The RISE FOR HEALTH study: Methods for in-person musculoskeletal assessment.

OBJECTIVES: To describe the methods for the in-person musculoskeletal (MSK) assessment of the RISE FOR HEALTH (RISE) study, a population-based multicenter prospective cohort study designed to identify factors associated with bladder health (BH) conducted by the Prevention of Lower Urinary Tract Symptoms Research Consortium (PLUS). METHODS: A subset of RISE participants who express interest in the in-person assessment are screened to ensure eligibility (planned n = 525). Eligible consenting participants are asked to complete a standardized MSK assessment to evaluate core stability (four component core stability test, lumbar spine pain (seated slump test), pelvic girdle pain, (sacroiliac joint, anterior superior iliac spine, pubic symphysis tenderness, and pelvic girdle pain provocation test), hip pain (flexion, abduction, internal rotation and flexion, adduction and external rotation) and pelvic girdle function (active straight leg raise). Participants are also asked to complete the Short Physical Performance Battery to measure balance, gait speed, lower extremity strength, and functional capacity. RESULTS: Detailed online and in-person MSK training sessions led by physical therapy were used to certify research staff at each clinical center before the start of RISE in-person assessments. All evaluators exceeded the pre-specified pass rates. CONCLUSIONS: The RISE in-person MSK assessment will provide further insight into the role of general body MSK health and dysfunction and the spectrum of BH.

RISE FOR HEALTH: Rationale and protocol for a prospective cohort study of bladder health in women.

INTRODUCTION: The spectrum of bladder health and the factors that promote bladder health and prevent lower urinary tract symptoms (LUTS) among women are not well understood. This manuscript describes the rationale, aims, study design, sampling strategy, and data collection for the RISE FOR HEALTH (RISE) study, a novel study of bladder health in women conducted by the Prevention of Lower Urinary Tract Symptom (PLUS) Research Consortium. METHODS AND RESULTS: RISE is a population-based, multicenter, prospective longitudinal cohort study of community-dwelling, English- and Spanish-speaking adult women based in the United States. Its goal is to inform the distribution of bladder health and the individual factors (biologic, behavioral, and psychosocial) and multilevel factors (interpersonal, institutional, community, and societal) that promote bladder health and/or prevent LUTS in women across the life course. Key study development activities included the: (1) development of a conceptual framework and philosophy to guide subsequent activities, (2) creation of a study design and sampling strategy, prioritizing diversity, equity, and inclusion, and (3) selection and development of data collection components. Community members and cross-cultural experts shaped and ensured the appropriateness of all study procedures and materials. RISE participants will be selected by simple random sampling of individuals identified by a marketing database who reside in the 50 counties surrounding nine PLUS clinical research centers. Participants will complete self-administered surveys at baseline (mailed paper or electronic) to capture bladder health and LUTS, knowledge about bladder health, and factors hypothesized to promote bladder health and prevent LUTS. A subset of participants will complete an in-person assessment to augment data with objective measures including urogenital microbiome specimens. Initial longitudinal follow-up is planned at 1 year. DISCUSSION: Findings from RISE will begin to build the necessary evidence base to support much-needed, new bladder health promotion and LUTS prevention interventions in women.

Sexual Function after Minimally Invasive Total Hysterectomy and Sacrocolpopexy.

STUDY OBJECTIVE: To evaluate sexual function in women undergoing minimally invasive total hysterectomy and sacrocolpopexy (TLH + SCP) with a lightweight polypropylene Y-mesh 1 year after surgery. DESIGN: This was a planned secondary analysis of a 5-site randomized trial comparing permanent (2-0 Gore-Tex; W. L. Gore & Associates, Inc., Newark, DE) vs absorbable suture (2-0 polydioxanone suture) for vaginal attachment of a Y-mesh (Upsylon; Boston Scientific Corporation, Natick, MA) graft during TLH + SCP. SETTING: Multicenter trial at 5 study sites (4 academic and 1 community). The study sites were: (1) University of North Carolina at Chapel Hill, Chapel Hill, NC; (2) Wake Forest Baptist Hospital, Winston-Salem, NC; (3) Northwestern University, Evanston, IL; (4) Georgia Regents University, Augusta, GA; and (5) Atlantic Health Medical Group, Morristown, NJ. PATIENTS: Women previously enrolled in an original study undergoing TLH + SCP. INTERVENTIONS: Quality-of-life questionnaires and physical examination. MEASUREMENTS AND MAIN RESULTS: The primary objective was to assess changes in sexual function at 1 year after surgery as measured by the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, International Urogynecological Association-Revised. The secondary objective was to assess the factors associated with postoperative sexual activity and dyspareunia. Of the 200 participants enrolled, 182 (92.8%) completed follow-up: n = 95/99 Gore-Tex and n = 87/101 polydioxanone suture. The mean age was 60 ± 10 years; body mass index was 27 ± 5 kg/m2; 78% were menopausal and 56% sexually active before surgery. At 1 year after surgery, 63% were sexually active: 93% of the sexually active women preoperatively remained so at 1 year, and 24% reported new sexual activity at 1 year (p <.001). Sexual function at 1 year showed marked improvement in activity, quality, and arousal/orgasm compared with baseline Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire scores. Dyspareunia rates decreased from 22% preoperatively to 16.5% at 1 year (p = .65). Women who were sexually active at 1 year were younger (56.8 ± 9.6 years vs 65.4 ± 9.2 years, p <.001), more likely to be premenopausal (31.6% vs 7.4%, p = .001), and less likely to undergo bilateral salpingo-oophorectomy (53.3% vs 78.9%, p <.001). CONCLUSION: Women undergoing TLH + SCP with a lightweight mesh graft report increased rates of sexual activity, improved sexual quality and arousal/orgasm, and lower rates of dyspareunia at 1 year after surgery.

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.

Validation of the surgical pain scales in women undergoing pelvic reconstructive surgery.

OBJECTIVE: Surgical pain scales (SPS) consist of 4 items that measure pain at rest, during normal activities, and during work/exercise and quantify unpleasantness of worst pain, which are valid and responsive in men undergoing hernia repair. Our objective was to evaluate the psychometric properties of SPS in women undergoing vaginal surgery for pelvic organ prolapse and stress urinary incontinence. METHODS: We modified SPS by converting original response scales from a visual analog scale to numerical rating scales. Numerical rating scales have lower error rates and higher validity than visual analog scale. The sample included 169 women with stage II to IV pelvic organ prolapse and stress urinary incontinence in a randomized trial comparing sacrospinous ligament fixation to uterosacral vault suspension with and without pelvic floor muscle training. Participants completed SPS and SF-36 at baseline, and 2 weeks and 6 months after surgery. Construct validity and responsiveness were examined in cross-sectional and longitudinal data using Pearson correlation and analysis of variance. RESULTS: Pain at rest, during normal activities, and during work/exercise worsened at 2 weeks (P<0.05); and all measures of pain improved from baseline to 6 months (P<0.0001). Construct validity was demonstrated by correlations of 0.51 to 0.74 between SPS and the SF-36 Bodily Pain Scale (P<0.0001). Pain worsened on SF-36 between baseline and 2 weeks in 63% of the participants, and this group demonstrated a mean (SD) increase in pain of 1.9 (2.8) on the SPS (effect size, 0.99), confirming responsiveness of the scale. CONCLUSIONS: The modified SPS are valid and responsive in women after pelvic reconstructive surgery.

Validation of the activities assessment scale in women undergoing pelvic reconstructive surgery.

OBJECTIVE: The Activities Assessment Scale (AAS) is a 13-item postoperative functional activity scale validated in men who underwent hernia surgery. We evaluated the psychometric characteristics of the AAS in women who underwent vaginal surgery for pelvic organ prolapse (POP) and stress urinary incontinence (SUI). METHODS: Participants included 163 women with POP and SUI enrolled in a randomized trial comparing sacrospinous ligament fixation to uterosacral vault suspension with and without perioperative pelvic floor muscle training. Participants completed the AAS and SF-36 at baseline and 2 weeks and 6 months postoperatively. Internal reliability of the AAS was evaluated using Cronbach α. Construct validity and responsiveness were examined in cross-sectional and longitudinal data using Pearson correlation coefficient and analysis of variance. The AAS is scored from zero to 100 (higher scores=better function). RESULTS: Mean (SD) baseline AAS score was 87 (17.3) (range, 25-100). Functional activity declined from baseline to 2 weeks postoperatively (mean change, -4.5; 95% confidence interval, -7.6 to -1.42) but improved above baseline at 6 months (mean change, +10.9; 95% confidence interval, 7.8-14.0). Internal reliability of the AAS was excellent (Cronbach α=0.93). Construct validity was demonstrated by a correlation of 0.59 to 0.60 between the AAS and SF-36 physical functioning scale (P<0.0001) and lower correlations between the AAS and other SF-36 scales. Patients who improved in physical functioning based on the SF-36 between 2 weeks and 6 months postoperatively showed an effect size of 0.86 for change in the AAS over the same period. CONCLUSIONS: The AAS is a valid, reliable, and responsive measure for evaluation of physical function in women after pelvic reconstructive surgery.

A midurethral sling to reduce incontinence after vaginal prolapse repair.

BACKGROUND: Women without stress urinary incontinence undergoing vaginal surgery for pelvic-organ prolapse are at risk for postoperative urinary incontinence. A midurethral sling may be placed at the time of prolapse repair to reduce this risk. METHODS: We performed a multicenter trial involving women without symptoms of stress incontinence and with anterior prolapse (of stage 2 or higher on a Pelvic Organ Prolapse Quantification system examination) who were planning to undergo vaginal prolapse surgery. Women were randomly assigned to receive either a midurethral sling or sham incisions during surgery. One primary end point was urinary incontinence or treatment for this condition at 3 months. The second primary end point was the presence of incontinence at 12 months, allowing for subsequent treatment for incontinence. RESULTS: Of the 337 women who underwent randomization, 327 (97%) completed follow-up at 1 year. At 3 months, the rate of urinary incontinence (or treatment) was 23.6% in the sling group and 49.4% in the sham group (P<0.001). At 12 months, urinary incontinence (allowing for subsequent treatment of incontinence) was present in 27.3% and 43.0% of patients in the sling and sham groups, respectively (P=0.002). The number needed to treat with a sling to prevent one case of urinary incontinence at 12 months was 6.3. The rate of bladder perforation was higher in the sling group than in the sham group (6.7% vs. 0%), as were rates of urinary tract infection (31.0% vs. 18.3%), major bleeding complications (3.1% vs. 0%), and incomplete bladder emptying 6 weeks after surgery (3.7% vs. 0%) (P≤0.05 for all comparisons). CONCLUSIONS: A prophylactic midurethral sling inserted during vaginal prolapse surgery resulted in a lower rate of urinary incontinence at 3 and 12 months but higher rates of adverse events. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women's Health; OPUS ClinicalTrials.gov number, NCT00460434.).

Association of baseline urodynamic measures of urethral function with clinical, demographic, and other urodynamic variables in women prior to undergoing midurethral sling surgery.

AIMS: To explore how baseline demographic, clinical, and urodynamic (UDS) variables correlate with measures of urethral function in women planning midurethral sling surgery. METHODS: Women with predominant stress urinary incontinence (SUI) as part of the trial of mid-urethral slings (TOMUS) were characterized preoperatively including: demographics, body mass index (BMI), responses to the Medical and Epidemiologic Social Aspects of Aging (MESA) and Urogenital Distress Inventory (UDI) questionnaires, pad weight (PW), incontinence duration, prior SUI surgery, prolapse, strength of pelvic contraction, Q-tip test, uroflow, cystometrogram, and detrusor pressures at maximum flow (Pdet at Qmax). Multivariate regression analysis and modeling confirmed variables with significant correlations with maximal urethral closure pressure (MUCP), functional urethral length (FUL), and Valsalva leak point pressure (VLPP). RESULTS: Five-hundred thirty-nine women were included in the analysis. In multivariable analyses, PW (P = 0.045) and age (P < 0.0001) were negatively correlated with MUCP (as PW and age increased, MUCP decreased); BMI (P = 0.02) and Pdet at Qmax (P < 0.0001) were positively correlated with MUCP (as BMI and Pdet at Qmax increased, MUCP increased). Age (P = 0.002) was negatively correlated with FUL; Qtip delta (P = 0.006), pelvic organ prolapse quantification examination (POPQ) stage (P = 0.002) and strength of pelvic contraction (P = 0.03) were positively correlated with FUL. Duration of incontinence (P = 0.01) was negatively correlated with VLPP; Qtip delta (P = 0.02), BMI (P = 0.0005) and Pdet at Qmax (P = 0.0005) were positively correlated with VLPP. CONCLUSIONS: Age, BMI, Qtip delta, and Pdet at Qmax were variables that correlated with two or more measures of urethral function. These correlations may help direct future research in female urethral function.

Baseline urodynamic predictors of treatment failure 1 year after mid urethral sling surgery.

PURPOSE: We determined whether baseline urodynamic study variables predict failure after mid urethral sling surgery. MATERIALS AND METHODS: Preoperative urodynamic study variables and postoperative continence status were analyzed in women participating in a randomized trial comparing retropubic to transobturator mid urethral sling. Objective failure was defined by positive standardized stress test, 15 ml or greater on 24-hour pad test, or re-treatment for stress urinary incontinence. Subjective failure criteria were self-reported stress symptoms, leakage on 3-day diary or re-treatment for stress urinary incontinence. Logistic regression was used to assess associations between covariates and failure controlling for treatment group and clinical variables. Receiver operator curves were constructed for relationships between objective failure and measures of urethral function. RESULTS: Objective continence outcomes were available at 12 months for 565 of 597 (95%) women. Treatment failed in 260 women (245 by subjective criteria, 124 by objective criteria). No urodynamic variable was significantly associated with subjective failure on multivariate analysis. Valsalva leak point pressure, maximum urethral closure pressure and urodynamic stress incontinence were the only urodynamic variables consistently associated with objective failure on multivariate analysis. No specific cut point was determined for predicting failure for Valsalva leak point pressure or maximum urethral closure pressure by ROC. The lowest quartile (Valsalva leak point pressure less than 86 cm H2O, maximum urethral closure pressure less than 45 cm H2O) conferred an almost 2-fold increased odds of objective failure regardless of sling route (OR 2.23, 1.20-4.14 for Valsalva leak point pressure and OR 1.88, 1.04-3.41 for maximum urethral closure pressure). CONCLUSIONS: Women with a Valsalva leak point pressure or maximum urethral closure pressure in the lowest quartile are nearly 2-fold more likely to experience stress urinary incontinence 1 year after transobturator or retropubic mid urethral sling.

Factors associated with quality of life in women undergoing surgery for stress urinary incontinence.

PURPOSE: We determined the association of clinicodemographic factors with urinary incontinence related quality of life in women undergoing surgery for stress urinary incontinence, and compared the incontinence specific Incontinence Impact Questionnaire and the International Consultation on Incontinence Questionnaire. Secondary objectives were to evaluate the contributions of incontinence severity and sexual function on quality of life. MATERIALS AND METHODS: We used baseline data on 597 women in the Trial of Mid-Urethral Slings. Tested quality of life correlates included health status and history, sexual function, and urinary incontinence type, severity and bother. RESULTS: On each questionnaire lower quality of life was associated with younger age, higher body mass index, more stress urinary incontinence symptoms, and more severe and bothersome urinary incontinence symptoms. Each measure identified factors associated with lower quality of life that were not identified by the other, including Hispanic ethnicity, poor health status and more urge urinary incontinence symptoms on the Incontinence Impact Questionnaire, and prior urinary incontinence treatment and more urinary incontinence episodes daily on the International Consultation on Incontinence Questionnaire. Sexually active women had similar quality of life as well as increased incontinence episodes on each questionnaire and more sexual dysfunction on the Incontinence Impact Questionnaire only. CONCLUSIONS: In women planning stress urinary incontinence surgery quality of life is associated with nonurinary incontinence factors, and with the type, severity and degree of urinary incontinence symptom bother. Many factors are associated with quality of life as measured by the Incontinence Impact Questionnaire and the International Consultation on Incontinence Questionnaire. However, more nonurinary incontinence factors were associated with quality of life when measured by the former than by the latter. More than 1 scale may be needed to evaluate quality of life after treatment for stress urinary incontinence.

Urodynamics, the supine empty bladder stress test, and incontinence severity.

AIMS: Determine whether urodynamic measures of urethral function [(valsalva leak point pressure (VLPP), maximum urethral closure pressure (MUCP), functional urethral length (FUL)] and the results of the supine empty bladder stress test (SEBST) correlate with each other and with subjective and objective measures of urinary incontinence (UI). METHODS: Data were collected preoperatively from subjects enrolled in a multicenter surgical trial of mid-urethral slings. Subjective measures included questionnaire scores from the Medical Epidemiological and Social Aspects of Aging Questionnaire, Urogenital Distress Inventory, and Incontinence Impact Questionnaire. Objective measures included a 24-hr pad weight test, incontinence episode frequency on a 3-day voiding diary, and a SEBST. RESULTS: Five hundred ninety-seven women enrolled. Three hundred seventy-two women had valid VLPP values; 539 had valid MUCP/FUL values. Subjective measures of severity had weak to moderate correlation with each other (r = 0.25-0.43) and with objective measures of severity (r = -0.06 to 0.45). VLPP and MUCP had moderate correlation with each other (r = 0.36, P< 0.001). Urodynamic measures of urethral function had little or no correlation with subjective or objective measures of severity. Subjects with a positive SEBST had more subjective and objective severity measures compared to the negative SEBST group, but they did not have significantly different VLPP and MUCP values. CONCLUSIONS: VLPP and MUCP have moderate correlation with each other, but each had little or no correlation with subjective or objective measures of severity or with the results of the SEBST. This data suggests that the urodynamic measures of urethral function are not related to subjective or objective measures of UI severity.

The effect of age on short-term outcomes after abdominal surgery for pelvic organ prolapse.

OBJECTIVES: To compare perioperative morbidity and 1-year outcomes of older and younger women undergoing surgery for pelvic organ prolapse (POP). DESIGN: Prospective ancillary analysis. SETTING: Academic medical centers in National Institutes of Health, National Institute of Child Health and Human Development Colpopexy and Urinary Reduction Study. PARTICIPANTS: Women with POP and no symptoms of stress incontinence. INTERVENTION: Abdominal sacrocolpopexy with randomization to receive Burch colposuspension for treatment of possible occult incontinence or not. MEASUREMENTS: Perioperative complications and Pelvic Organ Prolapse Quantification and quality-of-life (QOL) questionnaires (Pelvic Floor Distress Inventory, Pelvic Floor Impact Questionnaire, and Medical Outcomes Study Short-Form Health Survey (SF-36) preoperatively, immediately postoperatively, and 6 weeks and 3 and 12 months postoperatively). RESULTS: Three hundred twenty-two women aged 31 to 82 (21% aged > or =70), 93% white. Older women had higher baseline comorbidity (P<.001) and more severe POP (P=.003). Controlling for prolapse stage and whether Burch was performed, there were no age differences in complication rates. Older women had longer hospital stays (3.1+/-1.0 vs 2.7+/-1.5 days, P=.02) and higher prevalence of incontinence at 6 weeks (54.7% vs 37.2%, P=.005). At 3 and 12 months, there were no differences in self-reported incontinence, stress testing for incontinence, or prolapse stage. Improvements from baseline were significant on all QOL measures but with no age differences. CONCLUSION: Outcomes of prolapse surgery were comparable between older and younger women except that older women had slightly longer hospital stays.

Usefulness of urine dipstick in an urogynecologic population.

Urine dipstick alone is insufficient for diagnosing urinary tract infection in patients with pelvic floor disorders.

Peripartum urinary incontinence in a racially diverse obstetrical population.

To determine the rates of urinary incontinence in a racially diverse, tertiary care obstetrical population during the third trimester and postpartum using a validated symptom-screening questionnaire. Third trimester prenatal patients receiving obstetric care at Loyola University Medical Center between March and November 2003 participated in this prospective study approved by the Institutional Review Board. Third-trimester participants completed the 15-item, validated Medical, Epidemiological, and Social Aspects of Aging (MESA) questionnaire and the Hunskaar Severity Index. The MESA was readministered to participants during a 6- to 8-week postpartum visit. One hundred and thirteen women completed antenatal and postpartum MESAs. Seventy-four percent (83 of 113) of the patients in the third trimester were categorized as incontinent. The postpartum incontinence rates decreased to 44% (50 of 113). Twenty-one percent (24 of 113) of the participants after delivery reported pure stress incontinence, 3% (3 of 113) urge incontinence, and 20% (23 of 113) mixed incontinence. Only 4% (5 of 113) of the women developed de novo incontinence postpartum: three reported symptoms of pure stress incontinence and two reported symptoms consistent with urge incontinence. The MESA questionnaire identifies more women with antenatal and postpartum urinary incontinence than currently described in the literature.