We determined the association of clinicodemographic factors with urinary incontinence related qua... more We determined the association of clinicodemographic factors with urinary incontinence related quality of life in women undergoing surgery for stress urinary incontinence, and compared the incontinence specific Incontinence Impact Questionnaire and the International Consultation on Incontinence Questionnaire. Secondary objectives were to evaluate the contributions of incontinence severity and sexual function on quality of life. We used baseline data on 597 women in the Trial of Mid-Urethral Slings. Tested quality of life correlates included health status and history, sexual function, and urinary incontinence type, severity and bother. On each questionnaire lower quality of life was associated with younger age, higher body mass index, more stress urinary incontinence symptoms, and more severe and bothersome urinary incontinence symptoms. Each measure identified factors associated with lower quality of life that were not identified by the other, including Hispanic ethnicity, poor health status and more urge urinary incontinence symptoms on the Incontinence Impact Questionnaire, and prior urinary incontinence treatment and more urinary incontinence episodes daily on the International Consultation on Incontinence Questionnaire. Sexually active women had similar quality of life as well as increased incontinence episodes on each questionnaire and more sexual dysfunction on the Incontinence Impact Questionnaire only. In women planning stress urinary incontinence surgery quality of life is associated with nonurinary incontinence factors, and with the type, severity and degree of urinary incontinence symptom bother. Many factors are associated with quality of life as measured by the Incontinence Impact Questionnaire and the International Consultation on Incontinence Questionnaire. However, more nonurinary incontinence factors were associated with quality of life when measured by the former than by the latter. More than 1 scale may be needed to evaluate quality of life after treatment for stress urinary incontinence.
Longer term comparative efficacy information regarding transobturator and retropubic mid urethral... more 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. 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%. 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). 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.
To assess change in overactive bladder (OAB) symptoms up to 5 years after surgery and to identify... more To assess change in overactive bladder (OAB) symptoms up to 5 years after surgery and to identify associated predictors of change from baseline. This is a secondary analysis of data from three multicenter urinary incontinence (UI) surgical trials of women with stress-predominant mixed UI assigned to Burch colposuspension, autologous fascial sling, or retropubic or transobturator midurethral slings. The primary outcome was improvement of 70% or greater from baseline in symptoms measured by the Urinary Distress Inventory-Irritative subscale. Surgical groups were compared within respective trials. Generalized linear models were fit using 1-year and up to 5-year data. Significant improvements in Urinary Distress Inventory-Irritative scores were reported by each surgical group 1 year after surgery (P<.001). Most women (50-71%) reported improvement in OAB symptoms. Improvements were similar between midurethral sling groups at 1 year (65.5% compared with 70.7%, P=.32; odds ratio [OR] 0.83, 95% confidence interval [CI] 0.57-1.20 for retropubic compared with transobturator sling) and throughout the 5-year follow-up period. More women reported OAB symptom improvement after Burch compared with pubovaginal sling (67.9% compared with 56.6%, P=.01; OR 1.59, 95% CI 1.10-2.31 for Burch compared with sling); this group difference at 1 year persisted throughout the 5-year follow-up. At 1-year, 50.0-64.3% of patients reported 70% greater improvement in UI. This proportion declined to 36.5-54.1% at 5 years (P<.001). Preoperative use of anticholinergics and urodynamic parameters was not predictive of OAB symptom change after surgery. Most women with stress-predominant mixed UI experienced significant improvement in OAB symptoms after incontinence surgery although this initial improvement diminished over time. Obesity blunted symptom improvement. II.
Individuals with spinal cord injury and other neurologic disorders have conditions that affect th... more Individuals with spinal cord injury and other neurologic disorders have conditions that affect their urologic systems and their ability to store and empty urine. Urodynamic tests evaluate this dysfunction, but they have added risks of urinary tract infections and autonomic dysreflexia. A descriptive study investigated the incidence of urinary tract infections and autonomic dysreflexia in a large neurogenic population receiving urodynamics using standardized protocols.
The sexual behaviors, functioning, needs, and sexual satisfaction levels of men with spinal cord ... more The sexual behaviors, functioning, needs, and sexual satisfaction levels of men with spinal cord injuries (SCI) were studied. A sample of 50 men with SCI (median age = 50; median age at injury = 25.0), either married or in a committed relationship, responded to an anonymous survey of a large southern California regional spinal injury rehabilitation center. Multiple regression analyses indicated that perceived partner satisfaction, relationship quality, and sexual desire were significant predictors of sexual satisfaction and behavior. Erectile function, level of genital sensation, and orgasmic capacity all varied widely in the sample, as well. However, none of these variables were significantly related to sexual satisfaction. A varied sexual repertoire was independently related to sexual satisfaction and behavior, but did not offer additional predictive power. Results suggest that for married or partnered men with SCI, relationship factors including partner satisfaction and relations...
Few studies have characterized longer-term outcomes after retropubic and transobturator mid ureth... more Few studies have characterized longer-term outcomes after retropubic and transobturator mid urethral slings. 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. 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). 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.
Midurethral slings are increasingly used for the treatment of stress incontinence, but there are ... more Midurethral slings are increasingly used for the treatment of stress incontinence, but there are limited data comparing types of slings and associated complications. We performed a multicenter, randomized equivalence trial comparing outcomes with retropubic and transobturator midurethral slings in women with stress incontinence. The primary outcome was treatment success at 12 months according to both objective criteria (a negative stress test, a negative pad test, and no retreatment) and subjective criteria (self-reported absence of symptoms, no leakage episodes recorded, and no retreatment). The predetermined equivalence margin was +/-12 percentage points. A total of 597 women were randomly assigned to a study group; 565 (94.6%) completed the 12-month assessment. The rates of objectively assessed treatment success were 80.8% in the retropubic-sling group and 77.7% in the transobturator-sling group (3.0 percentage-point difference; 95% confidence interval [CI], -3.6 to 9.6). The rates of subjectively assessed success were 62.2% and 55.8%, respectively (6.4 percentage-point difference; 95% CI, -1.6 to 14.3). The rates of voiding dysfunction requiring surgery were 2.7% in those who received retropubic slings and 0% in those who received transobturator slings (P=0.004), and the respective rates of neurologic symptoms were 4.0% and 9.4% (P=0.01). There were no significant differences between groups in postoperative urge incontinence, satisfaction with the results of the procedure, or quality of life. The 12-month rates of objectively assessed success of treatment for stress incontinence with the retropubic and transobturator approaches met the prespecified criteria for equivalence; the rates of subjectively assessed success were similar between groups but did not meet the criteria for equivalence. Differences in the complications associated with the two procedures should be discussed with patients who are considering surgical treatment for incontinence. (ClinicalTrials.gov number, NCT00325039.)
To present the methodology, standardization techniques, and results from post hoc test-retest rep... more To present the methodology, standardization techniques, and results from post hoc test-retest reproducibility analyses for a large, placebo-controlled, multicenter trial, employing urodynamic studies (UDS) to assess the impact of daily tadalafil on men with lower urinary tract symptoms (LUTS) with or without benign prostatic obstruction (BPO). UDS implemented International Continence Society (ICS) Good Urodynamic Practice guidelines and standardized urodynamic and LUTS terminology. Further standardization procedures included: equipment calibration; a detailed procedure manual and centralized training; and implementation of a central reader. Measures included: monitoring of invalid studies, comparison of actual versus expected standard deviation (SD) for primary outcome (detrusor pressure at maximum urinary flow rate [p(detQmax)]), and test-retest reproducibility of the placebo arm at baseline and endpoint. Two hundred men with moderate to severe LUTS (baseline IPSS >or=13) at 20 sites were randomized to receive either tadalafil 20 mg or placebo. All men underwent non-invasive uroflow and pressure-flow studies. Numbers of invalid studies at baseline and endpoint were 9.3% and 0.6%, respectively. Variability of p(detQmax) was lower than anticipated based on actual versus expected SD of 15 and 30, respectively. Correlation coefficients were very good for pressure-flow parameters including p(detQmax) (r = .83). Multicenter clinical trials using urodynamic outcomes require additional standardized procedures to limit inter-site variability. By implementing centralized training with a detailed procedure manual and use of a central reader, we were able to limit common difficulties arising in multicenter clinical trials, as well as demonstrate good test-retest reproducibility of pressure flow measures.
We determined the association of clinicodemographic factors with urinary incontinence related qua... more We determined the association of clinicodemographic factors with urinary incontinence related quality of life in women undergoing surgery for stress urinary incontinence, and compared the incontinence specific Incontinence Impact Questionnaire and the International Consultation on Incontinence Questionnaire. Secondary objectives were to evaluate the contributions of incontinence severity and sexual function on quality of life. We used baseline data on 597 women in the Trial of Mid-Urethral Slings. Tested quality of life correlates included health status and history, sexual function, and urinary incontinence type, severity and bother. On each questionnaire lower quality of life was associated with younger age, higher body mass index, more stress urinary incontinence symptoms, and more severe and bothersome urinary incontinence symptoms. Each measure identified factors associated with lower quality of life that were not identified by the other, including Hispanic ethnicity, poor health status and more urge urinary incontinence symptoms on the Incontinence Impact Questionnaire, and prior urinary incontinence treatment and more urinary incontinence episodes daily on the International Consultation on Incontinence Questionnaire. Sexually active women had similar quality of life as well as increased incontinence episodes on each questionnaire and more sexual dysfunction on the Incontinence Impact Questionnaire only. In women planning stress urinary incontinence surgery quality of life is associated with nonurinary incontinence factors, and with the type, severity and degree of urinary incontinence symptom bother. Many factors are associated with quality of life as measured by the Incontinence Impact Questionnaire and the International Consultation on Incontinence Questionnaire. However, more nonurinary incontinence factors were associated with quality of life when measured by the former than by the latter. More than 1 scale may be needed to evaluate quality of life after treatment for stress urinary incontinence.
Longer term comparative efficacy information regarding transobturator and retropubic mid urethral... more 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. 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%. 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). 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.
To assess change in overactive bladder (OAB) symptoms up to 5 years after surgery and to identify... more To assess change in overactive bladder (OAB) symptoms up to 5 years after surgery and to identify associated predictors of change from baseline. This is a secondary analysis of data from three multicenter urinary incontinence (UI) surgical trials of women with stress-predominant mixed UI assigned to Burch colposuspension, autologous fascial sling, or retropubic or transobturator midurethral slings. The primary outcome was improvement of 70% or greater from baseline in symptoms measured by the Urinary Distress Inventory-Irritative subscale. Surgical groups were compared within respective trials. Generalized linear models were fit using 1-year and up to 5-year data. Significant improvements in Urinary Distress Inventory-Irritative scores were reported by each surgical group 1 year after surgery (P<.001). Most women (50-71%) reported improvement in OAB symptoms. Improvements were similar between midurethral sling groups at 1 year (65.5% compared with 70.7%, P=.32; odds ratio [OR] 0.83, 95% confidence interval [CI] 0.57-1.20 for retropubic compared with transobturator sling) and throughout the 5-year follow-up period. More women reported OAB symptom improvement after Burch compared with pubovaginal sling (67.9% compared with 56.6%, P=.01; OR 1.59, 95% CI 1.10-2.31 for Burch compared with sling); this group difference at 1 year persisted throughout the 5-year follow-up. At 1-year, 50.0-64.3% of patients reported 70% greater improvement in UI. This proportion declined to 36.5-54.1% at 5 years (P<.001). Preoperative use of anticholinergics and urodynamic parameters was not predictive of OAB symptom change after surgery. Most women with stress-predominant mixed UI experienced significant improvement in OAB symptoms after incontinence surgery although this initial improvement diminished over time. Obesity blunted symptom improvement. II.
Individuals with spinal cord injury and other neurologic disorders have conditions that affect th... more Individuals with spinal cord injury and other neurologic disorders have conditions that affect their urologic systems and their ability to store and empty urine. Urodynamic tests evaluate this dysfunction, but they have added risks of urinary tract infections and autonomic dysreflexia. A descriptive study investigated the incidence of urinary tract infections and autonomic dysreflexia in a large neurogenic population receiving urodynamics using standardized protocols.
The sexual behaviors, functioning, needs, and sexual satisfaction levels of men with spinal cord ... more The sexual behaviors, functioning, needs, and sexual satisfaction levels of men with spinal cord injuries (SCI) were studied. A sample of 50 men with SCI (median age = 50; median age at injury = 25.0), either married or in a committed relationship, responded to an anonymous survey of a large southern California regional spinal injury rehabilitation center. Multiple regression analyses indicated that perceived partner satisfaction, relationship quality, and sexual desire were significant predictors of sexual satisfaction and behavior. Erectile function, level of genital sensation, and orgasmic capacity all varied widely in the sample, as well. However, none of these variables were significantly related to sexual satisfaction. A varied sexual repertoire was independently related to sexual satisfaction and behavior, but did not offer additional predictive power. Results suggest that for married or partnered men with SCI, relationship factors including partner satisfaction and relations...
Few studies have characterized longer-term outcomes after retropubic and transobturator mid ureth... more Few studies have characterized longer-term outcomes after retropubic and transobturator mid urethral slings. 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. 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). 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.
Midurethral slings are increasingly used for the treatment of stress incontinence, but there are ... more Midurethral slings are increasingly used for the treatment of stress incontinence, but there are limited data comparing types of slings and associated complications. We performed a multicenter, randomized equivalence trial comparing outcomes with retropubic and transobturator midurethral slings in women with stress incontinence. The primary outcome was treatment success at 12 months according to both objective criteria (a negative stress test, a negative pad test, and no retreatment) and subjective criteria (self-reported absence of symptoms, no leakage episodes recorded, and no retreatment). The predetermined equivalence margin was +/-12 percentage points. A total of 597 women were randomly assigned to a study group; 565 (94.6%) completed the 12-month assessment. The rates of objectively assessed treatment success were 80.8% in the retropubic-sling group and 77.7% in the transobturator-sling group (3.0 percentage-point difference; 95% confidence interval [CI], -3.6 to 9.6). The rates of subjectively assessed success were 62.2% and 55.8%, respectively (6.4 percentage-point difference; 95% CI, -1.6 to 14.3). The rates of voiding dysfunction requiring surgery were 2.7% in those who received retropubic slings and 0% in those who received transobturator slings (P=0.004), and the respective rates of neurologic symptoms were 4.0% and 9.4% (P=0.01). There were no significant differences between groups in postoperative urge incontinence, satisfaction with the results of the procedure, or quality of life. The 12-month rates of objectively assessed success of treatment for stress incontinence with the retropubic and transobturator approaches met the prespecified criteria for equivalence; the rates of subjectively assessed success were similar between groups but did not meet the criteria for equivalence. Differences in the complications associated with the two procedures should be discussed with patients who are considering surgical treatment for incontinence. (ClinicalTrials.gov number, NCT00325039.)
To present the methodology, standardization techniques, and results from post hoc test-retest rep... more To present the methodology, standardization techniques, and results from post hoc test-retest reproducibility analyses for a large, placebo-controlled, multicenter trial, employing urodynamic studies (UDS) to assess the impact of daily tadalafil on men with lower urinary tract symptoms (LUTS) with or without benign prostatic obstruction (BPO). UDS implemented International Continence Society (ICS) Good Urodynamic Practice guidelines and standardized urodynamic and LUTS terminology. Further standardization procedures included: equipment calibration; a detailed procedure manual and centralized training; and implementation of a central reader. Measures included: monitoring of invalid studies, comparison of actual versus expected standard deviation (SD) for primary outcome (detrusor pressure at maximum urinary flow rate [p(detQmax)]), and test-retest reproducibility of the placebo arm at baseline and endpoint. Two hundred men with moderate to severe LUTS (baseline IPSS >or=13) at 20 sites were randomized to receive either tadalafil 20 mg or placebo. All men underwent non-invasive uroflow and pressure-flow studies. Numbers of invalid studies at baseline and endpoint were 9.3% and 0.6%, respectively. Variability of p(detQmax) was lower than anticipated based on actual versus expected SD of 15 and 30, respectively. Correlation coefficients were very good for pressure-flow parameters including p(detQmax) (r = .83). Multicenter clinical trials using urodynamic outcomes require additional standardized procedures to limit inter-site variability. By implementing centralized training with a detailed procedure manual and use of a central reader, we were able to limit common difficulties arising in multicenter clinical trials, as well as demonstrate good test-retest reproducibility of pressure flow measures.
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