Effect of prunes on gastrointestinal function after benign gynecological surgery: a randomized control trial.

OBJECTIVE: To investigate the effect of postoperative prune consumption on time to first bowel movement after benign gynecologic surgery. MATERIALS AND METHODS: In this randomized, open label, controlled trial, 77 adult women who had benign gynecologic surgery that required at least one night in the hospital were enrolled from July 2018 to April 2019. Participants were randomized in a 1:1 ratio to one of two groups using a randomization assignment: 4 oz prunes daily plus docusate sodium 100 g twice daily versus docusate alone. The study's primary objective was time to first bowel movement (BM). Secondary outcomes were pain associated with first BM, stool consistency using Bristol stool scale, and patient satisfaction with bowel regimen and surgery experience. RESULTS: Postoperative survey data was available for 68.4% of participants (n = 52). There was no difference in time to first BM between the two groups (p = 0.29); however, consumption of > 12 prunes was associated with an increased likelihood of having a BM in the study period. Among women who consumed at least 12 prunes, hospital discharge was earlier, and there was a not statistically significant greater satisfaction with postoperative bowel regimen. CONCLUSIONS: The addition of prunes to postoperative bowel regimen of docusate sodium may be a beneficial adjunct to postoperative bowel regimen. CLINICAL TRIAL: The Institutional Review Board at the University of Southern California approved the study, and the study was registered at clinicaltrials.gov (ID: NCT03523715).

Translation and linguistic validation of the Female Genitourinary Pain Index in Spanish.

INTRODUCTION AND HYPOTHESIS: We sought to develop a Spanish translation of the Female Genitourinary Pain Index (GUPI) and to validate this instrument in US Latina women. METHODS: Translation back-translation was performed to create the initial Spanish version. Bilingual women with pelvic and/or genitourinary pain were recruited from clinical sites and social media. Participants reported demographics and completed the Female GUPI in both English and Spanish. Agreement was assessed for each item, subscale and total score. Additionally, we performed cognitive debriefing interviews to further test face validity. A consensus group of bilingual physicians and healthcare personnel utilized comments from the interviews to create a final Spanish version. RESULTS: Thirty-four participants completed the questionnaire. Their average age was 33 years, 80% reported attending some college, and 20% reported an undergraduate degree or higher. Most were born in mainland USA (57%) or Mexico (27%). Agreement for the pain, urinary and quality of life subscales between the English and Spanish versions of the measure were excellent (0.91, 0.89 and 0.92, respectively) with 0.96 agreement for the measure as a whole. Despite favorable psychometrics, preferences for alternate wording were reported over 50 times. Based on that feedback, a consensus group was formed, which recommended changes to 13 of the 15 items, 3 of which required complete rewriting. CONCLUSIONS: The Spanish Female GUPI is strongly correlated with the English original; however, participants reported the language was overly complex. Translation and validation should include review of the measure and feedback by the target audience for optimal clarity and readability.

Does Obtaining a Diagnosis of Interstitial Cystitis/Bladder Pain Syndrome Improve Symptoms or Quality of Life? A Cross-sectional Questionnaire-Based Study.

OBJECTIVES: The aim of this study was to investigate whether receiving a clinical diagnosis of interstitial cystitis (IC) or bladder pain syndrome (BPS) improves patients' symptoms, health-related quality of life (HRQOL), or ability to cope with their symptoms. METHODS: In this cross-sectional study, participants with self-reported IC/BPS completed an online questionnaire recalling their perceived change in symptoms after diagnosis and treatment. The questionnaire included demographic information, overall HRQOL measured on a visual analog scale (VAS), O'Leary-Sant Interstitial Cystitis Problem Index, the Urinary Impact Questionnaire, and questions regarding patient beliefs about diagnosis. HRQOL and symptom impact scales were compared before and after diagnosis and treatment. Demographic data, symptom data, and beliefs were examined for correlation with improvement in quality of life after diagnosis. RESULTS: A total of 1052 participants initiated the survey and were included in the analysis; most of them identified as female, non-Hispanic, and white (90%). Before symptom onset, median VAS HRQOL score was 87 (interquartile range [IQR], 77-95). Median scores nadired at 34 (IQR, 20-59) after symptom onset before diagnosis, but improved to 61 after diagnosis and treatment (IQR, 38-74; all P < 0.001). Scores remained stable after diagnosis and initiation of treatment with a median score of 65 at the time of survey (IQR, 37-80; P > 0.05). Age, insurance type, and improvement in scores on the symptom impact scale predicted improvement in HRQOL after diagnosis and treatment in the multivariable model. CONCLUSIONS: Participants reported improvements on global and symptom-specific quality of life measures after diagnosis and treatment for IC/BPS.

Disparity of Racial/Ethnic Representation in Publications Contributing to Overactive Bladder Diagnosis and Treatment Guidelines.

OBJECTIVE: The aim of the study was to compare the racial/ethnic representation in studies supporting the 2019 American Urological Association/Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction overactive bladder diagnosis and treatment guideline to the racial/ethnic distribution of the U.S. population. METHODS: We analyzed the race and ethnicity of participants in the articles cited in the 2019 American Urological Association/Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction nonneurogenic overactive bladder guidelines. The primary outcome was the representation quotient, the ratio of the proportion of a racial/ethnic group in the guideline studies relative to the estimated proportion of that group in the U.S. population. Data were analyzed using descriptive statistics and Pearson χ2 test. RESULTS: There were 387 studies included, 35% of which reported participants' race. Of the studies that included U.S. participants, 111 (61%) reported race and 44 (24%) reported Hispanic ethnicity. The representation quotient for White and Asian participants was 1.06 and 1.62, indicating overrepresentation relative to the U.S. population, respectively. The representation quotient for Black, Hispanic, and American Indian/Alaska Native participants was 0.85, 0.56, and 0.02, respectively, indicating underrepresentation for these groups. Evaluation of the representation quotients over time revealed no meaningful change in representation from 1990 to 2019 for any racial/ethnic group. CONCLUSIONS: The evidence based on the overactive bladder guidelines is derived from studies that frequently failed to report race/ethnicity and is not reflective of the U.S. population. Black, Hispanic, and American Indian/Alaska Native participants that are underrepresented in U.S.-based studies, highlighting the need for more inclusive recruitment strategies in overactive bladder research.

The Effect of a Diagnosis on Patients With Interstitial Cystitis/Bladder Pain Syndrome: A Qualitative Approach.

INTRODUCTION: Interstitial cystitis/bladder pain syndrome (IC/BPS) is a chronic pain condition that significantly affects patient quality of life. We investigated whether receiving a formal medical diagnosis of IC/BPS was perceived by patients to improve symptoms and disease-specific quality of life. METHODS: Participants with self-reported IC/BPS completed publicly available online surveys. Surveys included demographic information, validated questionnaires, and a free-text response. Participants were asked to comment on the utility of obtaining a diagnosis. Investigators coded the responses and analyzed the results using grounded theory methodology. RESULTS: Six hundred seventy-three participants who responded to the free-text were analyzed. The mean age of respondents was 52 years, with an average of 10 years since IC/BPS diagnosis. The IC/BPS pain syndrome diagnosis had wide ranging effects on both symptoms and coping. These effects were often mediated by improvements in perceived control and empowerment after diagnosis. Although most participants noted benefit after diagnosis of IC/BPS, some reported harmful effects ranging from stigmatization by providers to desperation when told that there was not a cure. CONCLUSIONS: A formal medical diagnosis of IC/BPS has a significant effect on patients who experience the condition. Although diagnosis usually improves symptoms and coping, a universal experience was not described by all IC/BPS patients. Given that most patients report improvement, more work is needed to expedite diagnosis. In addition, we must better understand factors associated with lack of symptom and quality of life improvement after an IC/BPS diagnosis has been made by medical providers.

Assessing patients' preferences for gender, age, and experience of their urogynecologic provider.

INTRODUCTION AND HYPOTHESIS: Understanding patient preferences regarding provider characteristics is an under-explored area in urogynecology. This study aims to describe patient preferences for urogynecologic care, including provider gender, age, experience, and presence of medical trainees. METHODS: This was a multicenter, cross-sectional, survey-based study assessing patient preferences with a voluntary, self-administered, anonymous questionnaire prior to their first urogynecology consult. A 5-point Likert scale addressing provider gender, age, experience, and presence of trainees was used. Descriptive statistics summarized patient characteristics and provider preferences. Chi-squared (or Fisher's exact) test was used to test for associations. RESULTS: Six hundred fifteen women participated from eight sites including all geographic regions across the US; 70.8% identified as white with mean age of 58.5 ± 14.2 years. Urinary incontinence was the most commonly reported symptom (45.9%); 51.4% saw a female provider. The majority of patients saw a provider 45-60 years old (42.8%) with > 15 years' experience (60.9%). Sixty-five percent of patients preferred a female provider; 10% preferred a male provider. Sixteen percent preferred a provider < 45 years old, 36% preferred 45-60 years old, and 11% of patients preferred a provider > 60 years old. Most patients preferred a provider with 5-15 or > 15 years' experience (49% and 46%, respectively). Eleven percent preferred the presence of trainees while 24% preferred trainee absence. CONCLUSION: Patient preferences regarding urogynecologic providers included female gender and provider age 45-60 years old with > 5 years' experience. Further study is needed to identify qualitative components associated with these preferences.

Female Veterans With Diagnoses of Both Chronic Pelvic Pain and Overactive Bladder; How Do They Compare to Women Diagnosed With Interstitial Cystitis?

OBJECTIVE: The objective of this study was to compare women with a known diagnosis of interstitial cystitis (IC) to a population that might be at risk for the diagnosis of IC, women with diagnoses of both chronic pelvic pain (CPP) and overactive bladder (OAB). METHODS: We conducted a retrospective study of data from the Veterans Affairs Corporate Data Warehouse. The cohort included all female veterans who had established care with a primary care provider from 1997 to present. International Classification of Diseases, Ninth Revision codes were used to identify women with a diagnosis of IC, CPP, and OAB. Demographic data and comorbidities were compared between groups. RESULTS: A total of 596,815 women were identified. Two thousand three hundred one women (0.4%) were diagnosed with IC; 4459 women (0.7%) were diagnosed with CPP and OAB. At baseline, women with OAB and CPP were more likely to identify as minority (P < 0.001). Anxiety (57.3% vs 49.5%), depression (39.0% vs 46.0%), and posttraumatic stress disorder (29.7 vs 26.4%) were all more common in the CPP and OAB group than in the IC group. In the multivariable model, women with CPP and OAB were more likely to identify as a minority, use tobacco, and carry a diagnosis of anxiety. CONCLUSIONS: There were more patients diagnosed with CPP and OAB compared with patients diagnosed with IC in this population of female veterans. Given the high rate of comorbid anxiety and depression in both groups, further study is warranted to determine whether these women are misdiagnosed.

Important role of physicians in addressing psychological aspects of interstitial cystitis/bladder pain syndrome (IC/BPS): a qualitative analysis.

INTRODUCTION: Interstitial cystitis/bladder pain syndrome (IC/BPS) is a poorly understood source of chronic pain causing significant morbidity, with variable treatment success. Despite the need to understand patient perspectives in chronic pain, there is a paucity of qualitative data for IC/BPS. We aimed to acquire information regarding patient experience with IC/BPS symptoms and with their medical care to elicit suggestions to improve patient satisfaction with that care. METHODS: Fifteen women with IC/PBS participated in a total of four focus groups. Sessions were recorded and transcribed and information deidentified. Focus groups were conducted until thematic saturation was reached. All transcripts were coded and analyzed by a minimum of three independent physician reviewers. Investigators identified emergent themes and concepts using grounded-theory methodology. RESULTS: Participant's mean age was 52.6 years, with an average IC/BPS duration of 6.3 years. Thematic saturation was reached after four focus groups. We identified three emergent patient experience concepts: IC/PBS is debilitating, the disease course is unpredictable and unrelenting, and patients experience significant isolation. Importantly, suicidal ideation was expressed in each group. Patients voiced strong preference for physicians who provided education regarding the condition, an array of treatment options, organized treatment plans, and optimism and hope regarding treatment outcomes. CONCLUSIONS: Our study presents novel findings of the importance of patient-physician interaction in IC/BPS and reinforces the tremendous disability and burden of this disease, which frequently manifests in suicidal ideation. Patients preferred organized treatment plans with diverse choices and providers who offered hope in dealing with their condition.

Sunshine Act: shedding light on inaccurate disclosures at a gynecologic annual meeting.

BACKGROUND: Physicians and hospital systems often have relationships with biomedical manufacturers to develop new ideas, products, and further education. Because this relationship can influence medical research and practice, reporting disclosures are necessary to reveal any potential bias and inform consumers. The Sunshine Act was created to develop a new reporting system of these financial relationships called the Open Payments database. Currently all disclosures submitted with research to scientific meetings are at the discretion of the physician. We hypothesized that financial relationships between authors and the medical industry are underreported. OBJECTIVES: We aimed to describe concordance between physicians' financial disclosures listed in the abstract book from the 41st annual scientific meeting of the Society of Gynecologic Surgeons to physician payments reported to the Center for Medicaid and Medicare Services Open Payments database for the same year. STUDY DESIGN: Authors and scientific committee members responsible for the content of the 41st annual scientific meeting of the Society of Gynecologic Surgeons were identified from the published abstract book; each abstract listed disclosures for each author. Abstract disclosures were compared with the transactions recorded on the Center for Medicaid and Medicare Services Open Payments database for concordance. Two authors reviewed each nondisclosed Center for Medicaid and Medicare Services listing to determine the relatedness between the company listed on the Center for Medicaid and Medicare Services and abstract content. RESULTS: Abstracts and disclosures of 335 physicians meeting inclusion criteria were reviewed. A total of 209 of 335 physicians (62%) had transactions reported in the Center for Medicaid and Medicare Services, which totaled $1.99 million. Twenty-four of 335 physicians (7%) listed companies with their abstracts; 5 of those 24 physicians were concordant with the Center for Medicaid and Medicare Services. The total amount of all nondisclosed transactions was $1.3 million. Transactions reported in the Center for Medicaid and Medicare Services associated with a single physician ranged from $11.72 to $405,903.36. Of the 209 physicians with Center for Medicaid and Medicare Services transactions that were not disclosed, the majority (68%) had at least 1 company listed in the Center for Medicaid and Medicare Services that was determined after review to be related to the subject of their abstract. CONCLUSION: Voluntary disclosure of financial relationships was poor, and the majority of unlisted disclosures in the abstract book were companies related to the scientific content of the abstract. Better transparency is needed by physicians responsible for the content presented at gynecological scientific meetings.

Risk factors for brachial plexus injury in a large cohort with shoulder dystocia.

OBJECTIVE: To examine birthweight and other predictors of brachial plexus injury (BPI) among births complicated by shoulder dystocia. STUDY DESIGN: A retrospective cohort study of term births complicated by shoulder dystocia in California between 1997 and 2006. Birthweight at time of delivery was stratified into 500-g intervals. Women were further stratified by diabetes status, parity, and race/ethnicity. The perinatal outcome of BPI was assessed. RESULTS: This study included 62,762 deliveries complicated by shoulder dystocia, of which 3168 (5 %) resulted in BPI. The association between birthweight and BPI remained significant regardless of confounders. Each increasing birthweight interval was associated with an increasing risk of BPI compared with 3000-3499-g birthweight. Race/ethnicity, diabetes, and parity were also independently associated with BPI. CONCLUSION: Increasing birthweight increases the risk of BPI among births with shoulder dystocia, independent of advanced maternal age, race, parity, gestational diabetes, or operative vaginal delivery.