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1.
Int Urogynecol J ; 35(4): 803-810, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38252280

RESUMO

INTRODUCTION AND HYPOTHESIS: There are sparse data regarding the long-term efficacy of pelvic floor muscle training (PFMT) for the treatment of urinary incontinence (UI). The objective of this study was to evaluate the impact of an 8-week PFMT program guided by a motion-based intravaginal device versus a standard home program over 24 months. METHODS: Between October 2020 and March 2021, a total of 363 women with stress or stress-predominant mixed UI were randomized and completed an 8-week PFMT program using a motion-based intravaginal device (intervention group) or a home program following written/video instructions (control group). Participants were not asked to continue training after the 8-week program. At 18 and 24 months' follow-up, the Urogenital Distress Inventory, short-form (UDI-6) and Patient Global Impression of Improvement (PGI-I) were collected. In the original trial, a total of 139 participants in each arm were needed to detect a 0.3 effect size (alpha = 0.05, power 0.8, one-tailed t test) in the difference in UDI-6 scores. RESULTS: A total of 231 participants returned 24-month data. Mean age at 24 months was 51.7 ± 14.5 years, and mean BMI was 31.8 ± 7.4 kg/m2. Mean change in UDI-6 scores from baseline to 24 months was greater in the intervention group than the control group (-21.1 ± 24.5 vs -14.8 ± 19.4, p = 0.04). Reported improvement using PGI-I was greater in the intervention group than in the control group at 24 months (35% vs 22%, p = 0.03, OR 1.95(95% CI 1.08, 3.57). CONCLUSIONS: Pelvic floor muscle training guided by a motion-based prescription intravaginal device yielded durable and significantly greater UI symptom improvement than a standard home program, even in the absence of continued therapy.


Assuntos
Terapia por Exercício , Diafragma da Pelve , Incontinência Urinária , Adulto , Idoso , Feminino , Humanos , Pessoa de Meia-Idade , Terapia por Exercício/métodos , Terapia por Exercício/instrumentação , Estudos Longitudinais , Diafragma da Pelve/fisiopatologia , Fatores de Tempo , Resultado do Tratamento , Incontinência Urinária/terapia , Incontinência Urinária por Estresse/terapia , Seguimentos
2.
Curr Opin Obstet Gynecol ; 34(6): 391-395, 2022 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-36036463

RESUMO

PURPOSE OF REVIEW: To summarize some of the most recent evidence on disparities in the prevalence, treatment and outcomes of pelvic floor disorders (PFDs), and to address potential interventions to dismantle these inequities. RECENT FINDINGS: There is a paucity of data on the prevalence and treatment of PFDs in racial minority women. The existing studies are limited and poor quality. These studies suggest that racial and ethnic minorities may be at a higher risk of PFDs, however the epidemiologic data regarding prevalence varies by disorder and at times are conflicting. Nevertheless, the data on treatment and complications is clear. Racial and ethnic minorities are less likely to receive gold-standard treatment and are more likely to experience treatment related complications. SUMMARY: We discuss the lack of racially inclusive research that perpetuates ongoing health inequities.


Assuntos
Desigualdades de Saúde , Distúrbios do Assoalho Pélvico , Feminino , Humanos , Distúrbios do Assoalho Pélvico/epidemiologia , Distúrbios do Assoalho Pélvico/terapia , Prevalência
3.
Int Urogynecol J ; 32(10): 2757-2764, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32789810

RESUMO

OBJECTIVES: Interstitial cystitis/bladder pain syndrome (IC/BPS) is a chronic pain condition that requires multimodal management. The American Urologic Association includes sacral neuromodulation in the treatment algorithm for refractory IC/BPS. We sought to determine the rate of overall symptom improvement of IC/BPS symptoms, using validated measures, after treatment with percutaneous tibial nerve stimulation (PTNS), a form of peripheral neuromodulation. METHODS: This was a single-arm, dual-center, pilot study examining a standard PTNS protocol in subjects with IC/BPS. Our primary outcome was subject response of "moderately" or "markedly improved" on the Global Response Assessment (GRA) scale after 12-weekly PTNS sessions. Assuming a 60% response rate, 24 subjects were needed to detect a response rate between 40 and 80% with 95% confidence. Secondary objectives included change in urinary frequency on a 24-h bladder diary, bladder pain as measured by VAS and responses to validated questionnaires for pelvic pain and IC/BPS. RESULTS: Of 21 subjects enrolled, 16 initiated and 10 completed the PTNS treatment course. The GRA response rate was 40% at week 6 and 30% at week 12. Seventy percent of the cohort had some degree of improvement. There were no adverse events. CONCLUSIONS: While only a minority of subjects with IC/BPS were responders to PTNS per GRA criteria, 70% of the cohort had some degree of improvement. Due to low recruitment and loss to follow-up, we did not achieve our predetermined significance. However, our promising findings add to the limited literature on this subject.


Assuntos
Cistite Intersticial , Cistite Intersticial/terapia , Humanos , Medição da Dor , Dor Pélvica/terapia , Projetos Piloto , Nervo Tibial
4.
J Minim Invasive Gynecol ; 28(4): 881-890, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-32810604

RESUMO

STUDY OBJECTIVE: The primary objective was to describe practice patterns of benign hysterectomy within a large community health maintenance organization (HMO) and evaluate clinical and surgeon characteristics associated with the performance of vaginal hysterectomy (VH). Secondary objectives were to retrospectively apply a VH algorithm to determine how our practice patterns conform, and compare rates of perioperative complications among patients who did and did not meet the algorithm. Patient and surgeon characteristics, and perioperative complications, were compared between patients who underwent VH and did or did not meet the VH algorithm. DESIGN: Retrospective cohort study. SETTING: Large community HMO. PATIENTS: Women undergoing benign hysterectomy. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Route of hysterectomy, patient and surgeon characteristics, perioperative complications. One hundred and thirty-one of 984 (13.3%) benign hysterectomies from January 1, 2013 to June 30, 2015 were vaginal. Patients who were vaginally parous, Hispanic, had normal preoperative uterine size and documentation of uterine descent were more likely to have VH (all p <.05). High-volume surgeons performed 18.8% of their hysterectomies vaginally, as compared to low-volume surgeons who performed 11.4% of their hysterectomies vaginally (p <.01). VH were more likely to be performed by surgeons with longer practice durations than non-vaginal hysterectomies (16.3 vs 12.2 years, p <.01). Seventy-five percent of patients who met the VH algorithm underwent non-vaginal hysterectomy and they had longer operative durations and higher rates of postoperative complications compared to patients who underwent VH. Conversely, patients who underwent VH despite not meeting the VH algorithm did not have significantly different rates of perioperative complications or blood loss than patients who met the VH algorithm. CONCLUSION: Seventy-five percent of patients deemed appropriate for VH by our algorithm underwent non-vaginal hysterectomy and had more postoperative complications and longer operative durations. Our data suggest that surgeon characteristics, including surgical volume and duration of practice, may explain some of this performance gap. These findings contribute additional insight into current practice patterns and describe clinical factors that should be included in VH algorithms.


Assuntos
Histerectomia Vaginal , Laparoscopia , Algoritmos , Feminino , Humanos , Histerectomia/efeitos adversos , Histerectomia Vaginal/efeitos adversos , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Estudos Retrospectivos , Útero
5.
Am J Obstet Gynecol ; 216(6): 588.e1-588.e5, 2017 06.
Artigo em Inglês | MEDLINE | ID: mdl-28189609

RESUMO

BACKGROUND: Recent healthcare reform has led to increased emphasis on standardized provision of quality care. Use of government- and organization-approved quality measures is 1 way to document quality care. Quality measures, to improve care and aid in reimbursement, are being proposed and vetted in many areas of medicine. OBJECTIVES: We aimed to assess performance of proposed quality measures that pertain to hysterectomy for pelvic organ prolapse stratified by surgical training. The 4 quality measures that we assessed were (1) the documentation of offering conservative treatment of pelvic organ prolapse, (2) the quantitative assessment of pelvic organ prolapse (Pelvic Organ Prolapse-Quantification or Baden-Walker), (3) the performance of an apical support procedure, and (4) the performance of cystoscopy at time of hysterectomy. STUDY DESIGN: Patients who underwent hysterectomy for pelvic organ prolapse from January 1 to December 31, 2008, within a large healthcare maintenance organization were identified by diagnostic and procedural codes within the electronic medical record. Medical records were reviewed extensively for demographic and clinical data that included the performance of the 4 proposed quality measures and the training background of the primary surgeon (gynecologic generalist, fellowship-trained surgeon in Female Pelvic Medicine and Reconstructive Surgery, and "grandfathered" Female Pelvic Medicine and Reconstructive Surgery). Data were analyzed with the use of descriptive statistics. Inferential statistics with chi-squared tests were used to compare performance rates of quality measures that were stratified by surgical training. Probability values <.05 were considered statistically significant. RESULTS: Six hundred thirty patients who underwent hysterectomy for pelvic organ prolapse in 2008 had complete records available for analysis. Fellowship-trained surgeons performed 302 hysterectomies for pelvic organ prolapse; grandfathered Female Pelvic Medicine and Reconstructive Surgery surgeons performed 98 hysterectomies, and gynecologic generalist surgeons performed 230 hysterectomies. Fellowship-trained surgeons had the highest performance rates for individual quality measures (91.4-98.7%) and cumulative performance of all measures (80.8% of cases). Grandfathered Female Pelvic Medicine and Reconstructive Surgery surgeons performed significantly fewer measures (80.6-95.9% performance rate for individual measures; 65.3% cumulatively for all measures) than fellowship-trained surgeons and more than gynecologic generalists (64.3-70% for individual measures; 29.1% cumulatively for all measures). There was an association between surgeon training background and number of hysterectomies performed for pelvic organ prolapse, with specialist surgeons performing more hysterectomies. When quality measure performance was stratified by surgeon volume, similar significant associations were found, with high-volume surgeons performing more quality measures than low-volume surgeons. CONCLUSION: Within a large healthcare maintenance organization, fellowship-trained Female Pelvic Medicine and Reconstructive Surgery surgeons were more likely to perform proposed quality measures in women who underwent hysterectomy for pelvic organ prolapse compared with those surgeons without such training. Grandfathered Female Pelvic Medicine and Reconstructive Surgery surgeons performed measures more frequently than gynecologic generalists but less than fellowship-trained surgeons. Further study is indicated to correlate the proposed quality measures with clinical outcomes.


Assuntos
Procedimentos Cirúrgicos em Ginecologia/educação , Histerectomia/normas , Competência Clínica , Cistoscopia , Bolsas de Estudo , Feminino , Sistemas Pré-Pagos de Saúde , Humanos , Histerectomia/métodos , Prolapso de Órgão Pélvico/cirurgia , Qualidade da Assistência à Saúde , Procedimentos de Cirurgia Plástica/educação , Resultado do Tratamento
6.
Artigo em Inglês | MEDLINE | ID: mdl-38710019

RESUMO

IMPORTANCE: The importance of this study was to examine treatment patterns and surgical complications for stress urinary incontinence (SUI). OBJECTIVES: The aim of this study was to describe the treatment of SUI and associated complications in a racially and ethnically diverse population. STUDY DESIGN: This was a retrospective cohort study of patients with a new diagnosis of SUI. We identified patients who received treatment with a pessary, pelvic floor physical therapy, or surgery. Surgical complications were abstracted. Logistic regression was used to examine the association between race/ethnicity and treatment, as well as surgical complications. RESULTS: A total of 67,187 patients with a new diagnosis of SUI were included. The population was predominately Hispanic (47.5%) followed by White, Asian, Black, Native Hawaiian/Pacific Islander, and American Indian/Alaska Native. Comparing no treatment to any treatment, all racial/ethnic groups, except American Indian/Alaska Native, had decreased odds of receiving treatment compared with White women. Hispanic and Native Hawaiian/Pacific Islander women had increased odds of referral for pelvic floor physical therapy compared with White women. All racial/ethnic groups, except for American Indian/Alaska Native women, had decreased odds of receiving a sling procedure compared with White women. When these racial/ethnic minority groups did receive treatment, it was more likely to be conservative treatment compared with White women. There were no significant differences in individual surgical complications. CONCLUSIONS: Racial minority women were 20-50% less likely to undergo a sling procedure, commonly posited as the gold standard surgical treatment. Racial minority women were 40-100% more likely to receive conservative management and 20-50% less likely to receive any treatment compared with White women.

7.
Urogynecology (Phila) ; 30(1): 59-64, 2024 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-37326287

RESUMO

IMPORTANCE: The low incidence of de novo overactive bladder (OAB) symptoms after a midurethral sling (MUS) procedure better informs preoperative counseling. OBJECTIVE: The study aimed to measure the incidence and risk factors for de novo OAB after MUS. STUDY DESIGN: This was a retrospective cohort study of de novo OAB symptoms in patients who underwent MUS surgery in a health maintenance organization between January 1, 2008, and September 30, 2016. Patients were identified using Current Procedural Terminology codes for MUS and International Classification of Diseases, Tenth Revision codes for urinary urgency, frequency, nocturia, OAB, and urgency urinary incontinence (UUI). The cohort of patients was identified by the absence of these International Classification of Diseases, Tenth Revision codes 12 months preoperatively and the presence of these codes within 6 months after surgery. This cohort was used to calculate the rate of de novo OAB after MUS surgery. Clinical and demographic factors were abstracted. Statistical analysis was performed using descriptive, χ2 , simple logistic, and multiple logistic regression. RESULTS: During the study period, 13,893 patients underwent MUS surgery and 6,634 met the inclusion criteria. The mean age was 56.9 years, mean parity was 2.76, and mean body mass index was 28.9 (calculated as weight in kilograms divided by height in meters squared). Of these, 410 (6.1%) developed de novo OAB within 12 months. The most common symptoms were urgency (65.4%), UUI (42.2%), and frequency (19.8%). On multivariable regression modeling, de novo urgency and UUI were not associated with concurrent surgery ( P < 0.05). Increasing age and body mass index were associated with an increased risk of nocturia ( P < 0.05). CONCLUSIONS: The incidence of de novo OAB after MUS surgery was 6.1%. This aligns with current literature and critically informs preoperative counseling for MUS surgery.


Assuntos
Noctúria , Slings Suburetrais , Bexiga Urinária Hiperativa , Incontinência Urinária por Estresse , Incontinência Urinária , Humanos , Pessoa de Meia-Idade , Bexiga Urinária Hiperativa/epidemiologia , Estudos Retrospectivos , Slings Suburetrais/efeitos adversos , Noctúria/complicações , Incontinência Urinária por Estresse/complicações , Incontinência Urinária/complicações , Fatores de Risco
8.
Obstet Gynecol ; 141(1): 199-206, 2023 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-36701620

RESUMO

OBJECTIVE: To evaluate the long-term efficacy of an 8-week regimen of pelvic floor muscle training guided by a motion-based digital therapeutic device compared with a standard home program in the treatment of stress urinary incontinence (SUI) and stress-predominant mixed urinary incontinence (MUI). METHODS: The primary virtual trial was conducted from October 2020 to March 2021; 363 women with SUI or stress-predominant MUI were randomized to complete pelvic floor muscle training using the device (intervention group) or a standard home pelvic floor muscle training program (control group) for 8 weeks. Primary outcomes included change in UDI-6 (Urogenital Distress Inventory, Short Form) score and SUI episodes on a 3-day bladder diary. The PGI-I (Patient Global Impression of Improvement) was also assessed, with "much better" and "very much better" responses considered as improvement. In this planned secondary analysis, symptom and adherence data were collected in follow-up at 6 and 12 months. A modified intention-to-treat analysis was performed using Student's t tests and χ2 tests as appropriate. RESULTS: Of 299 participants analyzed at 8 weeks, 286 (95.7%) returned 6- and 12-month data (151 in the control group, 135 in the intervention group). Mean age was 51.9±12.8 years, and mean body mass index (BMI) was 31.8±7.4; 84.6% of participants were parous, and 54.9% were postmenopausal. Mean change in UDI-6 score from baseline to 6 and 12 months was significantly greater in the intervention group than in the control group (20.2±20.9 vs 14.8±19.5, P=.03 and 22.7±23.3 vs 15.9±20.3, P=.01, respectively). Participants in the intervention group had more than twice the odds of reporting improvement on the PGI-I compared with participants in the control group (OR 2.45, 95% CI 1.49-4.00). CONCLUSION: Pelvic floor muscle training guided by a motion-based digital therapeutic device yielded significantly greater urinary incontinence symptom improvement compared with a standard home pelvic floor muscle training program at 6 and 12 months, although continued improvement waned over time. This technology may facilitate pelvic floor muscle training access and adherence for women with SUI and stress-predominant MUI and represents an effective modality for scaling first-line care. FUNDING SOURCE: Renovia Inc. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT04508153.


Assuntos
Incontinência Urinária por Estresse , Incontinência Urinária , Feminino , Humanos , Adulto , Pessoa de Meia-Idade , Terapia por Exercício , Diafragma da Pelve , Incontinência Urinária/terapia , Incontinência Urinária por Estresse/terapia , Incontinência Urinária por Estresse/diagnóstico , Incontinência Urinária de Urgência/terapia , Resultado do Tratamento , Qualidade de Vida
9.
Urogynecology (Phila) ; 29(2): 133-138, 2023 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-36735425

RESUMO

IMPORTANCE: There is limited current literature regarding the retreatment of stress urinary incontinence (SUI) after midurethral sling (MUS) placement with prior urethral bulking. OBJECTIVE: The objective was to evaluate the retreatment and perioperative complications of MUS placement with prior urethral bulking compared with MUS placement without prior urethral bulking. STUDY DESIGN: This was a retrospective cohort study of patients within the Southern California Permanente Medical Group who underwent MUS placement from January 2009 to December 2020. Patients who underwent prior urethral bulking were compared with a control group without prior urethral bulking in a 1:1 ratio matched by age and MUS procedure date. The primary outcome was the retreatment of SUI after MUS placement with prior urethral bulking. Secondary outcomes were perioperative complications. Regression models were used to evaluate associations between retreatment and perioperative complications while controlling for confounding variables. RESULTS: Eighty-five patients who underwent MUS placement with prior urethral bulking were identified and matched with 85 control patients who underwent MUS placement without prior urethral bulking. Patients who underwent MUS placement without prior urethral bulking were more likely to have concomitant surgery. Linear regression analysis controlling for the effect of concomitant surgery revealed no difference in estimated blood loss and operative time between the 2 groups. In logistic regression analysis, there was no difference in the retreatment rate and perioperative complications between groups. CONCLUSION: We found that the unique treatment combination of MUS placement with prior urethral bulking for recurrent SUI seems to have a similar retreatment rate and perioperative complications as MUS placement without prior urethral bulking.


Assuntos
Slings Suburetrais , Incontinência Urinária por Estresse , Humanos , Estudos Retrospectivos , Incontinência Urinária por Estresse/cirurgia , Slings Suburetrais/efeitos adversos , Retratamento , Uretra/cirurgia
10.
Urogynecology (Phila) ; 29(7): 617-624, 2023 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-36701286

RESUMO

IMPORTANCE: There is a lack of consensus regarding the clinical applicability of fluoroscopic defecography in evaluation of pelvic organ prolapse. OBJECTIVES: The aim was to evaluate the association between rectocele on defecography and posterior vaginal wall prolapse (PVWP) on physical examination. The secondary objective was to describe radiologic and clinical predictors of surgical intervention and outcomes. STUDY DESIGN: This was a retrospective review of patients enrolled in a large health maintenance organization who underwent defecography and were examined by a urogynecologist within 12 months. The electronic medical record was reviewed for demographic and clinical variables, including pelvic organ prolapse and defecatory symptoms, physical examination, and surgical intervention through 12 months after initial urogynecologic examination or 12 months after surgery if applicable. RESULTS: One hundred eighty-six patients met inclusion criteria. Of those, 168 (90.3%) had a rectocele on defecography and 31 (16.6%) had PVWP at or beyond the hymen. Rectocele size on defecography was poorly correlated with PVWP stage (spearman ρ = 0.18). Forty patients underwent surgical intervention. Symptoms of splinting, digitation, and stool trapping were associated with surgical intervention (odds ratio, 4.24; 95% confidence interval, 1.59-11.34; P < 0.01) as was advanced PVWP stage ( P < 0.01), while rectocele presence and size on defecography were not. Large rectocele size on defecography was correlated with persistent postoperative defecatory symptoms ( P = 0.02). CONCLUSIONS: We demonstrated a poor correlation between rectocele size on defecography and PVWP stage. Defecatory symptoms (splinting, digitation, stool trapping) and higher PVWP stage were associated with surgical intervention, while rectocele on defecography was not.


Assuntos
Prolapso de Órgão Pélvico , Radiologia , Prolapso Uterino , Feminino , Humanos , Retocele/diagnóstico por imagem , Prolapso Uterino/complicações , Prolapso de Órgão Pélvico/complicações , Exame Físico
11.
Urogynecology (Phila) ; 29(8): 660-669, 2023 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-37490706

RESUMO

OBJECTIVES: Surgery for the correction of stress urinary incontinence is an elective procedure that can have a dramatic and positive impact on quality of life. Anti-incontinence procedures, like inguinal hernia repairs or cholecystectomies, can be classified as high-volume/low-morbidity procedures. The performance of a standard set of perioperative tasks has been suggested as one way to optimize quality of care in elective high-volume/low-morbidity procedures. Our primary objective was to evaluate the performance of 5 perioperative tasks-(1) offering nonsurgical treatment, (2) performance of a standard preoperative prolapse examination, (3) cough stress test, (4) postvoid residual test, and (5) intraoperative cystoscopy for women undergoing surgery for stress urinary incontinence-compared among surgeons with and without board certification in female pelvic medicine and reconstructive surgery (FPMRS). STUDY DESIGN: This study was a retrospective chart review of anti-incontinence surgical procedures performed between 2011 and 2013 at 9 health systems. Cases were reviewed for surgical volume, adverse outcomes, and the performance of 5 perioperative tasks and compared between surgeons with and without FPMRS certification. RESULTS: Non-FPMRS surgeons performed fewer anti-incontinence procedures than FPMRS-certified surgeons. Female pelvic medicine and reconstructive surgery surgeons were more likely to perform all 5 perioperative tasks compared with non-FPMRS surgeons. After propensity matching, FPMRS surgeons had fewer patients readmitted within 30 days of surgery compared with non-FPMRS surgeons. CONCLUSIONS: Female pelvic medicine and reconstructive surgery surgeons performed higher volumes of anti-incontinence procedures, were more likely to document the performance of the 5 perioperative tasks, and were less likely to have their patients readmitted within 30 days.


Assuntos
Incontinência Urinária por Estresse , Humanos , Feminino , Avaliação de Resultados em Cuidados de Saúde , Incontinência Urinária por Estresse/cirurgia
12.
Obstet Gynecol ; 139(4): 606-615, 2022 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-35271539

RESUMO

OBJECTIVE: To evaluate whether pelvic floor muscle training using a motion-based digital intravaginal device is more effective than home pelvic floor muscle training for treatment of stress or stress-predominant mixed urinary incontinence (UI). METHODS: In a remote, virtually executed 8-week prospective randomized controlled superiority trial, women with stress or stress-predominant mixed UI were randomized to pelvic floor muscle training using a motion-based digital therapeutic device or a home training program using written and narrated instructions. Primary outcomes were change in UDI-6 (Urogenital Distress Inventory, Short Form) score and stress urinary incontinence (SUI) episodes on a 3-day bladder diary. A sample size of 139 per group (n=278) was planned to meet the power analysis requirements for the UDI-6 score (n=278) and the bladder diary (n=78). Prespecified secondary outcomes included quality-of-life surveys and adherence reporting. RESULTS: From September 2020 to March 2021, 5,353 participants were screened, and 363 were randomized: 182 in the intervention and 181 in the control group. There were no baseline clinicodemographic differences between groups. The mean change in UDI-6 score was significantly greater for the intervention group compared with the control group (18.8 vs 14.7, P=.01). The median (interquartile range) number of SUI episodes on the 3-day bladder diary was significantly reduced from 5 (3-8) and 5 (3-8) episodes to 1 (0-3) and 2 (1-4) (P=.005) in the intervention group compared with control group, respectively. A significantly greater number of participants in the intervention group than in the control group reported they were "much improved" or "very much improved" on the PGI-I (Patient Global Impression of Improvement) (63/143 [44.1% vs 45/156 [28.8%], odds ratio 1.94, 95% CI 1.21-3.15). There were no device-related severe adverse events. CONCLUSION: In this all-remote, virtually conducted trial, pelvic floor muscle training guided by a motion-based digital therapeutic device resulted in significantly improved UI symptoms and reduction of UI episodes compared with a home training program. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT04508153. FUNDING SOURCE: Renovia Inc.


Assuntos
Incontinência Urinária por Estresse , Incontinência Urinária , Terapia por Exercício/métodos , Feminino , Humanos , Diafragma da Pelve , Estudos Prospectivos , Qualidade de Vida , Resultado do Tratamento , Incontinência Urinária/terapia , Incontinência Urinária por Estresse/terapia , Incontinência Urinária de Urgência/terapia
13.
Female Pelvic Med Reconstr Surg ; 28(3): e73-e79, 2022 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-35272337

RESUMO

OBJECTIVE: The primary objective was to evaluate the use of a novel video for enhancing patient knowledge of midurethral sling compared with standard handout. METHODS: Participants scheduled for midurethral sling were randomized to 1 of 2 preoperative educational interventions, either video or standard handout. The primary outcome was change in knowledge measured via a 15-question questionnaire completed immediately before and after the intervention. Secondary outcomes were knowledge retention, urinary symptoms, decision satisfaction, and regret measured via validated questionnaires at 2 and 6 weeks postoperatively. Data are presented as median (interquartile range) and comparisons between intervention groups made using non-parametric statistics. A sample size of 16 per arm was calculated to detect a 20% effect size. RESULTS: Thirty-eight participants, 19 per site, were randomized from August 2019 to October 2020 and 37 (97%) completed the primary outcome per protocol. Median age was 51 years (18 years), and there were no significant demographic differences between groups. Participants randomized to video demonstrated greater change in knowledge than those randomized to handout (+8.5 (3) vs +2.0 (4), P < 0.0001). Those randomized to video demonstrated improved 6 week postoperative urinary symptoms (Urogenital Distress Inventory-6, 0.0 [8.3] vs 14.6 [26.0]; P = 0.02; Incontinence Severity Index, 0.0 [2] vs 3.0 [4]; P = 0.005). There were no differences in satisfaction with decision (5.0 [0] video vs 5.0 [0.9] handout; P = 0.48) or decision regret (1.0 [0.5] video vs 1.0 [0.8] handout; P = 0.80) at 6 weeks postoperatively. CONCLUSIONS: A preoperative educational video improved knowledge and urinary symptoms after midurethral sling compared with a standard handout.


Assuntos
Slings Suburetrais , Incontinência Urinária por Estresse , Incontinência Urinária , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Período Pós-Operatório , Inquéritos e Questionários , Incontinência Urinária por Estresse/cirurgia
14.
Urogynecology (Phila) ; 28(12): 800-810, 2022 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-36409637

RESUMO

IMPORTANCE: There is a lack of high-quality long-term follow-up regarding pessary treatment. Most studies are case series or retrospective with a small sample size and short-term follow-up. OBJECTIVES: This study aimed to evaluate differences in women who continue versus discontinue pessary use and the effectiveness, quality of life, and safety associated with pessary management at 1 year. STUDY DESIGN: This study analyzed a multicenter national registry following women for 3 years with vaginal prolapse treated with a pessary or surgery. The primary outcome of this analysis was to compare the difference in characteristics among those who continue versus discontinue pessary use at 12 months. RESULTS: Among 1,153 participants enrolled, 376 (32.6%) opted for a pessary, and 296 (78.7%) were successfully fitted. Data were available for 240 participants (81%). At 1 year, 62% (n = 148) were still using pessaries, and 38% (n = 92) had stopped with 25% opting for surgery. Most commonly reported de novo adverse effects were urinary leakage (16%), feeling or seeing a bulge (12%), and vaginal discharge (11%). There was no difference in baseline characteristics among women who continued versus discontinued pessary use. At 12 months, subjective symptoms were similar between groups, with similar change in symptoms from baseline on most validated instruments. Those who continued to use a pessary reported worse urinary symptoms due to de novo urinary leakage ( P = 0.01). CONCLUSIONS: At 1 year, most women successfully fitted with a pessary continued pessary use. Although there was a significant improvement in condition-specific quality of life and low rates of complications, approximately 40% of women discontinued pessary use by 12 months. We were unable to identify any baseline characteristics associated with pessary discontinuation.


Assuntos
Distúrbios do Assoalho Pélvico , Prolapso de Órgão Pélvico , Feminino , Humanos , Pessários/efeitos adversos , Distúrbios do Assoalho Pélvico/complicações , Qualidade de Vida , Estudos Retrospectivos , Prolapso de Órgão Pélvico/epidemiologia , Sistema de Registros
15.
JAMA Surg ; 156(5): e210265, 2021 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-33760000

RESUMO

Importance: Workplace mistreatment can manifest as microaggressions that cause chronic, severe distress. As physician burnout becomes a global crisis, quantitative research to delineate the impact of microaggressions is imperative. Objectives: To examine the prevalence and nature of sexist and racial/ethnic microaggressions against female and racial/ethnic-minority surgeons and anesthesiologists and assess the association with physician burnout. Design, Setting, and Participants: This cross-sectional survey evaluated microaggressions and physician burnout within a diverse cohort of surgeons and anesthesiologists in a large health maintenance organization. A total of 1643 eligible participants were sent a recruitment email on January 8, 2020, 1609 received the email, and 652 replied, for a response rate of 41%. The study survey remained open until February 20, 2020. A total of 588 individuals (37%) were included in the study after exclusion criteria were applied. Exposures: The Maslach Burnout Inventory, the Racial Microaggression Scale, and the Sexist Microaggression Experience and Stress Scale. Main Outcomes and Measures: The primary outcomes were prevalence and nature of sexist and racial/ethnic microaggressions against female and racial/ethnic-minority surgeons and anesthesiologists using the Sexist Microaggression Experience and Stress Scale and Racial Microaggression Scale. Secondary outcomes were frequency and severity of microaggressions, prevalence of physician burnout, and associations between microaggressions and physician burnout. Results: Data obtained from 588 respondents (249 [44%] female, 367 [62%] racial/ethnic minority, 224 [38.1%] 40-49 years of age) were analyzed. A total of 245 of 259 female respondents (94%) experienced sexist microaggressions, most commonly overhearing or seeing degrading female terms or images. Racial/ethnic microaggressions were experienced by 299 of 367 racial/ethnic-minority physicians (81%), most commonly reporting few leaders or coworkers of the same race/ethnicity. Criminality was rare (18 of 367 [5%]) but unique to and significantly higher for Hispanic and Black physicians. Individuals who identified as underrepresented minorities were more likely to experience environmental inequities (odds ratio [OR], 4.21; 95% CI, 1.6-10.75; P = .002) and criminality (OR, 14.93; 95% CI, 4.5-48.5; P < .001). The prevalence of physician burnout was 47% (280 of 588 physicians) and higher among female physicians (OR, 1.60; 95% CI, 1.03-2.47; P = .04) and racial/ethnic-minority physicians (OR, 2.08; 95% CI, 1.31-3.30; P = .002). Female physicians who experienced sexist microaggressions (racial/ethnic-minority female physicians: OR, 1.84; 95% CI, 1.04-3.25; P = .04; White female physicians: OR, 1.99; 95% CI, 1.07-3.69; P = .03) were more likely to experience burnout. Racial/ethnic-minority female physicians (OR, 1.86; 95% CI, 1.03-3.35; P = .04) who experienced racial microaggressions were more likely to report burnout. Racial/ethnic-minority female physicians who had the compound experience of sexist and racial/ethnic microaggressions (OR, 2.05; 95% CI, 1.14-3.69; P = .02) were more likely to experience burnout. Conclusions and Relevance: The prevalence of sexist and racial/ethnic microaggressions against female and racial/ethnic-minority surgeons and anesthesiologists was high and associated with physician burnout. This study provides a valuable response to the increasing call for evidence-based data on surgical workplace mistreatment.


Assuntos
Anestesiologistas/estatística & dados numéricos , Esgotamento Profissional/epidemiologia , Microagressão , Racismo/estatística & dados numéricos , Sexismo/estatística & dados numéricos , Cirurgiões/estatística & dados numéricos , Adulto , Negro ou Afro-Americano/estatística & dados numéricos , Estudos Transversais , Etnicidade/estatística & dados numéricos , Feminino , Hispânico ou Latino/estatística & dados numéricos , Humanos , Incivilidade , Masculino , Pessoa de Meia-Idade , Grupos Minoritários/estatística & dados numéricos , Havaiano Nativo ou Outro Ilhéu do Pacífico/estatística & dados numéricos , Médicas/psicologia , Médicas/estatística & dados numéricos , Prevalência , Fatores Raciais , Fatores Sexuais , População Branca/psicologia , População Branca/estatística & dados numéricos , Adulto Jovem
16.
Female Pelvic Med Reconstr Surg ; 27(11): e677-e680, 2021 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-34705799

RESUMO

OBJECTIVES: Bowel obstruction after sacrocolpopexy (SC) can cause significant morbidity. The aim of this study was to delineate clinical and surgical factors associated with bowel obstruction after SC and to describe its presentation, management, and sequelae. METHODS: We performed a retrospective case series of patients who underwent open, laparoscopic, or robotic SC within a large health maintenance organization and a single academic medical center between January 1, 2009, and December 31, 2019. RESULTS: Of 3,231 patients who underwent SC, 32 (1.0%) experienced a bowel obstruction. Sacrocolpopexy was performed laparoscopically or robotically in 19 (59.4%) and abdominally in 13 (40.6%). The mean time to bowel obstruction was 1.9 years (SD, 2.5; range, 3 days to 8.8 years). In patients who experienced bowel obstruction, medical management was undertaken in 19 (61.3%) cases. Eight of the 13 (61.5%) surgically managed cases underwent bowel resection, and 3 cases (23.1%) reported partial mesh excision. Recurrent obstruction was seen in 2 (10.5%) of the medically managed and 2 (15.4%) of the surgically managed cases. CONCLUSIONS: Bowel obstruction is a rare complication of SC and our rate of at least 1.0% corroborates those in the literature. Obstruction occurs from days to years after SC. Nonsurgical management was effective in most cases, with low rates of recurrent obstruction. In surgically managed cases, the majority included bowel resection or mesh excision; however, mesh excision was not associated with a subsequent identifiable procedural intervention for recurrent prolapse. These data inform patient counseling and surgical planning before SC and aid in diagnosis and management of bowel obstruction after SC.


Assuntos
Laparoscopia , Robótica , Humanos , Laparoscopia/efeitos adversos , Estudos Retrospectivos , Telas Cirúrgicas/efeitos adversos , Resultado do Tratamento
17.
Female Pelvic Med Reconstr Surg ; 27(3): 151-158, 2021 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-33620897

RESUMO

OBJECTIVES: This study aims to determine the effect of opioid-specific counseling on postdischarge opioid consumption and opioid storage/disposal patterns after reconstructive pelvic surgery. METHODS: In this multicenter randomized-controlled trial, participants were randomized to standard generalized counseling or opioid-specific perioperative counseling. Opioid-specific counseling was provided at the preoperative and 2-week postoperative visits with educational handouts about the risks of opioids and U.S. Food and Drug Administration recommendations for appropriate opioid storage and disposal. The primary outcome was morphine milligram equivalent (MME) consumption between hospital discharge and 2 weeks postoperatively. Secondary outcomes included opioid storage 2 weeks postoperatively, opioid disposal 6 weeks postoperatively, and rate of opioid refills. RESULTS: Among 70 opioid-specific and 65 standard counseling participants, there were no significant differences in demographic characteristics, type of surgery, concomitant hysterectomy, or perioperative complications. For the primary outcome, there was no significant difference in median opioid consumption between the 2 arms. Median (interquartile range) postdischarge MME consumption for all participants was 15 mg (0-75). Forty percent of participants denied postdischarge MME consumption. For secondary outcomes, there were no significant differences in appropriate opioid storage between groups. The appropriate disposal rate of unused opioid tablets 6 weeks after surgery was higher among participants who received opioid-specific counseling. The rate of opioid refill was 7.4%. CONCLUSIONS: Opioid-specific counseling did not affect postdischarge consumption but increased the disposal rate of unused opioid tablets 6 weeks postoperatively. Opioid-specific counseling could minimize the potential for opioid misuse by reducing the number of unused opioid tablets in patients' possession after surgery.


Assuntos
Analgésicos Opioides/uso terapêutico , Aconselhamento/métodos , Educação de Pacientes como Assunto , Idoso , Armazenamento de Medicamentos/normas , Feminino , Humanos , Pessoa de Meia-Idade , Período Pós-Operatório , Procedimentos de Cirurgia Plástica/efeitos adversos , Transtornos Relacionados ao Uso de Substâncias/prevenção & controle
18.
Obstet Gynecol ; 140(1): 136-137, 2022 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-35849472
19.
Female Pelvic Med Reconstr Surg ; 22(5): 307-10, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27054790

RESUMO

OBJECTIVES: The aim of this study was to review the complete medical course, including safety, efficacy, and medical decision making, of patients who delivered a pregnancy after the placement of midurethral sling (MUS) within a large health maintenance organization. METHODS: We conducted a retrospective case series of patients within the Northern and Southern California Permanente Medical Group who were identified based on procedural codes for placement of MUS for stress urinary incontinence. Electronic medical records with MUS code were referenced against records of live births within the health care system. Demographic and clinical data were abstracted through extensive, standardized physician review of the electronic medical records of all identified patients. RESULTS: Twenty-six patients were identified and included in analysis. Sixteen patients had a retropubic MUS, and 10 had a transobturator MUS. Twenty-one of 26 patients reported subjective resolution of urinary incontinence after MUS. Fourteen of the 25 first deliveries after MUS were cesarean section (CS). Of these, 5 CS were elective primary for the indication of previous MUS, 5 were elective repeat CS, and the remaining 4 were for fetal indications. Eleven patients had spontaneous vaginal deliveries. There were no MUS-related pregnancy complications. One patient developed recurrent stress urinary incontinence postpartum, for which she underwent repeat MUS within a year resulting in cure of incontinence. CONCLUSIONS: This case series corroborates previous series demonstrating the safety and durability of MUS after subsequent pregnancy.


Assuntos
Parto Obstétrico/estatística & dados numéricos , Slings Suburetrais/efeitos adversos , Incontinência Urinária por Estresse/cirurgia , Adulto , Bases de Dados Factuais , Feminino , Humanos , Pessoa de Meia-Idade , Gravidez , Complicações na Gravidez , Resultado da Gravidez , Estudos Retrospectivos , Risco
20.
Artigo em Inglês | MEDLINE | ID: mdl-26516806

RESUMO

OBJECTIVE: The aim of the study was to determine whether surgeon case volume is associated with preoperative evaluation of pelvic organ prolapse before a hysterectomy for uterovaginal prolapse including a complete objective evaluation of prolapse (Baden-Walker or Pelvic Organ Prolapse Quantification), an offer of nonsurgical options for therapy (pessary), and a preoperative assessment of urinary incontinence METHODS: We performed a multicenter retrospective review of hysterectomies done for uterovaginal prolapse at 4 hospital systems between January 1, 2008 and December 31, 2011. The number of hysterectomies per surgeon for 4 years was evaluated to establish low-volume (≤10 cases), intermediate-volume (11-49 cases), and high-volume (≥50 cases) groups. Rates of preoperative standardized prolapse evaluations, offer of pessary, and evaluation of stress urinary incontinence were determined by chart review of 15% of the hysterectomy cases. Adjustment was made in a logistic regression model for age, race, insurance status, and prolapse size. RESULTS: Three hundred one surgeons performed 4238 hysterectomies for prolapse during the study period. Rates of preoperative assessment by standardized pelvic examination differed between high-, intermediate-, and low-volume surgeons (91.2% vs. 61.3% vs. 48.8%, respectively), as did offer of a pessary (86.5% vs. 71.9% vs. 69.9%, respectively) and preoperative stress test for urinary incontinence (93.5% vs. 72.8% vs. 63.5%, respectively). Regression analysis revealed that high-volume surgeons were more likely than intermediate- or low-volume surgeons to perform a standardized pelvic examination, offer a pessary, or perform preoperative evaluation for urinary incontinence. CONCLUSIONS: High-volume surgeons were more likely than low-volume surgeons to perform a standardized preoperative pelvic examination, offer a pessary, and evaluate stress urinary incontinence.


Assuntos
Competência Clínica/estatística & dados numéricos , Ginecologia/normas , Histerectomia/métodos , Padrões de Prática Médica , Cuidados Pré-Operatórios/métodos , Prolapso Uterino/cirurgia , Análise de Variância , Feminino , Ginecologia/estatística & dados numéricos , Hospitais com Alto Volume de Atendimentos/estatística & dados numéricos , Hospitais com Baixo Volume de Atendimentos/estatística & dados numéricos , Humanos , Pessoa de Meia-Idade , Pessários/estatística & dados numéricos , Exame Físico/métodos , Exame Físico/estatística & dados numéricos , Estudos Retrospectivos , Incontinência Urinária por Estresse/diagnóstico , Carga de Trabalho
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