RESUMEN
IMPORTANCE: Urinary incontinence can be a barrier to performing physical activities for many women. A midurethral sling (MUS) has shown symptom improvement for women experiencing stress urinary incontinence (SUI), suggesting the hypothesis that physical activity rates should increase after treatment. OBJECTIVE: The aim of this study was to determine the change in objectively measured physical activity levels in women following placement of MUS for SUI. STUDY DESIGN: In this prospective cohort study, patients undergoing MUS placement, with or without concomitant pelvic reconstructive surgery, were provided a commercial activity tracker. Physical activity was tracked for at least 1 week preoperatively and up to 6 months postoperatively. Participants were required to wear the tracker for at least 2 weeks in the postoperative period. The primary outcome, mean caloric daily expenditure (MCDE), was compared preoperatively and postoperatively. RESULTS: Seventy-two patients met criteria for data inclusion. The device was worn for a mean of 18.4 ± 12.1 days preoperatively and 91.7 ± 53.3 days postoperatively. Mean participant age was 51.9 ± 9.4 years. The MCDE was significantly higher postoperatively (preoperatively: 1,673 kcal/d vs postoperatively: 2,018 kcal/d; P < 0.01). There were no significant differences in postoperative MCDE in participants who had only MUS as the primary procedure versus participants who also had a concomitant procedure (2,020 ± 216 kcal/d vs 2,015 ± 431 kcal/d; P = 0.95). Of participants with class II/III obesity, 45% had at least a 500 kcal/d increase postoperatively. CONCLUSIONS: Treatment of SUI with MUS is associated with a significantly greater caloric expenditure in the postoperative period.
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Importance: The optimal surgical repair of vaginal vault prolapse after hysterectomy remains undetermined. Objective: To compare the efficacy and safety of 3 surgical approaches for vaginal vault prolapse after hysterectomy. Design, Setting, and Participants: This was a multisite, 3-arm, superiority and noninferiority randomized clinical trial. Outcomes were assessed biannually up to 60 months, until the last participant reached 36 months of follow-up. Settings included 9 clinical sites in the US National Institute of Child Health and Human Development (NICHD) Pelvic Floor Disorders Network. Between February 2016 and April 2019, women with symptomatic vaginal vault prolapse after hysterectomy who desired surgical correction were randomized. Data were analyzed from November 2022 to January 2023. Interventions: Mesh-augmented (either abdominally [sacrocolpopexy] or through a vaginal incision [transvaginal mesh]) vs transvaginal native tissue repair. Main Outcomes and Measures: The primary outcome was time until composite treatment failure (including retreatment for prolapse, prolapse beyond the hymen, or prolapse symptoms) evaluated with survival models. Secondary outcomes included patient-reported symptom-specific results, objective measures, and adverse events. Results: Of 376 randomized participants (mean [SD] age, 66.1 [8.7] years), 360 (96%) had surgery, and 296 (82%) completed follow-up. Adjusted 36-month failure incidence was 28% (95% CI, 20%-37%) for sacrocolpopexy, 29% (95% CI, 21%-38%) for transvaginal mesh, and 43% (95% CI, 35%-53%) for native tissue repair. Sacrocolpopexy was found to be superior to native tissue repair (adjusted hazard ratio [aHR], 0.57; 99% CI, 0.33-0.98; P = .01). Transvaginal mesh was not statistically superior to native tissue after adjustment for multiple comparisons (aHR, 0.60; 99% CI, 0.34-1.03; P = .02) but was noninferior to sacrocolpopexy (aHR, 1.05; 97% CI, 0-1.65; P = .01). All 3 surgeries resulted in sustained benefits in subjective outcomes. Mesh exposure rates were low (4 of 120 [3%] for sacrocolpopexy and 6 of 115 [5%] for transvaginal mesh) as were the rates of dyspareunia. Conclusions and Relevance: Among participants undergoing apical repair for vaginal vault prolapse, sacrocolpopexy and transvaginal mesh resulted in similar composite failure rates at study completion; both had lower failure rates than native tissue repair, although only sacrocolpopexy met a statistically significant difference. Low rates of mesh complications and adverse events corroborated the overall safety of each approach. Trial Registration: ClinicalTrials.gov Identifier: NCT02676973.
RESUMEN
Objectives: We aimed to describe obstetrics and gynecology (OBGYN) trainees' anticipation of how the Dobbs v. Jackson Women's Health Organization (Dobbs) U.S. Supreme Court decision may affect their training. Methods: A REDCap survey of OBGYN residents and fellows in the United States from September 19, 2022, to December 1, 2022, queried trainees' anticipated achievement of relevant Accreditation Council for Graduate Medical Education (ACGME) training milestones, their concerns about the ability to provide care and concern about legal repercussions during training, and the importance of OBGYN competence in managing certain clinical situations for residency graduates. The primary outcome was an ACGME program trainee feeling uncertain or unable to obtain the highest level queried for a relevant ACGME milestone, including experiencing 20 abortion procedures in residency. Results: We received 469 eligible responses; the primary outcome was endorsed by 157 respondents (33.5%). After correction for confounders, significant predictors of the primary outcome were state environment (aOR = 3.94 for pending abortion restrictions; aOR = 2.71 for current abortion restrictions), trainee type (aOR = 0.21 for fellow vs. resident), and a present or past Ryan Training Program in residency (aOR = 0.55). Although the vast majority of trainees believed managing relevant clinical situations are key to OBGYN competence, 10%-30% of trainees believed they would have to stop providing the standard of care in clinical situations during training. Conclusions: This survey of OBGYN trainees indicates higher uncertainty about achieving ACGME milestones and procedural competency in clinical situations potentially affected by the Dobbs decision in states with legal restrictions on abortion.
Asunto(s)
Ginecología , Internado y Residencia , Obstetricia , Decisiones de la Corte Suprema , Humanos , Obstetricia/educación , Ginecología/educación , Femenino , Estados Unidos , Encuestas y Cuestionarios , Adulto , Masculino , Competencia Clínica , Educación de Postgrado en Medicina , Salud de la Mujer/legislación & jurisprudencia , Embarazo , AcreditaciónRESUMEN
OBJECTIVE: To systematically review the literature to evaluate clinical and surgical outcomes for technologies that facilitate vaginal surgical procedures. DATA SOURCES: We systematically searched MEDLINE, EMBASE, and ClinicalTrials.gov from January 1990 to May 2022. METHODS OF STUDY SELECTION: Comparative and single-arm studies with data on contemporary tools or technologies facilitating intraoperative performance of vaginal gynecologic surgical procedures for benign indications were included. Citations were independently double screened, and eligible full-text articles were extracted by two reviewers. Data collected included study characteristics, technology, patient demographics, and intraoperative and postoperative outcomes. Risk of bias for comparative studies was assessed using established methods, and restricted maximum likelihood model meta-analyses were conducted as indicated. TABULATION, INTEGRATION, AND RESULTS: The search yielded 8,658 abstracts, with 116 eligible studies that evaluated pedicle sealing devices (n=32), nonrobotic and robotic vaginal natural orifice transluminal endoscopic surgery (n=64), suture capture devices (n=17), loop ligatures (n=2), and table-mounted telescopic cameras (n=1). Based on 19 comparative studies, pedicle sealing devices lowered vaginal hysterectomy operative time by 15.9 minutes (95% CI, -23.3 to -85), blood loss by 36.9 mL (95% CI, -56.9 to -17.0), hospital stay by 0.2 days (95% CI, -0.4 to -0.1), and visual analog scale pain scores by 1.4 points on a subjective 10-point scale (95% CI, -1.7 to -1.1). Three nonrandomized comparative studies and 53 single-arm studies supported the feasibility of nonrobotic vaginal natural orifice transluminal endoscopic surgery for hysterectomy, adnexal surgery, pelvic reconstruction, and myomectomy. Data were limited for robotic vaginal natural orifice transluminal endoscopic surgery, suture capture devices, loop ligatures, and table-mounted cameras due to few studies or study heterogeneity. CONCLUSION: Pedicle sealing devices lower operative time and blood loss for vaginal hysterectomy, with modest reductions in hospital stay and pain scores. Although other technologies identified in the literature may have potential to facilitate vaginal surgical procedures and improve outcomes, additional comparative effectiveness research is needed. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42022327490.