Conscientious Objection to Gender-Affirming Surgery: A Cross-Sectional Analysis of Plastic Surgery and Urology Residency Programs.

OBJECTIVE: Medical conscientious objection is a federally protected right of physicians to refuse participation in medically indicated services or research activities that are incompatible with their ethical, moral, or religious beliefs. Individual provider objections to gender-affirming surgery have been documented, however the prevalence of such objections is unknown. Our study aimed to characterize physician objections to gender-affirming surgery in plastic surgery and urology residencies and to assess related institutional policies. DESIGN, SETTING, PARTICIPANTS: A cross-sectional electronic survey was administered to program leadership of 239 accredited US plastic surgery and urology residencies from February to October 2023. Trainee exposure to gender-affirming surgery, programmatic experience with objections, and presence and content of institutional objection policies were collected. Bivariate analyses were performed to determine associations with objectors. RESULTS: One-hundred and twenty-four plastic surgery (n = 59) and urology (n = 65) residencies completed the survey, representing a 52% response rate. Most programs included didactic training (n = 107, 86%) and direct clinical exposure (n = 98, 79%) to gender-affirming surgery. Few (n = 24, 19%) endorsed existent objection policies. Sixteen programs (13%) experienced objections to gender-affirming surgery by trainees (n = 15), faculty (n = 6), and staff (n = 1). Neither geographic region, exposure to gender-affirming surgery, nor presence of objection policies significantly contributed to programmatic objections. Programs with formal objection policies reported increased confidence in addressing future objection events (p = 0.017). CONCLUSIONS: Objection to gender-affirming surgery is a rare, but plausible occurrence amongst plastic surgery and urology trainees. Residency programs should consider anticipatory policies to protect patients and, when feasible, provide reasonable accommodations for objecting trainees.

Break Wave Lithotripsy for Urolithiasis: Results of the First-in-Human International Multi-Institutional Clinical Trial.

PURPOSE: This study reports on a prospective, multicenter, single-arm, clinical trial utilizing the SonoMotion (San Mateo, California) Break Wave lithotripsy (BWL) device to fragment urinary stones. MATERIALS AND METHODS: Patients with a urinary stone underwent a single treatment of 30 minutes and peak negative pressure of 4.5 to 8 MPa. Subjects were contacted and outcomes assessed at 7, 14, and 35 days after treatment, with clinical follow-up and CT imaging 70 ± 14 days postprocedure. The primary objectives were to assess the safety (hematomas, complications, etc) and effectiveness of BWL (any fragmentation, residual fragments ≤4 mm or ≤2 mm, and completely stone-free rate) as assessed via noncontrast CT-kidneys, ureters, and bladder. RESULTS: Forty-four patients with a ureteral (43%) or renal (57%) stone were treated across 5 centers. Stone fragmentation occurred in 88% of cases; 70% had fragments ≤ 4 and 51% ≤ 2 mm, while 49% were completely stone free on CT; no serious adverse events were reported. Eighty-six percent of patients received either no analgesic medication at all (50%) or minor analgesia (36%). After determining optimal therapy settings, 36 patients were treated and the effectiveness improved exhibiting fragmentation in 92% (33/36), residual fragments ≤ 4 mm in 75% and 58% with fragments ≤ 2 mm with 58% completely stone free. Effectiveness was less in subjects with lower pole stones with 81% fragmentation, 71% having fragments ≤ 4 mm, 29% with fragments ≤ 2 mm, and 29% completely stone free; of distal ureteral stone patients, 89% were completely stone free. CONCLUSIONS: BWL offered safe and effective noninvasive stone therapy requiring little to no anesthesia and was carried out successfully in nonoperative environments. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03811171.

Randomized Controlled Trial of Ultrasonic Propulsion-Facilitated Clearance of Residual Kidney Stone Fragments vs Observation.

PURPOSE: Ultrasonic propulsion is an investigational procedure for awake patients. Our purpose was to evaluate whether ultrasonic propulsion to facilitate residual kidney stone fragment clearance reduced relapse. MATERIALS AND METHODS: This multicenter, prospective, open-label, randomized, controlled trial used single block randomization (1:1) without masking. Adults with residual fragments (individually ≤5 mm) were enrolled. Primary outcome was relapse as measured by stone growth, a stone-related urgent medical visit, or surgery by 5 years or study end. Secondary outcomes were fragment passage within 3 weeks and adverse events within 90 days. Cumulative incidence of relapse was estimated using the Kaplan-Meier method. Log-rank test was used to compare the treatment (ultrasonic propulsion) and control (observation) groups. RESULTS: The trial was conducted from May 9, 2015, through April 6, 2024. Median follow-up (interquartile range) was 3.0 (1.8-3.2) years. The treatment group (n = 40) had longer time to relapse than the control group (n = 42; P < .003). The restricted mean time-to-relapse was 52% longer in the treatment group than in the control group (1530 ± 92 days vs 1009 ± 118 days), and the risk of relapse was lower (hazard ratio 0.30, 95% CI 0.13-0.68) with 8 of 40 and 21 of 42 participants, respectively, experiencing relapse. Omitting 3 participants not asked about passage, 24 treatment (63%) and 2 control (5%) participants passed fragments within 3 weeks of treatment. adverse events were mild, transient, and self-resolving, and were reported in 25 treated participants (63%) and 17 controls (40%). CONCLUSIONS: Ultrasonic propulsion reduced relapse and added minimal risk. CLINICAL TRIAL REGISTRATION NO.: NCT02028559.

Low-fat dietary pattern reduces urinary incontinence in postmenopausal women: post hoc analysis of the Women's Health Initiative Diet Modification Trial.

BACKGROUND: Urinary incontinence affects >40% of women in the United States, with an annual societal cost of >$12 billion and demonstrated associations with depressive symptoms, social isolation, and loss of work productivity. Weight has been established as an exposure that increases urinary incontinence risk and certain dietary components have been associated with urinary incontinence symptoms. We hypothesized that diet plays a key role in the association between weight and urinary incontinence in US women. OBJECTIVE: This study aimed to examine the effect of a low-fat diet on urinary incontinence in postmenopausal women as a post hoc analysis of a randomized controlled trial of diet modification. STUDY DESIGN: This was a post hoc analysis of the Women's Health Initiative Dietary Modification randomized controlled trial of 48,835 postmenopausal women from 40 US centers assigned to a dietary intervention (20% energy from fat, 5 fruits or vegetable servings, and 6 whole grain servings daily and an intensive behavioral modification program) or to the usual diet comparison group. The outcome was urinary incontinence at 1 year. RESULTS: Of the participants, 60% were randomized to the usual diet comparison group and 40% to the dietary modification intervention. After adjusting for weight change, women assigned to the dietary modification intervention were less likely to report urinary incontinence (odds ratio, 0.94; 95% confidence interval, 0.90-0.98; P=.003), more likely to report urinary incontinence resolution (odds ratio, 1.11; 95% confidence interval, 1.03-1.19; P=.01), and less likely to develop urinary incontinence (odds ratio, 0.92; 95% confidence interval, 0.87-0.98; P=.01) in adjusted models. CONCLUSION: Dietary modification may be a reasonable treatment for postmenopausal women with incontinence and also a urinary incontinence prevention strategy for continent women. Our results provide evidence to support a randomized clinical trial to determine whether a reduced fat-intake dietary modification is an effective intervention for the prevention and treatment of urinary incontinence. In addition to providing further insights into mechanisms of lower urinary tract symptoms, these findings may have a substantial impact on public health based on the evidence that diet seems to be a modifiable risk factor for urinary incontinence.

First Series Using Ultrasonic Propulsion and Burst Wave Lithotripsy to Treat Ureteral Stones.

PURPOSE: Our goal was to test transcutaneous focused ultrasound in the form of ultrasonic propulsion and burst wave lithotripsy to reposition ureteral stones and facilitate passage in awake subjects. MATERIALS AND METHODS: Adult subjects with a diagnosed proximal or distal ureteral stone were prospectively recruited. Ultrasonic propulsion alone or with burst wave lithotripsy was administered by a handheld transducer to awake, unanesthetized subjects. Efficacy outcomes included stone motion, stone passage, and pain relief. Safety outcome was the reporting of associated anticipated or adverse events. RESULTS: Twenty-nine subjects received either ultrasonic propulsion alone (n = 16) or with burst wave lithotripsy bursts (n = 13), and stone motion was observed in 19 (66%). The stone passed in 18 (86%) of the 21 distal ureteral stone cases with at least 2 weeks follow-up in an average of 3.9±4.9 days post-procedure. Fragmentation was observed in 7 of the burst wave lithotripsy cases. All subjects tolerated the procedure with average pain scores (0-10) dropping from 2.1±2.3 to 1.6±2.0 (P = .03). Anticipated events were limited to hematuria on initial urination post-procedure and mild pain. In total, 7 subjects had associated discomfort with only 2.2% (18 of 820) propulsion bursts. CONCLUSIONS: This study supports the efficacy and safety of using ultrasonic propulsion and burst wave lithotripsy in awake subjects to reposition and break ureteral stones to relieve pain and facilitate passage.

Removal of Small, Asymptomatic Kidney Stones and Incidence of Relapse.

BACKGROUND: The benefits of removing small (≤6 mm), asymptomatic kidney stones endoscopically is unknown. Current guidelines leave such decisions to the urologist and the patient. A prospective study involving older, nonendoscopic technology and some retrospective studies favor observation. However, published data indicate that about half of small renal stones left in place at the time that larger stones were removed caused other symptomatic events within 5 years after surgery. METHODS: We conducted a multicenter, randomized, controlled trial in which, during the endoscopic removal of ureteral or contralateral kidney stones, remaining small, asymptomatic stones were removed in 38 patients (treatment group) and were not removed in 35 patients (control group). The primary outcome was relapse as measured by future emergency department visits, surgeries, or growth of secondary stones. RESULTS: After a mean follow-up of 4.2 years, the treatment group had a longer time to relapse than the control group (P<0.001 by log-rank test). The restricted mean (±SE) time to relapse was 75% longer in the treatment group than in the control group (1631.6±72.8 days vs. 934.2±121.8 days). The risk of relapse was 82% lower in the treatment group than the control group (hazard ratio, 0.18; 95% confidence interval, 0.07 to 0.44), with 16% of patients in the treatment group having a relapse as compared with 63% of those in the control group. Treatment added a median of 25.6 minutes (interquartile range, 18.5 to 35.2) to the surgery time. Five patients in the treatment group and four in the control group had emergency department visits within 2 weeks after surgery. Eight patients in the treatment group and 10 in the control group reported passing kidney stones. CONCLUSIONS: The removal of small, asymptomatic kidney stones during surgery to remove ureteral or contralateral kidney stones resulted in a lower incidence of relapse than nonremoval and in a similar number of emergency department visits related to the surgery. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the Veterans Affairs Puget Sound Health Care System; ClinicalTrials.gov number, NCT02210650.).

Multi-Institutional Variation in Performance of Low-Dose Computed Tomography for the Evaluation of Suspected Nephrolithiasis.

Introduction and Objective: Guidelines from the American Urological Association (AUA) and American College of Radiology (ACR) recommend that patients with suspected nephrolithiasis undergo low-dose CT of the kidney, ureter, and bladder (LD CT KUB) as opposed to higher dose conventional imaging. We hypothesized that even at institutions with established LD protocols, higher dose imaging is common. Materials and Methods: We identified four academic medical centers where LD CT KUB protocols were implemented to yield an effective dose (EDose) consistent with national guidelines. Fifty consecutive adult patients who underwent CT KUB specifically for the evaluation of nephrolithiasis were retrospectively reviewed at each site. Patient age, sex, body mass index (BMI), imaging location, and EDose (millisieverts [mSv]) were recorded. Results: Two hundred patients with a mean age of 54 years were identified. Forty-six patients (23%) underwent CT KUB with an EDose ≤4 mSv, accounting for 10% to 48% of each institution's cohort. One hundred sixteen patients had a BMI <30, and would have been expected to receive LD CTs by the AUA criteria for LD CT KUB. Within this subset, only 37 patients (32%) actually underwent LD CT KUB. The highest dose CT KUB at each institution resulted in an EDose of 33.8 to 44.6 mSv, exceeding the recommended exposure of LD CT KUB by 10-fold. Conclusions: At academic institutions where LD CT KUB was implemented for the evaluation of nephrolithiasis, a minority of patients with BMI <30 received guideline-concordant imaging. Differences in patient BMI did not account for the variation in radiation exposure. Further research is necessary to elucidate barriers to LD CT implementation.

Evaluation of the Educational Impact of the Urology Collaborative Online Video Didactics Lecture Series.

OBJECTIVE: To assess the impact of the Urology Collaborative Online Video Didactic (COViD) lecture series series on resident knowledge as a supplement to resident education during the coronavirus disease 2019 pandemic. METHODS: One hundred thirty-nine urology residents were voluntarily recruited from 8 institutions. A 20-question test, based on 5 COViD lectures, was administered before and after watching the lectures. Pre- and posttest scores (percent correct) and score changes (posttest minus pretest score) were assessed considering demographic data and number of lectures watched. Multiple linear regression determined predictors of improved scores. RESULTS: Of residents recruited, 95 and 71 took the pre- and posttests. Median number of lectures watched was 3. There was an overall increase in correct scores from pretest to posttest (45% vs 57%, P < .01). Watching any lectures vs none led to higher posttest scores (60% vs 44%, P < .01) and score changes (+16% vs +1%, P < .01). There was an increase in baseline pretest scores by post-graduate year (PGY) (P < .01); however there were no significant differences in posttest or score changes by PGY. When accounting for lectures watched, PGY, and time between lecture and posttest, being a PGY6 (P = .01) and watching 3-5 lectures (P < .01) had higher overall correct posttest scores. Watching 3-5 lectures led to greater score changes (P < .001-.04). Over 65% of residents stated the COViD lectures had a large or very large impact on their education. CONCLUSIONS: COViD lectures improved overall correct posttest scores and increased knowledge base for all resident levels. Furthermore, lectures largely impacted resident education during the coronavirus disease 2019 pandemic.

Improving Burst Wave Lithotripsy Effectiveness for Small Stones and Fragments by Increasing Frequency: Theoretical Modeling and Ex Vivo Study.

Introduction and Objective: In clinical trial NCT03873259, a 2.6-mm lower pole stone was treated transcutaneously and ex vivo with 390-kHz burst wave lithotripsy (BWL) for 40 minutes and failed to break. The stone was subsequently fragmented with 650-kHz BWL after a 4-minute exposure. This study investigated how to fragment small stones and why varying the BWL frequency may more effectively fragment stones to dust. Methods: A linear elastic theoretical model was used to calculate the stress created inside stones from shock wave lithotripsy (SWL) and different BWL frequencies mimicking the stone's size, shape, lamellar structure, and composition. To test model predictions about the impact of BWL frequency, matched pairs of stones (1-5 mm) were treated at (1) 390 kHz, (2) 830 kHz, and (3) 390 kHz followed by 830 kHz. The mass of fragments >1 and 2 mm was measured over 10 minutes of exposure. Results: The linear elastic model predicts that the maximum principal stress inside a stone increases to more than 5.5 times the pressure applied by the ultrasound wave as frequency is increased, regardless of the composition tested. The threshold frequency for stress amplification is proportionate to the wave speed divided by the stone diameter. Thus, smaller stones may be likely to fragment at a higher frequency, but not at a lower frequency below a limit. Unlike with SWL, this amplification in BWL occurs consistently with spherical and irregularly shaped stones. In water tank experiments, stones smaller than the threshold size broke fastest at high frequency (p = 0.0003), whereas larger stones broke equally well to submillimeter dust at high, low, or mixed frequencies. Conclusions: For small stones and fragments, increasing frequency of BWL may produce amplified stress in the stone causing the stone to break. Using the strategies outlined here, stones of all sizes may be turned to dust efficiently with BWL.

Fragmentation of Stones by Burst Wave Lithotripsy in the First 19 Humans.

PURPOSE: We report stone comminution in the first 19 human subjects by burst wave lithotripsy (BWL), which is the transcutaneous application of focused, cyclic ultrasound pulses. MATERIALS AND METHODS: This was a prospective multi-institutional feasibility study recruiting subjects undergoing clinical ureteroscopy (URS) for at least 1 stone ≤12 mm as measured on computerized tomography. During the planned URS, either before or after ureteroscope insertion, BWL was administered with a handheld transducer, and any stone fragmentation and tissue injury were observed. Up to 3 stones per subject were targeted, each for a maximum of 10 minutes. The primary effectiveness outcome was the volume percent comminution of the stone into fragments ≤2 mm. The primary safety outcome was the independent, blinded visual scoring of tissue injury from the URS video. RESULTS: Overall, median stone comminution was 90% (IQR 20, 100) of stone volume with 21 of 23 (91%) stones fragmented. Complete fragmentation (all fragments ≤2 mm) within 10 minutes of BWL occurred in 9 of 23 stones (39%). Of the 6 least comminuted stones, likely causative factors for decreased effectiveness included stones that were larger than the BWL beamwidth, smaller than the BWL wavelength or the introduction of air bubbles from the ureteroscope. Mild reddening of the papilla and hematuria emanating from the papilla were observed ureteroscopically. CONCLUSIONS: The first study of BWL in human subjects resulted in a median of 90% comminution of the total stone volume into fragments ≤2 mm within 10 minutes of BWL exposure with only mild tissue injury.

Virtual Reality Warm-up Before Robot-assisted Surgery: A Randomized Controlled Trial.

TRIAL DESIGN: This was a randomized controlled trial. BACKGROUND: Intraoperative errors correlate with surgeon skill and skill declines with intervals of inactivity. The goals of this research were to identify the optimal virtual reality (VR) warm-up curriculum to prime a surgeon's technical skill and validate benefit in the operating room. MATERIALS AND METHODS: Surgeons were randomized to receive six trial sessions of a designated set of VR modules on the da Vinci Skills Simulator to identify optimal VR warm-up curricula to prime technical skill. After performing their curricula, warm-up effect was assessed based on performance on a criterion task. The optimal warm-up curriculum was chosen from the group with the best task time and video review-based technical skill. Robot-assisted surgery-experienced surgeons were then recruited to either receive or not receive warm-up before surgery. Skill in the first 15 min of surgery was assessed by blinded surgeon and crowdworker review as well as tool motion metrics. The intervention was performing VR warm-up before human robot-assisted surgery. Warm-up effect was measured using objective performance metrics and video review using the Global Evaluative Assessment of Robotic Skills tool. Linear mixed effects models with a random intercept for each surgeon and nonparametric modified Friedman tests were used for analysis. RESULTS: The group performing only a Running Suture task on the simulator was on average 31.3 s faster than groups performing other simulation tasks and had the highest Global Evaluative Assessment of Robotic Skills scores from 41 surgeons who participated. This was chosen as the optimal curriculum. Thereafter, 34 surgeons completed 347 surgeries with corresponding video and tool motion data. No statistically significant differences in skill were observed with the warm-up intervention. CONCLUSIONS: We conclude that a robotic VR warm-up before performing the early stages of surgery does not impact the technical skill of the surgeon.

Program Directors' Perspectives of ACGME Requirements and Effectiveness of Training Urology Residents: A National Survey in the Era of the Next Accreditation System.

OBJECTIVE: To qualitatively assess Urology program directors' perspectives on the effectiveness of training residents after implementation of the Accreditation Council for Graduate Medical Education's (ACGME) 2011 Next Accreditation System, and identify differences in current perspectives and prior surveyed perspectives toward the ACGME Outcome Project. METHODS: A national survey was developed by an ad hoc committee and distributed electronically to 105 Urology program directors. Thirty-four (34) multiple-choice, Likert-scale questions were administered. Data were evaluated and the results from the survey were compared to the one performed 15 years earlier to determine changes in the learning environment and effectiveness of training urology residents. RESULTS: The current survey response rate was 89% which was similar to the 2005 response rate of 88%. Most program directors (61%) agreed that 20% protected time for program directors helped with administrative work and 31% felt this time needs to increase for larger residency programs. Seventy percent (70%) agreed that dedicated program administrator time has helped their program. More than half of the respondents agree that the ACGME is training the current workforce effectively. CONCLUSION: Current program directors appear to be more accepting of changes required by the Next Accreditation System as compared to the Outcome Project 15 years ago. Our study supports the need for protected time to train residents and to overcome barriers to change.

National Imaging Trends in Nephrolithiasis-Does Renal Ultrasound in the Emergency Department Pave the Way for Computerized Tomography?

INTRODUCTION: Concern regarding radiation exposure has led to increased interest in the use of ultrasound for the initial imaging of suspected renal colic in the emergency department. It is unknown whether such an approach simply defers computerized tomography to outpatient followup. We analyzed national imaging patterns to explore this relationship. METHODS: Using the MarketScan® insurance claims database we reviewed adult patients newly diagnosed with nephrolithiasis in U.S. emergency departments between 2007 and 2015. Patients were excluded if they had been diagnosed with or undergone treatment for nephrolithiasis in the preceding 180 days. RESULTS: From 2007 to 2015, 830,785 emergency department nephrolithiasis encounters met inclusion criteria. The ultrasound-only rate increased from 2.7% to 6.9%, while the computerized tomography-only rate remained stable at 85.8%. A history of computerized tomography in the 30 days before emergency department presentation increased the rate of ultrasound-only imaging from 4.6% to 8.9%. The mean cumulative computerized tomography scans from the emergency department visit to 90 days after was significantly lower in those imaged with emergency department ultrasound (0.82±0.77) compared to those imaged with emergency department computerized tomography (1.2±0.51, p <0.001). CONCLUSIONS: Patients who undergo ultrasonography in the emergency department for evaluation of renal colic undergo fewer cumulative computerized tomography scans in the 90 days following their visit than do patients initially imaged with computerized tomography. Ultrasound use for the evaluation of renal colic has increased while computerized tomography rates have remained stable.

Nephrolithiasis in Pregnancy: Treating for Two.

OBJECTIVES: To review the literature regarding the epidemiology of stone disease and develop a management algorithm based on current evidence and societal guidelines. METHODS: A structured literature review was performed to determine highest quality of evidence guiding care for pregnant patients with symptomatic nephrolithiasis. PUBMED and EMBASE databases were searched using terms "pregnancy," "nephrolithiasis," or "pregnancy" and "renal colic" alone and in combination with "stone", "kidney stone," "ultrasound," "MRI," "CT," "percutaneous nephrostomy," "ureteral stent," or "ureteroscopy." All English-language abstracts were reviewed for relevance and full-length articles were reviewed for content. Articles published prior to 1990 were excluded, and priority for inclusion was given to multi-institutional studies and larger institutional studies, reflecting the highest level of current available evidence and most contemporaneous practice patterns. RESULTS: Symptomatic nephrolithiasis affects less than 1% of pregnancies but poses unique diagnostic challenges due to the physiologic changes of pregnancy and risks of ionizing radiation exposure to the fetus. Ultrasound remains the imaging modality of choice. Most patients may be managed non-operatively, but drainage with percutaneous nephrostomy or ureteral stent may be performed if warranted. Growing evidence also supports the safety and efficacy of definitive stone treatment. CONCLUSIONS: Though rare, symptomatic nephrolithiasis poses significant clinical challenges due to the need to minimize risk for both mother and fetus with diagnostic and therapeutic interventions. A multi-disciplinary approach is paramount, as is shared decision making with the patient at each step of care.