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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

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.

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.

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

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: 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.

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.

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 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.

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.

The Prolapse Quality of Life (P-QOL) questionnaire is a specific health-related quality of life (HRQL) instrument to assess the impact of POP on women. It has been validated in English-speaking women and to date has been translated into several other languages. However, currently there is no Spanish translation of the P-QOL questionnaire. The aim of this study was to translate the P-QOL questionnaire into Spanish and to assess its feasibility, validity, and reliability. Following a forward- and back-translation of the original English P-QOL questionnaire into Spanish language, the translated questionnaire was reviewed by a group of patients as well as an expert panel to assess its comprehensibility. In this cross-sectional study women with POP symptoms were recruited from a tertiary referral teaching hospital. Women were defined as symptomatic if they report feeling a lump/bulge/pressure in the vagina. The Spanish translated P-QOL questionnaire was self-administered to all women. Reliability, content, and construct validity were evaluated using the Cronbach’s alpha coefficient, ANOVA, and Spearman’s correlation tests. One hundred and twenty-eight women were studied. There were no missing items. The Cronbach’s alpha ranged from 0.626 to 0.866 across domains, demonstrating the good reliability of the Spanish P-QOL. The severity of symptoms was related to the worst quality of life, but the severity of POP was not related to poorer QoL. The Spanish translated version of the P-QOL is a reliable, consistent and valid instrument to assess symptom severity and QoL impact in Chilean women with POP.

Objective: To determine the test-retest reliability of the cough stress test in women who present with complaints of urinary incontinence. Methods: This prospective observational study involved 50 women between the ages of 28 and 78 years with primary complaints of urinary incontinence. All subjects underwent a pelvic examination, cystometrogram, and a cough stress test. The cough stress test was performed in the standing position at a bladder volume of 300 mL or at maximum cystometric capacity if it was less than 300 mL. The results of the cough stress test were recorded as positive if urine loss occurred with a cough or as negative if no urine loss was seen and the bladder volume was recorded. The women returned in 1–4 weeks for a second cough stress test performed at the same bladder volume as at the initial examination. Results: Of the 50 women studied, 45 (90%) had similar results with both cough stress tests. Thirty-five had a positive cough stress test on the initial examination, and 32 of these patients (91%) also had a positive cough stress test at a repeat visit. Fifteen patients had a negative initial cough stress test, and 13 of these 15 (87%) had a negative cough stress test on repeat examination. All 20 patients diagnosed as having pure genuine stress incontinence had a positive cough stress test on initial and repeat examinations. Of the 15 patients diagnosed with detrusor instability or sensory urge incontinence, 13 (86%) had negative cough stress tests on initial and repeat examinations. Of the 15 patients diagnosed with mixed incontinence, 12 (80%) had positive cough stress tests on initial and repeat examinations. Conclusion: The cough stress test appears to be a reliable test. The reliability is more consistent in women with a diagnosis of pure genuine stress incontinence.

The aim of the study was, to determine whether maximum cystometric capacity accurately reflects the maximum functional bladder volume in women with urinary incontinence. We performed a retrospective chart review involving 85 women between the ages of 22 and 89 with primary complaints of urinary incontinence. The maximum cystometric capacity as determined by cystometry was compared with the maximum environmental voided volumes as recorded in a 24-hour voiding diary, using Pearson's correlation coefficients and paired t-tests. Patients diagnosed as having a small bladder capacity (300 ml maximum volume) based on cystometry were also examined with contingency table analysis to determine whether the bladder volumes in the voiding diaries supported the diagnosis of a small bladder. In 85 subjects the average maximum cystometric capacity was 14.7% less than the maximum volume recorded in the voiding diary. The correlation between the maximum cystometric capacity and maximum functional bladder volume was r = 0.473 (P0.001). However, there was a statistically significant difference between the two volumes by paired t-test analysis (P = 0.006). Using cystometry to diagnose small bladder capacity showed a sensitivity of 62.9% and a specificity of 71.2% when using voiding diary volumes as the criterion standard. The positive predictive value was 51.4% and the negative predictive value was 84.0%. These results suggest that whereas the maximum bladder capacity measured by cystometry correlates with maximum environmental bladder capacity as determined by 24-hour voiding diaries, there is a statistically significant difference. The diagnosis of a small bladder should not be based on office cystometry alone.

Objective: To determine if a cystometrogram performed using the intrauterine pressure channel of a fetal monitor can be used to screen for detrusor instability in women undergoing evaluation for urinary incontinence. Methods: Sixty-six women with primary complaints of urinary incontinence were randomized to have a cystometrogram performed at their initial visit with a multichannel electronic cystometer or with the intrauterine pressure channel of a fetal monitor. Subjects underwent a second cystometrogram 1–4 weeks later with the alternative technique. The results were analyzed with χ 2 analysis and correlation coefficients. Results: Twenty-two subjects had detrusor instability diagnosed by the multichannel electronic cystometer. The fetal monitor cystometrogram was 91% sensitive and 86% specific in detecting detrusor instability, and had a 77% positive predictive value and a 95% negative predictive value. The correlation coefficients between the two examinations for bladder volume at first sensation, maximum capacity, volume at first contraction, and intensity of uninhibited detrusor contraction were r = 0.51, r = 0.69, r = 0.87, and r = 0.79, respectively; all of these were statistically significant. Conclusion: The intrauterine pressure channel of a fetal monitor can be used reliably to perform a cystometrogram to screen for detrusor instability in patients presenting with complaints of urinary incontinence.

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.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 with0 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.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 P0.005). Diary-dry rates in women were significantly greater with fesoterodine (63%) than with tolterodine (57%; P = 0.002) or placebo (48%; P0.0001). 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 P0.04). 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,1%; ER tolterodine,1%; placebo, 0%) and men (fesoterodine, 2%; ER tolterodine1%; placebo, 2%).This analysis supports the superiority of fesoterodine 8 mg over ER tolterodine 4 mg on diary endpoints, including UUI, symptom bother and health-related quality of life in women. In men, fesoterodine 8 mg was superior to ER tolterodine 4 mg for improving severe urgency and symptom bother.

Objective To determine the sensitivity and specificity of several urodynamic testing methods in the diagnosis of genuine stress urinary incontinence (GSI). Methods One hundred eight consecutive patients were evaluated prospectively by history and physical examination, cough stress test, and single and multichannel urodynamics. Sensitivities and specificities in detecting genuine stress incontinence were calculated for: a positive cough stress test with a negative cystometrogram, equalization throughout a cough urethral pressure profile, a positive stress leak-point pressure determination, observed urine loss with cough during multichannel urodynamics, and a pressure transmission ratio of less than 90% for each third of the urethra. Results Sixty-five patients (60%) were found to have GSI. Observed urine loss with cough during multichannel studies was 91% sensitive and 1007c specific. A positive stress leak-point pressure determination had a 78% sensitivity and was 100% specific. A positive cough stress test with a negative cystometrogram was 77% sensitive and 100% specific. Pressure equalization throughout the length of the urethra during a cough urethral pressure profile was 49% sensitive and 98% specific. A pressure transmission ratio of less than 90% in the distal, middle, and proximal urethra had sensitivities and specificities of 54 and 79%, 51 and 65%, and 45 and 58%, respectively. A pressure transmission ratio of less than 90% along the entire length of the urethra was 22% sensitive and 93% specific. Conclusion Observed urine loss with cough during multichannel urodynamics was the best examination for diagnosing GSI in our population.

To determine the correlation between the maximal urethral closure pressure and the stress leak-point pressure in patients with genuine stress incontinence, and to define a critical stress leak-point pressure value to detect patients with a low-pressure urethra, as defined by a maximal urethral closure pressure less than 20 cm H2O.Fifty-nine patients with genuine stress incontinence were evaluated prospectively with multichannel urodynamics. Maximal urethral closure pressures and stress leak-point pressures were determined and correlated. Several stress leak-point pressure values were evaluated by contingency tables to detect a critical level for detecting a low-pressure urethra.There is a statistically significant relationship (P.0001) between the stress leak-point pressure and the maximal urethral closure pressure. However, a correlation coefficient of 0.56 demonstrates poor clinical relationship. A stress leak-point pressure less than or equal to 45 cm H2O was found to be 80% sensitive and 90% specific in diagnosing a low-pressure urethra. A stress leak-point pressure less than or equal to 60 cm H2O was 90% sensitive and 64% specific in detecting a low-pressure urethra.The stress leak-point pressure has poor clinical correlation to the maximal urethral closure pressure. A stress leak-point pressure less than or equal to 45 cm H2O has adequate sensitivity and specificity to diagnose a low-pressure urethra. A value less than or equal to 60 cm H2O would be an appropriate cutoff level to screen for those patients at risk of having a low-pressure urethra in need of further evaluation.

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.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.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.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.

The purpose of this study was to determine if anesthesia with neuromuscular blockade alters the Pelvic Organ Prolapse Quantification (POP-Q) examination. A prospective, multi-center trial was conducted of women undergoing pelvic surgery. A POP-Q examination performed pre-operatively was compared with an examination performed intra-operatively under neuromuscular blockade. For the latter examination, an Allis clamp was used to apply gentle traction until the point being examined did not undergo further descent. International Continence Society (ICS) stages and individual POP-Q points were compared using a paired sample t test. A sample size of 32 provided 80% power to detect a clinically significant difference between office and operating room measurements (Sample Power, SPSS, 1997). Of 153 women, 76% received general endotracheal anesthesia and 21% laryngeal mask airway. With an increase of 3 cm, the apical compartment was significantly more prolapsed in the operating room (OR; p

This study was conducted to determine the differences in the inter-observer agreement of the simplified Pelvic Organ Prolapse Quantification (POP-Q) system from center to center in a large international multicenter study. This is a secondary analysis of the results of a large prospective single blind multicenter trial studying the inter-observer agreement of a simplified POP-Q exam. Twelve centers from four continents with a total of 511 subjects were included in this study. The number of subjects recruited per center ranged from 20 to 81. Each patient was independently examined by two investigators, with examination order randomly assigned and investigators blinded to each other’s result. The weighted kappa statistic was used to evaluate the inter-observer agreement. Good and significant associations were observed on the anterior, posterior, and apical segments. Six out of 11 sites did not provide adequate number of subjects with prior hysterectomy for weighted kappa statistics or achieve significance regarding vaginal cuff measurement. The simplified POP-Q demonstrated good inter-examiner agreement across multiple centers.

The aim of this study was to evaluate the validity and reliability of a Persian translation of the Prolapse Quality-of-Life (P-QOL) questionnaire in women with pelvic organ prolapse (POP). One hundred and twenty-four women with POP symptoms and 125 asymptomatic women were studied. The asymptomatic group was used for discriminant validity. Seventy-two percent (89/124) of the symptomatic women had stage ≥2 POP while 86% (108/125) of the asymptomatic women had a stage

The primary aim of this study was to evaluate the inter-examiner agreement of a previously described simplified pelvic organ prolapse quantification (S-POP) system in a multicenter, prospective, randomized, blinded fashion. Pelvic organ prolapse quantification (POPQ) system’s use in daily practice is hampered due to perceived complexity and difficulty of use. The S-POP was introduced in order to make the POPQ user-friendly and increase its usage (Swift et al. in Int Urogynecol J 17(6):615–620, 2006). Five hundred eleven subjects underwent two separate pelvic exams in random order by two blinded examiners employing the S-POP at 12 centers around the world. Data were compared using weighted kappa statistics. The weighted kappa statistics for the inter-examiner reliability of the S-POP were 0.87 for the overall stage, 0.89 and 0.81 for the anterior and posterior vaginal walls, 0.82 for the apex/cuff 0.89, and 0.84 for the cervix and vaginal fornix, respectively. There is an almost perfect inter-examiner agreement of the S-POP system for the overall stage and each point within the system.

The objective of this study is to determine the association between the POPQ and a simplified version of the POPQ.This was an observational study. The subjects with pelvic floor disorder symptoms underwent two exams: a POPQ exam and a simplified POPQ. To compare with the simplified POPQ, vaginal segments of the POPQ exam were defined using points Ba, Bp, C, and D. Primary outcome was the association between the overall ordinal stages from each exam.One hundred forty-three subjects with mean age of 56 +/- 13 years. Twenty three subjects were status post-hysterectomy. The Kendall's tau-b statistic for overall stage was 0.80, for the anterior vaginal wall the Kendall's tau-b was 0.71, for the posterior vaginal wall segment the Kendall's tau-b was 0.71, for the cervix the Kendall's tau-b was 0.88, for the posterior fornix/vaginal cuff the Kendall's tau-b was 0.85.There is substantial association between the POPQ and a simplified version of the POPQ.

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).In this 12-week double-blind, double-dummy, placebo-controlled, randomized clinical trial, eligible patients reported OAB symptoms foror = 3 months and recordedor = 8 voids andor = 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.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; P0.001). Fesoterodine also produced significantly greater improvements than tolterodine ER in MVV (P = 0.005). Fesoterodine significantly improved all diary endpoints compared with placebo (P0.001), except for nocturnal voids (P = 0.327). Tolterodine ER significantly improved all diary endpoints vs placebo (P0.001), except for nocturnal voids (P = 0.506) and MVV (P = 0.103). Diary dry rates (the proportion of patients reporting no UUI episodes at endpoint among those with one or more UUI episodes at baseline) were significantly higher with fesoterodine (64%) than with tolterodine ER (57%; P = 0.015) and placebo (45%; P0.001). Improvements in PPBC, UPS and OAB-q scale and domain scores at week 12 were all significantly better with fesoterodine than placebo (all P0.001) and tolterodine ER (all P0.05) except for the OAB-q Sleep domain vs tolterodine ER (P = 0.081). Dry mouth and constipation rates were 28% and 5% in the fesoterodine group, 16% and 4% in the tolterodine ER group, and 6% and 3% with placebo, respectively. Discontinuations due to treatment-emergent adverse events were 6%, 4% and 2% in the fesoterodine, tolterodine ER, and placebo groups, respectively.In patients with OAB, fesoterodine 8 mg showed superior efficacy over tolterodine ER 4 mg and placebo in reducing UUI episodes (primary endpoint) and in improving most patient-reported outcome measures. Both active treatments were well tolerated.

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 ≥5 on the Patient Perception of Bladder Condition (PPBC) scale at baseline (on tolterodine extended release [ER] 4mg/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 4mg/day for ≥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 4mg/day). After ≥14 days’ washout, patients received oral solifenacin 5mg/day, with the option of continuing/adjusting the dose to 5 or 10mg/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

Objective The objective of this investigation was to test the ability of a feedforward artificial neural network (ANN) to differentiate patients who have pelvic organ prolapse (POP) from those who retain good pelvic organ support. Study Design Following institutional review board approval, patients with POP (n = 87) and controls with good pelvic organ support (n = 368) were identified from the urogynecology research database. Historical and clinical information was extracted from the database. Data analysis included the training of a feedforward ANN, variable selection, and external validation of the model with an independent data set. Results Twenty variables were used. The median-performing ANN model used a median of 3 (quartile 1:3 to quartile 3:5) variables and achieved an area under the receiver operator curve of 0.90 (external, independent validation set). Ninety percent sensitivity and 83% specificity were obtained in the external validation by ANN classification. Conclusion Feedforward ANN modeling is applicable to the identification and prediction of POP.

To determine which patients, based on selected patient, physician and visit information, were more likely to accept medical student participation in an outpatient visit.A cross-sectional study conducted at a university-based private practice, evaluated 560 patients presenting for routine outpatient obstetric or gynecologic care. Participants completed a consent form regarding medical student participation in their visit. Patient, visit and physician demographic variables were abstracted. Comparison groups were those patients who accepted vs. those who refused medical student involvement.The majority of patients (75.8%) accepted student participation in their care. Patients who were black, were new to the office, were scheduled to see junior faculty and were evaluated for a vaginal discharge were more likely to refuse student participation. Patients seen for urinary incontinence were more likely to agree to medical student participation.The majority of patients consented to medical student involvement. Using a brief survey, we identified patients who are more likely to allow medical students to participate in their visit. We will continue to query all patients regarding medical student teaching but will assign medical students accordingly to maximize their learning experience. We will also educate patients on the benefits of including medical students in the outpatient visit.

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.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, and25% 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.Of 119 women with Bpor = -1.00, 47% reported no constipation symptoms. Hard/lumpy stools (26%), incomplete emptying (24%), and straining (24%) were more prevalent; fewer women reported2 BMs/week (15%) or digitation (7%). Constipation scores were weakly correlated with Bp, gh+pb (both r.1, P.02). Women reportingor = 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.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.

Objective The purpose of this study was to describe the distribution of pelvic organ support in a gynecologic clinic population to define the clinical disease state of pelvic organ prolapse and to analyze its epidemiologic condition. Study design This was a multicenter observational study. Subjects who were seen at outpatient gynecology clinics who required an annual gynecologic examination underwent a pelvic organ prolapse quantification examination and completed a prolapse symptom questionnaire. Receiver operator characteristic curves were used to define pelvic organ prolapse with the use of symptoms and pelvic organ prolapse quantification examination measures. Standard age-adjusted univariate and multivariate logistic regression analysis were used to evaluate various relationships. Results The population consisted of 1004 women who were aged 18 to 83 years. The prevalence of pelvic organ prolapse quantification stages was 24% (stage 0), 38% (stage 1), 35% (stage 2), and 2% (stage 3). The definition of pelvic organ prolapse that was determined by the receiver operator characteristic curve was the leading edge of their vaginal wall that was −0.5 cm above the hymenal remnants. Multivariate analysis revealed age, Hispanic race, increasing body mass index, and the increasing weight of the vaginally delivered fetus as risk factors for pelvic organ prolapse, as defined in this population. Conclusion The results from this population suggest that there is a bell-shaped distribution of pelvic organ support in a gynecologic clinic population. Advancing age, Hispanic race, increasing body mass index, and the increasing weight of the vaginally delivered fetus have the strongest correlations with prolapse.

OBJECTIVE: The purpose of this study was to evaluate the correlation between the symptoms of pelvic organ prolapse and the stage of support as determined by the pelvic organ prolapse quantification system. STUDY DESIGN: Four hundred ninety-seven women who were seen for annual gynecologic examinations were recruited. Subjects underwent a pelvic examination and their degree of pelvic support was described according to the pelvic organ prolapse quantification system. They also completed a seven-question questionnaire regarding common symptoms of pelvic organ prolapse. Trend analysis was accomplished with linear regression. RESULTS: Only 477 subjects correctly responded to the questionnaire. They were aged 18 to 82 years (mean age, 44 years). Forty-seven percent were white, 52% were African American, and 1% were of another racial group. The number of subjects with the various pelvic organ prolapse quantification stages were stage 0 (18 subjects), stage I (214 subjects), stage II (231 subjects), and stage III (14 subjects). No subject had stage IV prolapse. The average number of positive responses per subject for the symptoms was 0.27 for stage 0, 0.55 for stage I, 0.77 for stage II, and 2.1 for stage III. This trend did not attain statistical significance. The correlation of symptoms with the leading edge of the prolapse revealed that the average number of symptoms that were reported per subject increased from 1 when the leading edge of the prolapse extended beyond the hymenal remnants. This trend was statistically significant. CONCLUSION: Women with pelvic organ prolapse with the leading edge of the prolapse beyond the hymenal remnants (some stage II and all stage III) have increased symptoms, which may help define symptomatic pelvic organ prolapse.

Objective: This study was undertaken to describe the distribution of pelvic organ support stages in a population of women seen at outpatient gynecology clinics for routine gynecologic health care. Study Design: This was an observational study. Women seen for routine gynecologic health care at four outpatient gynecology clinics were recruited to participate. After informed consent was obtained general biographic data were collected regarding obstetric history, medical history, and surgical history. Women then underwent a pelvic examination. Pelvic organ support was measured and described according to the pelvic organ prolapse quantification system. Stages of support were evaluated by variable for trends with Pearson χ 2 statistics. Results: A total of 497 women were examined. The average age was 44 years, with a range of 18 to 82 years. The overall distribution of pelvic organ prolapse quantification system stages was as follows: stage 0, 6.4%; stage 1, 43.3%; stage 2, 47.7%; and stage 3, 2.6%. No subjects examined had pelvic organ prolapse quantification system stage 4 prolapse. Variables with a statistically significant trend toward increased pelvic organ prolapse quantification system stage were advancing age, increasing gravidity and parity, increasing number of vaginal births, delivery of a macrosomic infant, history of hysterectomy or pelvic organ prolapse operations, postmenopausal status, and hypertension. Conclusion: The distribution of the pelvic organ prolapse quantification system stages in the population revealed a bell-shaped curve, with most subjects having stage 1 or 2 support. Few subjects had either stage 0 (excellent support) or stage 3 (moderate to severe pelvic support defects) results. There was a statistically significant trend toward increased pelvic organ prolapse quantification system stage of support among women with many of the historically quoted etiologic factors for the development of pelvic organ prolapse. (Am J Obstet Gynecol 2000;183:277-85.)

Objective: To determine if there is a significant difference in the degree of pelvic organ prolapse assigned during examination in the standing position compared with the dorsal lithotomy position with the patient performing maximal Valsalva maneuver. Methods: Fifty-one women with symptoms of pelvic organ prolapse were examined in both the dorsal lithotomy position, while performing maximal Valsalva, and in the standing position at the same visit by one of two examiners. Nine site-specific measures and summary stages were recorded, as outlined by the International Continence Society’s classification system for pelvic organ prolapse. The data were analyzed by Wilcoxon signed-rank test and correlation coefficients. Results: The mean age was 52 ± 15 years. Excellent correlation was noted between all six points representing the vaginal prolapse. The R values for point Aa were 0.97, Ba 0.96, C 0.98, Ap 0.97, Bp 0.96, and D 0.97. The total vaginal length, perineal body, and genital hiatus measurements were performed in the dorsal lithotomy position with the patient at rest and were not repeated. The stages were identical in 48 of 51 patients. The average stage in the dorsal lithotomy position was 2.3 and in the standing position, 2.3. There was no statistically significant difference between the stage or any of the measured points in the dorsal lithotomy and standing examinations. Conclusion: The degree of pelvic organ prolapse can be assessed adequately in the dorsal lithotomy position with the patient performing maximal Valsalva. It is not necessary to routinely repeat the examination in the standing position.

OBJECTIVE: Our purpose was to determine the intraobserver and interobserver reliability of site-specific measurements and stages with the proposed International Continence Society, Society of Gynecologic Surgeons, and American Urogynecologic Society 1994 draft prolapse terminology document. STUDY DESIGN: Women who completed informed consent procedures underwent pelvic examinations by two investigators, each blinded to the results of the other's examination. The reproducibility of the nine site-specific measurements and the summary stage and substage were analyzed with Spearman's correlation coefficient ( r s ) and Kendel τ B Correlation Coefficient ( τ b ), respectively. Similar analyses were performed on supine and upright examinations performed at two different times by one examiner. RESULTS: Experienced examiners averaged 2.05 minutes per examination and new examiners averaged 3.73 minutes. In the study of interobserver reliability, 48 subjects, mean age 61 ± 14 years, parity 3 ± 2, weight 74 ± 31 kg, comprised the study population. Correlations for each of the nine measurements were substantial and highly significant ( r s 0.817, 0.895, 0.522, 0.767, 0.746, 0.747, 0.913, 0.514, and 0.488, p = 0.0008 to τ b 0.702 and 0.652). In no subject did the stage vary by more than one; in 69% stages were identical. In the study of intraobserver reliability, for 25 subjects correlations for each of the nine measurements were equally strong ( r s 0.780, 0.934, 0.765, 0.759, 0.859, 0.826, 0.812, 0.659, 0.431). Measurements from the upright examinations reflected greater prolapse. Staging and substaging were highly reproducible ( τ b 0.712 and 0.712). In no subject did the stage vary by more than one; in 64% stages were identical. All stage discrepancies represented an increase in the upright position. CONCLUSIONS: There is good reproducibility of measures with the proposed system. The data suggest that the reliability is independent of examiner experience. Patient position is likely important in maximizing the severity of the prolapse. (Am J Obstet Gynecol 1996;175:1467-71.)

Objective The purpose of this study was to determine if there is any difference between AM and PM POPQ exam results. Study Design Prospective, IRB approved study of women presenting with pelvic organ prolapse symptoms. Initial POPQ exams were performed in the morning or afternoon; a second exam was performed within 4 weeks at the opposite time of day. Statistical analysis included Wilcoxon signed rank test, paired t test, Spearman correlation, and Stuart-Maxwell test. Results The study consisted of 32 subjects. Mean age was 58.8 years, mean BMI 28.6, median parity 2.0, 75% white, 22% black, and 3% Hispanic. The POPQ exam stages were 47% stage II, 50% stage III, and 3.0% stage IV. There was no significant difference for the 9 POPQ exam measures between morning and afternoon exams. There was good agreement between AM and PM POPQ ordinal stages (Stewart Maxwell P = 1.0, kappa 0.76). Conclusion There is no difference between AM and PM POPQ exam results.