Urinary incontinence in women who have undergone bariatric surgery.

INTRODUCTION: Obesity is a known risk factor for urinary incontinence (UI). As bariatric surgery can result in significant and sustainable weight loss, many chronic diseases closely linked to obesity have likewise shown improvement after surgical weight loss. We propose that bariatric surgery may significantly improve obesity-related UI symptoms as well as improve quality of life. METHODS AND PROCEDURES: This is an interim analysis of an ongoing, prospective, single-institution observational study looking at UI in women enrolled in a bariatric surgery program. Participants completed the Pelvic Floor Distress Inventory (PFDI-20), International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF), King's Health Questionnaire (KHQ), and Patient Global Impression of Improvement (PGI-I). Questionnaires were administered upon enrollment, pre-operatively, and at 3, 6, and 12 months post-operatively. Demographic data were collected at each interval and analyzed with descriptive statistics. RESULTS: At analysis, 108 patients had enrolled in the study and 60% had progressed to surgery. We analyzed the following surveys: enrollment (n = 108), pre-operative (n = 43), 3-month (n = 29), 6-month (n = 26), and 1-year (n = 27). Mean BMI decreased from 49.8 to 31.1 at 1-year. All surveys showed significant improvement in UI symptoms over time. Overall, UI symptoms (PDFI-20) are correlated with BMI at time of survey and %TBWL (p = 0.03, p = 0.019). Additionally, perception of symptom improvement with surgery (PGI-I) improved over time (3-month p = 0.0289, 6-month p = 0.0024, 12-month p = 0.0035). Quality of life related to UI symptoms (KHQ) significantly improved after surgery (p = 0.0047 3-month, p = 0.0042 6-month, p = 0.0165 1-year). CONCLUSIONS: Although the relationship is complex and likely depends on many factors, weight loss after bariatric surgery is associated with improvement in UI symptoms and UI-related quality of life. Bariatric surgery can play a role in the long-term treatment of UI in women with obesity that may negate the need for further invasive UI procedures.

Efficacy and Safety of a Nonanimal Stabilized Hyaluronic Acid/Dextranomer in Improving Fecal Incontinence: A Prospective, Single-Arm, Multicenter, Clinical Study With 36-Month Follow-up.

BACKGROUND: Fecal incontinence affects 7% to 12% of the US adult population, causing social, financial, and quality of life burdens. OBJECTIVE: The primary aim of this study was to evaluate the efficacy and safety of nonanimal stabilized hyaluronic acid/dextranomer through 36 months as a condition of postmarket approval application. DESIGN: This was a prospective, single-arm, multicenter, observational Food and Drug Administration-mandated postapproval clinical study. SETTINGS: This study was designed and executed by participating centers in 18 hospitals and colorectal health clinics in coordination with the Food and Drug Administration and the study sponsor. PATIENTS: A total of 283 subjects who previously failed conservative therapy were enrolled across 18 US sites. INTERVENTIONS: Participants received 1 to 2 nonanimal stabilized hyaluronic acid/dextranomer treatments. The first treatment occurred within 30 days of baseline, and a second treatment was administered 1 to 3 months after initial treatment if determined necessary by the physician. Subjects were followed through 7 visits over 36 months after last treatment. MAIN OUTCOME MEASURES: Efficacy (as specified by the Food and Drug Administration) was measured as a fecal incontinence reintervention rate of <50% at 36 months. Reintervention included nonanimal stabilized hyaluronic acid/dextranomer re-treatment, surgical interventions, and physical therapy. Safety was measured by device-related adverse events. Secondary end points included Fecal Incontinence Quality of Life Scale and Cleveland Clinic Florida Fecal Incontinence Score. RESULTS: Using a Bayesian estimate, the reintervention rate of the intention-to-treat population (n = 283) was 18.9% (95% CI, 14.0-24.4) at 36 months. At 36 months, the reintervention rate for subjects with complete data (n = 192) was 20.8% (95% CI, 15.1-26.6). Significant improvement ( p < 0.0001) was noted across the Cleveland Clinic Florida Fecal Incontinence Score and Fecal Incontinence Quality of Life subscales at 36 months. Ninety-two device-related adverse events were reported by 15.2% of enrolled patients; most were GI disorders and resolved quickly. There were no serious adverse events. LIMITATIONS: Limitations of the study included a 32% attrition rate and homogeneous patient population (91.8% white; 85.5% female), possibly limiting generalizability. CONCLUSIONS: Nonanimal stabilized hyaluronic acid/dextranomer demonstrated clinically significant, sustained improvement in symptoms and quality of life for fecal incontinence patients without the occurrence of any serious adverse events. See Video Abstract at http://links.lww.com/DCR/B890 . REGISTRATION: ClinicalTrials.gov ; Unique identifier: NCT01647906. EFICACIA Y SEGURIDAD DE UN CIDO HIALURNICO/ DEXTRANMERO ESTABILIZADO DE ORGEN NO ANIMAL PARA MEJORAR LA INCONTINENCIA FECAL UN ESTUDIO CLNICO PROSPECTIVO, MULTICNTRICO Y DE UN SOLO BRAZO CON SEGUIMIENTO DE MESES: ANTECEDENTES:La incontinencia fecal afecta entre el 7 y el 12% de la población adulta de los EE. UU. Y genera cargas sociales, económicas y de calidad de vida.OBJETIVO:Los objetivos principales de este estudio fueron evaluar la eficacia y seguridad del ácido hialurónico/ dextranómero estabilizado de origen no animal durante 36 meses como condición para la solicitud de aprobación posterior a la comercialización.DISEÑO:Este fue un estudio clínico prospectivo, observacional, de un solo brazo, multicéntrico, ordenado por la FDA después de la aprobación.AJUSTES:Este estudio fue diseñado por los investigadores participantes, la FDA y el patrocinador del estudio que gestionó la recopilación de datos.PACIENTES:Un total de 283 sujetos en quienes previamente falló la terapia conservadora se inscribieron en el estudio prospectivo de un solo brazo en 18 sedes de EE. UU. (NCT01647906).INTERVENCIONES:Los participantes recibieron 1-2 tratamientos con ácido hialurónico/ dextranómero estabilizado no animal. El primer tratamiento se dio dentro de los 30 días posteriores al inicio, mientras que un segundo tratamiento se administró 1-3 meses después del tratamiento inicial si el médico lo determinaba necesario. Los sujetos fueron seguidos durante 7 visitas durante 36 meses después del último tratamiento.PRINCIPALES MEDIDAS DE RESULTADO:La eficacia (según especificado por la FDA) se midió como una tasa de reintervención de incontinencia fecal de <50% a los 36 meses. La reintervención incluyó retratamiento con ácido hialurónico/ dextranómero estabilizado no animal, intervenciones quirúrgicas y fisioterapia. La seguridad se midió mediante los eventos adversos relacionados con tratamiento. Los criterios de valoración secundarios incluyeron la escala de calidad de vida de incontinencia fecal y la puntuación de incontinencia fecal de Cleveland Clinic Florida.RESULTADOS:Utilizando una estimación bayesiana, la tasa de reintervención de la población por intención de tratar (n = 283) fue del 18.9% (IC del 95%: 14.0%, 24.4%) a los 36 meses. A los 36 meses, la tasa de reintervención para los sujetos con datos completos (n = 192) fue del 20.8% (IC del 95%: 15.1%, 26.6%). Se observó una mejora significativa (p <0.0001) en las subescalas de la puntuación de incontinencia fecal de la Cleveland Clinic Florida y de la calidad de vida de la incontinencia fecal a los 36 meses. El 15.2% de los pacientes inscritos informaron 92 eventos adversos relacionados con el tratmiento; la mayoría eran trastornos gastrointestinales y se resolvieron rápidamente. No hubo eventos adversos graves.LIMITACIONES:Las limitaciones incluyen una tasa de deserción del 32% y una población de pacientes homogénea (91.8% blancos, 85.5% mujeres), lo que posiblemente limite la generalización.CONCLUSIÓNES:El ácido hialurónico/ dextranómero estabilizado de origen no animal demostró una mejora sostenida y clínicamente significativa de los síntomas y la calidad de vida de los pacientes con incontinencia fecal, sin que se produjeran efectos adversos graves. Consulte el Video Resumen en http://links.lww.com/DCR/B890 . ( Traducción-Dr. Jorge Silva Velazco )Registro: ClinicalTrials.gov número NCT01647906.

The Correlation Between the Sonographic Course of Transobturator Slings and Sling-Related Pain.

OBJECTIVES: To determine whether transobturator slings follow a consistent path and whether there is an association between ultrasonographically visualized sling pattern or position with sling-related pain. METHODS: This was a cross-sectional retrospective pilot study. We evaluated women who were presented to our clinic for pain or other urogynecologic symptoms following transobturator sling placement between 2009 and 2014. Patients had undergone a 3-dimensional endovaginal pelvic floor ultrasound, assessing minimal levator hiatus, antero-posterior diameter, left-right diameter, and the hiatal shape. The mesh patterns were categorized as seagull patterns (normal), lopsided, flat, and convoluted. RESULTS: A total of 68 cases were reviewed. Fifty patients reported pain, and 18 did not. There were wide variations in the course of the slings. The sling center- minimal levator hiatus position ranged 14.8 mm below and 17.9 mm above the minimal levator hiatus. The lateral arm insertion points ranged between 17.1 mm below and 16.6 mm above the minimal levator hiatus. The right arm insertion points ranged between 9.6 mm below and 18.8 mm above the minimal levator hiatus. Thirty-five of 68 (70%) patients with pain and 13 of 18 (72.2%) without had abnormal sling patterns. The abnormal sling shape was not correlated with pain (P = 1). The levator shape trended toward a statistical significant correlation with sling shape abnormality (P = .084). CONCLUSIONS: This population of women with transobturator sling complications demonstrated wide variations in anatomic paths. Neither the abnormal sling shape nor the distance of the center of the tape from the minimal levator hiatus level were correlated with pain.

Multicenter Randomized Controlled Trial of Pelvic Floor Muscle Training with a Motion-based Digital Therapeutic Device versus Pelvic Floor Muscle Training Alone for Treatment of Stress-predominant Urinary Incontinence.

OBJECTIVE: To determine whether use of an intravaginal motion-based digital therapeutic device for pelvic floor muscle training (PFMT) was superior to PFMT alone in women with stress-predominant urinary incontinence (SUI). METHODS: A multicenter, randomized-controlled trial was conducted where women with SUI or SUI-predominant mixed urinary incontinence were treated with either PFMT using the device (intervention group) or PFMT alone (control group). Primary outcomes, measured at 8 weeks, included change in Urinary Distress Inventory, short-version and improvement in the Patient Global Impression of Improvement, defined as "much better" or "very much better." Participants also completed Pelvic Organ Prolapse and Colorectal-anal Distress Inventories, Pelvic-Floor-Impact Questionnaire and a 3-day bladder diary. Primary analysis used a modified intention-to-treat approach. Statistical analysis used Student t test and χ2 test. The trial was prematurely halted due to device technical considerations. RESULTS: Seventy-seven women were randomized, and final analysis included 61 participants: 29 in intervention and 32 in control group. There was no statistical difference in Urinary Distress Inventory, short-version scores between the intervention (-13.7 ± 18.7) and the control group (-8.7 ± 21.8; P = 0.85), or in Patient Global Impression of Improvement (intervention 51.7% and control group 40.6%; P = 0.47). Pelvic Organ Prolapse and Colorectal-anal Distress Inventories and Pelvic-Floor-Impact Questionnaire scores improved significantly more in the intervention group than the control group (all P < 0.05). Median number of SUI episodes decreased from baseline to 8 weeks by -1.7 per-day [(-3)-0] in the intervention group and -0.7[(-1)-0] in the control group, (P = 0.047). CONCLUSIONS: In this prematurely terminated trial, there were no statistically significant differences in primary outcomes; however, PFMT with this digital therapeutic device resulted in significantly fewer SUI episodes and greater improvement in symptom-specific quality of life outcomes. A larger powered trial is underway.

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.

Ultrasonographic Imaging of the Pelvic Floor.

This article discusses various pelvic floor ultrasonographic modalities and the clinical applications of ultrasonography of the pelvic floor. Ultrasonography provides a detailed anatomic assessment of the muscles and surrounding organs of the pelvic floor. Different anatomic variabilities and pathologic conditions, such as prolapse, fecal incontinence, urinary symptoms, vaginal wall cysts, synthetic implanted material, and pelvic pain, are assessed with pelvic floor ultrasonography. This imaging modality is an important adjunct to the evaluation and diagnosis of pelvic floor disorders.

The Prevalence of Pelvic Floor Hematoma After Vaginal Delivery.

OBJECTIVE: The goal of this study was to evaluate differences in levator ani hematoma formation within 3 days of delivery between adult women after their first vaginal delivery and adult women who have had multiple vaginal deliveries. METHODS: This was a cross-sectional study at a single institution from 2013 to 2015 using a high-resolution endovaginal ultrasound transducer to identify postvaginal delivery hematoma formation. Logistic regression was used to examine the association between hematoma formation and vaginal parity while considering potential confounders including induction, vaginal operative delivery, vaginal birth after cesarean, fetal weight, fetal head circumference, race and ethnicity, body mass index, age at delivery, gestational age, and length of second-stage labor. RESULTS: Ninety women (46 vaginal-primiparous; 44 vaginal-multiparous) were included in this study. After adjusting for oxytocin use, length of second-stage labor, and body mass index, the odds of pelvic floor hematoma of 1000 mm3 or greater were 2.93 (95% confidence interval, 0.78-10.91) times greater in women after their first vaginal delivery compared with women with a history of multiple vaginal deliveries. The adjusted odds of pelvic floor hematoma of 1500 mm3 or greater were 6.02 (95% confidence interval, 1.09-33.24) times greater in vaginal-primiparous compared with vaginal-multiparous women. CONCLUSIONS: Although the prevalence of pelvic floor hematoma was higher in vaginal-primiparous women than vaginal-multiparous women after vaginal delivery, hematomas were present in both groups. Future prospective studies are needed to evaluate the additive effect of multiple vaginal deliveries on the pelvic floor.

Comparing Ketorolac With Ibuprofen for Postoperative Pain: A Randomized Clinical Trial.

OBJECTIVES: The objective of this study was to identify differences in pain perception and satisfaction with pain control in women receiving nonsteroidal anti-inflammatory drugs postoperatively. METHODS: This was a prospective, randomized controlled trial including urogynecology surgical patients. After surgery, all patients were randomized to receive either intravenous (IV) ketorolac or ibuprofen. The patients completed 3 visual analog scales (VAS) assessing pain at rest, pain with ambulation, and satisfaction with pain control. Postoperative opioid use was also measured. RESULTS: A total of 224 patients (112 in each arm) were included. Pain scores (SD) at rest in all patients who received ketorolac versus those who received ibuprofen was 2.30 (2.1) versus 2.68 (2.34) (P = 0.20). Pain scores (SD) with ambulation was 3.94 (2.57) versus 4.16 (2.73) (P = 0.57) in patients who received ketorolac and ibuprofen, respectively. Patients who received ketorolac rated their satisfaction with their pain regimen similarly to those who received ibuprofen (P = 0.50). The average amount (SD) of hydromorphone used in the ketorolac and ibuprofen arm was 3.68 (4.58) mg and 4.04 (4.97) mg, respectively (P = 0.58). A subgroup analysis based on type of surgery showed decreased pain at rest (VAS, 2.77 vs 4.88; P = 0.04) and increased satisfaction (VAS, 1.69 vs 4.67; P = 0.003) in patients who had laparotomy and received ketorolac. CONCLUSIONS: There was no difference in pain and satisfaction with IV ketorolac compared with IV ibuprofen in patients who underwent all modalities of urogynecologic surgery. A subgroup of patients who underwent laparotomy had less pain with ketorolac.

Opioid Pain Medication Use in New Urogynecology Patients.

OBJECTIVES: The aim of this study was to determine the prevalence of opioid pain medication use among patients presenting for a new visit to the urogynecology clinic compared with those presenting to general gynecology. METHODS: We identified all patients who presented for new patient visits to the urogynecology and gynecology clinics between January 1, 2016, and December 31, 2016. Any previous or current opioid use was extracted from the electronic medical record medication list. Statistical analysis was performed using χ and Fisher exact tests for comparisons of categorical variables. Modified Poisson regression models were used to estimate prevalence proportion ratios (PPRs). RESULTS: There were 1835 (955 gynecology, 880 urogynecology) patients included. Median age was 47 years (interquartile range, 29 years), and median body mass index was 28.15 kg/m (interquartile range, 9.96 kg/m). Prevalence of opioid use was lowest among women who identified as Asian or other race and highest among black and Native American women; however, when compared by ethnicity, use was lowest among Hispanic women (P = 0.01). Among new urogynecology patients, 14% had self-reported opioid pain medication usage. Opioid use was almost twice as likely in the urogynecology group (PPR, 1.86; 95% confidence interval, 1.4-2.4). When adjusted for confounders, the urogynecology group was 1.3 times as likely to report opioid use (PPR 1.29; 95% confidence interval, 1.0-1.8), with this result approaching statistical significance. CONCLUSIONS: Opioid use is greater in patients presenting to the urogynecology clinic compared with general gynecology. Urogynecologists need to know this information for planning and optimizing pain management in this population.