Factors affecting patient choice for continued observation versus intervention for pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: 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. METHODS: 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. RESULTS: 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 < 0.001) after confounding factors were controlled for using multivariate regression analysis. CONCLUSION: In subjects with bothersome POP who initially choose observation and subsequently elect to pursue a therapeutic intervention, worsening symptom bother is the most important factor.

Transcultural translation and validation of the FIGO Assessment Scoring System (FASS) to Portuguese language.

INTRODUCTION AND HYPOTHESIS: 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. METHODS: 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 < 0.05 was considered statistically significant. RESULTS: The calculated Cronbach's alpha coefficient was 0.76, indicating strong reliability for the validation sample. Symptomatic women had different scores on all FASS items as well as total score when compared with asymptomatic women (p < 0.001). Intraobserver coefficient ranged from 0.91 (urinary symptoms) to 0.98 (FASS total score), indicating excellent concordance level in all items. Interobserver coefficient ranged from 0.47 (intestinal symptoms) to 0.90 (FASS total score), indicating moderate to excellent correlation. CONCLUSIONS: The psychometric properties tested in the FASS Portuguese version proved to be a valid and reliable for evaluating signs and symptoms related to pelvic floor function in Brazilian women.

Standing Vs Supine; Does it Matter in Cough Stress Testing?

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.

An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint terminology and classification of the complications related to native tissue female pelvic floor surgery.

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, colour 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.

International Urogynecological Association (IUGA)/International Continence Society (ICS) joint terminology and classification of the complications related to native tissue female pelvic floor surgery.

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.

An International Urogynecological Association (IUGA) / International Continence Society (ICS) joint terminology and classification of the complications related directly to the insertion of prostheses (meshes, implants, tapes) & grafts in female pelvic floor surgery.

INTRODUCTION AND HYPOTHESIS: 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. METHODS: 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). RESULTS: 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 ). CONCLUSIONS: 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.

An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint terminology and classification of the complications related directly to the insertion of prostheses (meshes, implants, tapes) and grafts in female pelvic floor surgery.

INTRODUCTION AND HYPOTHESIS: 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. METHODS: 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). RESULTS: 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). CONCLUSION: A consensus-based terminology and classification report for prosthesis and grafts complications in female pelvic floor surgery has been produced, aimed at being a significant aid to clinical practice and research.

An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction.

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 International Organizations, the International Urogynecological Association (IUGA) and the International Continence Society (ICS), assisted at intervals by many external referees. Appropriate core clinical categories and a subclassification were developed to give an alphanumeric coding to each definition. An extensive process of 15 rounds of internal and external review was developed to exhaustively examine each definition, with decision-making by collective opinion (consensus). RESULTS: A terminology report for female pelvic floor dysfunction, encompassing over 250 separate definitions, has been developed. It is clinically based with the six most common diagnoses defined. Clarity and user-friendliness have been key aims to make it interpretable by practitioners and trainees in all the different specialty groups involved in female pelvic floor dysfunction. Female-specific imaging (ultrasound, radiology, and MRI) has been a major addition while appropriate figures have been included to supplement and help clarify the text. Ongoing review is not only anticipated but will be required to keep the document updated and as widely acceptable as possible. CONCLUSIONS: A consensus-based terminology report for female pelvic floor dysfunction has been produced aimed at being a significant aid to clinical practice and a stimulus for research.

An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction.

INTRODUCTION: 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 international organizations, the International Urogynecological Association (IUGA), and the International Continence Society (ICS), assisted at intervals by many external referees. Appropriate core clinical categories and a subclassification were developed to give an alphanumeric coding to each definition. An extensive process of 15 rounds of internal and external review was developed to exhaustively examine each definition, with decision-making by collective opinion (consensus). RESULTS: A terminology report for female pelvic floor dysfunction, encompassing over 250 separate definitions, has been developed. It is clinically based with the six most common diagnoses defined. Clarity and user-friendliness have been key aims to make it interpretable by practitioners and trainees in all the different specialty groups involved in female pelvic floor dysfunction. Female-specific imaging (ultrasound, radiology, and MRI) has been a major addition while appropriate figures have been included to supplement and help clarify the text. Ongoing review is not only anticipated but will be required to keep the document updated and as widely acceptable as possible. CONCLUSION: A consensus-based terminology report for female pelvic floor dysfunction has been produced aimed at being a significant aid to clinical practice and a stimulus for research.

Diary and patient-reported outcomes in patients with severe overactive bladder switching from tolterodine extended release 4 mg/day to solifenacin treatment: An open-label, flexible-dosing, multicentre study.

OBJECTIVE: We report outcomes from the VERSUS (VESIcare Efficacy and Research Study US) study in a cohort with severe overactive bladder (OAB), defined as patients with a score >or=5 on the Patient Perception of Bladder Condition (PPBC) scale at baseline (on tolterodine extended release [ER] 4 mg/day) who remained severe at post-washout (on no drug). METHODS: VERSUS was a 12-week, open-label, flexible-dosing study assessing the efficacy, tolerability and effects on health-related quality of life (HRQOL) of solifenacin in patients with OAB. The current study is a post hoc analysis of a severely affected subgroup, as self-defined using the PPBC scale. Patients had received tolterodine ER 4 mg/day for >or=4 weeks but wished to switch therapy because of a lack of sufficient subjective improvement in urgency. They had to have continued to have three or more urgency episodes/24 hours at baseline (pre-washout, i.e. while taking tolterodine ER 4 mg/day). After >or=14 days' washout, patients received oral solifenacin 5 mg/day, with the option of continuing/adjusting the dose to 5 or 10 mg/day at weeks 4 and 8. Diary-documented improvements in urgency, urge incontinence, frequency, nocturia and nocturnal voids were compared with pre-washout (on tolterodine) and post-washout (on no drug) diary entries. The PPBC scale and Overactive Bladder Questionnaire (OAB-q) assessed patient-reported outcomes. Tolerability was evaluated based on the nature, frequency and severity of observed or reported adverse events (AEs). RESULTS: In this severe OAB cohort, the mean number of urgency episodes/24 hours decreased by 3.95 (95% CI -4.81, -3.08; p < 0.0001) from pre-washout (7.38) to study end (3.26). All other diary variables were also significantly reduced (p < 0.0001). Patients had a mean PPBC score of 5.3 at pre-washout and 3.6 at study end, representing an improvement of 1.7 (95% CI -2.0, -1.5; p < 0.0001). Patients also reported significant improvements for all OAB-q scales and domains (p < 0.0001). Treatment-emergent AEs were mostly mild/moderate, and resulted in few discontinuations (5/116, 4.3%). CONCLUSION: In patients with severe OAB symptoms, solifenacin was effective and well tolerated. Solifenacin improved urgency, incontinence, micturition frequency, nocturia and nocturnal voids in patients continuing to experience urgency episodes on tolterodine ER 4 mg/day. Patients experienced improvements in HRQOL and perceived bother from OAB.

Institution and validation of an observed structured assessment of technical skills (OSATS) for obstetrics and gynecology residents and faculty.

OBJECTIVE: This study was undertaken to further evaluate the construct validity of the observed structured assessment of technical skills (OSATS) by comparing resident scores to faculty scores. STUDY DESIGN: This study is a prospective blinded observational study. Four residents from each year (1-4) and 5 faculty members were examined. The OSATS examination was in the form of a dry laboratory with 10 stations: 4 laparoscopic and 6 open surgical skills. The sessions were videotaped and graded by the senior authors who used a task-specific checklist. The scoring of the videos was performed by the 2 senior authors blinded to the other examiners results. The examinations were videotaped, and the identity of the participants was blinded. The scores for each station were determined by adding all the numbers from the skills rating with a time score. Higher scores denote superior performance. Statistical analysis was performed with a nonparametric test (Kruskal-Wallis) for a total score with resident years divided into junior residents (first and second year), senior residents (third and fourth year), and faculty status as the independent variable. To determine the interrelater reliability between the 2 scores, the Kendall tau beta statistic was used. RESULTS: The results show definite trends for 7 stations, with junior residents performing the worst and faculty performing the best. This trend was statistically significant for 6 of the 10 stations. CONCLUSION: The OSATS examination has good construct validity that extends beyond residency to faculty.

Prevalence of severe pelvic organ prolapse in relation to job description and socioeconomic status: a multicenter cross-sectional study.

The aim of this study was to determine if certain occupations or socioeconomic levels are associated with pelvic organ prolapse. Investigators at six American sites performed pelvic organ prolapse quantification examinations on women presenting for routine gynecologic care. Between September 1999 and March 2002, 1,004 patients were examined. Severe pelvic organ prolapse was defined as the leading edge being 1 cm or more beyond the hymeneal ring. The data was analyzed with the Kruskal-Wallis analysis of variance, Bonferroni test, multiple logistic regression, and descriptive statistics. The prevalence of severe pelvic organ prolapse in our group was 4.3%. Women who were laborers/factory workers had significantly more severe prolapse than the other job categories (p < 0.001). Women with annual income of Dollars 10,000 or less had significantly more severe pelvic organ prolapse than other income groups (p < 0.001). These differences persisted even when controlling for age, race, number of deliveries, body mass index >30, and smoking status (all p < 0.001). Laborers/factory worker jobs and an annual household income of Dollars 10,000 or less are associated with severe pelvic organ prolapse.

The effect of pregnancy and mode of delivery on the prevalence of urinary and fecal incontinence.

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.

Pelvic Organ Support Study (POSST) and bowel symptoms: straining at stool is associated with perineal and anterior vaginal descent in a general gynecologic population.

OBJECTIVE: The purpose of this study was to evaluate the association of constipation symptoms and anal incontinence with vaginal wall and pelvic organ descent in a general gynecologic population. STUDY DESIGN: In this multicenter, cross-sectional study, 1004 women attending routine gynecologic healthcare underwent pelvic organ prolapse quantification (POPQ) measurements, and were surveyed regarding anal incontinence, digitation, < 2 bowel movements (BMs)/week, and > 25% frequency of: straining, hard/lumpy stools, and incomplete emptying. Constipation scores reflected the sum of positive responses. Associations between POPQ measurements (Ba, C, Bp, gh+pb), constipation scores, and anal incontinence were evaluated using multivariable regression. RESULTS: Of 119 women with Bp > or = -1.00, 47% reported no constipation symptoms. Hard/lumpy stools (26%), incomplete emptying (24%), and straining (24%) were more prevalent; fewer women reported < 2 BMs/week (15%) or digitation (7%). Constipation scores were weakly correlated with Bp, gh+pb (both r < .1, P < .02). Women reporting > or = 2 symptoms had greater gh+pb measurements than women reporting 0 or 1 symptom (P = .03). Women with anal incontinence had greater gh+pb and gh values than women without anal incontinence (P < .01). POPQ measurements were regressed separately onto (1) total constipation scores, (2) dichotomized scores, and (3) individual symptoms, with BMI, age, number of vaginal deliveries (NVD), weight of largest vaginal delivery (WLVD), race, hysterectomy, study site, and income included as covariates. Total constipation scores and dichotomized scores were nonsignificant in all models. With regard to individual symptoms, straining at stool was significant in the models for Ba and gh+pb, with greater Ba and gh+pb measurements among strainers relative to nonstrainers. CONCLUSION: Most associations between bowel symptoms and vaginal or pelvic organ descent were weak. After controlling for important covariates, straining at stool remained associated with anterior vaginal wall and perineal descent.