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Transvaginal mesh/grafts have been popularized over the past 20 years in an attempt to improve the longevity of traditional vaginal pelvic organ prolapse (POP) surgery. Several national bodies have concluded that the proposed benefits of mesh/graft implantation are outweighed by the significant increase in surgery complications related to these products. As a consequence mesh products for vaginal POP surgery have been withdrawn from use in many countries. This article is a narrative review of newer mesh and graft products including lightweight polypropylene mesh products, biological grafts, hybrid grafts, and tissue engineered grafts.

Mental health and mental health disorders among clinicians remain a taboo, despite increasing evidence showing the direct impact on medical teams and patient care. This editorial is aimed at increasing awareness of mental issues amongst healthcare professionals, identifying perceived barriers to seeking help, and suggesting ways in which to seek help. Mental health disorders, including anxiety and depression, are prevalent from medical school, leading to increased burnout and suicide risks at later stages of a clinician’s career. There is often a reluctance to seek help, particularly amongst the surgical specialties, caused by self-criticism, lack of convenient access and the potential negative impact on medical licensure. This editorial has been written in loving memory of our colleague, friend and board member Dr. Nikolaus Veit-Rubin, who sadly passed away at the beginning of the year. It is written in the hope of highlighting the importance of maintaining mental wellbeing amongst the medical team, supporting help-seeking behaviour and changing attitudes toward mental health disorders amongst clinicians.

OBJECTIVE The aim of the study was to determine the accuracy of postvoid residual (PVR) by subtraction as compared with objective measurement by bladder scan or catheterization. METHODS This is a secondary analysis of postoperative patients who underwent avoiding trial by retrograde bladder instillation. Fill volume, spontaneous voided volume, and PVR were objectively measured; PVR was also calculated. Pearson correlation compared PVR by subtraction versus objective measurement. We then defined postoperative urinary retention (POUR) at 3 different PVR values (100 mL, 150 mL, and 200 mL) to compare the sensitivity, specificity, and positive and negative predictive values of subtraction for detecting urinary retention at these 3 thresholds. RESULTS Data were available for 155 patients after urogynecologic surgery. Median PVR by objective measurement was 46 mL (interquartile range = 11-146 mL). Median calculated PVR by subtraction was 10 mL (interquartile range = 0-100 mL). Objective measure and subtraction PVR values were strongly correlated (Pearson coefficient = 0.78, P < 0.001). Using a threshold of 200 mL to define POUR resulted in the highest negative predictive value and the lowest absolute number of both false negatives and false positives. Even using this threshold, 11 (48%) of 23 women with POUR by measurement were misclassified as not having POUR when ascertained by subtraction. CONCLUSIONS Although subtraction PVR correlates well with objective PVR measurement, almost half of women with a PVR volume of greater than 200 mL by objective measurement are miscategorized as voiding normally by subtraction PVR. Based on these findings, reliance on objective PVR measurement in postoperative patients is preferable to subtraction PVR.

Treatment options for refractory overactive bladder (OAB) following behavioral modifications and oral OAB medications remain limited. Up to 33% of women fail botulinum toxin injections (Amundsen et al. Eur Urol. 74(1):66–73, 7). This study evaluates the effectiveness of combining oral OAB agents with botulinum toxin in subjects who failed botulinum toxin therapy alone. This is a retrospective observational study. Eligible women were those who received botulinum toxin injections for OAB between 2013 and 2018 at one academic institution. Women were given the option of oral medications as add-back therapy following failed treatment with botulinum toxin alone. Treatment response was a subjective outcome, with subjects reporting being satisfied or unsatisfied. The primary outcome was the proportion of subjects who achieved satisfactory treatment response with the combination of oral OAB medications and botulinum toxin injections. A subanalysis was performed to further investigate any risk factors associated with poor response to combination treatment. Variables were analyzed using chi-squared or Fisher’s exact test and Student's t-test or Mann-Whitney U when appropriate. A total of 107 charts were reviewed. Forty-five (48%) women failed botulinum toxin alone as a treatment; 26 (29%) elected to try one or more oral OAB medications. Of the 26 women who received the combination treatment, 17 (65%) reported satisfaction and 9 (35%) remained unsatisfied. Risk factors associated with treatment failure were not identified. This is an initial report on adding back oral OAB meds to patients who have failed botulinum toxin injections suggesting there may be a role for add-back oral OAB medications.

To analyze the reasons for eventual choice of a therapeutic intervention in subjects who initially chose observation for bothersome pelvic organ prolapse (POP) over therapeutic intervention at their first urogynecology clinic visit. This is a retrospective cohort study of women with bothersome POP who initially chose observation over therapeutic intervention at one institution from 2002 to 2015. Subjects were followed over time with sequential pelvic organ prolapse quantification examinations (POP-Q) and assessments of symptoms and bother utilizing non-validated standard questions. Subjects were divided into two groups: (1) those who chose continued observation versus (2) those who chose therapeutic intervention with either pessary or surgery. Demographic information, POP-Q examinations, and POP symptoms and bother were collected. We analyzed which clinical variables influenced patient decision to elect for therapeutic intervention. A total of 111 subjects were enrolled. The distribution of initial POP-Q stage was: stage 2 = 54%; stage 3 = 45%; stage 4 = 1%. Median follow-up was 24 months (range 6 and 110 months). At their last recorded visit, 73 subjects (66%) continued observation and 38 subjects (34%) chose pessary or surgical intervention. We investigated clinical factors for choosing intervention. Increase in POP symptom bother was the only variable that remained significant in determining patient choice of a therapeutic intervention (p

To identify the optimal cost-effectiveness threshold of post-void residual (PVR) by bladder scan in postoperative urogynecologic patients.A cost-effectiveness analysis was performed as a secondary analysis of a previously published study of patients undergoing urogynecologic procedures with planned voiding trials, setting thresholds for postoperative PVR bladder scan volumes at 100 ml, 150 ml, and 200 ml. Patient-based scenarios were modeled for ambulatory office or emergency department (ED) resource utilization and to determine the cost-effectiveness of each threshold. Costs were obtained from a southeastern academic medical center, only utilizing direct medical costs and hospital costs, not including societal costs. Quality-adjusted life years (QALY's) were used as health outcomes determining the incremental cost-effectiveness ratio (ICER).A total of 151 patients from the original study were included. A willingness to pay threshold of $100,000 per QALY was assumed. A PVR of 100 ml exceeded this at $373,824. A PVR threshold of 150 ml was dominant (-$1,211,716), while minimizing ED visits for postoperative urinary retention (POUR) and unnecessary clinic appointments. While a PVR of 200 ml appeared a cost-effective strategy (-$488,389), there was increased ED utilization and under-detection of postoperative urinary retention (POUR).A PVR threshold of 100 ml created a healthcare system burden due to increased office voiding trials. Both PVR thresholds of 150 ml and 200 ml were cost-effective strategies; however, ED utilization for POUR increased with 200 ml. Utilizing 150 ml as the PVR cut-off proved the most cost-effective strategy, avoiding POUR under-detection and undue health costs.

OBJECTIVE This study aimed to determine if genital hiatus (GH) size is a predictor of worsening pelvic organ prolapse and a preference for a therapeutic intervention in women with pelvic organ prolapse who opt for expectant management over therapeutic intervention at their initial encounter. METHODS This was a retrospective cohort study analyzing the GH size of women who opted for expectant management in the initial treatment of pelvic organ prolapse at one academic institution from 2002 to 2015. Participants were divided into 2 groups: (1) large GH was defined as ≥4 cm and (2) normal GH was defined as

Previous studies have found that administration of phenazopyridine decreased short-term urinary retention following surgery but other more recent trials have shown mixed results. This study sought to investigate the potential benefit of preoperative administration of oral phenazopyridine in relation to the prevention of short-term urinary retention following urogynecologic surgery. This is a retrospective cohort study of a convenience sample of women undergoing urogynecologic surgery from June 2016 to March 2019. Following surgery, subjects underwent a standardized retrograde voiding trial. The data had previously been gathered from a prior prospective trial at our institution (Kesty et al. Int Urogynecol J 31(9):1899–1905, 11). Chart review was performed to determine whether patients that received 200 mg of preoperative oral phenazopyridine to better visualize ureteral efflux during cystourethroscopy were more or less likely to pass their postoperative voiding trial. Bivariate statistical analysis was performed as well as a multivariate logistic regression model. A total of 165 subjects were included in the final analysis; 100 who did not receive preoperative phenazopyridine and 65 who did receive phenazopyridine. There was no statistical difference between voiding trial pass rates following urogynecologic surgery between those who did not receive preoperative phenazopyridine compared to those who did [77% (77/100) and 82% (53/65), respectively, p = 0.37)]. The multivariate logistic regression model demonstrated no difference in postoperative voiding trial pass rates among those who received preoperative phenazopyridine compared to those who did not (OR 1.7, 95% CI: 0.53, 5.8). Preoperative administration of oral phenazopyridine does not decrease short-term urinary retention following urogynecologic surgery.

Standardized terminology for surgical procedures commonly performed to treat stress urinary incontinence in women is needed to facilitate research, clinical care, and teaching in female pelvic medicine and reconstructive surgery.This report combines the input of members of the American Urogynecologic Society and the International Urogynecological Association, assisted by external referees. Extensive searches of the literature were performed, including Instructions for Use brochures and original source documents where possible. Historical context was considered along with procedural modifications, and expert opinion was included when appropriate.A terminology report for the procedures commonly performed to treat stress urinary incontinence in women was produced. Included procedures are midurethral sling, retropubic colposuspension, pubovaginal sling, urethral bulking, and artificial urinary sphincter. Appropriate figures have been included to supplement and help clarify the text. Ongoing review will be performed periodically to keep the document updated and widely acceptable.This document is a literature and consensus-based terminology report for surgical procedures to treat stress urinary incontinence in women. Future publications in female pelvic medicine and reconstructive surgery should use this standardized terminology whenever possible.

The purpose of this study is to reanalyze data from the original 2005 Pelvic Organ Support Study (POSST) data set to define normal values for apical Pelvic Organ Prolapse Quantification (POP-Q) points C and D and total vaginal length (TVL) in an asymptomatic population of women. In this retrospective observational data-set review, patient were >18 years presenting for annual gynecologic exams to six centers in the United States. Data included demographics, questions about prolapse symptoms, and POP-Q points. Means and standard deviations were determined for each POP-Q point in the total population. The data set comprised 1011 women; 59 were excluded because they met criteria for having POP or were missing data. This left 948 for study. Mean age of our study population was 42 ± 14 years, and 45.6% were white, 25.1% black, and 25.2% Hispanic. One hundred fifty-six had a prior hysterectomy. Mean values with standard deviations (SD) for POP-Q values are as following: point C (vaginal cuff) −7.3 ± 1.5 cm, point C (cervix) −5.9 ± 1.5, point D −8.7 cm ± 1.5 cm, TVL (no hysterectomy) 9.8 cm ± 1.3 cm, and TVL (hysterectomy) 8.9 cm ± 1.5 cm. This data suggests normal values for POP-Q apical points in a population of patient with annual gynecological exams.

The purpose of the review is to explore the utility of urodynamic testing and guide readers on how to choose the best between simple and complex urodynamic testing. The literature discussed includes clinical scenarios in which urodynamic testing is usually not necessary, when a simple urodynamic assessment provides sufficient clinical information and when complex testing is particularly helpful in clinical decision-making. The evaluation of a straightforward incontinent woman usually does not require urodynamic testing when planning initial behavioral or pharmacologic therapy. The assessment of stress urinary incontinence and prolapse without incontinence can often be accomplished with simple urodynamics. Refractory or complicated urinary incontinence often necessitates complex urodynamics.

Introduction and Hypothesis Following the US Food and Drug Administration’s (FDA’s) warning about the use of transvaginal mesh to treat pelvic organ prolapse (POP) and the use of single-incision slings to treat incontinence, the number of lawsuits for medical negligence regarding the use of any polypropylene mesh in the vagina has increased tremendously. Methods This same FDA document did not question the use of polypropylene midurethral slings and polypropylene for sacrocolpopexies. Surprisingly, despite all the evidence and recommendations from respected international scientific societies, we are constantly being called upon by our patients to defend the use of midurethral slings. The most common reasons for the new rash of medicolegal proceedings involving midurethral slings has to do with “breach of duties” resulting from undisclosed postoperative complications on the consent form and/or the lack of information in the medical records confirming that all possible alternative treatment options were presented to and discussed with the patient. Results One response to these lawsuits involves the addition of preoperative checklists when performing informed consent with patients electing surgical correction of stress urinary incontinence (SUI). Conclusions This clinical opinion provides an expert clinician’s perspectives and legal point of view on this controversial topic and discusses the role of a preoperative checklist supplementary to the standard informed consent form.

We tested the hypothesis that women can subjectively determine if they have emptied their bladder after a spontaneous voiding attempt following urogynecological surgery to rule out post-operative urinary retention as determined by a voiding trial. This is a prospective observational study of women undergoing urogynecological surgery at two academic institutions from June 2016 to March 2019. Following surgery, subjects underwent a voiding trial followed by measurement of the PVR via ultrasound bladder scan or straight catheterization. A successful voiding trial was defined as a PVR of ≤150 ml. Subjects were queried about their subjective sensation of bladder emptying; “Do you feel that you completely emptied your bladder?” Their responses were either “Yes”, “No” or “I don’t know”. Their subjective responses were correlated with the voiding trial results using a Chi-squared analysis for sensitivity, specificity, and positive (PPV) and negative predictive values (NPV). A total of 266 subjects were included in the final evaluation. The screening subjective question had a sensitivity of 85.7% (CI 71.46 to 94.57%), a specificity of 91.5% (CI 87.01 to 94.79%), a PPV of 65.4% (CI 54.78 to 74.77%), and an NPV of 97.14% (CI 94.18 to 98.62%) to detect a failed voiding trial. The NPV of the subjective question regarding bladder emptying in the post-operative urogynecological setting is high at >97%, suggesting that it might be reasonable to forgo a formal voiding trial in patients who subjectively feel that they have emptied their bladder.

Aims To review the current literature on the development of latent stress urinary incontinence (SUI) or SUI that occurs following pelvic organ prolapse therapy in patients who were continent prior to therapy. To make recommendations on how to best evaluate and manage patients with pelvic organ prolapse who are continent. Methods This is a narrative review using Google scholar and cross referencing identified manuscripts. We used the British Medical Journals grading of literature to assign letter grades to level of statements and recommendations. Results The literature suggest about 40% of women with advanced pelvic organ prolapse who are continent will develop SUI after surgery to correct their pelvic organ prolapse. Reduction cough stress testing can help identify those patients at risk to develop SUI with a PPV of 60%. Reduction cough stress testing is best done using large rectal swabs or scopettes. The literature on how to best manage patients with advanced pelvic organ prolapse and are continent to avoid latent SUI is mixed and the best recommendations are based on sound literature that is incomplete. Conclusions Understanding that latent SUI is a potential complication in any subject with advanced pelvic organ prolapse is necessary to pre-operative counseling. Deciding on the best management strategy is not clear cut and therefore should involve patient input in the decision making process.

Introduction and hypothesis The aim of this study was to evaluate the effectiveness of transcutaneous posterior tibial nerve stimulation (T.C. PTNS) versus extended release oxybutynin (E.R.O.) in patients with overactive bladder. Materials and methods Seventy female patients were randomized to receive either 10 mg E.R.O. daily or T.C. PTNS, using a TENS machine program with the 20 Hz, 200 cycles/s, and normal stimulation setting for two 30-min sessions, each week for a 12-week period. Pre-treatment and after the 12-week intervention, each patient completed a 3-day voiding diary and a self-report quality of life questionnaire (OAB-q). Statistical analysis was performed using Stata V12.1. Results Sixty-four patients completed the treatment protocol. There were no significant differences between study groups in terms of age, body mass index, past hormone replacement therapy, smoking habits, menopause status, and parity. Prior to treatment, there were also no significant differences in the analysis of the 3-day voiding diary or in the OAB-q questionnaire results. Following the 12-week study, there was a statistically significant reduction in frequency of urination, urgency episodes, and urge incontinent episodes compared to pre-treatment values. However, there were no significant differences in these values between intervention groups after 12-weeks of therapy. There was a similar improvement in OAB-q scores in both treatment groups following therapy, and the T.C. PTNS group showed a statistically significant improvement over the E.R.O. in domain 2 of the OAB-q questionnaire. The other two domains showed similar improvement in both study groups. Conclusion T.C. PTNS and E.R.O. demonstrated similar improvements in subjects with OAB in a 12-week study.

PURPOSE The aim of this study was to demonstrate the construct and predictive validity of a task-specific checklist for cystoscopy in the operating room. METHODS This study is a prospective observational study evaluating the validity of a task-specific checklist for cystoscopic proficiency on residents performing cystoscopy in the operating room over a 4-year period. Residents were scored on 2 task-specific checklists: (1) assembly and (2) performance of a diagnostic cystoscopy. Construct validity was evaluated by comparing absolute checklist scores based on resident year with a Kruskal-Wallis and χ test, respectively. Paired analysis was performed with Wilcoxon sign rank and McNemar tests to assess differences between initial and final observations. Predictive validity was evaluated by determining the percent of competently performed task-specific checklists subsequent to 1 competent task-specific checklist completion. RESULTS One hundred fifty-three evaluations were performed on 30 residents from all 4 levels of training. The median task-specific checklist scores for both (1) assembly and (2) performance of a diagnostic cystoscopy demonstrated construct validity with statistically significant trends demonstrating improved scores as resident year increased from intern to chief, P values of

Our aim was to validate the Brazilian Portuguese version of the International Federation of Gynecology and Obstetrics (FIGO) Assessment Scoring System (FASS) to identify and quantify signs and symptoms related to pelvic floor dysfunction. One hundred and seventy-nine women aged 18–82 (47.68 ± 14.42) years participated in this validation study. Collected data included a sociodemographic and clinical questionnaire, application of the FASS, and physical examination using the Pelvic Prgan Prolapse Quantification (POP-Q) system. The translation and cross-cultural adaptation were performed following the international methodology. The psychometric properties tested were criterion validity, construct validity, stability, and reliability. For this purpose, the comparison with POP-Q findings and between symptomatic and asymptomatic patients, test–retest and internal consistency (Cronbach’s alpha) were used, respectively. The intraclass correlation coefficient (ICC) was calculated to assess the level of agreement between evaluations (inter- and intraobservers). P

Aims To set out the basic description of pelvic organ prolapse (POP) using the International Continence Society/International Urogynecology Association Pelvic Organ Prolapse Quantification (POP-Q) system. Methods The basic approach to use of the POP-Q was identified and summarized. Results Six defined points in the vagina are identified; points Aa and Ba for the anterior vagina, Ap and Bp for the posterior vagina, and C and D for the cervix/vault. Point D is not used in women who previously had a hysterectomy. The patient is asked to strain, ideally when in the standing position, to elicit the POP to its maximum extent. The location of the defined points is then gauged relative to the hymenal ring and recorded on a grid. Three additional measurements are taken to achieve a full description; the genital hiatus length, perineal body length, and total vaginal length. Staging a POP relies on identifying the lowest extent of any part of the six defined points; if any point reaches close to the hymenal ring (at least stage 2), the prolapse is usually symptomatic. Conclusions The POP-Q system is readily cataloged and offers detailed description of considerable benefit in clinical practice and research.

The aim of our study was to assess the interobserver and intraobserver reliability as well as the content and construct validity of the FIGO prolapse assessment scoring system (FASS). Women with and without (controls) symptoms of pelvic organ prolapse (POP) attending gynaecology outpatient clinics in four different countries were recruited prospectively. Each woman was assessed using the FASS which included: (1) physical examination findings designated with the letter P; (2) presence of symptoms of prolapse, urinary and bowel symptoms designated with the letter S; and (3) assessment of degree of bother designated with the letter B. A scoring system was also developed. For interobserver reliability women were examined by two separate examiners using the FASS. For intraobserver reliability the FASS was repeated by the same examiner within 2 weeks. The interclass correlation coefficient (ICC) was also calculated to assess limits of agreements. Validity was assessed by comparing the FASS scores between symptomatic and asymptomatic women using the Mann-Whitney U test (p value

To evaluate the impact of pelvic organ prolapse (POP) on quality of life in symptomatic and asymptomatic women.This is a cross-sectional study in a general population of adult women. Symptomatic and asymptomatic women with POP were studied. Symptomatic women were defined as those who reported the presence/feeling of lump/bulge/pressure in the vagina and on vaginal examination had the sign of POP defined as the leading edge of the vagina wall/cervix presenting at or beyond the hymeneal remnants. All women were asked to self-complete the Prolapse Quality of life questionnaire (P-QOL) to estimate the disability-adjusted life-years (DALYs) lost due to symptomatic POP. DALYs for a symptomatic POP were calculated as the sum of the years of life lost due to premature mortality (YLL) in the population and the years lost due to disability (YLD). To determinate the optimal threshold of each P-QOL domain in relationship to the symptomatic POP population a receiver operating curve (ROC) and area under curve (AUC) analysis were used.A total of 785 were recruited. Only 539 (68.7%) consented to participate in the study. The mean age was 47 years (range 18-82 years). The total scores for each of the P-QOL domains were found to be significantly higher in symptomatic prolapse subjects compared to asymptomatic subjects (p0.05). Estimated DALY lost per year per 1000 women obtained were 217.0 vs 324.8, lost years of 14.5 vs 10.3 in 50 vs 60-year old women.In this group of women with POP the quality of life is severely affected. The DALYs revealed lost years due to symptomatic POP.

Objectives The aim of this study was to compare the sensitivity of cough stress test in the standing versus supine position in the evaluation of incontinent females. Methods We performed a prospective observational study of women with the chief complaint of urinary incontinence (UI) undergoing a provocative cough stress test (CST). Subjects underwent both a standing and a supine CST. Testing order was randomized via block randomization. Cough stress test was performed in a standard method via backfill of 200 mL or until the subject described strong urge. The subjects were asked to cough, and the physician documented urine leakage by direct observation. The gold standard for stress UI diagnosis was a positive CST in either position. Results Sixty subjects were enrolled, 38 (63%) tested positive on any CST, with 38 (63%) positive on standing compared with 29 (28%) positive on supine testing. Nine women (15%) had positive standing and negative supine testing. No subjects had negative standing with positive supine testing. There were no significant differences in positive tests between the 2 randomized groups (standing first and supine second vs. supine first and standing second). When compared with the gold standard of any positive provocative stress test, the supine CST has a sensitivity of 76%, whereas the standing CST has a sensitivity of 100%. Conclusions The standing CST is more sensitive than the supine CST and should be performed in any patient with a complaint of UI and negative supine CST. The order of testing either supine or standing first does not affect the results.

Objective To assess the efficacy of fesoterodine 8 mg vs extended-release (ER) tolterodine 4 mg for overactive bladder (OAB) symptoms in terms of patient-reported outcomes in women and in men. Subjects and Methods Pooled data from two 12-week, randomized, double-blind, double-dummy studies were analysed. Participants eligible for the studies were ≥18 years old, had self-reported OAB symptoms for ≥3 months in 3-day baseline diaries and had ≥8 micturitions and ≥1 urgency urinary incontinence (UUI) episode per 24 h. Individuals were randomized to fesoterodine (4 mg for 1 week then 8 mg for 11 weeks), ER tolterodine (4 mg), or placebo. Changes from baseline in 3-day bladder diary variables and scores from the Patient Perception of Bladder Condition (PPBC), Urgency Perception Scale (UPS), and Overactive Bladder Questionnaire (OAB-q), were assessed, as was the ‘diary-dry’ rate (the proportion of subjects with >0 UUI episodes according to baseline diary and no UUI episodes according to post-baseline diary). The primary endpoint was the change from baseline to week 12 in UUI episodes. Results At week 12, women showed significantly greater improvement with fesoterodine 8 mg (n = 1374) than with ER tolterodine 4 mg (n = 1382) and placebo (n = 679) in UUI episodes (primary endpoint), micturition frequency, urgency episodes, and all other diary endpoints (except nocturnal micturitions versus ER tolterodine), and also in scores on the PPBC, UPS, and all OAB-q scales and domains (all P < 0.005). Diary-dry rates in women were significantly greater with fesoterodine (63%) than with tolterodine (57%; P = 0.002) or placebo (48%; P < 0.0001). In men, there were no significant differences in improvement in UUI episodes between any treatment groups at week 12. Improvements in men were significantly greater with fesoterodine 8 mg (n = 265) than with ER tolterodine (n = 275) for severe urgency and the OAB-q Symptom Bother domain and were also significantly greater with fesoterodine than with placebo (n = 133) for micturition frequency, urgency episodes, severe urgency episodes, PPBC responses and scores on all OAB-q scales and domains at week 12 (all P < 0.04). The most frequently reported treatment-emergent adverse events in both genders were dry mouth (women: fesoterodine, 29%; ER tolterodine, 15%; placebo, 6%; men: fesoterodine, 21%; ER tolterodine, 13%; placebo, 5%) and constipation (women: fesoterodine, 5%; ER tolterodine, 4%; placebo, 2%; men: fesoterodine, 5%; ER tolterodine, 3%; placebo, 1%). Urinary retention rates were low in women (fesoterodine

Objective: Pelvic organ prolapse (POP) is a common morbidity that affects many women and significantly decreases quality of life. The severity and the impact of the prolapse on the quality of life are important parameters in the management and follow-up of affected patients. The aim of this validation study was to validate the Polish version of the Prolapse Quality of Life questionnaire (P-QoL). Material and methods: The P-QOL questionnaire was translated into Polish and administered to women recruited from two gynecological outpatient clinics (n = 231). Both symptomatic and asymptomatic women were included in the study and examined in supine position using the Pelvic Organ Prolapse Quantification System (POP-Q). The validity was assessed by comparing symptom scores and quality-of-life scores between symptomatic and asymptomatic women. Results: A total number of 154 symptomatic and 77 asymptomatic women were included. There was a strong correlation between severity of the disease based on physical findings (POP-Q scale) and the P-QoL scores in main prolapse quality-of-life domains. The overall scores for each life domain were significantly different between symptomatic and asymptomatic women (p < 0.001). All the questions regarding symptoms showed significant differences (p < 0.001) between both groups. Conclusions: The Polish version of P-QoL is a valid, reliable, and easily comprehensible instrument to assess quality of life and symptoms in Polish-speaking women suffering from urogenital prolapse.

Aims To determine the rate of progression or regression of pelvic organ prolapse (POP) in subjects with symptomatic POP who decline intervention (pessary or surgery) and elect observation. Methods Sixty-four patients choosing observation as primary management of symptomatic POP were followed with sequential pelvic organ prolapse quantification (POP-Q) exams. A change in the leading edge value of ±≥2 cm was considered significant. POP-Q exam results, choice of therapy and symptom severity at last visit were recorded. Results The leading vaginal edge POP-Q exam value at initial exam ranged from −1.5 to 7 cm. Distribution of patients by POP-Q stages on initial exam was: stage I: 1%, stage II: 31%, stage III: 31%, and stage IV: 1.78% (50/64) of patients demonstrated no change in leading edge value from first to last visit on POP-Q exams. Nineteen percent (12/64) demonstrated progression (≥2 cm increase in leading edge); 3% (2/64) demonstrated regression (≥2 cm decrease in leading edge). Median follow-up was 16 months (range 6–91 months). On multivariate analysis, no variable, including length of follow-up, was associated with change in leading edge value (P = 0.09, data not shown). At their last recorded visit, 63% (40/64) of subjects continued observation, 38% (24/64) desired a pessary trial or surgical correction. Those desiring intervention had no greater worsening of prolapse on exam at last follow-up compared with subjects who continued observation. Conclusion The natural history of pelvic organ prolapse is most often one of very minimal change in subjects who decline intervention (pessary or surgery) and choose observation. Neurourol. Urodynam. 32: 383–386, 2013. © 2012 Wiley Periodicals, Inc.

Introduction and Hypothesis Standardized terminology has yet to be developed for reporting the outcomes for surgery for pelvic organ prolapse (POP). Methods: This report combines the input of the Terminology and Standardization Committees of the International Urogynecological Association (IUGA) and the International Continence Society (ICS) and a joint Working Group on this topic, as well as expert external referees. The aim was to present a standardized terminology for the definitions of surgery and propose a structure for reporting the outcomes of surgical procedures for POP. An extensive drafting and review process was undertaken, as well as open review on both IUGA and ICS websites. Results: A terminology report was developed outlining the recommended structure for reporting outcomes of surgical trials involving POP. This document does not define success and failure. The report includes patientreported subjective and objective outcomes to enable researchers to report on their results and compare them with other studies. Conclusions: A consensus- based method for standardizing terminology for reporting outcome measures of POP surgery was developed to aid clinicians working in this area of research. Neurourol. Urodynam. 31: 415421, 2012. (C) 2012 Wiley Periodicals, Inc.

Introduction and Hypothesis A terminology and standardized classification has yet to be developed for those complications related to native tissue female pelvic floor surgery. Methods: This report on the terminology and classification combines the input of members of the Standardization and Terminology Committees of two International Organizations, the International Urogynecological Association (IUGA) and the International Continence Society (ICS) and a Joint IUGA/ ICS Working Group on Complications Terminology, assisted at intervals by many external referees. A process of rounds of internal and external review took place with decision- making by collective opinion (consensus). Results: A terminology and classification of complications related to native tissue female pelvic floor surgery has been developed, with the classification based on category (C), time (T), and site (S) classes and divisions, that should encompass all conceivable scenarios for describing operative complications and healing abnormalities. The CTS code for each complication, involving three (or four) letters and three numerals, is likely to be very suitable for any surgical audit or registry, particularly one that is procedure- specific. Users of the classification have been assisted by case examples, color charts, and online aids (www. icsoffice. org/ ntcomplication). Conclusions: A consensus- based terminology and classification report for complications in native tissue female pelvic floor surgery has been produced. It is aimed at being a significant aid to clinical practice and particularly to research. Neurourol. Urodynam. 31: 406-414, 2012. (C) 2012 Wiley Periodicals, Inc.

As we begin our tenure as Editors-in-Chief of the International Urogynecology Journal (IUJ), we would like to thank the previous Editors-in-Chief for establishing the IUJ as the premier journal in the field of urogynecology. Our journal is the “go-to” journal for practicing urogynecologists across the globe, and the IUJ publishes more urogynecology articles than any other subspecialty journal in the field. We fully recognize that the greatest strength of the IUJ is the international makeup of our Editors, readership, reviewers, and authors. Our main task as incoming Editors-in-Chief will be to maintain that representation and promote further engagement with scientists and clinicians internationally so that our journal continues to attract and publish the best manuscripts in the field of urogynecology. We feel strongly that our mission is to provide a platform for the publication of the best that we as urogynecologists have to offer. This means that we will reach out to our readership, Editorial Board and fellow Editors to find new and innovative ways to ensure that the best science is published with efficient, high-quality reviews that are completed in a timely manner. To achieve this, we will focus on improving the work flow of the Editors such that their job in managing submissions is efficient, effective, and timely. This will mean further reductions in time-to-decision and more productive manuscript reviews for authors. We will focus on providing better guidance to our reviewers so that we receive only high-quality reviews from all who participate in the manuscript review process. Finally, we will focus on making the manuscript submission process an easy one that provides authors with a simple process for submission and a short time to decision. Although these processes have already improved substantially, our job is to determine how to improve them even further. As times change, we as Editors-in-Chief will work to put the IUJ in a position to flourish. This will means engaging new international communities that have up and coming research units. We must also find new and different ways to engage younger readers while maintaining our standing amongst our traditional readership. We look forward to working with the International Urogynecological Association leadership to promote research and publication in our field and work closely with our partners at Springer to promote the journal. * Steven Swift swifts@musc.edu

A terminology and standardized classification has yet to be developed for those complications arising directly from the insertion of synthetic (prostheses) and biological (grafts) materials in female pelvic floor surgery. This report on the above terminology and classification combines the input of members of the Standardization and Terminology Committees of two International Organizations, the International Urogynecological Association (IUGA) and the International Continence Society (ICS) and a Joint IUGA/ICS Working Group on Complications Terminology, assisted at intervals by many expert external referees. An extensive process of 11 rounds of internal and external review took place with exhaustive examination of each aspect of the terminology and classification. Decision-making was by collective opinion (consensus). A terminology and classification of complications related directly to the insertion of prostheses and grafts in female pelvic floor surgery has been developed, with the classification based on category (C), time (T) and site (S) classes and divisions, that should encompass all conceivable scenarios for describing insertion complications and healing abnormalities. The CTS code for each complication, involving three (or four) letters and three numerals, is likely to be very suitable for any surgical audit or registry, particularly one that is procedure-specific. Users of the classification have been assisted by case examples, colour charts and online aids ( www.icsoffice.org/complication ). A consensus-based terminology and classification report for prosthess and grafts complications in female pelvic floor surgery has been produced, aimed at being a significant aid to clinical practice and research.

The objective of this study was to determine the test-retest reliability of the cotton swab test.Prospective, blinded, study of the cotton swab test. Subjects underwent two tests within 2-4 weeks. Agreement between resting angles and straining angles was analyzed using a Wilcoxon signed rank test. Agreement of a positive and negative test result, using 30 degrees as cutoff, was evaluated with McNemar's test and kappa statistic.Fifty subjects participated. The mean resting angle was 3.16 degrees (-6.0 degrees, 10 degrees) and 3.24 degrees (-5.0 degrees, 10 degrees) on repeat (p = 0.99). The mean straining angle was 34.4 degrees (20 degrees, 50 degrees) and 37.0 degrees (25 degrees, 55 degrees) on repeat (p = 0.14). McNemar's test demonstrated good agreement between observations. As the straining angle approached 30 degrees, the agreement between positive and negative exams was only 57%.There is good test-retest reliability of the cotton swab test. When the straining angle is 21-49 degrees, there is poor agreement regarding a positive or negative test result.

Protease-activated receptor-1 (PAR1) is a G protein-coupled receptor that plays critical roles in cancer, angiogenesis, inflammation, and thrombosis. Proteolytic cleavage of the extracellular domain of PAR1 generates a tethered ligand that activates PAR1 in an unusual intramolecular mode. The signal emanating from the irreversibly cleaved PAR1 is terminated by G protein uncoupling and internalization; however, the mechanisms of PAR1 signal shut off still remain unclear. Using a yeast two-hybrid screen, we identified Bicaudal D1 (BicD1) as a direct interactor with the C-terminal cytoplasmic domain of PAR1. BICD was originally identified as an essential developmental gene associated with mRNA and Golgi-endoplasmic reticulum transport. We discovered a novel function of BicD1 in the modulation of G protein signaling, cell proliferation, and endocytosis downstream of PAR1. BicD1 and its C-terminal CC3 domain inhibited PAR1 signaling to G(q)-phospholipase C-beta through coiled-coil interactions with the cytoplasmic 8th helix of PAR1. Unexpectedly, BicD1 was also found to be a potent suppressor of PAR1-driven proliferation of breast carcinoma cells. The growth-suppressing effects of BicD1 required the ability to interact with the 8th helix of PAR1. Silencing of BicD1 expression impaired endocytosis of PAR1, and BicD1 co-localized with PAR1 and tubulin, implicating BicD1 as an important adapter protein involved in the transport of PAR1 from the plasma membrane to endosomal vesicles. Together, these findings provide a link between PAR1 signal termination and internalization through the non-G protein effector, BicD1.

Study Type – Therapy (RCT) Level of Evidence 1b OBJECTIVE To compare the efficacy and tolerability of fesoterodine 8 mg with tolterodine extended-release (ER) 4 mg and placebo in a randomized clinical trial of patients with an overactive bladder (OAB). PATIENTS AND METHODS In this 12-week double-blind, double-dummy, placebo-controlled, randomized clinical trial, eligible patients reported OAB symptoms for ≥3 months and recorded ≥8 voids and ≥1 urgency urinary incontinence (UUI) episode per 24 h in 3-day bladder diaries at baseline. Patients were randomized in a 2:2:1 ratio to fesoterodine (4 mg for 1 week then 8 mg for 11 weeks); tolterodine ER 4 mg; or placebo (with sham dose escalation for tolterodine ER and placebo). Endpoints were changes from baseline to week 12 in UUI episodes (primary endpoint), total and nocturnal voids, urgency episodes, severe urgency episodes, and frequency-urgency sum per 24 h; mean voided volume per void (MVV); and the OAB questionnaire (OAB-q), Patient Perception of Bladder Condition (PPBC), and Urgency Perception Scale (UPS). Safety and tolerability were assessed and summarized over the 12-week study period. RESULTS Fesoterodine (636 patients) significantly improved UUI episodes at week 12 (primary endpoint) compared with tolterodine ER (641 patients; P = 0.017) and placebo (313 patients; P

Introduction and hypothesis Next to existing terminology of the lower urinary tract, due to its increasing complexity, the terminology for pelvic floor dysfunction in women may be better updated by a female-specific approach and clinically based consensus report. Methods This report combines the input of members of the Standardization and Terminology Committees of two Inter

Our objective was to determine the inter-examiner agreement of a simplified pelvic organ prolapse quantification (POPQ) exam and to assess its correlation with the standard POPQ exam. This study consists of two parts; both were performed in a prospective, randomized, blinded fashion on women presenting with complaints attributed to pelvic organ support defects. The first study was done to determine the inter-examiner reliability of a simplified POPQ exam. The simplified POPQ exam is based on the POPQ with similar ordinal staging but with only four points measured instead of nine. Forty-eight women underwent exams by five different investigators. The order of exams was randomized and the examiners were blinded to the results of each other's findings. The results of these two exams were compared using weighted kappa statistics. The second part of the study was done to determine the inter-system agreement between the simplified vs standard POPQ exam. A group of 49 women were examined by four different investigators: one using the simplified and the other using standard POPQ exams. The order of the exams was randomized and the examiners were blinded to the results of each other's exam. Kendall's tau-b statistics were used to determine the inter-system agreement. For the inter-examiner reliability of the POPQ exam, the average age was 60+/-13 years. The weighted kappa statistics for the inter-examiner reliability of the simplified prolapse classification system were 0.86 for the overall stage, 0.89 and 0.86 for the anterior and posterior vaginal walls, respectively, 0.82 for the apex/cuff, and 0.72 for the cervix. All demonstrate significant agreement. For the inter-system association between the simplified POPQ and standard POPQ, the average age was 61+/-15 year. The Kendall's tau-b value for overall stage was 0.90, 0.83, and 0.87 for the anterior and posterior walls respectively, and 0.78 for the cuff/apex and 0.98 for the cervix. There is good inter-examiner agreement of a simplified POPQ classification system and it appears to have good inter-system association with the POPQ.

The protease-activated receptors are tethered ligand G protein-coupled receptors that are activated by proteolytic cleavage of the extracellular domain of the receptor. The archetypic protease-activated receptor PAR1 strongly activates Gq signaling pathways, but very little is known regarding the mechanism of signal transference between receptor and internally located G protein. The recent x-ray structure of rhodopsin revealed the presence of a highly conserved amphipathic 8th helix that is likely to be physically interposed between receptor and G protein. We found that the analogous 8th helix region of PAR1 was critical for activation of Gq-dependent signaling. Engineering an 8th helix α-aneurysm with a downwards-directed alanine residue markedly interfered with signal transference to Gq. The 8th helix-anchoring cysteine palmitoylation sites were important for the affinity of ligand-dependent G protein coupling but did not affect the maximal signal. A network of H-bond and ionic interactions was found to connect the N-terminal portion of the 8th helix to the nearby NPXXY motif on transmembrane helix 7 and also to the adjacent intracellular loop-1. Disruption of these pairwise interactions caused additive defects in coupling to G protein, indicating that the transmembrane 7–8th helix-i1 loop may move in a coordinated manner to transfer the signal from PAR1 to G protein. This “7-8-1” interaction network was found to be prevalent in G protein-coupled receptors involved in endothelial signaling and angiogenesis.

The aim of this analysis was to determine the effects of solifenacin in patients considered overactive bladder (OAB) dry at baseline.This was a pooled analysis of 4 randomized, placebo-controlled 12-week, phase 3 studies. Patients received placebo or solifenacin 10 mg once daily (2 studies), or placebo or solifenacin 5 mg or 10 mg once daily (2 studies). A subgroup of patients without incontinence at baseline was identified from a 3-day diary. Mean changes from baseline to endpoint for urgency episodes, micturition, frequency and nocturia episodes per 24 hours, and volume voided/micturition were evaluated. The proportion of patients with normalization of micturition frequency (8 micturitions), resolution of urgency, or resolution of nocturia at endpoint was also determined.Of 2848 evaluable patients treated with placebo or solifenacin, 975 (34%) were OAB dry at baseline. Solifenacin 5 mg and 10 mg were significantly (p0.001) more effective than placebo for improving urgency, micturition frequency, and volume voided. In addition, solifenacin 10mg was significantly (p0.01) more effective than placebo for improving nocturia. Resolution of urgency occurred significantly (p0.05) more often with solifenacin 5 mg (37%) and 10 mg (33%) than with placebo (25%). Significantly (p0.01) more OAB dry patients had normalization of micturition frequency with solifenacin 5 mg (29%) and 10 mg (35%) compared with placebo (19%). Resolution of nocturia occurred in 14%, 21%, and 13% of patients treated with solifenacin 5mg, solifenacin 10 mg, and placebo, respectively (p0.01 for solifenacin 10 mg versus placebo).Solifenacin significantly improved urgency, frequency, and nocturia symptoms and increased volume voided in OAB dry patients.

Objective The purpose of this study was to determine the relative effects of pregnancy and mode of delivery on the prevalence of urinary and fecal incontinence. Study design This was a prospective, observational multicenter study of women presenting to 6 gynecology clinics. Demographic data collected included: height, weight, gravidity, parity, and number of vaginal deliveries. Patients were diagnosed with incontinence by questionnaire. Standard univariate logistic regression analyses' were performed to determine the contribution of pregnancy, mode of delivery, and BMI on the prevalence of urinary and fecal incontinence. Results One thousand and four women were enrolled over an 18-month period. Two hundred and thirty-seven and 128 subjects had urinary and fecal incontinence, respectively. Odds ratio (95% CI) calculated for the prevalence of urinary incontinence by pregnancy and mode of delivery were: any term pregnancy vs no term pregnancy was 2.46 (1.53-3.95), any term pregnancy but no vaginal deliveries (cesarean section only) vs no term pregnancy was 1.95 (0.99-3.80), any term pregnancy and at least 1 vaginal delivery vs no term pregnancy was 2.53 (1.57-4.07), and any term pregnancy but no vaginal delivery (cesarean section only) vs any term pregnancy, and at least 1 vaginal delivery was 1.30 (0.77-3.95). Odds ratio (95% CI) calculated for the prevalence of fecal incontinence by pregnancy and mode of delivery were: any term pregnancy vs no term pregnancy was 2.26 (1.22-4.19), any term pregnancy but no vaginal deliveries (cesarean section only) vs no term pregnancy was 1.13 (0.43-2.96), any term pregnancy and at least 1 vaginal delivery vs no term pregnancy was 2.41 (1.30-4.49), and any term pregnancy but no vaginal deliveries (cesarean section only) vs any term pregnancy, and at least 1 vaginal delivery was 2.15 (0.97-4.77). BMI and age did not impact these results. Conclusion Pregnancy increases the risk of urinary and fecal incontinence. Cesarean section does not decrease the risk of urinary or fecal incontinence compared to pregnancy with a vaginal delivery.

This study evaluated the efficacy and tolerability of new extended-release (ER) tolterodine for the treatment of overactive bladder in women. In this subpopulation analysis of a double-blind multicenter trial, 1235 female patients were randomized to oral therapy with tolterodine ER 4 mg once daily (n=417), tolterodine IR 2 mg twice daily (n=408) or placebo (n=410) for 12 weeks. Both formulations reduced the mean number of urge incontinence episodes per week (both P=0.001 vs placebo); tolterodine ER was more effective than tolterodine IR (P=0.036). Both formulations significantly improved all other micturition chart variables compared to placebo. Dry mouth was the most common adverse event. There were no safety concerns. Toltrodine ER 4 mg once daily is effective and well tolerated in the treatment of women with overactive bladder, and reduces urge incontinence episodes more than the existing IR twice-daily formulation.