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.

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.

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.

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.

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.

Development of a core set of outcome measures for OAB treatment.

INTRODUCTION AND HYPOTHESIS: Standardized measures enable the comparison of outcomes across providers and treatments giving valuable information for improving care quality and efficacy. The aim of this project was to define a minimum standard set of outcome measures and case-mix factors for evaluating the care of patients with overactive bladder (OAB). METHODS: The International Consortium for Health Outcomes Measurement (ICHOM) convened an international working group (WG) of leading clinicians and patients to engage in a structured method for developing a core outcome set. Consensus was determined by a modified Delphi process, and discussions were supported by both literature review and patient input. RESULTS: The standard set measures outcomes of care for adults seeking treatment for OAB, excluding residents of long-term care facilities. The WG focused on treatment outcomes identified as most important key outcome domains to patients: symptom burden and bother, physical functioning, emotional health, impact of symptoms and treatment on quality of life, and success of treatment. Demographic information and case-mix factors that may affect these outcomes were also included. CONCLUSIONS: The standardized outcome set for evaluating clinical care is appropriate for use by all health providers caring for patients with OAB, regardless of specialty or geographic location, and provides key data for quality improvement activities and research.

Impact of Rising Grades of Internal Rectal Intussusception on Fecal Continence and Symptoms of Constipation.

BACKGROUND: A theory of rectal intussusception has been advanced that intrarectal intussusception, intra-anal intussusception, and external rectal prolapse are points on a continuum and are a cause of fecal incontinence and constipation. OBJECTIVE: This study evaluates the association among rectal intussusception, constipation, fecal incontinence, and anorectal manometry. DESIGN: Patients undergoing defecography were studied from a prospectively maintained database and classified according to the Oxford Rectal Prolapse Grade as normal or having intra-rectal, intra-anal, or external intussusception. Patient symptoms were assessed using the Constipation Severity Index and the Fecal Incontinence Severity Index. Quality-of-life surveys were also used. Patients also underwent anorectal manometry. SETTINGS: The study was conducted at a tertiary care university medical center (Massachusetts General Hospital). PATIENTS: The study included 147 consecutive patients undergoing evaluation for evacuatory dysfunction and involved defecography, symptoms questionnaires, and anorectal physiology testing from January 2011 to December 2013. MAIN OUTCOME MEASURES: Symptom severity and quality-of-life scores were measured, as well as anal manometry results. RESULTS: Increasing Oxford grade was associated with an increase in severity of fecal incontinence (median score: normal = 23.9, intrarectal = 21.0, intra-anal = 30.0, external prolapse = 35.3; ß = 4.71; p = 0.009), which persisted in a multivariable model including age (ß = 2.13; p = 0.03), and decreased sphincter pressures (median mean resting pressure: normal = 75.4, intra-rectal = 69.7, intra-anal = 64.3, external prolapse = 48.3; ß = -8.57; p = 0.003), which did not persist in a multivariable model. Constipation severity did not increase with rising intussusception (mean score: normal = 37.4, intrarectal = 35.0, intra-anal = 41.4, external prolapse = 32.9; p = 0.79), and balloon expulsion improved rather than worsened (normal = 47.1%, intrarectal = 60.5%, intra-anal = 82.9%, external prolapse = 93.1%; p < 0.001). LIMITATIONS: The study was limited because it was an observational study from a single center. CONCLUSIONS: Increasing grades of rectal intussusception are associated with increasing fecal incontinence but not constipation.

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.

Real-World Evidence From a Digital Health Treatment Program for Female Urinary Incontinence: Observational Study of Outcomes Following User-Centered Product Design.

BACKGROUND: Urinary incontinence (UI) affects millions of women with substantial health and quality-of-life impacts. Supervised pelvic floor muscle training (PFMT) is the recommended first-line treatment. However, multiple individual and institutional barriers impede women's access to skilled care. Evidence suggests that digital health solutions are acceptable and may be effective in delivering first-line incontinence treatment, although these technologies have not yet been leveraged at scale. OBJECTIVE: The primary objective is to describe the effectiveness and safety of a prescribed digital health treatment program to guide PFMT for UI treatment among real-world users. The secondary objectives are to evaluate patient engagement following an updated user platform and identify the factors predictive of success. METHODS: This retrospective cohort study of women who initiated device use between January 1, 2022, and June 30, 2023, included users aged ≥18 years old with a diagnosis of stress, urgency, or mixed incontinence or a score of >33.3 points on the Urogenital Distress Inventory Short Form (UDI-6). Users are prescribed a 2.5-minute, twice-daily, training program guided by an intravaginal, motion-based device that pairs with a smartphone app. Data collected by the device or app include patient-reported demographics and outcomes, adherence to the twice-daily regimen, and pelvic floor muscle performance parameters, including angle change and hold time. Symptom improvement was assessed by the UDI-6 score change from baseline to the most recent score using paired 2-tailed t tests. Factors associated with meeting the UDI-6 minimum clinically important difference were evaluated by regression analysis. RESULTS: Of 1419 users, 947 met inclusion criteria and provided data for analysis. The mean baseline UDI-6 score was 46.8 (SD 19.3), and the mean UDI-6 score change was 11.3 (SD 19.9; P<.001). Improvement was reported by 74% (697/947) and was similar across age, BMI, and incontinence subtype. Mean adherence was 89% (mean 12.5, SD 2.1 of 14 possible weekly uses) over 12 weeks. Those who used the device ≥10 times per week were more likely to achieve symptom improvement. In multivariate logistic regression analysis, baseline incontinence symptom severity and maximum angle change during pelvic floor muscle contraction were significantly associated with meeting the UDI-6 minimum clinically important difference. Age, BMI, and UI subtype were not associated. CONCLUSIONS: This study provides real-world evidence to support the effectiveness and safety of a prescribed digital health treatment program for female UI. A digital PFMT program completed with visual guidance from a motion-based device yields significant results when executed ≥10 times per week over a period of 12 weeks. The program demonstrates high user engagement, with 92.9% (880/947) of users adhering to the prescribed training regimen. First-line incontinence treatment, when implemented using this digital program, leads to statistically and clinically substantial symptom improvements across age and BMI categories and incontinence subtypes.

Low back pain does not improve with surgical treatment of pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: Our goal was to determine if there is a correlation between low back pain (LBP) and pelvic organ prolapse (POP) by assessing for change in LBP after surgical correction of prolapse. METHODS: Patients undergoing POP surgery were recruited to participate. They completed the Oswestry Disability Index (ODI), a validated back pain questionnaire, at their preoperative and postoperative visits at 1, 3, and 6 months. A higher ODI score (0-100) represents more severe disability. A 9-point change represents a minimal clinically important difference (MCID). The primary outcome was the change in ODI scores from preoperative to 3 months postoperative. We analyzed ODI scores with repeated measures analysis of variance (ANOVA). Power analysis showed that a sample size of 50 was needed for 88 % power to resolve a MCID on ODI. RESULTS: A total of 51 patients were recruited and 43 (84 %), 34 (67 %), and 36 (71 %) completed the 1-, 3-, and 6-month follow-up, respectively. The mean ODI scores at the preoperative and the 1-, 3-, and 6-month postoperative visits were 15, 19, 9, and 9. The mean ODI score from preoperative to 3 months postoperative improved by 5 points [confidence interval (CI) -9.2 to -0.5, p = 0.03]. Of the participants 7 (20.6 %, CI 11-35 %) experienced a MCID improvement, 24 (70.6 %, CI 56-83 %) reported no substantial change, and 3 (8.8 %, CI 3-20 %) experienced a MCID worsening. CONCLUSIONS: Our study found a statistically significant but not clinically significant improvement of LBP after surgical repair of prolapse.

Performance of Perioperative Tasks for Women Undergoing Anti-incontinence Surgery: Developed by the AUGS Quality Improvement and Outcomes Research Network.

OBJECTIVES: Surgery for the correction of stress urinary incontinence is an elective procedure that can have a dramatic and positive impact on quality of life. Anti-incontinence procedures, like inguinal hernia repairs or cholecystectomies, can be classified as high-volume/low-morbidity procedures. The performance of a standard set of perioperative tasks has been suggested as one way to optimize quality of care in elective high-volume/low-morbidity procedures. Our primary objective was to evaluate the performance of 5 perioperative tasks-(1) offering nonsurgical treatment, (2) performance of a standard preoperative prolapse examination, (3) cough stress test, (4) postvoid residual test, and (5) intraoperative cystoscopy for women undergoing surgery for stress urinary incontinence-compared among surgeons with and without board certification in female pelvic medicine and reconstructive surgery (FPMRS). STUDY DESIGN: This study was a retrospective chart review of anti-incontinence surgical procedures performed between 2011 and 2013 at 9 health systems. Cases were reviewed for surgical volume, adverse outcomes, and the performance of 5 perioperative tasks and compared between surgeons with and without FPMRS certification. RESULTS: Non-FPMRS surgeons performed fewer anti-incontinence procedures than FPMRS-certified surgeons. Female pelvic medicine and reconstructive surgery surgeons were more likely to perform all 5 perioperative tasks compared with non-FPMRS surgeons. After propensity matching, FPMRS surgeons had fewer patients readmitted within 30 days of surgery compared with non-FPMRS surgeons. CONCLUSIONS: Female pelvic medicine and reconstructive surgery surgeons performed higher volumes of anti-incontinence procedures, were more likely to document the performance of the 5 perioperative tasks, and were less likely to have their patients readmitted within 30 days.

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.

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.

Is a Postvoid Residual Necessary? A Randomized Trial of Two Postoperative Voiding Protocols.

OBJECTIVES: This study aimed to compare a backfill-assisted voiding trial (VT) with and without a postvoid residual (PVR) after pelvic reconstructive surgery. METHODS: This was a nonblinded randomized controlled trial of women undergoing pelvic organ prolapse and/or stress incontinence surgery. Participants were randomized immediately after surgery to either a PVR VT or a PVR-free VT. Our primary outcome was the rate of VT failure at discharge. Secondary outcomes included days of catheterization, urinary tract infection (UTI), and prolonged voiding dysfunction. With a power of 80% and an α of 0.05, we needed 126 participants to detect a 25% difference in VT failure (60% in PVR VT vs 35% in PVR-free VT). RESULTS: Participants were enrolled from March 2017 to October 2017. Of the 150 participants, mean age was 59 years, and 33% underwent vaginal hysterectomy, 48% underwent anterior repair, and 75% underwent midurethral sling. Seventy-five (50%) were randomized to PVR VT and 75 (50%) to PVR-free VT, with no differences in baseline demographic or intraoperative characteristics between the 2 groups. Our primary outcome, VT failure, was not significantly different (53% PVR VT vs 53% PVR-free VT, P = 1.0). There were no significant differences in days of postoperative catheterization (1 [0, 4] in PVR VT vs 1 [0, 4] in PVR-free VT, P = 0.90), UTI (20% PVR VT vs 20% PVR-free VT, P = 1.0), or postoperative voiding dysfunction (4% PVR VT vs 5% PVR-free VT, P = 1.0). CONCLUSIONS: When performing a backfill-assisted VT, checking a PVR does not affect VT failure, postoperative duration of catheterization, UTI, or voiding dysfunction.