Women's attitudes towards pessary self-care: a qualitative study.

INTRODUCTION AND HYPOTHESIS: Patients with vaginal pessaries can learn to care for their pessary by themselves or they can have provider-led care, which requires more frequent follow-up visits. We aimed to understand motivations for and barriers to learning self-care of a pessary to inform strategies to promote pessary self-care. METHODS: In this qualitative study, we recruited patients recently fitted with a pessary for stress incontinence or pelvic organ prolapse, and providers who perform pessary fittings. Semi-structured, one-on-one interviews were completed to data saturation. A constructivist approach to thematic analysis using the constant comparison method was used to analyze interviews. A coding frame was created following independent review of a subset of interviews by three members of the research team and this frame was used to code interviews and develop themes through interpretive engagement with the data. RESULTS: Ten pessary users and four health care providers (physicians and nurses) participated. Three major themes were identified: motivators, benefits, and barriers. There were several motivators for learning self-care, including care provider advice, personal hygiene, and ease of care. Benefits of learning self-care included autonomy, convenience, facilitation of sexual relations, avoidance of complications, and decreased burden on the health care system. Barriers to self-care included physical, structural, mental, and emotional barriers; lack of knowledge; lack of time; and social taboo. CONCLUSIONS: Promotion of pessary self-care should focus on patient education about benefits and ways of mitigating common barriers while focusing on normalizing patient engagement in pessary self-care.

Short term complications in mesh augmented vaginal repair of pelvic organ prolapse are not higher when compared with native tissue repair.

INTRODUCTION AND HYPOTHESIS: Accumulating evidence regarding the negative long-term consequences of transvaginal mesh-based procedures for pelvic organ prolapse has led to a sharp decline in mesh-based procedures. We aimed to evaluate the short-term complications of mesh-based procedures for carefully selected patients with pelvic organ prolapse after Food and Drug Administration warnings. METHODS: A retrospective database review of the ACS NSQIP database was completed to examine 30-day complications including re-operation, prolonged length of stay, blood transfusion, surgical site infection, urinary tract infection, readmission and wound dehiscence in mesh-augmented and native tissue-based transvaginal procedures for pelvic organ prolapse. RESULTS: A total of 36,234 patients were included in the analysis, with only 7.1% (2574 women) having mesh-augmented repair. Using a multivariable logistical regression analysis adjusting for confounders, we found that the primary composite outcome (re-operation, hospital stay, blood transfusion and surgical site infection) was less common in the mesh group compared with the native tissue repair group (adjusted OR 0.80, CI 0.67-0.95, p = 0.009). The secondary outcomes (urinary tract infection, re-admission and wound dehiscence) were not different between the group. CONCLUSION: These results suggest that in well-chosen patients, short-term complications are not increased when using transvaginal mesh for pelvic organ prolapse repair.

Complications Following Posterior Colporrhaphy With and Without Anal Sphincteroplasty: An Analysis of Cases in the National Surgical Quality Improvement Program Database.

OBJECTIVE: We aimed to compare postoperative complications for patients undergoing posterior colporrhaphy with or without sphincteroplasty. METHODS: A retrospective cohort of women undergoing posterior colporrhaphy with or without anal sphincteroplasty was completed using the National Surgery Quality Improvement Program (NSQIP) database (2012-2019). The primary outcome was a composite of important surgical complications, including wound complications, blood transfusion, hospital stay >48 hours, reoperation, readmission, and urinary tract infection. Multivariable logistic regression was used to adjust for important potential confounders, including age, BMI, diabetes, and anterior prolapse surgery. RESULTS: A total of 5079 patients were included. Of these, 82 patients underwent a concurrent sphincteroplasty. The primary composite outcome occurred in 10.4% of patients having posterior colporrhaphy versus 19.5% having posterior colporrhaphy with sphincteroplasty. On multivariable analysis there was no increased odds of complication associated with concomitant anal sphincteroplasty (1.58, 95% CI 0.89-2.90, P = 0.12). CONCLUSION: Nearly one in five women who have posterior colporrhaphy with anal sphincteroplasty had an important surgical complication. Higher complication rates may be related to patient factors, as this was not observed after adjustment for patient factors and additional surgical procedures. Sphincteroplasty may be considered with posterior colporrhaphy in select women.

Surgical approach and unplanned readmission following pelvic organ prolapse surgery: a retrospective cohort study using data from the National Surgical Quality Improvement Program Database (NSQIP).

INTRODUCTION AND HYPOTHESIS: To define the reasons for hospital readmissions following surgery for pelvic organ prolapse by surgical approach. METHODS: Patients undergoing surgery for pelvic organ prolapse from 2012 to 2018 were identified in the American College of Surgeons National Surgical Quality Improvement Program database using Current Procedural Terminology and International Classification of Diseases codes. Hazard risks of readmission by surgical approach (vaginal, laparoscopic, abdominal, or combined) were determined by multivariable cox regression. Diagnoses and timing of readmission by surgical approach were examined. RESULTS: Of 57,233 women undergoing surgery for pelvic organ prolapse during the study period, 1073 (1.9%) were readmitted to the hospital within 30 days postoperatively. After adjusting for prespecified potential confounders, laparoscopic and abdominal surgical approaches were associated with higher risks of readmission relative to a vaginal approach (aHR 1.30, 95% CI 1.08-1.57, and 1.97, 95% CI 1.44-2.71, respectively). The most common reason for readmission was a gastrointestinal issue among those undergoing both laparoscopic (28.0%) and abdominal surgery (30.2%). Surgical site infection was the most common readmission diagnosis among women undergoing vaginal surgery (16.2%). Of the 418 women readmitted within 7 days of surgery, the most common diagnoses were gastrointestinal issues (26.6%), medical disorders (12.0%), or surgical complications (e.g., bleeding) (11.0%). CONCLUSIONS: Women undergoing laparoscopic or abdominal surgery for pelvic organ prolapse were at higher risk of readmission relative to those undergoing surgery via a vaginal approach. The reasons and timing of readmission differed based on surgical approach.

Journal Initiatives to Enhance Preclinical Research: Analyses of Stroke, Nature Medicine, Science Translational Medicine.

Background and Purpose- Preclinical research using animals often informs clinical trials. However, its value is dependent on its scientific validity and reproducibility, which are, in turn, dependent on rigorous study design and reporting. In 2011, Stroke introduced a Basic Science Checklist to enhance the reporting and methodology of its preclinical studies. Except for Nature and Science journals, few others have implemented similar initiatives. We sought to estimate the impact of these journal interventions on the quality of their published reports. Methods- All articles published in Stroke, Nature Medicine, and Science Translational Medicine over 9 to 18 years and in 2 control journals without analogous interventions over a corresponding 11.5 years were reviewed to identify reports of experiments in nonhuman mammals with proposed clinical relevance. The effect of journal interventions on the reporting and use of key study design elements was estimated via interrupted time-series analyses. Results- Of 33 009 articles screened, 4162 studies met inclusion criteria. In the 3.5 to 12 years preceding each journal's intervention, the proportions of studies reporting and using key study design elements were stable except for blinding in Stroke and randomization in Science Translational Medicine, which were both increasing. Post-intervention, abrupt and often marked increases were seen in the reporting of randomization status (level change: +17% to +44%, P≤0.005), blinding (level change: +20% to +40%, P≤0.008), and sample size estimation (level change: 0% to +40%, P≤0.002 in 2 journals). Significant but more modest improvements in the use of these study design elements were also observed. These improvements were not seen in control journals. Conclusions- Journal interventions such as Stroke's author submission checklist can meaningfully improve the quality of published preclinical research and should be considered to enhance study transparency and design. However, such interventions are alone insufficient to fully address widespread shortcomings in preclinical research practices.

Patient attitudes toward pooled surgical waitlists in urogynecology.

INTRODUCTION AND HYPOTHESIS: Pooled surgical waitlists are used to maximize the use of surgical resources; however, patients' views of this strategy are poorly understood. We sought to evaluate patients' attitudes toward a pooled waitlist for urogynecology and pelvic reconstructive surgical procedures. METHODS: Patient and provider focus groups were used to inform the design of a survey that was distributed to patients at the time of consent for female pelvic reconstructive surgical procedures. All responses were collected anonymously. Patient attitudes toward surgical wait times and the potential for a pooled surgical waitlist were explored. Grouped responses by age, procedure type, and perceived disease severity were examined. RESULTS: One hundred seventy-six patients were surveyed. Thirty-four percent were amenable to the option of a pooled surgical waitlist; 86% agreed or strongly agreed that they preferred to have their surgery performed by their own care provider. Only 18% would agree to be on a pooled surgical waitlist if it shortened their wait time. Older women (≥ 65 years) were more likely to disagree or strongly disagree that they "would like the option of having surgery done by the next available skilled surgeon" (56.2% vs. 72.0%, p = 0.028). Self-perceived severe disease and mid-urethral sling surgery were not associated with a higher acceptance of pooled surgical waitlists. CONCLUSIONS: Acceptance of pooled surgical waitlists among urogynecology patients was overall low, irrespective of disease severity. Improving our understanding of urogynecology patients' concerns and potentially negative perceptions of surgical waitlists is needed to ensure patient comfort and satisfaction are not compromised if this strategy is adopted.

Correction to: Patient attitudes toward pooled surgical waitlists in urogynecology.

Table 3 in the originally published article contains layout error. Corrected Table 3 shown below.

Methodological Rigor in Preclinical Cardiovascular Studies: Targets to Enhance Reproducibility and Promote Research Translation.

RATIONALE: Methodological sources of bias and suboptimal reporting contribute to irreproducibility in preclinical science and may negatively affect research translation. Randomization, blinding, sample size estimation, and considering sex as a biological variable are deemed crucial study design elements to maximize the quality and predictive value of preclinical experiments. OBJECTIVE: To examine the prevalence and temporal patterns of recommended study design element implementation in preclinical cardiovascular research. METHODS AND RESULTS: All articles published over a 10-year period in 5 leading cardiovascular journals were reviewed. Reports of in vivo experiments in nonhuman mammals describing pathophysiology, genetics, or therapeutic interventions relevant to specific cardiovascular disorders were identified. Data on study design and animal model use were collected. Citations at 60 months were additionally examined as a surrogate measure of research impact in a prespecified subset of studies, stratified by individual and cumulative study design elements. Of 28 636 articles screened, 3396 met inclusion criteria. Randomization was reported in 21.8%, blinding in 32.7%, and sample size estimation in 2.3%. Temporal and disease-specific analyses show that the implementation of these study design elements has overall not appreciably increased over the past decade, except in preclinical stroke research, which has uniquely demonstrated significant improvements in methodological rigor. In a subset of 1681 preclinical studies, randomization, blinding, sample size estimation, and inclusion of both sexes were not associated with increased citations at 60 months. CONCLUSIONS: Methodological shortcomings are prevalent in preclinical cardiovascular research, have not substantially improved over the past 10 years, and may be overlooked when basing subsequent studies. Resultant risks of bias and threats to study validity have the potential to hinder progress in cardiovascular medicine as preclinical research often precedes and informs clinical trials. Stroke research quality has uniquely improved in recent years, warranting a closer examination for interventions to model in other cardiovascular fields.

Patient-targeted websites on overactive bladder: What are our patients reading?

AIMS: Patients often turn to the Internet for information on medical conditions. We sought to evaluate the quality and readability of highly visible websites on overactive bladder (OAB). METHODS: A survey of 42 consecutive patients attending outpatient urogynecology clinics was performed to identify the most commonly used Internet search engines and search terms for information on OAB. The three most commonly used search engines (Google, Bing, and Yahoo!) were then queried using the three most commonly used search terms. The first 20 relevant websites from each search were reviewed. After excluding duplicates, 35 websites were analyzed. Website quality of information on OAB was evaluated using the DISCERN score, JAMA benchmark criteria, and Health on the Net code (HONcode) accreditation status. Readability was assessed using the Simplified Measure of Gobbledygook (SMOG) and Dale-Chall indices. RESULTS: Websites were classified as advertisement/commercial (31%), health portal (29%), professional (26%), patient group (6%), and other (9%). The overall mean DISCERN score was 44 ± 18 (maximum possible score of 80). Three websites (9%) met all four JAMA benchmark criteria. Seventeen percent of websites provided adequate information on content authorship and contributions. Median SMOG and Dale-Chall indices were 9.9 (IQR 9.3-11.2) and 9.0 (IQR 8.1-9.4), respectively. Nine websites (26%) were HONcode certified. CONCLUSIONS: Popular websites on OAB are of low quality, written for a high school to college-level readership, and often lack adequate information to assess the potential for commercial bias. Patients should be cautioned that incomplete and potentially biased information on OAB is prevalent online.

Complications after minimally invasive sacrocolpopexy with and without concomitant incontinence surgery: A National Surgical Quality Improvement Program (NSQIP) database study.

AIMS: To compare surgical complications for patients having minimally invasive sacrocolpopexy (MISCP) with concomitant incontinence procedure, to those having MISCP alone. METHODS: Patients undergoing MISCP with and without a concomitant incontinence procedure between 2006 and 2015 were identified in the American College of Surgeons National Surgical Quality Improvement Program database using Current Procedural Terminology codes. The main outcome of interest was a composite of surgical site infection, bleeding requiring blood transfusion, return to the operating room within 30 days, and surgical stay >48 h. Log-binomial regression was used to identify independent risk factors for the outcome and to generate adjusted effect measures for variables of interest. RESULTS: Seven thousand ninety-seven women met the inclusion criteria, of which 2433 (34%) underwent a concomitant incontinence procedure. Patients having incontinence procedures were slightly older (59 ± 11 vs 58 ± 12, P < 0.0001) and had longer total operating time (225 IQR 170-267 vs 184 IQR 120-232 min, P < 0.0001). Pre-operative steroid use, wound class III/IV (vs I/II), and longer operative time were independent predictors of the composite outcome. After adjusting for baseline patient characteristics and co-morbidities, no association was observed between concomitant incontinence procedure and the composite outcome (adjusted RR 0.87, 95%CI 0.65-1.18) but there was an increased likelihood of urinary tract infection (adjusted RR 2.47 95%CI 1.89-3.27). CONCLUSIONS: Despite being associated with a longer operative time, performing an incontinence procedure at the time of MSCIP was not associated with an increased risk of clinically important surgical complications other than urinary tract infection.

Water-Related Vaginal Injury: A Case Report and Review of the Literature.

BACKGROUND: Vaginal injury can result from entry of water into the vagina under high pressure. Previously reported cases describe water-jet vaginal injuries in women participating in water-related activities, including: water skiing, personal watercraft use, waterslides, water hose and fountains, with and without foreign body in situ. CASE: We describe the case of a severe vaginal laceration and hemorrhage in a 44-year-old female from a high-pressure water-jet generated during a water-ski fall requiring operative repair. Timely management resulted in excellent patient outcome. CONCLUSION: A literature review demonstrated that, although uncommon, watersport-related gynaecologic injuries can be life-threatening, and women who regularly engage in watersports can be counselled regarding potential preventative measures. Physicians encountering patients with these injuries should rule out intraperitoneal injury and consider benefits of antibiotics.