The Response of the Urinary Microbiome to Botox.

INTRODUCTION AND HYPOTHESIS: Our objective was to evaluate if botox alters the urinary microbiome of patients with overactive bladder and whether this alteration is predictive of treatment response. METHODS: This multicenter prospective cohort study included 18-89-year-old patients undergoing treatment for overactive bladder with 100 units of botox. Urine samples were collected by straight catheterization on the day of the procedure (S1) and again 4 weeks later (S2). Participants completed the Patient Global Impression of Improvement form at their second visit for dichotomization into responders and nonresponders. The microbiome was sequenced using 16s rRNA sequencing. Wilcoxon signed rank and Wilcoxon rank sum were used to compare the microbiome, whereas chi-square, Wilcoxon rank sum, and the independent t-test were utilized for clinical data. RESULTS: Sixty-eight participants were included in the analysis. The mean relative abundance and prevalence of Beauveria bassiana, Xerocomus chrysenteron, Crinipellis zonata, and Micrococcus luteus were all found to increase between S1 and S2 in responders; whereas in nonresponders the mean relative abundance and prevalence of Pseudomonas fragi were found to decrease. The MRA and prevalence of Weissella cibaria, Acinetobacter johnsonii, and Acinetobacter schindleri were found to be greater in responders than nonresponders at the time of S1. Significant UM differences in the S1 of patients who did (n = 5) and did not go on to develop a post-treatment UTI were noted. CONCLUSIONS: Longitudinal urobiome differences may exist between patients who do and do not respond to botox.

Characterization of a Peruvian coastal fishery targeting the Pacific guitarfish Pseudobatos planiceps.

From December 2012 to June 2014, 796 Pacific guitarfish were caught in 183 fishing sets in northern Peru. Catch occurred in 86.3% of sets. Most individuals caught were mature with a bias toward males. The mean total length for females and males was 83.4 cm, and 91.1 cm, respectively. The capture per unit effort (CPUE) was 12.6 ± 3.4 guitarfish (km.12 h)-1. The length-weight relationships showed that this species presents a sexual dimorphism in growth. These results support the importance of Sechura Bay as a key area for this species. This study represents the first species-specific fishery data for the Pacific guitarfish.

At-sea solid waste production by a small-scale fishery in Peru.

Marine litter is a growing environmental problem for which fisheries-sourced waste remains poorly understood. In Peru, there is an ongoing challenge of waste management from the small-scale fisheries fleet given the lack of facilities to receive the variety of debris produced by fishers, which includes hazardous wastes such as batteries. In this study, onboard solid waste production was monitored daily by land-based observers upon landing at the port of Salaverry, Peru, from March to September 2017. The analysed small-scale gillnet and longline fishing fleets produced annually an estimated 11,260 kg of solid waste. Of particular concern is the production of single use plastics (3427 kg) and batteries (861 kg) due to their potential long-lasting impacts on the environment and challenges related to their proper disposal. A management plan for solid waste has been developed for Salaverry; therefore, a subsequent assessment was conducted in 2021-2022 of the behaviours and perceptions of fishers regarding the implementation of this plan. Most fishers (96%) reported disposing of their waste on land, except organic waste which is disposed of at sea. While fishers in Salaverry have become more conscious of the issues surrounding at-sea waste disposal and have an interest in better segregating and managing their waste, there remains a need for improved waste management and recycling protocols and procedures at the port to make this possible.

Does the setting for intradetrusor onabotulinumtoxinA injection for management of overactive bladder matter?

Introduction: Intradetrusor onabotulinumtoxinA (Botox) injections, to treat idiopathic overactive bladder (OAB), can be performed in the office setting under local analgesia alone or in the operating room (OR) under local and/or sedation. The objective of this study was to compare the symptomatic improvement in patients with OAB who underwent treatment with intradetrusor onabotulinumtoxinA injections in an in-office versus the OR setting. Methods: We performed a multicenter retrospective cohort study of women with the diagnosis of refractory non-neurogenic OAB who elected to undergo treatment with intradetrusor onabotulinumtoxinA injections between January 2015 and December 2020. The electronic medical records were queried for all the demographic and peri-procedural data, including the report of subjective improvement post procedure. Patients were categorized as either "in-office" versus "OR" based on the setting in which they underwent their procedure. Results: Five hundred and thirty-nine patients met the inclusion criteria: 297 (55%) in the in-office group and 242 (45%) in the OR group. A total of 30 (5.6%) patients reported retention after their procedure and it was more common in the in-office group (8.1%) versus the OR group (2.5%), (P = 0.003). The rate of urinary tract infection within 6 months of the procedure was higher in the OR group (26.0% vs. 16.8%, P = 0.009). The overall subjective improvement rate was 77% (95% confidence interval: 73%-80%). Patients in the OR group had a higher reported improvement as compared to the in-office group (81.4% vs. 73.3%, P = 0.03). Conclusions: In this cohort study of patients with OAB undergoing intradetrusor onabotulinumtoxinA injections, post procedural subjective improvement was high regardless of the setting in which the procedure was performed.

A novel anchoring system for pelvic organ prolapse repair: an observational study.

INTRODUCTION AND HYPOTHESIS: Sacrospinous ligament (SSL) fixation is an effective and widely used vaginal procedure for correcting apical prolapse. The Saffron Fixation System (Coloplast Corp., Minneapolis, MN, USA) is a new anchoring device aimed at facilitating a durable, easy, and short procedure for SSL fixation with the goal of minimizing operative complications. The objective was to demonstrate the efficacy and safety of anchor deployment and suture fixation for pelvic organ prolapse repair using the Saffron Fixation System. METHODS: An observational human cadaver study was conducted to measure the distance between anchor location and anatomical landmarks in the pelvis, and the holding force of the fixated anchors. Anchors were placed in four human cadavers by different implanters. The pull-out force of these anchors was measured to assess efficacy (three cadavers by three implanters) and the distance between anchors and primal vessels and nerves was measured to assess safety (one cadaver by one implanter). RESULTS: Nineteen out of 20 anchors (95%) were correctly placed as judged by independent assessment performed by non-implanting surgeons. Distance between anchors and surrounding nerves and vessels exceeded 10 mm. Mean (SD) pull out-force was 17.9 (5.6) N. CONCLUSION: The innovative anchoring device that was developed appeared to enable precise and solid anchor placement in the SSL. Future clinical studies are needed to explore if the theoretical advantages of this device translate to improved clinical outcomes in comparison with available suturing and anchoring devices.

Opioid use following pelvic reconstructive surgery: a predictive calculator.

INTRODUCTION AND HYPOTHESIS: Our objective was to evaluate the amount of opioids used by patients undergoing surgery for pelvic floor disorders and identify risk factors for opioid consumption greater than the median. METHODS: This was a prospective cohort study of 18- to 89-year-old women undergoing major urogynecological surgery between 1 November2020 and 15 October 2021. Subjects completed one preoperative questionnaire ("questionnaire 1") that surveyed factors expected to influence postoperative pain and opioid use. At approximately 1 and 2 weeks following surgery, patients completed two additional questionnaires ("questionnaire 2" and "questionnaire 3") about their pain scores and opioid use. Risk factors for opioid use greater than the median were assessed. Finally, a calculator was created to predict the amount of opioid used at 1 week following surgery. RESULTS: One hundred and ninety patients were included. The median amount of milligram morphine equivalents prescribed was 100 (IQR 100-120), whereas the median amount used by questionnaire 2 was 15 (IQR 0-50) and by questionnaire 3 was 20 (IQR 0-75). On multivariate logistic regression, longer operative time (aOR 1.64 per hour of operative time, 95% CI 1.07-2.58) was associated with using greater than the median opioid consumption at the time of questionnaire 2; whereas for questionnaire 3, a diagnosis of fibromyalgia (aOR=16.9, 95% CI 2.24-362.9) was associated. A preliminary calculator was created using the information collected through questionnaires and chart review. CONCLUSIONS: Patients undergoing surgery for pelvic floor disorders use far fewer opioids than they are prescribed.

Review of threats to the Pacific seahorse Hippocampus ingens (Girard 1858) in Peru.

Illegal wildlife trade has been identified as a major source of global commerce of seahorses. The Convention on International Trade in Endangered Species of Wild Fauna and Flora listed the genus Hippocampus in Appendix II in 2004, when several countries that commercialized these species also banned transactions through domestic legislation, Peru being one of them. Nevertheless, since the 2004 ban was decreed in Peru, transactions have continued, including international commerce, as well confiscations of illegal seahorse Hippocampus ingens (Girard 1858) products. The authors reviewed three official government sources for information on seahorse trade in Peru, identifying differences in the reporting of the two agencies that monitor exports and imports of seahorses, likely due to non-standardized use of product categorization codes (Partidas Arancelarias). Confiscations reported by one of the agencies confirmed that illegal trade continued despite the ban and in similar amounts of what was exported by Peru before the ban (1053 kg confiscated in 2019 vs. 1460 kg exported in 2004, an estimated 437,888 and 607,067 seahorses, respectively). This review highlights gaps in seahorse conservation in Peru, which include research gaps (e.g., taxonomy, biology and use of habitats) as well as the identification of fisheries impact and improvements in by-catch reporting. This review also highlights areas for possible improvement in international trade (e.g., standardized descriptions of Partidas) that ultimately would allow the country to follow the Convention for Illegal Trade of Endangered Species regulations for seahorses.

Lessons from 12 years of marine fauna stranding data in the south of Peru.

In Peru, while several mass mortality events have been reported in the last two decades, there has been minimal systematic stranding monitoring. In this study, we report on repeated stranding monitoring that took place between October 2003 and October 2015, at Ite beach, Tacna (17° 54' 47" S 70° 58' 21" W). The objectives of the study were to assess the proportion of strandings by taxon and whether there were seasonal effects on abundance of stranded marine fauna. The study location was assessed opportunistically by trained observers who recorded and identified every stranded marine animal to the highest taxonomic degree possible. Stranded specimens of seabirds and marine mammals were grouped into overarching taxa of coastal and oceanic seabirds, and cetaceans and carnivorans. A principal component analysis (PCA) to visualize the association among stranded taxa registered along the study period and sea surface temperature anomalies using the Oceanic El Niño Index (ONI 3.4) and El Niño Coastal Index (ICEN) indexes and a Kruskal-Wallis test were conducted to evaluate abundance differences among taxonomic groups, taxa strandings and seasons. A total of 17,827 carcasses were encountered, 92.4% was seabirds and 7.6% marine mammals. Differences in abundances were significant among coastal and oceanic seabirds and marine mammals. Significant differences among seasons for cormorants and boobies were also identified. Coastal seabirds and pinnipeds dominated the stranding counts. A massive mortality of cormorants and boobies was registered between June and July 2014 possibly due to a moderate El Niño event. These strandings provide valuable information that could help lay the groundwork for implementation of a stranding network and science-based management projects in southern Peru.

Green, yellow or black? Genetic differentiation and adaptation signatures in a highly migratory marine turtle.

Marine species may exhibit genetic structure accompanied by phenotypic differentiation related to adaptation despite their high mobility. Two shape-based morphotypes have been identified for the green turtle (Chelonia mydas) in the Pacific Ocean: the south-central/western or yellow turtle and north-central/eastern or black turtle. The genetic differentiation between these morphotypes and the adaptation of the black turtle to environmentally contrasting conditions of the eastern Pacific region has remained a mystery for decades. Here we addressed both questions using a reduced-representation genome approach (Dartseq; 9473 neutral SNPs) and identifying candidate outlier loci (67 outlier SNPs) of biological relevance between shape-based morphotypes from eight Pacific foraging grounds (n = 158). Our results support genetic divergence between morphotypes, probably arising from strong natal homing behaviour. Genes and enriched biological functions linked to thermoregulation, hypoxia, melanism, morphogenesis, osmoregulation, diet and reproduction were found to be outliers for differentiation, providing evidence for adaptation of C. mydas to the eastern Pacific region and suggesting independent evolutionary trajectories of the shape-based morphotypes. Our findings support the evolutionary distinctness of the enigmatic black turtle and contribute to the adaptive research and conservation genomics of a long-lived and highly mobile vertebrate.

Tamsulosin vs placebo to prevent postoperative urinary retention following female pelvic reconstructive surgery: a multicenter randomized controlled trial.

BACKGROUND: Postoperative urinary retention is common after female pelvic reconstructive surgery. Alpha receptor antagonists can improve dysfunctional voiding by relaxing the bladder outlet and may be effective in reducing the risk of postoperative urinary retention. OBJECTIVE: This study aimed to determine whether tamsulosin is effective in preventing postoperative urinary retention in women undergoing surgery for pelvic organ prolapse. STUDY DESIGN: This was a multicenter, double-blind, randomized controlled trial between August 2018 and June 2020, including women undergoing surgery for pelvic organ prolapse. Patients were excluded from recruitment if they had elevated preoperative postvoid residual volume, history of postoperative urinary retention, or a contraindication to tamsulosin. Those who experienced cystotomy were excluded from analysis. Participants were randomized to a 10-day perioperative course of tamsulosin 0.4 mg vs placebo, beginning 3 days before surgery. A standardized voiding trial was performed on postoperative day 1. The primary outcome was the development of postoperative urinary retention, as defined by the failure of the voiding trial or subsequent need for catheterization to empty the bladder. Secondary outcomes included the rate of urinary tract infection and the impact on lower urinary tract symptoms as measured by the American Urological Association Symptom Index. RESULTS: Of 119 patients, 57 received tamsulosin and 62 received placebo. Groups were similar in regard to demographics, preoperative prolapse and voiding characteristics, and surgical details. Tamsulosin was associated with a lower rate of postoperative urinary retention than placebo (5 patients [8.8%] vs 16 patients [25.8%]; odds ratio, 0.28; 95% confidence interval, 0.09-81; P=.02). The number needed to treat to prevent 1 case of postoperative urinary retention was 5.9 patients. The rate of urinary tract infection did not differ between groups. American Urological Association Symptom Index scores significantly improved after surgery in both groups (median total score, 14 vs 7; P<.01). Scores related to urinary stream improved more in the tamsulosin group than in placebo (P=.03). CONCLUSION: In this placebo-controlled trial, tamsulosin use was associated with a reduced risk of postoperative urinary retention in women undergoing surgery for pelvic organ prolapse.

Two-year outcomes of the ARTISAN-SNM study for the treatment of urinary urgency incontinence using the Axonics rechargeable sacral neuromodulation system.

AIMS: Sacral neuromodulation (SNM) is a guideline-recommended treatment with proven therapeutic benefit for urinary urgency incontinence (UUI) patients. The Axonics® System is the first Food and Drug Administration-approved rechargeable SNM system and is designed to deliver therapy for a minimum of 15 years. The ARTISAN-SNM study was designed to evaluate UUI participants treated with the Axonics System. Two-year follow-up results are presented. METHODS: One hundred and twenty-nine UUI participants underwent implantation with the Axonics System. Therapeutic response rate, participant quality of life (QoL), and satisfaction were determined using 3-day voiding diaries, ICIQ-OABqol, and satisfaction questionnaires. Participants were considered responders if they had a 50% or greater reduction in UUI episodes post-treatment. As-treated and Completers analyses are presented. RESULTS: At 2 years, 93% of the participants (n = 121 Completers at 2 years) were therapy responders, of which 82% achieved ≥ 75% reduction in UUI episodes and 37% were dry (100% reduction). Daily UUI episodes reduced from 5.6 ± 0.3 at baseline to 1.0 ± 0.2 at 2 years. Statistically significant improvements in ICIQ-OABqol were reported. All participants were able to recharge their device and 94% of participants reported that the recharging frequency and duration were acceptable. Participant demographics nor condition severity were correlated with clinical outcomes or recharging experience. No unanticipated or serious device-related adverse events occurred. CONCLUSIONS: At 2 years, participants treated with the Axonics System demonstrated sustained safety and efficacy, high levels of satisfaction with therapy and recharging. Participant-related factors were not associated with efficacy or recharging outcomes, indicating the reported results are applicable to a diverse population.

Diet, trophic interactions and possible ecological role of commercial sharks and batoids in northern Peruvian waters.

The Peruvian sea represents one of the most productive ocean ecosystems and possesses one of the largest elasmobranch fisheries in the Pacific Ocean. Ecosystem-based management of these fisheries will require information on the trophic ecology of elasmobranchs. This study aimed to understand the diet, trophic interactions and the role of nine commercial elasmobranch species in northern Peru through the analysis of stomach contents. A total of 865 non-empty stomachs were analysed. Off northern Peru, elasmobranchs function as upper-trophic-level species consuming 78 prey items, predominantly teleosts and cephalopods. Two distinctive trophic assemblages were identified: (a) sharks (smooth hammerhead shark Sphyrna zygaena, thresher shark Alopias spp. and blue shark Prionace glauca) that feed mainly on cephalopods in the pelagic ecosystem; and (b) sharks and batoids (Chilean eagle ray Myliobatis chilensis, humpback smooth-hound Mustelus whitneyi, spotted houndshark Triakis maculata, Pacific guitarfish Pseudobatos planiceps, copper shark Carcharhinus brachyurus and school shark Galeorhinus galeus) that feed mainly on teleosts and invertebrates in the benthonic and pelagic coastal ecosystem. This study reveals for the first time the diet of T. maculata and the importance of elasmobranchs as predators of abundant and commercial species (i.e., jumbo squid Dosidicus gigas and Peruvian anchovy Engraulis ringens). The results of this study can assist in the design of an ecosystem-based management for the northern Peruvian sea and the conservation of these highly exploited, threatened or poorly understood group of predators in one of the most productive marine ecosystems.

Treatment of Urinary Urgency Incontinence Using a Rechargeable SNM System: 6-Month Results of the ARTISAN-SNM Study.

PURPOSE: Sacral neuromodulation is a guideline recommended treatment of urinary dysfunction and fecal incontinence in patients in whom conservative treatments have failed. Historically sacral neuromodulation has been delivered using a nonrechargeable device with an average life span of 4.4 years. Surgery is required to replace the implanted neurostimulator due to battery depletion. Implantation of a long-lived implanted neurostimulator can eliminate the need for replacement surgeries, potentially reducing patient surgical risks and health care costs. The Axonics r-SNM System™ is a miniaturized, rechargeable sacral neuromodulation system designed to deliver therapy for at least 15 years. The ARTISAN-SNM (Axonics® Sacral Neuromodulation System for Urinary Urgency Incontinence Treatment) study is a pivotal study using rechargeable sacral neuromodulation therapy to treat urinary urgency incontinence. Six-month results are presented. MATERIALS AND METHODS: A total of 129 eligible patients with urinary urgency incontinence were treated. All participants were implanted with a tined lead and the rechargeable sacral neuromodulation system in a nonstaged procedure. Efficacy data were collected using a 3-day bladder diary, the validated ICIQ-OABqol (International Consultation on Incontinence Questionnaire Overactive Bladder quality of life) questionnaire and a participant satisfaction questionnaire. Therapy responders were identified as participants with a 50% or greater reduction in urinary urgency incontinence episodes compared to baseline. We performed an as-treated analysis in all implanted participants. RESULTS: At 6 months 90% of participants were therapy responders. The mean ± SE number of urinary urgency incontinence episodes per day was reduced from 5.6 ± 0.3 at baseline to 1.3 ± 0.2. Participants experienced a clinically meaningful 34-point improvement on the ICIQ-OABqol questionnaire. There were no serious device related adverse events. CONCLUSIONS: The Axonics r-SNM System is safe and effective with 90% of participants experiencing clinically and statistically significant improvements in urinary urgency incontinence symptoms.

Cystoscopy with antibiotic irrigation during pelvic reconstruction and minimally invasive gynecologic surgery: A double-blind randomized controlled trial.

AIMS: After pelvic reconstructive surgery, the risk of postoperative urinary tract infection (UTI) is significant; intraoperative cystoscopy may contribute to this risk. Intravesical antibiotics are used in the ambulatory setting and may be applied to the surgical arena. Our objective was to evaluate the efficacy of antibiotic irrigation during intraoperative cystoscopy to prevent postoperative UTI. METHODS: This double-blind randomized controlled trial enrolled 216 women undergoing cystoscopy with elective surgery for pelvic organ prolapse, stress urinary incontinence, or laparoscopic gynecologic surgery at an academic medical center 2016-2019. Participants were randomized to cystoscopic irrigation fluid type: normal saline (control) or 200,000 U polymyxin B + 40 mg neomycin solution in normal saline (antibiotic). Patients and providers who treated UTIs were blinded. The primary outcome was treatment of UTI within 6 weeks postoperatively, defined as positive culture or treatment for a symptomatic UTI. χ2 and multivariable logistic regression analyses were performed. RESULTS: We enrolled 216 women: 111 control (51.4%) and 105 antibiotic (48.6%). Mean age was 51.6 years. Groups were well matched in medical comorbidities and surgery type. Primary vaginal surgery was most common (n = 127, 58.8%). Overall, 10.7% of patients developed a postoperative UTI with no difference in incidence between groups: 9.9% of control (n = 11, 95% confidence interval [CI]: 4.0%-16.0%) versus 11.4% of antibiotic subjects (n = 12, 95% CI: 5.0%-18.0%), on χ2 (p = .718) and logistic regression analysis (adjusted odds ratio, 1.3; CI: 0.53-3.16; p = .569). CONCLUSION: When cystoscopy is performed during elective pelvic surgery, use of antibiotic irrigation does not impact the rate of postoperative UTI.

One-year outcomes of the ARTISAN-SNM study with the Axonics System for the treatment of urinary urgency incontinence.

AIMS: Sacral neuromodulation (SNM) is a guideline-recommended treatment for voiding dysfunction including urgency, urge incontinence, and nonobstructive retention as well as fecal incontinence. The Axonics® System is a miniaturized, rechargeable SNM system designed to provide therapy for at least 15 years, which is expected to significantly reduce revision surgeries as it will not require replacement as frequently as the non-rechargeable SNM system. The ARTISAN-SNM study is a pivotal study designed to treat patients with urinary urgency incontinence (UUI). Clinical results at 1-year are presented. METHODS: A total of 129 eligible UUI patients were treated. All participants were implanted with a quadripolar tined lead and neurostimulator in a single procedure. Efficacy data were collected using a 3-day bladder diary, a validated quality of life questionnaire (ICIQ-OABqol), and a participant satisfaction questionnaire. Therapy responders were defined as participants with ≥50% reduction in UUI episodes compared to baseline. Data were analyzed on all 129 participants. RESULTS: At 1 year, 89% of the participants were therapy responders. The average UUI episodes per day reduced from 5.6 ± 0.3 at baseline to 1.4 ± 0.2. Participants experienced an overall clinically meaningful improvement of 34 points on the ICIQ-OABqol questionnaire. All study participants (100%) were able to recharge their device at 1 year, and 96% of participants reported that the frequency and duration of recharging was acceptable. There were no serious device-related adverse events. CONCLUSIONS: The Axonics System is safe and effective at 1 year, with 89% of participants experiencing clinically and statistically significant improvements in UUI symptoms.

Effect of mirabegron on cognitive function in elderly patients with overactive bladder: MoCA results from a phase 4 randomized, placebo-controlled study (PILLAR).

BACKGROUND: Antimuscarinics are often used for treatment of overactive bladder (OAB), but exposure to medications such as antimuscarinics that have anticholinergic properties has been linked to adverse cognitive effects. A phase 4 placebo-controlled study (PILLAR; NCT02216214) described the efficacy and safety of mirabegron, a ß3-adrenoreceptor agonist, for treatment of wet OAB in patients aged ≥65 years. This pre-planned analysis aimed to measure differences in cognitive function between mirabegron and placebo, using a rapid screening instrument for mild cognitive impairment: the Montreal Cognitive Assessment (MoCA). METHODS: Outpatients aged ≥65 years with wet OAB were randomized 1:1 to mirabegron or placebo, stratified by age (<75/≥75 years). There were no exclusion criteria regarding cognitive status. Patients randomized to mirabegron initially received 25 mg/day with an optional increase to 50 mg/day after week 4/8 based on patient/investigator discretion. The MoCA was administered at baseline and end of treatment (EoT, week 12). The study protocol was Independent Ethics Committee/Institutional Review Board-approved. RESULTS: Of the 887 randomized patients who received ≥1 dose of study drug, 72.3% were female, 79.5% were white, and 28.1% were aged ≥75 years. All patients had ≥1 comorbidity and 94.3% were receiving ≥1 concomitant medication. One third of patients had a history of psychiatric disorders, the most common being depression (17.2%), insomnia (15.7%), and anxiety (11.4%). Baseline mean (standard error, SE) MoCA total scores were 26.9 (0.1) and 26.8 (0.1) in the mirabegron and placebo groups, respectively. Among patients with MoCA data available at baseline/EoT, 27.1% (115/425) and 25.8% (106/411) of mirabegron and placebo group patients, respectively, had impaired cognitive function at baseline (MoCA total score <26). There was no statistically significant change in adjusted mean (SE) MoCA total score from baseline to EoT in the mirabegron group (-0.2 [0.1]) or the placebo group (-0.1 [0.1]). CONCLUSIONS: Treatment with mirabegron for 12 weeks did not contribute to drug-related cognitive side effects in patients aged ≥65 years, as measured by the MoCA. Furthermore, the pattern of change in cognition over time in an older OAB trial population does not appear to differ from that of subjects receiving placebo. TRIAL REGISTRATION: NCT02216214 (prospectively registered August 13, 2014).

Multimodal opioid-sparing postoperative pain regimen compared with the standard postoperative pain regimen in vaginal pelvic reconstructive surgery: a multicenter randomized controlled trial.

BACKGROUND: Postoperative pain control after urogynecological surgery has traditionally been opioid centered with frequent narcotic administration. Few studies have addressed optimal pain control strategies for vaginal pelvic reconstructive surgery that limit opioid use. OBJECTIVE: The objective of the study was to determine whether, ice packs, Tylenol, and Toradol, a novel opioid-sparing multimodal postoperative pain regimen has improved pain control compared with the standard postoperative pain regimen in patients undergoing inpatient vaginal pelvic reconstructive surgery. STUDY DESIGN: This was a multicenter randomized controlled trial of women undergoing vaginal pelvic reconstructive surgery. Patients were randomized to the ice packs, Tylenol, and Toradol postoperative pain regimen or the standard regimen. The ice packs, Tylenol, and Toradol regimen consists of around-the-clock ice packs, around-the-clock oral acetaminophen, around-the-clock intravenous ketorolac, and intravenous hydromorphone for breakthrough pain. The standard regimen consists of as-needed ibuprofen, as-needed acetaminophen/oxycodone, and intravenous hydromorphone for breakthrough pain. The primary outcome was postoperative day 1 pain evaluated the morning after surgery using a visual analog scale. Secondary outcomes included the validated Quality of Recovery Questionnaire, satisfaction scores, inpatient narcotic consumption, outpatient pain medication consumption, and visual analog scale scores at other time intervals. In all, 27 patients in each arm were required to detect a mean difference of 25 mm on a 100 mm visual analog scale (90% power). RESULTS: Thirty patients were randomized to ice packs, Tylenol, and Toradol and 33 to the standard therapy. Patient and surgical demographics were similar. The median morning visual analog scale pain score was lower in the ice packs, Tylenol, and Toradol group (20 mm vs 40 mm, P = .03). Numerical median pain scores were lower at the 96 hour phone call in the ice packs, Tylenol, and Toradol group (2 vs 3, P = .04). Patients randomized to the ICE-T regimen received fewer narcotics (expressed in oral morphine equivalents) from the postanesthesia care unit exit to discharge (2.9 vs 20.4, P < .001) and received fewer narcotics during the entire hospitalization (55.7 vs 91.2, P < .001). At 96 hour follow up, patients in the ice packs, Tylenol, and Toradol group used 4.9 ketorolac tablets compared with 4.6 oxycodone/acetaminophen tablets in the standard group (P = .81); however, ice packs, Tylenol, and Toradol patients required more acetaminophen than ibuprofen by patients in the standard arm (10.7 vs 6.2 tablets, P = .012). There were no differences in Quality of Recovery Questionnaire or satisfaction scores either in the morning after surgery or at 96 hour follow up. CONCLUSION: The ice packs, Tylenol, and Toradol multimodal pain regimen offers improved pain control the morning after surgery and 96 hours postoperatively compared with the standard regimen with no differences in patient satisfaction and quality of recovery. Ice packs, Tylenol, and Toradol can significantly limit postoperative inpatient narcotic use and eliminate outpatient narcotic use in patients undergoing vaginal pelvic reconstructive surgery.

National survey of urogynecological practice patterns among United States OB/GYN oral board examinees in different practice settings.

INTRODUCTION AND HYPOTHESIS: The current urogynecological surgical experience of recent OB/GYN graduates in different practice settings is unclear. The aim of this study was to evaluate differences in urogynecological surgical care between private practitioners (PPs) and other generalist OB/GYN oral board examinees. METHODS: A total of 699 OB/GYN oral board examination examinees were administered a survey during board preparatory courses with a 70.7% response rate. The primary outcome was to determine differences in subjective reported performance of urogynecological surgery with and without apical support procedures (female pelvic medicine and reconstructive surgery, FPMRS, ± apical) between PP and generalists in other practice models (academic, managed care, other). Secondary outcomes included urogynecological case list reporting, referral patterns, and residency training. RESULTS: A total of 473 surveys were completed; after excluding subspecialists, 210 surveys were completed by PP and 162 by individuals in other settings. 6.7% of PPs subjectively reported that they perform FPMRS + apical surgery compared with 4.3% of those in other practice settings (p = 0.33). Although 29.2% of PPs reported adequate FPMRS training in residency compared with 39.7% of those in other practice settings (p = 0.04), 53.6% of PPs reported that they refer patients with pelvic organ prolapse (POP), compared with 66.5% of those in other practice settings (p = 0.013). 38.9% of PPs report that they performed POP surgery compared with 27.8% of non-PPs (p = 0.014). CONCLUSIONS: Regardless of practice setting, surgical volumes are low and few general OB/GYN board examinees report that they perform comprehensive FPMRS ± apical support surgery. The practice environment may affect providers' management of patients with pelvic floor disorders.

Survey of pelvic reconstructive surgeons on performance of opportunistic salpingectomy at the time of pelvic organ prolapse repair.

INTRODUCTION AND HYPOTHESIS: Opportunistic salpingectomy (OS) at the time of benign hysterectomy has recently emerged as a potential primary preventive modality for ovarian cancer. Our objective was to determine whether the reported rate of OS at the time of prolapse surgery is similar to the rate of OS at the time of gynecologic surgery for non-prolapse indications. METHODS: An anonymous online survey was sent to the Society of Gynecologic Surgery members. Responses were divided into surgeons who did and did not perform OS at the time of prolapse repair. Differences between surgeons who did and did not perform OS were evaluated using the chi-square test. Multivariable logistic regression was used to identify which responses related to increased odds of performing OS. RESULTS: There were 117 (33.1%) completed responses; of these, 98 (83.8%) reported performing OS at the time of prolapse repair, which was similar to the reported rate of OS at the time of hysterectomy for non-prolapse indications, 82.1%. After multivariable logistic regression, performance of salpingectomy at the time of hysterectomy for a non-prolapse indication (aOR: 17.9, 95% CI: 3.11-42.01), use of a laparoscopic or robotic surgical approach (aOR 14.1, 95% CI: 1.81-32.21) and completion of an FPMRS fellowship (aOR: 3.47, 95% CI: 1.20-10.02) were associated with a higher likelihood of performing OS at the time of prolapse repair. CONCLUSIONS: OS at the time prolapse repair is performed more frequently with concomitant hysterectomy compared with OS at the time of post-hysterectomy prolapse repair and is similar to rates of OS performed at the time of hysterectomy for non-prolapse indications.

Cerebral White Matter Disease and Response to Anti-Cholinergic Medication for Overactive Bladder in an Age-Matched Cohort.

OBJECTIVE: To determine if the presence of cerebral white matter disease (WMD) affects the response to anti-cholinergic medications. MATERIALS AND METHODS: This was a retrospective cohort of age-matched patients treated for OAB with anti-cholinergic medications between January 2010 and December 2017. Inclusion criteria were a chief complaint of OAB, never evaluated by a urogynecologist for OAB, treated with a maximum dose for a minimum of 4 weeks, and underwent head computed tomography (CT) within 12 months of starting therapy. Patients with WMD were matched 1:1 by age and number of prior failed antimuscarinics to controls with normal head CTs. Exclusion criteria included incomplete documentation of therapeutic response, non-WMD CT abnormalities, and non-idiopathic OAB. The primary outcome was anti-cholinergic treatment failure. Pairwise analysis between groups was performed using Wilcoxon rank-sum and Fisher's exact test where appropriate. Univariate logistic regression was performed, and any variable that was associated with treatment failure and a p value ≤ 0.2 was included in the multivariable regression analysis. RESULTS: Sixty-eight cases were matched with 68 controls. Patients with WMD were more likely to have undergone hysterectomy (57.4% vs. 41.2%, p = 0.04) and to use diuretics (31.1% vs. 19.1%, p = 0.04). Patients with WMD were more likely to fail treatment compared with controls (60.7% vs. 29.4%, p = 0.004). After adjusting for confounders, WMD was strongly associated with an increased probability of failure (aOR = 7.31, 95% CI: 1.49-12.20). Additional significant risk factors for treatment failure were the previous number of failed medications (aOR = 3.65 per medication, 95% CI: 1.48-9.01) and a rising HbA1c (aOR: 1.39 per 1.0% increase, 95% CI: 1.0-1.91). CONCLUSION: WMD is independently associated with anti-muscarinic treatment failure in women with overactive bladder symptoms.