W. Thomas Gregory

Reoperation 10 years after surgically managed pelvic organ prolapse and urinary incontinence.

OBJECTIVE This study measured the 10-year risk of reoperation for surgically treated pelvic organ prolapse and urinary incontinence (POPUI) in a community population. STUDY DESIGN We conducted a prospective cohort analysis of 374 women who were > 20 years old and who underwent surgery for POPUI in 1995. RESULTS The 10-year reoperation rate was 17% by Kaplan Meier analysis. Previous POPUI surgery at the time of index surgery conferred a hazard ratio of 1.9 (95% CI, 1.1-3.2; P = .018). The abdominal approach was protective against reoperation compared with the vaginal approach (hazard ratio, 0.37; 95% CI, 0.17-0.83; P = .02) With the use of Cox regression, no association was observed for age, vaginal parity, previous hysterectomy, body mass index, prolapse severity, ethnicity, chronic lung disease, smoking, estrogen status, surgical indication, or anatomic compartment. CONCLUSION A reoperation rate of 17% is unacceptably high and likely represents an underestimate of the true rate. Most of the factors that influence reoperation have not yet been identified.

OnabotulinumtoxinA vs Sacral Neuromodulation on Refractory Urgency Urinary Incontinence in Women: A Randomized Clinical Trial.

Importance Women with refractory urgency urinary incontinence are treated with sacral neuromodulation and onabotulinumtoxinA with limited comparative information. Objective To assess whether onabotulinumtoxinA is superior to sacral neuromodulation in controlling refractory episodes of urgency urinary incontinence. Design, Setting, and Participants Multicenter open-label randomized trial (February 2012-January 2015) at 9 US medical centers involving 381 women with refractory urgency urinary incontinence. Interventions Cystoscopic intradetrusor injection of 200 U of onabotulinumtoxinA (n = 192) or sacral neuromodulation (n = 189). Main Outcomes and Measures Primary outcome, change from baseline mean number of daily urgency urinary incontinence episodes over 6 months, was measured with monthly 3-day diaries. Secondary outcomes included change from baseline in urinary symptom scores in the Overactive Bladder Questionnaire Short Form (SF); range, 0-100, higher scores indicating worse symptoms; Overactive Bladder Satisfaction questionnaire; range, 0-100; includes 5 subscales, higher scores indicating better satisfaction; and adverse events. Results Of the 364 women (mean [SD] age, 63.0 [11.6] years) in the intention-to-treat population, 190 women in the onabotulinumtoxinA group had a greater reduction in 6-month mean number of episodes of urgency incontinence per day than did the 174 in the sacral neuromodulation group (-3.9 vs -3.3 episodes per day; mean difference, 0.63; 95% CI, 0.13 to 1.14; P = .01). Participants treated with onabotulinumtoxinA showed greater improvement in the Overactive Bladder Questionnaire SF for symptom bother (-46.7 vs -38.6; mean difference, 8.1; 95% CI, 3.0 to 13.3; P = .002); treatment satisfaction (67.7 vs 59.8; mean difference, 7.8; 95% CI, 1.6 to 14.1; P = .01) and treatment endorsement (78.1 vs 67.6; mean difference; 10.4, 95% CI, 4.3 to 16.5; P < .001) than treatment with sacral neuromodulation. There were no differences in convenience (67.6 vs 70.2; mean difference, -2.5; 95% CI, -8.1 to 3.0; P = .36), adverse effects (88.4 vs 85.1; mean difference, 3.3; 95% CI, -1.9 to 8.5; P = .22), and treatment preference (92.% vs 89%; risk difference, -3%; 95% CI, -16% to 10%; P = .49). Urinary tract infections were more frequent in the onabotulinumtoxinA group (35% vs 11%; risk difference, -23%; 95% CI, -33% to -13%; P < .001). The need for self-catheterization was 8% and 2% at 1 and 6 months in the onabotulinumtoxinA group. Neuromodulation device revisions and removals occurred in 3%. Conclusions and Relevance Among women with refractory urgency urinary incontinence, treatment with onabotulinumtoxinA compared with sacral neuromodulation resulted in a small daily improvement in episodes that although statistically significant is of uncertain clinical importance. In addition, it resulted in a higher risk of urinary tract infections and need for transient self-catheterizations.

Quantitative electromyography of the anal sphincter after uncomplicated vaginal delivery

OBJECTIVE: Fecal incontinence in women is thought to be associated with sphincter laceration or pudendal nerve damage. A prolonged pudendal nerve terminal motor latency is evidence of profound nerve damage, but pudendal nerve terminal motor latency can be normal even when nerve injury has been sustained. We performed quantitative electromyography (EMG) to compare multiple motor unit action potential parameters between recently postpartum women and nulliparous women. METHODS: Standardized examinations were prospectively performed on 2 groups: 1) healthy nulliparous women without pelvic floor disorders (n = 28) and 2) asymptomatic women who were postpartum following vaginal delivery of their first child (n = 23). The examinations included pelvic organ prolapse quantification measurements, endoanal ultrasonography, pudendal nerve terminal motor latency, sacral reflexes, and concentric needle EMG using multiple motor unit action potential analysis. RESULTS: A mean of 11.5 (standard deviation [sd] 1.1) weeks had elapsed since first vaginal deliveries in the postpartum group. The mean fetal weight at delivery was 3,495 (sd 458) grams. There were no sphincter defects seen by ultrasonography. Compared with the nulliparous women, pudendal nerve terminal motor latency and sacral reflexes (clitoral-anal reflex, urethral-anal reflex) were not increased in the postpartum group. Each of the quantitative parameters (duration, amplitude, area, turns, and phases), measured from motor unit action potentials in the postpartum group, were larger than in the nulliparous group (P ≤ .004, nested analysis of variance [ANOVA]). CONCLUSION: Quantitative EMG using multiple motor unit action potential analysis can detect the presence after vaginal childbirth of subtle nerve injury not demonstrable by pudendal nerve terminal motor latency. Even asymptomatic women show evidence of pelvic floor nerve injury after uncomplicated deliveries. LEVEL OF EVIDENCE: II-2

Does the Urinary Microbiome Play a Role in Urgency Urinary Incontinence and Its Severity

Objectives: Traditionally, the urinary tract has been thought to be sterile in the absence of a clinically identifiable infection. However, recent evidence suggests that the urinary tract harbors a variety of bacterial species, known collectively as the urinary microbiome, even when clinical cultures are negative. Whether these bacteria promote urinary health or contribute to urinary tract disease remains unknown. Emerging evidence indicates that a shift in the urinary microbiome may play an important role in urgency urinary incontinence (UUI). The goal of this prospective pilot study was to determine how the urinary microbiome is different between women with and without UUI. We also sought to identify if characteristics of the urinary microbiome are associated with UUI severity. Methods: We collected urine from clinically well-characterized women with UUI (n = 10) and normal bladder function (n = 10) using a transurethral catheter to avoid bacterial contamination from external tissue. To characterize the resident microbial community, we amplified the bacterial 16S rRNA gene by PCR and performed sequencing using Illumina MiSeq. Sequences were processed using the workflow package QIIME. We identified bacteria that had differential relative abundance between UUI and controls using DESeq2 to fit generalized linear models based on the negative binomial distribution. We also identified relationships between the diversity of the urinary microbiome and severity of UUI symptoms with Pearsons correlation coefficient. Results: We successfully extracted and sequenced bacterial DNA from 95% of the urine samples and identified that there is a polymicrobial community in the female bladder in both healthy controls and women with UUI. We found the relative abundance of 14 bacteria significantly differed between control and UUI samples. Furthermore, we established that an increase in UUI symptom severity is associated with a decrease in microbial diversity in women with UUI. Conclusions: Our study provides further characterization of the urinary microbiome in both healthy controls and extensively phenotyped women with UUI. Our results also suggest that the urinary microbiome may play an important role in the pathophysiology of UUI and that the loss of microbial diversity may be associated with clinical severity.

Severity of pelvic organ prolapse associated with measurements of pelvic floor function.

This study tested the hypothesis that clinical measurements of the superficial perineum and of pelvic floor muscle (PFM) function correlate with the severity of pelvic organ prolapse. This retrospective cross-sectional study assessed 1037 women in an academic urogynecologic practice. Greatest descent of prolapse, by the Pelvic Organ Prolapse Quantification system, was correlated with two assessments of levator function—the Oxford grading scale and levator hiatus (LH) size measured by digital examination. Correlations were calculated using Pearson’s correlation for continuous variables and Kendall’s tau-b. Severity of prolapse correlated moderately with genital hiatus (GH) (r=0.5, p<0.0001) and with LH (transverse r=0.4, p<0.0001; longitudinal r=0.5, p<0.0001), but weakly with the Oxford grading scale (r=−0.16, p<0.0001). LH correlated with GH (r=0.5, p<0.0001) but not with perineal body (r=0.06, p=0.06). Both GH and LH size are associated with the severity of prolapse. LH size correlates more strongly to prolapse severity than assessment of PFM function by the Oxford grading scale.

Isolated pleural effusion in severe ovarian hyperstimulation: A case report

Assisted reproductive technology programs use controlled ovarian hyperstimulation to maximize pregnancy rates. Severe ovarian hyperstimulation syndrome is a well-known risk. Pleural effusion often accompanies severe ovarian hyperstimulation syndrome. We describe 2 cases of isolated hydrothorax without concomitant ascites and review the literature of this rare finding.

A pilot randomized controlled trial comparing the efficacy of exercise, spinal manipulation, and neuro emotional technique for the treatment of pregnancy-related low back pain

BackgroundThis pilot randomized controlled trial evaluated the feasibility of conducting a full scale study and compared the efficacy of exercise, spinal manipulation, and a mind-body therapy called Neuro Emotional Technique for the treatment of pregnancy-related low back pain, a common morbidity of pregnancy.MethodsHealthy pregnant women with low back pain of insidious onset were eligible to enroll in the study at any point in their pregnancy. Once enrolled, they remained in the study until they had their babies. Women were randomly allocated into one of three treatment groups using opaque envelopes. The treatment schedule paralleled the prenatal care schedule and women received individualized intervention. Our null hypothesis was that spinal manipulation and Neuro Emotional Technique would perform no better than exercise in enhancing function and decreasing pain. Our primary outcome measure was the Roland Morris Disability Questionnaire and our secondary outcome measure was the Numeric Pain Rating Scale. Intention to treat analysis was conducted. For the primary analysis, regression was conducted to compare groups on the outcome measure scores. In a secondary responder analysis, difference in proportions of participants in attaining 30% and 50% improvement were calculated. Feasibility factors for conducting a future larger trial were also evaluated such as recruitment, compliance to study protocols, cost, and adverse events.ResultsFifty-seven participants were randomized into the exercise (n = 22), spinal manipulation (n = 15), and Neuro Emotional Technique (n = 20) treatment arms. At least 50% of participants in each treatment group experienced clinically meaningful improvement in symptoms for the Roland Morris Disability Questionnaire. At least 50% of the exercise and spinal manipulation participants also experienced clinically meaningful improvement for the Numeric Pain Rating Scale. There were no clinically meaningful or statistically significant differences between groups in any analysis.ConclusionsThis pilot study demonstrated feasibility for recruitment, compliance, safety, and affordability for conducting a larger study in the future. Spinal manipulation and exercise generally performed slightly better than did Neuro Emotional Technique for improving function and decreasing pain, but the study was not powered to detect the between-group differences as statistically significant.Trial registrationClinicalTrials.gov (Identifier: NCT00937365).

Surgical outcome of abdominal sacrocolpopexy with synthetic mesh versus abdominal sacrocolpopexy with cadaveric fascia lata.

Nineteen women who had an abdominal sacrocolpopexy (ASC) with synthetic mesh and 18 women who had an ASC with freeze-dried, irradiated cadaveric fascia lata returned for blinded pelvic organ prolapse quantification (POPQ) examinations. The mean relative vaginal descent (delta) from perfect total vaginal length in the mesh group was 1.1 (0.3) cm, and the delta in the fascia group was 2.8 (0.8) cm (p=0.02, Mann–Whitney U). The proportion of women with “optimal” surgical outcome in the mesh group was 89% and 61% in the fascia group (p=0.06, Fischer’s exact test). This study suggests that cadaveric fascia lata may not be a good choice for ASC.

Quantitative anal sphincter electromyography in primiparous women with anal incontinence

OBJECTIVE The purpose of this study was to determine whether evidence of denervation/reinnervation of the external anal sphincter is associated with anal incontinence symptoms immediately after delivery. STUDY DESIGN After a first vaginal delivery, 42 women completed an anal incontinence questionnaire. They also underwent concentric needle electromyography of the external anal sphincter. For each subject, motor unit action potential and interference pattern parameters were determined. RESULTS For the motor unit action potential, no difference was observed between patients with and without anal incontinence symptoms (t-test). For the interference pattern, the amplitude/turn was greater in subjects with fecal urgency (318 +/- 48 [SD] microV) and fecal incontinence (332 +/- 48 microV), compared with those without fecal urgency (282 +/- 38 microV) and fecal incontinence (286 +/- 41 microV; P = .02, t-test). CONCLUSION In this group of postpartum women with mild anal incontinence symptoms, interference pattern analysis shows evidence of denervation and subsequent reinnervation.

Using the Brink score to predict postpartum anal incontinence.

OBJECTIVE To evaluate whether antepartum pelvic floor muscle strength, as measured by the Brink scale, predicts postpartum anal incontinence. STUDY DESIGN This prospective cohort study of primigravid women used validated questionnaires and standardized pelvic examinations to evaluate subjects during the third trimester and at 2 postpartum time points. RESULTS Of the initial 129 subjects, 102 and 81 completed 2 week and 6 month postpartum visits. 35% had cesarean deliveries. The antepartum prevalence of fecal incontinence (14%) did not differ significantly from the postpartum (17% at 2 weeks, 11% at 6 months). However, the prevalence of flatal incontinence fell from antepartum (65%) to postpartum (47% at 2 weeks, P = .001; 49% at 6 months, P = .012). Mean Brink score decreased postpartum; no correlations were found between Brink score and questionnaire scores. CONCLUSION Anal incontinence symptoms are common in the third trimester of a first pregnancy and may regress or resolve after delivery. Brink score did not predict postpartum anal incontinence.