A Motion-based Device Urinary Incontinence Treatment: A Longitudinal Analysis at 18 and 24 Months.

INTRODUCTION AND HYPOTHESIS: There are sparse data regarding the long-term efficacy of pelvic floor muscle training (PFMT) for the treatment of urinary incontinence (UI). The objective of this study was to evaluate the impact of an 8-week PFMT program guided by a motion-based intravaginal device versus a standard home program over 24 months. METHODS: Between October 2020 and March 2021, a total of 363 women with stress or stress-predominant mixed UI were randomized and completed an 8-week PFMT program using a motion-based intravaginal device (intervention group) or a home program following written/video instructions (control group). Participants were not asked to continue training after the 8-week program. At 18 and 24 months' follow-up, the Urogenital Distress Inventory, short-form (UDI-6) and Patient Global Impression of Improvement (PGI-I) were collected. In the original trial, a total of 139 participants in each arm were needed to detect a 0.3 effect size (alpha = 0.05, power 0.8, one-tailed t test) in the difference in UDI-6 scores. RESULTS: A total of 231 participants returned 24-month data. Mean age at 24 months was 51.7 ± 14.5 years, and mean BMI was 31.8 ± 7.4 kg/m2. Mean change in UDI-6 scores from baseline to 24 months was greater in the intervention group than the control group (-21.1 ± 24.5 vs -14.8 ± 19.4, p = 0.04). Reported improvement using PGI-I was greater in the intervention group than in the control group at 24 months (35% vs 22%, p = 0.03, OR 1.95(95% CI 1.08, 3.57). CONCLUSIONS: Pelvic floor muscle training guided by a motion-based prescription intravaginal device yielded durable and significantly greater UI symptom improvement than a standard home program, even in the absence of continued therapy.

Impact of sex and aging on radiographic and functional parameters of the anal sphincter complex in patients with accidental bowel leakage.

AIMS: Treatment outcomes for accidental bowel leakage (ABL) may be influenced by age-related sarcopenia. We sought to determine if thickness of the anal sphincter complex on endoanal ultrasound correlated with function in women and men with ABL and if women demonstrated age-related anal sphincter thinning. METHODS: Consecutive patients with ABL presenting to our pelvic floor clinic from 2012 to 2017 were included. Clinical data were obtained from medical records. External anal sphincter (EAS), imaged by endoanal ultrasound at proximal, mid and distal locations, and IAS thickness were measured at 12, 3, 6, and 9 o'clock; puborectalis muscle (PRM) was measured at 4, 6, and 8 o'clock; and averaged. Anorectal manometry was conducted when clinically indicated. Data were compared using Mann-Whitney tests and linear regression. Results are reported as mean ± SD or median (IQR). RESULTS: Women (n = 136) were younger than men (n = 26) (61 ± 13 vs. 67 ± 13 years, p = 0.02). More women than men had pelvic surgery and less had colorectal surgery, spinal disorders, or a history of smoking (p < 0.05). Eighty-two percentage of women had an anal sphincter defect versus 31% of men (p < 0.01). All anal sphincter complex components were thinner in women than men with lower squeeze and resting pressures (p < 0.03), even in nulliparous women. Mean resting pressure was lower in older 6.1 (4.6-7.8) versus younger women 8.3 (5.0-12.9) mmHg, p = 0.04. CONCLUSIONS: Women, even nulliparous, with ABL demonstrate thinner and weaker anal sphincters than men, Aging correlated with an increase in anal sphincter thickness, suggesting that age-related changes in the intrinsic components of the anal sphincter complex associated with ABL are complex and are not always well demonstrated on endoanal ultrasound.

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.

Consensus Definitions and Interpretation Templates for Magnetic Resonance Imaging of Defecatory Pelvic Floor Disorders: Proceedings of the Consensus Meeting of the Pelvic Floor Disorders Consortium of the American Society of Colon and Rectal Surgeons, the Society of Abdominal Radiology, the International Continence Society, the American Urogynecologic Society, the International Urogynecological Association, and the Society of Gynecologic Surgeons.

The Pelvic Floor Disorders Consortium (PFDC) is a multidisciplinary organization of colorectal surgeons, urogynecologists, urologists, gynecologists, gastroenterologists, radiologists, physiotherapists, and other advanced care practitioners. Specialists from these fields are all dedicated to the diagnosis and management of patients with pelvic floor conditions, but they approach, evaluate, and treat such patients with their own unique perspectives given the differences in their respective training. The PFDC was formed to bridge gaps and enable collaboration between these specialties. The goal of the PFDC is to develop and evaluate educational programs, create clinical guidelines and algorithms, and promote high quality of care in this unique patient population. The recommendations included in this article represent the work of the PFDC Working Group on Magnetic Resonance Imaging of Pelvic Floor Disorders (members listed alphabetically in Table 1). The objective was to generate inclusive, rather than prescriptive, guidance for all practitioners, irrespective of discipline, involved in the evaluation and treatment of patients with pelvic floor disorders.

Urinary symptoms in women with faecal incontinence.

AIM: Faecal incontinence (FI) is estimated to affect 8.9% of women in the United States, with a significant impact on quality of life. Our aim was to compare urinary symptoms in patients with and without FI with different degrees of severity. METHODS: This prospective cohort of women presented for care at a pelvic floor disorder centre between May 2007 and January 2019. We excluded women with a history of bowel resection, prior history of pelvic organ prolapse surgery or existing prolapse symptoms reported by the patient during intake. The primary outcome was the presence of urinary symptoms in women with and without FI by validated questionnaires. A logistic regression model for association of urinary symptoms with FI was performed, adjusting for age, smoking, diabetes, prior hysterectomy and irritable bowel syndrome. RESULTS: A total of 2932 met inclusion criteria, and of these 1404 (47.89%) reported FI. In the univariate analysis, patients with FI were more likely to have urgency urinary incontinence (P = 0.01) or mixed urinary incontinence (P < 0.001), report nocturnal enuresis (P < 0.001) or have leakage of urine during sex (P < 0.001). In an adjusted model, FI was associated with concurrent stress (adjusted OR 1.28, P = 0.034), urgency (adjusted OR 1.52, P < 0.001) and mixed incontinence (adjusted OR 1.94, P < 0.001). CONCLUSION: In women with pelvic floor disorders, the presence of FI is associated with a higher prevalence of urinary incontinence. Pelvic floor specialists should assess urinary incontinence symptoms along with the presence and severity of FI to provide comprehensive care and guide appropriate therapy.

A Quality-of-Life Comparison of Two Fecal Incontinence Phenotypes: Isolated Fecal Incontinence Versus Concurrent Fecal Incontinence With Constipation.

BACKGROUND: Many patients with fecal incontinence report coexisting constipation. This subset of patients has not been well characterized or understood. OBJECTIVE: The purpose of this study was to report the frequency of fecal incontinence with concurrent constipation and to compare quality-of-life outcomes of patients with fecal incontinence with and without constipation. DESIGN: This was a prospective cohort study. Survey data, including Fecal Incontinence Severity Index, Constipation Severity Instrument, Fecal Incontinence Quality of Life survey (categorized as lifestyle, coping, depression, and embarrassment), Pelvic Organ Prolapse Inventory and Urinary Distress Inventory surveys, and anorectal physiology testing were obtained. SETTINGS: The study was conducted as a single-institution study from January 2007 to January 2017. PATIENTS: Study patients had fecal incontinence presented to a tertiary pelvic floor center. MAIN OUTCOME MEASURES: Quality-of-life survey findings were measured. RESULTS: A total of 946 patients with fecal incontinence were identified, and 656 (69.3%) had coexisting constipation. Patients with fecal incontinence with constipation were less likely to report a history of pregnancy (89.2% vs 91.4%; p = 0.001) or complicated delivery, such as requiring instrumentation (9.1% vs 18.1%; p = 0.005), when compared with patients with isolated fecal incontinence. Patients with fecal incontinence with constipation had higher rates of coexisting pelvic organ prolapse (Pelvic Organ Prolapse Inventory: 18.4 vs 8.2; p < 0.01), higher rates of urinary incontinence (Urinary Distress Inventory: 30.2 vs 23.4; p = 0.01), and higher pressure findings on manometry; intussusception on defecography was common. Patients with fecal incontinence with concurrent constipation had less severe incontinence scores at presentation (21.0 vs 23.8; p < 0.001) and yet lower overall health satisfaction (28.9% vs 42.5%; p < 0.001). Quality-of-life scores declined as constipation severity increased for lifestyle, coping, depression, and embarrassment. LIMITATIONS: This was a single-institution study, and surgeon preference could bias population and anorectal physiology testing. CONCLUSIONS: Patients with fecal incontinence with concurrent constipation represent a different disease phenotype and have different clinical and anorectal physiology test findings and worse overall quality of life. Treatment of these patients requires careful consideration of prolapse pathology with coordinated treatment of coexisting disorders. See Video Abstract at http://links.lww.com/DCR/A783.

The Contributions of Internal Intussusception, Irritable Bowel Syndrome, and Pelvic Floor Dyssynergia to Obstructed Defecation Syndrome.

BACKGROUND: Recently, there has been a trend toward surgical management of internal intussusception despite an unclear correlation with constipation symptoms. OBJECTIVE: This study characterizes constipation in patients with obstructed defecation syndrome and identifies whether internal intussusception or other diagnoses such as irritable bowel syndrome may be contributing to symptoms. DESIGN: Patients evaluated for obstructed defecation at a pelvic floor disorder center were studied from a prospectively maintained database. With the use of defecography, patients were classified by Oxford Rectal Prolapse Grade. Coexisting disorders such as enterocele, rectocele, and dyssynergia were also identified. The presence of irritable bowel syndrome was defined using Rome IV criteria, and constipation severity was quantified with the Varma constipation severity instrument. SETTINGS: This study was conducted at a tertiary care university medical center (Massachusetts General Hospital). PATIENTS: The study included 317 consecutive patients with defecography imaging and a completed constipation severity instrument survey from May 2007 to July 2016. MAIN OUTCOME MEASURES: The primary outcome measures were the Varma Constipation Severity Instrument overall score and obstructed defecation subscale score. RESULTS: Of 317 patients evaluated, 95 (30.0%) had no internal intussusception, 126 (39.7%) had intra-rectal intussusception, and 96 (30.3%) had intra-anal intussusception. There was no association between rising grade of internal intussusception and either overall constipation score or obstructed defecation subscale score. Irritable bowel syndrome was associated with an increase in overall constipation score and obstructed defecation subscale score (40.5 ± 13.6 vs 36.0 ± 15.1, p = 0.007, and 22.3 ± 5.8 vs 20.0 ± 6.6, p < 0.001). Multivariate regression found irritable bowel syndrome and dyssynergia to be associated with a significant increase in obstructed defecation subscale scores. LIMITATIONS: The study was limited because it was an observational study from a single center. CONCLUSIONS: Patients referred for surgical management of obstructive defecation syndrome should be screened and treated for irritable bowel syndrome and dyssynergia before considering surgical intervention. See Video Abstract at http://links.lww.com/DCR/A782.

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.