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1.
J Robot Surg ; 18(1): 208, 2024 May 10.
Article in English | MEDLINE | ID: mdl-38727857

ABSTRACT

It is unknown whether the July Effect (a theory that medical errors and organizational inefficiencies increase during the influx of new surgical residents) exists in urologic robotic-assisted surgery. The aim of this study was to investigate the impact of urology resident training on robotic operative times at the beginning of the academic year. A retrospective chart review was conducted for urologic robotic surgeries performed at a single institution between 2008 and 2019. Univariate and multivariate mix model analyses were performed to determine the association between operative time and patient age, estimated blood loss, case complexity, robotic surgical system (Si or Xi), and time of the academic year. Differences in surgery time and non-surgery time were assessed with/without resident presence. Operative time intervals were included in the analysis. Resident presence correlated with increased surgery time (38.6 min (p < 0.001)) and decreased non-surgery time (4.6 min (p < 0.001)). Surgery time involving residents decreased by 8.7 min after 4 months into the academic year (July-October), and by an additional 5.1 min after the next 4 months (p = 0.027, < 0.001). When compared across case types stratified by complexity, surgery time for cases with residents significantly varied. Cases without residents did not demonstrate such variability. Resident presence was associated with prolonged surgery time, with the largest effect occurring in the first 4 months and shortening later in the year. However, resident presence was associated with significantly reduced non-surgery time. These results help to understand how new trainees impact operating room times.


Subject(s)
Internship and Residency , Operative Time , Robotic Surgical Procedures , Urologic Surgical Procedures , Urology , Internship and Residency/statistics & numerical data , Internship and Residency/methods , Robotic Surgical Procedures/education , Robotic Surgical Procedures/methods , Robotic Surgical Procedures/statistics & numerical data , Humans , Retrospective Studies , Urologic Surgical Procedures/education , Urology/education , Female , Male , Middle Aged , Medical Errors/prevention & control , Medical Errors/statistics & numerical data , Time Factors
2.
Int Urogynecol J ; 2024 Apr 26.
Article in English | MEDLINE | ID: mdl-38668760

ABSTRACT

INTRODUCTION AND HYPOTHESIS: In limited studies vibrators have been shown to improve sexual function and pelvic floor health; however, there are even fewer studies on the effect of vibrator use on overall genitourinary and mental health. To investigate the effect of regular vibrator use on sexual, genitourinary, and mental health in addition to quality of life. METHODS: We performed a prospective pilot study of women aged 18 to 80 years recruited from a urogynecology clinic. Study participants were instructed to use a vibrator according to the protocol. Sexual function, pelvic floor function, mental health, and pelvic examination were assessed at the initial visit and at 3 months' follow-up using validated questionnaires. RESULTS: Of the 79 participants enrolled in the study, 53 women (66%) completed the study. The mean age of the participants was 54.7 years (range 19-80 years), and the majority of participants were white (n = 59, 74.7%), post-menopausal (n = 48, 60.8%), and not receiving systemic (n = 63, 79.7%) or local (n = 63, 79.7%) hormone therapy. Sexual function significantly improved over time (p = 0.002), whereas the rate of bothersome pelvic organ prolapse symptoms and pain scores significantly decreased (p = 0.034 and 0.0008 respectively). Rates of urge urinary incontinence decreased although this was not statistically significant (p = 0.059). There was a significant improvement in the gross appearance of lichen sclerosus lesions (p = 0.025) and in the severity of vaginal atrophy (p = 0.018). Rates of depression were significantly decreased (p = 0.011). CONCLUSIONS: Vibrator use was associated with improved sexual, genitourinary, and mental health.

3.
Front Pain Res (Lausanne) ; 5: 1241015, 2024.
Article in English | MEDLINE | ID: mdl-38601924

ABSTRACT

Specific Aim: Provide an overview of the literature addressing major areas pertinent to pain in transgender persons and to identify areas of primary relevance for future research. Methods: A team of scholars that have previously published on different areas of related research met periodically though zoom conferencing between April 2021 and February 2023 to discuss relevant literature with the goal of providing an overview on the incidence, phenotype, and mechanisms of pain in transgender patients. Review sections were written after gathering information from systematic literature searches of published or publicly available electronic literature to be compiled for publication as part of a topical series on gender and pain in the Frontiers in Pain Research. Results: While transgender individuals represent a significant and increasingly visible component of the population, many researchers and clinicians are not well informed about the diversity in gender identity, physiology, hormonal status, and gender-affirming medical procedures utilized by transgender and other gender diverse patients. Transgender and cisgender people present with many of the same medical concerns, but research and treatment of these medical needs must reflect an appreciation of how differences in sex, gender, gender-affirming medical procedures, and minoritized status impact pain. Conclusions: While significant advances have occurred in our appreciation of pain, the review indicates the need to support more targeted research on treatment and prevention of pain in transgender individuals. This is particularly relevant both for gender-affirming medical interventions and related medical care. Of particular importance is the need for large long-term follow-up studies to ascertain best practices for such procedures. A multi-disciplinary approach with personalized interventions is of particular importance to move forward.

4.
Am J Obstet Gynecol ; 2024 Mar 01.
Article in English | MEDLINE | ID: mdl-38432414

ABSTRACT

BACKGROUND: Cross-sectional and short-term cohort studies have demonstrated an association between urinary incontinence and dementia, as well as lower performance on cognitive testing. The Health and Retirement Study, a longitudinal study of community-dwelling older adults, offers an opportunity to assess the temporal association between these conditions because it included an assessment of incontinence symptoms and biennial assessments of cognitive function. OBJECTIVE: This study aimed to evaluate if urinary incontinence before the age of 70 years had an effect on changes in cognitive function among women participating in the Health and Retirement Study. STUDY DESIGN: This secondary analysis included data from female respondents in the Health and Retirement Study aged 58 to 67 years with ≥2 cognitive assessments. Urinary incontinence was defined as any involuntary loss of any urine in the preceding 12 months. A control group without incontinence was reweighted for better comparability using coarsened exact matching for age and comorbidities. Validated methods, including neuropsychological test data, estimated a memory score and dementia probability for each participant biennially. Coprimary outcomes were the changes in memory score and dementia probability. Linear regression models were used to estimate the association of urinary incontinence with change in memory score and dementia probability, adjusting for baseline demographics and comorbidities. A subgroup analysis was performed to assess the effects of urinary incontinence frequency on these outcomes. The infrequent subgroup reported <15 days of leakage per month and the frequent subgroup reported ≥15 days of leakage per month. RESULTS: Among eligible female respondents, 40.6% reported urinary incontinence between the ages of 58 and 69 years. Baseline memory scores and dementia probability were similar between those with urinary incontinence (n=1706) and controls (n=2507). Memory score declined significantly in both cohorts, indicating poorer memory over time (-0.222 among those with incontinence [95% confidence interval, -0.245 to -0.199] vs -0.207 in controls [95% confidence interval, -0.227 to -0.188]). The decline of memory score was not statistically significantly different between cases and controls (mean difference, -0.015; 95% confidence interval, -0.045 to 0.015). Dementia probability increased significantly in both groups, indicating a greater probability of developing dementia by 0.018 among those with incontinence (95% confidence interval, 0.015-0.020) and by 0.020 among controls (95% confidence interval, 0.017-0.022). The change in dementia probability was not significantly different between groups (mean difference, -0.002; 95% confidence interval, -0.006 to 0.002). Frequent urinary incontinence was reported in 105 of 1706 (6%) of those with urinary incontinence. Memory score declined and dementia probability increased with time (P<.001) in frequent and infrequent urinary incontinence subgroups. There was no dose-response relationship. CONCLUSION: Measures of cognitive performance declined during approximately 10 years of observation. The changes in performance were not associated with the presence of urinary incontinence in the participants' younger years.

5.
Article in English | MEDLINE | ID: mdl-38465990

ABSTRACT

IMPORTANCE: Urinary retention is a common adverse effect after intravesical injection of onabotulinum toxin A (BTX) for overactive bladder (OAB). Reported retention rates range from 1.6% to more than 40%. This variation may be due to varying definitions of retention in the literature. OBJECTIVE: We aimed to assess the variation in definitions of urinary retention across studies of BTX for the treatment of OAB. STUDY DESIGN: We performed a systematic review of studies of BTX for OAB by querying MEDLINE and EMBASE according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We included original research studies on adults with overactive bladder treated with BTX and urinary retention reported as an outcome from January 2000 to December 2020. RESULTS: From 954 results, we identified 53 articles that met inclusion criteria. There were 6 definitions for urinary retention. The majority of studies (60.4%) reported initiating clean intermittent catheterization (CIC) as the metric for retention. Five (9.5%) studies provided no definition despite reporting retention as an adverse event. Twenty studies (37.7%) specified a postvoid residual volume (PVR) threshold for initiating CIC in asymptomatic patients; 19 (35.8%) specified a PVR threshold for CIC in symptomatic patients. The PVR thresholds ranged from 100 to 400 mL. Twenty-three studies (43.4%) did not address asymptomatic elevation of PVR, and 22 (41.5%) did not address how symptomatic patients were managed. CONCLUSIONS: Urinary retention after BTX injection is inconsistently defined in the literature. Lack of standardization in reporting retention after intravesical BTX prevents accurate assessment of the risk of urinary retention and comparison of outcomes between studies.

6.
Med Decis Making ; 44(3): 320-334, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38347686

ABSTRACT

BACKGROUND: Physician treatment preference may influence how risks are communicated in prostate cancer consultations. We identified persuasive language used when describing cancer prognosis, life expectancy, and side effects in relation to a physician's recommendation for aggressive (surgery/radiation) or nonaggressive (active surveillance/watchful waiting) treatment. METHODS: A qualitative analysis was performed on transcribed treatment consultations of 40 men with low- and intermediate-risk prostate cancer across 10 multidisciplinary providers. Quotes pertaining to cancer prognosis, life expectancy, and side effects were randomized. Coders predicted physician treatment recommendations from isolated blinded quotes. Testing characteristics of consensus predictions against the physician's treatment recommendation were reported. Coders then identified persuasive strategies favoring aggressive/nonaggressive treatment for each quote. Frequencies of persuasive strategies favoring aggressive/nonaggressive treatment were reported. Logistic regression quantified associations between persuasive strategies and physician treatment recommendations. RESULTS: A total of 496 quotes about cancer prognosis (n = 127), life expectancy (n = 51), and side effects (n = 318) were identified. The accuracy of predicting treatment recommendation based on individual quotes containing persuasive language (n = 256/496, 52%) was 91%. When favoring aggressive treatment, persuasive language downplayed side effect risks and amplified cancer risk (recurrence, progression, or mortality). Significant predictors (P < 0.05) of aggressive treatment recommendation included favorable side effect interpretation, downplaying side effects, and long time horizon for cancer risk due to longevity. When favoring nonaggressive treatment, persuasive language amplified side effect risks and downplayed cancer risk. Significant predictors of nonaggressive treatment recommendation included unfavorable side effect interpretation, favorable interpretation of cancer risk, and short time horizon for cancer risk due to longevity. CONCLUSIONS: Physicians use persuasive language favoring their preferred treatment, regardless of whether their recommendation is appropriate. IMPLICATIONS: Clinicians should quantify risk so patients can judge potential harm without solely relying on persuasive language. HIGHLIGHTS: Physicians use persuasive language favoring their treatment recommendation when communicating risks of prostate cancer treatment, which may influence a patient's treatment choice.Coders predicted physician treatment recommendations based on isolated, randomized quotes about cancer prognosis, life expectancy, and side effects with 91% accuracy.Qualitative analysis revealed that when favoring nonaggressive treatment, physicians used persuasive language that amplified side effect risks and downplayed cancer risk. When favoring aggressive treatment, physicians did the opposite.Providers should be cognizant of using persuasive strategies and aim to provide quantified assessments of risk that are jointly interpreted with the patient so that patients can make evidence-based conclusions regarding risks without solely relying on persuasive language.


Subject(s)
Prostatic Neoplasms , Humans , Male , Communication , Language , Persuasive Communication , Prostate-Specific Antigen , Prostatic Neoplasms/therapy , Qualitative Research
7.
JAMA Netw Open ; 7(2): e2356088, 2024 Feb 05.
Article in English | MEDLINE | ID: mdl-38353948

ABSTRACT

Importance: There is no consensus in prostate-specific antigen (PSA) screening guidelines regarding transgender women despite their known prostate cancer risk. Objective: To identify factors associated with recent (within the last 2 years) PSA screening in transgender women compared with cisgender men. Design, Setting, and Participants: This case-control study used data from the 2018 and 2020 Behavioral Risk Factor Surveillance System (BRFSS) surveys to characterize rates of PSA screening for prostate cancer within the past 2 years and multivariable logistic regressions to characterize factors associated with recent screening among transgender women. The BRFSS program of the Centers for Disease Control and Prevention annually surveys over 400 000 US adults on behavioral risk factors, chronic illnesses, and use of preventive services. Respondents to the BRFSS who were cisgender men or transgender women 40 years or older and who had complete PSA testing responses and no prostate cancer history were included; 313 transgender women and 138 937 cisgender men met inclusion criteria. Matching was performed by age, race and ethnicity, educational level, employment, annual income, survey year, and cost barriers to care. Data were collected on November 2, 2022, and analyzed from November 2, 2022, to December 3, 2023. Main Outcomes and Measures: Rates of and factors associated with recent PSA screening in transgender women. Results: Among the 1275 participants included in the matched cohort (255 transgender women and 1020 cisgender men; 570 [44.7%] aged 55-69 years), recent PSA screening rates among transgender women and cisgender men aged 55 to 69 were 22.2% (n = 26) and 36.3% (n = 165), respectively; among those 70 years and older, these rates were 41.8% (n = 26) and 40.2% (n = 98), respectively. In the matched cohort, transgender women had lower univariable odds of recent screening than cisgender men (odds ratio [OR], 0.65 [95% CI, 0.46-0.92]; P = .02). In a hierarchical regression analysis adding time since the last primary care visit, effect size and significance were unchanged (OR, 0.61 [95% CI, 0.42-0.87]; P = .007). After adding whether a clinician recommended a PSA test, there was no statistically significant difference in odds of screening between transgender women and cisgender men (OR, 0.83 [95% CI, 0.45-1.27]; P = .21). The results were further attenuated when clinician-led discussions of PSA screening advantages and disadvantages were added (OR, 0.87 [95% CI, 0.47-1.31]; P = .32). In a multivariable logistic regression among transgender women, having a recommendation for PSA testing was the factor with the strongest association with recent screening (OR, 12.40 [95% CI, 4.47-37.80]; P < .001). Conclusions and Relevance: In this case-control study of one of the largest cohorts of transgender women studied regarding PSA screening, the findings suggest that access to care or sociodemographic factors were not principal drivers of the screening differences between transgender women and cisgender men; rather, these data underscore the clinician's role in influencing PSA screening among transgender women.


Subject(s)
Prostatic Neoplasms , Transgender Persons , United States , Adult , Male , Humans , Early Detection of Cancer , Prostatic Neoplasms/diagnosis , Prostate-Specific Antigen , Case-Control Studies , Pathologic Complete Response
8.
Neurourol Urodyn ; 43(2): 407-414, 2024 Feb.
Article in English | MEDLINE | ID: mdl-38032120

ABSTRACT

INTRODUCTION: Onabotulinumtoxin A (BTX-A) is a well-established treatment for overactive bladder (OAB). The American Urological Association (AUA) 2008 Antibiotic Best Practice Statement (BPS) recommended trimethoprim-sulfamethoxazole or fluoroquinolone for cystoscopy with manipulation. The aim of the study was to evaluate concordance with antibiotic best practices at the time of BTX-A injection and urinary tract infection (UTI) rates based on antibiotic regimen. METHODS: Men and women undergoing first-time BTX-A injection for idiopathic OAB with 100 units in 2016, within the SUFU Research Network (SURN) multi-institutional retrospective database were included. Patients on suppressive antibiotics were excluded. The primary outcome was concordance of periprocedural antibiotic use with the AUA 2008 BPS antimicrobials of choice for "cystoscopy with manipulation." As a secondary outcome we compared the incidence of UTI among women within 30 days after BTX-A administration. Each outcome was further stratified by procedure setting (office vs. operating room; OR). RESULTS: Of the cohort of 216 subjects (175 women, 41 men) undergoing BTX-A, 24 different periprocedural antibiotic regimens were utilized, and 98 (45%) underwent BTX-A injections in the OR setting while 118 (55%) underwent BTX-A injection in the office. Antibiotics were given to 86% of patients in the OR versus 77% in office, and 8.3% of subjects received BPS concordant antibiotics in the OR versus 82% in office. UTI rates did not vary significantly among the 141 subjects who received antibiotics and had 30-day follow-up (8% BPS-concordant vs. 16% BPS-discordant, CI -2.4% to 19%, p = 0.13). A sensitivity analysis of UTI rates based on procedure setting (office vs. OR) did not demonstrate any difference in UTI rates (p = 0.14). CONCLUSIONS: This retrospective multi-institutional study demonstrates that antibiotic regimens and adherence to the 2008 AUA BPS were highly variable among providers with lower rates of BPS concordant antibiotic use in the OR setting. UTI rates at 30 days following BTX-A did not vary significantly based on concordance with the BPS or procedure setting.


Subject(s)
Botulinum Toxins, Type A , Urinary Bladder, Overactive , Urinary Tract Infections , Male , Humans , Female , Anti-Bacterial Agents/therapeutic use , Urinary Bladder, Overactive/drug therapy , Urinary Bladder, Overactive/complications , Retrospective Studies , Urinary Tract Infections/drug therapy , Urinary Tract Infections/epidemiology , Urinary Tract Infections/etiology , Repressor Proteins
9.
Urogynecology (Phila) ; 29(11): 914-919, 2023 11.
Article in English | MEDLINE | ID: mdl-38107872

ABSTRACT

Purpose: To determine intravesical instillation patterns among women receiving treatment for interstitial cystitis/bladder pain syndrome (IC/BPS). Methods: Using the Veterans Affairs Informatics and Computing Infrastructure, active female users of the Veterans Affairs system with an ICD-9 diagnosis of IC/BPS (595.1) were randomly sampled. Patients were considered to have IC/BPS (by chart review) if they had two visits complaining of bladder-centric pain in the absence of positive urine culture ≥6 weeks apart or history of bladder pain with one additional visit for bladder-centric pain. We abstracted the dates of intravesical instillations for each patient. A "course" of instillations was defined as ≥1 instillations made with <21 days between visits. Results: We identified 641 women with confirmed diagnosis of IC/BPS, 78 of whom underwent a total of 344 intravesical instillations. On average each subject had 1.5 +/- 0.8 courses between October 2004-July 2016. Each course was an average of 3.1 +/- 2.6 instillations. 55% of courses consisted of one instillation. Only 22% of courses had 6 or more instillations, the number typically recommended to achieve clinical response. Each instillation within a course was an average of 9.4 +/- 4.0 days apart. Most instillations (77%) were a cocktail of two or more drugs. Conclusions: In our cohort, few women with IC/BPS received a recommended treatment course of six weekly instillations, with most receiving only one per course. Future studies are needed to determine if instillation courses were altered from the guideline due to provider practice patterns, early improvement, or poor tolerance of instillations.


Subject(s)
Cystitis, Interstitial , Humans , Female , Cystitis, Interstitial/drug therapy , Administration, Intravesical , Pain Measurement , Pelvic Pain/drug therapy
10.
Sex Med Rev ; 12(1): 26-34, 2023 12 23.
Article in English | MEDLINE | ID: mdl-37888490

ABSTRACT

INTRODUCTION: Sexual health, an integral component of overall well-being, is frequently compromised by common yet underdiagnosed sexual dysfunctions. Traditional interventions encompass pharmaceutical and psychological treatments. Unconventional therapies, like MDMA, offer hope for sexual dysfunction. This review delves into MDMA's effects on sexual responsiveness and its potential role in treating sexual dysfunction. OBJECTIVES: The purpose of this review is to elucidate effects of MDMA on different domains of the female and male sexual response cycles. METHODS: We conducted a systematic review on the effects of MDMA on each domain of the female and male sexual response cycles. PubMed, MEDLINE, and EMBASE were queried, and results were screened using PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Search terms utilized were "MDMA" or "ecstasy" in combination with "desire," "arousal," "lubrication," "orgasm," "pleasure," "libido," "erection," and "ejaculation." Inclusion criteria for this review were MDMA use by study subjects and sexual outcomes in at least 1 domain of the female and/or male sexual response cycles were described and measured. Randomized controlled trials, cohort studies (both prospective and retrospective), surveys, and literature reviews published between January 2000 and June 2022 were included. Case reports and studies that did not address conditions of interest were excluded from analysis. Duplicated search results were screened out. The remaining studies were then read in full text to ensure they met inclusion and exclusion criteria for analysis. RESULTS: We identified 181 studies, of which 6 met criteria for assessment of the female sexual response cycle and 8 met criteria for assessment of the male sexual response cycle. Four of 6 studies reported increased sexual desire with MDMA use among women. Arousal and lubrication were improved with MDMA use in 3 of 4 studies, but they were not affected in 1 randomized control study. In men, 7 studies evaluated the effects of MDMA on desire and/or arousal, 5 studies measured impact on erection, 3 on orgasm, and 2 on ejaculation. Sixty percent of interview-based studies reported increased sexual desire in men, while 40% reported mixed or no effect. Two studies reported impairment of erection, 2 reported mixed effects, and 1 reported fear of erection impairment. In both men and women, all studies evaluating orgasm reported delay in achieving orgasm but increased intensity and pleasure if achieved. Primary outcome measures were variable and largely qualitative. CONCLUSION: Our findings suggest that MDMA generally increases sexual desire and intensifies orgasm when achieved. While producing conflicting evidence on sexual arousal in both sexes, MDMA may impair erectile and ejaculatory function in men.


Subject(s)
N-Methyl-3,4-methylenedioxyamphetamine , Sexual Dysfunction, Physiological , Female , Humans , Male , N-Methyl-3,4-methylenedioxyamphetamine/adverse effects , N-Methyl-3,4-methylenedioxyamphetamine/pharmacology , N-Methyl-3,4-methylenedioxyamphetamine/therapeutic use , Prospective Studies , Retrospective Studies , Sexual Behavior/psychology , Sexual Dysfunction, Physiological/chemically induced , Sexual Dysfunction, Physiological/drug therapy
11.
J Patient Saf ; 19(7): 465-468, 2023 10 01.
Article in English | MEDLINE | ID: mdl-37729644

ABSTRACT

BACKGROUND: Evidence suggests that more women are harmed by implantable medical devices than men. It is unknown whether this difference includes gender-specific devices. METHODS: In this study, we examine the differences in reported adverse events between 6 female- and 5 male-specific implantable devices from the Manufacturer and User Facility Device Experience (MAUDE) database from 1993 to 2018. Primary endpoints were injury type (life-threatening, disability, death) and the rate of device evaluation by the manufacturer. Proportions of valid entries across these variables were compared using either the Fisher exact test or χ2 test. RESULTS: Female-specific devices had higher rates of life-threatening outcomes (1.6% versus 0.3%, P < 0.001), disabilities (5.0% versus 4.3%, P < 0.001), and deaths (0.6% versus 0.1%, P < 0.001) compared with the male-specific devices. Of the 8159 devices that were evaluated by the manufacturer, 56% were female specific while 44% were male specific. Female-specific devices were evaluated far less frequently by the manufacturer (4.5% versus 38.2%, P < 0.001). CONCLUSIONS: Increased adverse events reports for female-specific devices and associated high-grade complications necessitates improved postmarket surveillance.


Subject(s)
Health Facilities , Prostheses and Implants , United States , Humans , Female , Male , Databases, Factual , Prostheses and Implants/adverse effects
12.
Urogynecology (Phila) ; 29(10): 787-799, 2023 10 01.
Article in English | MEDLINE | ID: mdl-37733440

ABSTRACT

OBJECTIVE: The aim of the study was to compare 12-month subjective and objective outcomes between 3 approaches to apical pelvic organ prolapse (POP) surgery in patients presenting with uterovaginal or posthysterectomy vaginal prolapse enrolled in the Pelvic Floor Disorders Registry for Research. STUDY DESIGN: This was an analysis of a multicenter, prospective registry that collected both patient- and physician-reported data for up to 3 years after conservative (pessary) and surgical treatment for POP. Twelve-month subjective and anatomic outcomes for patients who underwent surgical treatment were extracted from the registry for analysis. Pelvic organ prolapse recurrence was defined as a composite outcome and compared between the 3 apical surgery groups (native tissue repair, sacrocolpopexy, colpocleisis) as well as the 2 reconstructive surgery groups (native tissue repair and sacrocolpopexy). RESULTS: A total of 1,153 women were enrolled in the registry and 777 (67%) opted for surgical treatment, of whom 641 underwent apical repair and were included in this analysis (404 native tissue repair, 187 sacrocolpopexy, and 50 colpocleisis). The overall incidence of recurrence was as follows: subjective 6.5%, anatomic 4.7%, retreatment 7.2%, and composite 13.6%. The incidence of recurrence was not different between the 3 surgical groups. When baseline patient characteristics were controlled for, composite POP recurrence between the native tissue and sacrocolpopexy groups remained statistically nonsignificant. Concurrent perineorrhaphy with any type of apical POP surgery was associated with a lower risk of recurrence (adjusted odds ratio, 0.43; 95% confidence interval, 0.25-0.74; P = 0.002) and prior hysterectomy was associated with a higher risk (adjusted odds ratio, 1.77, 95% confidence interval, 1.04-3.03; P = 0.036). CONCLUSION: Pelvic Floor Disorders Registry for Research participants undergoing native tissue apical POP repair, sacrocolpopexy, and colpocleisis surgery had similar rates of POP recurrence 12 months after surgery.


Subject(s)
Pelvic Floor Disorders , Pelvic Organ Prolapse , Uterine Prolapse , Humans , Female , Pregnancy , Uterine Prolapse/epidemiology , Pelvic Organ Prolapse/epidemiology , Registries , Colpotomy
13.
Neurourol Urodyn ; 42(8): 1655-1667, 2023 Nov.
Article in English | MEDLINE | ID: mdl-37497812

ABSTRACT

INTRODUCTION: Over 350 000 sacral neuromodulation (SNM) devices have been implanted since approval by the Food and Drug Administration (FDA) in 1998. SNM technology and clinical applications have evolved, with minimal safety updates after initial trials. We aim to provide an updated overview of real-world SNM safety. These insights will guide informed consent, preoperative counseling, and patient expectation-setting. MATERIALS AND METHODS: The FDA Manufacturer and User Facility Device Experience (MAUDE) database is a repository for medical device safety reports. We performed MAUDE categorical (1/1/98-12/31/10) and keyword (1/1/11-9/30/21) searches for "Interstim." A random sample of 1000 reports was reviewed and categorized by theme. To corroborate our MAUDE database analysis, a legal librarian searched the Public Access to Court Electronic Records (PACER) database, as well as Bloomberg Law's dockets database for all lawsuits related to SNM devices. RESULTS: Our search of the MAUDE database returned 44 122 SNM-related adverse events (AEs). The figure illustrates the prevalence of event categories in the random sample. The largest proportion of reports (25.6%) related to a patient's need for assistance with device use, followed by loss/change of efficacy (19.0%). Interestingly, a fall preceded issue onset in 32% of non-shock pain, 30% of lead/device migration, and 27% of painful shock reports. Our legal search revealed only four lawsuits: one for patient complications after an SNM device was used off-label, one case of transverse myelitis after implant, one for device migration or poor placement, and the fourth claimed the device malfunctioned requiring removal and causing permanent injury. CONCLUSIONS: This review confirms the real-world safety of SNM devices and very low complication rates as seen in the original clinical trials. Our findings indicate that 43.2% (95% confidence interval 40.1%-46.3%) of SNM "complications" are not AEs, per se, but rather reflect a need for improved technical support or more comprehensive informed consent to convey known device limitations to the patient, such as battery life. Similarly, the number of lawsuits is shockingly low for a device that has been in the market for 24 years, reinforcing the safety of the device. Legal cases involving SNM devices seem to relate to inappropriate patient selection-including at least one case in which SNM was used for a non-FDA approved indication-lack of appropriate follow-up, and/or provider inability to assist the patient with utilizing the device after implantation.


Subject(s)
Electric Stimulation Therapy , United States , Humans , United States Food and Drug Administration , Electric Stimulation Therapy/adverse effects , Databases, Factual
14.
Front Pain Res (Lausanne) ; 4: 1149783, 2023.
Article in English | MEDLINE | ID: mdl-37305204

ABSTRACT

Objective: To compare health-related quality of life (HRQOL) and pelvic pain levels over time in patients with interstitial cystitis/bladder pain syndrome (IC/BPS) and those with other pelvic pain conditions (OPPC) including chronic prostatitis, dyspareunia, vaginismus, vulvodynia, and vulvar vestibulitis. Methods: We prospectively enrolled male and female patients from any Veterans Health Administration (VHA) center in the US. They completed the Genitourinary Pain Index (GUPI) quantifying urologic HRQOL and the 12-Item Short Form Survey version 2 (SF-12) quantifying general HRQOL at enrollment and 1 year later. Participants were classified by ICD diagnosis codes and confirmed by chart review to be IC/BPS or OPPC (308 and 85 patients respectively). Results: At baseline and follow-up, IC/BPS patients, on average, had worse urologic and general HRQOL than OPPC patients. IC/BPS patients demonstrated improvement in urologic HRQOL measures over the study but demonstrated no significant change in any general HRQOL measure suggesting a condition-specific impact. Patients with OPPC demonstrated similar improvements in urologic HRQOL but had deteriorating mental health and general HRQOL at follow-up suggesting a wider general HRQOL impact for these diseases. Conclusions: We found that patients with IC/BPS had worse urologic HRQOL compared to other pelvic conditions. Despite this, IC/BPS showed stable general HRQOL over time, suggesting a more condition-specific impact on HRQOL. OPPC patients showed deteriorating general HRQOL, suggesting more widespread pain symptoms in these conditions.

15.
Am J Surg ; 226(3): 365-370, 2023 09.
Article in English | MEDLINE | ID: mdl-37330385

ABSTRACT

BACKGROUND: Current approaches to assessing workload in robotic-assisted surgery (RAS) focus on surgeons and lack real-world data. Understanding how workload varies by role and specialty aids in identifying effective ways to optimize workload. METHODS: SURG-TLX surveys with six domains of workload were administered to surgical staff at three sites. Staff reported workload perceptions for each domain on a 20-point Likert scale, and aggregate scores were determined per participant. RESULTS: 188 questionnaires were obtained across 90 RAS procedures. Significantly higher aggregate scores were reported for gynecology (Mdn â€‹= â€‹30.00) (p â€‹= â€‹0.034) and urology (Mdn â€‹= â€‹36.50) (p â€‹= â€‹0.006) than for general (Mdn â€‹= â€‹25.00). Surgeons reported significantly higher scores for task complexity (Mdn â€‹= â€‹8.00) than both technicians (Mdn â€‹= â€‹5.00) (p â€‹= â€‹0.007), and nurses (Mdn â€‹= â€‹5.00). CONCLUSIONS: Staff reported significantly higher workload during urology and gynecology procedures, and experienced significant differences in domain workload by role and specialty, elucidating the need for tailored workload interventions.


Subject(s)
Gynecology , Robotic Surgical Procedures , Surgeons , Urology , Humans , Workload
16.
Obes Surg ; 33(7): 2083-2089, 2023 07.
Article in English | MEDLINE | ID: mdl-37147465

ABSTRACT

PURPOSE: Bariatric surgery is an effective and durable treatment for weight loss for patients with extreme obesity. Although traditionally approached laparoscopically, robotic bariatric surgery (RBS) has unique benefits for both surgeons and patients. Nonetheless, the technological complexity of robotic surgery presents new challenges for OR teams and the wider clinical system. Further assessment of the role of RBS in delivering quality care for patients with obesity is necessary and can be done through a human factors approach. This observational study sought to investigate the impact of RBS on the surgical work system via the study of flow disruptions (FDs), or deviations from the natural workflow progression. MATERIALS AND METHODS: RBS procedures were observed between October 2019 and March 2022. FDs were recorded in real time and subsequently classified into one of nine work system categories. Coordination FDs were further classified into additional sub-categories. RESULTS: Twenty-nine RBS procedures were observed at three sites. An average FD rate of 25.05 (CI = ± 2.77) was observed overall. FDs were highest between insufflation and robot docking (M = 29.37, CI = ± 4.01) and between patient closing and wheels out (M = 30.00, CI = ± 6.03). FD rates due to coordination issues were highest overall, occurring once every 4 min during docking (M = 14.28, CI = ± 3.11). CONCLUSION: FDs occur roughly once every 2.4 min and happen most frequently during the final patient transfer and robot docking phases of RBS. Coordination challenges associated with waiting for staff/instruments not readily available and readjusting equipment contributed most to these disruptions.


Subject(s)
Bariatric Surgery , Obesity, Morbid , Robotic Surgical Procedures , Humans , Robotic Surgical Procedures/methods , Workflow , Obesity, Morbid/surgery , Obesity
17.
Cureus ; 15(3): e36748, 2023 Mar.
Article in English | MEDLINE | ID: mdl-37123779

ABSTRACT

Background Gender-affirming pelvic surgery (GAPS) can be associated with significant postoperative pelvic pain. Given the lack of available peripheral nerve blocks to the perineum, intrathecal morphine (ITM) injection could offer a potent analgesic modality for this patient population. No prior studies to date have been performed examining the analgesic effects of intrathecal morphine for these patients. Methods This retrospective case-control study aims to understand the postoperative analgesic effects of intrathecal morphine for these patients with a historical comparison group of patients who did not receive intrathecal morphine. Results Fourteen patients presented for gender-affirming pelvic surgery over an eight-month period at a single institution and were offered intrathecal morphine for postoperative analgesia. Their analgesic results were compared to a similar historical group of 13 patients who were not offered or declined intrathecal morphine. Conclusions Intrathecal morphine injection is a potent analgesic modality for patients presenting for gender-affirming pelvic surgery.

19.
Int Urogynecol J ; 34(9): 2265-2274, 2023 09.
Article in English | MEDLINE | ID: mdl-37099159

ABSTRACT

INTRODUCTION AND HYPOTHESIS: Patient-reported outcome measures (PROMs) are important for understanding the success of surgery for stress urinary incontinence, as patient perception of success does not always correlate with physician perception of success. We report PROMS after single-incision slings (SIS) and transobturator mid-urethral slings (TMUS). METHODS: This was a planned outcome analysis of secondary endpoints in a study in which the primary aim was to compare efficiency and safety using a non-inferiority design (results reported previously). In this analysis of quality of life (QOL), validated PROMs were collected at baseline, 6, 12, 18, 24, and 36 months to quantify incontinence severity (Incontinence Severity Index), symptom bother (Urogenital Distress Inventory), disease-specific QOL impact (Urinary Impact Questionnaire), and generic QOL impact (PGI-I; not applicable at baseline). PROMs were analyzed within treatment groups as well as between groups. Propensity score methods were used to adjust for baseline differences between groups. RESULTS: A total of 281 subjects underwent the study procedure (141 SIS, 140 TMUS). Baseline characteristics were balanced after propensity score stratification. Participants had significant improvement in incontinence severity, disease-specific symptom bother, and QOL impact. Improvements persisted through the study and PROMs were similar between treatment groups in all assessment at 36 months CONCLUSIONS: Following SIS and TMUS, patients with stress urinary incontinence had significant improvement in PROMs including Urogenital Distress Inventory, Incontinence Severity Index, and Urinary Impact Questionnaire at 36 months, indicating disease-specific QOL improvement. Patients have a more positive impression of change in stress urinary incontinence symptoms at each follow-up visit, indicating generic QOL improvement.


Subject(s)
Suburethral Slings , Urinary Incontinence, Stress , Urinary Incontinence , Female , Humans , Urinary Incontinence, Stress/surgery , Quality of Life , Urologic Surgical Procedures/methods , Urinary Incontinence/surgery , Patient Reported Outcome Measures , Treatment Outcome
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