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1.  Surgical Preparation: Are Patients “Ready” for Stress Urinary Incontinence Surgery? 
International urogynecology journal  2013;25(1):10.1007/s00192-013-2184-x.
Introduction and Hypothesis:
Patient preparedness for stress urinary incontinence (SUI) surgery is associated with improvements in post-operative satisfaction, symptoms and quality of life (QoL). This planned secondary analysis examined the association of patient preparedness with surgical outcomes, treatment satisfaction and quality of life.
The ValUE trial compared the effect of pre-operative urodynamic studies to a standardized office evaluation on outcomes of SUI surgery at one year. In addition to primary and secondary outcome measures, patient satisfaction with treatment was measured with a 5-point Likert scale (very dissatisfied to very satisfied) that queried subjects to rate the treatment’s effect on overall incontinence, urge incontinence, SUI, and frequency. Preparedness for surgery was assessed using an 11-question Patient Preparedness Questionnaire (PPQ).
Based on PPQ Question 11, 4 out of 5 (81%) of women reported they “agreed” or “strongly agreed” that they were prepared for surgery. Selected demographic and clinical characteristics were similar in unprepared and prepared women. Among SUI severity baseline measures, total UDI score was significantly but weakly associated with preparedness (question 11 of the PPQ) (Spearman r = 0.13, p = 0.001). Although preparedness for surgery was not associated with successful outcomes, it was associated with satisfaction (rs=0.11, p = 0.02) and larger PGI-S improvement (increase) (p=0.008).
Approximately half (48%) of women “strongly agreed” that they felt prepared for SUI. Women with higher pre-operative preparedness scores were more satisfied although surgical outcomes did not differ.
PMCID: PMC3833875  PMID: 23912506
Stress Incontinence; Mid-urethral Sling; Randomized Trial; Urodynamics; Satisfaction; Surgical Outcomes
2.  Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies (ACCESS)☆ 
Contemporary clinical trials  2012;33(5):1011-1018.
Robotic assistance during laparoscopic surgery for pelvic organ prolapse rapidly disseminated across the United States without level I data to support its benefit over traditional open and laparoscopic approaches. This manuscript describes design and methodology of the Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies (ACCESS) Trial [1].
ACCESS is a randomized comparative effectiveness trial enrolling patients at two academic teaching facilities, UCLA (Los Angeles, CA) and Loyola University (Chicago, IL). The primary aim is to compare costs of robotic assisted versus pure laparoscopic abdominal sacrocolpopexy (RASC vs LASC). Following a clinical decision for minimally-invasive abdominal sacrocolpopexy (ASC) and research consent, participants with symptomatic stage≥II pelvic organ prolapse are randomized to LASC or RASC on the day of surgery. Costs of care are based on each patient’s billing record and equipment costs at each hospital. All costs associated with surgical procedure including costs for robot and initial hospitalization and any re-hospitalization in the first 6 weeks are compared between groups. Secondary outcomes include post-operative pain, anatomic outcomes, symptom severity and quality of life, and adverse events. Power calculation determined that 32 women in each arm would provide 95% power to detect a $2500 difference in total charges, using a two-sided two sample t-test with a significance level of 0.05.
Enrollment was completed in May 2011. The 12-month follow-up will end in May 2012.
This is a multi-center study to assess cost as a primary outcome in a comparative effectiveness trial of LASC versus RASC.
PMCID: PMC4203307  PMID: 22643040
Pelvic organ prolapse; Randomized controlled trial; Cost effectiveness
3.  Repeat Post-Op Voiding Trials: An Inconvenient Correlate with Success 
Neurourology and urodynamics  2013;33(8):1225-1228.
This study examined the association between the need for a repeat voiding trial after midurethral sling (MUS) surgery and 1-year success rates.
We conducted this secondary analysis of the participants in the Urinary Incontinence Treatment Network Trial Of Midurethral Sling (TOMUS) study which compared retropubic vs. 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.
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).
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 postoperative result.
PMCID: PMC3937293  PMID: 23983149
Stress Urinary Incontinence; Voiding Dysfunction; Midurethral Sling
4.  Five Year Continence Rates, Satisfaction and Adverse Events of Burch Urethropexy and Fascial Sling Surgery for Urinary Incontinence 
The Journal of urology  2012;187(4):1324-1330.
To characterize continence, satisfaction, and adverse events in women at least 5 years after a Burch urethropexy or fascial sling with longitudinal follow-up of randomized clinical trial participants at least 5 years post-operatively.
482 (73.6520 (79.4%) of 655 women participated in a randomized surgical trial comparing efficacy of the Burch and sling treatments enrolled in this long-term observational study. Urinary continence status was assessed yearly for a minimum of five years postoperatively. Continence was defined as no urinary leakage on a three-day voiding diary and no self-reported stress incontinence symptoms AND no stress incontinence surgical retreatment.
Incontinent participants were more likely to enroll in the follow-up study than continent patients (85.5% vs. 52.2%), regardless of surgical group (p <0.0001). Overall the continence rates were lower in the Burch urethropexy group than in the fascial sling group (p=0.002). The continence rates at five years were 24.1% (95% CI 18.5% to 29.7%) compared to 30.8% (24.7% to 36.9%), respectively.
Satisfaction at 5 years was related to continence status and higher in women undergoing a sling (83% vs. 73%, p=0.04). Satisfaction declined over time (P=0.001) and remained higher in the sling group (p=0.03). The two groups had similar adverse event rates (10% Burch vs.9 % sling) and similar numbers of participants with adverse events (23 Burch vs. 22 sling).
Continence rates in both groups declined substantially over five years, yet most women reported satisfaction with their continence status. Satisfaction was higher in continent women and those who underwent fascial sling, despite the voiding dysfunction associated with this procedure.
PMCID: PMC3586411  PMID: 22341290
Surgical Outcome; Stress Incontinence; Longitudinal Study
5.  Quantification of Vaginal Support: Are Continuous Summary Scores Better than POPQ Stage? 
This analysis compared 3 continuous variables as summary support loss scores with POPQ ordinal stages.
Study Design
We used pooled baseline data from 1141 subjects in 3 randomized trials (CARE, n=322; OPUS, n = 380; ATLAS, n =439) to test 3 support loss measures. The relative responsiveness was assessed using the standardized response mean of 2-year outcome data from the CARE trial.
Each support loss measure was strongly correlated with POPQ ordinal staging; the single most distal POPQ point had the strongest correlation. Improvements in anatomic support were weakly correlated with improvements in POPDI (r = .17-.24, p <.01 for each) but not with changes in POPIQ for all measures of support loss or POPQ stage.
While continuous, single number summary measures compared favorably to ordinal POPQ staging system, the single most distal POPQ point may be preferable to POPQ ordinal stages to summarize or compare group data.
PMCID: PMC2975822  PMID: 20728072
Pelvic organ prolapse; prolapse; pelvic surgery; outcome measures; quantification of prolapse
6.  Symptoms of Combined Prolapse and Urinary Incontinence in Large Surgical Cohorts 
Obstetrics and gynecology  2010;115(2 Pt 1):310-316.
To estimate whether prolapse severity is a major contributor to urinary incontinence severity, as measured by validated incontinence questionnaires.
We analyzed data from two large female stress urinary incontinence (SUI) surgical cohorts: the Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr) study (N=655) and the subsequent Trial of Mid-Urethral Slings (TOMUS) study (N=597). All participants completed a standardized baseline assessment including validated measures of symptom severity, quality of life, objective measures of urine loss [Urogenital Distress Inventory (UDI), Medical, Epidemiologic, and Social Aspects of Aging questionnaire (MESA), Incontinence Impact Questionnaire (IIQ) and pad test], as well as the Pelvic Organ Prolapse – Quantification (POP-Q) assessment. Groups were compared using the χ2 test (categorical measures) or the one-way analysis of variance (continuous measures). Statistical significance was defined at p-value <0.05.
The SISTEr and TOMUS samples were similar for many variables including age (52 vs. 53 years, respectively), nulliparity (9 vs. 12%), prior UI surgery (14 vs. 13%), and prior hysterectomy (31 vs 28%), but other differences necessitated separate analysis of the two cohorts. There was not a statistically significant difference in UDI scores according to prolapse stage in either study population. Patients with prior surgery for POP and SUI had more incontinence symptoms and were more bothered by their UI, regardless of prolapse stage.
Prolapse stage is not strongly or consistently associated with incontinence severity in women who select surgical treatment of stress urinary incontinence. Prior POP and UI surgery is associated with worse UI severity and bother.
Clinical Trial Registration:,, NCT00064662 and NCT00325039.
PMCID: PMC3094711  PMID: 20093904
7.  The Standardization of Terminology for Researchers in Female Pelvic Floor Disorders  
The lack of standardized terminology in pelvic floor disorders (pelvic organ prolapse, urinary incontinence, and fecal incontinence) is a major obstacle to performing and interpreting research. The National Institutes of Health convened the Terminology Workshop for Researchers in Female Pelvic Floor Disorders to: (1) agree on standard terms for defining conditions and outcomes; (2) make recommendations for minimum data collection for research; and (3) identify high priority issues for future research. Pelvic organ prolapse was defined by physical examination staging using the International Continence Society system. Stress urinary incontinence was defined by symptoms and testing; ‘cure’ was defined as no stress incontinence symptoms, negative testing, and no new problems due to intervention. Overactive bladder was defined as urinary frequency and urgency, with and without urge incontinence. Detrusor instability was defined by cystometry. For all urinary symptoms, defining ‘improvement’ after intervention was identified as a high priority. For fecal incontinence, more research is needed before recommendations can be made. A standard terminology for research on pelvic floor disorders is presented and areas of high priority for future research are identified.
PMCID: PMC2815805  PMID: 11451006
Key words:Clinical research - Fecal incontinence - Pelvic organ prolapse - Standardization of terminology - Urinary incontinence
8.  Serum calcitonin-lowering effect of magnesium in patients with medullary carcinoma of the thyroid. 
Journal of Clinical Investigation  1975;56(6):1615-1621.
The effect of magnesium chloride or magnesium sulfate infusion on circulating levels of immunoreactive calcitonin (iCT) was evaluated on nine occasions in three patients with metastatic medullary carcinoma of the thyroid. One patient was normocalcemic and had normal circulating levels of immunoreactive parathyroid hormone (iPTH), one patient was hypocalcemic and had surgical hypoparathyroidism, and one patient had mild to moderate hypercalcemia associated with bone metastases. The basal serum iPTH levels were undetectable in the latter two patients. In every instance magnesium administration produced a rapid and striking fall in circulating iCT and usually a detectable fall in serum calcium. During the hypermagnesemic state, serum iPTH fell from normal to undetectable in the patient with normal parathyroid function, while serum iPTH levels remained undetectable in the hypoparathyroid patient and in the patient with hypercalcemia associated with bone metastases. The results of these studies indicate that: (a) contrary to what has been reported in normal experimental animals, magnesium administration lowers circulating iCT in human subjects with thyroid medullary carcinoma and (b) the calcium-lowering effect produced by magnesium in patients with medullary carcinoma may, in part at least, be due to a redistribution of body calcium that is not mediated by the actions of either parathyroid hormone or clacitonin.
PMCID: PMC333141  PMID: 1202087

Results 1-8 (8)