[Show abstract][Hide abstract] ABSTRACT: We present the rationale for and design of a randomized, open-label, active-control trial comparing the effectiveness of 200 units of onabotulinum toxin A (Botox A®) versus sacral neuromodulation (InterStim®) therapy for refractory urgency urinary incontinence (UUI). The Refractory Overactive Bladder: Sacral NEuromodulation vs. BoTulinum Toxin Assessment (ROSETTA) trial compares changes in urgency urinary incontinence episodes over 6months, as well as other lower urinary tract symptoms, adverse events and cost effectiveness in women receiving these two therapies. Eligible participants had previously attempted treatment with at least 2 medications and behavioral therapy. We discuss the importance of evaluating two very different interventions, the challenges related to recruitment, ethical considerations for two treatments with significantly different costs, follow up assessments and cost effectiveness. The ROSETTA trial will provide information to healthcare providers regarding the technical attributes of these interventions as well as the efficacy and safety of these two interventions on other lower urinary tract and pelvic floor symptoms. Enrollment began in March, 2012 with anticipated end to recruitment in mid 2014. This trial is registered at www.clinicaltrials.gov under Registration #: NCT01502956.
[Show abstract][Hide abstract] ABSTRACT: Surgical pain scales (SPS) consist of 4 items that measure pain at rest, during normal activities, and during work/exercise and quantify unpleasantness of worst pain, which are valid and responsive in men undergoing hernia repair. Our objective was to evaluate the psychometric properties of SPS in women undergoing vaginal surgery for pelvic organ prolapse and stress urinary incontinence.
We modified SPS by converting original response scales from a visual analog scale to numerical rating scales. Numerical rating scales have lower error rates and higher validity than visual analog scale. The sample included 169 women with stage II to IV pelvic organ prolapse and stress urinary incontinence in a randomized trial comparing sacrospinous ligament fixation to uterosacral vault suspension with and without pelvic floor muscle training. Participants completed SPS and SF-36 at baseline, and 2 weeks and 6 months after surgery. Construct validity and responsiveness were examined in cross-sectional and longitudinal data using Pearson correlation and analysis of variance.
Pain at rest, during normal activities, and during work/exercise worsened at 2 weeks (P<0.05); and all measures of pain improved from baseline to 6 months (P<0.0001). Construct validity was demonstrated by correlations of 0.51 to 0.74 between SPS and the SF-36 Bodily Pain Scale (P<0.0001). Pain worsened on SF-36 between baseline and 2 weeks in 63% of the participants, and this group demonstrated a mean (SD) increase in pain of 1.9 (2.8) on the SPS (effect size, 0.99), confirming responsiveness of the scale.
The modified SPS are valid and responsive in women after pelvic reconstructive surgery.
Journal of Pelvic Medicine and Surgery 07/2012; 18(4):198-204. DOI:10.1097/SPV.0b013e31825d65aa · 1.09 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The Activities Assessment Scale (AAS) is a 13-item postoperative functional activity scale validated in men who underwent hernia surgery. We evaluated the psychometric characteristics of the AAS in women who underwent vaginal surgery for pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
Participants included 163 women with POP and SUI enrolled in a randomized trial comparing sacrospinous ligament fixation to uterosacral vault suspension with and without perioperative pelvic floor muscle training. Participants completed the AAS and SF-36 at baseline and 2 weeks and 6 months postoperatively. Internal reliability of the AAS was evaluated using Cronbach α. Construct validity and responsiveness were examined in cross-sectional and longitudinal data using Pearson correlation coefficient and analysis of variance. The AAS is scored from zero to 100 (higher scores=better function).
Mean (SD) baseline AAS score was 87 (17.3) (range, 25-100). Functional activity declined from baseline to 2 weeks postoperatively (mean change, -4.5; 95% confidence interval, -7.6 to -1.42) but improved above baseline at 6 months (mean change, +10.9; 95% confidence interval, 7.8-14.0). Internal reliability of the AAS was excellent (Cronbach α=0.93). Construct validity was demonstrated by a correlation of 0.59 to 0.60 between the AAS and SF-36 physical functioning scale (P<0.0001) and lower correlations between the AAS and other SF-36 scales. Patients who improved in physical functioning based on the SF-36 between 2 weeks and 6 months postoperatively showed an effect size of 0.86 for change in the AAS over the same period.
The AAS is a valid, reliable, and responsive measure for evaluation of physical function in women after pelvic reconstructive surgery.
Journal of Pelvic Medicine and Surgery 07/2012; 18(4):205-10. DOI:10.1097/SPV.0b013e31825e6422 · 1.09 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Women without stress urinary incontinence undergoing vaginal surgery for pelvic-organ prolapse are at risk for postoperative urinary incontinence. A midurethral sling may be placed at the time of prolapse repair to reduce this risk.
We performed a multicenter trial involving women without symptoms of stress incontinence and with anterior prolapse (of stage 2 or higher on a Pelvic Organ Prolapse Quantification system examination) who were planning to undergo vaginal prolapse surgery. Women were randomly assigned to receive either a midurethral sling or sham incisions during surgery. One primary end point was urinary incontinence or treatment for this condition at 3 months. The second primary end point was the presence of incontinence at 12 months, allowing for subsequent treatment for incontinence.
Of the 337 women who underwent randomization, 327 (97%) completed follow-up at 1 year. At 3 months, the rate of urinary incontinence (or treatment) was 23.6% in the sling group and 49.4% in the sham group (P<0.001). At 12 months, urinary incontinence (allowing for subsequent treatment of incontinence) was present in 27.3% and 43.0% of patients in the sling and sham groups, respectively (P=0.002). The number needed to treat with a sling to prevent one case of urinary incontinence at 12 months was 6.3. The rate of bladder perforation was higher in the sling group than in the sham group (6.7% vs. 0%), as were rates of urinary tract infection (31.0% vs. 18.3%), major bleeding complications (3.1% vs. 0%), and incomplete bladder emptying 6 weeks after surgery (3.7% vs. 0%) (P≤0.05 for all comparisons).
A prophylactic midurethral sling inserted during vaginal prolapse surgery resulted in a lower rate of urinary incontinence at 3 and 12 months but higher rates of adverse events. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women's Health; OPUS ClinicalTrials.gov number, NCT00460434.).
New England Journal of Medicine 06/2012; 366(25):2358-67. DOI:10.1056/NEJMoa1111967 · 55.87 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To explore how baseline demographic, clinical, and urodynamic (UDS) variables correlate with measures of urethral function in women planning midurethral sling surgery.
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).
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.
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.
Neurourology and Urodynamics 04/2012; 31(4):496-501. DOI:10.1002/nau.21198 · 2.87 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: We determined whether baseline urodynamic study variables predict failure after mid urethral sling surgery.
Preoperative urodynamic study variables and postoperative continence status were analyzed in women participating in a randomized trial comparing retropubic to transobturator mid urethral sling. Objective failure was defined by positive standardized stress test, 15 ml or greater on 24-hour pad test, or re-treatment for stress urinary incontinence. Subjective failure criteria were self-reported stress symptoms, leakage on 3-day diary or re-treatment for stress urinary incontinence. Logistic regression was used to assess associations between covariates and failure controlling for treatment group and clinical variables. Receiver operator curves were constructed for relationships between objective failure and measures of urethral function.
Objective continence outcomes were available at 12 months for 565 of 597 (95%) women. Treatment failed in 260 women (245 by subjective criteria, 124 by objective criteria). No urodynamic variable was significantly associated with subjective failure on multivariate analysis. Valsalva leak point pressure, maximum urethral closure pressure and urodynamic stress incontinence were the only urodynamic variables consistently associated with objective failure on multivariate analysis. No specific cut point was determined for predicting failure for Valsalva leak point pressure or maximum urethral closure pressure by ROC. The lowest quartile (Valsalva leak point pressure less than 86 cm H2O, maximum urethral closure pressure less than 45 cm H2O) conferred an almost 2-fold increased odds of objective failure regardless of sling route (OR 2.23, 1.20-4.14 for Valsalva leak point pressure and OR 1.88, 1.04-3.41 for maximum urethral closure pressure).
Women with a Valsalva leak point pressure or maximum urethral closure pressure in the lowest quartile are nearly 2-fold more likely to experience stress urinary incontinence 1 year after transobturator or retropubic mid urethral sling.
The Journal of urology 06/2011; 186(2):597-603. DOI:10.1016/j.juro.2011.03.105 · 4.47 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: 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.
The Journal of urology 10/2010; 184(6):2411-5. DOI:10.1016/j.juro.2010.08.019 · 4.47 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Determine whether urodynamic measures of urethral function [(valsalva leak point pressure (VLPP), maximum urethral closure pressure (MUCP), functional urethral length (FUL)] and the results of the supine empty bladder stress test (SEBST) correlate with each other and with subjective and objective measures of urinary incontinence (UI).
Data were collected preoperatively from subjects enrolled in a multicenter surgical trial of mid-urethral slings. Subjective measures included questionnaire scores from the Medical Epidemiological and Social Aspects of Aging Questionnaire, Urogenital Distress Inventory, and Incontinence Impact Questionnaire. Objective measures included a 24-hr pad weight test, incontinence episode frequency on a 3-day voiding diary, and a SEBST.
Five hundred ninety-seven women enrolled. Three hundred seventy-two women had valid VLPP values; 539 had valid MUCP/FUL values. Subjective measures of severity had weak to moderate correlation with each other (r = 0.25-0.43) and with objective measures of severity (r = -0.06 to 0.45). VLPP and MUCP had moderate correlation with each other (r = 0.36, P< 0.001). Urodynamic measures of urethral function had little or no correlation with subjective or objective measures of severity. Subjects with a positive SEBST had more subjective and objective severity measures compared to the negative SEBST group, but they did not have significantly different VLPP and MUCP values.
VLPP and MUCP have moderate correlation with each other, but each had little or no correlation with subjective or objective measures of severity or with the results of the SEBST. This data suggests that the urodynamic measures of urethral function are not related to subjective or objective measures of UI severity.
Neurourology and Urodynamics 09/2010; 29(7):1306-11. DOI:10.1002/nau.20836 · 2.87 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To compare perioperative morbidity and 1-year outcomes of older and younger women undergoing surgery for pelvic organ prolapse (POP).
Prospective ancillary analysis.
Academic medical centers in National Institutes of Health, National Institute of Child Health and Human Development Colpopexy and Urinary Reduction Study.
Women with POP and no symptoms of stress incontinence.
Abdominal sacrocolpopexy with randomization to receive Burch colposuspension for treatment of possible occult incontinence or not.
Perioperative complications and Pelvic Organ Prolapse Quantification and quality-of-life (QOL) questionnaires (Pelvic Floor Distress Inventory, Pelvic Floor Impact Questionnaire, and Medical Outcomes Study Short-Form Health Survey (SF-36) preoperatively, immediately postoperatively, and 6 weeks and 3 and 12 months postoperatively).
Three hundred twenty-two women aged 31 to 82 (21% aged > or =70), 93% white. Older women had higher baseline comorbidity (P<.001) and more severe POP (P=.003). Controlling for prolapse stage and whether Burch was performed, there were no age differences in complication rates. Older women had longer hospital stays (3.1+/-1.0 vs 2.7+/-1.5 days, P=.02) and higher prevalence of incontinence at 6 weeks (54.7% vs 37.2%, P=.005). At 3 and 12 months, there were no differences in self-reported incontinence, stress testing for incontinence, or prolapse stage. Improvements from baseline were significant on all QOL measures but with no age differences.
Outcomes of prolapse surgery were comparable between older and younger women except that older women had slightly longer hospital stays.
Journal of the American Geriatrics Society 06/2007; 55(6):857-863. DOI:10.1111/j.1532-5415.2007.01178.x · 4.57 Impact Factor