The Design of a Prospective Trial to Evaluate the Role of Preoperative Frailty Assessment in Older Women Undergoing Surgery for the Treatment of Pelvic Organ Prolapse: The FASt Supplemental Trial.

OBJECTIVE: We present the rationale for and the design of a prospective trial to evaluate the role of preoperative frailty and mobility assessments in older women undergoing surgery for the treatment of pelvic organ prolapse (POP) as a planned prospective supplemental trial to the ASPIRe (Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design) trial. The Frailty ASPIRe Study (FASt) examines the impact of preoperative frailty and mobility on surgical outcomes in older women (≥65 years) participating in the ASPIRe trial. The primary objective of FASt is to determine the impact of preoperative age, multimorbidity, frailty, and decreased mobility on postoperative outcomes in older women (≥65 years old) undergoing surgery for POP. METHODS: The selection of the preoperative assessments, primary outcome measures, and participant inclusion is described. Frailty and mobility measurements will be collected at the preoperative visit and include the 6 Robinson frailty measurements and the Timed Up and Go mobility test. The main outcome measure in the FASt supplemental study will be moderate to severe postoperative adverse events according to the Clavien-Dindo Severity Classification. CONCLUSIONS: This trial will assess impact of preoperative age, multimorbidity, frailty, and decreased mobility on postoperative outcomes in older women (≥65 years old) undergoing surgical procedures for the correction of apical POP. Information from this trial may help both primary care providers and surgeons better advise/inform women on their individual risks of surgical complications and provide more comprehensive postoperative care to women at highest risk of complications.

Responsiveness and minimally important difference of SF-6D and EQ-5D utility scores for the treatment of pelvic organ prolapse.

BACKGROUND: Utility preference scores are standardized, generic, health-related quality of life (HRQOL) measures that quantify disease severity and burden and summarize morbidity on a scale from 0 (death) to 1 (optimal health). Utility scores are widely used to measure HRQOL and in cost-effectiveness research. OBJECTIVE: To determine the responsiveness, validity properties, and minimal important difference (MID) of utility scores, as measured by the Short Form 6D (SF-6D) and EuroQol (EQ-5D), in women undergoing surgery for pelvic organ prolapse (POP). MATERIALS AND METHODS: This study combined data from 4 large, U.S., multicenter surgical trials enrolling 1321 women with pelvic organ prolapse. We collected condition-specific quality of life data using the Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ). A subset of women completed the SF6D; women in 2 trials also completed the EQ5D. Mean utility scores were compared from baseline to 12 months after surgery. Responsiveness was assessed using effect size (ES) and standardized response mean (SRM). Validity properties were assessed by (1) comparing changes in utility scores at 12 months between surgical successes and failures as defined in each study, and (2) correlating changes in utility scores with changes in the PFDI and PFIQ. MID was estimated using both anchor-based (SF-36 general health global rating scale "somewhat better" vs "no change") and distribution-based methods. RESULTS: The mean SF-6D score improved 0.050, from 0.705 ± 0.126 at baseline to 0.761 ± 0.131 at 12 months (P < .01). The mean EQ-5D score improved 0.060, from 0.810 ± 0.15 at baseline to 0.868 ± 0.15 at 12 months (P < .01). The ES (0.13-0.61) and SRM (0.13-0.57) were in the small-to-moderate range, demonstrating the responsiveness of the SF-6D and EQ-5D similar to other conditions. SF-6D and EQ-5D scores improved more for prolapse reconstructive surgical successes than for failures. The SF-6D and EQ-5D scores correlated with each other (r = 0.41; n = 645) and with condition-specific instruments. Correlations with the PFDI and PFIQ and their prolapse subscales were in the low to moderate range (r = 0.09-0.38), similar to other studies. Using the anchor-based method, the MID was 0.026 for SF-6D and 0.025 for EQ-5D, within the range of MIDs reported in other populations and for other conditions. These findings were supported by distribution-based estimates. CONCLUSION: The SF-6D and EQ-5D have good validity properties and are responsive, preference-based, utility and general HRQOL measures for women undergoing surgical treatment for prolapse. The MIDs for SF-6D and EQ-5D are similar and within the range found for other medical conditions.

Trends and Factors Influencing Inpatient Prolapse Surgical Costs and Length of Stay in the United States.

OBJECTIVE: This study aimed to assess trends and factors affecting inpatient hospital costs and length of stay (LOS) in surgical treatment of pelvic organ prolapse in the United States. METHODS: A retrospective cross-sectional study along with longitudinal trend analysis from the 2001 to 2011 National Inpatient Sample included subjects who underwent inpatient prolapse repairs. The primary outcomes were inpatient mean cost per admission and LOS. We compared unadjusted differences in primary outcomes for each patient and hospital characteristic using 2011 data with analysis of variance. Multivariable regression estimated proportional change in cost and LOS associated with each characteristic. RESULTS: Unadjusted analysis revealed increased LOS with age of 80 years or older, African American race, uninsured status, lower income, and lower surgical volume hospitals (≤75%) as well as increased costs in the West and public hospitals. On multivariable analyses, African Americans had 1.09 (95% confidence interval [CI], 1.05-1.13; P < 0.001) times longer LOS compared with Caucasians, and the uninsured had 1.15 (95% CI, 1.01-1.30; P = 0.032) times longer LOS compared with those privately insured. Comorbidities associated with 20% increase in LOS and costs were pulmonary circulation disorders, metastatic cancer, weight loss, coagulopathy, and electrolyte/fluid imbalance (P < 0.001). Congestive heart failure and blood loss/deficiency anemia lead to 20% longer LOS (P < 0.001). In 2001-2011, mean LOS declined from 2.42 days (95% CI, 2.37-2.47) to 1.79 days (95% CI, 1.71-1.87) (P < 0.001), whereas mean total cost increased from $6233 (95% CI, $5859-$6607) to $9035 (95% CI, $8632-$9438) (P < 0.001). CONCLUSIONS: Inpatient surgical costs for prolapse increased despite decreasing LOS. Some patient and hospital characteristics are associated with increased inpatient costs and LOS.

Functional status in older women diagnosed with pelvic organ prolapse.

BACKGROUND: Functional status plays an important role in the comprehensive characterization of older adults. Functional limitations are associated with an increased risk of adverse treatment outcomes, but there are limited data on the prevalence of functional limitations in older women with pelvic floor disorders. OBJECTIVE: The aim of the study was to describe the prevalence of functional limitations based on health status in older women with pelvic organ prolapse (POP). STUDY DESIGN: This pooled, cross-sectional study utilized data from the linked Health and Retirement Study and Medicare files from 1992 through 2008. The analysis included 890 women age ≥65 years with POP. We assessed self-reported functional status, categorized in strength, upper and lower body mobility, activities of daily living (ADL), and instrumental ADL (IADL) domains. Functional limitations were evaluated and stratified by respondents self-reported general health status. Descriptive statistics were used to compare categorical and continuous variables, and logistic regression was used to measure differences in the odds of functional limitation by increasing age. RESULTS: The prevalence of functional limitations was 76.2% in strength, 44.9% in upper and 65.8% in lower body mobility, 4.5% in ADL, and 13.6% in IADL. Limitations were more prevalent in women with poor or fair health status than in women with good health status, including 91.5% vs 69.9% in strength, 72.9% vs 33.5% in upper and 88.0% vs 56.8% in lower body mobility, 11.6% vs 0.9% in ADL, and 30.6% vs 6.7% in IADL; all P < .01. The odds of all functional limitations also increased significantly with advancing age. CONCLUSION: Functional limitations, especially in strength and body mobility domains, are highly prevalent in older women with POP, particularly in those with poor or fair self-reported health status. Future research is necessary to evaluate if functional status affects clinical outcomes in pelvic reconstructive and gynecologic surgery and whether it should be routinely assessed in clinical decision-making when treating older women with POP.

Life Space Assessment in Older Women Undergoing Non-Surgical Treatment for Urinary Incontinence.

OBJECTIVES: Urinary incontinence (UI) impacts all aspects of life activities. This study aims to characterize change in mobility within the community utilizing the Life Space Assessment (LSA) questionnaire in women undergoing non-surgical UI treatment. DESIGN: Prospective cohort study, performed from July 2007 to March 2009, which followed women seeking non-surgical UI treatment and assessed their mobility and symptoms using LSA, Urogenital Distress Inventory (UDI-6), and Incontinence Impact Questionnaire (IIQ-7) at baseline and 2, 6, and 12 months post-treatment. Estimated Percent Improvement (EPI) and Patient Satisfaction Question (PSQ) were obtained post-treatment. SETTING: Outpatient tertiary-care clinic. PARTICIPANTS: 70 ambulatory, community-dwelling women, aged 65 years or older, seeking non-surgical care for UI. INTERVENTION: Multi-component behavioral and/or pharmacologic therapies. MEASUREMENTS: We hypothesized LSA would improve with treatment. Repeated measures analysis with Tukey's HSD and backwards selection linear regression model were performed. RESULTS: LSA score decreased from baseline to 2 months (mean±SD; 63±29 to 56±28, p<0.001) and was sustained at 6 and 12 months (54±28, 54±28). UDI scores improved from 36±23 to 25±24, p<0.001, at 2 months, and improvement persisted at 6 and 12 months (22±22, 21±24). Improvements in UDI and patient perceived improvement in UI were not associated with LSA change. Age, race, and depression impacted LSA, which decreased 1-point for each additional year of age (p=0.004), 6-points for each point higher on the Geriatric Depression Scale (GDS) (p=0.002), and 6-points for African American race (p=0.048). CONCLUSION: Decreased mobility represented by LSA was related to age, depression, and race, but not UI symptom improvement.

An Evidence-Based Approach to the Evaluation, Diagnostic Assessment and Treatment of Fecal Incontinence in Women.

Fecal incontinence (FI) is a debilitating disorder which negatively impacts quality of life. The etiology is often multifactorial and although most women with FI are able to be treated, many remain untreated because a significant proportion of women do not report their symptoms and seek care. The evaluation and treatment of FI can be also hindered by a lack of understanding of the mechanisms and current options. This article provides a review on the evidence-based evaluation and management for FI.

Considerations to improve the evidence-based use of vaginal hysterectomy in benign gynecology.

Vaginal hysterectomy fulfills the evidence-based requirements as the preferred route of hysterectomy for benign gynecologic disease. Despite proven safety and effectiveness, the vaginal approach for hysterectomy has been and remains underused in surgical practice. Factors associated with underuse of vaginal hysterectomy include challenges during residency training, decreasing case numbers among practicing gynecologists, and lack of awareness of evidence supporting vaginal hysterectomy. Strategies to improve resident training and promote collaboration and referral among practicing physicians and increasing awareness of evidence supporting vaginal hysterectomy can improve the primary use of this hysterectomy approach.

The Refractory Overactive Bladder: Sacral NEuromodulation vs. BoTulinum Toxin Assessment: ROSETTA trial.

We present the rationale for and design of a randomized, open-label, active-control trial comparing the effectiveness of 200 units of onabotulinum toxin A (Botox A®) versus sacral neuromodulation (InterStim®) therapy for refractory urgency urinary incontinence (UUI). The Refractory Overactive Bladder: Sacral NEuromodulation vs. BoTulinum Toxin Assessment (ROSETTA) trial compares changes in urgency urinary incontinence episodes over 6 months, as well as other lower urinary tract symptoms, adverse events and cost effectiveness in women receiving these two therapies. Eligible participants had previously attempted treatment with at least 2 medications and behavioral therapy. We discuss the importance of evaluating two very different interventions, the challenges related to recruitment, ethical considerations for two treatments with significantly different costs, follow-up assessments and cost effectiveness. The ROSETTA trial will provide information to healthcare providers regarding the technical attributes of these interventions as well as the efficacy and safety of these two interventions on other lower urinary tract and pelvic floor symptoms. Enrollment began in March, 2012 with anticipated end to recruitment in mid 2014.

Menorrhagia Impact Questionnaire: assessing the influence of heavy menstrual bleeding on quality of life.

OBJECTIVE: Menorrhagia, or heavy menstrual bleeding (HMB), has a negative impact on women's quality of life (QOL). The objective was to develop, validate, and assess the performance of a disease-specific patient-reported outcome (PRO) measurement instrument for HMB (the Menorrhagia Impact Questionnaire [MIQ]). RESEARCH DESIGN AND METHODS: The MIQ was designed to measure the effect of HMB on a woman's self-assessment of menstrual blood loss (MBL), limitations in social/leisure activities, physical activities, and ability to work. Meaningfulness of these observed MBL changes were also measured. The development and psychometric validation of the MIQ was performed utilizing data from a long-term safety study of tranexamic acid (Lysteda * *Lysteda is a registered trade name of Ferring Pharmaceuticals Inc., Parsippany, NJ, USA. ), with comparison to an age-matched normal control group recruited from the general population. Performance of the MIQ was also evaluated using data from a six-cycle, randomized, double-blind, clinical study of tranexamic acid for the treatment of HMB. Correlations and sensitivity of each pertinent MIQ item to the treatment-induced changes in MBL were assessed, and the minimally important differences (MID) for the individual MIQ items were determined. RESULTS: The psychometric properties of the MIQ were fully validated. Correlations between individual MIQ items and changes in MBL were statistically significant (p < 0.001). A clear differentiation between tranexamic acid and placebo groups confirmed sensitivity of the MIQ and its ability to detect treatment-induced changes in MBL. MIDs were estimated for the individual MIQ items, with sensitivities and specificities in the 64-79% and 63-82% ranges using receiver operating characteristic (ROC) curve analyses, respectively. MIDs were found to be equal to or greater than 0.5. Statistically significant treatment differences were also observed for the proportions of subjects achieving at least 1-point improvement in MIQ scores. CONCLUSION: The MIQ contains validated constructs important to women with HMB. CLINICAL TRIAL REGISTRATION: NCT00113568 and NCT00386308 (ClinicalTrials.gov ID).

Testing and validation of a low-cost cystoscopy teaching model: a randomized controlled trial.

OBJECTIVE: To estimate whether the use of a low-cost cystoscopy model effectively trains residents in cystourethroscopy and to validate the model as a teaching tool. METHODS: A randomized, controlled, and evaluator-blinded study was performed. Twenty-nine obstetrician-gynecologist residents had access to fresh-frozen cadavers on which baseline cystoscopic skills were assessed using the validated Objective Structured Assessment of Technical Skills checklists for cystourethroscopy. Subsequently, residents were randomized to one of two arms, a didactic study arm using the cystoscopy model and a control arm. Repeated technical skills testing was performed. RESULTS: The study group demonstrated statistically significant decreases in cystoscope assembly time (128.8 seconds at baseline to 54.9 seconds postintervention; P=.005), and increases in task-specific checklist scores (from 59.3 at baseline to 92.9 postintervention; P<.001) and in global rating scale scores (from 61.0 at baseline to 87.8 postintervention; P<.001). Further, there was a significant improvement in task-specific checklist (P<.001), global rating scale (P=.002), and knowledge quiz scores (P=.011) in the study arm compared with the control arm. CONCLUSION: Use of the bladder model exhibited validity in enhancing performance and knowledge of cystourethroscopy among ob-gyn residents. LEVEL OF EVIDENCE: I.

Life-space assessment in urogynecology and gynecological oncology surgery patients: a measure of perioperative mobility and function.

OBJECTIVE: To assess the effect of gynecological surgery on mobility and functional status in women aged 60 and older using Life-Space Assessment (LSA). DESIGN: Observational prospective cohort study. SETTING: Academic outpatient urogynecology and gynecological oncology clinics. PARTICIPANTS: Women presenting for urogynecology (n=51) and gynecological oncology (n=51) surgery. MEASUREMENTS: LSA scores 6 weeks, 6 months, and 1 year after surgery. Information on participant demographics, preoperative diagnoses, surgical approach, and medical comorbidities was collected. Analyses used repeated measures. RESULTS: Mean age was 71 +/- 7. Urogynecology participants started and maintained a higher LSA (P=.03) than oncology participants at all study intervals. Six weeks after surgery, urogynecology and oncology participants' mean decline was 13 points (95% confidence interval (CI)=4-21; P=.004) and 23 points (95% CI=13-33; P<.001), respectively. At 6 months, the urogynecology and oncology participants' scores increased by a mean of 9 points (95% CI=1-17; P=.03) and 13 points (95% CI=5-20; P=.001), respectively. No significant difference was found 1 year from baseline within each group or between groups in LSA scores. Income, depression, body mass index, and having an operative complication predicted a larger decline in life-space over time in both groups. CONCLUSION: Gynecological surgical interventions in older women limit physical and functional ability at 6 weeks after surgery. The urogynecology and gynecological oncology cohorts returned to baseline levels by 6 months, which was sustained to 1 year.

Factors associated with undergoing bilateral salpingo-oophorectomy at the time of hysterectomy for benign conditions.

OBJECTIVE: To identify possible factors associated with undergoing bilateral salpingo-oophorectomy (BSO) at the time of hysterectomy among women with benign conditions. METHODS: This was a cross-sectional analysis using the 2005 Nationwide Inpatient Sample. Women aged 18 years or older who underwent hysterectomy with BSO or hysterectomy only for a benign condition were included. We examined a broad range of factors associated with undergoing BSO in multivariable analyses. RESULTS: Fifty-two percent of 461,321 hysterectomies included BSO, with a mean age of 49 years compared with 43 years in the hysterectomy-only group (P<.001). The odds of BSO were two times higher in the Midwest and South and 1.67 times higher in the West as compared with the Northeast (P<.001). Women who were uninsured or had Medicaid were more likely to undergo BSO compared with those with private insurance (odds ratio 1.86, 95% confidence interval 1.14-3.04 for "no charge/charity," odds ratio 1.21, 95% confidence interval 1.08-1.35 for Medicaid) Although BSO was more common among white women than African-American, Latina, and Asian women (P<.001), lower income was associated with BSO among African-American and white women only, not among Asian and Latina women (P=.007 for test for interaction). BSO was eight times as likely with a laparoscopic hysterectomy and 12 times as likely with an abdominal hysterectomy compared with a vaginal approach (P<.001). Women who had endometriosis, pelvic infection, or an ovarian cyst were more likely to undergo BSO (P<.001) compared with women who did not have these diagnoses. CONCLUSION: There is significant nationwide variation in the practice of BSO. Age, route of hysterectomy, and diagnosis at surgery affect BSO rates. Nonclinical factors such as race or ethnicity, insurance status, income, and geographic location are also associated with BSO practice. LEVEL OF EVIDENCE: II.

Outcomes following vaginal prolapse repair and mid urethral sling (OPUS) trial--design and methods.

BACKGROUND: The primary aims of this trial are to determine whether the use of a concomitant prophylactic anti-incontinence procedure may prevent stress urinary incontinence symptom development in women undergoing vaginal prolapse surgery and to evaluate the cost-effectiveness of this prophylactic approach. PURPOSE: To present the rationale and design of a randomized controlled surgical trial (RCT), the Outcomes following vaginal Prolapse repair and mid Urethral Sling (OPUS) Trial highlighting the challenges in the design and implementation. METHODS: The challenges of implementing this surgical trial combined with a cost-effectiveness study and patient preference group are discussed including the study design, ethical issues regarding use of sham incision, maintaining the masking of study staff, and pragmatic difficulties encountered in the collection of cost data. The trial is conducted by the NICHD-funded Pelvic Floor Disorders Network. RESULTS: The ongoing OPUS trial started enrollment in May 2007 with a planned accrual of 350. The use of sham incision was generally well accepted but the collection of cost data using conventional billing forms was found to potentially unmask key study personnel. This necessitated changes in the study forms and planned timing for collection of cost data. To date, the enrollment to the patient preference group has been lower than the limit established by the protocol suggesting a willingness on the part of women to participate in the randomization. LIMITATIONS: Given the invasive nature of surgical intervention trials, potential participants may be reluctant to accept random assignment, potentially impacting generalizability. CONCLUSION: Findings from the OPUS trial will provide important information that will help surgeons to better counsel women on the benefits and risks of concomitant prophylactic anti-incontinence procedure at the time of vaginal surgery for prolapse. The implementation of the OPUS trial has necessitated that investigators consider ethical issues up front, remain flexible with regards to data collection and be constantly aware of unanticipated opportunities for unmasking. Future surgical trials should be aware of potential challenges in maintaining masking and collection of cost-related information.

Pilot study utilizing a patient educational brochure at a vesicovaginal fistula hospital in Nigeria, Africa.

This paper presents a pilot study exploring the utility and feasibility of use of a vesicovaginal fistula (VVF) patient educational brochure. Women awaiting or recently having undergone VVF surgery examined a six-paneled educational brochure detailing the causes, treatment options, and prevention methods of VVF. Participants answered demographic questions and gave detailed responses to a questionnaire that addressed the brochure material. A convenience sample of 50 patients, with a mean age of 26.1 years, participated. Universally, these women felt that the information they learned from the brochure was useful. Suggestions by participants regarding prevention of VVF included laboring in a hospital (80%), educating other women (30%), and discouraging early marriage (8%). Primary barriers to prevention and treatment included financial restraints (84%) and transportation difficulties (30%). The utilization of a simple, low-cost educational brochure has the ability to educate women on the causes, treatment, and prevention of VVF.

Magnetic resonance assessment of pelvic anatomy and pelvic floor disorders after childbirth.

To compare pelvic anatomy, using magnetic resonance imaging, between postpartum women with or without pelvic floor disorders. We measured postpartum bony and soft tissue pelvic dimensions in 246 primiparas, 6-12-months postpartum. Anatomy was compared between women with and without urinary or fecal incontinence, or pelvic organ prolapse; P < 0.01 was considered statistically significant. A deeper sacral hollow was significantly associated with fecal incontinence (P = 0.005). Urinary incontinence was marginally associated with a wider intertuberous diameter (P = 0.017) and pelvic arch (P = 0.017). There were no significant differences in pelvimetry measures between women with and without prolapse (e.g., vaginal or cervical descent to or beyond the hymen). We did not detect meaningful differences in soft tissue dimensions for women with and without these pelvic floor disorders. Dimensions of the bony pelvis do not differ substantially between primiparous women with and without postpartum urinary incontinence, fecal incontinence and prolapse.

Challenges of conducting multi-center, multi-disciplinary urinary incontinence clinical trials: experience of the urinary incontinence treatment network.

AIMS: The Urinary Incontinence Treatment Network (UITN) was established in 2000 as a multi-disciplinary, multi-institutional network by the National Institute for Diabetes, Digestive, and Kidney Diseases (NIDDK) to investigate treatments for urinary incontinence in women. METHODS: Over 8 years this network composed of urologists, urogynecologists, geriatricians, behavioral psychologists, physical therapists, nurses, epidemiologists, social scientists and statisticians from nine academic sites and a Data Coordinating Center has been effective in designing and completing prospective randomized clinical trials for treatments of urinary incontinence in women. RESULTS: Two major clinical trials have been completed and a third has completed recruitment. The focus of the completed trials was a comparison of surgical methods to treat stress urinary incontinence whereas the third examined the potential benefit of combined behavioral intervention and antimuscarinic drug therapy to eliminate the need for long-term use of drug therapy alone to manage urge urinary incontinence. The scientific output of the network measured by abstracts, original papers and presentations demonstrates the productivity of the network. CONCLUSIONS: Many unique challenges are posed by a multi-disciplinary team located at sites across the United States undertaking several clinical trials. This review presents some of the logistics, barriers, tactics, and strategies used to create this successful clinical trials network focused on urinary incontinence.

Correlates of urinary, fecal, and dual incontinence in older African-American and white men and women.

OBJECTIVES: To determine prevalence and correlates of urinary (UI), fecal (FI), and dual (DI) incontinence in community-dwelling older adults. DESIGN: Cross-sectional, population-based in-home survey. SETTING: Three rural and two urban Alabama counties (1999-2001). PARTICIPANTS: Stratified random sample of 1,000 Medicare beneficiaries aged 65 and older: 25% African-American men, 25% white men, 25% African-American women, 25% white women. MEASUREMENTS: UI defined as involuntary urine loss at least monthly; FI defined as "In the past year, have you had any loss of control of your bowels, even a small amount that stained the underwear?" Independent variables were sociodemographics, medical history, and activities of daily living (ADLs) excluding toileting. Multinomial logistic regression models were constructed using UI, FI, and DI as dependent variables. RESULTS: UI, FI, and DI prevalences were 27%, 6%, and 6%, respectively. White women had higher prevalence of UI (41.1% vs 24.6%, P<.001) and DI (18.5% vs 8.0%, P=.07) but not FI (4.4% vs 3.8%, P=.83) than African-American women. Men had no racial differences in prevalence (UI 22.2%, FI 7.7%, DI 4.6%). In women, UI, FI, and DI correlates included higher Charlson comorbidity score and depressive symptoms and greater ADL difficulty for UI and DI. In men, UI was associated with prostate disease and depressive symptoms; FI with chronic diarrhea, history of transient ischemic attack (TIA), and poor self-perceived health; and DI with history of TIA, foot and leg swelling, and depressive symptoms. CONCLUSION: Women had racial differences as well as similar correlates of incontinence subtypes, whereas men did not.

Prevention of obstetric urogenital fistulae: some thoughts on a daunting task.

Significant obstetric-related pelvic floor injury is still all too common in many areas of the world. Vesicovaginal fistula formation typically results from obstructed labor in the setting of limited medical resources for the patient. Many people have dedicated their time and even their lives to repairing these types of pelvic floor injuries, which certainly can impact in a positive way on the quality of life of these suffering women. However, it is time to consistently combine surgical repair initiatives with education, training, and prevention strategies, as well as outcomes research in order to improve on these efforts. It is only through committed initiatives with all of these elements that we may be able to ultimately decrease the prevalence of these types of pelvic floor sequelae.

The "costs" of urinary incontinence for women.

OBJECTIVE: To estimate costs of routine care for female urinary incontinence, health-related quality of life, and willingness to pay for incontinence improvement. METHODS: In a cross-sectional study at 5 U.S. sites, 293 incontinent women quantified supplies, laundry, and dry cleaning specifically for incontinence. Costs were calculated by multiplying resources used by national resource costs and presented in 2005 United States dollars (2005). Health-related quality of life was estimated with the Health Utilities Index. Participants estimated willingness to pay for 25-100% improvement in incontinence. Potential predictors of these outcomes were examined using multivariable linear regression. RESULTS: Mean age was 56 +/- 11 years; participants were racially diverse and had a broad range of incontinence severity. Nearly 90% reported incontinence-related costs. Median weekly cost (25%, 75% interquartile range) increased from 0.37 dollars (0, 4 dollars) for slight to 10.98 dollars (4, 21 dollars) for very severe incontinence. Costs increased with incontinence severity (P < .001). Costs were 2.4-fold higher for African American compared with white women (P < .001) and 65% higher for women with urge compared with those having stress incontinence (P < .001). More frequent incontinence was associated with lower Health Utilities Index score (mean 0.90 +/- 0.11 for weekly and 0.81 +/- 0.21 for daily incontinence; P = .02). Women were willing to pay a mean of 70 dollars +/- 64 dollars per month for complete resolution of incontinence, and willingness to pay increased with income and greater expected benefit. CONCLUSION: Women with severe urinary incontinence pay 900 dollars annually for incontinence routine care, and incontinence is associated with a significant decrement in health-related quality of life. Effective incontinence treatment may decrease costs and improve quality of life. LEVEL OF EVIDENCE: III.

Randomized trial of medical treatment versus hysterectomy for abnormal uterine bleeding: resource use in the Medicine or Surgery (Ms) trial.

OBJECTIVE: This study was undertaken to compare resource use outcomes for participants in the Medicine or Surgery (Ms) randomized trial. STUDY DESIGN: In a randomized controlled trial, we compared resources used during a 24-month follow-up period by women with abnormal uterine bleeding who were randomly assigned to either expanded medical treatment or hysterectomy. RESULTS: Women randomly assigned to hysterectomy used significantly more resources (medicine = $4479, hysterectomy = $6777; P = .03), with almost all the difference caused by the hysterectomy procedure. Fifty-three percent of women randomly assigned to medicine had a hysterectomy during the follow-up period; women who were able to continue on medical therapy had mean total resource use of $2595 compared with $6128 for medicine patients who eventually had surgery. CONCLUSION: For women with abnormal uterine bleeding refractory to cyclic medroxyprogesterone acetate, compared with expanded medical treatment, hysterectomy increases resource use significantly and results in better clinical and 6-month quality-of-life outcomes.