale for pain, and a global response assessment [GRA]), 2-day voiding diaries, and 24-hour pain diaries were completed by the subjects and were evaluated using SPSS (Chicago, IL). RESULTS: More than 45% of the treatment group were responders to guided imagery therapy noting a moderate or marked improvement on the GRA. Pain scores and episodes of urgency significantly decreased in the treatment group. Responders had significant reductions in IC-SIPI scores (problem index, p = 0.006; symptom index, p = 0.004). In addition, responders on the GRA had significant (p = 0.039) improvements in mean pain scores from 5.50 to 2.57 at the end of the study in contrast to the nonresponders, whose pain levels remained the same (4.89 to 4.39). CONCLUSIONS: This is the first study providing preliminary data supporting the use of guided imagery as a potential therapy for IC. Guided imagery may be a useful tool to offer women with IC for pain and IC symptom management. It is an intervention without negative side-effects, is readily available, and shows a trend toward improvement of IC symptoms.


Assuntos
Cistite Intersticial/terapia , Imagens, Psicoterapia/métodos , Qualidade de Vida , Autoeficácia , Saúde da Mulher , Adulto , Cistite Intersticial/psicologia , Feminino , Humanos , Pessoa de Meia-Idade , Medição da Dor , Satisfação do Paciente , Projetos Piloto , Estudos Prospectivos , Índice de Gravidade de Doença , Inquéritos e Questionários , Resultado do Tratamento
14.
Urol Pract ; 5(4): 266-271, 2018 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-37312310

RESUMO

INTRODUCTION: Many women choose behavioral interventions as first line treatment for urinary incontinence. We developed a 20-minute abbreviated video, which proved to be similar to a 2-hour in-person class in a randomized trial. This study examines economic end points for the 20-minute video relative to the 2-hour class. METHODS: We randomized 332 participants to the 2-hour class and 315 to the 20-minute video. We estimated the cost for the 2-hour class, the 20-minute video and followup health care utilization. Participants were followed for 3, 12 and 24 months, and asked about health care utilization, quality of life and lost productivity. To measure perceived value, we queried each participant regarding willingness to pay. Regression analysis was used for statistical comparisons. RESULTS: The estimated per participant cost for a 2-hour class was $38, which was more than the marginal cost of the video ($0). We found no significant differences between the treatment groups at each followup for quality of life, lost productivity or health care utilization. Women were willing to pay $26, $21 and $30 for a copy of the DVD, video on the Web and in-person class, respectively, all of which were less than the average cost of the in-person class ($38). CONCLUSIONS: Poor adherence remains a challenge for many behavioral interventions designed to prevent urinary incontinence. The 20-minute video is less expensive than the 2-hour class and is equally effective. Distributing the video on the Internet will improve access and will be easier to sustain than in-person classes.

15.
JAMA Intern Med ; 178(10): 1333-1341, 2018 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-30193294

RESUMO

Importance: Urinary incontinence (UI) guidelines recommend behavioral interventions as first-line treatment using individualized approaches. A one-time, group-administered behavioral treatment (GBT) could enhance access to behavioral treatment. Objective: To compare the effectiveness, cost, and cost-effectiveness of GBT with no treatment for UI in older women. Design, Setting, and Participants: Multisite randomized clinical trial (the Group Learning Achieves Decreased Incidents of Lower Urinary Symptoms [GLADIOLUS] study), conducted from July 7, 2014, to December 31, 2016. The setting was outpatient practices at 3 academic medical centers. Community-dwelling women 55 years or older with UI were recruited by mail and screened for eligibility, including a score of 3 or higher on the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), symptoms of at least 3 months' duration, and absence of medical conditions or treatments that could affect continence status. Of 2171 mail respondents, 1125 were invited for clinical screening; 463 were eligible and randomized; 398 completed the 12-month study. Interventions: The GBT group received a one-time 2-hour bladder health class, supported by written materials and an audio CD. Main Outcomes and Measures: Outcomes were measured at in-person visits (at 3 and 12 months) and by mail or telephone (at 6 and 9 months). The primary outcome was the change in the ICIQ-SF score. Secondary outcome measures assessed UI severity, quality of life, perceptions of improvement, pelvic floor muscle strength, and costs. Evaluators were masked to group assignment. Results: Participants (232 in the GBT group and 231 in the control group) were aged 55 to 91 years (mean [SD] age, 64 [7] years), and 46.2% (214 of 463) were African American. In intent-to-treat analyses, the ICIQ-SF scores for GBT were consistently lower than control across all time points but did not achieve the projected 3-point difference. At 3 months, the difference in differences was 0.96 points (95% CI, -1.51 to -0.41 points), which was statistically significant but clinically modest. The mean (SE) treatment effects at 6, 9, and 12 months were 1.36 (0.32), 2.13 (0.33), and 1.77 (0.31), respectively. Significant group differences were found at all time points in favor of GBT on all secondary outcomes except pelvic floor muscle strength. The incremental cost to achieve a treatment success was $723 at 3 months; GBT dominated at 12 months. Conclusions and Relevance: The GLADIOLUS study shows that a novel one-time GBT program is modestly effective and cost-effective for reducing UI frequency, severity, and bother and improving quality of life. Group-administered behavioral treatment is a promising first-line approach to enhancing access to noninvasive behavioral treatment for older women with UI. Trial Registration: ClinicalTrials.gov identifier: NCT02001714.


Assuntos
Terapia Comportamental/métodos , Terapia por Exercício , Psicoterapia de Grupo/métodos , Incontinência Urinária/terapia , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Pessoa de Meia-Idade , Inquéritos e Questionários , Resultado do Tratamento , Incontinência Urinária/psicologia
16.
N Engl J Med ; 349(25): 2387-98, 2003 Dec 18.
Artigo em Inglês | MEDLINE | ID: mdl-14681504

RESUMO

BACKGROUND: Benign prostatic hyperplasia is commonly treated with alpha-adrenergic-receptor antagonists (alpha-blockers) or 5alpha-reductase inhibitors. The long-term effect of these drugs, singly or combined, on the risk of clinical progression is unknown. METHODS: We conducted a long-term, double-blind trial (mean follow-up, 4.5 years) involving 3047 men to compare the effects of placebo, doxazosin, finasteride, and combination therapy on measures of the clinical progression of benign prostatic hyperplasia. RESULTS: The risk of overall clinical progression--defined as an increase above base line of at least 4 points in the American Urological Association symptom score, acute urinary retention, urinary incontinence, renal insufficiency, or recurrent urinary tract infection--was significantly reduced by doxazosin (39 percent risk reduction, P<0.001) and finasteride (34 percent risk reduction, P=0.002), as compared with placebo. The reduction in risk associated with combination therapy (66 percent for the comparison with placebo, P<0.001) was significantly greater than that associated with doxazosin (P<0.001) or finasteride (P<0.001) alone. The risks of acute urinary retention and the need for invasive therapy were significantly reduced by combination therapy (P<0.001) and finasteride (P<0.001) but not by doxazosin. Doxazosin (P<0.001), finasteride (P=0.001), and combination therapy (P<0.001) each resulted in significant improvement in symptom scores, with combination therapy being superior to both doxazosin (P=0.006) and finasteride (P<0.001) alone. CONCLUSIONS: Long-term combination therapy with doxazosin and finasteride was safe and reduced the risk of overall clinical progression of benign prostatic hyperplasia significantly more than did treatment with either drug alone. Combination therapy and finasteride alone reduced the long-term risk of acute urinary retention and the need for invasive therapy.


Assuntos
Inibidores de 5-alfa Redutase , Antagonistas Adrenérgicos alfa/uso terapêutico , Doxazossina/uso terapêutico , Inibidores Enzimáticos/uso terapêutico , Finasterida/uso terapêutico , Hiperplasia Prostática/tratamento farmacológico , Antagonistas Adrenérgicos alfa/efeitos adversos , Análise de Variância , Progressão da Doença , Método Duplo-Cego , Doxazossina/efeitos adversos , Quimioterapia Combinada , Inibidores Enzimáticos/efeitos adversos , Finasterida/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Hiperplasia Prostática/classificação , Hiperplasia Prostática/cirurgia , Índice de Gravidade de Doença
17.
Health Educ Behav ; 34(6): 942-52, 2007 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-17456856

RESUMO

Past research suggests a positive correlation between self-efficacy (SE) and adherence to behavioral interventions. Less is known about SE and adherence in behavioral programs that are preventive in nature and specific to urinary incontinence (UI). Using treatment-group data from a previously reported randomized controlled trial, the authors assess the role of SE in predicting adherence to pelvic-floor muscle training (PFMT) for UI prevention in a sample of postmenopausal women. Results indicate that at 12 months follow-up, nearly 70% of participants reported medium or high adherence, performing the recommended PFMT regimen 2 to 3 times per week or more. Summary scores of both Task SE, beta = .25, SE (beta) = .08, p < .01, and Regulatory SE, beta = .43, SE (beta) = .06, p < .0001, predict adherence. Also, the authors found a modest decline in self-efficacy scores over time. These findings highlight the importance of SE in sustained behavioral change.


Assuntos
Terapia por Exercício/estatística & dados numéricos , Contração Muscular/fisiologia , Cooperação do Paciente/psicologia , Diafragma da Pelve/fisiologia , Autoeficácia , Incontinência Urinária/prevenção & controle , Idoso , Idoso de 80 Anos ou mais , Feminino , Previsões , Comportamentos Relacionados com a Saúde , Humanos , Pessoa de Meia-Idade , Análise de Regressão
18.
West J Nurs Res ; 29(1): 36-56; discussion 57-64, 2007 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-17228060

RESUMO

This exploratory study assesses factors predicting adherence to a behavioral intervention to prevent urinary incontinence. Community-dwelling, post-menopausal women (N = 164) were taught pelvic floor muscle training (PFMT) and bladder training (BT) and followed with surveys for 1 year. Content analysis of open-ended responses coded descriptions of approaches participants used to incorporate PFMT into daily life. Exploratory bivariate and logistic regression analyses determined predictors of approach used and adherence. Results indicate women incorporated PFMT into their lives using either a routine or ad hoc approach. Those using a routine approach at 3 months were 12 times more likely to adhere (odds ratio [OR] = 12.4, confidence interval [CI] = 4.0-38.8, p < .001) at a high level at 3 months and significantly more likely to maintain that level 12 months post-intervention (OR = 2.7, CI = 1.2-6.0, p < .014). Practicing BT was related to high adherence.


Assuntos
Terapia Comportamental , Terapia por Exercício , Cooperação do Paciente/psicologia , Incontinência Urinária/prevenção & controle , Incontinência Urinária/psicologia , Idoso , Idoso de 80 Anos ou mais , Terapia Comportamental/métodos , Distribuição de Qui-Quadrado , Intervalos de Confiança , Terapia por Exercício/métodos , Feminino , Seguimentos , Humanos , Modelos Logísticos , Pessoa de Meia-Idade , Análise Multivariada , Pesquisa Metodológica em Enfermagem , Razão de Chances , Educação de Pacientes como Assunto/métodos , Diafragma da Pelve , Prevalência , Pesquisa Qualitativa , Ensaios Clínicos Controlados Aleatórios como Assunto , Inquéritos e Questionários , Treinamento no Uso de Banheiro , Incontinência Urinária/diagnóstico
19.
Int Urol Nephrol ; 39(1): 129-36, 2007.
Artigo em Inglês | MEDLINE | ID: mdl-17086446

RESUMO

PURPOSE: Epidemiological studies on urinary incontinence (UI) in adult men of all ages are scarce. We aim to describe the UI phenomenon among community dwelling adult males in the United States (US). MATERIALS AND METHODS: We analyzed data from male respondents to a 14-item mailed UI symptoms questionnaire to the National Family Opinion (NFO) World Group Panel of 45,000 households matching the US 2000 census population on five key demographic elements. RESULTS: A total of 29,903 households responded, of which 21,590 were male heads of household (mean age 50 +/-15.2 years old). A total of 2,059 men (12.7%) reported symptoms of UI during the last 30 days. Symptoms of urge urinary incontinence (UUI), stress urinary incontinence (SUI), mixed urinary incontinence (MUI) symptoms, and other types of urinary incontinence (OUI) symptoms, were reported by 44.6%, 24.5%, 18.8%, and 12.3%, respectively. Among those with UI symptoms, the proportion of UUI and MUI symptoms increases with age while SUI symptoms decrease as age increases. Of those with UI symptoms, 44% consulted a physician of whom 57% did so within 6 months of the onset of symptoms. Treatments reported included absorbent pads (48%), prescription medication (30%), surgical procedure (18%), and intermittent catheterization (4%). CONCLUSIONS: Almost 1 in 10 males reported symptoms of UI. The UI prevalence rate increases with age and UUI symptoms is the most prevalent type reported. Less than half of men with UI symptoms sought professional help and half of them did so within 6 months of onset of UI symptoms.


Assuntos
Características de Residência/estatística & dados numéricos , Incontinência Urinária/epidemiologia , Adolescente , Adulto , Distribuição por Idade , Idoso , Estudos Transversais , Coleta de Dados , Demografia , Estudos Epidemiológicos , Humanos , Masculino , Pessoa de Meia-Idade , Prevalência , Inquéritos e Questionários , Estados Unidos/epidemiologia
20.
Int Urol Nephrol ; 39(2): 489-95, 2007.
Artigo em Inglês | MEDLINE | ID: mdl-17431811

RESUMO

PURPOSE: Reported estimates of IC prevalence vary widely. The objective of this study is to determine the prevalence of IC among community-dwelling adult women. METHODS: We analyzed survey responses from 215 established IC cases and 823 age-matched community-dwelling controls. Using a history of diagnosis of urinary conditions and presence of pelvic pain within the last six months, we identified those with possible IC among the controls using various operative definitions. RESULTS: The prevalence rates of self-reported IC (SRIC) and IC-like symptoms (ICLS) among controls in the community were 3.7% and 4.4%, respectively. Expanding ICLS by including women who reported pelvic pain only raised the prevalence to 17.3%. CONCLUSIONS: According to our prevalence rates and population estimates in the United States census 2000, the number of adult women who possibly have interstitial cystitis is estimated to be between 422,803 and 21,454,813. Although estimates based on the question of having ever been diagnosed with IC lead to an estimate close to that derived from symptoms, underestimation of IC prevalence might occur in the absence of additional questions and testing to validate and qualify the responses further. There is also a need for clinical studies to verify and validate the diagnoses to enable accurate assessment of the sensitivity and specificity of such history survey questions.


Assuntos
Cistite Intersticial/diagnóstico , Cistite Intersticial/epidemiologia , Estudos de Casos e Controles , Estudos Transversais , Feminino , Humanos , Pessoa de Meia-Idade , Prevalência
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