Pain Related to Intradetrusor BotulinumtoxinA: A Randomized Clinical Trial.

IMPORTANCE: OnabotulinumtoxinA (BTX-A) is an effective treatment for overactive bladder (OAB), but few studies have been done to evaluate injection techniques. OBJECTIVE: The primary objective was to evaluate procedural discomfort between 2 commonly used injection techniques for BTX-A. STUDY DESIGN: This was a single-blinded, randomized clinical trial of women undergoing injection of 100 U BTX-A for idiopathic OAB. Patients were randomized to 5 mL/5 injection or 10 mL/10 injection groups. Bladder pain was assessed by a validated Numeric Pain Rating Scale. Overactive bladder symptoms were assessed with a standardized questionnaire (Overactive Bladder Questionnaire Short Form). Patient satisfaction, treatment efficacy, and adverse events were assessed at 30 days after procedure. RESULTS: One hundred eight patients were randomized to 52 in the 5 mL/5 injection arm and 56 in the 10 mL/10 injection arm. Mean procedural pain scores were 3.2 (±2.3) in the 5 mL/5 injection group versus 3.6 (±2.1) in the 10 mL/10 injection group (P = 0.21). No difference was found when categorizing pain scores into ordinal outcomes of low (P = 0.55), medium (P = 0.70), and high (P = 1.0) or a binary outcome of low (P = 0.55) versus medium + high (P = 0.55). Multivariate analyses did not effect statistical significance between the 2 groups for the ordinal outcome (odds ratio = 1.86; 95% confidence interval = 0.77 = 4.52; P = 0.17) or the binary outcome (odds ratio = 1.81; 95% confidence interval = 0.68-4.77; P = 0.28). No difference was observed between overall patient satisfaction, global impression of improvement, Overactive Bladder Questionnaire Short Form scores, or adverse outcomes. CONCLUSIONS: Procedural discomfort related to BTX-A injection for idiopathic OAB was not different between 2 injection protocols. Overall satisfaction was high for both groups, and there was no difference in symptom scores or adverse events.

Healthcare disparities and pelvic organ prolapse operative complications: a nationwide analysis.

INTRODUCTION AND HYPOTHESIS: The objective of this study was to evaluate the differences in the incidence of peri-operative complications at the time of pelvic organ prolapse (POP) repair based on health care disparities such as race and socioeconomic status. METHODS: The National Inpatient Sample (NIS) database was queried using ICD-9/-10 codes for patients aged >18 years undergoing POP repair in 2008-2018. Demographic information, Elixhauser Comorbidity Index (ECI), insurance status, and peri-operative complications were extracted. Multivariate weighted logistic regression using the discharge weights from NIS were constructed on binary outcomes. Complications with at least 1% incidence were included in the analysis. RESULTS: A total of 172,483 POP repair patients were analyzed: 130,022 (75.4%) were white, 10,561 (6.1%) were Black, 21,915 (12.7%) were Hispanic, and 9,985 (5.8%) were of other races. Patients with Medicaid as well as Black, Hispanic, and other races had higher odds of developing postoperative complications such as urinary tract infections, sepsis, and acute renal failure (p value <0.001-0.02). These were also more common in smaller, rural hospitals and with patients with an annual income of $45,999 or less (p value <0.001-0.03). Black and Hispanic patients had lower odds of intraoperative complications such as hemorrhage (aOR 0.77, 95% CI 0.71-0.84; aOR 0.75, 95% CI 0.7-0.8 respectively) or abdominopelvic injury (aOR 0.86, 95% CI 0.81-0.92; aOR 0.93, 95% CI 0.79-0.88 respectively) compared with white patients. CONCLUSION: Nonwhite patients with lower socioeconomic status had increased postoperative complications and fewer intraoperative complications from POP surgery, whereas white patients with higher socioeconomic status had more intraoperative complications.

Health Care Disparities in Surgical Management of Pelvic Organ Prolapse: A Contemporary Nationwide Analysis.

OBJECTIVES: Our objective was to compare the rate of native tissue repair (NTR) versus sacrocolpopexy (SCP) and reconstructive (RECON) versus obliterative repair (OBR) for the treatment of pelvic organ prolapse (POP), evaluating for health care disparities based on race, socioeconomic, and geographic factors. METHODS: The National Inpatient Sample database was queried for patients older than 18 years undergoing POP surgery from 2008 to 2018. Baseline demographics, comorbidity index, socioeconomic, and hospital variables were extracted. The weighted t test, Wilcoxon test, and χ2 test were used to compare the rate of (1) NTR versus SCP and (2) RECON vs OBR. Multivariate weighted logistic regression was used to compare while controlling for confounders. Reference groups were White race, Medicare patients, northeast region, small hospital size, and rural location. RESULTS: Of 71,262 patients, 67,382 (94.6%) underwent RECON. Patients undergoing OBR were older and had a higher comorbidity score. Multivariate analysis showed the following: (1) Black, Hispanic, and other races; (2) Medicaid patients; (3) patients at urban teaching hospitals are less likely to receive RECON. Patients in the midwest were more likely to receive RECON. Among 68,401 patients, 23,808 (34.8%), and 44,593 (65.19%) underwent SCP and NTR, respectively. Hysterectomy was more common in the NTR group. Multivariate analysis showed the following:(1) Black, Hispanic, and "other" races; (2) uninsured and Medicaid patients; (3) patients in the midwest, south, and west were at higher odds of receiving NTR. Patients in large and urban hospitals were less likely to undergo NTR. CONCLUSIONS: Racial, socioeconomic, and geographic disparities exist in surgical management for POP warranting further study to seek to eliminate these disparities.