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.

Validity of utility measures for women with urge, stress, and mixed urinary incontinence.

OBJECTIVE: We sought to evaluate the construct validity of 3 health status classification system instruments-Health Utilities Index Mark 3 (HUI-3), EuroQol (EQ-5D), and Short Form 6D (SF-6D)-and a visual analog scale (VAS) for measuring utility scores in women with urge, stress, and mixed urinary incontinence. STUDY DESIGN: Utility scores were measured in 202 women with urinary incontinence. Pelvic floor symptom severity and quality of life were measured using the Pelvic Floor Distress Inventory and Pelvic Floor Impact Questionnaire, respectively. Construct, discriminant, and concurrent validity were evaluated. RESULTS: Significant correlations were noted between utility scores and the Pelvic Floor Distress Inventory (r = -0.22 to -0.42, P < .05) and the Pelvic Floor Impact Questionnaire (r = -0.32 to -0.50, P < .05). Mean utility scores were significantly lower for women with urge or mixed incontinence compared to stress incontinence for the EQ-5D (0.71 ± 0.23, 0.73 ± 0.26, and 0.81 ± 0.16, respectively, P = .02) and the SF-6D (0.76 ± 0.12, 0.74 ± 0.12, and 0.81 ± 0.11, respectively, P = .02) but not the HUI-3 or the VAS. There was a clinically important difference in utility scores (>0.03) between women with urge or mixed incontinence as compared to stress incontinence for the HUI-3, EQ-5D, and SF-6D but not the VAS. Utility preference scores were significantly lower for women with combined urinary and fecal incontinence (0.69-0.73) than urinary incontinence alone (0.77-0.84, P < .01). CONCLUSION: The HUI-3, EQ-5D, and SF-6D, but not the VAS, provide valid measurements for utility scores in women with stress, urge, and mixed urinary incontinence.

Beliefs about medications as a predictor of treatment adherence in women with urinary incontinence.

OBJECTIVE: To investigate the association between beliefs about medications and primary adherence in women prescribed anticholinergic medications for urgency urinary incontinence (UUI). METHODS: We enrolled 160 women with UUI who were prescribed anticholinergic medications between 2009 and 2010. Validated questionnaires were administered to measure the diagnosis of UUI, its impact on quality of life, and beliefs about medications. Primary adherence, filling of a prescription within 30 days, was measured through pharmacy records. The association between healthcare beliefs and primary adherence was measured using multivariable analysis. RESULTS: The incidence of primary adherence to anticholinergic medication was 73%. Of the women, 5% reported belief in the general harm of medicines, 31% reported belief in the general overuse of medicines, and 90% reported belief in the general benefit of medicines. Responses to the Beliefs about Medicines Questionnaire (BMQ) had good internal consistency in women with UUI (Cronbach's alpha 0.59-0.75). On univariable analysis, belief in the general overuse of medicines (odds ratio [OR] 0.48, 95% confidence interval [CI] 0.23-0.99) and belief in the general harm of medicines (OR 0.11, 95% CI 0.02-0.57) were significant negative predictors of primary adherence to anticholinergic medications. A significant relationship between the impact of urinary symptoms on quality of life and primary adherence was not noted (OR 1.02, 95% CI 0.86-1.22). On multivariable analysis, belief in the general overuse of medicines remained a significant negative predictor of primary adherence (OR 0.35, 95% CI 0.16-0.79). CONCLUSIONS: Women with UUI who believe that medicines in general are overused are less likely to fill their prescriptions for anticholinergic medications.

Self-assessment of fluid intake behavior in women with urinary incontinence.

OBJECTIVE: To determine if women with urinary incontinence are able to recognize patterns of fluid intake associated with lower urinary tract symptoms. METHODS: We performed a cross-sectional study of 256 consecutive women with urinary incontinence at an initial visit to a urogynecology practice. Data from the Questionnaire-Based Voiding Diary, a validated instrument that measures volume of fluid intake, fluid intake behavior, and lower urinary tract symptoms, were abstracted. Carbonated, caffeinated, and total fluid intake volumes were analyzed. Behaviors of excess consumption of caffeinated, carbonated, and total fluid intake as well as restriction of fluid intake were measured. Fluid intake volumes were divided into quartiles and correlated to fluid intake behavior and lower urinary tract symptoms. RESULTS: Fluid intake behaviors of drinking excess carbonated and caffeinated beverages were significantly associated with the volume of carbonated (p<0.001) and caffeinated fluid intake (p<0.001). The behavior of drinking excess fluid was significantly associated with the total volume of fluid intake (p=0.019). A significant relationship between quartiles of total fluid intake and increasing number of daily voids (p<0.001) and quartiles of caffeinated fluid intake and increasing severity of urgency urinary incontinence (p=0.038) was noted. A direct statistical association between fluid intake behavior and lower urinary tract symptoms was not noted. CONCLUSIONS: Women with urinary incontinence recognize their pattern of fluid intake and fluid intake behavior. The type and volume of fluid intake are significantly associated with symptoms of urinary frequency and urgency urinary incontinence.