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Introduction Pelvic floor disorders (PFDs), including pelvic organ prolapse (POP), stress and urgency urinary incontinence, and faecal incontinence, are common and arise from loss of pelvic support. Although severe disease often does not occur until women become older, pregnancy and childbirth are major risk factors for PFDs, especially POP. We understand little about modifiable factors that impact pelvic floor function recovery after vaginal birth. This National Institutes of Health (NIH)-funded Program Project, ‘Bridging physical and cultural determinants of postpartum pelvic floor support and symptoms following vaginal delivery’, uses mixed-methods research to study the influences of intra-abdominal pressure, physical activity, body habitus and muscle fitness on pelvic floor support and symptoms as well as the cultural context in which women experience those changes. Methods and analysis Using quantitative methods, we will evaluate whether pelvic floor support and symptoms 1 year after the first vaginal delivery are affected by biologically plausible factors that may impact muscle, nerve and connective tissue healing during recovery (first 8 weeks postpartum) and strengthening (remainder of the first postpartum year). Using qualitative methods, we will examine cultural aspects of perceptions, explanations of changes in pelvic floor support, and actions taken by Mexican-American and Euro-American primipara, emphasising early changes after childbirth. We will summarise project results in a resource toolkit that will enhance opportunities for dialogue between women, their families and providers, and across lay and medical discourses. We anticipate enrolling up to 1530 nulliparous women into the prospective cohort study during the third trimester, following those who deliver vaginally 1 year postpartum. Participants will be drawn from this cohort to meet the project9s aims. Ethics and dissemination The University of Utah and Intermountain Healthcare Institutional Review Boards approved this study. Data are stored in a secure password-protected database. Papers summarising the primary results and ancillary analyses will be published in peer-reviewed journals.

Re: 5-Year Longitudinal Follow-up after Retropubic andTransobturator Midurethral SlingsKenton K, Stoddard AM, Zyczynski H, et alJ Urol. In press. http://dx.doi.org/10.1016/j.juro.2014.08.089Experts’ summary:The observational study by Kenton et al [1] includes a largepercentage of women enrolled in the TOMUS trial, a random-ized equivalence trial of retropubic and transobturator mid-urethral sling (MUS) approaches, published in 2010. In thisarticle, the authors present the 5-yr outcomes for 404 womenin terms of success, satisfaction, symptom-specific distress,quality of life, and adverse events after MUS. Treatmentsuccess was defined as no retreatment and no self-reportedsymptomsofstressurinaryincontinence.Ananswerof‘‘never’’or ‘‘rarely’’ to all stress-specific questions was considered neg-ative for symptoms. Treatment success declined over-time inboth group, and 5 yr after surgery it was 51.3% and 43.4% afterretropubic and transobturator MUS, respectively. In addition,the proportion of women who stated they were ‘‘very muchbetter’’ or ‘‘much better’’ according to a patient global impres-sion of improvement declined over-time in both groups(p < 0.0001). However, a greater proportion of women in thetransobturator group reported that they were ‘‘very muchbetter’’ or ‘‘much better’’ at 5 yr (88% vs 77%, p = 0.01). Theauthorsconcludedthatlong-termtreatmentsuccessandsatis-faction for both retropubic and transobturator MUS declineover time; nevertheless, women undergoing transobturatorMUSreportedagreaterimprovementinurinarysymptoms[1].Experts’ comments:In the present midurethral sling era, the medium- and long-term outcomes for MUS and comparisons between retropubicand transobturator MUS are the two most debated topics.Several randomized or prospective studies showed veryhigh and long-lasting objective cure rates using MUS[2–4]. A recently published randomized control trialcomparing the retropubic tension-free vaginal tape (TVT)procedure with transobturator TVT (TVT-O) showed thatobjective cure rates remained very high forboth approaches(84.7% and 86.2%, respectively) at 5 yr after surgery.Furthermore,subjectivetreatmentsatisfactionwasexcellent(94.2% in the TVT group and 91.7% in the TVT-O group). Nodifferences in terms of objective or subjective cure ratesbetweenretropubicandtransobturatorMUSwerefound[5].The great merit of the study by Kenton et al [1] is that itfocuses attention on these hot topics. However, data on theefficacyofMUStreatmentat5-yrfollow-uparesignificantlylowerincomparisontothosereportedinthevastmajorityoftheliteratureonthisissue.Theauthorsrepeatedlyunderlinethat in their study, pelvic examinations were performed atannual visits to assess for visual and palpable evidence ofmesh exposure and patient symptoms associated withphysical findings. This is a strength of the study, but it isunusual that no objective methods were used during theseannual examinations to assess the efficacy of MUS position-ing. In the study, success was defined as no retreatment andno self-reported symptoms of stress urinary incontinence.However, using this definition, the success rate of MUSappears to be unusually low (43–51%) at 5-yr follow-up; inaddition, the rate is not in agreement with data reported byother authors on this topic or with findings by the sameauthors in terms of patient satisfaction (79–85%).Therefore, we believe that this study offers interestingdataforphysiciansandpatients,butitisnotveryrealistictoattribute a success rate

IMPORTANCE: More than 300 000 surgeries are performed annually in the United States for pelvic organ prolapse. Sacrospinous ligament fixation (SSLF) and uterosacral ligament suspension (ULS) are commonly performed transvaginal surgeries to correct apical prolapse. Little is known about their comparative efficacy and safety, and it is unknown whether perioperative behavioral therapy with pelvic floor muscle training (BPMT) improves outcomes of prolapse surgery. OBJECTIVE: To compare outcomes between (1) SSLF and ULS and (2) perioperative BPMT and usual care in women undergoing surgery for vaginal prolapse and stress urinary incontinence. DESIGN, SETTING, AND PARTICIPANTS: Multicenter, 2 x 2 factorial, randomized trial of 374 women undergoing surgery to treat both apical vaginal prolapse and stress urinary incontinence was conducted between 2008 and 2013 at 9 US medical centers. Two-year follow-up rate was 84.5%. INTERVENTIONS: The surgical intervention was transvaginal surgery including midurethral sling with randomization to SSLF (n = 186) or ULS (n = 188); the behavioral intervention was randomization to receive perioperative BPMT (n = 186) or usual care (n = 188). MAIN OUTCOMES AND MEASURES: The primary outcome for the surgical intervention (surgical success) was defined as (1) no apical descent greater than one-third into vaginal canal or anterior or posterior vaginal wall beyond the hymen (anatomic success), (2) no bothersome vaginal bulge symptoms, and (3) no re-treatment for prolapse at 2 years. For the behavioral intervention, primary outcome at 6 months was urinary symptom scores (Urinary Distress Inventory; range 0-300, higher scores worse), and primary outcomes at 2 years were prolapse symptom scores (Pelvic Organ Prolapse Distress Inventory; range 0-300, higher scores worse) and anatomic success. RESULTS: At 2 years, surgical group was not significantly associated with surgical success rates (ULS, 59.2% [93/157] vs SSLF, 60.5% [92/152]; unadjusted difference, -1.3%; 95% CI, -12.2% to 9.6%; adjusted odds ratio [OR], 0.9; 95% CI, 0.6 to 1.5) or serious adverse event rates (ULS, 16.5% [31/188] vs SSLF, 16.7% [31/186]; unadjusted difference, -0.2%; 95% CI, -7.7% to 7.4%; adjusted OR, 0.9; 95% CI, 0.5 to 1.6). Perioperative BPMT was not associated with greater improvements in urinary scores at 6 months (adjusted treatment difference, -6.7; 95% CI, -19.7 to 6.2), prolapse scores at 24 months (adjusted treatment difference, -8.0; 95% CI, -22.1 to 6.1), or anatomic success at 24 months. CONCLUSIONS AND RELEVANCE: Two years after vaginal surgery for prolapse and stress urinary incontinence, neither ULS nor SSLF was significantly superior to the other for anatomic, functional, or adverse event outcomes. Perioperative BPMT did not improve urinary symptoms at 6 months or prolapse outcomes at 2 years. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00597935 Copyright 2014 American Medical Association. All rights reserved.

Genetic epidemiology, the study of genetic contributions to risk for disease, is an innovative area in medicine. While research in this arena has advanced in other disciplines, few genetic epidemiologic studies have been conducted in obstetrics and gynecology. It is crucial that we study the genetic susceptibility for issues in women’s health, as this information will shape the new frontier of “personalized medicine.” To date, preterm birth may be one of the best examples of genetic susceptibility in obstetrics and gynecology, but many areas are being evaluated including endometriosis, fibroids, polycystic ovarian syndrome and pelvic floor disorders. An essential component to genetic epidemiologic studies is to characterize, or “phenotype,” the disorder in order to identify genetic effects. Given the growing importance of genomics and genetic epidemiology, we discuss the importance of accurate phenotyping of clinical disorders and highlight critical considerations and opportunities in phenotyping, using pelvic organ prolapse as a clinical example.

Objective To identify urodynamic changes that correlate with successful outcomes after stress urinary incontinence (SUI) surgery. Methods Six-hundred fifty-five women were randomized to Burch colposuspension or autologous fascial sling as part of the multicenter Stress Incontinence Surgical Treatment Efficacy Trial. Preoperatively and 24 months after surgery, participants underwent standardized urodynamic testing that included noninvasive uroflowmetry, cystometrogram, and pressure flow studies. Changes in urodynamic parameters were correlated to a successful outcome, defined a priori as (1) negative pad test; (2) no urinary incontinence on 3-day diary; (3) negative cough and Valsalva stress test; (4) no self-reported SUI symptoms on the Medical, Epidemiologic and Social Aspects of Aging Questionnaire; and (5) no re-treatment for SUI. Results Subjects who met criteria for surgical success showed a greater relative increase in mean Pdet@Qmax (baseline vs 24 months) than women who were considered surgical failures ( P = .008). Although a trend suggested an association between greater increases in bladder outlet obstruction index and outcome success, this was not statistically significant. Other urodynamic variables, such as maximum uroflow, bladder compliance, and the presence of preoperative or de novo detrusor overactivity did not differ with respect to outcome status. Conclusions Successful outcomes in both surgical groups (Burch and sling) were associated with higher voiding pressures relative to preoperative baseline values. However, concomitant changes in other urodynamic voiding parameters were not significantly associated with outcome.

To estimate whether prolapse severity is a major contributor to urinary incontinence severity, as measured by validated incontinence questionnaires.We analyzed data from two large female stress urinary incontinence (SUI) surgical cohorts: the Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr) study (N=655) and the subsequent Trial of Mid-Urethral Slings (TOMUS) study (N=597). All participants completed a standardized baseline assessment including validated measures of symptom severity, quality of life, objective measures of urine loss (Urogenital Distress Inventory [UDI], Medical, Epidemiologic, and Social Aspects of Aging questionnaire, Incontinence Impact Questionnaire, and pad test), as well as the Pelvic Organ Prolapse Quantification assessment. Groups were compared using the chi; test (categorical measures) or the one-way analysis of variance (continuous measures). Statistical significance was defined as P.05.The SISTEr and TOMUS samples were similar for many variables including age (52 and 53 years, respectively), nulliparity (9% and 12%), prior urinary incontinence (UI) surgery (14% and 13%), and prior hysterectomy (31% and 28%), but other differences necessitated separate analysis of the two cohorts. There was not a statistically significant difference in UDI scores according to prolapse stage in either study population. Patients with prior surgery for pelvic organ prolapse and SUI had more incontinence symptoms and were more bothered by their UI regardless of prolapse stage.Prolapse stage is not strongly or consistently associated with incontinence severity in women who select surgical treatment of SUI. Prior pelvic organ prolapse and UI surgery is associated with worse UI severity and bother.ClinicalTrials.gov, www.clinicaltrials.gov, NCT00064662 and NCT00325039.II.

OBJECTIVE: The aim of this study was to determine if alterations in fibrillar collagen synthesis were associated with the development of inguinal hernias. SUMMARY BACKGROUND DATA: Previous work has suggested that alterations in connective tissue accumulation may play a functional role in the development of inguinal hernias. In particular, several investigators have suggested that alterations in collagen synthesis, causally related to connective disorders such as osteogenesis imperfecta, may also be responsible for the inguinal herniation that is markedly increased in such patients. This study was undertaken therefore to study collagen synthesis in patients with inguinal hernia in the absence of any other connective tissue disease. METHODS: Skin fibroblasts from 9 patients with hernias and 15 control individuals were radiolabeled with 3H-proline. Trypsin-chymotrypsin-resistant type I and III collagens were isolated and analyzed by sodium dodecyl sulfate polyacrylamide gel electrophoresis, and recovery was quantified by laser densitometry. Steady-state levels of alpha 1(I) and alpha 1(III) procollagen mRNAs were also determined by northern and slot-blot hybridization analysis. RESULTS: The alpha 1(I)/alpha 1(III) collagen ratios were shown to be 6.3 +/- 0.34 in fibroblasts from control individuals and 3.0 +/- 0.25 in fibroblasts from patients with inguinal hernias. This statistically significant difference (p < 0.0001) was caused by an increase in the secretion of alpha 1(III) procollagen from the fibroblasts of patients with hernias. A concomitant increase in the steady-state levels of alpha 1(III) procollagen mRNA was observed in total RNA isolated from the patients' fibroblasts. CONCLUSIONS: A constitutive and systemic increase in type III collagen synthesis may result in reduced collagen fibril assembly in the abdominal wall, eventually leading to the development of herniation. Although it is not yet clear what genetic factors are responsible for the elevation in type III collagen synthesis in patients with hernias, this study represents the first attempt to define individuals with an abnormality in collagen production that may be specifically related to herniation. A clearer understanding of the possible genetic factors that influence the pathophysiology of this disease will be important to improve the treatment of patients in whom inguinal hernias develop.

The aim of this study was to determine whether preoperative voiding detrusor pressures were associated with postoperative outcomes after stress incontinence surgery.Opening detrusor pressure, detrusor pressure at maximum flow (p (det) Q(max)), and closing detrusor pressure were assessed from 280 valid preoperative urodynamic studies in subjects without advanced prolapse from a multicenter randomized trial comparing Burch and autologous fascia sling procedures. These pressures were compared between subjects with and without overall success, stress-specific success, postoperative detrusor overactivity, and postoperative urge incontinence using independent sample t tests.There were no clinically or statistically significant differences in mean preoperative voiding detrusor pressures in any comparison of postoperative outcomes.We found no evidence that preoperative voiding detrusor pressures predict outcomes in women with stress predominant urinary incontinence undergoing Burch or autologous fascial sling procedures.