Transition to surgery after pessary among female Medicare beneficiaries with pelvic organ prolapse.

BACKGROUND: The American College of Obstetricians and Gynecologists recommends offering a vaginal pessary to women seeking treatment of pelvic organ prolapse. However, single-institution series have suggested that a sizable proportion of women fitted with a pessary will transition to surgery within the first year. OBJECTIVE: This study aimed to estimate the proportion of female US Medicare beneficiaries with pelvic organ prolapse who undergo surgery after pessary fitting, to describe the median time to surgery from pessary fitting, and to identify factors associated with the transition from pessary to surgery. STUDY DESIGN: The Medicare 5% Limited Data Set was queried from 2011 to 2016 for women aged ≥65 years with a diagnosis of prolapse who underwent pessary fitting. Cases with at least 3 years of follow-up in the Medicare Data Set were followed longitudinally for the primary outcome of surgery for prolapse. The cumulative incidence of prolapse surgery following index pessary fitting was calculated. Characteristics of women who underwent surgery and those who did not were compared using time-varying Cox regression analysis. RESULTS: Among 2032 women fitted with a pessary, 608 underwent surgery within 7 years. The median time to surgery was 496 days (interquartile range, 187-1089 days). The cumulative incidence of prolapse surgery was 12.2% at 1 year and 30.9% at 7 years. After adjusting for covariates, factors significantly associated with the transition to surgery included previous prolapse surgery (adjusted hazard ratio, 1.50; 1.09-2.07) and a diagnosis of urinary incontinence at the time of pessary fitting (adjusted hazard ratio, 1.20; 0.62-0.99). Factors associated with a lower hazard of surgery included age (adjusted hazard ratio, 0.96 per year; 95% confidence interval, 0.95-0.97), dual Medicare/Medicaid eligibility (adjusted hazard ratio, 0.75; 95% confidence interval, 0.56-1.00), and pessary fitting by a nongynecologist (adjusted hazard ratio, 0.78; 95% confidence interval, 0.62-0.99). CONCLUSION: In this population of Medicare beneficiaries, within 7 years of pessary fitting, almost one-third of women aged >65 years underwent surgery for prolapse. These results add to our current understanding of the demographics of pessary use in an older population and may aid in counseling older patients presenting for treatment of symptomatic pelvic organ prolapse.

The impact of anxiety on postoperative pain following pelvic reconstructive surgery.

INTRODUCTION AND HYPOTHESIS: Despite the prevalence of anxiety, its impact on postoperative pain remains poorly characterized. The present study was aimed at assessing the impact of preoperative anxiety on postoperative pain in patients undergoing pelvic reconstructive surgery. We hypothesized that greater anxiety would be associated with increased postoperative pain for patients undergoing pelvic reconstructive surgery. METHODS: This was a prospective multi-center observational study in Baltimore between September 2018 and June 2019. The Beck Anxiety Inventory was used to assess preoperative anxiety and the validated Surgical Pain Scale instrument was used to assess pain in the postoperative period. The association between anxiety and postoperative pain was analyzed using multivariate logistic regression, adjusting for relevant confounders. RESULTS: A total of 149 patients undergoing pelvic reconstructive surgery completed preoperative surveys. The median age of the study population was 59. The prevalence of preoperative anxiety (anxiety score > 9) in our study population was 26.8% (95% CI 19.7-34.0%). Women with preoperative anxiety reported higher postoperative pain on days 1-2 (relative odds 1.05, 95% confidence interval 1.01-1.10) and day 14 (relative odds 1.53, 95% confidence interval 1.00-2.34). CONCLUSIONS: A large fraction of women undergoing pelvic reconstructive surgery have moderate to severe preoperative anxiety. Women with preoperative anxiety appear to have greater odds of increased postoperative pain. Understanding this association may help surgeons with preoperative counseling and expectations regarding postoperative pain.

Prolapse and mesh reoperations following sacrocolpopexy: comparing supracervical hysterectomy, total hysterectomy, and no hysterectomy.

INTRODUCTION AND HYPOTHESIS: Sacrocolpopexy is effective for apical prolapse repair and is often performed with hysterectomy. It is unknown whether supracervical or total hysterectomy at time of sacrocolpopexy influences prolapse recurrence and mesh complications. The primary objective of this study is to compare reoperations for recurrent prolapse after sacrocolpopexy with either supracervical hysterectomy or total hysterectomy, or without concomitant hysterectomy. We also sought to compare these three groups for the incidence of mesh complications and describe cervical interventions following supracervical hysterectomy. METHODS: A retrospective cohort study of sacrocolpopexy was performed using the MarketScan® Research Database. Women > 18 years who underwent sacrocolpopexy between 2010 to 2014 were identified. Utilizing diagnostic and procedural codes, reoperations for prolapse and mesh complications were identified. Women with < 2 years of follow-up were excluded. RESULTS: From 2010 to 2014, 3463 women underwent sacrocolpopexy with at least 2 years of follow-up, 910 (26.3%) with supracervical hysterectomy, 1243 (35.9%) with total hysterectomy, and 1310 (37.8%) without hysterectomy. Reoperations for prolapse were similar after supracervical hysterectomy (1.5%), after total hysterectomy (1.1%, p = 0.40), and without hysterectomy (1.5%, p = 0.98). Mesh complications after sacrocolpopexy were similar after supracervical hysterectomy (1.8%), after total hysterectomy (1.5%, p = 0.68), and without hysterectomy (2.8%, p = 0.11). Following supracervical hysterectomy, 0.9% underwent cervical procedures. CONCLUSIONS: When comparing supracervical and total hysterectomy at time of sacrocolpopexy, there were no significant differences in reoperations for recurrent prolapse, reoperations for mesh complications, or mesh complication diagnoses. This study shows that surgeons can be reassured on performing hysterectomy with sacrocolpopexy.

Characteristics Associated With Repeated Evaluations for Urinary Tract Infections in Older Women: A Case-Control Study.

OBJECTIVES: The aims of this study were to estimate the incidence of repeated evaluations for urinary tract infection (UTI) after a single occurrence and to identify characteristics associated with repeated evaluations in a female Medicare population. METHODS: This was a case-control study of women aged 65 years or older undergoing incident outpatient evaluation for UTI between the years of 2011 and 2018. We defined UTI evaluation as an outpatient encounter with diagnostic codes for UTI and an order for urine culture. We excluded women with diagnostic codes suggestive of a complicated UTI. Among all women with an incident UTI evaluation, cases were defined as those with repeated evaluations, defined as either a total of ≥2 UTI evaluations in 6 months and/or ≥3 in 1 year. The characteristics of cases versus controls were compared with both an unadjusted and adjusted logistic regression model. RESULTS: Our overall cohort consisted of 169,958, of which 13,779 (8.1%) had repeated evaluations for UTI. In unadjusted analyses, cases were more likely to be older than 75 years, of White race, and to have cardiovascular conditions, diabetes, dementia, renal disease, and chronic obstructive pulmonary disease (all P's < 0.01) as compared with controls. In adjusted analysis, ages 75 years to 84 years (P < 0.01) and ages older than 84 years (P < 0.01) along with multiple medical comorbidities were significant risk factors for repeated evaluations for UTI. Black women had lower odds of repeated evaluations for UTI (P < 0.01). CONCLUSIONS: Among women with a single UTI evaluation, repeated evaluations for UTI were associated with older age, White race, and medical comorbidities. Future studies should investigate racial disparities seen in care-delivery behavior and/or care-seeking behavior.

Obstructed defecation syndrome in the first week after pelvic reconstructive surgery.

INTRODUCTION AND HYPOTHESIS: Research shows that patients are concerned about postoperative bowel function after pelvic reconstructive surgery. The objectives of this study were to estimate the proportion of patients with obstructed defecation syndrome (ODS), a subtype of constipation, in the week after surgery, to identify associated patient-level and perioperative characteristics and the associated bother. METHODS: Women completed a preoperative and postoperative ODS questionnaire and postoperative bowel diary. Characteristics of women with and without postoperative ODS were compared. Chi-squared or Fisher's exact tests compared categorical variables. Student's t test or Wilcoxon rank-sum tests compared continuous variables. Multivariate logistic regression was assessed for independent effects. Wilcoxon rank-sum tests compared the groups with regard to bother. Spearman correlation coefficients described the relationship among bother, postoperative ODS score, and bowel diary variables. RESULTS: Of the 186 participants enrolled, 165 completed the postoperative ODS questionnaire. Of these, 39 women (23.6%, 95% CI 17.2-30.1) had postoperative ODS. Postoperative ODS was significantly associated with preoperative ODS (p < 0.001), posterior colporrhaphy (p = 0.03), surgery type (p = 0.01), and longer duration of surgery (p = 0.03). Using multivariate logistic regression controlling for age, only preoperative ODS was significantly associated with postoperative ODS (OR 2.68, 95% CI 1.73-4.17). Women with postoperative ODS reported more bother with their defecatory symptoms (p < 0.001). The degree of bother was significantly associated with postoperative ODS score (p < 0.001). CONCLUSION: Using a validated disease-specific questionnaire to identify ODS, this complication was identified in 23.6% of patients in the week after pelvic reconstructive surgery. Preoperative ODS was a significant and important risk factor for this complication.

Vaginal Complications after Cystectomy: Results from a Medicare Sample.

PURPOSE: Cystectomy with a vaginal-sparing approach may be associated with unique complications specific to the female population. The objective of this study was to estimate the incidence of vaginal complications (defined to include vaginal prolapse, vaginal fistula, dyspareunia and vaginal cuff dehiscence/evisceration) after cystectomy and to determine risk factors for these complications. MATERIALS AND METHODS: Women 65 years or older undergoing cystectomy for any indication were identified by procedural codes in the Medicare Limited Data Set 5% sample from January 1, 2011 to December 31, 2017. Patients experiencing a vaginal complication after cystectomy were compared to those who did not. Demographic and biological factors that could increase likelihood of complications were identified and time to development of complications determined. Cumulative incidence was calculated using cumulative incidence function. Multivariable cause-specific Cox proportional hazards model assessed risk factors for vaginal complications. RESULTS: In all, 481 women undergoing cystectomy were identified during the study period, and 37.2% were younger than 70 years old. The majority (378, 79%) had bladder cancer, and 401 (83.4%) underwent an incontinent conduit or catheterizable channel diversion. Within 2 years of cystectomy, 93 patients (19.5%) had 1 or more complications on record. Vaginal cuff dehiscence had the highest cumulative incidence, occurring in 49 patients (10.2%). Over the entire study period (2011-2017), 102 women (21.2%) were diagnosed with a vaginal complication, and 27 (5.6%) received an intervention. CONCLUSIONS: Among women who undergo cystectomy, vaginal complications occur at rates higher than expected with over 20% of women experiencing a complication and over a quarter of those diagnosed undergoing intervention.

Abdominal hysterectomy and high frailty score are associated with complications among older patients.

OBJECTIVE: To evaluate effects of frailty and hysterectomy route on 30-day postoperative morbidity for older hysterectomy patients. METHODS: Participants included patients in the American College of Surgeons' National Surgical Quality Improvement Program database aged 60 years or older and undergoing simple hysterectomy from 2014 to 2018. The Five-Factor Modified Frailty Index approximated frailty: women with scores of 3 or more, indicating more severe comorbidities, were considered frail. Logistic regression multivariable models with and without an interaction term were used to study the independent and interactive effects of frailty and route on postoperative complications. RESULTS: Of 19 888 hysterectomies, 4356 (21.9%) were abdominal, 13 382 (67%) were laparoscopic, and 2150 (10.8%) were vaginal, with 251 (1.3%) frail patients. Frailty (odds ratio [OR] 1.89, 95% confidence interval [CI] 1.32-2.70, P = 0.001) and abdominal versus laparoscopic hysterectomy (OR 2.14, 95% CI 1.88-2.45, P < 0.001) increased complication odds. Assessing interaction, complication odds for abdominal versus laparoscopic hysterectomy were higher for frail patients (OR 4.12, 95% CI 1.96-8.67, P < 0.001) versus non-frail patients (OR 2.10, 95% CI 1.84-2.40). CONCLUSION: Frail older patients have increased risk for hysterectomy complications, especially with abdominal hysterectomy versus laparoscopic hysterectomy. A frailty index can be a useful preoperative tool to guide counseling and route choice.

Vaginal Complications after Radical Cystectomy for Bladder Cancer: A Systematic Review.

OBJECTIVES: To summarize the published literature regarding pelvic organ prolapse, dehiscence or evisceration, vaginal fistula, and dyspareunia after radical cystectomy and to describe the management approaches used to treat these conditions. METHODS: Ovid MEDLINE, Ovid EMBASE, and Web of Science were systematically searched from January 1, 2001 to January 25, 2021 using a combination of search terms for bladder cancer and radical cystectomy with terms for four categories of vaginal complications (prolapse, fistula, evisceration/dehiscence, and dyspareunia). A total of 229 publications were identified, the final review included 28 publications. RESULTS: Neobladder vaginal fistula was evaluated in 17 publications, with an incidence rate of 3 - 6% at higher volume centers, often along the anterior vaginal wall at the location of the neobladder-urethral anastomosis. Sexual function was evaluated in 10 studies, 7 of which utilized validated instruments. Maintaining the anterior vaginal wall and the distal urethra appeared to be associated with improved sexual function. Pelvic organ prolapse was assessed in 5 studies, only 1 used a validated questionnaire and none included a validated objective measure of pelvic organ support. CONCLUSION: There is a need for more prospective studies, using standardized instruments and subjective outcome measures to better define the incidence of vaginal complications after radical cystectomy for bladder cancer, and to understand their impact on quality of life measures.

Association between pelvic floor disorders and hernias.

INTRODUCTION AND HYPOTHESIS: Connective tissue disorders may contribute to pelvic floor disorders (PFDs). Like PFDs, abdominal wall hernias are more common in patients with systemic connective tissue disorders. We conducted this study to explore the possible association between PFDs and hernias in adult women. METHODS: We obtained the data for this study from a study of PFDs among parous women. At enrollment, stress urinary incontinence (SUI), overactive bladder (OAB), and anal incontinence (AI) were assessed using the Epidemiology of Prolapse and Incontinence Questionnaire (EPIQ) and pelvic organ prolapse (POP) was assessed through the Pelvic Organ Prolapse Quantification (POP-Q) examination. Participants were asked to report hernia surgery and list their hernia types. We compared the prevalence of PFDs in those with and without hernias using chi-square test. We used multiple regression analysis to adjust for obstetric and sociodemographic variables. RESULTS: Among 1529 women, 79 (5.2%) reported history of hernia surgery. The prevalence of POP was 7.6% (6 cases) vs. 7.4% (107 cases), the prevalence of SUI was 7.6% (6 cases) vs. 9.9% (144 cases), the prevalence of OAB was 7.6% (6 cases) vs. 5.7% (83 cases), and the prevalence of AI was 7.6% (6 cases) vs. 10.8% (156 cases) in those with hernias compared to those without hernias, respectively. None of these differences were statistically significant. There was no association between hernias and PFDs after adjustment for type of delivery, number of deliveries, age group, primary racial background, weight category, and smoking status. CONCLUSION: In this study, we could not find any association between hernias and PFDs.

Surgical Repair of the Genital Hiatus: A Narrative Review.

INTRODUCTION AND HYPOTHESIS: An enlarged genital hiatus (GH) is associated with the development of prolapse and may be associated with prolapse recurrence following surgery; however, there is insufficient evidence to support surgical reduction of the GH as prophylaxis against future prolapse. The objective of this review is (1) to review the association between GH size and pelvic organ prolapse and (2) to discuss the existing literature on surgical procedures that narrow the GH. METHODS: A literature search was performed in the PubMed search engine, using the keyword "genital hiatus." Articles were included if they addressed any of the following topics: (1) normative GH values; (2) associations between the GH and prolapse development or recurrence; (3) surgical alteration of the GH; (4) indications, risks or benefits of surgical alteration of the GH. RESULTS: An enlarging GH has been observed prior to the development of prolapse. Multiple studies show that an enlarged pre- and/or postoperative GH is associated with an increased risk of recurrent prolapse following prolapse repair surgery. There are limited data on the specific risks of GH alteration related to bowel and sexual function. CONCLUSIONS: GH size and prolapse appear to be strongly associated. Because GH size appears to be a risk factor for pelvic organ prolapse, the GH size should be carefully considered at the time of surgery. Surgeons should discuss with their patients the risks and potential benefits of additional procedures designed to reduce GH size.

Genital Hiatus Size and the Development of Prolapse Among Parous Women.

OBJECTIVE: In cross-sectional studies, pelvic organ prolapse is strongly associated with genital hiatus (GH) size. The objective of this study was to estimate prolapse incidence by the size of the GH among parous women followed prospectively. METHODS: Data were derived from a longitudinal study of pelvic floor disorders. Participants were followed annually for 2-9 years. Genital hiatus size and prolapse beyond the hymen were assessed with annual pelvic organ prolapse quantification examinations. Kaplan-Meier methods described prolapse-free survival as a function of GH size. Accounting for changes over time in GH size, lognormal models were used to estimate prolapse-free survival by GH size. This analysis was repeated separately for women who gave birth exclusively by cesarean versus those with at least one vaginal birth. RESULTS: Among 1,492 participants, median age at enrollment was 38 years; 153 (10.3%) developed prolapse over 2-9 years. The cumulative probability of prolapse increased substantially as the size of the GH increased. Lognormal models predicted that the estimated median time to develop prolapse would be 33.4 years for women with a persistent GH of 3 cm; in contrast, the estimated median time to develop prolapse would be 5.8 years for a GH of 4.5 cm or greater. Considering separately women who gave birth by cesarean versus those with at least 1 vaginal birth, GH size drastically modified prolapse risk in both birth groups. CONCLUSIONS: Prolapse incidence is strongly associated with GH size, regardless of delivery mode. These findings suggest that a wider GH is an important predictor of future prolapse risk.

Pregnancy in Women With Prior Treatments for Pelvic Floor Disorders.

Although the peak incidence of surgery for pelvic floor disorders does not occur until after menopause, an increasing number of younger women are seeking treatment for these problems. Whereas most surgeons would recommend delaying surgery until the completion of childbearing, published cases and case series address outcomes after subsequent pregnancies in women who have been treated for urinary incontinence and pelvic organ prolapse. This document synthesizes the available evidence on the impact of pregnancy on women with prior treatment for pelvic floor disorders and on the impact of these prior treatments on subsequent pregnancy. Pregnancy after the repair of obstetrical anal sphincter laceration is also discussed. Consensus recommendations are presented based on available literature review and expert involvement.

Levator Morphology and Strength After Obstetric Avulsion of the Levator Ani Muscle.

OBJECTIVES: Obstetric levator avulsion may be an important risk factor for prolapse. This study compares the size of the levator hiatus, the width of the genital hiatus, and pelvic muscle strength between vaginally parous women with or without levator avulsion, 5 to 15 years after delivery. METHODS: Parous women were assessed for levator ani avulsion, using 3-dimensional transperineal ultrasound. Women with and without levator ani avulsion were compared with respect to levator hiatus areas (measured on ultrasound), genital hiatus (measured on examination), and pelvic muscle strength (measured with perineometry). Further analysis also considered the association of forceps-assisted birth. RESULTS: At a median interval of 11 years from first delivery, levator avulsion was identified in 15% (66/453). A history of forceps-assisted delivery was strongly associated with levator avulsion (45% vs 8%; P < 0.001). Levator avulsion was also associated with a larger levator hiatus area (+7.3 cm; 95% confidence interval [CI], 4.1-10.4, with Valsalva), wider genital hiatus (+0.6 cm; 95% CI, 0.3-0.9, with Valsalva), and poorer muscle strength (-14.5 cm H2O; 95% CI, -20.4 to -8.7, peak pressure). Among those with levator avulsion, forceps-assisted birth was associated with a marginal increase in levator hiatus size but not genital hiatus size or muscle strength. CONCLUSIONS: Obstetric levator avulsion is associated with a larger levator hiatus, wider genital hiatus, and poorer pelvic muscle strength. Forceps-assisted birth is an important marker for levator avulsion but may not be an independent risk factor for the development of pelvic muscle weakness or changes in hiatus size in the absence of levator avulsion.

Lessons Learned From a Review of Malpractice Litigations Involving Obstetric Anal Sphincter Injury in the United States.

OBJECTIVE: The aim of this article is to review all litigations involving obstetric anal sphincter injury (OASIS) in the United States to highlight the most common allegations and factors that aided the involved obstetricians and gynecologists (ob/gyns). METHODS: We used Lexis Nexis, a comprehensive legal database, to search all publicly available high-profile federal and state level litigations related to OASIS. RESULTS: Of 68 cases that resulted and reviewed, 19 were deemed to be pertinent to the question being addressed. These 19 cases occurred between 1964 and 2011 and all alleged medical negligence. Among these 19 cases, 6 were ruled in favor of the plaintiffs, with most of them being awarded an amount ranging from US $110,000 to US $841,810.80. All 6 cases involved episiotomy. Thorough medical recordkeeping, comprehensive discharge instructions and counseling, and timely evaluation and referral to a female pelvic medicine and reconstructive surgery specialist were the key factors that aided the ob/gyns facing these litigations. CONCLUSIONS: Avoidance of episiotomy, thorough medical recordkeeping, comprehensive discharge instruction and counseling, and timely evaluation and referral to a female pelvic medicine and reconstructive surgery specialist may help an ob/gyn prevail in OASIS-related litigations.

Longitudinal Changes in the Genital Hiatus Preceding the Development of Pelvic Organ Prolapse.

We aimed to explore relationships between changes in genital hiatus (GH) and development of pelvic organ prolapse using data from the Mothers' Outcomes After Delivery (MOAD) Study, a Baltimore, Maryland, cohort study of parous women who underwent annual assessments during 2008-2018. Prolapse was defined as any vaginal segment protrusion beyond the hymen or reported prolapse surgery. For each case, 5 controls (matched on birth type and interval from first delivery to study enrollment) were selected using incidence sampling methods. We used a mixed model whose fixed effects described the initial size and slope of the GH as a function of prolapse status (case vs. control) and with nested (women within matched sets) random effects. Among 1,198 women followed for 1.0-7.3 years, 153 (13%) developed prolapse; 754 controls were matched to those women, yielding 3,664 visits for analysis. GH was 20% larger among the cases at enrollment (3.16 cm in cases vs. 2.62 cm in controls; P < 0.001), and the mean rate of increase in the size of the GH was more than 3 times greater (0.56 cm per 5-year period vs. 0.15 cm per 5-year period in controls; P < 0.001). Thus, to identify women at highest risk for developing prolapse, health-care providers could evaluate not simply the size of the GH but also changes in the GH over time.

Pelvic Floor Disorders After Obstetric Avulsion of the Levator Ani Muscle.

OBJECTIVES: With vaginal childbirth, 10% to 30% of women sustain levator ani muscle avulsion. The objective of this study was to estimate the cumulative incidence of prolapse and other pelvic floor disorders (PFDs), comparing vaginally parous women with and without levator avulsion. METHODS: Parous women enrolled in a longitudinal study were assessed annually for PFDs with the Pelvic Organ Prolapse Quantification Examination (for prolapse) and the Epidemiology of Prolapse and Incontinence Questionnaire (for stress incontinence, overactive bladder, and anal incontinence). Three-dimensional transperineal ultrasound was used to identify levator avulsion. Women with and without levator avulsion after vaginal delivery were compared for the cumulative incidence of PFDs. Further analysis also stratified by forceps delivery. RESULTS: At the time of assessment, 453 participants were 6 to 17 years from first delivery (median, 11 years). Levator avulsion was identified in 15% (66/453) and was more common among those who had undergone forceps-assisted delivery (P < 0.001). Levator avulsion was strongly associated with prolapse beyond the hymen (odds ratio, 2.7; 95% confidence interval, 1.3-5.7) and with symptoms of prolapse (odds ratio, 3.0; 95% confidence interval-1.2, 7.3). These associations persisted after controlling for forceps-assisted delivery. In contrast, the odds of stress incontinence, overactive bladder, and anal incontinence were marginally (but not significantly) increased among women with levator avulsion in this cohort. CONCLUSIONS: Obstetric levator avulsion is strongly associated with pelvic organ prolapse. The relationship between levator avulsion and other PFDs may not be significant.

American Urogynecologic Society Prolapse Consensus Conference Summary Report.

OBJECTIVES: The 2016 American Urogynecologic Society Prolapse Consensus Conference brought together thought leaders in the field of pelvic organ prolapse (POP). The goal was to identify critical areas of need for future research. This article summarizes the findings. METHODS: Prior to the conference, 5 major focus areas were identified. Focus areas were explored over the 2-day conference. Clinicians, clinical and basic science researchers, and representatives from government agencies, industry, patient advocacy groups, and the public convened to identify the major gaps in knowledge in each of these focus areas. RESULTS: The 5 major topics were as follows: (1) mechanistic research on pelvic supportive structures and how these are altered with pregnancy, delivery, and aging; (2) novel prostheses or implants that address pathophysiology and provide mechanical support; (3) large-scale community-based research; (4) clinical trials to optimize outcomes after POP surgery; and (5) evidence-based quality measures for POP outcomes. Key recommendations were made for each topic. CONCLUSIONS: Critical gaps in our knowledge were identified. These limit scientific discovery across all 5 topic areas. Further scientific progress would be advanced by (1) developing a standardized group of POP outcomes and quality measures for large trials and community-based research, (2) creating specimen biorepositories that are integrated with robust clinical data, and (3) developing collaborative teams with expertise from a variety of disciplines, convened to tackle our most challenging and complex scientific questions.

Patient satisfaction and informed consent for surgery.

BACKGROUND: Informed consent is a process that necessitates time and effort. Underlying this investment is the belief that informing patients about the surgery promotes patient satisfaction with the decision for surgery and potentially satisfaction more broadly. OBJECTIVE: The objective of the study was to investigate the extent to which preoperative satisfaction with a decision to pursue surgery is associated with understanding after an informed consent discussion. STUDY DESIGN: We performed an observational study of adult women seeking surgical treatment for pelvic floor disorders. Study participants were recruited after routine preoperative counseling by board-certified or board-eligible urogynecologists. In our practice, the preoperative informed consent process typically includes a discussion of the indications, risks, benefits, alternatives, and chance of success of the procedures. Participants completed a 35 question survey preoperatively at one setting. The primary outcome, satisfaction with decision, was measured with a validated 6 item Satisfaction with Decision Scale-Pelvic Floor Disorder. Participants were classified as highly satisfied if they indicated the highest level of satisfaction for all items. The primary exposure was patient knowledge of the planned surgery, measured using a newly adapted 20 item Informed Consent Questionnaire including 15 yes/no questions and 5 free-text questions. Additionally, the survey included a validated 3 item tool for health literacy, a single-item anxiety measure, and demographic data. Analyses were performed with a χ2 test, a Student t test, and a multivariable logistic regression using the binary outcome variable, highly satisfied or not highly satisfied. RESULTS: A total of 150 participants were enrolled, with a mean age of 57.5 years. The majority were non-Hispanic (97.3%) or white (87.3%), with at least some college education (51.0%). The median number of days between the informed consent discussion and the survey was 35. The mean total Satisfaction with Decision score was 27.9 (SD, 2.6; range, 19-30), indicating overall high satisfaction with the decision. A patient's preoperative satisfaction with her decision was strongly associated with increased knowledge of the planned surgery, as measured on the Informed Consent Questionnaire (P = .003). The mean score for the highly satisfied group was 17.8 (n = 70; SD, 3.6; range, 6-20) and for the not highly satisfied group was 16.1 (n = 77; SD, 2.8; range, 9-20). There were no significant differences between the highly satisfied and not highly satisfied groups with respect to age, race, education level, anxiety score, or health literacy. The odds of being highly satisfied increased for every 1 point increase in the Informed Consent Questionnaire score (odds ratio, 1.28; 95% confidence interval, 1.06-1.32; P = .003). The association between decisional satisfaction and knowledge persisted after controlling for demographic and clinical variables including education level, health literacy, race/ethnicity, age, surgeon years since completing fellowship, diagnosis, surgery category, number of visits in the past 6 months, and number of days between informed consent discussion and survey. CONCLUSION: This study found that patient knowledge and understanding of surgery are important components of a patient's satisfaction with her decision to proceed with pelvic floor surgery. By measuring patient understanding after informed consent discussions, clinicians may be able to better manage preoperative expectations, increase patient satisfaction, and improve the informed consent process.

Care-Seeking for Stress Incontinence and Overactive Bladder Among Parous Women in the First Two Decades After Delivery.

OBJECTIVE: This study aimed to establish the extent to which care-seeking for urinary incontinence is a function of symptom bother; and to identify bother-score thresholds that predict care-seeking in the first 2 decades after delivery. METHODS: In this longitudinal cohort, women were assessed annually for symptom bother related to stress urinary incontinence (SUI) and overactive bladder (OAB), as well as for recent episodes of care-seeking for urinary symptoms. Because the goal was to model care-seeking as a function of the woman's characteristics at her prior visit, women who completed 2 or more consecutive visits were included. The population was randomly divided into "training" (model development) and "testing" (model validation) sets. The predictive model was developed in the training set. For SUI and OAB bother scores, we identified thresholds to define statistically distinct probabilities of care-seeking. A multivariable model was created, including SUI and OAB bother categories as well as characteristics associated with care seeking at the P < 0.05 level. The resultant prediction model was then applied to the "testing set"; predicted and observed care-seeking frequencies were compared. RESULTS: Care-seeking was strongly associated with SUI and OAB bother. We defined 3 categories for OAB score and 4 categories for SUI score. The resulting 12 risk categories were then collapsed into 5 distinct risk-groups. These groups accurately predicted care-seeking in the testing set (area under the receiver operating curve, 0.760; 95% confidence interval, 0.713-0.807). Inclusion of other risk factors did not improve the model. CONCLUSIONS: Symptom bother is a strong determinant of care-seeking in the first 2 decades after delivery. These results define 5 ordinal categories that predict seeking care for urinary symptoms in a community population.