Search

OBJECTIVE: To compare postoperative urinary retention rates in the early postoperative period between home and office catheter removal. Secondary outcomes included pain, difficulty, satisfaction, likelihood to use again, and health care utilization. METHODS: We conducted a nonblinded, randomized controlled, noninferiority trial of women undergoing surgery for stress incontinence and prolapse from March 2021 to June 2022. Exclusion criteria were preoperative voiding dysfunction (need for self-catheterization or postvoid residual [PVR] greater than 150 mL), urethral bulking, and need for prolonged postoperative catheterization. Participants discharged with indwelling catheters because of an initial failed void trial were randomized 1:1 to home compared with office removal on postoperative day 3-4. For home removal, participants were instructed to remove the catheter at 7 am and to drink two glasses of water. If they had difficulty voiding 5 hours after catheter removal, they came to the office for a void trial. For office removal, participants returned for a backfill void trial with PVR assessment. Our primary outcome was rate of early postoperative urinary retention, defined as confirmed retention (PVR greater than half the voided volume) after catheter removal. Secondary outcomes were assessed at a 2-week call. Health care utilization (telephone calls and office visits) related to catheter issues was also assessed. At 80% power and a=0.05, we needed 100 participants (50/group) to detect a noninferiority margin of 11%. RESULTS: Among 117 participants, the home (n=59) and office (n=58) removal groups were similar in mean age (60 years vs 61 years), mean body mass index (29 vs 30), pelvic organ prolapse quantification system stage 3 or 4, and proportion who underwent hysterectomy or apical suspension. Sling procedures were more common in the office group (45.8% vs 77.6%). For our primary outcome, the rate of early postoperative retention was 11.9% in the home group and 22.4% in the office group (P=.13). Our predetermined noninferiority margin was greater than the upper bound of our 95% CI;thus, we conclude non-inferiority of home removal. For secondary outcomes, the home removal group was more likely to report "no pain" (P=.02) and "very likely" to use this method again (P=.004). There were no differences in difficulty or satisfaction between groups. Number of nursing calls was not different (P=.66);however, number of office visits was higher in the office group (median 0 [interquartile range 0-1] vs 1 [1-1], PC001). CONCLUSION: Postoperative urinary catheter removal by the patient at home was noninferior to office removal when early urinary retention rates were compared. Participants in the home removal group had fewer office visits and reported low pain, low difficulty, and high satisfaction. [ABSTRACT FROM AUTHOR]

Objective: To examine surgical site infection rates before and after the addition of a closing protocol to an existing surgical site infection risk-reduction bundle used during cesarean delivery.Methods: We conducted a single-center retrospective cohort study to review the association of a closing protocol with rates of surgical site infection after cesarean delivery. The closing protocol included fresh surgical instruments and physician and scrub nurse glove change before fascia closure. Surgical site infections were defined using Centers for Disease Control and Prevention criteria. Eligible patients underwent cesarean delivery at our institution from July 1, 2013, through December 31, 2015 (n=1,708; preimplementation group), or from June 1, 2016, through April 30, 2018 (n=1,228; postimplementation group).Results: The surgical site infection rate was 2.3% preimplementation and 2.7% postimplementation (difference 0.4%, 95% CI -1.6 to 0.7%]. The mean [SD] duration of the surgical procedure was longer postimplementation (59.6 [23.7] vs 55.6 [21.5] minutes; P<.001).Conclusion: Addition of a closing tray and glove change to our existing surgical site infection risk-reduction bundle was not associated with a reduction in the frequency of postcesarean surgical site infection but was associated with longer operating times. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the association of primary infertility with subsequent bilateral oophorectomy and hysterectomy, using a population-based cohort of women with primary infertility and age-matched women in a referent group.Methods: The Rochester Epidemiology Project record-linkage system was used to assemble a population-based cohort of women with primary infertility diagnosed between 1980 and 1999 (index date). Women were age-matched (±1 year) 1:1 to women without a history of infertility or hysterectomy at the index date (referent group). Cox proportional hazards models were fit to compare long-term risks of bilateral oophorectomy and hysterectomy, respectively, between women with infertility and women in the referent group.Results: Among both groups of 1,001 women, the mean age at the index date was 29.2±4.4 years. Median duration of follow-up was 23.7 years for both groups. Women with primary infertility were 1.7 times (adjusted hazard ratio [aHR] 1.69, 95% CI 1.22-2.33) more likely to undergo bilateral oophorectomy compared with women in the referent group. In a sensitivity analysis that excluded women with a diagnosis of infertility related to endometriosis and their matched referent group participants, this association persisted (aHR 1.50, 95% CI 1.06-2.14). Women with primary infertility did not have a significant increased risk of hysterectomy (aHR 0.98, 95% CI 0.79-1.23). However, risk of hysterectomy was increased in those with primary infertility related to endometriosis (aHR 1.94, 95% CI 1.12-3.34). We observed that women with primary infertility were more likely to undergo hysterectomy with bilateral oophorectomy. Women in the referent group were more likely to undergo hysterectomy with ovarian conservation. Few women in either group had isolated bilateral oophorectomy.Conclusion: Primary infertility, with and without a diagnosis of endometriosis, is associated with an increased risk of bilateral oophorectomy. In women with endometriosis-related infertility, there is an association with future hysterectomy. These findings represent important confounders in the evaluation of long-term health outcomes related to primary infertility. [ABSTRACT FROM AUTHOR]

Objective: To evaluate noninferiority of virtual transvaginal ultrasonography compared with in-clinic ultrasonography for ovarian reserve assessment.Methods: We conducted a single-site, head-to-head crossover trial. Participants performed self-administered virtual transvaginal ultrasonography at home, guided by a remote-certified ultrasound technologist, then underwent transvaginal ultrasonography in-clinic with another ultrasound technologist. Participants were women in the greater Boston area interested in evaluating ovarian reserve and recruited through social media, health care referrals, and professional networks. The uterus and ovaries were captured in sagittal and transverse views. These randomized recordings were reviewed by two or three independent, blinded reproductive endocrinologists. The primary outcome was noninferiority of the rate of clinical quality imaging produced at home compared with in clinic. Sample size was selected for greater than 90% power, given the 18% noninferiority margin. Secondary outcomes included antral follicle count equivalency and net promoter score superiority.Results: Fifty-six women were enrolled from December 2020 to May 2021. Participants varied in age (19-35 years), BMI (19.5-33.9), and occupation. Ninety-six percent of virtual and 98% of in-clinic images met "clinical quality." The difference of -2.4% (97.5% CI lower bound -5.5%) was within the noninferiority margin (18%). Antral follicle counts were equivalent across settings, with a difference in follicles (0.23, 95% CI -0.36 to 0.82) within the equivalence margin (2.65). Virtual examinations had superior net promoter scores (58.1 points, 97.5% CI of difference 37.3-79.0, P<.01), indicating greater satisfaction with the virtual experience.Conclusion: Virtual transvaginal ultrasonography remotely guided by an ultrasonography technologist is noninferior to in-clinic transvaginal ultrasonography for producing clinical quality images and is equivalent for estimating antral follicle count. Virtual transvaginal ultrasonography had superior patient satisfaction and has potential to significantly expand patient access to fertility care.Funding Source: This study was sponsored by Turtle Health.Clinical Trial Registration: ClinicalTrials.gov, NCT04687189. [ABSTRACT FROM AUTHOR]