Assessment of Urinary Dysfunction After Midurethral Sling Placement: A Comparison of Two Voiding Trial Methods.

STUDY OBJECTIVE: Temporary urinary retention after midurethral sling (MUS) surgery requiring indwelling catheter or self-catheterization usage is common. Different methods for assessment of immediate postoperative urinary retention have been described. This study aimed to compare postoperative voiding trial (VT) success after active vs passive VT in women undergoing MUS surgery. DESIGN: Comparative retrospective cohort study. SETTING: Female pelvic medicine and reconstructive surgery practice at a university-affiliated tertiary medical center. PATIENTS: Patients with stress urinary incontinence who underwent surgical treatment during the study period were eligible for inclusion. Excluded were patients younger than the age of 18 years, combined cases with other surgical services, planned laparotomy, and a history of urinary retention and patients for whom their VT was performed on postoperative day 1. The cohort was divided into 2 groups: (1) patients who underwent an active retrofill of their bladder using a Foley catheter and (2) patients who were allowed to have a spontaneous void. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: A total of 285 patients met the inclusion criteria for the study. Of these subjects, 94 underwent an active VT and 191 underwent a passive VT. There were no statistically significant differences in immediate postoperative urinary retention (30.8% vs 29.3%; p = .79) or time from surgery end to VT (233.0 ± 167.6 minutes vs 203.1 ± 147.8 minutes; p = .13) between groups. Urinary retention, as defined by a failed VT, increased from 10% to 29.3% when MUS placement was accompanied by concomitant prolapse repair procedure. Multivariate logistic regression analysis revealed that undergoing a combined anterior and posterior colporrhaphy (odds ratio [OR], 5.13; p <.001) and undergoing an apical prolapse procedure (OR, 2.75; p = .004) were independently associated with immediate postoperative urinary retention whereas increased body mass index (OR, 0.89; p <.001) lowered likelihood of retention. CONCLUSION: The method used to assess immediate postoperative urinary retention did not affect VT success. Concomitant combined anterior and posterior colporrhaphy and apical suspension were correlated with greater likelihood of VT failure whereas increased body mass index decreased odds of retention.

Postoperative complications and unanticipated healthcare encounters following mini-laparotomy vs. laparoscopic/robotic-assisted sacrocolpopexy: a comparative retrospective study.

BACKGROUND: Pelvic organ prolapse is a debilitating condition impacting lives of millions of women worldwide. Sacrocolpopexy (SCP) is considered an effective and durable surgical technique for treatment of apical prolapse. The aim of this study was to compare short-term outcomes including postoperative complications and unanticipated healthcare encounters between patients who underwent SCP with a mini-laparotomy approach compared to patients treated with laparoscopic and robotic-assisted laparoscopic SCP. METHODS: This was a retrospective cohort study including patients treated for apical prolapse at a university affiliated urogynecology practice. Patients over the age of 18 who underwent abdominal SCP between 2019 and 2023 were included. The cohort was formed into two groups: (1) Patients who underwent SCP through a mini-laparotomy incision (Mini-lap group); (2) Patients who underwent laparoscopic or robotic-assisted laparoscopic SCP (Lap/Robot group). RESULTS: A total of 116 patients were included in the final analysis. Ninety patients underwent either laparoscopic or robotic-assisted SCP, whereas 26 patients underwent SCP with a mini-laparotomy approach. Study participants exhibited a mean age of 63.1 ± 10.3 years, mean body mass index (BMI) of 25.8 ± 4.9 Kg/m2, and 77.6% of them identified as Caucasian. Upon comparison of demographic and past medical history between groups there were no statistically significant differences in age, BMI, menopausal status, race, parity or comorbid conditions. Patients in the Mini-lap group were less likely to have undergone previous abdominal surgery (11.5% vs. 50.6%, p < 0.001) and had more severe apical prolapse (stage 4 prolapse, 40% vs. 21.2%, p < 0.001) than their counterparts in the Lap/robot group. Regarding intraoperative parameters, length of surgery was significantly shorter in the Mini-lap group compared to the Lap/robot group (97.3 ± 35.0 min vs. 242.0 ± 52.6 min, p < 0.001). When focusing on the primary outcome, postoperative complications within the first 30 days after surgery, there were no differences noted between groups. Additionally, the number of unanticipated healthcare encounters, such as phone calls, clinic visits, emergency department visits, urgent care visits, readmissions and reoperations were similar between groups. CONCLUSIONS: Mini-laparotomy approach for SCP is safe with comparable intra- and postoperative complications, and unanticipated healthcare encounters compared to conventional minimally invasive methods.

Should Penicillin Allergy Testing Be Included as Part of Preoperative Testing?

INTRODUCTION: Penicillin allergy is the most commonly reported drug allergy in the United States. Patients labeled with penicillin allergy are at risk of receiving broad-spectrum antibiotics for surgical site infection prophylaxis, which can lead to increased antibiotic resistance, higher morbidity, suboptimal antibiotic therapy, and higher medical costs. This study aimed to determine the true prevalence of penicillin allergy among surgical patients and to decrease the unnecessary use of broad-spectrum antibiotics. METHODS: A retrospective chart review was performed of patients who underwent urogynecologic surgery in 2017. In 2018, a quality initiative was started, and all patients reporting penicillin allergies were offered antibiotic allergy testing as part of their preoperative testing. RESULTS: In 2017, 15% of patients reported penicillin allergy and 52% of them received surgical prophylaxis with broad-spectrum antibiotics. In 2018, 463 patients underwent surgery, 55 of whom reported penicillin allergy and were offered penicillin allergy testing. 35 (64%) agreed to proceed with testing, and of those tested, 33 (94%) tested negative for penicillin allergy. CONCLUSIONS: 94% of patients with stated penicillin allergy who consented to allergy testing proved to have negative test. Penicillin allergy testing should be considered as part of preoperative management.

A prospective, randomized trial comparing intravesical dimethyl sulfoxide (DMSO) to bupivacaine, triamcinolone, and heparin (BTH), for newly diagnosed interstitial cystitis/painful bladder syndrome (IC/PBS).

INTRODUCTION AND HYPOTHESIS: The primary aim of this study was to compare the effect of bladder instillations using dimethyl sulfoxide (DMSO) with triamcinolone versus bupivacaine, triamcinolone, and heparin (BTH) in women with newly diagnosed interstitial cystitis/painful bladder syndrome. The primary outcome was improvement in symptoms measured using the O'Leary-Sant Interstitial Cystitis Symptoms Index (ICSI) score. Secondary comparisons included changes in urinary frequency, nocturia, and bladder capacity. MATERIALS AND METHODS: This was a prospective, randomized study. Patients with a recent diagnosis of interstitial cystitis/painful bladder syndrome (IC/PBS) were randomized 1:1 to treatment with either 6 weekly bladder instillations of DMSO with triamcinolone or BTH. During follow-up visits, patients completed the ICSI questionnaire, and bladder capacity was determined through the retrograde filling of the bladder. The χ2 test or Student's t test were used for data analysis. RESULTS: A total of 83 patients were randomized, and final analysis included 70 participants who completed the 6 weekly instillations (42 DMSO, 28 BTH). The groups were similar in baseline demographics and clinical characteristics, except for cystometric maximum capacity (DMSO 338.62± 139.44 mL, BTH 447.43 ± 180.38 mL, p = 0.01). In the DMSO group, 63% of patients had a greater than 29.5% reduction in total ICSI score versus 43% in the BTH group (p = 0.15). Nocturia and pain were significantly reduced in the DMSO group. There was a significant increase from baseline in bladder capacity for both groups. CONCLUSION: In women with newly diagnosed IC/PBS, bladder instillations with DMSO and triamcinolone provide greater improvement in pain and nocturia compared to BTH.

Long term surgical outcomes of vaginal colposuspension using the Uphold Lite™ mesh system vs. vaginal vault uterosacral ligament suspension for treatment of apical prolapse.

OBJECTIVE: The aim of this study is to compare long-term outcomes (7-10 years) between vaginal hysterectomy with uterosacral ligament suspension (VHUSLS) and sacrospinous hysteropexy with the Uphold™ Lite mesh System (SHU) for management of apical prolapse. METHODS: Patients undergoing VHUSLS or SHU from 2008 to 2012 at a single tertiary referral center were included. Patients were contacted, asked to return for physical examination, and to complete the Pelvic Floor Distress Inventory (PFDI-20) questionnaire. Our primary outcome was anatomic failure defined as Stage 2 POP or higher of any compartment. The secondary outcome was subjective changes in symptoms based upon PFDI-20 responses. RESULTS: Two-hundred and two women were identified to have undergone the index surgeries from 2008 to 2012. Sixty-three agreed to return for follow up symptom evaluation and examination (30 VHUSLS and 33 SHU). Baseline characteristics were similar between groups. Clinical cure was high for both groups reaching 93.4 % and 94.0 % for the VHUSLS and SHU groups, respectively (p = 0.721). Anatomical success was lower with 44.7 % and 66.7 % of patients in the VHUSLS and SHU groups, respectively, meeting criteria for success (p = 0.138). There were no mesh complications among patients returning for exams. However, two patients who were contacted and were not interested in this study reported mesh complications and need for additional surgeries. Anterior vaginal wall support was noted to be significantly better supported for SHU (Ba -2.03 ± 0.75 vs -1.42 ± 0.92, p = 0.008). There were no differences between groups for overall PFDI-20 scores postoperatively. However, SHU patients reported higher rates of stress urinary incontinence compared to VHUSLS patients. CONCLUSION: In women with apical prolapse, VHUSLS and SHU afford similar long-term outcomes. SHU patients reported higher rates of stress urinary incontinence.

Risk factors for unplanned admission following surgical repair of apical prolapse.

INTRODUCTION AND HYPOTHESIS: Same-day discharge (SDD) is increasing in popularity following surgical repair of pelvic organ prolapse. The aim of this study was to evaluate factors associated with unplanned admission (UA) in women undergoing apical prolapse repair. METHODS: This retrospective, observational cohort study included patients who underwent apical prolapse repair and planned same-day discharge (SDD) between March 2019 and December 2021. The cohort was divided into two groups: patients who were discharged on the same day as surgery (SDD group) and patients who had an unplanned admission (UA group). Demographic, pre-, intra-, and post-operative data were collected. Risk factors associated with unplanned admission were evaluated using univariate and multivariate analyses. RESULTS: One-hundred and eighty-four cases of apical prolapse repair met the criteria for inclusion in the final analysis; this included 142 in the SDD group and 42 in the UA group. Patients in the UA group had significantly increased estimated blood loss, longer total operative time, later time arriving to the Post-Anesthesia Care unit (PACU) and longer overall stay in the PACU. No differences were observed in the 30-day complication rate, or 30-day unanticipated healthcare encounters, between groups. Multivariate analysis revealed that receiving ketorolac post-operatively was associated with a higher likelihood of SDD (OR=2.6, 95% CI 1.032-6.580, p=0.043). CONCLUSIONS: Among women undergoing apical prolapse repair, same-day discharge was associated with comparable immediate and 30-day complication rates. Within our cohort, post-operative treatment with ketorolac was associated with greater likelihood of SDD.

Effect of less aggressive treatment on diabetic retinopathy severity scale scores: analyses of the RIDE and RISE open-label extension.

OBJECTIVE: To evaluate factors associated with Diabetic Retinopathy Severity Scale (DRSS) changes with less frequent ranibizumab after induction therapy. METHODS AND ANALYSIS: Post hoc analyses of RIDE/RISE and their open-label extension (OLE). Analyses included patients with diabetic retinopathy (DR)/diabetic macular oedema who completed the OLE. Comparisons were made between patients with improved/maintained (≥0 step decrease from OLE baseline (month 36) to month 48) versus worsened (≥1 step increase) DRSS during the OLE. DRSS changes over 12 months were compared between patients randomised to ranibizumab at RIDE/RISE baseline who improved to DRSS score ≤43 at OLE baseline (induced) versus those randomised to sham with DRSS score ≤43 at RIDE/RISE baseline (native). RESULTS: From OLE baseline to month 48, 72% (263/367) of patients improved/maintained DRSS scores. These patients had similar mean best-corrected visual acuity at RIDE/RISE (56.4 letters) and OLE baseline (68.6 letters) versus patients with worsened scores (58.2 and 70.8 letters). Patients who improved/maintained DRSS scores had similar mean central foveal thickness at RIDE/RISE (492 µm) and OLE baseline (196 µm) versus patients with worsened scores (441 and 167 µm). Patients who improved/maintained DRSS scores received a significantly higher (p<0.0001) mean number of pro re nata (PRN) injections (4.4) between OLE baseline and month 48 versus those with worsened scores (2.3). Patients with more severe DR at baseline who achieved mild-to-moderate non-proliferative DR (NPDR) induced by monthly ranibizumab injections were significantly more likely to worsen (p<0.0001) than those with mild-to-moderate NPDR at baseline randomised to sham injections (1.0-step versus 0.1-step worsening). CONCLUSIONS: Most patients improved/maintained DRSS scores with less-than-monthly PRN ranibizumab. Some minimum treatment/monitoring may be necessary to maintain improvements after induction therapy. TRIAL REGISTRATION NUMBERS: NCT00473382/NCT00473330.

Same-day Discharge vs Planned Admission after Surgical Treatment for Apical Prolapse.

STUDY OBJECTIVE: Same-day discharge (SDD) after surgery is becoming more common, with studies supporting the safety of this practice in gynecologic surgeries. The aim of this study was to compare short-term outcomes of SDD with planned admission in patients undergoing apical pelvic organ prolapse repair, through 30-day complications and 30-day unanticipated healthcare encounters. SETTING: Female pelvic medicine and reconstructive surgery practice at a university-affiliated tertiary medical center. PATIENTS: Patients with apical prolapse who underwent surgical treatment during the study period were eligible for inclusion. Excluded were patients under the age of 18, cases planned for SDD with an unexpected admission, cases with a planned open procedure, and those performed in combination with another surgical service. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: A total of 296 patients were included in the final analysis. A total of 154 patients had a planned admission, and 142 were discharged on the day of surgery (SDD group). There were no differences in reoperations, development of venous thromboembolism, and blood transfusions between the 2 groups. Patients in the SDD group were more likely to have no postoperative complications (95% vs 88.3%, p = .037). Number of unanticipated urogynecology office visits, urgent/immediate care visits, readmissions, or unplanned phone calls were also similar between the 2 groups. There was a statistically significant difference observed in mean emergency department (ED) visits (0.16 ± 0.40 in the planned admission group vs 0.06 ± 0.27 in the SDD group, p = .02); however, this number was low in both groups. CONCLUSION: This comparative study suggests that SDD after apical prolapse repair is safe and may be considered for patients interested in this option.

PNEUMATIC WITHOUT PEXY: A CASE REPORT OF A RETINAL DETACHMENT REPAIR.

PURPOSE: To present a case of pneumatic retinal detachment repair that did not require retinal pexy. METHODS: Report of a case and review of the literature. RESULTS: Pneumatic retinopexy was performed with a plan for photocoagulation of the retinal tear once the retina was reattached. During postoperative evaluation, the superotemporal retinal tear had operculated and the retina was reattached. No laser or cryopexy was performed, and the retina remained attached during long-term follow-up. DISCUSSION: Addressing traction on the retina and intraocular microcurrents that allow subretinal fluid accumulation is the core principle of detachment repair; if the traction is released, pexy may not be necessary.

Urethral support in female urinary continence part 1: dynamic measurements of urethral shape and motion.

INTRODUCTION AND HYPOTHESIS: Urethral closure mechanism dysfunction in female stress urinary incontinence (SUI) is poorly understood. We aimed to quantify these mechanisms through changes in urethral shape and position during squeeze (voluntary closure) and Valsalva (passive closure) via endovaginal ultrasound in women with varying SUI severity. METHODS: In this prospective cohort study, 76 women who presented to our tertiary center for urodynamic testing as preoperative assessment were recruited. Urodynamics were performed according to International Continence Society criteria. Urethral pressures were obtained during serial Valsalva maneuvers. Urethral lengths, thicknesses, and angles were measured in the midsagittal plane via dynamic anterior compartment ultrasound. Statistical shape modeling was carried out by a principal component analysis on aligned urethra shapes. RESULTS: Age, parity, and BMI did not vary by SUI group. Ultrasound detected a larger retropubic angle, urethral knee-pubic bone angle (a novel measure developed for this study), and infrapubic urethral length measurements at Valsalva in women with severe SUI (p = 0.016, 0.015, and 0.010). Shape analysis defined increased "c" shape concavity and distal wall pinching during squeeze and increased "s" shape concavity and distal wall thickening during Valsalva (p < 0.001). It also described significant urethral shape differences across SUI severity groups (p < 0.001). CONCLUSIONS: Dynamic endovaginal ultrasound can visualize and allow for quantification of voluntary and passive urethral closure and variations with SUI severity. In women with severe SUI, excessive bladder neck and distal urethra swinging during Valsalva longitudinally compressed the urethra, resulting in a proportionally thicker wall at the mid-urethra and urethral knee.

Methenamine hippurate compared with trimethoprim for the prevention of recurrent urinary tract infections: a randomized clinical trial.

INTRODUCTION AND HYPOTHESIS: The objective was to find an alternative treatment to a low-dose antibiotic for the prevention of recurrent urinary tract infections (UTI) and to evaluate the difference in rates of reinfection within 1 year when treated with methenamine hippurate for prophylaxis compared with trimethoprim. METHODS: We present a non-blinded randomized trial comparing methenamine hippurate with trimethoprim for the prevention of recurrent UTI at 12 months after starting treatment. Women over 18 who had at least two culture-positive UTI in the prior 6 months or three in the prior year were included. Ninety-two patients met enrollment criteria and were randomized to receive daily prophylaxis with methenamine hippurate or trimethoprim for a minimum of 6 months. Both intent-to-treat and per-protocol analyses if patients received the alternative drug after randomization were analyzed using Student's t test, Mann-Whitney U test, Kaplan-Meier curves, log-rank test, and a logistic and multivariate regression model. The primary outcome of this study was culture-proven UTI recurrence by 12 months after initiating prophylaxis. RESULTS: In the intent-to-treat analysis, we found no difference between groups in recurrent UTI, with a 65% (28 out of 43) recurrence in the trimethoprim group versus 65% (28 out of 43) in the methenamine hippurate group (p = 1.00). In the per-protocol analysis, 65% (26 out of 40) versus 65% (30 out of 46) of patients had UTI recurrences in the trimethoprim group versus the methenamine hippurate group (p = 0.98). CONCLUSIONS: Methenamine hippurate may be an alternative for the prevention of recurrent UTI, with similar rates of recurrence and adverse effects to trimethoprim.

Pelvic floor architectural defects in female patients with urge fecal incontinence versus passive fecal leakage: a dynamic ultrasound study.

INTRODUCTION AND HYPOTHESIS: Fecal incontinence (FI) has two primary subtypes: urgency fecal incontinence (UFI) and passive fecal leakage (PFL). The pathophysiology underlying the subtypes is incompletely understood. OBJECTIVES: To compare the bowel habits, physical examinations and pelvic floor anatomical defects in patients with UFI-dominant FI versus patients with PFL-dominant FI. STUDY DESIGN: This is a retrospective cross-sectional study of female patients who presented with fecal incontinence symptoms to our tertiary urogynecology center. All subjects underwent a comprehensive history, physical examination, 3D-static pelvic floor ultrasound, and 2D-dynamic ultrasound of the posterior compartment. Patients with UFI-dominant FI were compared to patients with PFL-dominant FI. RESULTS: One hundred forty-five patients were included in the analysis; 57 categorized as UFI-dominant FI, 69 PFL-dominant FI and 19 categorized as having "both" leakage patterns. In comparing bowel habits, patient with UFI-dominant FI had more frequent bowel movements (15.5 ± SD 13.0/week vs. 10.9 ± SD 7.6 /week, p = 0.022) and were more likely to have loose stools (48.2% vs. 26.1%, p = 0.01). No statistically significant differences were observed in the prevalence of external anal sphincter defect (11.3% vs. 17.2%, p = 0.38) or internal anal sphincter defect (11.3% vs. 19%, p = 0.26) between groups. Finally, patients with UFI-dominant FI had a higher incidence of rectal hypermobility (loss of rectal support on Valsalva) (58% vs. 36.9%, p = 0.025). CONCLUSION: Patients with urge-predominant FI have increased frequency of bowel movements, looser stools, and increased rectal folding diagnosed via dynamic ultrasound as compared to patients with passive-dominant FI.

Safety and Tolerability of Intravitreal Carotuximab (DE-122) in Patients With Persistent Exudative Age-Related Macular Degeneration: A Phase I Study.

Purpose: Carotuximab (DE-122) is a novel endoglin antibody that exhibits potent anti-angiogenic activity. The aim of this study was to evaluate the safety and tolerability of a single intravitreal injection of four ascending doses of carotuximab in patients with persistent exudative age-related macular degeneration (AMD). Methods: In an open-label, dose-escalating, sequential cohort study, patients with persistent exudative AMD were assigned to an intravitreal injection of carotuximab 0.5 mg, 1.0 mg, 2.0 mg, or 4.0 mg (n = 3 per group). Safety and change in central subfield thickness (CST), as measured by spectral domain-optical coherence tomography, were assessed from baseline until day 90. Rescue therapy with an anti-vascular endothelial growth factor medication was allowed on days 8, 30, and 60. Results: Seven patients (58%) experienced at least one adverse event (AE), including five patients (41.7%) who experienced one or more AEs in the study eye and two patients (16.7%) who experienced one or more non-ocular AEs. Posterior eye deposits were reported in one patient 2 days after receiving 1.0 mg, but they resolved spontaneously by day 43. A >50-µm reduction in CST on two consecutive visits was observed in four patients (33%), including one patient in each dose cohort. Conclusions: In this study, carotuximab was generally well tolerated, with no serious AEs reported, when administered as a single intravitreal injection to patients with persistent exudative AMD. Translational Relevance: Further characterization of the safety and efficacy of carotuximab will be needed to determine what role it may have in the treatment of exudative AMD.

Brolucizumab-associated intraocular inflammation in eyes without retinal vasculitis.

PURPOSE: To analyze a series of eyes with brolucizumab-associated intraocular inflammation (IOI) without retinal vasculitis reported to the American Society of Retina Specialists (ASRS). METHODS: The ASRS Research and Safety in Therapeutics (ReST) Committee analyzed clinical characteristics from submitted reports of IOI after brolucizumab. Eyes with retinal vasculitis or that received intraocular antibiotics were excluded. RESULTS: Forty-nine eyes of 45 patients were collected. Mean visual acuity (VA) at baseline was 20/49 (range 20/20 - 5/200). Patients presented with IOI a mean of 24 (range 3-63) days after most recent brolucizumab injection; 61% presented for an unscheduled visit while 39% presented at routine follow-up. Mean VA at IOI presentation was 20/67 (range 20/20 - 3/200). Most common symptoms were floaters (78%) and blurry vision (76%). Pain (20%) and redness (16%) were less common; 3 (6%) eyes were asymptomatic. IOI was anterior only in 18%, posterior only in 31%, and both anterior and posterior in 51% of eyes. Treatment included topical steroids alone in 67% eyes, while 10% eyes received no treatment. Mean VA at last follow-up was 20/56 (range 20/20 - 1/200). Three (6%) eyes lost 3 or more lines and 1 (2%) eye lost 6 or more lines. CONCLUSIONS: Brolucizumab-associated IOI without retinal vasculitis typically presented with a delayed onset of a few weeks. Often, visual acuity decline was relatively mild. Most symptoms resolved and nearly all had a return to baseline VA, but a small percentage of patients had a significant decrease in VA at last follow-up.

Obstructed Defecation Symptom Severity and Degree of Rectal Hypermobility and Folding Detected by Dynamic Ultrasound.

ABSTRACT: We used dynamic pelvic floor ultrasound to investigate the relationship between obstructed defecation symptom (ODS) severity and the degree of rectal hypermobility/folding. In this retrospective study, women who presented with ODS from October 2017 to January 2019 and underwent an interview, pelvic examination, and pelvic floor ultrasound were recruited. Patients were diagnosed with abdominal constipation, dyssynergia, or pelvic constipation. Pelvic constipation patients were categorized based on their reported frequency of incomplete emptying of stool (<50% or ≥50% of bowel movements) representing mild and severe ODS, respectively. Using dynamic ultrasound, rectal hypermobility was quantified via rectovaginal septum length at rest and Valsalva and its compression ratio, where shorter lengths and larger compression ratios are indicative of increased rectal hypermobility. One hundred twenty-one patients (41 with abdominal constipation, 7 with dyssynergia, and 73 with pelvic constipation) were included. Compression ratios were higher in women with severe versus mild ODS (17.36 ± 16.89 vs 36.38 ± 25.82, P = 0.0039). The risk of having severe symptoms was 4 times greater (odds ratio = 4.2, 95% confidence interval = 1.4 to 12.6, P = 0.01) among those with a high compression ratio (≥20%) after controlling for age, body mass index, and levator plate descent angle. Incomplete emptying was weakly, positively, linearly correlated with rectal hypermobility/folding (r = -0.2724, -0.3767 to 0.3922, and P = 0.0197, 0.0010, 0.0006, respectively). Women with more severe ODS experienced more rectal hypermobility/folding as measured via dynamic ultrasound-a cheaper, effective alternative to magnetic resonance defecography for evaluation of obstructed defecation.

Impact of Delayed Time to Treatment on Visual Outcomes in Neovascular AMD: Data From the HARBOR Study.

BACKGROUND AND OBJECTIVE: To determine the potential impact on visual outcomes of delayed treatment initiation in patients with neovascular age-related macular degeneration (nAMD). PATIENTS AND METHODS: Post hoc analysis of anti-vascular endothelial growth factor treatment-naïve patients with nAMD from HARBOR. Time to treatment was defined as first ranibizumab injection date minus screening date. Comparisons were made between the prompt (≤ 6 days) versus delayed (> 10 days) treatment groups. Main outcome measures were best-corrected visual acuity (BCVA) change over time, BCVA, number of ranibizumab injections, and proportion of 3-line gainers/losers. RESULTS: In HARBOR, more than 50% of patients received their first injection within 7 days of screening, with mean (median) time to treatment of 4.6 (5) and 15.9 (14) days for the prompt and delayed treatment groups, respectively. Mean (95% confidence interval [CI]) BCVA change from baseline to Month 24 was 9.1 (7.4-10.8) and 8.8 (6.7-10.8) Early Treatment Diabetic Retinopathy Study letters in the prompt (n = 395) and delayed (n = 230) treatment groups, respectively. Mean (95% CI) total number of ranibizumab injections for the as-needed arms was 12.4 (11.6-13.3) and 11.4 (10.3-12.4) for the prompt and delayed treatment groups, respectively. CONCLUSION: In HARBOR, time from screening to first ranibizumab injection did not seem to significantly affect mean BCVA change or number of injections. [Ophthalmic Surg Lasers Imaging Retina. 2021;52:62-69.].

PARTICULATE MATTER FROM SYRINGES USED FOR INTRAVITREAL INJECTIONS.

BACKGROUND: Syringes containing anti-vascular endothelial growth factor drugs to treat retinal diseases are prepared in different ways by various parties with syringe selection, preparation, and storage conditions affecting the risk of injecting particles into the vitreous. This study examines particle loads from various syringes over time. METHODS: Four syringes were studied: two plastic transfer syringes lubricated with silicone oil or oleamide, a glass syringe with baked-on silicone, and a lubricant-free polymer syringe. Syringes were rinsed with water or filled with buffer and analyzed over time; particles were quantified by flow imaging. Particle formation in a bevacizumab formulation was also characterized. RESULTS: Insulin syringes consistently showed very high particle counts. Oleamide-lubricated syringes had substantially fewer particles, but showed appreciable increases over time (leading to visible particles). Baked-on silicone glass syringes and lubricant-free polymer syringes both showed low particle levels ≥10 µm. Lubricant-free syringes showed the lowest particle levels ≥1 µm and the lowest particle levels with bevacizumab agitation. CONCLUSION: Syringes have different intrinsic particle loads which can contribute to particle loads in the delivered drug. Oleamide-lubricated transfer syringes, commonly used for bevacizumab repackaging, have time-dependent particle loads and are associated with the formation of visible particles beyond 30 days of storage.

Statistical shape modeling of the pelvic floor to evaluate women with obstructed defecation symptoms.

Obstructed defecation (OD) is common and may be related to compromised pelvic floor integrity. Magnetic resonance (MR) defecography and statistical shape modeling were used to define pelvic floor shape variations, hypothesizing that State (rest vs peak evacuation) and Group (control vs case) would significantly influence shape. 16 women underwent MR defecography (9 cases vs 7 controls). Midsagittal, 2D pelvic floors were segmented and aligned by corresponding points. Principal component scores were compared using a Two-Way Mixed MANOVA. Three modes described differences between State (p < 0.001) and Group (p = 0.023). The pelvic floor shape differed significantly between women with and without OD and during evacuation.

Transvaginal sacrospinous ligament suture rectopexy for obstructed defecation symptoms: 1-year outcomes.

INTRODUCTION AND HYPOTHESIS: The current study was aimed at investigating the safety, efficiency, and durability of transvaginal sacrospinous ligament suture rectopexy in women with obstructed defecation symptoms (ODS) and significant rectal hypermobility/folding. METHODS: This was a prospective case series study performed during December 2018 to July 2020. Women presenting to our center with pelvic organ prolapse electing for surgical treatment were screened for ODS utilizing the PFDI-20 questionnaire. Patients were eligible for inclusion if they reported OD symptoms accompanying >50% of bowel movements (BMs), BM frequency ≥3 per week, stool type 3 or 4 based on the Bristol stool chart, absence of dyssynergic Valsalva, and dynamic ultrasound indicating a rectal compression ratio >25%. Patients underwent transvaginal sacrospinous ligament rectopexy and were followed up at 2 and 12 months postoperatively. RESULTS: A total of 20 patients underwent the procedure and completed the follow-up. Statistically significant improvements were observed in all OD symptoms and subjective improvement (94.7% ± 13.4 and 90.6% ± 18) at 2 and 12 months after the surgery respectively. Mean rectal compression ratio, detected via ultrasound, improved from 45.5% ± 18.4 preoperatively to 9.2% ± 13.7 at 2 months (p < 0.0001) and 19.6% ± 14.4 at 12 months (p < 0.0012). Surgical failure, defined as combined subjective (ODS >50% of bowel movements) and anatomical failure (rectal compression ratio >25%), occurred in 2 patients. CONCLUSION: Transvaginal sacrospinous ligament suture rectopexy was safe, feasible, and effectively treated ODS within this cohort of women undergoing POP surgery with rectal hypermobility confirmed by dynamic ultrasound.

Occlusive Retinal Vasculitis Following Intravitreal Brolucizumab.

PURPOSE: To analyze a case series of retinal vasculitis reported to the American Society of Retina Specialists (ASRS) following Food and Drug Administration approval of brolucizumab for treatment of neovascular age-related macular degeneration. METHODS: The ASRS Research and Safety in Therapeutics Committee analyzed clinical and imaging characteristics from submitted reports of retinal vasculitis after brolucizumab. RESULTS: Retinal vasculitis was reported in 26 eyes of 25 patients (22 [88%] female) after treatment with brolucizumab. Imaging studies were available for 24 of 26 eyes. Most cases (92%) were associated with intraocular inflammation, which presented at a mean of 25 days (range, 3-63 days) after the most recent brolucizumab injection. Mean visual acuity (VA) was 20/52 (range, 20/25-4/200) before the adverse event, 20/151 (range, 20/25-hand motion) at presentation of the adverse event, and 20/243 (range, 20/30-light perception) at last follow-up. Twelve eyes (46%) had a greater than 3-line decrease in VA at final follow-up, and 12 eyes (46%) had a final VA of 20/200 or worse. Analysis of retinal imaging identified vasculopathy that involved retinal arteries (91%), retinal veins (79%), and choroidal vessels (48%). Occlusive disease was apparent on imaging in 83% of eyes. Treatment approaches were varied. CONCLUSIONS: Retinal vasculitis has been identified in a series of eyes following brolucizumab. Although a few eyes in this series were asymptomatic or minimally symptomatic, some eyes had significant vision loss. A careful examination for signs of active inflammation prior to brolucizumab injection is recommended. Once vasculopathy is suspected, angiographic imaging may help define the spectrum of involvement. Optimal treatment strategies remain unknown.