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Purpose Few studies have characterized longer-term outcomes after retropubic and transobturator mid urethral slings. Materials and Methods Women completing 2-year participation in a randomized equivalence trial who had not undergone surgical re-treatment for stress urinary incontinence were invited to participate in a 5-year observational cohort. The primary outcome, treatment success, was defined as no re-treatment or self-reported stress incontinence symptoms. Secondary outcomes included urinary symptoms and quality of life, satisfaction, sexual function and adverse events. Results Of 597 women 404 (68%) from the original trial enrolled in the study. Five years after surgical treatment success was 7.9% greater in women assigned to the retropubic sling compared to the transobturator sling (51.3% vs 43.4%, 95% CI −1.4, 17.2), not meeting prespecified criteria for equivalence. Satisfaction decreased during 5 years but remained high and similar between arms (retropubic sling 79% vs transobturator sling 85%, p=0.15). Urinary symptoms and quality of life worsened with time (p <0.001), and women with a retropubic sling reported greater urinary urgency (p=0.001), more negative impact on quality of life (p=0.02) and worse sexual function (p=0.001). There was no difference in the proportion of women experiencing at least 1 adverse event (p=0.17). Seven new mesh erosions were noted (retropubic sling 3, transobturator sling 4). Conclusions Treatment success decreased during 5 years for retropubic and transobturator slings, and did not meet the prespecified criteria for equivalence with retropubic demonstrating a slight benefit. However, satisfaction remained high in both arms. Women undergoing a transobturator sling procedure reported more sustained improvement in urinary symptoms and sexual function. New mesh erosions occurred in both arms over time, although at a similarly low rate. [ABSTRACT FROM AUTHOR]

Aims This study examined the association between the need for a repeat voiding trial after midurethral sling (MUS) surgery and 1-year success rates. Methods We conducted this secondary analysis of the participants in the Urinary Incontinence Treatment Network trial of midurethral sling (TOMUS) study which compared retropubic versus transobturator MUS. A standard voiding trial was attempted on all subjects. The 'repeat voiding trial' group included subjects discharged with catheterization. All others were considered 'self voiding.' Success rates between the groups at 1-year were compared, followed by multivariate analyses controlling for previously reported clinical predictors of success. Results Most women (76%) were self-voiding, while 24% required a repeat voiding trial. The objective success rate at 1-year was 85.8% in the repeat voiding trial group and 75.3% in the self-voiding group ( P = 0.01). Subjective success rate at 1-year was 61.0% in the repeat voiding trial group and 55.1% in the self-voiding group ( P = 0.23). Women in the repeat voiding trial group continued to demonstrate greater objective success than the self-voiding group in multivariate analysis that controlled for previous incontinence surgery, pad weight, urethral mobility, urge score, and type of MUS ( P = 0.04, OR 1.82, 95% CI 1.03-3.22). Conclusions Women who require a repeat voiding trial following MUS surgery have greater objective success at 1-year postoperatively when compared to those who are self-voiding at the time of discharge. These results may help reassure women who require catheterization after MUS surgery that their outcome is not compromised by this immediate transient post-operative result. Neurourol. Urodynam. 33:1225-1228, 2014. © 2013 Wiley Periodicals, Inc. [ABSTRACT FROM AUTHOR]

Purpose We investigated age related changes in urodynamic parameters in 2 large cohorts of women planning stress urinary incontinence surgery. Materials and Methods Using a standardized protocol we obtained urodynamic parameters for participants in SISTEr (Stress Incontinence Surgical Treatment Efficacy Trial) and TOMUS (Trial of Mid-Urethral Slings) undergoing baseline noninvasive flow followed by filling cystometrogram and pressure flow study. The bladder contractility index (defined as detrusor pressure at maximum flow + 5 x maximum flow) and detrusor hypocontractility (defined as detrusor pressure at maximum flow less than 10 cm H2O) were also characterized. Patients excluded from analysis had undergone prior stress urinary incontinence surgery or had prolapse stage greater than II. Propensity score analysis controlled for the potential bias of combining participants from 2 clinical trials. Linear and logistic regression analysis adjusting for propensity score quintile was done to assess the association of age and an age cutoff (less than 65 vs 65 or greater years) with urodynamic parameters. Results A total of 945 women (468 in SISTEr and 477 in TOMUS) were included in analysis. Mean age was 50 years in SISTEr (range 27 to 75) and 51 years (range 24 to 82) in TOMUS. Noninvasive maximum urinary flow decreased significantly with age (26.2 vs 22 ml per second, p = 0.002). Noninvasive flow voiding time increased 2.7 seconds for each 10-year age increment and detrusor pressure at maximum flow decreased 2.1 cm H2O for each 10-year increase in age (each p = 0.003). Hypocontractility was more likely in women 65 years old or older (OR 2.89, 95% CI 1.59, 5.27). The bladder contractility index was inversely related to age, decreasing a mean ± SD of 7.68 ± 1.96 cm H2O for each 10-year age increase (p <0.001). Conclusions In these 2 cohorts the observed changes in voiding parameters suggest that detrusor contractility and efficiency decrease with age. [ABSTRACT FROM AUTHOR]

Aims To determine if pre-operative urodynamic testing (UDS) affects physicians' diagnostic confidence and if physician confidence affects treatment outcomes at 1 year. Methods The Value of Urodynamic Evaluation (ValUE) trial randomized 630 women with predominant stress urinary incontinence (SUI) to office evaluation (OE) or OE plus UDS prior to surgery. After OE, physicians completed a checklist of five clinical diagnoses: SUI, overactive bladder (OAB) wet and dry, voiding dysfunction (VD), and intrinsic sphincter deficiency (ISD), and reported their confidence in each. Responses ranged from 1 to 5 with; 1 = 'not very confident (<50%)' to 5 = 'extremely confident (95 + %).' After UDS, investigators again rated their confidence in these five clinical diagnoses. Logistic regression analysis correlated physician confidence in diagnosis with treatment success. Results Of 315 women who received OE plus UDS, 294 had complete data. Confidence improved after UDS in patients with baseline SUI (4.52-4.63, P < 0.005), OAB-wet (3.55-3.75, P < 0.001), OAB-dry (3.55-3.68 P < 0.005), VD (3.81-3.95, P < 0.005), and suspected ISD (3.63-3.92, P < 0.001). Increased confidence after UDS was not associated with higher odds of treatment success although mean changes in confidence were slightly higher for those who achieved treatment success. Physician diagnoses shifted more from not confident to confident for ISD and OAB-wet after UDS (McNemar's P-value <0.001 for both). Conclusions In women undergoing UDS for predominant SUI, UDS increased physicians' confidence in their clinical diagnoses; however, this did not correlate with treatment success. Neurourol. Urodynam. 33:302-306, 2014. © 2013 Wiley Periodicals, Inc. [ABSTRACT FROM AUTHOR]

Purpose: We evaluated the efficacy and safety of flexible dose fesoterodine in medically complex vulnerable elderly subjects with urgency urinary incontinence. Materials and Methods: In this 12-week, randomized, double-blind, flexible dose, placebo controlled trial, subjects were community dwelling men and women 65 years old or older. Subjects had scores of 3 or more on the VES-13 (Vulnerable Elders Survey) and 20 or more on the MMSE (Mini-Mental State Examination), and 2 to 15 urgency urinary incontinence episodes and 8 or more micturitions per 24 hours on 3-day baseline diaries. Subjects randomized to fesoterodine received 4 mg once daily for 4 weeks and could then increase to 8 mg based on discussion with the investigator. Subjects receiving 8 mg could decrease the dose to 4 mg at any time (sham escalation and de-escalation for placebo). The primary outcome measure was change in daily urgency urinary incontinence episodes. Secondary outcomes included changes in other diary variables and patient reported quality of life measures. Safety evaluations included self-reported symptoms and post-void residual volume. Results: A total of 562 patients were randomized (mean age 75 years, 50.4% age 75 years or greater). Subjects had high rates of comorbidities, polypharmacy and functional impairment. At week 12 the fesoterodine group had significantly greater improvements in urgency urinary incontinence episodes per 24 hours (–2.84 vs –2.20, p = 0.002) and most other diary variables and quality of life, as well as a higher diary dry rate (50.8% vs 36.0%, p = 0.002). Adverse effects were generally similar to those of younger populations including risk of urinary retention. Conclusions: To our knowledge this is the first antimuscarinic study in a community based, significantly older, medically complex elderly population with urgency urinary incontinence. Flexible dose fesoterodine significantly improved urgency urinary incontinence episodes and other outcomes vs placebo, and was generally well tolerated. [ABSTRACT FROM AUTHOR]

Purpose: We evaluated the influence of preoperative urodynamic studies on diagnoses, global treatment plans and outcomes in women treated with surgery for uncomplicated stress predominant urinary incontinence. Materials and Methods: We performed a secondary analysis from a multicenter, randomized trial of the value of preoperative urodynamic studies. Physicians provided diagnoses before and after urodynamic studies and global treatment plans, defined as proceeding with surgery, surgery type, surgical modification and nonoperative therapy. Treatment plan changes and surgical outcomes between office evaluation and office evaluation plus urodynamic studies were compared by the McNemar test. Results: Of 315 subjects randomized to urodynamic studies after office evaluation 294 had evaluable data. Urodynamic studies changed the office evaluation diagnoses in 167 women (56.8%), decreasing the diagnoses of overactive bladder-wet (41.6% to 25.2%, p <0.001), overactive bladder-dry (31.4% to 20.8%, p = 0.002) and intrinsic sphincter deficiency (19.4% to 12.6%, p = 0.003) but increasing the diagnosis of voiding dysfunction (2.2% to 11.9%, p <0.001). After urodynamic studies physicians canceled surgery in 4 of 294 women (1.4%), changed the incontinence procedure in 13 (4.4%) and planned to modify mid urethral sling tension (more or less obstructive) in 20 women (6.8%). Nonoperative treatment plans changed in 40 of 294 women (14%). Urodynamic study driven treatment plan changes were not associated with treatment success (OR 0.96, 95% CI 0.41, 2.25, p = 0.92) but they were associated with increased postoperative treatment for urge urinary incontinence (OR 3.23, 95% CI 1.46, 7.14, p = 0.004). Conclusions: Urodynamic studies significantly changed clinical diagnoses but infrequently changed the global treatment plan or influenced surgeon decision to cancel, change or modify surgical plans. Global treatment plan changes were associated with increased treatment for postoperative urgency urinary incontinence. [Copyright &y& Elsevier]

Purpose: Longer term comparative efficacy information regarding transobturator and retropubic mid urethral slings is needed. We report 24-month continence rates, complications and symptom outcomes from a randomized equivalence trial. Materials and Methods: Primary outcomes were objective (negative stress test, negative pad test and no re-treatment for stress urinary incontinence) and subjective (no self-report of stress urinary incontinence symptoms, no leakage episodes on 3-day bladder diary and no re-treatment for stress urinary incontinence) success at 24 months. The predetermined equivalence margin was ±12%. Results: Of 597 randomized participants 516 (86.4%) were assessed. Objective success rates for retropubic and transobturator mid urethral slings were 77.3% and 72.3%, respectively (95% CI for difference of 5.1% was −2.0, 12.1), and subjective success rates were 55.7% and 48.3%, respectively (CI for difference of 7.4% was −0.7, 15.5). Neither objective nor subjective success rates met the prespecified criteria for equivalence. Patient satisfaction (retropubic 86.3% vs transobturator 88.1%, p = 0.58), frequency of de novo urgency incontinence (retropubic 0% vs transobturator 0.3%, p = 0.99) and occurrence of mesh exposure (retropubic 4.4% vs transobturator 2.7%, p = 0.26) were not significantly different. The retropubic mid urethral sling group had higher rates of voiding dysfunction requiring surgery (3.0% vs 0%, p = 0.002) and urinary tract infections (17.1% vs 10.7%, p = 0.025), whereas the transobturator group had more neurological symptoms (9.7% vs 5.4%, p = 0.045). Conclusions: Objective success rates met the criteria for equivalence at 12 months but no longer met these criteria at 24 months. Subjective success rates remained inconclusive for equivalence. Patient satisfaction remained high and symptom severity remained markedly improved. Continued surveillance is important in women undergoing mid urethral sling surgery. [Copyright &y& Elsevier]

Urodynamic studies (UDS) have been used to objectively characterize a patient's complaint of urinary incontinence. Presumably, the clinician can utilize the UDS data to guide treatment options. It is even hoped that UDS can help predict which treatments should be utilized to produce the most effective outcomes. However, is this currently the case? The Urinary Incontinence Treatment Network (UITN) has completed four large randomized clinical trials related to treatments for urinary incontinence. Two trials compared outcomes of different surgeries for stress urinary incontinence (SUI) in which standardized UDS protocols were used. Secondary analyses of these UDS data showed that UDS were neither prognostic of treatment outcomes nor correlative with severity of UI symptoms, suggesting limited utility of UDS in the evaluation and management of the uncomplicated SUI patient. A third trial was designed to answer whether a basic office examination is not noninferior to UDS in affecting SUI surgical outcomes. The results of this study are currently in press. A fourth trial examined treatment of urgency urinary incontinence (UUI). Because UDS was not part of this trial, the utility of UDS in management and treatment of UUI could not be assessed. In summary, UDS will need to undergo further refinements to increase its clinical effectiveness in the area of urinary incontinence. [ABSTRACT FROM AUTHOR]

Purpose: We examined preoperative and postoperative patient related factors associated with continence status up to 7 years after surgery for stress urinary incontinence. Materials and Methods: Women randomized to Burch colposuspension or fascial sling surgery and assessed for the primary outcome of urinary continence 2 years after surgery were eligible to enroll in a prospective observational study. Survival analysis was used to investigate baseline and postoperative factors in the subsequent risk of stress urinary incontinence, defined as self-report of stress urinary incontinence symptoms, incontinence episodes on a 3-day diary or surgical re-treatment. Results: Of the women who participated in the randomized trial 74% (482 of 655) were enrolled in the followup study. Urinary continence rates decreased during a period of 2 to 7 years postoperatively from 42% to 13% in the Burch group and from 52% to 27% in the sling group, respectively. Among the baseline factors included in the first multivariable model age (p = 0.03), prior stress urinary incontinence surgery (p = 0.02), menopausal status (0.005), urge index (0.006), assigned surgery (p = 0.01) and recruiting site (p = 0.02) were independently associated with increased risk of incontinence. In the final multivariable model including baseline and postoperative factors, Burch surgery (p = 0.01), baseline variables of prior urinary incontinence surgery (p = 0.04), menopausal status (p = 0.03) and postoperative urge index (p <0.001) were each significantly associated with a greater risk of recurrent urinary incontinence. Conclusions: Preoperative and postoperative urgency incontinence symptoms, Burch urethropexy, prior stress urinary incontinence surgery and menopausal status were negatively associated with long-term continence rates. More effective treatment of urgency urinary incontinence in patients who undergo stress urinary incontinence surgery may improve long-term overall continence status. [Copyright &y& Elsevier]

Aims To explore how baseline demographic, clinical, and urodynamic (UDS) variables correlate with measures of urethral function in women planning midurethral sling surgery. Methods Women with predominant stress urinary incontinence (SUI) as part of the trial of mid-urethral slings (TOMUS) were characterized preoperatively including: demographics, body mass index (BMI), responses to the Medical and Epidemiologic Social Aspects of Aging (MESA) and Urogenital Distress Inventory (UDI) questionnaires, pad weight (PW), incontinence duration, prior SUI surgery, prolapse, strength of pelvic contraction, Q-tip test, uroflow, cystometrogram, and detrusor pressures at maximum flow (Pdet at Qmax). Multivariate regression analysis and modeling confirmed variables with significant correlations with maximal urethral closure pressure (MUCP), functional urethral length (FUL), and Valsalva leak point pressure (VLPP). Results Five-hundred thirty-nine women were included in the analysis. In multivariable analyses, PW ( P = 0.045) and age ( P < 0.0001) were negatively correlated with MUCP (as PW and age increased, MUCP decreased); BMI ( P = 0.02) and Pdet at Qmax ( P < 0.0001) were positively correlated with MUCP (as BMI and Pdet at Qmax increased, MUCP increased). Age ( P = 0.002) was negatively correlated with FUL; Qtip delta ( P = 0.006), pelvic organ prolapse quantification examination (POPQ) stage ( P = 0.002) and strength of pelvic contraction ( P = 0.03) were positively correlated with FUL. Duration of incontinence ( P = 0.01) was negatively correlated with VLPP; Qtip delta ( P = 0.02), BMI ( P = 0.0005) and Pdet at Qmax ( P = 0.0005) were positively correlated with VLPP. Conclusions Age, BMI, Qtip delta, and Pdet at Qmax were variables that correlated with two or more measures of urethral function. These correlations may help direct future research in female urethral function. Neurourol. Urodynam. 31:496-501, 2012. © 2012 Wiley Periodicals, Inc. [ABSTRACT FROM AUTHOR]

Background: Previous work has demonstrated the efficacy and safety of fesoterodine in older and younger subjects with overactive bladder (OAB) symptoms. The effect of long-term fesoterodine treatment in different age groups has not been assessed. Objective: The aim was to determine the impact of age on the safety, tolerability and efficacy of long-term treatment with fesoterodine 8mg in subjects with OAB syndrome. Methods: This was a pooled analysis of two identically designed open-label extensions of 12-week, randomized, double-blind, placebo-controlled studies. The setting was urology and general practice offices. Subjects who participated in the 12-week, double-blind studies and opted to continue long-term, open-label treatment with fesoterodine were included. Subjects were initiated on fesoterodine 8mg/day at open-label baseline. After 1 month, subjects could elect dose reduction to 4mg/day and subsequent re-escalation to 8 mg; each was permitted once annually. Maximal duration of open-label treatment ranged from 24 to 36 months. Discontinuations, subject-reported treatment tolerance, and efficacy (3-day diaries) were assessed at open-label baseline and months 1, 4, 8, 12 and 24. Results: Atotal of 890 subjects were treated (age <45 years, n = 140; 45-64 years, n = 444; 65-74 years, n = 208; ≥75 years, n = 98); 49% continued treatment for ≥24 months (age <45 years, 43%; 45-64 years, 54%; 65-74 years, 50%; ≥75 years, 37%). Seventy-seven percent of subjects remained on fesoterodine 8mg throughout treatment; this rate was highest among subjects aged ≥75 years (age <45 years, 72%; 45-64 years, 77%; 65-74 years, 73%; ≥75 years, 87%). Approximately 80% of continuing subjects were receiving fesoterodine 8mg at each visit after open-label baseline up to 36 months. No new or unexpected safety signals were observed in any age group. Most subjects reported 'good' or 'excellent' treatment tolerance throughout the study (age <45 years, ≥90%; 45-64 years, ≥93%; 65-74 years, ≥85%; ≥75 years, ≥86%). Dry mouth, the most commonly reported treatment-emergent adverse event, was lowest among subjects aged ≥75 years (age <45 years, 31%; 45-64 years, 30%; 65-74 years, 32%; ≥75 years, 26%). Rates of discontinuation due to dry mouth were low in all age groups. Significant improvements in all diary variables, including urgency urinary incontinence episodes per 24 hours, micturitions per 24 hours, urgency episodes per 24 hours, and mean voided volume per micturition, observed between double-blind baseline and openlabel baseline were sustained or increased during open-label treatment in the overall population and all age groups. Conclusions: Long-term fesoterodine (administered primarily as 8 mg) was well tolerated and associated with sustained improvements in OAB symptoms, irrespective of age. [ABSTRACT FROM AUTHOR]

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

Objective: To characterize the urodynamic (UDS) changes in subjects 24 months after Burch urethropexy and autologous fascial sling surgery for stress urinary incontinence. Methods: In the Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr), 655 women underwent standardized UDSs before and 2 years after Burch or sling surgery. Paired t tests were used to compare the pre- and postoperative UDS measures by treatment group. Analysis of variance models were fit predicting the change in UDS measures, controlling for the treatment group. Results: The noninstrumented maximal flow rate decreased 3.6 mL/s in the Burch group and 4.7 mL/s in the sling group (P = .42). The average flow rates also decreased (2.4 mL/s in the Burch group and 3.8 mL/s in the sling group, P = .039). No difference was found in the increases in first sensation between the Burch and sling groups (23.3 and 29.3 mL, respectively, P = .61). Also, no differences were found in the reduction in the pressure flow study maximal flow rates (2.3 mL/s in the Burch group and 4.4 mL/s in the sling group, P = .11). An increased detrusor pressure at maximal flow rate (11.4 cm H2O, P < .001) was seen only after the sling procedure. Increases in the bladder outlet obstruction index occurred after both procedures, with greater increases seen after sling surgery (change, Burch +6.27 vs sling +20.12, P = .001). Conclusion: The Burch colposuspension and autologous fascial sling procedures were associated with similar decreases in noninstrumented flow rates, and the sling was associated with greater increases in the detrusor pressure at maximal flow rate and bladder outlet obstruction index. These changes suggest that both procedures are effective, in part, because of increased outlet resistance. However, the sling procedure might be more obstructive. [Copyright &y& Elsevier]

Aims To describe perineal surface patch electromyography (EMG) activity during urodynamics (UDS) and compare activity between filling and voiding phases and to assess for a relationship between preoperative EMG activity and postoperative voiding symptoms. Methods 655 women underwent standardized preoperative UDS that included perineal surface EMG prior to undergoing surgery for stress urinary incontinence. Pressure-flow studies were evaluated for abdominal straining and interrupted flow. Quantitative EMG values were extracted from 10 predetermined time-points and compared between fill and void. Qualitative EMG activity was assessed for the percent of time EMG was active during fill and void and for the average amplitude of EMG during fill compared to void. Postoperative voiding dysfunction was defined as surgical revision or catheterization more than 6 weeks after surgery. Fisher's exact test with a 5% two-sided significance level was used to assess differences in EMG activity and postoperative voiding dysfunction. Results 321 UDS had interpretable EMG studies, of which 131 (41%) had EMG values at all 10 predetermined and annotated time-points. Quantitative and qualitative EMG signals during flow were usually greater than during fill. The prevalence of postoperative voiding dysfunction in subjects with higher preoperative EMG activity during void was not significantly different. Results were similar in the 42 subjects who had neither abdominal straining during void nor interrupted flow. Conclusions Perineal surface patch EMG did not measure expected pelvic floor and urethral sphincter relaxation during voiding. Preoperative EMG did not predict patients at risk for postoperative voiding dysfunction. Neurourol. Urodynam. 30: 1591-1596, 2011. © 2011 Wiley Periodicals, Inc. [ABSTRACT FROM AUTHOR]