Urogynecology (Hagerstown, Md.)最新文献

Importance: Female external urinary collection devices were designed with the goal of decreasing the risk of catheter-associated urinary tract infections, which can have significant clinical complications. The BD PureWick urinary collection system, C. R. Bard, Inc., a wholly owned subsidiary of BD, Franklin Lakes, NJ, was the first device to enter the market and has had a widespread distribution. There is a lack of clinical data evaluating the safety of the PureWick device.

Objectives: This study aimed to evaluate adverse events associated with the PureWick device using reports from the U.S. Food and Drug Administration Manufacturer and User Device Experience database.

Study design: A retrospective case series was conducted of adverse events from the database, which includes the adverse events and patient demographics from mandatory and voluntary reporters. Grounded theory was applied, utilizing inductive reasoning to identify salient keywords in the analysis of adverse events.

Results: A total of 1,406 reports were submitted to the database from January 2016 to October 2023, with each report having at least 1 adverse event complaint. Report complaints were classified by patient injury (n = 1412, 67.6%), device malfunction (n = 459, 22.1%), user error (n = 125, 6.0%), device instructions (n = 83, 4.0%) and death (n = 6, 0.29%). Salient keywords include urinary tract infection, skin irritation, and device leakage.

Conclusions: There are adverse events associated with the PureWick external urinary collection device in reports from the U.S. Food and Drug Administration database. These findings warrant additional studies to assess the safety of the PureWick for patients using the device in the hospital and at home.

Importance: Postoperative urinary retention (POUR) affects up to 51% of women undergoing surgery for pelvic organ prolapse (POP). Effective prevention strategies remain elusive, although alpha receptor antagonists show promise in recent literature.

Objectives: This study sought to evaluate the effect of preoperative tamsulosin on POUR after vaginal surgery for POP.

Study design: We conducted a retrospective cohort study of female patients undergoing vaginal surgery for POP, with or without concomitant midurethral sling. Patients who received preoperative tamsulosin were compared with controls. All patients were discharged on the day of surgery after undergoing a standardized voiding trial. The primary outcome was the rate of POUR, defined by a failed voiding trial. Secondary outcomes included complication rates and risk factors for POUR.

Results: A total of 195 patients were included for analysis, with 60 patients (30.8%) receiving tamsulosin and 135 (69.2%) not. Baseline demographics were similar between groups, except the tamsulosin group had lower parity and were less likely to splint to void. The tamsulosin group had similar rates of POUR compared with control (31.7% vs 34.8%, P = 0.67). Multivariate logistic regression controlling for confounders showed no significant effect of tamsulosin on POUR rates (odds ratio, 0.65; 95% confidence interval, 0.31-1.35; P = 0.24). Concomitant sling placement was identified as the only independent risk factor for POUR (odds ratio, 3.00; 95% confidence interval, 1.55-5.81; P = 0.001).

Conclusions: Preoperative tamsulosin does not appear to be effective in preventing postoperative urinary retention in women undergoing vaginal surgery for POP, whereas concomitant sling placement appears to increase its risk.

Importance: Sacrocolpopexy is essential in the surgical management of advanced pelvic organ prolapse, and selecting the appropriate route for concomitant hysterectomy is critical.

Objectives: The aim of this study was to evaluate the effect of the hysterectomy route at the time of robot-assisted laparoscopic sacrocolpopexy (RA-SCP) on mesh exposure. Secondary outcomes were perioperative complications and prolapse recurrence.

Study design: This was a retrospective cohort study of 405 patients who underwent an RA-SCP at our institution from January 2013 to July 2019 with at least 6 month follow-up; the patients were grouped with respect to hysterectomy route as robot-assisted supracervical hysterectomy (SCH), total vaginal hysterectomy (VH), and posthysterectomy (PH). The primary outcome measure was mesh exposure. Short-term complications and anatomic failure were also analyzed.

Results: Two hundred three of our patients (50.1%) had a concomitant SCH, 93 (23.0%) had a concomitant VH, and 109 (26.9%) were PH at the time of their robotic sacrocolpopexy. Sacrocolpopexy mesh exposure occurred in 4 patients (1%), with an additional 6 patients (1.5%) with midurethral sling mesh exposure. Mesh exposure rates did not differ significantly between groups. At 6 months after surgery, anatomic failure rates did not differ significantly between groups (P = 0.69).Intraoperative and postoperative complication rates were low (bowel obstruction, 2.0%; bladder injury, 1.2%, after excluding those caused by sling trocars; venous thromboembolism, 0.7%; transfusion, 0.5%). Postoperative infection and readmission rates did not differ significantly between groups.

Conclusions: Patients with different routes of hysterectomy at the time of RA-SCP have similar mesh exposure and prolapse recurrence rates. Serious complications are rare in all groups.

Importance: Patients with urogynecologic conditions commonly present to general gynecology practices. Consequently, it is imperative that journals for obstetrics and gynecology (OBGYN) represent topics pertinent to comprehensive women's health, including urogynecology topics.

Objective: The aim of the study was to analyze the prevalence of urogynecology research compared to other topics in top OBGYN journals.

Study design: This was a retrospective review of all papers published in top OBGYN-focused journals from 2000 to 2023. The publicly available PubMed package in R was used to extract papers. Stata, a statistical software package, was used to develop an algorithm searching for key words concerning urogynecology, obstetrics, benign gynecology, gynecologic oncology, and reproductive endocrinology and infertility. The algorithm was tested and cross-validated via manual review of papers published in 1999 to determine whether identified key words were accurate in determining paper content. The algorithm was modified with additional key words and revalidated based on this initial analysis.

Results: Validation of the algorithm using all 1999 publications from several top OBGYN journals found a 93.48% accuracy for correct identification and classification of papers. Analysis was performed for 81,174 articles between 2000 and 2023. An average of 6.64% of publications focused on urogynecology topics. In contrast, 41.42% of publications concerned obstetrics, 33.9% on other benign gynecology, 41.9% on gynecologic oncology, and 24.7% on reproductive endocrinology and infertility.

Conclusions: This study reveals consistent underrepresentation of urogynecology topics in leading OBGYN journals. Given that generalist gynecologists may not subscribe to subspecialty journals, this study underscores the need for the inclusion of urogynecologic research in OBGYN journals.

Importance: Women who identify as Black or African American are underrepresented in research about pelvic floor disorders.

Objectives: The objectives of this study were to describe the prevalence of and factors associated with urinary incontinence (UI) and UI care-seeking among adult women in a Wisconsin household survey.

Study design: This was a cross-sectional analysis of data collected by the Survey of the Health of Wisconsin (SHOW). Using community engagement, individuals who identified as Black or African American were purposively oversampled in the 2018-2019 wave. Descriptive analyses compared women with and without UI, and those who had and had not sought care.

Results: Among 237 study participants, 46% (110) had UI: 46% mild, 36% moderate, and 18% severe. Most participants (84%) self-identified as non-Hispanic Black (84%), with a mean age of 49 ± 16 years and mean body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) of 34 ± 9; 62% were insured by Medicaid. The prevalence of UI was 44% among women who identified as non-Hispanic Black versus 59% (P = 0.085) among other women. Older age, obesity, needing help to read medical instructions, and identifying as a race other than non-Hispanic Black were significantly associated with UI. Among 110 women with UI, 53% had previously sought care. Rates of UI care seeking were similar (P = 0.32) among women who identified as non-Hispanic Black (55%) and those who identified as another race or ethnicity (43%).

Conclusion: Needing help to read medical instructions emerged as a factor associated with UI diagnosis in this sample that included almost 200 women who identified as non-Hispanic Black.

Importance: Limited data exist on postoperative recovery among patients with chronic pain undergoing pelvic reconstructive surgical procedures.

Objective: The objective of this study was to evaluate if patients with versus without self-reported chronic pain experience different recovery after pelvic reconstructive surgery.

Study design: From September 2022 to May 2023, this prospective cohort study enrolled patients with and without chronic pain, who were undergoing vaginal or laparoscopic procedures for pelvic organ prolapse. Preoperative pain was assessed using the Brief Pain Inventory (BPI) and Pepper Assessment Tool for Disability (PAT-D). Postoperative recovery was evaluated at 2, 4, and 12 weeks using the Postdischarge Surgical Recovery (PSR) scale, Global Surgical Recovery (GSR) index, and PAT-D questionnaire. The primary outcome was PSR scores at 4 weeks postoperatively.

Results: Ninety patients were recruited, with 43 reporting chronic pain and 47 without. Demographics were similar. Patients with chronic pain had higher preoperative BPI and PAT-D scores. Perioperative outcomes and hospital stay were similar. Patients with chronic pain used more postoperative opioids in the hospital (27.0 ± 27.8 vs 24.3 ± 60.3 morphine milligram equivalents [MME]; P = 0.03) and at home (40.1 ± 54.7 vs 19.9 ± 39.0 MME; P = 0.03). The PSR scores at 4 weeks were not significantly different. No differences were observed in PSR or GSR scores at all time points. Patients with chronic pain had a higher PAT-D score at 12 weeks. Fewer chronic pain patients returned to work by 12 weeks and desired more time off work.

Conclusions: Patients with and without chronic pain had similar surgical outcomes and recovery. However, chronic pain patients required more postoperative opioid pain medication and preferred more time off work.

Importance: Proper training is necessary to develop the highly specialized skills required to safely perform laparoscopic sacrocolpopexy. Currently, there is no validated training model for laparoscopic sacrocolpopexy that includes dissection of the presacral space, both vaginal and presacral mesh attachments, and peritoneal closure.

Objectives: This study aimed to create a procedure specific hierarchical task analysis for laparoscopic sacrocolpopexy and then develop and validate a corresponding laparoscopic sacrocolpopexy pelvic training model for the simulation environment.

Study design: This was an observational simulation study that was divided into 5 phases: (1) development of hierarchical task analysis, (2) model construction, (3) participant recruitment and simulation testing, (4) reliability and validity testing, and (5) creation of a standard passing performance measure.

Results: Construct, face, and content validity were established for this model. According to the participating experts, the model was able to replicate the steps of presacral dissection, anterior vaginal and sacral mesh attachment, and peritoneal closure. Thirteen trainees and 5 experts completed the simulation, and all "agreed" or "strongly agreed" that the model seemed useful for improving suturing technique and learning the procedure. Additionally, a passing performance measure was determined through contrasting groups methodology.

Conclusions: We developed a novel, reusable, and validated training model that can be utilized as a training resource for the many critical skills necessary to safely and efficiently perform laparoscopic sacrocolpopexy.

Abstract: Female bladder pain syndrome (FBPS), previously known as interstitial cystitis/bladder pain syndrome, is a life-altering and morbid condition that occurs primarily in female patients and can be variable in presentation. Given the absence of pathognomonic symptoms and sensitive diagnostic tests, significant symptomatic overlap with numerous other pelvic conditions (such as pelvic floor tension myalgia or endometriosis) occurring in women makes diagnosis of FBPS challenging. The frequent co-occurrence of FBPS with other pain conditions and functional somatic syndromes further complicates diagnosis and management. The challenges have limited the progress made in understanding the pathophysiology of the condition and improving approaches to treatment and prevention. Improvement in standardization of the terminology used to describe this unique condition is needed to improve the accuracy of diagnosis and the clinical care for affected patients. Given the variability in presentation and the differing definitions for the condition world-wide, the American Urogynecologic Society and the International Urogynecologic Association convened a joint writing group to standardize terminology around common signs and symptoms of the condition and to clarify the diagnosis as it pertains to female patients with the condition. After careful consideration of a broad range of available data and clinical experiences, consensus opinion recommended adopting the term "FBPS" instead of the misleading "interstitial cystitis" to describe a chronic, intermittent condition of at least 3 months' duration affecting women involving symptoms of pain or discomfort localized to the bladder, often with bladder filling, which are not attributed to other pathology. This term will allow clinicians, researchers, and learners alike to standardize their understanding of FBPS.

Importance: Bladder health in high school and collegiate females is not well understood.

Objective: The objective of this study was to compare toileting behaviors, lower urinary tract symptoms (LUTSs), and fluid intake in female athletes and nonathletes.

Study design: English-speaking nulliparous females aged 13-23 years were recruited. Participants completed the Toileting Behaviors: Women's Elimination Behaviors Scale, Bristol Female LUTS Questionnaire, and Beverage Questionnaire. Statistical analysis included univariable analyses and multivariable comparisons of athletes to nonathletes adjusting for age and fluid intake.

Results: One hundred athletes and 98 nonathletes participated (mean age 20 ± 2, mean body mass index 23 ± 4). Athletes' sports were predominantly high impact. Dysmenorrhea and anxiety were higher in nonathletes ( P < 0.01) versus more stress fractures in athletes ( P < 0.001). Problematic toileting behaviors were prevalent regardless of athletic status; nonathletes were more likely to hold urine until home and empty away from home without the urge (both P = 0.04). Lower urinary tract symptoms were prevalent regardless of athletic status, including frequency (34.2%), hesitancy (33.3%), urgency (32.8%), stress incontinence (15.3%), and urgency incontinence (11.8%). Athletes had significantly more stress incontinence and urgency and higher incontinence subscores on univariable analysis, although the difference was attenuated after multivariable adjustment. Athletes consumed lower total fluids ( P = 0.03).

Conclusions: Problematic toileting behaviors and LUTSs were prevalent in high school and collegiate females, regardless of athletic status. Athletes had higher stress urinary incontinence and urgency and lower fluid intake. These findings support future work toward enhancing early bladder health interventions (screening, education, and LUTS prevention) among high school and collegiate females.

Importance: The Neomedic Knotless Incontinence Mesh (KIM) sling with sterilizable trocars decreases medical waste versus midurethral slings with disposable trocars. Limited comparative data exist.

Objective: The aim of the study was to assess to the success of the retropubic KIM sling compared to the Gynecare TVT Exact sling.

Study design: This was a single-center, randomized noninferiority trial comparing outcomes of 2 retropubic slings-KIM sling and TVT Exact sling-in women with stress urinary incontinence from August 2021 to May 2023. Primary outcome was subjective success at 6 weeks defined by a composite outcome of the response to the question #17 on the The Pelvic Floor Distress Inventory-20 questionnaire and no retreatment of stress urinary incontinence. Secondary outcomes included rates of urinary retention, mesh erosion, and reoperation for mesh complications. Sample size estimate based on noninferiority margin of 14%, equal success of 90%, alpha 0.05, and 80% power with a 20% dropout was 72 per group.

Results: Among 147 patients, 74 (50.3%) were randomized to KIM sling versus 73 (49.7%) to TVT exact. The rates of 6-week success were 68.5% for the KIM sling and 83.3% for the TVT exact with a risk difference 14.8% (95% confidence interval, 1.1-28.5). The KIM sling is not noninferior to the TVT Exact sling. There were no differences in secondary outcomes.

Conclusions: The KIM sling is not noninferior to the TVT Exact sling for success at 6 weeks based on a composite outcome score. This clinical trial is ongoing to assess outcomes at 6 months and 1 year. ( Clinicaltrials.gov NCT04985799).