Poly(curcumin ß-amino ester)-Based Tablet Formulation for a Sustained Release of Curcumin.

Oral drug delivery remains the most common and well tolerated method for drug administration. However, its applicability is often limited due to low drug solubility and stability. One approach to overcome the solubility and stability limitations is the use of amorphous polymeric prodrug formulations, such as poly(ß-amino ester) (PBAE). PBAE hydrogels, which are biodegradable and pH responsive, have shown promising results for the controlled release of drugs by improving the stability and increasing the solubility of these drugs. In this work, we have evaluated the potential use of PBAE prodrugs in an oral tablet formulation, studying their sustained drug release potential and storage stability. Curcumin, a low solubility, low stability antioxidant drug was used as a model compound. Poly(curcumin ß-amino ester) (PCBAE), a crosslinked amorphous network, was synthesized by a previously published method using a commercial diacrylate and a primary diamine, in combination with acrylate-functionalized curcumin. PCBAE-based tablets were made and exhibited a sustained release for 16 h, following the hydrolytic degradation of PCBAE particles into native curcumin. In addition to the release studies, preliminary storage stability was assessed using standard and accelerated stability conditions. As PCBAE degradation is hydrolysis driven, tablet stability was found to be sensitive to moisture.

Functional ecological convergence between the thylacine and small prey-focused canids.

BACKGROUND: Morphological convergence is a fundamental aspect of evolution, allowing for inference of the biology and ecology of extinct species by comparison with the form and function of living species as analogues. The thylacine (Thylacinus cynocephalus), the iconic recently extinct marsupial, is considered a classic example of convergent evolution with the distantly related placental wolf or dog, though almost nothing is actually known regarding its ecology. This lack of data leads to questions regarding the degree of convergence with, and the similarity of, the functional ecology of the thylacine and the wolf/dog. Here, we examined the cranium of the thylacine using 3D geometric morphometrics and two quantitative tests of convergence to more precisely determine convergent analogues, within a phylogenetically informed dataset of 56 comparative species across 12 families of marsupial and placental faunivorous mammals. Using this dataset, we investigated patterns of correlation between cranial shape and diet, phylogeny, and relative prey size across these terrestrial faunivores. RESULTS: We find a correlation between cranial, facial, and neurocranial shape and the ratio of prey-to-predator body mass, though neurocranial shape may not correlate with prey size within marsupials. The thylacine was found to group with predators that routinely take prey smaller than 45% of their own body mass, not with predators that take subequal-sized or larger prey. Both convergence tests find significant levels of convergence between the thylacine and the African jackals and South American 'foxes', with lesser support for the coyote and red fox. We find little support for convergence between the thylacine and the wolf or dog. CONCLUSIONS: Our study finds little support for a wolf/dog-like functional ecology in the thylacine, with it instead being most similar to mid-sized canids such as African jackals and South American 'foxes' that mainly take prey less than half their size. This work suggests that concepts of convergence should extend beyond superficial similarity, and broader comparisons can lead to false interpretations of functional ecology. The thylacine was a predator of small to mid-sized prey, not a big-game specialist like the placental wolf.

Did the thylacine violate the costs of carnivory? Body mass and sexual dimorphism of an iconic Australian marsupial.

The relative body masses of predators and their prey strongly affect the predators' ecology. An accurate estimate of the mass of an extinct predator is therefore key to revealing its biology and the structure of the ecosystem it inhabited. Until its extinction, the thylacine was the largest extant carnivorous marsupial, but little data exist regarding its body mass, with an average of 29.5 kg the most commonly used estimate. According to the costs of carnivory model, this estimate predicts that thylacines would have focused on prey subequal to or larger than themselves; however, many studies of their functional morphology suggest a diet of smaller animals. Here, we present new body mass estimates for 93 adult thylacines, including two taxidermy specimens and four complete mounted skeletons, representing 40 known-sex specimens, using three-dimensional volumetric model-informed regressions. We demonstrate that prior estimates substantially overestimated average adult thylacine body mass. We show mixed-sex population mean (16.7 kg), mean male (19.7 kg), and mean female (13.7 kg) body masses well below prior estimates, and below the 21 kg costs of carnivory threshold. Our data show that the thylacine did not violate the costs of carnivory. The thylacine instead occupied the 14.5-21 kg predator/prey range characterized by small-prey predators capable of occasionally switching to relatively large-bodied prey if necessary.

Contemporaneity of Australopithecus, Paranthropus, and early Homo erectus in South Africa.

Understanding the extinction of Australopithecus and origins of Paranthropus and Homo in South Africa has been hampered by the perceived complex geological context of hominin fossils, poor chronological resolution, and a lack of well-preserved early Homo specimens. We describe, date, and contextualize the discovery of two hominin crania from Drimolen Main Quarry in South Africa. At ~2.04 million to 1.95 million years old, DNH 152 represents the earliest definitive occurrence of Paranthropus robustus, and DNH 134 represents the earliest occurrence of a cranium with clear affinities to Homo erectus These crania also show that Homo, Paranthropus, and Australopithecus were contemporaneous at ~2 million years ago. This high taxonomic diversity is also reflected in non-hominin species and provides evidence of endemic evolution and dispersal during a period of climatic variability.

A new large-bodied Pliocene seal with unusual cutting teeth.

Today, monachine seals display the largest body sizes in pinnipeds. However, the evolution of larger body sizes has been difficult to assess due to the murky taxonomic status of fossil seals, including fossils referred to Callophoca obscura, a species thought to be present on both sides of the North Atlantic during the Neogene. Several studies have recently called into question the taxonomic validity of these fossils, especially those from the USA, as the fragmentary lectotype specimen from Belgium is of dubious diagnostic value. We find that the lectotype isolated humerus of C. obscura is too uninformative; thus, we designate C. obscura as a nomen dubium. More complete cranial and postcranial specimens from the Pliocene Yorktown Formation are described as a new taxon, Sarcodectes magnus. The cranial specimens display adaptations towards an enhanced ability to cut or chew prey that are unique within Phocidae, and estimates indicate S. magnus to be around 2.83 m in length. A parsimony phylogenetic analysis found S. magnus is a crown monachine. An ancestral state estimation of body length indicates that monachines did not have a remarkable size increase until the evolution of the lobodontins and miroungins.

The pre-Pleistocene fossil thylacinids (Dasyuromorphia: Thylacinidae) and the evolutionary context of the modern thylacine.

The thylacine is popularly used as a classic example of convergent evolution between placental and marsupial mammals. Despite having a fossil history spanning over 20 million years and known since the 1960s, the thylacine is often presented in both scientific literature and popular culture as an evolutionary singleton unique in its morphological and ecological adaptations within the Australian ecosystem. Here, we synthesise and critically evaluate the current state of published knowledge regarding the known fossil record of Thylacinidae prior to the appearance of the modern species. We also present phylogenetic analyses and body mass estimates of the thylacinids to reveal trends in the evolution of hypercarnivory and ecological shifts within the family. We find support that Mutpuracinus archibaldi occupies an uncertain position outside of Thylacinidae, and consider Nimbacinus richi to likely be synonymous with N. dicksoni. The Thylacinidae were small-bodied (< ~8 kg) unspecialised faunivores until after the ~15-14 Ma middle Miocene climatic transition (MMCT). After the MMCT they dramatically increase in size and develop adaptations to a hypercarnivorous diet, potentially in response to the aridification of the Australian environment and the concomitant radiation of dasyurids. This fossil history of the thylacinids provides a foundation for understanding the ecology of the modern thylacine. It provides a framework for future studies of the evolution of hypercarnivory, cursoriality, morphological and ecological disparity, and convergence within mammalian carnivores.

Posterior Compartment Surgery Provides No Differential Benefit for Defecatory Symptoms Before or After Concomitant Mesh-Augmented Apical Suspension.

OBJECTIVES: The aim of this study was to determine the value of posterior compartment surgery during concomitant mesh-augmented apical suspension by comparing obstructed defecatory symptoms after laparoscopic sacrocolpopexy (LSC) with LSC with posterior repair (LSC + PR) and laparoscopic sacrocolpoperineopexy (LSCP) procedures. METHODS: This was a retrospective cohort study of women who underwent LSC, LSC + PR, and LSCP between July 2007 and July 2016 at a tertiary referral center in Indianapolis, Ind. Our primary outcome was differential change in Colorectal-Anal Distress Inventory (CRADI-8) and Colorectal-Anal Impact Questionnaire (CRAIQ-7) scores between the groups including patient-specific symptoms of splinting, straining, incomplete emptying, and pain with defecation. Our secondary outcomes were the rates of postoperative persistent, new, and resolved obstructed defecation symptoms. Anatomic outcomes were also compared between the groups as measured by change in Pelvic Organ Prolapse Quantification System points Ap, GH, and PB. RESULTS: A total of 312 women were included in the study (47 LSC, 133 LSC + PR, and 132 LSCP), with a median follow-up time of 366 days. The majority of patients who underwent surgery had stage III pelvic organ prolapse (61%). Baseline demographics were similar between groups, including preoperative CRADI-8 and CRAIQ-7 scores. All surgical groups demonstrated improvement in CRADI-8 and CRAIQ-7 scores postoperatively (P < 0.001). However, despite differential change in Pelvic Organ Prolapse Quantification System points Ap, GH, and PB, there was no change in CRADI-8 and CRAIQ-7 scores or rates of persistent, new, and resolved symptoms of splinting to defecate, incomplete emptying, and pain with defecation between the groups. The only factor that seemed to be differentially improved by the addition of a posterior compartment repair was postoperative straining. There was a greater rate of de novo straining in the LSC group compared with LSCP (P = 0.01) (LSC + PR v LSCP, P = NS, for both). CONCLUSIONS: We cannot recommend posterior compartment surgery as providing any patient-centered benefit beyond improved cosmesis because the addition of perineal body stabilization either before (LSCP) or posterior repair after (LSC + PR) concomitant mesh-augmented apical suspension did not differentially affect bowel symptoms compared with LSC alone.

Systematic literature review of clinical trials evaluating pharmacotherapy for overactive bladder in elderly patients: An assessment of trial quality.

AIMS: Overactive bladder (OAB) disproportionately affects older-aged adults, yet most randomized controlled trials (RCTs) underrepresent patients ≥65. This systematic literature review (SLR) identified RCTs evaluating ß-3 adrenergic agonists or muscarinic antagonists in elderly patients with OAB, and compared study quality across trials. METHODS: MEDLINE® , Embase® , and Cochrane Collaboration Central Register of Clinical Trials databases were searched from inception through April 28, 2015 to identify published, peer-reviewed RCT reports evaluating ß-3 adrenergic agonists or muscarinic antagonists in elderly OAB patients (either ≥65 years or study-described as "elderly"). To assess study quality of RCT reports, we focused on internal/external validity, assessed via two scales: the validated Effective Public Health Practice Project [EPHPP]): Quality Assessment Tool for Quantitative Studies, and a tool commissioned by the Agency for Healthcare Research and Quality (AHRQ). RESULTS: Database searches yielded 1380 records that were then screened according to predefined inclusion/exclusion criteria. We included eight papers meeting study criteria. Despite scientific community efforts to improve RCT reporting standards, published reports still include incomplete and inconsistent reporting-of subject attrition, baseline patient characteristics, inclusion/exclusion criteria, and other important details. Only three of the eight OAB RCTs in this review received quality ratings of Strong (EPHPP) or Fair (AHRQ) and were multicenter with large samples. CONCLUSIONS: Despite the prevalence of OAB among older age individuals, relatively few RCTs evaluate OAB treatments explicitly among elderly subjects. The findings from this quality assessment suggest some areas for improvement in both conduct and reporting of future RCTs assessing OAB treatment in elderly.

Curcumin Acrylation for Biological and Environmental Applications.

Curcumin has recently gained interest for use in drug delivery, chemical sensing, and environmental applications. As a result, the development of synthesis strategies for the incorporation of curcumin into novel materials has become a priority. One such strategy, curcumin acrylation, involves the introduction of acrylate functional groups to the curcumin scaffold, with the potential generation of mono-, di-, and triacrylate curcumin species. The relative populations of these species in the resulting multiacrylate mixture can be controlled by the ratio of curcumin to acryloyl chloride in the initial reaction formulation. Characterization of the acrylation reaction and the resulting curcumin multiacrylate product is essential for the effective preparation of new curcumin-containing materials. In this work, a synthesis method for curcumin acrylation is presented and the resulting curcumin multiacrylate product is characterized via various techniques, i.e., HPLC, LCMS, and NMR, as a basis to establish the relationship between synthesis conditions and the extent of acrylation that is achieved.

If you could see what we see, would it bother you?

OBJECTIVE: The purpose of our study was to determine whether the anatomic threshold for pelvic organ prolapse (POP) diagnosis and surgical success remains valid when the patient sees what we see on exam. METHODS: Two hundred participants were assigned, by computer-generated block randomization, to see one of four videos. Each video contained the same six clips representative of various degrees of anterior vaginal wall support. Participants were asked questions immediately after each clip. They were asked: "In your opinion, does this patient have a bulge or something falling out that she can see or feel in the vaginal area?" Similarly, they were asked to give their opinion on surgical outcome on a 4-point Likert scale. RESULTS: The proportion of participants who identified the presence of a vaginal bulge increased substantially at the level of early stage 2 prolapse (1 cm above the hymen), with 67 % answering yes to the question regarding bulge. The proportion of participants who felt that surgical outcome was less desirable also increased substantially at early stage 2 prolapse (1 cm above the hymen), with 52 % describing that outcome as "not at all" or "somewhat" successful. CONCLUSION: Early stage 2 POP (1 cm above the hymen) is the anatomic threshold at which women identify both a vaginal bulge and a less desirable surgical outcome when they see what we see on examination.

Suprapubic versus transurethral bladder drainage following reconstructive pelvic surgery: a comparison of patient satisfaction and quality of life.

INTRODUCTION AND HYPOTHESIS: To assess the differences in patient-reported, catheter-specific satisfaction and quality of life with either suprapubic or transurethral postoperative bladder drainage following reconstructive pelvic surgery. METHODS: This was a prospective study of all eligible women who were scheduled to undergo reconstructive surgery requiring bladder drainage during the study period November 2013 to March 2015. Women who did not undergo the planned procedure(s) or did not require bladder drainage were excluded. The primary outcome was patient-reported quality of life using catheter-specific instruments including the Catheter-related Quality of Life (CIQOL) instrument, and a modified version of the Intermittent Self-Catheterization Questionnaire (ISC-Q), designed to evaluate aspects of catheter-related quality of life and satisfaction specific to the needs of the individual. RESULTS: A total of 178 women were analyzed, 108 in the transurethral catheter group and 70 in the suprapubic group. Women with suprapubic bladder drainage had higher quality of life and satisfaction scores than women with transurethral bladder drainage as measured by the ISC-Q (68.31 ± 16.87 vs. 54.04 ± 16.95, mean difference 14.27, 95 % CI 9.15 - 19.39). There was no difference in quality of life by the CIQOL. After regression analysis, women with suprapubic bladder drainage were more satisfied with their catheter-specific needs despite longer duration of catheter use, more concurrent continence surgery, and higher trait anxiety. CONCLUSIONS: Differences in catheter-specific quality of life and patient satisfaction scores favoring suprapubic bladder drainage support its continued use in appropriately selected women for treatment of temporary postoperative urinary retention after reconstructive pelvic surgery.

Macromammalian faunas, biochronology and palaeoecology of the early Pleistocene Main Quarry hominin-bearing deposits of the Drimolen Palaeocave System, South Africa.

The Drimolen Palaeocave System Main Quarry deposits (DMQ) are some of the most prolific hominin and primate-bearing deposits in the Fossil Hominids of South Africa UNESCO World Heritage Site. Discovered in the 1990s, excavations into the DMQ have yielded a demographically diverse sample of Paranthropus robustus (including DNH 7, the most complete cranium of the species recovered to date), early Homo, Papio hamadryas robinsoni and Cercopithecoides williamsi. Alongside the hominin and primate sample is a diverse macromammalian assemblage, but prior publications have only provided a provisional species list and an analysis of the carnivores recovered prior to 2008. Here we present the first description and analysis of the non-primate macromammalian faunas from the DMQ, including all 826 taxonomically identifiable specimens catalogued from over two decades of excavation. We also provide a biochronological interpretation of the DMQ deposits and an initial discussion of local palaeoecology based on taxon representation.The current DMQ assemblage consists of the remains of minimally 147 individuals from 9 Orders and 14 Families of mammals. The carnivore assemblage described here is even more diverse than established in prior publications, including the identification of Megantereon whitei, Lycyaenops silberbergi, and first evidence for the occurrence of Dinofelis cf. barlowi and Dinofelis aff. piveteaui within a single South African site deposit. The cetartiodactyl assemblage is dominated by bovids, with the specimen composition unique in the high recovery of horn cores and dominance of Antidorcas recki remains. Other cetartiodactyl and perissodactyl taxa are represented by few specimens, as are Hystrix and Procavia; the latter somewhat surprisingly so given their common occurrence at penecontemporaneous deposits in the region. Equally unusual (particularly given the size of the sample) is the identification of single specimens of giraffoid, elephantid and aardvark (Orycteropus cf. afer) that are rarely recovered from regional site deposits. Despite the diversity within the DMQ macromammalian faunas, there are few habitat- or biochronologically-sensitive species that provide specific ecologic or age boundaries for the deposits. Recovered species can only support the non-specific, mixed open-to-closed palaeohabitats around Drimolen that have been reconstructed for the other penecontemporaneous South African palaeokarst deposits. The identified Equus quagga ssp. specimens recovered from the floor of the current excavation (∾-4.5-5 m below datum) suggests that most, if not all the DMQ specimens, were deposited after 2.33 Ma. Simultaneously, the carnivore specimens (D. cf. barlowi, L. silberbergi) suggest earlier Pleistocene (pre- 2.0-1.8 Ma) to maximally 1.6 Ma deposition (D. aff. piveteaui) for most of the DMQ fossil assemblage.

Patterns of Care for Newly Diagnosed Benign Prostatic Hyperplasia in the United States.

PURPOSE: We examined diagnostic tests and treatment patterns in men with new onset benign prostatic hyperplasia using consolidated national electronic health record data. MATERIALS AND METHODS: The Humedica® electronic health record database consists of de-identified patient records from approximately 25 million patients in the United States. Using this database, men with a new benign prostatic hyperplasia diagnosis (benign prostatic hyperplasia, bladder neck obstruction, urinary retention and incomplete bladder emptying) between July 1, 2009 and June 30, 2012 were included in study. Exclusion criteria included conditions such as genitourinary cancers, radiation cystitis, neurogenic bladder and urological pain diagnoses. Diagnostic tests and treatments were summarized and stratified by age (less than 65 vs 65 years or greater) and serum prostate specific antigen level. RESULTS: A total of 38,252 men met inclusion criteria. Mean followup was 1,020 days. Serum creatinine in 92% of patients, serum prostate specific antigen in 76% and urinalysis in 52% were the most common tests. Invasive testing was obtained in less than 20% of patients. Treatments included watchful waiting in 40% of patients, pharmacological therapy in 59.4% and surgery in 2.2%. α-Blockers were prescribed in 50.7% of men. Men older than 65 years and with higher prostate specific antigen levels were less likely to be treated with watchful waiting. Therapy with a 5-ARI (5-α reductase inhibitor) was prescribed in 23% to 29% of men across all prostate specific antigen categories. CONCLUSIONS: The majority of clinical care for new onset benign prostatic hyperplasia was in concordance with guideline recommendations. Based on prostate specific antigen values, 5-ARI therapy was underutilized in men with large prostates and was over utilized in men with small prostates.

Impact of a Novel Vaginal Bowel Control System on Bowel Function.

BACKGROUND: Bowel dysfunction, including frequency, fecal urgency, stool consistency, and evacuation symptoms, contributes to fecal incontinence. OBJECTIVE: The purpose of this study was to examine the impact of a vaginal bowel control system on parameters of bowel function, including frequency, urgency, stool consistency, and evacuation. DESIGN: This was a secondary analysis of a multicenter, prospective clinical trial. SETTINGS: This study was conducted at 6 sites in the United States, including university hospitals and private practices in urogynecology and colorectal surgery. PATIENTS: A total of 56 evaluable female subjects aged 19 to 75 years with 4 or more fecal incontinence episodes on a 2-week bowel diary were included. INTERVENTIONS: The study intervention was composed of the vaginal bowel control system, consisting of a vaginal insert and pressure-regulated pump. MAIN OUTCOME MEASURES: Subjects completed a 2-week baseline diary of bowel function before and after treatment completed at 1 month. Fecal urgency, consistency of stool (Bristol score), and completeness of evacuation were recorded for all bowel movements. RESULTS: Use of the insert was associated with an improvement in bowel function across all 4 categories. Two thirds (8/12) of subjects with a high frequency of daily stools (more than 2 per day) shifted to a normal or low frequency of stools. Analysis of Bristol stool scale scores demonstrated a significant reduction in the proportion of all bowel movements reported as liquid (Bristol 6 or 7), from 36% to 21% (p = 0.0001). On average, 54% of stools were associated with urgency at baseline compared with 26% at 1 month (p < 0.0001). Incomplete evacuations with all bowel movements were reduced from 39% to 26% of subjects at 1 month (p = 0.0034). LIMITATIONS: The study follow-up period was 1 month (with an optional additional 2 months). CONCLUSIONS: The vaginal bowel control system was associated with an improvement in bowel symptoms and function, including reduced bowel movement frequency, less fecal urgency, increased solid consistency, and improved evacuation in patients with significant fecal incontinence.

Consistently inconsistent, the posterior vaginal wall.

Posterior vaginal wall prolapse is one of the most common prolapses encountered by gynecological surgeons. What appears to be a straightforward condition to diagnose and treat surgically for physicians has proven to be frustratingly unpredictable with regard to symptom relief for patients. Functional disorders such as dyssynergic defecation and constipation are often attributed to posterior vaginal wall prolapse. Little scientific evidence supports this assumption, emphasizing that structure and function are not synonymous when treating posterior vaginal wall prolapse. Rectoceles, enteroceles, sigmoidoceles, peritoneoceles, rectal and intraanal intussusception, rectal prolapse, and descending perineal syndrome are all conditions that have an impact on the posterior vaginal wall. All too often these different anatomic conditions are treated with the same surgical approach, addressing a posterior vaginal wall bulge with a traditional posterior colporrhaphy. Studies that examine the correlation between stage of posterior wall prolapse and patient symptoms have failed to reliably do so. Surgical outcomes measured by prolapse staging appear successful, yet patient expectations are often not met. As increasing attention is being placed on patient satisfaction outcomes concerning surgical treatments, this fact will need to be addressed. Surgeons will have to clearly communicate what can and what cannot be expected with surgical repair of posterior vaginal wall prolapse.

Obliterative Surgery for the Treatment of Pelvic Organ Prolapse: A Patient Survey on Reasons for Surgery Selection and Postoperative Decision Regret and Satisfaction.

OBJECTIVES: To identify patient-reported reasons for selecting obliterative surgery for the purpose of predicting decision regret and satisfaction. METHODS: We created a deidentified database of patients who underwent an obliterative procedure for prolapse from 2006 to 2013. Patients were excluded if they declined study participation, were deceased, or had dementia. Participants completed a survey regarding reasons for selecting obliterative surgery and a modified version of validated questionnaires on decision regret (Decision Regret Scale-Pelvic Floor Disorder) and satisfaction (Satisfaction with Decision Scale-Pelvic Floor Disorder). Parsimonious multivariate linear regression models were constructed to determine if any of the reasons given for choosing obliterative surgery were independent predictors of decision regret and satisfaction after controlling for significant sociodemographic, clinical, and surgical outcome data identified by bivariate analysis. RESULTS: Seventy-seven women completed the surveys. "To follow my doctor's recommendations" and "no longer sexually active," and/or "did not plan to be" as reasons for selecting obliterative surgery made the most difference; however, these reasons were not identified as independent predictors of decision regret or satisfaction after controlling for confounders. The regret linear regression models identified preoperative sexual activity rather than the patient-reported reason "no longer sexually active and/or did not plan to be," as the only independent predictor of more decision regret after obliterative surgery (B coefficient 1.68, P < 0.01). The satisfaction linear regression models identified reoperation for any reason as an independent predictor of lower satisfaction (ß, -0.24; P = 0.04) and the patient-reported reason for choosing obliterative surgery "not interested in pessary" as a predictor of higher satisfaction (ß, 0.30, P = 0.01). CONCLUSIONS: This study advances our knowledge about the obliterative surgical decision making process. Behavioral and educational interventions directed at improving patient and physician communications concerning the dynamics of sexual health issues in an aging population will likely decrease regret when obliterative surgery is chosen. Minimizing reoperation after obliterative surgery through increased experience, knowledge, and improved surgical skills and patient validation when pessary is declined will likely improve satisfaction when obliterative surgery is chosen.

Balloon expulsion testing for the diagnosis of dyssynergic defecation in women with chronic constipation.

INTRODUCTION AND HYPOTHESIS: Dyssynergic defecation can be difficult to diagnose. Anorectal manometry and defecography are often used to make this diagnosis. However, these tests are expensive and require expertise. Balloon expulsion testing may be a simple alternative. We compared balloon expulsion to anorectal manometry and defecography for diagnosing dyssynergia in women with chronic constipation. METHODS: We conducted a retrospective review. All women presenting for evaluation of chronic constipation who underwent concurrent balloon testing, manometry, and defecography were included. A diagnosis of dyssynergic defecation was established by either defecography revealing prolonged/incomplete rectal evacuation and/or by manometry revealing paradoxical contraction/inadequate relaxation of the pelvic floor. Inability to expel a 50-ml balloon defined dyssynergic defecation by balloon testing. Sensitivity, specificity, and predictive values were calculated. RESULTS: A total of 61 women met inclusion criteria. Mean age was 50 years. There were 36 women (59 %) who met Rome III criteria for dyssynergic defecation on defecography and/or manometry. Only 12 of these 36 (33 %) were similarly diagnosed by balloon testing. The sensitivity and positive predictive value of balloon testing for dyssynergia were 33 and 71 %, respectively. Of the 25 (41 %) women who did not meet Rome III criteria for dyssynergia on defecography and/or manometry, 20 (80 %) also had negative balloon testing. Thus, the specificity and negative predictive value of balloon testing for diagnosing dyssynergia were 80 and 50 %, respectively. CONCLUSIONS: In our population, balloon expulsion was not an ideal screening test for dyssynergic defecation in women with constipation. Multimodal testing is necessary for more accurate diagnosis.

A vaginal bowel-control system for the treatment of fecal incontinence.

OBJECTIVE: To evaluate the effectiveness and safety of a vaginal bowel-control device and pump system for fecal incontinence treatment. METHODS: Women with a minimum of four fecal incontinence episodes over 2 weeks were fit with the intravaginal device. Treatment success, defined as a 50% or greater reduction of incontinent episodes, was assessed at 1 month. Participants were invited into an optional extended-wear period of another 2 months. Secondary outcomes included symptom improvement measured by the Fecal Incontinence Quality of Life, Modified Manchester Health Questionnaire, and Patient Global Impression of Improvement. Adverse events were collected. Intention-to-treat analysis included participants who were successfully fit entering treatment. Per protocol, analysis included participants with a valid 1-month treatment diary. RESULTS: Sixty-one of 110 (55.5%) participants from six clinical sites were successfully fit and entered treatment. At 1 month, intention-to-treat success was 78.7% (48/61, P<.001); per protocol success, 85.7% (48/56, P<.001) and 85.7% (48/56) considered bowel symptoms "very much better" or "much better." There was significant improvement in all Fecal Incontinence Quality of Life (P<.001) and Modified Manchester (P≤.007) subscales. Success rate at 3 months was 86.4% (38/44; 95% confidence interval 73-95%). There were no serious adverse events; the most common study-wide device-related adverse event was pelvic cramping or discomfort (25/110 participants [22.7%]), the majority of events (16/25 [64%]) occurring during the fitting period. CONCLUSION: In women successfully fit with a vaginal bowel-control device for nonsurgical treatment for fecal incontinence, there was significant improvement in fecal incontinence by objective and subjective measures. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01655498. LEVEL OF EVIDENCE: : II.

Documentation of specific mesh implant at the time of midurethral sling surgery in women with stress incontinence.

OBJECTIVE: We aimed to assess documentation completeness of the operative record for mesh implanted at the time of midurethral sling surgery and to identify modifiable predictors of documentation completeness. METHODS: A retrospective cross-sectional study of women with stress incontinence who underwent midurethral sling placement between January 2009 and December 2011 was conducted. Data from the dictated operative note and nursing operative record were extracted to determine if the specific mesh implanted during surgery was documented. The primary outcome was the rate of documentation of mesh implanted in the physician's dictated operative note and in the nursing record. Logistic regression was used to determine if any characteristics were associated with the rate of documentation while accounting for correlation of patients from the same dictating surgeon. RESULTS: There were 816 surgeries involving the implantation of a midurethral sling during the study period. All surgeries were performed at 6 Indiana University hospitals. Fifty-two surgeons of varying specialties and levels of training dictated the operative notes. A urogynecologist dictated 71% of the operative notes. The rate of documentation completeness for mesh implanted in the physician's note was 10%. The rate of documentation completeness for mesh implanted in the nursing operative record was 92%. Documentation of mesh implanted in the physician's note was not significantly associated with the level of training, specialty, or year of surgery. CONCLUSIONS: Documentation completeness for specific mesh implant in the physician's note is low, independent of specialty and level of training. Nursing documentation practices are more rigorous. Postmarket surveillance, currently mandated by the Food and Drug Administration, may not be feasible if only the physician's note is available or if nursing practices are inconsistent. Development of documentation guidelines for physicians would improve the feasibility of surveillance.