RESUMO
BACKGROUND: Pessaries are an effective treatment for pelvic organ prolapse, yet currently available pessaries can cause discomfort during removal and insertion. An early feasibility trial of an investigational, collapsible pessary previously demonstrated mechanical feasibility during a brief 15-minute office trial. Longer-term, patient-centered safety and efficacy data are needed. OBJECTIVE: This study aimed to assess the effectiveness and safety of the investigational vaginal pessary for pelvic organ prolapse at 3 months. STUDY DESIGN: This was a prospective, 7-center, open-label equivalence study with participants serving as their own controls. Subjects were current users of a Gellhorn or ring pessary with ≥stage 2 prolapse. Subjective and objective data were collected at baseline for 1 month while subjects used their current pessary. Data were then collected throughout a 3-month treatment phase with the study pessary. The primary outcome was change in Pelvic Floor Distress Inventory-20 score. Secondary outcome measures included objective assessment of prolapse support, changes in the Pelvic Floor Impact Questionnaire-7, and pain with insertion and removal, measured using a visual analog scale. Data from subjects fitted with the study pessary were analyzed using an intention-to-treat approach, and those who dropped out were assigned scores at the upper limit of the predefined equivalence limits. Secondary per protocol analyses included subjects who completed treatment. The study was powered to 80% with a minimal important change equivalence limit of 18.3 points on the Pelvic Floor Distress Inventory-20 scale. Square root transformations were used for nonparametric data, and P values were adjusted for multiple comparisons. RESULTS: A total of 78 subjects were enrolled, however, 16 withdrew before study pessary placement. The study pessary was fitted in 62 subjects (50 ring and 12 Gellhorn pessary users), and 48 (62%) completed the 3-month intervention. The change in Pelvic Floor Distress Inventory-20 scores at 3 months demonstrated equivalence when compared with the subjects' baseline scores (mean difference, -3.96 [improvement]; 90% confidence interval, -11.99 to 4.08; P=.002). Among those completing study, the Pelvic Floor Distress Inventory-20 scores, equivalence was not demonstrated and scores favored the study pessary (mean difference, -10.45; 90% confidence interval, -20.35 to 0.54; P=.095). Secondary outcomes included objective measures of support, which were similar (mean difference: Ba, 0.54 cm; Bp, 0.04 cm, favoring study pessary; improvement in mean Pelvic Floor Impact Questionnaire-7 scores for those who completed the trial: before, 32.23; after, 16.86; P=.019), and pain with insertion and removal, which was lower with the study pessary than with the subject's own pessary (mean difference visual analog scale score insertion, 9.91 mm; P=.019; removal, 11.23 mm; P=.019). No serious adverse events related to the pessary were reported. CONCLUSION: Equivalence was demonstrated in the primary outcome of the study pessary when compared with current, noncollapsible pessaries in terms of change in severity and bother of pelvic floor symptoms. Among participants who completed the trial, the Pelvic Floor Impact Questionnaire-7 improved with study pessary use and change in Pelvic Floor Distress Inventory-20 scores were nonequivalent, favoring the study pessary. Subjects reported significantly lower pain scores with both pessary insertion and removal with the novel collapsible pessary when compared with their standard pessary.
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Prolapso de Órgão Pélvico , Pessários , Humanos , Feminino , Prolapso de Órgão Pélvico/terapia , Idoso , Pessoa de Meia-Idade , Estudos Prospectivos , Resultado do TratamentoRESUMO
OBJECTIVES: A chargemaster is a database of all of the billable items offered by a hospital with their base price listings. A 2018 executive order required all American hospitals to publish their chargemasters to increase price transparency and reduce healthcare expenditures. Chargemaster listings, however, demonstrate marked variability and inconsistency and have not been associated with consumer benefit. The objective of this study was to analyze chargemasters for commonly billed interventional cardiology procedures across five diverse states to explore relationships between price listings and hospital characteristics, ownership, location, and hospital quality. METHODS: Chargemasters were downloaded from hospitals in five states selected to represent the nation's healthcare diversity. Price listings for five interventional cardiology procedures (percutaneous coronary angiography, coronary angiography, single-vessel angioplasty, single-vessel stent, and percutaneous coronary intervention of acute myocardial infarction) were extracted. Statistical analyses such as the Kruskal-Wallis test were performed to explore relationships between mean chargemaster price listings for each procedure and hospital characteristics, ownership, location, and quality ratings. RESULTS: The median mean chargemaster price of four of the five interventional cardiology procedures significantly differed across all states. Price listings were significantly higher in urban versus rural areas and in general acute care hospitals and state government-owned facilities. The highest prices were found with the highest hospital quality rating. CONCLUSIONS: Chargemaster price listings for common interventional cardiology procedures varied significantly across these five states. Urban and metropolitan hospital location, hospital type, and hospital ownership could be factors driving increased chargemaster procedure prices. Prices were highest at hospitals with the highest quality rating.
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Cardiologia , Gastos em Saúde , Humanos , Angiografia Coronária , Bases de Dados Factuais , Hospitais UrbanosRESUMO
BACKGROUND: The inclusion of participants who are Black, Indigenous people of color, and participants of various ethnicities is a priority of federally sponsored research. OBJECTIVE: This study aimed to describe the reporting of race and ethnicity in federally funded research published by the Eunice Kennedy Shriver National Institute of Child Health and Human Development-funded Pelvic Floor Disorders Network. STUDY DESIGN: Pelvic Floor Disorders Network publications were reviewed to determine whether race or ethnicity was reported. The number of participants included in each manuscript who were identified as White, Black, Asian, American Indian or Alaska Native, Native Hawaiian or Other Pacific Islander, and "other," and the number of participants who identified as having Hispanic ethnicity were recorded. Data were analyzed by publication and by the pelvic floor disorder investigated, including urinary incontinence, pelvic organ prolapse, fecal incontinence, pregnancy-related pelvic floor disorders, and multiple pelvic floor disorders. Many publications reported on overlapping patient populations, which included primary trials and secondary analyses and studies. Data were analyzed both by counting participants every time they were reported in all papers and by counting the unique number of participants in only the original trials (primary paper published). RESULTS: A total of 132 Pelvic Floor Disorders Network publications were published between 2003 and 2020. Of these, 21 were excluded because they were methods papers or described research without participants. Of the 111 remaining articles, 90 (81%) included descriptions of race and 55 (50%) included descriptions of ethnicity. All 13 primary trials described race and 10 of 13 (76.9%) described ethnicity. Of those publications that described race, 50 of 90 (56%) included only the categories of "White," "Black," and "Other," and 14 of 90 (16%) only described the percentage of White patients. Of the 49,218 subjects, there were 43,058 (87%) with reported race and 27,468 (56%) with reported ethnicity. Among subjects with race and ethnicity reported, 79% were reported as White, 9.9% as Black, 0.4% as Asian, 0.1% as American Indian or Alaska Native, and 4% as "other," whereas 13% were reported to be of Hispanic ethnicity. The racial and ethnic diversity varied based on the pelvic floor disorder studied (P<.01), which was driven by pregnancy-related and fecal incontinence studies because these had lower proportions of White patients than studies of other pelvic floor disorders. CONCLUSION: Federally funded Pelvic Floor Disorders Network research does not consistently report the race and ethnicity of participants. Even in the publications that report these characteristics, Black, Indigenous people of color, and people of Hispanic ethnicity are underrepresented. Consistent reporting and recruitment of a diverse population of women is necessary to address this systemic inequity.
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Pesquisa Biomédica , Etnicidade/estatística & dados numéricos , Distúrbios do Assoalho Pélvico , Grupos Raciais/estatística & dados numéricos , Sujeitos da Pesquisa/estatística & dados numéricos , Feminino , Humanos , National Institute of Child Health and Human Development (U.S.) , Apoio à Pesquisa como Assunto , Estados UnidosRESUMO
This case presents the work-up and management of a patient experiencing acute kidney injury, urinary retention, and neuropathy following surgery for pelvic organ prolapse and stress urinary incontinence. Four international experts provide their evaluation of and approach to this complex case.
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Prolapso de Órgão Pélvico , Procedimentos de Cirurgia Plástica , Incontinência Urinária por Estresse , Retenção Urinária , Feminino , Humanos , Prolapso de Órgão Pélvico/cirurgia , Pelve , Incontinência Urinária por Estresse/cirurgiaRESUMO
This case presents the work-up and management of a patient with a fibroid uterus and urinary incontinence. Five international experts also provide their evaluation and approach to this case. According to the literature, there is uncertainty surrounding the relationship between fibroids and urinary incontinence. The experts emphasize patient counseling and a staged approach.
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Ginecologia , Leiomioma , Procedimentos de Cirurgia Plástica , Incontinência Urinária , Feminino , Humanos , Leiomioma/complicações , Leiomioma/cirurgia , Pelve , Incontinência Urinária/etiologia , Incontinência Urinária/terapiaRESUMO
AIMS: The aim is to assess whether subjects with diabetes mellitus (DM) have greater urinary retention and increased post-void residual volume (PVR) following mid-urethral sling (MUS) surgery. METHODS: This multi-center retrospective study included patients who underwent MUS (2012-2016). Baseline data included demographics, comorbidities, urinary symptoms, urodynamics data, PVR, and responses to validated questionnaires (UDI6 and IIQ7). Intraoperative data, postoperative voiding trial results, postop questionnaires, and complications were also noted. Patients with and without DM were compared. Significance was defined as P < .05. RESULTS: A total of 605 MUS were included, 538(89%) without DM and 67(11%) with DM, of which 69% were transobturator and 31% retropubic. No differences were seen in urinary retention and passing void trial(79% DM vs 81% non-DM; P = .72). Mean PVR at discharge was similar between groups (136 mL DM vs 139 mL non-DM; P = .922). There were no differences between groups in UDI6 and IIQ7 sum scores at baseline and 1 month. DM subjects reported more bother at baseline on certain UDI-6 and IIQ-7 items including frequent urination, leakage related to urgency, and feeling frustrated. At 3 months postop, all subjects demonstrated improvement in scores. Interestingly, patients with DM reported worse quality of life on the IIQ7 sum. CONCLUSIONS: Among subjects with well-controlled diabetes and more comorbidities who underwent MUS there were few differences in postoperative voiding dysfunction or PVR compared to nondiabetic women. DM patients were more bothered at baseline by urge-related symptoms. Quality of life following sling surgery appears to be worse in patients with DM at 3 months based on IIQ7. This data suggests that diabetic women with lower HbA1C can be counseled similarly to these complication rates and voiding dysfunction after MUS.
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Complicações do Diabetes , Slings Suburetrais , Incontinência Urinária/cirurgia , Adulto , Idoso , Idoso de 80 Anos ou mais , Comorbidade , Feminino , Humanos , Pessoa de Meia-Idade , Qualidade de Vida , Estudos Retrospectivos , Inquéritos e Questionários , Resultado do Tratamento , Bexiga Urinária/fisiopatologia , Incontinência Urinária/fisiopatologia , Urodinâmica , Procedimentos Cirúrgicos UrológicosRESUMO
This case presents the work-up and management of a patient requesting surgical intervention for recurrent stress urinary incontinence after previous excision of a portion of her midurethral sling because of mesh exposure. Four international experts provide their approach to this complex case. There is little consensus regarding further surgery in a patient who has required mesh excision. Treatment by fascial sling was commonly considered and the literature review outlines the pros and cons of autologous fascia versus donor fascia for this specific case.
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Procedimentos de Cirurgia Plástica , Slings Suburetrais , Incontinência Urinária por Estresse , Fáscia/transplante , Feminino , Humanos , Pelve , Slings Suburetrais/efeitos adversos , Incontinência Urinária por Estresse/cirurgiaRESUMO
INTRODUCTION AND HYPOTHESIS: The COVID-19 pandemic and the desire to "flatten the curve" of transmission have significantly affected the way providers care for patients. Female Pelvic Medicine and Reconstructive Surgeons (FPMRS) must provide high quality of care through remote access such as telemedicine. No clear guidelines exist on the use of telemedicine in FPMRS. Using expedited literature review methodology, we provide guidance regarding management of common outpatient urogynecology scenarios during the pandemic. METHODS: We grouped FPMRS conditions into those in which virtual management differs from direct in-person visits and conditions in which treatment would emphasize behavioral and conservative counseling but not deviate from current management paradigms. We conducted expedited literature review on four topics (telemedicine in FPMRS, pessary management, urinary tract infections, urinary retention) and addressed four other topics (urinary incontinence, prolapse, fecal incontinence, defecatory dysfunction) based on existing systematic reviews and guidelines. We further compiled expert consensus regarding management of FPMRS patients in the virtual setting, scenarios when in-person visits are necessary, symptoms that should alert providers, and specific considerations for FPMRS patients with suspected or confirmed COVID-19. RESULTS: Behavioral, medical, and conservative management will be valuable as first-line virtual treatments. Certain situations will require different treatments in the virtual setting while others will require an in-person visit despite the risks of COVID-19 transmission. CONCLUSIONS: We have presented guidance for treating FPMRS conditions via telemedicine based on rapid literature review and expert consensus and presented it in a format that can be actively referenced.
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Infecções por Coronavirus/prevenção & controle , Doenças Urogenitais Femininas/terapia , Ginecologia/métodos , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Telemedicina/métodos , Betacoronavirus , COVID-19 , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/virologia , Feminino , Doenças Urogenitais Femininas/virologia , Humanos , Controle de Infecções/métodos , Pneumonia Viral/epidemiologia , Pneumonia Viral/virologia , SARS-CoV-2RESUMO
STUDY OBJECTIVE: The primary objective was to compare carbon dioxide (CO2) absorption rates in patients undergoing gynecologic laparoscopy with a standard versus valveless insufflation system (AirSeal; ConMed, Utica, NY) at intra-abdominal pressures (IAPs) of 10 and 15 mm Hg. Secondary objectives were assessment of surgeons' visualization of the operative field, anesthesiologists' ability to maintain adequate end-tidal CO2 (etCO2), and patients' report of postoperative shoulder pain. DESIGN: A randomized controlled trial using an equal allocation ratio into 4 arms: standard insufflation/IAP 10 mm Hg, standard insufflation/IAP 15 mm Hg, valveless insufflation/IAP 10 mm Hg, and valveless insufflation/IAP 15 mm Hg. SETTING: Single tertiary care academic institution. PATIENTS: Women ≥ 18 years old undergoing nonemergent conventional or robotic gynecologic laparoscopic surgery. INTERVENTIONS: A standard or valveless insufflation system at IAPs of 10 or 15 mm Hg. MEASUREMENTS AND MAIN RESULTS: One hundred thirty-two patients were enrolled and randomized with 33 patients per group. There were 84 robotic cases and 47 conventional laparoscopic cases. CO2 absorption rates (mL/kg*min) did not differ across groups with mean rates of 4.00 ± 1.3 in the valveless insufflation groups and 4.00 ± 1.1 in the standard insufflation groups. The surgeons' rating of overall visualization of the operative field on a 10-point Likert scale favored the valveless insufflation system (median visualization, 9.0 ± 2.0 cm and 9.5 ± 1.8 cm at 10 and 15 mm Hg, respectively) over standard insufflation (7.0 ± 3.0 cm and 7.0 ± 2.0 cm at 10 and 15 mm Hg, respectively; p <.001). The anesthesiologists' ability to maintain adequate etCO2 was similar across groups (pâ¯=â¯.417). Postoperative shoulder pain scores were low overall with no significant difference across groups (p >.05). CONCLUSION: CO2 absorption rates, anesthesiologists' ability to maintain adequate etCO2, and postoperative shoulder pain did not differ based on insufflation system type or IAP. Surgeons' rating of visualization of the operative field was significantly improved when using the valveless over the standard insufflation system.
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Dióxido de Carbono/farmacocinética , Procedimentos Cirúrgicos em Ginecologia , Insuflação , Laparoscopia/métodos , Adulto , Dióxido de Carbono/efeitos adversos , Feminino , Absorção Gastrointestinal , Procedimentos Cirúrgicos em Ginecologia/efeitos adversos , Procedimentos Cirúrgicos em Ginecologia/métodos , Procedimentos Cirúrgicos em Ginecologia/normas , Humanos , Insuflação/efeitos adversos , Insuflação/instrumentação , Insuflação/métodos , Insuflação/normas , Laparoscopia/efeitos adversos , Pessoa de Meia-Idade , Dor Pós-Operatória/etiologia , Complicações Pós-Operatórias/etiologia , Pressão , Procedimentos Cirúrgicos Robóticos/efeitos adversos , Procedimentos Cirúrgicos Robóticos/instrumentação , Procedimentos Cirúrgicos Robóticos/métodos , Procedimentos Cirúrgicos Robóticos/normas , Dor de Ombro/etiologia , Instrumentos Cirúrgicos/normas , Resultado do TratamentoRESUMO
Discussion and management of incontinence in a patient with spina bifida by four international experts followed by a literature review.
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Disrafismo Espinal/complicações , Bexiga Urinaria Neurogênica/terapia , Incontinência Urinária/terapia , Feminino , Humanos , Bexiga Urinaria Neurogênica/congênito , Incontinência Urinária/congênito , Adulto JovemRESUMO
This case presents the work-up and management of a spina bifida patient with recurrent prolapse. Four international experts also provide their evaluation of and approach to this complex case. According to the literature, little is known regarding the approach to the management of this specific patient population.
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Obesidade Mórbida/complicações , Prolapso de Órgão Pélvico/complicações , Prolapso de Órgão Pélvico/cirurgia , Disrafismo Espinal/complicações , Adulto , Feminino , Procedimentos Cirúrgicos em Ginecologia/métodos , Humanos , Procedimentos de Cirurgia Plástica/métodos , Recidiva , Telas CirúrgicasRESUMO
INTRODUCTION AND HYPOTHESIS: Several posterior compartment surgical approaches are used to address posterior vaginal wall prolapse and obstructed defecation. We aimed to compare outcomes for both conditions among different surgical approaches. METHODS: A systematic review was performed comparing the impact of surgical interventions in the posterior compartment on prolapse and defecatory symptoms. MEDLINE, Embase, and ClinicalTrials.gov were searched from inception to 4 April 2018. Randomized controlled trials, prospective and retrospective comparative and single-group studies of women undergoing posterior vaginal compartment surgery for vaginal bulge or bowel symptoms were included. Studies had to include both anatomical and symptom outcomes both pre- and post-surgery. RESULTS: Forty-six eligible studies reported on six surgery types. Prolapse and defecatory symptoms improved with native-tissue transvaginal rectocele repair, transanal rectocele repair, and stapled transanal rectocele repair (STARR) surgeries. Although prolapse was improved with sacrocolpoperineopexy, defecatory symptoms worsened. STARR caused high rates of fecal urgency postoperatively, but this symptom typically resolved with time. Site-specific posterior repairs improved prolapse stage and symptoms of obstructed defecation. Compared with the transanal route, native-tissue transvaginal repair resulted in greater improvement in anatomical outcomes, improved obstructed defecation symptoms, and lower chances of rectal injury, but higher rates of dyspareunia. CONCLUSIONS: Surgery in the posterior vaginal compartment typically has a high rate of success for anatomical outcomes, obstructed defecation, and bulge symptoms, although these may not persist over time. Based on this evidence, to improve anatomical and symptomatic outcomes, a native-tissue transvaginal rectocele repair should be preferentially performed.
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Constipação Intestinal/cirurgia , Procedimentos Cirúrgicos em Ginecologia/métodos , Prolapso de Órgão Pélvico/cirurgia , Retocele/cirurgia , Cirurgia Endoscópica Transanal/métodos , Vagina/cirurgia , Constipação Intestinal/etiologia , Feminino , Humanos , Prolapso de Órgão Pélvico/complicações , Guias de Prática Clínica como Assunto , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Retocele/complicações , Estudos RetrospectivosRESUMO
INTRODUCTION AND HYPOTHESIS: We aimed to systematically review the literature on pelvic organ prolapse (POP) surgery with uterine preservation (hysteropexy). We hypothesized that different hysteropexy surgeries would have similar POP outcomes but varying adverse event (AE) rates. METHODS: MEDLINE, Cochrane, and clinicaltrials.gov databases were reviewed from inception to January 2018 for comparative (any size) and single-arm studies (n ≥ 50) involving hysteropexy. Studies were extracted for participant characteristics, interventions, comparators, outcomes, and AEs and assessed for methodological quality. RESULTS: We identified 99 eligible studies: 53 comparing hysteropexy to POP surgery with hysterectomy, 42 single-arm studies on hysteropexy, and four studies comparing stage ≥2 hysteropexy types. Data on POP outcomes were heterogeneous and usually from <3 years of follow-up. Repeat surgery prevalence for POP after hysteropexy varied widely (0-29%) but was similar among hysteropexy types. When comparing sacrohysteropexy routes, the laparoscopic approach had lower recurrent prolapse symptoms [odds ratio (OR) 0.18, 95% confidence interval (CI) 0.07-0.46), urinary retention (OR 0.05, 95% CI 0.003-0.83), and blood loss (difference -104 ml, 95% CI -145 to -63 ml) than open sacrohysteropexy. Laparoscopic sacrohysteropexy had longer operative times than vaginal mesh hysteropexy (difference 119 min, 95% CI 102-136 min). Most commonly reported AEs included mesh exposure (0-39%), urinary retention (0-80%), and sexual dysfunction (0-48%). CONCLUSIONS: Hysteropexies have a wide range of POP recurrence and AEs; little data exist directly comparing different hysteropexy types. Therefore, for women choosing uterine preservation, surgeons should counsel them on outcomes and risks particular to the specific hysteropexy type planned.
Assuntos
Procedimentos Cirúrgicos em Ginecologia/métodos , Tratamentos com Preservação do Órgão/métodos , Prolapso de Órgão Pélvico/cirurgia , Útero/cirurgia , Feminino , Procedimentos Cirúrgicos em Ginecologia/efeitos adversos , Humanos , Histerectomia , Duração da Cirurgia , Tratamentos com Preservação do Órgão/efeitos adversos , Tratamentos com Preservação do Órgão/instrumentação , Recidiva , Reoperação , Disfunções Sexuais Fisiológicas/etiologia , Telas Cirúrgicas/efeitos adversos , Retenção Urinária/etiologiaRESUMO
OBJECTIVE: We aimed to systematically review the literature on apical pelvic organ prolapse surgery with uterine preservation compared with prolapse surgeries including hysterectomy and provide evidence-based guidelines. DATA SOURCES: The sources for our data were MEDLINE, Cochrane, and clinicaltrials.gov databases from inception to January 2017. STUDY ELIGIBILITY CRITERIA: We accepted randomized and nonrandomized studies of uterine-preserving prolapse surgeries compared with those involving hysterectomy. STUDY APPRAISAL AND SYNTHESIS METHODS: Studies were extracted for participant information, intervention, comparator, efficacy outcomes, and adverse events, and they were individually and collectively assessed for methodological quality. If 3 or more studies compared the same surgeries and reported the same outcome, a meta-analysis was performed. RESULTS: We screened 4467 abstracts and identified 94 eligible studies, 53 comparing uterine preservation to hysterectomy in prolapse surgery. Evidence was of moderate quality overall. Compared with hysterectomy plus mesh sacrocolpopexy, uterine preservation with sacrohysteropexy reduces mesh exposure, operative time, blood loss, and surgical cost without differences in prolapse recurrence. Compared with vaginal hysterectomy with uterosacral suspension, uterine preservation in the form of laparoscopic sacrohysteropexy improves the C point and vaginal length on the pelvic organ prolapse quantification exam, estimated blood loss, postoperative pain and functioning, and hospital stay, but open abdominal sacrohysteropexy worsens bothersome urinary symptoms, operative time, and quality of life. Transvaginal mesh hysteropexy (vs with hysterectomy) decreases mesh exposure, reoperation for mesh exposure, postoperative bleeding, and estimated blood loss and improves posterior pelvic organ prolapse quantification measurement. Transvaginal uterosacral or sacrospinous hysteropexy or the Manchester procedure compared with vaginal hysterectomy with native tissue suspension both showed improved operative time and estimated blood loss and no worsening of prolapse outcomes with uterine preservation. However, there is a significant lack of data on prolapse outcomes >3 years after surgery, the role of uterine preservation in obliterative procedures, and longer-term risk of uterine pathology after uterine preservation. CONCLUSION: Uterine-preserving prolapse surgeries improve operating time, blood loss, and risk of mesh exposure compared with similar surgical routes with concomitant hysterectomy and do not significantly change short-term prolapse outcomes. Surgeons may offer uterine preservation as an option to appropriate women who desire this choice during apical prolapse repair.
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Histerectomia/métodos , Tratamentos com Preservação do Órgão/métodos , Prolapso de Órgão Pélvico/cirurgia , Perda Sanguínea Cirúrgica , Feminino , Procedimentos Cirúrgicos em Ginecologia/métodos , Humanos , Histerectomia Vaginal , Laparoscopia , Tempo de Internação , Duração da Cirurgia , Dor Pós-Operatória , Guias de Prática Clínica como Assunto , Qualidade de Vida , Procedimentos de Cirurgia Plástica/métodos , Recidiva , Reoperação , Telas Cirúrgicas , Resultado do Tratamento , Vagina/cirurgiaRESUMO
BACKGROUND: The American Congress of Obstetricians and Gynecologists recommends that "the surgeon and patient discuss the potential benefits of the removal of the fallopian tubes during a hysterectomy in women at population risk of ovarian cancer who are not having an oophorectomy," resulting in an increasing rate of salpingectomy at the time of hysterectomy. Rates of salpingectomy are highest for laparoscopic and lowest for vaginal hysterectomy. OBJECTIVE: The primary objective of this study was to determine the feasibility of bilateral salpingectomy at the time of vaginal hysterectomy. Secondary objectives included identification of factors associated with unsuccessful salpingectomy and assessment of its impact on operating time, blood loss, surgical complications, and menopausal symptoms. STUDY DESIGN: This was a multicenter, prospective study of patients undergoing planned vaginal hysterectomy with bilateral salpingectomy. Baseline medical data along with operative findings, operative time, and blood loss for salpingectomy were recorded. Uterine weight and pathology reports for all fallopian tubes were reviewed. Patients completed the Menopause Rating Scale at baseline and at postoperative follow-up. Descriptive analyses were performed to characterize the sample and compare those with successful and unsuccessful completion of planned salpingectomy using Student t test, and χ2 test when appropriate. Questionnaire scores were compared using paired t tests. RESULTS: Among 77 patients offered enrollment, 74 consented (96%), and complete data were available regarding primary outcome for 69 (93%). Mean age was 51 years. Median body mass index was 29.1 kg/m2; median vaginal parity was 2, and 41% were postmenopausal. The indications for hysterectomy included prolapse (78%), heavy menstrual bleeding (20%), and fibroids (11%). When excluding conversions to alternate routes, vaginal salpingectomy was successfully performed in 52/64 (81%) women. Mean operating time for bilateral salpingectomy was 11 (±5.6) minutes, with additional estimated blood loss of 6 (±16.3) mL. There were 8 surgical complications: 3 hemorrhages >500 mL and 5 conversions to alternate routes of surgery, but none of these were due to the salpingectomy. Mean uterine weight was 102 g and there were no malignancies on fallopian tube pathology. Among the 17 patients in whom planned bilateral salpingectomy was not completed, unilateral salpingectomy was performed in 7 patients. Reasons for noncompletion included: tubes high in the pelvis (8), conversion to alternate route for pathology (4), bowel or sidewall adhesions (3), tubes absent (1), and ovarian adhesions (1). Prior adnexal surgery (odds ratio, 2.9; 95% confidence interval, 1.5-5.5; P = .006) and uterine fibroids (odds ratio, 5.8; 95% confidence interval, 1.5-22.5; P = .02) were the only significant factors associated with unsuccessful bilateral salpingectomy. Mean menopause scores improved after successful salpingectomy (12.7 vs 8.6; P < .001). CONCLUSION: Vaginal salpingectomy is feasible in the majority of women undergoing vaginal hysterectomy and increases operating time by 11 minutes and blood loss by 6 mL. Women with prior adnexal surgery or uterine fibroids should be counseled about the possibility that removal may not be feasible.
Assuntos
Histerectomia Vaginal/métodos , Neoplasias Ovarianas/prevenção & controle , Complicações Pós-Operatórias/epidemiologia , Procedimentos Cirúrgicos Profiláticos/métodos , Salpingectomia/métodos , Adulto , Perda Sanguínea Cirúrgica , Estudos de Viabilidade , Feminino , Humanos , Leiomioma/cirurgia , Menorragia/cirurgia , Pessoa de Meia-Idade , Duração da Cirurgia , Estudos Prospectivos , Neoplasias Uterinas/cirurgia , Prolapso Uterino/cirurgiaRESUMO
BACKGROUND: Many gynecologic, urologic, and pelvic reconstructive surgeries require accurate intraoperative evaluation of ureteral patency. OBJECTIVE: We performed a randomized controlled trial to compare surgeon satisfaction with 4 methods of evaluating ureteral patency during cystoscopy at the time of benign gynecologic or pelvic reconstructive surgery: oral phenazopyridine, intravenous sodium fluorescein, mannitol bladder distention, and normal saline bladder distention. STUDY DESIGN: We conducted an unblinded randomized controlled trial of the method used to evaluate ureteral patency during cystoscopy at time of benign gynecologic or pelvic reconstructive surgery. Subjects were randomized to receive 200 mg oral phenazopyridine, 25 mg intravenous sodium fluorescein, mannitol bladder distention, or normal saline bladder distention during cystoscopy. The primary outcome was surgeon satisfaction with the method, assessed via a 100-mm visual analog scale with 0 indicating strong agreement and 100 indicating strong disagreement with the statement. Secondary outcomes included comparing visual analog scale responses about ease of each method and visualization of ureteral jets, bladder mucosa and urethra, and operative information, including time to surgeon confidence in the ureteral jets. Adverse events were evaluated for at least 6 weeks after the surgical procedure, and through the end of the study. All statistical analyses were based on the intent-to-treat principle, and comparisons were 2-tailed. RESULTS: In all, 130 subjects were randomized to phenazopyridine (n = 33), sodium fluorescein (n = 32), mannitol (n = 32), or normal saline (n = 33). At randomization, patient characteristics were similar across groups. With regard to the primary outcome, mannitol was the method that physicians found most satisfactory on a visual analog scale. The median (range) scores for physicians assessing ureteral patency were 48 (0-83), 20 (0-82), 0 (0-44), and 23 (3-96) mm for phenazopyridine, sodium fluorescein, mannitol, and normal saline, respectively (P < .001). Surgery length, cystoscopy length, and time to surgeon confidence in visualization of ureteral jets were not different across the 4 randomized groups. During the 189-day follow-up, no differences in adverse events were seen among the groups, including urinary tract infections. CONCLUSION: The use of mannitol during cystoscopy to assess ureteral patency provided surgeons with the most overall satisfaction, ease of use, and superior visualization without affecting surgery or cystoscopy times. There were no differences in adverse events, including incidence of urinary tract infections.
Assuntos
Cistoscopia/métodos , Histerectomia/métodos , Procedimentos de Cirurgia Plástica/métodos , Ureter , Procedimentos Cirúrgicos Urológicos/métodos , Administração Intravenosa , Administração Oral , Adulto , Corantes , Meios de Contraste , Feminino , Fluoresceína , Procedimentos Cirúrgicos em Ginecologia/métodos , Humanos , Índigo Carmim , Leiomioma/cirurgia , Manitol , Pessoa de Meia-Idade , Fenazopiridina , Complicações Pós-Operatórias/epidemiologia , Cloreto de Sódio , Incontinência Urinária/cirurgia , Hemorragia Uterina/cirurgia , Neoplasias Uterinas/cirurgia , Prolapso Uterino/cirurgiaRESUMO
The purpose of the study was to determine the efficacy and safety of nonantimuscarinic treatments for overactive bladder. Medline, Cochrane, and other databases (inception to April 2, 2014) were used. We included any study design in which there were 2 arms and an n > 100, if at least 1 of the arms was a nonantimuscarinic therapy or any comparative trial, regardless of number, if at least 2 arms were nonantimuscarinic therapies for overactive bladder. Eleven reviewers double-screened citations and extracted eligible studies for study: population, intervention, outcome, effects on outcome categories, and quality. The body of evidence for categories of interventions were summarized and assessed for strength. Ninety-nine comparative studies met inclusion criteria. Interventions effective to improve subjective overactive bladder symptoms include exercise with heat and steam generating sheets (1 study), diaphragmatic (1 study), deep abdominal (1 study), and pelvic floor muscle training exercises (2 studies). Pelvic floor exercises are more effective in subjective and objective outcomes with biofeedback or verbal feedback. Weight loss with diet and exercise, caffeine reduction, 25-50% reduction in fluid intake, and pelvic floor muscle exercises with verbal instruction and or biofeedback were all efficacious. Botulinum toxin A improves urge incontinence episodes, urgency, frequency, quality of life, nocturia, and urodynamic testing parameters. Acupuncture improves quality of life and urodynamic testing parameters. Extracorporeal magnetic stimulation improves urodynamic parameters. Mirabegron improves daily incontinence episodes, nocturia, number of daily voids, and urine volume per void, whereas solabegron improves daily incontinence episodes. Short-term posterior tibial nerve stimulation is more efficacious than pelvic floor muscle training exercises and behavioral therapy for improving: urgency, urinary incontinence episodes, daily voids, volume per void, and overall quality of life. Sacral neuromodulation is more efficacious than antimuscarinic treatment for subjective improvement of overactive bladder and quality of life. Transvaginal electrical stimulation demonstrates subjective improvement in overactive bladder symptoms and urodynamic parameters. Multiple therapies, including physical therapy, behavioral therapy, botulinum toxin A, acupuncture, magnetic stimulation, mirabegron, posterior tibial nerve stimulation, sacral neuromodulation, and transvaginal electrical stimulation, are efficacious in the treatment of overactive bladder.
Assuntos
Bexiga Urinária Hiperativa/terapia , Feminino , HumanosRESUMO
INTRODUCTION AND HYPOTHESIS: We hypothesized that there would be a significant difference in changes in obstructed defecation symptoms and posterior compartment prolapse between women who underwent posterior vaginal wall prolapse repair (PR) and those who did not. METHODS: This was a two-site prospective cohort study of women undergoing prolapse or incontinence surgery in which a PR was, or was not, performed at the discretion of the surgeon. Women were assessed using validated obstructed defecation questionnaires and standardized examination measures (including POP-Q, measurement of transverse gh, and assessment for a rectovaginal pocket and laxity) prior to pelvic surgery and 12 weeks after surgery. RESULTS: Of 68 women who underwent surgery, 43 had PR. The PR group had higher obstructed defecation symptoms and greater posterior compartment prolapse at baseline. At 12 weeks, obstructed defecation symptoms had improved significantly more in the PR group than in the no PR group (all p < 0.03). Anatomic outcomes showed greater improvement in point Bp in the PR group (-3.4 vs. -0.7 no PR, p < 0.001) and resolution of the rectovaginal pocket (86 % vs. 42 %, p = 0.002). There were no significant changes in obstructed defecation symptoms or anatomic outcomes from baseline in the no PR group, while the PR group showed significantly improved obstructed defecation symptoms and anatomic outcomes after repair (p < 0.001 for both). CONCLUSIONS: Significant improvements in obstructed defecation symptoms and posterior compartment prolapse were seen after PR, but not in women who did not receive PR. Obstructed defecation symptoms, Bp and rectovaginal pocket were the measures best able to demonstrate improvement after PR. We recommend the use of these measures to assess the impact of surgery in the posterior compartment.