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Prevalence data on nocturnal polyuria (NP), nocturia caused by overproduction of urine during sleep, is primarily limited to men and varies by NP definition. This U.S.-representative epidemiological study of men and women ≥30 years old assessed the prevalence of NP.Consenting participants completed the baseline EpiNP (Epidemiology of Nocturnal Polyuria) survey (eg Lower Urinary Tract Symptoms Tool, comorbidities). All reporting ≥2 voids/night and a target of 100 random respondents reporting 0 or 1 void/night were asked to complete 3-day bladder diaries. NP was defined as nocturnal polyuria index (NPI)0.33 (NPI33) and nocturnal urine production90 ml/hour (NUP90). Extrapolated prevalence was stratified by sex and subgroups: idiopathic (without underlying causes), associated with overactive bladder (NPOAB), bladder outlet obstruction (NPBOO; men) and comorbidities. Voided volumes and timing, including first uninterrupted sleep period, were assessed by subgroup.A total of 10,190 individuals completed the baseline survey; mean age (range) was 54.4 (30-95). A total of 3,938 individuals were invited to complete the diary; 1,763 (49.3%) completed 3-day bladder diaries. Urine production (maximum nighttime volume, total volume, nocturnal urine production, nocturia index) was higher in both men and women with idiopathic NP and comorbidities. The median number of nighttime voids was greatest for NPBOO in men and NPOAB in women. Bother associated with nighttime voiding differed by NP subgroup but was highest in NPBOO for men (NPI33: 69.6%; NUP90: 71.1%) and NPOAB for women (NPI33: 67.5%; NUP90: 66.0%).This population-based NP prevalence study including men and women characterizes NP subgroups and provides insights into nocturia treatment by emphasizing factors influencing urine production versus factors influencing bladder capacity.

Introduction and hypothesis Mirabegron, a beta-3 agonist, is prescribed for urgency urinary incontinence (UUI). We assessed the correlation of symptom improvement with urobiome characteristics in adult women participants prescribed mirabegron for UUI treatment. Methods We enrolled participants seeking UUI treatment who selected mirabegron and agreed to participate in this 12-week, open label study conducted at the Female Pelvic Medicine and Reconstructive Surgery Center at Loyola University Medical Center. Following eligibility screening and research consent, participants completed the overactive bladder questionnaire (OAB-Q) and provided a catheterized urine sample at baseline, 4, 8, and 12 weeks. The primary outcome, symptom improvement at 12 weeks, was based on the validated Patient Global Symptom Control questionnaire score to dichotomize symptom response (responder vs nonresponder [PGSC score ≤3]). Urine samples were processed by the Expanded Quantitative Urine Culture (EQUC) protocol. Results Eighty-three participants (mean age 68 years) completed baseline assessment. Of the 47 participants with primary outcome data and samples analysis, there were 16 responders and 31 nonresponders; responder groups were similar demographically. Living microbes were detected in most participants. There were no significant differences in alpha diversity (within sample) at baseline between groups. However, at the 12-week follow-up, the responder urobiome became significantly richer, with a larger number of genera (p = 0.027) and was significantly more diverse than the nonresponders. Conclusions Longitudinal urobiome changes are associated with symptom improvement in adult women being treated with mirabegron for UUI. The mechanism for symptoms improvement may relate to the detected changes in the urobiome and warrants further study.

It is unknown whether the pessary management type influences the need for surgery.The aim of this study was to evaluate the rate of surgical treatment for pelvic organ prolapse or stress urinary incontinence with the type of pessary management (self-management or office management).We conducted a retrospective cohort study that included first-time pessary users treated at a tertiary urogynecologic clinic from 2012 to 2014 for pelvic organ prolapse, stress urinary incontinence, or both. For the primary outcome, we explored the relationship between pessary management type and the likelihood of surgery using multivariable Cox proportional hazards models. Secondary outcomes assessed relationships between patient factors (eg, demographics and clinical attributes) and pessary management type using multivariable logistics regression models.There were 218 patients included in our analysis. Of all pessary users, 59 (27.1%) required office management and 159 (72.9%) participated in self-management. Surgery was performed in 22 (35.1%) office-managed patients and 33 (19.3%) self-managed patients. Women who self-managed their pessaries were significantly less likely to undergo surgery than those who received office management (multivariable hazards ratios, 0.416; P = 0.005). In the multivariable logistic regression model for pessary management type, increasing age (odds ratio [OR], 1.098; P ≤ 0.0001), increasing body mass index (OR, 1.078; P0.05), and increasing genital hiatus (OR, 1.547; P0.05) were associated with increased odds of pessary office management compared with self-management.In a urogynecology clinic setting, pessary self-management is associated with lower rates of surgical treatment compared with office management. Factors associated with office management include increased age, body mass index, and large genital hiatus.

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.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.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.

To describe the methods for the in-person assessment of the RISE FOR HEALTH (RISE) study, a population-based multicenter prospective cohort study designed to identify factors that promote bladder health and/or prevent lower urinary tract symptoms in adult women, conducted by the Prevention of Lower Urinary Tract Symptoms Research Consortium (PLUS).A subset of RISE participants who express interest in the in-person assessment will be screened to ensure eligibility (planned n = 525). Eligible consenting participants are asked to complete 15 physical assessments in addition to height and weight, to assess pelvic floor muscle function, musculoskeletal (MSK) status, and pain, and to provide urogenital microbiome samples. Pelvic floor muscle assessments include presence of prolapse, strength, levator attachment integrity (tear) and myofascial pain. MSK tests evaluate core stability, lumbar spine, pelvic girdle and hip pain and function. Participants are asked to complete the Short Physical Performance Battery to measure balance, lower extremity strength, and functional capacity. All participants are asked to provide a voided urine sample and a vaginal swab for microbiome analyses; a subset of 100 are asked to contribute additional samples for feasibility and validation of a home collection of urinary, vaginal, and fecal biospecimens.Online and in-person training sessions were used to certify research staff at each clinical center before the start of RISE in-person assessments. Standardized protocols and data collection methods are employed uniformly across sites.The RISE in-person assessment is an integral portion of the overall population-based RISE study and represents an innovative approach to assessing factors hypothesized to promote bladder health and/or prevent lower urinary tract symptoms. Data collected from this assessment will be used to prioritize future research questions and prevention strategies and interventions. This description of the assessment methods is intended to provide methodologic transparency and inform other researchers who join efforts to understand and improve bladder health.

Objectives We aimed to investigate the effect of music listening on preoperative anxiety compared with usual care in patients undergoing pelvic reconstructive surgery. Methods Patients scheduled for pelvic reconstructive surgery were enrolled on the day of surgery. Participants were randomized to either the usual care (control group) or to music listening on headphones (music group) before their surgery. Participants completed the Spielberg State-Trait Anxiety Inventory form Y1 to measure baseline state anxiety levels before surgery and again after 30 minutes of usual care or music listening. The primary outcome was the change in state anxiety score as measured by the State-Trait Anxiety Inventory form Y1. Results Sixty-nine women completed the study (35 assigned to the control group and 34 assigned to the music group). Analysis of the primary outcome included 66 participants (34 in the control group and 32 in the music group). Improvement in state anxiety was significantly better for patients assigned to music listening (-6.69; SD, 6.98) than for patients assigned to the control group (-1.32; SD, 8.03; P = 0.01). Six weeks postoperatively, patients in the music group (n = 29) reported higher overall satisfaction when compared with those in the control group (n = 31, P = 0.03). Conclusion Patients undergoing pelvic reconstructive surgery present with moderate anxiety on the day of surgery. Allowing patients to listen to their preferred music is a simple intervention that may lower preoperative anxiety and improve satisfaction in this patient population.

Objective To explore the perspectives of normal bladder function among women with lower urinary tract symptoms. Methods This was a secondary analysis of qualitative data from structured interviews with 50 adult women with lower urinary tract symptoms. A directed content analysis of the transcripts explored women's perspectives on normal bladder function. Results Participants’ descriptions of “normal” took many forms and were based on several aspects of bladder function. A prominent feature of normal was that voiding occurred as a seamless process, beginning with an urge sensation, followed by voiding with ease and to completion, and then “being done.” Descriptions of normal were based largely on concepts of voiding regularity, including voiding frequency, intervals, and patterns during the day and night. Another aspect of normal bladder function was the notion of having control in terms of not leaking urine, as well as the ability to hold urine and defer urination. Views of normal bladder function extended to the absence of symptoms and the impact of being symptom-free on day-to-day life, including not having to think about or worry about the bladder or limit daily activities. Conclusion Women's perspectives on normal bladder function are multifaceted, reflecting attributes most salient to each individual and likely informed by their personal experience with symptoms and their influence on daily life. This work has implications for how clinicians might engage women in discussing bladder symptoms and can inform future research and public health messaging about normal bladder function.

(s): Existing bladder-specific measures lack ability to assess a range of bladder health from poor to optimal health. We report evidence for validity of the self-administered, multidimensional Bladder Health Scales and Function Indices for research in adult women.A cross-sectional population-based validation study with random assignment to paper or electronic administration was conducted using national address-based probability sampling supplemented by purposive sampling of women with lower urinary tract symptoms surrounding 7 clinical research centers. Construct validity of the Bladder Health Scales and Function Indices was guided by Multitrait-Multimethod approach using health and condition-specific questionnaires, bladder diaries, expert ratings of bladder health, and noninvasive bladder function testing. Internal dimensional validity was evaluated using factor analysis; internal reliability was assessed using paired t-tests and 2-way mixed effects Intraclass Correlation Coefficient models. Mode comparisons used chi-square, Fisher Exact or t-tests. Convergent validity was evaluated using Pearson correlations with the external construct measures and known-group validity was established with comparison of women known and unknown to be symptomatic with urinary conditions.The sample included 1,072 participants. Factor analysis identified ten scales with Cronbach's alpha ranging 0.74-0.94. Intraclass correlation coefficients of scales ranged from 0.55-0.94. Convergent validity of ten scales and six indices ranged from 0.52- 0.83. Known-group validity was confirmed for all scales and indices. Item distribution was similar by mode of administration.The paper and electronic forms of the Bladder Health Scales and Function Indices are reliable and valid measures of bladder health for use in women's health research.

The optimal method of managing stress urinary incontinence (SUI) in women undergoing colpocleisis remains unclear, especially in a setting of urinary retention. We aim to compare postoperative retention after colpocleisis with or without concomitant midurethral sling (MUS). A retrospective chart review of all women who underwent colpocleisis with or without MUS from October 2007 to October 2017 was performed. Women with preoperative and 2-week postoperative post-void residual volume (PVR) measurements were included. Urinary retention was defined as PVR of ≥100 ml. Analysis included t tests/Wilcoxon rank, Chi-squared/Fisher’s exact, and multivariate linear regression models. A total of 231 women with a mean age of 77.7 years (± 6.0 years SD) met the inclusion criteria. One hundred and thirty-eight women underwent colpocleisis alone, whereas 93 women had colpocleisis with MUS. Preoperative retention rates were high (44.9% vs 34.4%, for colpocleisis alone versus with MUS, p = 0.114). Postoperative retention rates were lower and similar between the groups (10.1% vs 11.8%, for colpocleisis alone vs with MUS, p = 0.69). Linear regression models showed the adjusted odds ratio for postoperative urinary retention in patients with concomitant MUS was 1.68 (95% confidence interval: 0.64–4.41) compared with patients with colpocleisis alone and this did not reach statistical significance (p = 0.292). Fortunately, after colpocleisis, women had high rates of resolution of retention, regardless of MUS (80.3% vs 90.6% for colpocleisis alone vs with MUS; p = 0.20). Few women required reoperation for retention (3.1%). Placement of an MUS at the time of colpocleisis is a safe and effective therapy. This appears to be unaffected by preoperative urinary retention status.

The aim of this study was to compare patients' preferred role in medical decision-making before the initial urogynecology visit to their perceived role after the visit.This prospective cohort study enrolled women presenting for their initial urogynecology visit. Before and after the visit, patients completed the Control Preference Scale (CPS), which categorizes the role that patients want to have in medical decision-making: active, collaborative, or passive. Patients also completed the Pelvic Floor Distress Inventory, CollaboRATE, Patient Global Impression of Improvement, patient satisfaction, and Short Test of Functional Health Literacy in Adults questionnaires. Univariable and multivariable generalized estimating equations were used.Women (n = 100) with a mean age of 59.1 years (SD = 15.5) participated in the study. Based on CPS before the visit, 50% of the women preferred active involvement, whereas 45% preferred collaborative and 5% preferred passive involvement. After the visit, these rates change to 40%, 48%, and 11%, respectively. On univariable analysis, women were 1.56 times more likely to report a collaborative or passive CPS response after the visit (P = 0.02). This remained true on multivariable analysis (odds ratio, 1.57; P = 0.04). Patients' CPS responses were not associated with their responses on CollaboRATE, Patient Global Impression of Improvement, patient satisfaction, or Short Test of Functional Health Literacy in Adults. Eighty-eight percent of women reported a fully collaborative visit based on CollaboRATE, and 87% reported being "completely satisfied" with the visit.Despite a change in women's reported involvement in decision-making after their first urogynecology visit compared with their preferences before the visit, most women perceived collaboration during their visit and were completely satisfied.

Aim To conduct an evidence synthesis of normative reference values for bladder function parameters in women. Methods We conducted a systematic review and meta-analysis of studies reporting bladder function parameters obtained from noninvasive tests in healthy women. Seven databases were searched for relevant studies from inception through December 2018, with manual searching of reference lists. We included English language articles that provided quantitative data on urination frequency, voided and postvoid residual volumes, and uroflowmetry results in women without lower urinary tract symptoms. Study selection, data extraction, and quality assessment were undertaken by at least two independent reviewers. Random-effects meta-analytic models were used to derive study-level pooled mean estimates and 95% confidence intervals. Results A total of 24 studies (N = 3090 women, age range, 18-91 years) met eligibility criteria. Pooled mean estimates of bladder function parameters were: 6.6 daytime voids (95% confidence interval (95% CI), 6.2, 7.0), 0.4 nighttime voids (95% CI, 0.0, 0.8), 1577 mL for 24-hour voided volume (95% CI 1428,1725); 12 mL for postvoid residual volume (95% CI, 4, 20); and 28 mL/sec for maximum flow rate (95% CI, 27,30). Between-study heterogeneity was high for all outcomes (I2 = 61.1-99.6%), but insufficient data were available to explore reasons for this high heterogeneity (eg, differences by age). Conclusion Although summary mean estimates of bladder function parameters were calculated, the wide heterogeneity across studies precludes generalization of these estimates to all healthy women. Further research is needed to determine normative reference values within specific groups, such as those defined by age.

Oral pharmacotherapy consisting of antimuscarinics, β3-adrenoreceptor agonists, or combinations of these agents forms the mainstay of overactive bladder (OAB) management.To evaluate the efficacy and safety of combination therapy in patients with OAB.A literature search was conducted in June 2018 using Embase, MEDLINE, and Cochrane databases via Ovid and relevant congress abstracts. Studies reporting the efficacy/safety of two antimuscarinics or a β3-adrenoreceptor agonist plus an antimuscarinic were included.Publications reported on clinical efficacy, safety, and health-related quality of life (HRQoL) for mirabegron (M) plus solifenacin (S) from three 12-wk randomised controlled trials (RCTs)-SYMPHONY, SYNERGY, and BESIDE-and a 12-mo RCT, SYNERGY II. SYMPHONY reported statistically significant improvements in clinical symptoms and HRQoL with combination therapy versus solifenacin 5 mg (S5) and placebo. In SYNERGY, there were consistent improvements in urinary incontinence (UI) episodes/24 h and micturitions/24 h (coprimary endpoints), and in secondary efficacy parameters with mirabegron 25 mg (M25) + S5 and mirabegron 50 mg (M50) + S5 versus respective monotherapies. In patients with an inadequate response to S5 monotherapy (BESIDE), greater improvements in UI (primary endpoint) were noted for M50 + S5 versus S5 (p = 0.001). Combination therapy was noninferior to solifenacin 10 mg (S10) for reduction in UI and superior to S10 for improvement in micturition frequency (p 0.001), and resulted in greater improvements from baseline in OAB-5 Dimension scores versus S5 and S10 (p 0.01). In SYNERGY II, clinically meaningful and sustained improvements in clinical outcomes were observed for M50 + S5 versus M50 or S5. Combination therapy was well tolerated in all four trials. The incidence of adverse events (AEs) was similar across groups, and there were no notable differences in the incidence of specific AEs. Positive efficacy outcomes were observed in five studies of dual antimuscarinic therapy (trospium + solifenacin).Mirabegron plus solifenacin provides effective, well-tolerated treatment for patients with OAB. Limited data for dual antimuscarinic therapy suggest a benefit in patients with moderate-to-severe symptoms.Overactive bladder (OAB) is treated with medicines called antimuscarinics, such as solifenacin, propiverine, or trospium, or another β-adrenoreceptor agonist medicine called mirabegron, which works in a different way. We looked at published scientific studies of patients with OAB treated with mirabegron plus solifenacin together, or with two antimuscarinics. We found that mirabegron plus solifenacin can help reduce symptoms and improve quality of life. Patients tolerate this treatment well, with few patients experiencing side effects.

The prevalence of nocturnal polyuria (NP), which is passing large volumes of urine during the main sleep period, has been investigated primarily in middle-aged to older men. There is thus a gap in the NP evidence base for women and for younger individuals.To estimate the prevalence of nocturia due to NP in the USA.This large epidemiologic study used a US population-representative sample of men and women aged ≥30 yr to assess the prevalence of NP (NCT04125186).Consenting participants completed an online survey (Lower Urinary Tract Symptoms Tool and comorbidities). All who reported two or more voids per night and 100 random respondents each reporting no or one void per night were asked to complete a 3-d bladder diary. Two NP definitions were used: nocturnal urine production90 ml/h (NUP90) and Nocturnal Polyuria Index0.33 (NPI33). Crude and population-adjusted prevalence results were calculated from completed diaries for the following subgroups by sex and age: idiopathic NP; NP with overactive bladder (NP-OAB) or bladder outlet obstruction (NP-BOO; men only); NP associated with other comorbidities; and no NP (did not meet the NPI33 or NUP90 definition).Among the 10,190 respondents who completed the survey, the mean age was 54.4 yr (range 30-95); 3,339 reported two or more nocturnal voids and 1,763 completed the 3-d diary (response rate 49.3%). The adjusted overall NP prevalence was 31.5% among men and 38.5% among women using the NPI33 definition, and 23.8% among men and 18.1% among women using NUP90. The adjusted idiopathic NP prevalence was lower among men (NPI33: 5.2%; NUP90: 1.4%) than among women (NPI33: 9.8%; NUP90: 4.0%). The prevalence of idiopathic NP decreased with age as NP associated with other possible causes increased with age in men (most common, BOO) and women (most common, OAB).This is the first population-based study of NP prevalence to include men, women, and young adults. NP is common; a multifactorial etiology should be considered, particularly as age increases.In this population-based US study, we examined the frequency of nighttime urination among men and women aged ≥30 y and older. We found that nighttime urination is common among men and women. Many conditions can lead to increased nighttime urination as people age.

We aimed to investigate the effect of music listening on preoperative anxiety compared with usual care in patients undergoing pelvic reconstructive surgery.Patients scheduled for pelvic reconstructive surgery were enrolled on the day of surgery. Participants were randomized to either the usual care (control group) or to music listening on headphones (music group) before their surgery. Participants completed the Spielberg State-Trait Anxiety Inventory form Y1 to measure baseline state anxiety levels before surgery and again after 30 minutes of usual care or music listening. The primary outcome was the change in state anxiety score as measured by the State-Trait Anxiety Inventory form Y1.Sixty-nine women completed the study (35 assigned to the control group and 34 assigned to the music group). Analysis of the primary outcome included 66 participants (34 in the control group and 32 in the music group). Improvement in state anxiety was significantly better for patients assigned to music listening (-6.69; SD, 6.98) than for patients assigned to the control group (-1.32; SD, 8.03; P = 0.01). Six weeks postoperatively, patients in the music group (n = 29) reported higher overall satisfaction when compared with those in the control group (n = 31, P = 0.03).Patients undergoing pelvic reconstructive surgery present with moderate anxiety on the day of surgery. Allowing patients to listen to their preferred music is a simple intervention that may lower preoperative anxiety and improve satisfaction in this patient population.

We compared urinary tract infection (UTI) symptom resolution rates at 7-10 days in symptomatic women randomized to treatment based on standard urine culture (SUC) versus expanded quantitative urine culture (EQUC) results.Women ≥18 years old who responded "yes" to "do you feel you have a UTI?" agreed to urethral catheterization and followup. Symptoms were assessed using the validated UTI Symptom Assessment (UTISA) questionnaire. Culture method was randomized 2:1 (SUC:EQUC); antibiotics were prescribed to women with positive cultures. The primary outcome, UTI symptom resolution, was determined 7-10 days following enrollment on all participants regardless of treatment.Demographic data were similar between groups. Of the SUC and EQUC groups 63% and 74% had positive cultures (p=0.10), respectively. Of participants with positive cultures 97% received antibiotics. Primary outcome data were provided by 215 of 225 participants (SUC 143 [95%], EQUC 72 [97%]). At the primary outcome assessment, 64% and 69% in the SUC and EQUC groups, respectively, reported UTI symptom resolution (p=0.46); UTISA scores improved from baseline in the EQUC arm compared to the SUC arm (p=0.04). In the subset of women predominated by non-Symptom resolution was similar for the overall population (

OBJECTIVE To characterise the bladder microbiota of continent adult women. DESIGN Cross-sectional study of adult women who contributed catheterised urine samples, completed validated symptom questionnaires, and provided demographic data. SETTING US academic medical centre. POPULATION Well-characterised continent adult women. METHODS Participants contributed symptoms questionnaires, demographic data, and catheterised urine samples that were analysed by enhanced urine culture methodology and 16S rRNA gene sequencing. MAIN OUTCOME MEASURES Associations between demographics and microbial community state structures (urotypes, defined by the dominant taxon of each specimen). RESULTS The bladder microbiota (urobiome) of a control group of 224 continent women were characterised, demonstrating variability in terms of urotype. The most common urotype was Lactobacillus (19%), which did not differ with any demographic. In contrast, the Gardnerella (P

Colpocleisis is a surgical treatment of pelvic organ prolapse for elderly women who are no longer sexually active. The risk calculator of the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) predicts perioperative complications. We aim to determine if the NSQIP calculated risk correlates with true perioperative complications in women 80 years or older undergoing colpocleisis.Octogenarian women who underwent colpocleisis at our institution from 2007 to 2017 were included in this retrospective chart review. Medical comorbidities were entered into ACS NSQIP calculator, and the calculated risk was compared with actual complications.One hundred twenty-six octogenarians were included in the analysis. The true complication rate was higher than predicted by NSQIP (28.6% [36/126] vs 4.3% (SD, ±1.1%), which we attribute to our relatively high detection rate of urinary tract infection (32/36). Four patients (3.2%) had serious complications (pulmonary embolus, deep vein thrombosis, sepsis, and reintubation). In only 57% of cases, NSQIP risk calculation was concordant with true complication, showing significant departure from correct classification (P0.0001). The sensitivity and specificity of the NSQIP calculator were 66.7% and 53.3%, respectively. Multivariable analysis showed higher-than-predicted incidence of complications for patients requiring antiplatelet medication (Plavix or aspirin81 mg vs none; odds ratio, 4.84, 95% confidence interval, 1.72-13.60; P = 0.002) and a diagnosis of hypertension (odds ratio, 4.24; 95% confidence interval, 1.31-13.72; P = 0.016).Serious complication rates are low in octogenarians undergoing colpocleisis. The ACS NSQIP risk calculator does not strongly correlate with actual complications. Further refinement and evolvement of the database may improve its predictive value.

Author(s): Lowder, Jerry L; Bavendam, Tamara G; Berry, Amanda; Brady, Sonya S; Fitzgerald, Colleen M; Fok, Cynthia S; Goode, Patricia S; Lewis, Cora E; Mueller, Elizabeth R; Newman, Diane K; Palmer, Mary H; Rickey, Leslie; Stapleton, Ann; Lukacz, Emily S | Abstract: AimTo report research terminology and definitions for describing healthy bladder function among women and girls.MethodsThe Prevention of Lower Urinary tract Symptoms (PLUS) Consortium developed research terminology and definitions for elements of healthy bladder function based on existing understanding of storage and emptying functions of the bladder and accepted definitions of lower urinary tract symptoms (LUTS). The novel concept of a bladder "bioregulatory" function was also proposed. Elements of bladder function corresponding to bladder health (BH) and LUTS were developed and refined using an iterative process. A comprehensive reference table structured by bladder function (Storage, Emptying, and Bioregulatory) and elements of each function was created to document proposed research terminology and definitions.ResultsThe BH research definitions for each bladder function are: (1) Storage: the ability to hold urine for a reasonable duration of time and sense bladder fullness without fear of or concern about urgency, discomfort or leakage; (2) Emptying: the ability to empty the bladder completely in a timely, efficient, effortless, comfortable manner; and (3) Bioregulatory: the bladder barrier protects the individual/host from pathogens, chemicals, and malignancy. Research definitions for seven Storage, seven Emptying, and three Bioregulatory elements of function are presented. Novel LUTS research definitions were developed when gaps in existing definitions were identified or nonclinical language was desired.ConclusionsPLUS BH definitions reflect a transdisciplinary approach to standardizing research definitions for elements of bladder function from a perspective of health rather than dysfunction and provide a framework for studying BH in clinical practice, public health promotion, and LUTS prevention.

Presence of microbial communities (microbiota) in an organ system depends on environmental factors, such as oxygen availability. We describe a novel technique to measure bladder urine oxygen tension (BUOT) in ambulatory women and use that technique to compare BUOT values to female urinary microbiota and participant urinary signs and symptoms. Ambulatory female urogynecology patients presenting for clinical care who were willing to undergo transurethral catheterization underwent BUOT determination with a non-invasive flow-through oxygen sensor. To detect urinary microbiota in the bladder, 16S rRNA gene sequencing was performed on catheterized urine. Multivariate statistical analyses were performed to examine potential correlations among BUOT, urinary microbiota compositions and clinical variables. Significant variation in BUOT existed between individuals (range: 0.47–51.5 mmHg; median: 23.1 ± 13.5). Microbiota compositions were associated with BUOT (p = 0.03). BUOT was significantly lower in urines that were nitrite negative on dipstick analysis (p = 0.0001) and in participants who answered yes to having urinary leakage on the validated Urinary Distress Inventory (p = 0.01). BUOTs can be measured in ambulatory women. For urogynecology patients, a wide range of values exist. BUOT may be associated with the presence of urinary microbiota and resultant signs and symptoms.

Aims SYNERGY II was a 12‐month phase III trial in patients with overactive bladder (OAB) symptoms that investigated the safety and efficacy of the combination of mirabegron and solifenacin in comparison with each monotherapy. This analysis evaluated the trial findings using four age subgroups (1 bpm were noted in the combination and mirabegron younger age groups only. No clinically significant findings were observed in the other safety parameters. The efficacy variables improved with all treatments and the greatest improvements were typically observed with combination therapy. Conclusions Mirabegron and solifenacin combination therapy was a well‐tolerated and effective treatment for patients with OAB symptoms irrespective of their age.

Objectives The expanded quantitative urine culture protocol was used to compare the microbial abundance and diversity of voided urines obtained using a standard urine collection or using the Peezy midstream device versus paired periurethral specimens. Methods Sixty-two female participants were assigned to 1 of 3 cohorts. One cohort used a standard clean catch midstream urine protocol that included a castile soap wipe, the second cohort used a Peezy midstream collection device with castile soap wipe and the third used the Peezy device without a castile soap wipe. Each participant watched a video that detailed the collection method. Before using the castile soap wipe, a periurethral swab was obtained to measure periurethral microbial abundance. Demographics and pelvic floor symptoms were assessed by validated questionnaires. Microbes were detected using expanded quantitative urine culture. Diversity within each sample was analyzed using alpha diversity measures. Results Paired periurethral and urine samples for each woman were analyzed and compared for species abundance, richness, and diversity. Bacterial profiles of Peezy-collected urines differed significantly by multiple diversity indices and had significantly reduced colony-forming units compared to paired periurethral swabs. In contrast, within the standard clean catch cohort, voided urine had higher abundance and richness than paired periurethral swabs. Conclusions Compared with standard clean catch method, the Peezy urine collection device with and without the castile soap wipe resulted in urine with lower bacterial abundance that was distinct from the periurethra. Voided urine collected by Peezy may reduce postbladder microbial contribution.

This secondary analysis studied 50 transcripts of women who shared day-to-day experiences of lower urinary tract symptoms (LUTS) and characterized temporal (time-associated) features of living with LUTS. Findings revealed two overarching time-associated themes: The Complexity of LUTS and The Quest for Empowerment over LUTS. Findings suggest that the temporal burden of LUTS is the accumulated impact of symptoms and symptom management on women's daily lives within multiple contexts across the life course. Increasing nurses' knowledge of the temporal context of LUTS may heighten awareness and improve symptom detection and management.

Research into the lower urinary tract (LUT) microbiota has primarily focused on its relationship to LUT symptoms (LUTS), taking snapshots of these communities in individuals with and without LUTS. While certain bacterial taxa have been associated with LUTS, or the lack thereof, the temporal dynamics of this community were largely unknown. Recently, we conducted a longitudinal study and found that vaginal intercourse resulted in a shift in species richness and diversity within the LUT microbiota. This is particularly relevant as frequent vaginal intercourse is a major risk factor for urinary tract infection (UTI) in premenopausal women (Aydin et al. Int Urogynecol J 2015;26:795–804). To further investigate the relationship between vaginal intercourse and LUT microbiota, here we present the results of a 3 week study in which daily urogenital specimens were collected from a female participant and her male sexual partner. Consistent with our previous findings, the LUT microbiota changed after vaginal intercourse, most notably a high abundance of Streptococcus mitis was observed post-coitus. We isolated and sequenced S. mitis from both sexual partners finding that: (i) the S. mitis isolates from the female partner’s urogenital tract were genomically similar throughout the duration of the study, and (ii) they were related to one isolate from the male partner’s oral cavity collected at the end of the study, suggesting transmission between the two individuals. We hypothesize that blooms in S. mitis after vaginal intercourse may play a role in coitus-related UTI. We found that a S. mitis isolate, in contrast to a Lactobacillus jensenii isolate displaced after vaginal intercourse, cannot inhibit the growth of uropathogenic Escherichia coli . Thus, this bloom in S. mitis may provide a window of opportunity for a uropathogen to colonize the LUT.

Research into the lower urinary tract (LUT) microbiota has primarily focused on its relationship to LUT symptoms (LUTS), taking snapshots of these communities in individuals with and without LUTS. While certain bacterial taxa have been associated with LUTS, or the lack thereof, the temporal dynamics of this community were largely unknown. Recently, we conducted a longitudinal study and found that vaginal intercourse resulted in a shift in species richness and diversity within the LUT microbiota. This is particularly relevant as frequent vaginal intercourse is a major risk factor for urinary tract infection (UTI) in premenopausal women (Aydin et al. Int Urogynecol J 2015;26:795–804). To further investigate the relationship between vaginal intercourse and LUT microbiota, here we present the results of a 3 week study in which daily urogenital specimens were collected from a female participant and her male sexual partner. Consistent with our previous findings, the LUT microbiota changed after vaginal intercourse, most notably a high abundance of Streptococcus mitis was observed post-coitus. We isolated and sequenced S. mitis from both sexual partners finding that: (i) the S. mitis isolates from the female partner’s urogenital tract were genomically similar throughout the duration of the study, and (ii) they were related to one isolate from the male partner’s oral cavity collected at the end of the study, suggesting transmission between the two individuals. We hypothesize that blooms in S. mitis after vaginal intercourse may play a role in coitus-related UTI. We found that a S. mitis isolate, in contrast to a Lactobacillus jensenii isolate displaced after vaginal intercourse, cannot inhibit the growth of uropathogenic Escherichia coli . Thus, this bloom in S. mitis may provide a window of opportunity for a uropathogen to colonize the LUT.

Background Bladder health is an understudied state and difficult to measure due to lack of valid and reliable instruments. While condition specific questionnaires assess presence, severity and degree of bother from lower urinary tract symptoms, the absence of symptoms is insufficient to assume bladder health. This study describes the methodology used to validate a novel bladder health instrument to measure the spectrum of bladder health from very healthy to very unhealthy in population based and clinical research. Methods Three samples of women are being recruited: a sample from a nationally representative general population and two locally recruited clinical center samples—women with a targeted range of symptom severity and type, and a postpartum group. The general population sample includes 694 women, 18 years or older, randomly selected from a US Postal delivery sequence file. Participants are randomly assigned to electronic or paper versions of the bladder health instrument along with a battery of criterion questionnaires and a demographic survey; followed by a retest or a two-day voiding symptom diary. A total of 354 women around 7 clinical centers are being recruited across a spectrum of self-reported symptoms and randomized to mode of completion. They complete the two-day voiding symptom diary as well as a one-day frequency volume diary prior to an in-person evaluation with a standardized cough stress test, non-invasive urine flowmetry, chemical urine analysis and post void residual measurement. Independent judge ratings of bladder health are obtained by interview with a qualified health care provider. A total of 154 postpartum women recruited around 6 of the centers are completing similar assessments within 6–12 weeks postpartum. Dimensional validity will be evaluated using factor analysis and principal components analysis with varimax rotation, and internal consistency with Cronbach’s alpha. Criterion validity will be assessed using multitrait-multimethod matrix including correlations across multiple data sources and multiple types of measures. Discussion We aim to validate a bladder health instrument to measure the degree of bladder health within the general population and among women (including postpartum) recruited from local clinical centers. Trial registration NCT04016298 Posted July 11, 2019 (https://www.clinicaltrials.gov/ct2/show/NCT04016298?cond=bladder+health&draw=2&rank=1).

Summary Background Lower urinary tract symptoms (LUTS) are common in children and adolescents. Non-invasive tests evaluating bladder function are generally preferred over invasive tests, yet few studies have explored the range of normative values for these tests in healthy, asymptomatic children. Objective To define normative reference ranges for non-invasive tests of bladder function in healthy, asymptomatic girls and adolescents. Study design A comprehensive search strategy was performed in seven electronic databases through October 2019. English-language studies reporting data on voiding frequency, voided and postvoid residual volumes (PVR) and uroflowmetry results in healthy, asymptomatic girls (mean age ≥ 5 years) were included. Two independent reviewers performed study review, data extraction, and quality assessment. Overall mean estimates and 95% confidence intervals for each bladder function parameter were calculated using random effects models, and 95% normative reference values were estimated. Results Ten studies met eligibility criteria for the meta-analysis (n = 2143 girls, age range: 3–18). Mean estimates of maximum voided volume and PVR were 233.4 ml (95% CI 204.3–262.6; n = 1 study) and 8.6 ml (95% CI 4.8–12.4; n = 2 studies) respectively. Pooled mean estimates for uroflowmetry parameters were: 21.5 ml/s (95% CI 20.5–2.5) for maximum flow rate (n = 6 studies), 12.5 ml/s (95% CI 11.2–13.8) for mean flow rate (n = 6 studies), 6.8 s (95% CI 4.4–9.3) for time to maximum flow (n = 3 studies), 15.7 s (95% CI 13.0–18.5) for flow time (n = 3 studies), and 198.7 ml (95% CI 154.2–234.2) for voided volume (n = 9 studies). No studies reported estimates of voiding frequency. Between-study heterogeneity was high (89.0–99.6%). Conclusions Although we were able to calculate pooled mean estimates for several parameters, the small number of included studies and the wide age ranges of participants preclude generalization of reference values to all healthy girls. Further research is needed to determine normative reference values within specific age groups.

We examined the urethral microbiota, determined if it differs from the bladder urinary microbiota, and assessed if its composition differs based on patient demographic factors and presence of lower urinary tract symptoms.Patients presenting to our urogynecology clinic were enrolled in the study. Demographic information and responses to the Pelvic Floor Distress Inventory questionnaire were collected. All participants provided midstream voided urine, periurethral swab, transurethral swab and catheterized urine samples, which were analyzed by Expanded Quantitative Urine Culture and MALDI-TOF mass spectrometry. Bray-Curtis dissimilarity analysis assessed diversity between sample types for each participant. Kruskal-Wallis, chi-square, McNemar, Wilcoxon signed rank and Fisher's exact tests tested for significance.A total of 49 patients participated in the study. Bladder microbiota were dissimilar to urethral, periurethral and voided urine microbiota (p0.0001). Urethral and periurethral microbiota were similar (p0.05), but the urethral microbiota were dissimilar to voided urine microbiota (p=0.001) while the periurethral microbiota were not (p0.05). Women less than 55 years old were more likely to be sexually active, premenopausal and Hispanic compared to women 55 years old or older. Women in the younger cohort hadNiches of microbiota along the female lower urinary tract may be influenced by age, menopausal status and sexual activity. More research is needed to determine the function and clinical significance of the urethral microbiome.

Prevention strategies have been effective in many areas of human health, yet have not been utilized for lower urinary tract symptoms (LUTS) or bladder health (BH). This commentary outlines LUTS prevention research initiatives underway within the NIH-sponsored Prevention of Lower Urinary Tract Symptoms Research Consortium (PLUS). Prevention science involves the systematic study of factors associated with health and health problems, termed protective and risk factors, respectively. PLUS is enhancing traditional prevention science approaches through use of: (1) a transdisciplinary team science approach, (2) both qualitative and quantitative research methodology (mixed methodology), and (3) community engagement. Important foundational work of PLUS includes development of clear definitions of both BH and disease, as well as a BH measurement instrument that will be validated for use in the general population, adolescents, and Latinx and Spanish-speaking women.1 The BH measurement instrument will be used in an upcoming nationally-representative cohort study that will measure BH and investigate risk and protective factors. PLUS investigators also developed a conceptual framework to guide their research agenda; this framework organizes a broad array of candidate risk and protective factors that can be studied across the life course of girls and women.1 As PLUS begins to fill existing knowledge gaps with new information, its efforts will undoubtedly be complemented by outside investigators to further advance the science of LUTS prevention and BH across additional populations. Once the BH community has broadened its understanding of modifiable risk and protective factors, intervention studies will be necessary to test LUTS prevention strategies and support public health efforts. LUTS providers may be able to translate this evolving evidence for individual patients under their care and act as BH advocates in their local communities.

Females and males differ significantly in gross anatomy and physiology of the lower urinary tract, and these differences are commonly discussed in the medical and scientific literature. However, less attention is dedicated to investigating the varied development, function, and biology between females and males on a cellular level. Recognizing that cell biology is not uniform, especially in the lower urinary tract of females and males, is crucial for providing context and relevance for diverse fields of biomedical investigation. This review serves to characterize the current understanding of biological sex differences between female and male lower urinary tracts, while identifying areas for future research. First, the differences in overall cell populations are discussed in the detrusor smooth muscle, urothelium, and trigone. Second, the urethra is discussed, including anatomic discussions of the female and male urethra followed by discussions of cellular differences in the urothelial and muscular layers. The pelvic floor is then reviewed, followed by an examination of the sex differences in hormonal regulation, the urinary tract microbiome, and the reticuloendothelial system. Understanding the complex and dynamic development, anatomy, and physiology of the lower urinary tract should be contextualized by the sex differences described in this review.

Background The long-term potential of solifenacin and mirabegron combination treatment for patients with overactive bladder (OAB) has not been previously assessed. Objectives To evaluate the safety and efficacy of solifenacin succinate 5mg plus mirabegron 50mg tablets (combination treatment) versus solifenacin or mirabegron monotherapy in patients with OAB over 12 mo. Design, setting, and participants Randomised, double-blind, multicentre, phase 3 trial (SYNERGY II) of patients with "wet" OAB symptoms (urinary frequency and urgency with incontinence) for ≥3 mo. The study was conducted from March 2014 to September 2016; with 1829 patients randomised. The full analysis set was comprised of 1794 patients. Outcome measurements and statistical analysis The primary objective was safety, measured as treatment-emergent adverse events (TEAEs). Efficacy was measured as the change from baseline to the end of treatment in the mean number of incontinence episodes/24h and micturitions/24h. Results and limitations The median age was 60 yr (range 19–86 yr) and 1434 patients (80%) were female. Overall, 856 patients (47%) experienced ≥1 TEAE. TEAE frequency was slightly higher in the combination group (596 patients, 49%; mirabegron 126 patients, 41%; solifenacin 134 patients, 44%). Serious TEAEs were reported by 67 patients (3.7%); one was considered possibly treatment-related (mirabegron group, atrial fibrillation). Dry mouth was the most common TEAE (combination 74 patients, 6.1%; solifenacin 18 patients, 5.9%; mirabegron 12 patients, 3.9%). Combination therapy was statistically superior to mirabegron and solifenacin for the number of incontinence episodes (vs mirabegron: adjusted mean difference [AMD] −0.5, 95% confidence interval [CI] −0.7 to −0.2, p Conclusions Mirabegron and solifenacin combination treatment for OAB symptoms was well tolerated over 12 mo and led to efficacy improvements over each monotherapy. This innovative combination is a treatment option that could become widely used in the clinic. Patient summary This study looked at the safety and efficacy of a combination of solifenacin succinate 5mg plus mirabegron 50mg tablets over 12 mo in patients with the overactive bladder (OAB) symptoms of increased urination frequency, heightened urgency to urinate, and unintentional passing of urine. We compared this treatment with solifenacin succinate 5mg or mirabegron 50mg alone, and found that the combination treatment was well tolerated by patients and led to greater improvements in symptoms. This novel combination could be an improved treatment option in the clinical setting for patients with OAB. This study is registered at ClinicalTrials.gov as NCT02045862.

Women have a 20% risk of developing a urinary tract infection (UTI) following urogynecologic surgery. This study assessed the association of postoperative UTI with bacteria in preoperative samples of catheterized urine. Immediately before surgery, vaginal swabs, perineal swabs, and catheterized urine samples were collected, and the V4 region of the 16S ribosomal RNA (rRNA) gene was sequenced. The cohort was dichotomized in two ways: (1) standard day-of-surgery urine culture result (positive/negative), and (2) occurrence of postoperative UTI (positive/negative). Characteristics of bladder, vaginal, and perineal microbiomes were assessed to identify factors associated with postoperative UTI. Eighty-seven percent of the 104 surgical patients with pelvic organ prolapse/urinary incontinence (POP/UI) were white; mean age was 57 years. The most common genus was Lactobacillus, with a mean relative abundance of 39.91% in catheterized urine, 53.88% in vaginal swabs, and 30.28% in perineal swabs. Two distinct clusters, based on dispersion of catheterized urine (i.e., bladder) microbiomes, had highly significant (p

Objectives The objective of this study was to evaluate patient attendance and preparedness for pelvic floor physical therapy (PFPT) after comparing standard counseling versus standard counseling plus an educational video. Methods A randomized controlled trial of 200 patients in a Female Pelvic Medicine and Reconstructive Surgery practice was performed in a tertiary care referral center. Participants were randomized to 1 of 2 educational modalities after being prescribed PFPT. Women either received standard handout counseling or enhanced video counseling. A sample size of 96 per group (N = 192) was needed to detect a 20% difference in PFPT attendance corresponding to a priori estimates of 50% compliance for the standard counseling group (handout) versus 70% compliance for the enhanced counseling group (handout plus video). Compliance data were assessed at least 3 months after the initial referral to determine attendance at PFPT. Results Sixty-five percent of patients attended at least 1 PFPT visit, whereas 46.5% completed therapy. There was no difference between the standard and enhanced counseling groups in PFPT attendance (P = 0.056) or in completion of half the recommended visits (P = 0.17). Similarly, level of preparedness after viewing the assigned counseling modality did not differ between standard and enhanced counseling groups. For each additional completed visit, the odds of successfully completing PFPT increased by approximately 38% (odds ratio, 1.38; 95% confidence interval, 1.19-1.59). Conclusions The addition of enhanced patient counseling did not improve patient preparedness or odds of attending PFPT. Adherence behaviors surrounding PFPT attendance are multifactorial and require further qualitative research to elucidate barriers to PFPT attendance.

Urinary tract infection (UTI) is clinically important, given that it is one of the most common bacterial infections in adult women. However, the current understanding of UTI remains based on a now disproven concept that the urinary bladder is sterile. Thus, current standards for UTI diagnosis have significant limitations that may reduce the opportunity to improve patient care. Using data from our work and numerous other peer-reviewed studies, we identified four major limitations to the contemporary UTI description: the language of UTI, UTI diagnostic testing, the Escherichia coli-centric view of UTI, and the colony-forming units (CFU) threshold-based diagnosis. Contemporary methods and technology, combined with continued rigorous clinical research can be used to correct these limitations.

Purpose of reviewThe newly discovered female urinary microbiota has the potential to deepen our understanding of urinary tract health and disease, including common lower urinary tract conditions such as urinary incontinence and urinary tract infection. The spectrum of painful bladder disorders and o

OBJECTIVES The objectives of this were to determine the correlation of greater than or equal to 3 red blood cells per high-power field (RBCs/HPF) with a positive urine dipstick for blood and to identify clinically relevant factors than can influence this relationship. METHODS The charts of women with positive blood urine dipsticks were reviewed from August 2012 to August 2013. The cohort of women was divided into 2 groups; those with urine with greater than or equal to 3 RBCs/HPF on microscopy and those without. Relevant clinical and demographic variables were extracted from the electronic medical record. Data analysis was conducted using SAS version 9.4 (SAS Institute, Cary, NC). RESULTS Most of the 203 patients eligible for analysis were Caucasian, and the total cohort had a mean age of approximately 62.8 years. Microscopy confirmed greater than or equal to 3 RBCs/HPF in 25.6% of the urine samples. A dipstick finding of moderate or large blood was significantly more likely to have greater than or equal to 3 RBCs/HPF on univariate and multivariable analyses (P < 0.001). Factors significantly associated with greater than or equal to 3 RBCs/HPF were increasing age, recurrent urinary tract infections, and urinary specific gravity of greater than 1.010. CONCLUSIONS Lower urinary specific gravities appear to be associated with underestimating microhematuria, likely owing to the underrepresentation of the true number of red blood cells. Urine dipstick indicators of moderate or large blood increase the likelihood the microscopy samples demonstrated greater than or equal to 3 RBCs/HPF. These findings suggest that clarification of microhematuria detection and evaluation guidelines should be considered, given both important clinical and economic consequences.