A digital health program for treatment of urinary incontinence: retrospective review of real-world user data.

INTRODUCTION AND HYPOTHESIS: To determine the effectiveness of a prescription digital therapeutic (pDTx) in reducing urinary incontinence (UI) symptoms in real-world users. METHODS: This is a retrospective cohort study of real-world data from users of a pDTx designed to guide pelvic floor muscle training(PFMT) between July 1, 2020-December 31, 2021. The primary outcome was UI symptom change as reported via in-app Urogenital Distress Inventory (UDI-6). Included subjects were female, ≥ 18 years with a diagnosis of stress, urgency, or mixed UI who completed the UDI-6 at baseline and 8 weeks. Demographic, symptom, and adherence data were summarized. Paired t-test and Wilcoxon signed rank test were used to analyze change in outcomes from baseline to 8 weeks across adherence and UI diagnosis groups. RESULTS: Of 532 women with UI, 265 (50%) met criteria and were included in the analysis. Mean age was 51.2 ± 11.5 years (range 22-84, N = 265). Mean body mass index (BMI) was 27.3 ± 6.2 kg/m2 (range 15.2-46.9, N = 147). Most participants had stress UI (59%) followed by mixed UI (22%), urgency UI/OAB (11%), and unspecified UI (8%). UDI-6 scores improved by 13.90 ± 15.53 (p ≤ 0.001); 62% met or exceeded MCID. Device-reported PFMT adherence was 72% at 4 weeks and 66% at 8 weeks (100% = 14 uses/week). Participants in each diagnosis category reported significant improvement on UDI-6 score from baseline to 8 weeks. No association between UDI-6 score improvement and adherence category, age, BMI, or UI subtype was identified. CONCLUSIONS: This study demonstrates effectiveness of a pDTx in reducing UI symptoms in a real-world setting. Users achieved statistically and clinically significant symptom improvement over an 8-week period.

Healthcare resource use and cost burden of urinary incontinence to United States payers.

OBJECTIVE: To assess healthcare resource utilization and costs for female patients diagnosed with stress or mixed urinary incontinence (SUI/MUI) compared to a matched cohort of patients without SUI/MUI. METHODS: We conducted a retrospective matched cohort study of women using the IBM MarketScan research database. Women diagnosed with SUI/MUI between July 1, 2014 and June 30, 2016 were identified using International Classification of Diseases 9 and 10 codes for SUI or MUI with the date of first diagnosis as the index date from which 2-year postindex healthcare resource use and direct cost data were derived from claims, examined, and compared 1:1 with patients without a SUI/MUI diagnosis, matched by age and Charlson's Comorbidity Index. RESULTS: A total of 68 636 women with SUI/MUI were matched 1:1 with controls. In the 2-year postindex date, a significantly higher proportion of SUI/MUI patients had ≥1 inpatient visit and ≥1 outpatient visit compared to the control group (inpatient: 18.89% vs. 12.10%, p < 0.0001; outpatient: 88.44% vs. 73.23%, p < 0.0001). Mean primary care visits were significantly higher in SUI/MUI patients compared to controls (7.33 vs. 5.53; p < 0.0001) as were specialist visits (1.2 vs. 0.08; p < 0.0001). Mean all-cause outpatient costs were higher in SUI/MUI patients compared to controls ($7032.10 vs. $3348.50; p < 0.0001), as were inpatient costs ($3990.70 vs. $2313.70; p < 0.0001). CONCLUSION: Women with SUI/MUI consume significantly higher medical resources and incur higher costs to payers, compared to women without SUI/MUI. While reasons for this are not fully understood, improved and standardized treatment for women with SUI/MUI may positively affect cost and outcomes.

Adherence to professional society guidelines among women with stress or mixed urinary incontinence.

AIMS: The objective of this analysis was to describe longitudinal adherence with recommended urinary incontinence (UI) evaluation and treatment guidelines over a 2-year period in patients newly diagnosed with stress (SUI) or mixed UI (MUI), and average 2-year cost associated with initial treatment. METHODS: A retrospective claims analysis using the IBM MarketScan database was conducted. Women diagnosed with SUI/MUI between July 1, 2014 and June 30, 2016 were identified using the International Classification of Diseases (ICD) 9 and 10 codes for SUI or MUI. Newly diagnosed SUI/MUI patients who did not have a UI-related diagnosis for at least 1 year before their index date were assessed. RESULTS: 103 813 patients with newly diagnosed SUI or MUI were identified. Of those, 96.15% (99 821/103 813) received an initial evaluation in accordance with professional guidelines (e.g., patient history, physical examination, urinalysis). Only 6.8% (5086/74 925) and 7.7% (2229/28 888) of patients with SUI and MUI, respectively, received a first-line behavioral treatment (e.g., pelvic floor muscle exercises, bladder training), according to guidelines. The 2-year average UI-related medical costs associated with guideline adherence for SUI were $5770.93 ± $9454.81 and for MUI, $4416.16 ± $7401.53. Nonadherence was observed in 59.2% (44 382/74 925) of SUI and 64.1% (18 530/28 888) of MUI patients. Two-year average UI-related medical costs for the nonadherent group were $8568.00 ± $11 275.52 for SUI and $6986.66 ± $10 765.55 for MUI, significantly more than the adherent group (p < 0.0001). CONCLUSION: The majority of SUI or MUI patients do not receive a documented behavioral intervention as their first-line treatment, which is a recommendation by professional society guidelines. This was found to affect the cost burden for payers; those that were nonadherent had significantly higher costs 2-year postindex.

Retrospective claims analysis of physical therapy utilization among women with stress or mixed urinary incontinence.

OBJECTIVE: To describe the characteristics of women with stress or mixed urinary incontinence (SUI/MUI) receiving physical therapy (PT) services, including referral patterns and PT utilization. METHODS: Female patients with claims associated with an SUI or MUI diagnosis (International Classification of Disease-Clinical Modification [ICD-9-CM]: 625.6, 788.33, or ICD-10-CM: N39.3, N39.46) between July 01, 2014 and June 30, 2016 were identified in International business machines (IBM)'s MarketScan Research Database. Inclusion criteria included the absence of pregnancy claims and ≥80% medical and pharmacy enrollment pre- and postindex. First SUI/MUI diagnosis claim determined index. Patients were followed for 2 years, and associated UI-associated PT encounters were identified. Descriptive statistics were calculated for patients with at least one PT visit during the postindex period. RESULTS: In a cohort of 103,813 women with incident SUI or MUI diagnosis, 2.6% (2792/103,813) had at least one PT visit in the 2 years following their diagnosis. Mean age at index PT encounter was 50.55 years. A total of 52.36% (1462/2792) women had one to four PT visits; 21.2% (592/2792) had >8 PT visits. In subanalysis of the PT cohort (1345/2792), women who received PT only had the lowest average 2-year postindex total medical cost (mean: $12,671; SD: $16,346), compared with PT plus medications (mean: $27,394; SD: $64,481), and PT plus surgery (mean: $33,656; SD: $26,245), respectively. Over 40% had their first PT visit ≥3 months after their index date. CONCLUSIONS: The percentage of women with a PT visit associated with an incident SUI or MUI diagnosis was low (2.6%), and 30% of this group completed three or more PT visits. This suggests poor adherence to clinical guidelines regarding supervised treatment of UI in women. IMPACT STATEMENT: Our study suggests underutilization of PT among insured women with SUI and MUI in the 2 years following diagnosis. Interventions to improve this gap in first-line care may represent an opportunity for an increased role for PTs in the care of women with UI.

Rectoceles: Is There a Correlation Between Presence of Vaginal Prolapse and Radiographic Findings in Symptomatic Women?

BACKGROUND: Constipation is highly prevalent. Women with constipation are evaluated for the presence of vaginal prolapse that may contribute to obstructed defecation syndrome. Defecography can identify anatomic causes of obstructed defecation syndrome (rectocele, intussusception, and enterocele). OBJECTIVE: This study aimed to assess the characteristics of women with obstructed defecation syndrome and radiographic rectoceles with and without posterior vaginal wall prolapse and to characterize the relationship between anatomical abnormalities and dysfunction. DESIGN: This is a retrospective case-control study of women with obstructed defecation syndrome who had radiographic rectoceles on defecography. SETTINGS: Women who presented to a Pelvic Floor Disorders Center were included. PATIENTS: Cases were defined as constipated women with radiographic rectoceles and at least stage II posterior vaginal wall prolapse on examination. Controls were patients with radiographic rectoceles but without posterior vaginal wall prolapse on examination. MAIN OUTCOME MEASURES: Patient characteristics, anorectal testing results, and validated questionnaires were compared between groups. RESULTS: A total of 106 women met inclusion criteria. Women with posterior vaginal wall prolapse (48 (45.3%)) had larger rectoceles on defecography than women without it on examination (3.4 cm vs 3.0 cm, p < 0.01). Women with posterior vaginal wall prolapse on examination were more likely to splint during defecation than women without vaginal wall prolapse (63.8% vs 27.3%, p < 0.01). All other defecatory symptoms, anorectal manometry parameters, and questionnaire responses were similar between groups. LIMITATIONS: This study was limited by its retrospective study design. Our data were taken from a single institution within a center specializing in the treatment of pelvic floor disorders, potentially limiting generalizability. CONCLUSIONS: Patients with constipation, radiographic rectoceles, and vaginal prolapse may differ from those without evidence of prolapse. Patients with vaginal prolapse were more likely to splint to aide evacuation and demonstrated larger rectoceles on defecography. Further studies are needed to determine whether constipation causes progression along this continuum or whether progression of prolapse is a cause of worsening defecatory dysfunction. See Video Abstract at http://links.lww.com/DCR/B626. RECTOCELES EXISTE UNA CORRELACIN ENTRE LA PRESENCIA DE PROLAPSO VAGINAL Y LOS HALLAZGOS RADIOLGICOS EN MUJERES SINTOMTICAS: ANTECEDENTES:El estreñimiento es una enfermedad muy prevalente. Las mujeres con estreñimiento se evalúan para detectar la presencia de prolapso vaginal que pueda contribuir al síndrome de defecación obstructiva. La defecografía puede identificar las causas anatómicas del síndrome de defecación obstructiva (rectocele, invaginación intestinal (intususcepción) y enterocele).OBJETIVO:Este estudio tiene como objetivo evaluar las características de las mujeres con síndrome de defecación obstructiva y la presencia de rectocele como hallazgo radiológico, con y sin prolapso de la pared vaginal posterior, y caracterizar la relación entre las anomalías anatómicas y la presencia de disfunción.DISEÑO:Este es un estudio retrospectivo de casos y controles, de mujeres con síndrome de defecación obstructiva, que tenían rectocele como hallazgo radiológico en una defecografía.MARCO:Mujeres que acudieron a un Centro de Trastornos del Piso Pélvico.PACIENTES:Los casos fueron definidos como mujeres con estreñimiento con hallazgos radiológicos de rectocele, con al menos un prolapso estadio II de la pared vaginal posterio, en el examen físico. Los controles fueron pacientes con solo rectocele por hallazgos radiológicos, sin prolapso de la pared vaginal posterior en el examen físico.PRINCIPALES MEDIDAS DE RESULTADO:Se compararon entre los grupos: las características de las pacientes, los resultados de las pruebas diagnósticas anorrectales y los cuestionarios validados.RESULTADOS:Un total de 106 mujeres cumplieron los criterios de inclusión. Las mujeres con prolapso de la pared vaginal posterior 48 (45,3%) tenían rectoceles de mayor tamaño en la defecografía en comparación con las mujeres sin rectocele en el examen físico (3,4 cm versus 3,0 cm, p <0,01). Las mujeres con prolapso de la pared vaginal posterior en el examen, tenían una mayor probabilidad de que les fuera necesario ejercer una maniobra de presión manual o digital del periné durante la defecación, comparado con las mujeres sin rectocele clínico (63,8% versus 27,3%, p <0,01). Todos los demás síntomas defecatorios, los parámetros de la manometría anorrectal, y las respuestas al cuestionario fueron similares entre los grupos.LIMITACIONES:Estudio retrospectivo. Los datos fueron obtenidos de la base de datos de un centro especializado en el tratamiento de los trastornos del piso pélvico lo que potencialmente limita generalizar.CONCLUSIONES:Las pacientes con estreñimiento, rectocele como hallazgo radiológico, y prolapso vaginal pueden ser diferentes de aquellas sin evidencia de prolapso. Las pacientes con prolapso vaginal, tenían una mayor probabilidad de que les fuera necesario ejercer maniobras manuales o digitales de presión a nivel del periné para ayudar a la evacuación, y tenían rectoceles de mayor tamaño en la defecografía. Se necesitan más estudios para determinar si el estreñimiento causa que el rectocele aumente progresivamente de tamaño, empeorando la disfunción defecatoria. Consulte Video Resumen en http://links.lww.com/DCR/B626.

Female Urinary Incontinence Evidence-Based Treatment Pathway: An Infographic for Shared Decision-Making.

Objectives: Urinary incontinence (UI) is a highly prevalent burdensome condition among adult females in the United States, yet rates of care-seeking, evaluation, and treatment are nonoptimal. Components of evaluation and treatment are informed by research and professional society guidelines; however, a visual representation of this guidance does not exist. The objectives of this study are to review the literature regarding female UI care and to synthesize this information into a graphical format to facilitate health education, health care delivery, and shared decision-making. Methods: We reviewed published society guidelines, position statements, and associated references from the American College of Obstetrics and Gynecology, the Women's Preventive Services Initiative, American Academy of Family Physicians, American College of Physicians, the Society of Urodynamics and Female Urology, the American Urological Association, and the American Urogynecologic Society, and searched PubMed for related literature. We synthesized these findings into an evidence-based infographic depicting female UI risk factors, influences on care-seeking and provision, screening, evaluation, and a stepwise treatment approach. Results: This study summarizes current evidence and professional guidelines related to female UI into a compelling visual format and accompanying narrative. The infographic is intended as a tool for patient education, clinical practice, and research to facilitate shared decision-making and health care delivery. Conclusions: Female UI is highly prevalent, yet diagnosis and treatment are suboptimal. Use of an evidence-based infographic may positively impact patient knowledge and certainty about UI treatment and support health care provider counseling and decision-making.

Use of a motion-based digital therapeutic in women with fecal incontinence: A pilot study.

AIMS: There is limited data addressing the value of vaginal biofeedback (VBF) on fecal incontinence (FI) symptoms. The objective of this pilot study was to evaluate whether use of a motion-based VBF device and app was effective for at-home treatment of women with FI. We hypothesized that VBF would result in improvement in FI symptoms. METHODS: A single-arm 10-week prospective pilot trial in women with FI was conducted using the VBF device. The primary outcome was change in St. Mark's score from baseline to week 10. Secondary outcomes included change in 2-week bowel diary and FI quality of life (FIQoL). Statistical analysis included paired t test and Wilcoxon's signed-rank test. RESULTS: Of 29 enrolled women, 27 had data available for analysis. Mean (±SD) age was 60.9 (±14.4). 63% (17) subjects were White, 33% (9) were Black. Mean St. Mark's score was 14.6 (±4.4) at baseline and 11.6 (±5.1) at 10-weeks (p = 0.005). Changes in the total FIQol, and three of four subsets of the FIQoL scores were also significantly improved (p < 0.001). Bowel diary showed decrease in FI episodes, baseline 8.4 (±8.73) to 10 weeks 4.8 (±3.79), (p = 0.052). CONCLUSIONS: In this pilot study, there was significant improvement in FI symptom-specific severity and quality of life using a vaginal, motion-based device for biofeedback. A larger study is needed to better understand the value of this device, which may be useful for women who prefer a vaginal device, which can be utilized at home compared with standard anal biofeedback for treatment of FI in the clinical setting.

Randomized trial comparing efficacy of pelvic floor muscle training with a digital therapeutic motion-based device to standard pelvic floor exercises for treatment of stress urinary incontinence (SUV trial): An all-virtual trial design.

OBJECTIVE: To compare the efficacy of an Intravaginal Motion-Based Digital Health System (PDHS) compared to standardized Pelvic Floor Muscle Training (PFMT) for the treatment of stress or stress-predominant urinary incontinence (SUI). METHODS: This is a virtually conducted prospective randomized controlled trial. The primary outcomes are change in urinary incontinence episodes by 3-day bladder diary and change in Urogenital Distress Inventory-6 score, measured at 8 weeks. Secondary outcomes include: Patient Global Impression of Severity (PGI-S), PGI-Improvement (PGI-I), Pelvic Floor Distress Inventory-20(PFDI-20), Pelvic Floor Impact Questionnaire-7(PFIQ-7), Pelvic Organ Prolapse-Urinary Incontinence Sexual Function Questionnaire (PISQ-IR), Short Form-2 (SF-20), and assessment of adverse event (AE). Subjects are randomized 1:1 to an intervention group using leva PDHS for PFMT or a control group, using a home Kegel exercise program. Sample size needed to identify a 60% difference in incontinence episodes from baseline to 8 weeks post-randomization using alpha = 0.05, and a power of 0.8 is 156 subjects. To identify a 30% difference in the UDI-6 score from Baseline to Week 8 (alpha = 0.05, power = 0.8, using a one-tailed t-test) the needed sample size is 278, and allowing for an attrition rate of 15%, will require approximately 350 subjects, providing power to detect differences in both primary outcomes. RESULTS: Recruitment was initiated September 2020 and is on target to date. The trial is projected to be complete in 2021and is registered at clinicaltrials.govNCT04508153. CONCLUSION: This novel virtual recruitment approach may provide more efficient recruitment of large numbers of subjects and provide input into the use of app-based management of pelvic floor interventions.

Development of a wireless accelerometer-based Intravaginal device to detect pelvic floor motion for evaluation of pelvic floor dysfunction.

Urinary incontinence (UI) is experienced by an estimated 51% of women in the U.S. and often results from impaired function or weakening of the pelvic floor muscles. Pelvic floor muscle training (PFMT) is a frontline nonsurgical treatment, yet a number of symptomatic individuals cannot accurately perform a pelvic floor muscle contraction with simple verbal or written instruction. Long-term adherence to PFMT regimens is often a barrier to resolution of symptoms. Various biofeedback tools have been utilized to aid correct pelvic floor muscle performance and adherence. One novel device, the leva® Pelvic Digital Health System, utilizes an intravaginal probe embedded with MEMS accelerometer sensors that allow real-time visualization of the shape and motion of the vagina during PFMT. Early positive results with this device prompted design of a wearable version. The purpose of this study was to design a wearable, wireless clinical research device to optimize MEMS accelerometer sensor placement to detect maximal movement during a pelvic floor muscle exercise (PFME) and to test the form factor for retention and user acceptability. The device comprised a ring designed to sit at the fornix with an extension following the length of the vagina. This paper presents design components and results from clinical testing of 10 subjects. It was determined that a ring form factor alone, similar to other vaginal rings (pessaries, estrogen rings) provided less accurate visual information about PFME performance. By contrast, we determined that a ring with an extension allowed for device retention and improved real-time detection of vaginal shape and motion during PFMT.

Evaluation of an accelerometer-based digital health system for the treatment of female urinary incontinence: A pilot study.

AIMS: To assess the effectiveness and patient satisfaction of pelvic floor muscle training (PFMT) guided by an intravaginal accelerometer-based system for the treatment of female urinary incontinence (UI). METHODS: Premenopausal women with mild-to-moderate stress or mixed UI were recruited to participate in PFMT with an accelerometer-based system for 6 weeks with supervision. Objective outcomes included pelvic floor muscle (PFM) contraction duration, number of contractions in 15 seconds, and angular displacement of the accelerometer relative to earth during PFM contraction. Subjective outcomes and quality-of-life were assessed with validated, condition-specific questionnaires. Results are presented as means, standard error of the mean, and 95% confidence intervals unless otherwise indicated. RESULTS: Twenty-three women (age 42.0 ± 10.7 years, mean ± standard deviation) completed the study. Scores on the Urogenital Distress Inventory (UDI) decreased from 36.7 ± 4.7 at baseline to 1.45 ± 0.8 at 6 weeks (P < .0001). The Patient's Global Impression of Severity score decreased from 1.5 ± 0.1 to 0.2 ± 0.1 (P < .0001) at study endpoint. At 6 weeks, the PFM contraction duration increased from 13 ± 2.6 at baseline to 187 ± 9.6 seconds (P < .0001). Repeated contractions in 15 seconds increased from 5.9 ± 0.4 at enrollment to 9.6 ± 0.5 at 6 weeks (P < .0001). Maximum pelvic floor angle (a measure of lift) increased from 65.1 ± 2.0° to 81.1 ± 1.8° (P < .0001). Increasing PFM contraction duration and maximum pelvic floor angle correlated with decreasing UDI-6 scores, r = -0.87, P = .01; r = -0.97, P = .0003, respectively. No device-related adverse events occurred. CONCLUSIONS: Pilot testing of this accelerometer-based system demonstrates improvements in objective PFM measures, patient-reported UI severity and condition-specific quality of life, with results evident after 1 week of use.

So Tired: Predictive Utility of Baseline Sleep Screening in a Longitudinal Observational Survey Cohort of First-Year Residents.

BACKGROUND: Sleep impairment is highly prevalent among resident physicians and is associated with both adverse patient outcomes and poor resident mental and physical health. Risk factors for sleep problems during residency are less clear, and no screening model exists to identify residents at risk for sleep impairment. OBJECTIVE: The objective of this study was to assess change in resident sleep during training and to evaluate utility of baseline sleep screening in predicting future sleep impairment. DESIGN: This is a prospective observational repeated-measures survey study. PARTICIPANTS: The participants comprised PGY-1 residents across multiple specialties at Partners HealthCare hospitals. MAIN MEASURES: Main measures used for this study were demographic queries and two validated scales: the Pittsburgh Sleep Quality Index (PSQI), measuring sleep quality, and the Epworth Sleepiness Scale (ESS), measuring excessive daytime sleepiness. KEY RESULTS: Two hundred eighty-one PGY-1 residents completed surveys at residency orientation, and 153 (54%) completed matched surveys 9 months later. Mean nightly sleep time decreased from 7.6 to 6.5 hours (p < 0.001). Mean PSQI score increased from 3.6 to 5.2 (p < 0.001), and mean ESS score increased from 7.2 to 10.4 (p < 0.001). The proportion of residents exceeding the scales' clinical cutoffs increased over time from 15 to 40% on the PSQI (p < 0.001) and from 26 to 59% on the ESS (p < 0.001). Baseline normal sleep was not protective: 68% of residents with normal scores on both scales at baseline exceeded the clinical cutoff on at least one scale at follow-up. Greater age and fewer children increased follow-up PSQI score (p < 0.001) but not ESS score. CONCLUSIONS: During PGY-1 training, residents experience worsening sleep duration, quality of sleep, and daytime sleepiness. Residents with baseline impaired sleep tend to remain impaired. Moreover, many residents with baseline normal sleep experience sleep deterioration over time. Sleep screening at residency orientation may identify some, but not all, residents who will experience sleep impairment during training.

Hormone Modulation of Toll-Like Receptor 5 in Cultured Human Bladder Epithelial Cells.

AIM: The effect of hormone levels on the stimulation of Toll-like receptor 5 (TLR5) in the bladder is unknown. We aimed to study the effect of estradiol and progesterone on TLR5 expression and function in human bladder epithelial cells. METHODS: After growing to near confluence, T24 human urinary bladder (HUB) cells were incubated in hormone-free (HF) media for 72 hours. Human urinary bladder cells were then incubated in (1) HF media, (2) estradiol media, (3) progesterone media, or (4) media containing estradiol and progesterone at physiologic concentrations. Following flagellin exposure, cells and media were collected. Toll-like receptor 5 expression and stimulated cytokine release were analyzed using enzyme-linked immunosorbent assays. Results were normalized with cellular protein assays. A TLR5 antagonist was used to confirm that stimulation from flagellin was mediated by TLR5 signaling. RESULTS: Cultured HUB cells express TLR5 protein. Estradiol and progesterone environments suppress TLR5 expression compared to HF environment. The function of TLR5 was measured by interleukin 6 (IL-6) and monocyte chemoattractant protein 1 production after flagellin exposure. Interleukin 6 production was 75% higher in the estradiol than progesterone environment. The progesterone environment produced IL-6 levels twice that observed in HF and combined estrogen-progesterone environments. Interestingly, higher TLR5 expression was associated with lower IL-6 production. CONCLUSION: Our study demonstrated that TLR5 expression and functional activity as measured by IL-6 are modulated by hormones. The increase in TLR5-associated IL-6 may play a role in increasing the rate of symptomatic urinary tract infection. Likewise, low TLR5 functional activity may dampen the response of the innate immune system, thereby lessening the likelihood of a symptomatic bladder infection.

Differences in Patterns of Preoperative Assessment Between High, Intermediate, and Low Volume Surgeons When Performing Hysterectomy for Uterovaginal Prolapse.

OBJECTIVE: The aim of the study was to determine whether surgeon case volume is associated with preoperative evaluation of pelvic organ prolapse before a hysterectomy for uterovaginal prolapse including a complete objective evaluation of prolapse (Baden-Walker or Pelvic Organ Prolapse Quantification), an offer of nonsurgical options for therapy (pessary), and a preoperative assessment of urinary incontinence METHODS: We performed a multicenter retrospective review of hysterectomies done for uterovaginal prolapse at 4 hospital systems between January 1, 2008 and December 31, 2011. The number of hysterectomies per surgeon for 4 years was evaluated to establish low-volume (≤10 cases), intermediate-volume (11-49 cases), and high-volume (≥50 cases) groups. Rates of preoperative standardized prolapse evaluations, offer of pessary, and evaluation of stress urinary incontinence were determined by chart review of 15% of the hysterectomy cases. Adjustment was made in a logistic regression model for age, race, insurance status, and prolapse size. RESULTS: Three hundred one surgeons performed 4238 hysterectomies for prolapse during the study period. Rates of preoperative assessment by standardized pelvic examination differed between high-, intermediate-, and low-volume surgeons (91.2% vs. 61.3% vs. 48.8%, respectively), as did offer of a pessary (86.5% vs. 71.9% vs. 69.9%, respectively) and preoperative stress test for urinary incontinence (93.5% vs. 72.8% vs. 63.5%, respectively). Regression analysis revealed that high-volume surgeons were more likely than intermediate- or low-volume surgeons to perform a standardized pelvic examination, offer a pessary, or perform preoperative evaluation for urinary incontinence. CONCLUSIONS: High-volume surgeons were more likely than low-volume surgeons to perform a standardized preoperative pelvic examination, offer a pessary, and evaluate stress urinary incontinence.

Clinical application of IUGA/ICS classification system for mesh erosion.

AIMS: Our aim was to assess the usability of the IUGA/ICS classification system for mesh erosion in a tertiary clinical practice and to determine if assigned classification is associated with patient symptoms, treatment, and outcome. METHODS: We retrospectively identified women who had mesh erosion after prolapse or incontinence surgery. Each erosion was classified using the IUGA/ICS category time site (CTS) system. Associations between classification and presenting symptom (asymptomatic, pain, bleeding, voiding, or defecatory dysfunction, infection, prolapse), treatment type, and outcome were evaluated with chi-squared test, student's t-test, and univariate logistic regression. RESULTS: We identified 74 subjects with mesh erosion; only 70% were classifiable. Asymptomatic patients (n = 19) (Category A) were more likely to be managed conservatively (P = 0.001). Symptomatic patients (n = 55) (Category B) were more likely to be managed surgically (P = 0.003). Other variables had no association with treatment. No variables were associated with outcome. Presenting symptom was associated with both treatment (P = 0.005) and outcome (P = 0.03). Asymptomatic subjects were more likely to have satisfactory outcome (P = 0.03). Urinary frequency and urgency were highly correlated with surgical management (P = 0.02). CONCLUSIONS: One third of mesh erosions could not be retrospectively coded using the IUGA/ICS classification. The components of the system were not predictive of treatment nor outcome with exception of the Category A (asymptomatic) and Category B (symptomatic). Asymptomatic women with mesh erosion can be successfully managed with conservative measures. Use of a classification system may be enhanced if the system is simplified by limiting the number of variables to those associated with interventions and patient outcome. Neurourol. Urodynam. 35:589-594, 2016. © 2015 Wiley Periodicals, Inc.

Effect of Coexisting Pelvic Floor Disorders on Fecal Incontinence Quality of Life Scores: A Prospective, Survey-Based Study.

BACKGROUND: The association between an objective measure of fecal incontinence severity and patient-reported quality of life is poorly understood. OBJECTIVE: The purpose of this study was to evaluate patients with various degrees of fecal incontinence to determine whether their quality of life as measured by the Fecal Incontinence Quality of Life Scale is affected by coexisting pelvic floor disorders. DESIGN: This was a prospective, survey-based study. SETTINGS: The study was conducted at a tertiary pelvic floor disorders center. PATIENTS: Included patients were all of those presenting between January 2007 and March 2014. MAIN OUTCOME MEASURES: Survey data were analyzed to determine the association between Fecal Incontinence Severity Index and Fecal Incontinence Quality of Life Scale, as well as scores from the Constipation Severity Instrument, Pelvic Floor Impact Questionnaire, Pelvic Organ Distress Inventory, and Urinary Distress Inventory. RESULTS: A total of 585 patients reported fecal incontinence ranging from none (n = 191) to mild/moderate (n = 159) to severe (n = 235). As expected, patients with severe fecal incontinence have worse scores on all fecal incontinence quality-of-life subscales (lifestyle, coping/behavior, depression/self-perception, and embarrassment) and worse colorectal/anal symptoms than those with mild/moderate or no fecal incontinence (p < 0.0001). Patients with severe fecal incontinence also have worse bladder/urinary symptoms (p ≤ 0.0001). Pelvic organ prolapse and constipation symptoms were similar between groups (p ≥ 0.61). After correcting for baseline differences in patient comorbidities and bladder/urinary symptoms, a significant association persisted between Fecal Incontinence Severity Index and all of the subscales of the fecal incontinence quality-of-life instrument (p < 0.0001). However, urinary distress scores also remained significantly associated with all of the fecal incontinence quality-of-life subscales except for embarrassment after risk adjustment (p < 0.01). LIMITATIONS: Nongeneral population and a lack of patient data on previous medical management of fecal incontinence were limitations of this study. CONCLUSIONS: The Fecal Incontinence Quality of Life Scale correlates strongly with instruments measuring both fecal and urinary incontinence. This underscores the importance of quantifying the presence or absence of coexistent urinary leakage in studies where a drop in fecal incontinence quality of life is considered a primary end point.

Minimally invasive apical sacropexy: a retrospective review of laparoscopic and robotic operating room experiences.

OBJECTIVES: Minimally invasive apical sacropexies (MI-APSC) can be performed using robotics or laparoscopy. We hypothesized that operative characteristics of MI-APSC, laparoscopic (LSC) and robotic (RSC), were similar. The objective of our study was to compare operative characteristics, objective prolapse outcomes, and robotic learning curve. METHODS: Ninety-two women planning MI-APSC for treatment of apical pelvic organ prolapse from 2006 to 2010 were included in the study. The primary outcome was operative time. The secondary outcomes included estimated blood loss, rate of conversion, intraoperative complications, hospital stay, and objective prolapse outcome. We also analyzed the robotic learning curve. Statistical analysis included independent samples t test, Wilcoxon rank sum test, χ, and multiple logistic regressions; significance was set at P < 0.05. Learning curve was graphed with moving average and analyzed with moving block technique. RESULTS: Forty-eight RSCs and 43 LSCs were analyzed. Mean operative times were LSC, 238 ± 59 minutes; and RSC, 242 ± 54 minutes. Robotic MI-APSC setup was longer (P = 0.02). Complications, conversions, estimated blood loss and hospital stay were low and similar between groups. Patients' characteristics were similar. Concomitant procedures produced longer operative times. CONCLUSIONS: Operating room experiences with laparoscopic- and robotic-assisted approaches to MI-APSC were similar, but setup time is longer for the robotic-assisted approach. The robotic learning curve is short for surgeons who have experience with LSC.

Baseline sleep dysfunction among matriculating interns.

BACKGROUND: Work hour limitations for graduate medical trainees, motivated by concerns about patient safety, quality of care, and trainee well-being, continue to generate controversy. Little information about sleep habits and the prevalence of sleep disorders among residents is available to inform policy in this area. OBJECTIVES: To evaluate the sleep habits of matriculating residents, postgraduate year-1 (PGY-1). DESIGN: An anonymous, voluntary, self-administered survey study was used with 3 validated questionnaires: the Pittsburgh Sleep Quality Index, the Insomnia Severity Index, and the Epworth Sleepiness Scale, which were fielded to PGY-1 residents entering the Accreditation Council for Graduate Medical Education-accredited programs at Massachusetts General Hospital and/or Brigham and Women's Hospitals in June and July 2009. RESULTS: Of 355 eligible subjects, 310 (87%) participated. Mean sleep time for PGY-1 residents was 7 hours and 34 minutes, and 5.6% of PGY-1 residents had Pittsburgh Sleep Quality Index global scores greater than 5, indicating poor quality sleep. Using multiple linear and ordinal logistic regression models, men had higher Pittsburgh Sleep Quality Index sleep latency scores, whereas women and those with children had higher Epworth Sleepiness Scale daytime sleepiness scores, and 18% of PGY-1 residents had abnormal amounts of daytime sleepiness based on the Epworth Sleepiness Scale. The Insomnia Severity Index identified 4.2% of PGY-1 residents with moderate insomnia. CONCLUSIONS: Some PGY-1 residents may begin residency with sleep dysfunctions. Efforts to provide targeted help to selected trainees in managing fatigue during residency should be investigated.

Hysterectomies and Urologic Symptoms: Results from the Boston Area Community Health (BACH) Survey.

OBJECTIVES: To describe the characteristics of women who have had a hysterectomy and to assess the association of a past hysterectomy on current urologic symptoms. METHODS: The Boston Area Community Health (BACH) survey is a random sample of Boston, Massachusetts residents aged 30-79 years using a stratified two-stage cluster design (3202 women; 1067 Black, 1111 Hispanic, 1024 White). Urologic symptoms, hysterectomy, co-morbidities, lifestyle factors, and medical indications for a hysterectomy were by self-report. Socioeconomic status was measured as a combination of education and income. RESULTS: Hysterectomies were reported by 587 women and 1782 women reported one or more urologic symptoms. Minorities and those of lower socioeconomic status are more likely to have had a hysterectomy, even after adjusting for age and potential medical indications for a hysterectomy. Hispanic women were least likely to report fibroids, polycystic ovarian syndrome, or genitourinary cancers, but they were more likely to have had a hysterectomy if they reported these conditions than Black or White women. Women with a hysterectomy were more likely to report lower urinary tract symptoms, painful bladder syndrome, urinary frequency, urgency, and overactive bladder after adjusting for age, race/ethnicity, socioeconomic status, body mass index, depression, diabetes, heart disease, hypertension, smoking history, alcohol use, and physical activity. CONCLUSIONS: Minorities and those of lower socioeconomic status are more likely to report having a hysterectomy and urologic symptoms (including painful bladder syndrome) may be an unintended consequence of a hysterectomy.