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.

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.

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.

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.

Characteristics of Providers Performing Urogynecologic Procedures on Medicare Patients 2012-2014.

OBJECTIVE: To analyze the characteristics of providers performing stress urinary incontinence (SUI) and pelvic organ prolapse (POP) procedures in the United States. METHODS: The Centers for Medicare Services public database, released for years 2012 through 2014, was queried for SUI-related and POP-related Healthcare Common Procedure Coding System. Providers were categorized as Female Pelvic Medicine and Reconstructive Surgery (FPMRS) providers and non-FPMRS providers, using a list of FPMRS board-certified providers compiled through the American Board of Medical Subspecialties website. Other physician specialties that submitted SUI and POP procedures claims were tabulated. RESULTS: Six hundred twenty-nine FPMRS and 833 non-FPMRS providers submitted claims for SUI and POP procedures. The SUI procedures claims had the following provider specialty distribution: obstetrics and gynecology (OB/GYN)-FPMRS, 46.7%; urology, 26.3%; OB/GYN, 12.2%; and urology-FPMRS, 13.9%, with the remaining 0.9% being performed by other specialties. The POP procedures had the following specialty distribution: OB/GYN-FPMRS, 63.4%; OB/GYN, 16.7%; urology, 8.3%; and urology-FPMRS, 7.1%, with the remaining 4.5% being performed by other specialties.Provider distribution was compared between transvaginal mesh and sling insertion procedures to transvaginal mesh and sling removal procedures. The FPMRS providers claimed 63.6% of sling and transvaginal mesh insertion procedures and performed 84.9% of mesh and sling removal procedures. CONCLUSIONS: Medicare reimbursement data provides a unique insight into the distribution of provider specialties performing SUI-related and POP-related procedures in the Medicare population. The OB/GYN-FPMRS providers submitted the majority of claims for SUI and POP procedures from 2012 to 2014. The FPMRS providers are also performing the majority of mesh removal procedures.

In Vivo Ultrasound Characteristics of Vaginal Mesh Kit Complications.

OBJECTIVE: The objective of this study was to investigate the ultrasound characteristics of vaginal mesh in women with vaginal mesh complications. METHODS: This was a cross-sectional study of women presenting with extrusion complications from vaginal mesh kit for prolapse at our tertiary care center between years 2009 and 2014. We included women who concurrently underwent a 3-dimensional endovaginal ultrasound (EVUS) as part of the clinical evaluation. We excluded women with incomplete charts and poor imaging quality. Subjects were categorized by the presence or absence of associated pelvic pain. Based on ultrasound findings, we compared the location of mesh, the appearance of mesh pattern (flat, folding, prominence, convoluted), and other EVUS characteristics of mesh. RESULTS: Forty-six women with vaginal mesh complications and good image quality were included. When comparing mesh length between posterior and anterior compartments, the posterior meshes were significantly longer than the anterior meshes (42.1 [SD, 11.9] mm vs 25.8 [SD, 9] mm; P < 0.0001) and more often associated with pain. In the posterior compartment, the mean mesh length seen on EVUS was significantly longer in women with pain than in women without pain (46.5 [SD, 9] mm vs 31.8 [SD, 12.1] mm; P = 0.0001). There was also a higher proportion of a "flat" mesh pattern, 14 (58.3%) of 25, in the posterior compartment associated with the presence of pain (P = 0.013). In the posterior compartment, a smaller distance between the distal edge of the mesh and the anal sphincter was significantly associated with the presence of pain (8 mm [0-37] vs 21 mm [8-35], P = 0.024). In both compartments, the EVUS had 100% sensitivity for detection of mesh extrusions. CONCLUSIONS: In this population of patients presenting with mesh complications, the posterior meshes were more often visualized as a "flat" pattern with a higher frequency of pain. Mesh complications of the anterior compartment had a higher frequency of folding and shrinkage.

Increasing Age Is a Risk Factor for Decreased Postpartum Pelvic Floor Strength.

OBJECTIVES: This study aimed to determine factors associated with decreased pelvic floor strength (PFS) after the first vaginal delivery (VD) in a cohort of low-risk women. METHODS: This is a secondary analysis of a prospective study examining the risk of pelvic floor injury in a cohort of primiparous women. All recruited participants underwent an examination, three-dimensional ultrasound and measurement of PFS in the third trimester and repeated at 4 weeks to 6 months postpartum using a perineometer. RESULTS: There were 84 women recruited for the study, and 70 completed the postpartum assessment. Average age was 28.4 years (standard deviation, 4.8). There were 46 (66%) subjects with a VD and 24 (34%) with a cesarean delivery who labored. Decreased PFS was observed more frequently in the VD group compared with the cesarean delivery group (68% vs 42%, P = 0.03).In modified Poisson regression models controlling for mode of delivery and time of postpartum assessment, women who were aged 25 to 29 years (risk ratio = 2.80, 95% confidence interval, 1.03-7.57) and 30 years and older (risk ratio = 2.53, 95% confidence interval, 0.93-6.86) were over 2.5 times more likely to have decreased postpartum PFS compared with women younger than 25 years. CONCLUSIONS: In this population, women aged 25 years and older were more than twice as likely to have a decrease in postpartum PFS.

Decreased Urethral Volume Is Comparable to Funneling as a Predictor of Intrinsic Sphincter Deficiency.

OBJECTIVES: The aims of this study were to determine the association between x-ray funneling and ultrasound urethral sphincter complex measurements and to compare the reliability of funneling versus urethral volume measurement in the detection of intrinsic sphincter deficiency (ISD). METHODS: This was a retrospective analysis, which included 54 stress incontinent women dichotomized into those with (1) ISD and (2) no ISD. The presence of bladder neck funneling was diagnosed by fluoroscopic images obtained at the time of video-urodynamics testing. Measurements of the urethral sphincter complex were obtained from ultrasound volumes. Reliability measures were obtained for both funneling and urethral volume measurements. RESULTS: Rhabdomyosphincter length and area were found to be smaller in patients with funneling compared with those with no funneling (P = 0.0161, P = 0.0359). The urethral volume was significantly smaller in the ISD versus no-ISD group (P = 0.0002). For those who had funneling, the ISD group had smaller urethral volume compared with the no-ISD group (P = 0.0019). For those who did not have funneling, the ISD group still had a smaller urethral volume compared with the no-ISD group (P = 0.0054). An ultrasound urethral volume of less than 3.5 cm had a sensitivity of 81% and a specificity of 64% for the presence of ISD, whereas x-ray funneling had a sensitivity of 76% and a specificity of 73%. CONCLUSIONS: Smaller rhabdomyosphincter length and area on ultrasound are associated with x-ray funneling. Ultrasound urethral volume of 3.5 cm as a cutoff provides the same reliability as x-ray funneling for the diagnosis of ISD.

How does 3D endovaginal ultrasound compare to magnetic resonance imaging in the evaluation of levator ani anatomy?

INTRODUCTION AND HYPOTHESIS: To compare magnetic resonance imaging (MRI) to 3D endovaginal ultrasound (EVUS) in the evaluation of major levator ani defects in women with pelvic floor disorders. METHODS: A total of 21 subjects with pelvic floor with complaints of pelvic floor disorders were included in this study. EVUS imaging of the levator ani muscle (LAM) was performed in all subjects, and the LA muscle groups of interest evaluated were the puboanalis (PA), puborectalis (PR), and pubovisceralis (PV) muscles. The right and left subdivisions were evaluated separately, and classified as (i) normal, normal with only minor irregularities, grossly abnormal, or absent, or (ii) by the levator ani deficiency (LAD) score and classified by no defect (complete attachment of muscle to the pubic bone), <50% detachment or loss, >50% detachment or loss, and completely detached or complete muscle loss. Paired data were analyzed with McNemar's test or Bowker's test of symmetry. RESULTS: When unilateral LAM subdivisions were classified as "normal," "normal with minor irregularity," "grossly abnormal," and "absent," there were no significant differences between MRI and EVUS by categorization of LAM defects. Comparing "normal" versus "abnormal," there was no difference between imaging modalities. When compared by LAD score evaluation, there were no differences in the categorization of unilateral defects between MRI and EVUS. CONCLUSIONS: Endovaginal 3D US is comparable to MRI in its ability to identify both normal and abnormal LAM anatomy. Neurourol. Urodynam. 36:409-413, 2017. © 2015 Wiley Periodicals, Inc.

Variability of the pubic arch architecture and its influence on the minimal levator hiatus area.

OBJECTIVE: To investigate the association between the minimal levator hiatus (MLH) area at rest with its surrounding soft-tissue and bony structures in nulliparous asymptomatic women with a normal levator ani muscle. METHODS: A subanalysis was undertaken of a prospective study of the appearance of the levator ani in asymptomatic nulliparous women conducted between September 2010 and September 2011. The subanalysis included women with a normal levator ani muscle. Three-dimensional ultrasonography volumes were used to obtain pelvic floor measurements. RESULTS: The analysis included 56 women with mean age of 43.0±13.4years. The mean MLH area was 13.1±1.8cm(2) (range 9.0-17.3). The pubic arch angle had no influence on the MLH area (Pearson correlation coefficient r=0.13). Height and pubic arch length were positively correlated with the MLH area (r=0.26 [P=0.52] and r=0.50 [P<0.001], respectively). CONCLUSION: The MLH size of nulliparous women varied widely and was positively correlated with the height and pubic arch length of the women. Therefore, caution is warranted when interpreting the MLH area as an indicator of a levator ani defect or a predictor of pelvic organ prolapse without taking a woman's pelvic bone characteristics into account.