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Objective: To compare the effectiveness of a continence pessary to evidence-based behavioral therapy for stress incontinence and to assess whether combined pessary and behavioral therapy is superior to single-modality therapy.Methods: This was a multisite, randomized clinical trial (Ambulatory Treatments for Leakage Associated with Stress Incontinence [ATLAS]) that randomly assigned 446 women with stress incontinence to pessary, behavioral therapy, or combined treatment. Primary outcome measures, at 3 months, were Patient Global Impression of Improvement and the stress incontinence subscale of the Pelvic Floor Distress Inventory. A priori, to be considered clinically superior, combination therapy had to be better than both single-modality therapies. Outcome measures were repeated at 6 and 12 months. Primary analyses used an intention-to-treat approach.Results: At 3 months, scores from 40% of the pessary group and 49% of the behavioral group were "much better" or "very much better" on the Patient Global Impression of Improvement (P=.10). Compared with the pessary group, more women in the behavioral group reported having no bothersome incontinence symptoms (49% compared with 33%, P=.006) and treatment satisfaction (75% compared with 63%, P=.02). Combination therapy was significantly better than pessary as shown on the Patient Global Impression of Improvement (53%, P=.02) and Pelvic Floor Distress Inventory (44%, P=.05) but not better than behavioral therapy; it was therefore not superior to single-modality therapy. Group differences were not sustained to 12 months on any measure, and patient satisfaction remained above 50% for all treatment groups.Conclusion: Behavioral therapy resulted in greater patient satisfaction and fewer bothersome incontinence symptoms than pessary at 3 months, but differences did not persist to 12 months. Combination therapy was not superior to single-modality therapy.Clinical Trial Registration: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00270998. [ABSTRACT FROM AUTHOR]

Objective: To review the current literature and summarize the effect of obesity on outcomes of surgical treatment of pelvic floor disorders as well as the effect of weight loss on pelvic floor disorder symptoms.Data Sources: Relevant sources were identified by a MEDLINE search from 1966 to 2007 using the key words obesity, pelvic floor disorders, urinary incontinence (UI), fecal incontinence, and pelvic organ prolapse (POP). References of relevant studies were hand searched.Methods Of Study Selection: Relevant human observational studies, randomized trials, and review articles were included. A total of 246 articles were identified; 20 were used in reporting and analyzing the data. Meta-analyses were performed for topics meeting the appropriate criteria.Tabulation, Integration, and Results: There is good evidence that surgery for stress UI in obese women is as safe as in their nonobese counterparts, but cure rates may be lower in the obese patient. Meta-analysis revealed cure rates of 81% and 85% for the obese and nonobese groups, respectively (P<.001; odds ratio [OR] 0.576, 95% confidence interval [CI] 0.426-0.779). Combined bladder perforation rates were 1.2% in the obese and 6.6% in the nonobese (P=.015; OR 0.277, 95% CI 0.098-0.782). There is little evidence on which to base clinical decisions regarding the treatment of fecal incontinence and POP in obese women, because few comparative studies were identified addressing the outcomes of prolapse surgery in obese patients compared with healthy-weight patients. Weight loss studies indicate that both bariatric and nonsurgical weight loss lead to significant improvements in pelvic floor disorder symptoms.Conclusion: Surgery for UI in obese women is safe, but more trials are needed to evaluate its long-term effectiveness as well as treatments for both fecal incontinence and POP. Weight loss, both surgical and nonsurgical, should be considered in the treatment of pelvic floor disorders in the obese woman. [ABSTRACT FROM AUTHOR]

Background: Women with urge urinary incontinence are commonly treated with antimuscarinic medications, but many discontinue therapy.Objective: To determine whether combining antimuscarinic drug therapy with supervised behavioral training, compared with drug therapy alone, improves the ability of women with urge incontinence to achieve clinically important reductions in incontinence episodes and to sustain these improvements after discontinuing drug therapy.Design: 2-stage, multicenter, randomized clinical trial conducted from July 2004 to January 2006.Setting: 9 university-affiliated outpatient clinics.Patients: 307 women with urge-predominant incontinence.Intervention: 10 weeks of open-label, extended-release tolterodine alone (n = 153) or combined with behavioral training (n = 154), followed by discontinuation of therapy and follow-up at 8 months.Measurements: The primary outcome, measured at 8 months, was no receipt of drugs or other therapy for urge incontinence and a 70% or greater reduction in frequency of incontinence episodes. Secondary outcomes were reduction in incontinence, self-reported satisfaction and improvement, and scores on validated questionnaires measuring symptom distress and bother and health-related quality of life. Study staff who performed outcome evaluations, but not participants and interventionists, were blinded to group assignment.Results: 237 participants completed the trial. According to life-table estimates, the rate of successful discontinuation of therapy at 8 months was the same in the combination therapy and drug therapy alone groups (41% in both groups; difference, 0 percentage points [95% CI, -12 to 12 percentage points]). A higher proportion of participants who received combination therapy than drug therapy alone achieved a 70% or greater reduction in incontinence at 10 weeks (69% vs. 58%; difference, 11 percentage points [CI, -0.3 to 22.1 percentage points]). Combination therapy yielded better outcomes over time on the Urogenital Distress Inventory and the Overactive Bladder Questionnaire (both P <0.001) at both time points for patient satisfaction and perceived improvement but not health-related quality of life. Adverse events were uncommon (12 events in 6 participants [3 in each group]).Limitations: Behavioral therapy components (daily bladder diary and recommendations for fluid management) in the group receiving drug therapy alone may have attenuated between-group differences. Assigned treatment was completed by 68% of participants, whereas 8-month outcome status was assessed on 77%.Conclusion: The addition of behavioral training to drug therapy may reduce incontinence frequency during active treatment but does not improve the ability to discontinue drug therapy and maintain improvement in urinary incontinence. Combination therapy has a beneficial effect on patient satisfaction, perceived improvement, and reduction of other bladder symptoms. [ABSTRACT FROM AUTHOR]

Objectives: Using computer models for the study of complex atrial arrhythmias such as atrial fibrillation is computationally demanding as long observation periods in the order of tens of seconds are required. A well established approach for reducing computational workload is to approximate the thin atrial walls by curved monolayers. On the other hand, the finite element method (FEM) is a well established approach to solve the underlying partial differential equations.Methods: A generalized 2D finite element method (FEM) is presented which computes the corresponding stiffness and coupling matrix for arbitrarily shaped monolayers (ML). Compared to standard 2D FEM, only one additional coordinate transformation is required. This allows the use of existing FEM software with minor modifications. The algorithm was tested to simulate wave propagation in benchmark geometries and in a model of atrial anatomy.Results: The ML model was able to simulate electric activation in curved tissue with anisotropic conductivity. Simulations in branching tissue yielded slightly different patterns when compared to a volumetric model with finite thickness. In the model of atrial anatomy the computed activation times for five different pacing protocols displayed a correlation of 0.88 compared to clinical data.Conclusions: The presented method provides a useful and easily implemented approach to model wave propagation in MLs with a few restrictions to volumetric models. [ABSTRACT FROM AUTHOR]

Background: Many surgical procedures are available for women with urinary stress incontinence, yet few randomized clinical trials have been conducted to provide a basis for treatment recommendations.Methods: We performed a multicenter, randomized clinical trial comparing two procedures--the pubovaginal sling, using autologous rectus fascia, and the Burch colposuspension--among women with stress incontinence. Women were eligible for the study if they had predominant symptoms associated with the condition, a positive stress test, and urethral hypermobility. The primary outcomes were success in terms of overall urinary-incontinence measures, which required a negative pad test, no urinary incontinence (as recorded in a 3-day diary), a negative cough and Valsalva stress test, no self-reported symptoms, and no retreatment for the condition, and success in terms of measures of stress incontinence specifically, which required only the latter three criteria. We also assessed postoperative urge incontinence, voiding dysfunction, and adverse events.Results: A total of 655 women were randomly assigned to study groups: 326 to undergo the sling procedure and 329 to undergo the Burch procedure; 520 women (79%) completed the outcome assessment. At 24 months, success rates were higher for women who underwent the sling procedure than for those who underwent the Burch procedure, for both the overall category of success (47% vs. 38%, P=0.01) and the category specific to stress incontinence (66% vs. 49%, P<0.001). However, more women who underwent the sling procedure had urinary tract infections, difficulty voiding, and postoperative urge incontinence.Conclusions: The autologous fascial sling results in a higher rate of successful treatment of stress incontinence but also greater morbidity than the Burch colposuspension. (ClinicalTrials.gov number, NCT00064662 [ClinicalTrials.gov] .). [ABSTRACT FROM AUTHOR]

Objective: To estimate whether endoanal ultrasound findings are more prevalent in primiparous women with a history of anal sphincter tear than in women without this history and whether the findings are associated with fecal incontinence symptoms.Methods: A total of 251 primiparous women at seven clinical sites underwent standardized ultrasound assessment of the internal and external anal sphincter 6-12 months after delivery. Participants were women in the three cohorts of the Childbirth and Pelvic Symptoms Study: 1) women with clinically evident third- or fourth-degree tear at vaginal delivery (n=106); 2) no tear at vaginal delivery (n=106); and 3) cesarean delivery without labor (n=39). Women completed the Fecal Incontinence Severity Index to assess fecal incontinence symptoms.Results: Thirty-five percent of the sphincter tear group exhibited internal sphincter gaps compared with 3% of vaginal controls (odds ratio [OR] 18.4, 95% confidence interval [CI] 5.5-62.1) and 10% of cesarean controls. External sphincter gaps were identified in 51% of the tear group compared with 31% of vaginal controls (OR 2.3, 95% CI 1.3-4.0) and 28% of cesarean controls. In the tear group, fecal incontinence severity was greater in those with internal sphincter gaps compared with those with no internal sphincter gaps (Fecal Incontinence Severity Index score 6.6+/-8.3 compared with 3.3+/-6.1, P=.02), as well as in those with external sphincter gaps (6.1+/-8.4 compared with 2.7+/-5.0, P=.01), and greatest in those with both internal and external sphincter gaps compared with at least one gap not present (7.2+/-8.1 compared with 3.4+/-6.4, P=.003).Conclusion: Anal sphincter gaps detected by ultrasonography are prevalent in postpartum primiparous women with a history of sphincter tear and are associated with fecal incontinence severity.Level Of Evidence: II-2. [ABSTRACT FROM AUTHOR]

Objective: The purpose of this study was to describe the methods of a randomized clinical trial of intra-vesical botulinum toxin for refractory urge urinary incontinence. Methods: Clinical sites of the Pelvic Floor Disorders Network (www.pfdn.org) recruited patients with refractory urge urinary incontinence and urodynamic evidence of detrusor overactivity incontinence (DOI) to a 2:1 placebo controlled cystoscopic injection of botulinum toxin A. Results: The primary outcome is time to failure after first injection, with failure defined as a Patient Global Impression of Improvement (PGI-I) score 4 or greater at least 2 months after the first injection or the commencement of any new treatment at any time after the first injection, or an increased intensity of previously established treatment for DOI. Conclusions: This trial was designed to test the efficacy of intra-detrusor botulinum toxin A for the treatment of refractory urge incontinence. Progress of the trial can be monitored on www.clinicaltrials. gov [ABSTRACT FROM AUTHOR]

Background: Urinary incontinence is common in women. Because treatments differ, urge incontinence should be distinguished from stress incontinence. To make this distinction, current guidelines recommend an extensive evaluation that is too time-consuming for primary care practice.Objective: To test the accuracy of a simple questionnaire to categorize type of urinary incontinence in women.Design: Multicenter, prospective study of the accuracy of the 3 Incontinence Questions (3IQ) compared with an extended evaluation to distinguish between urge incontinence and stress incontinence.Setting: 5 academic medical centers in the United States.Participants: 301 women enrolled from April to December 2004 who were older than 40 years of age (mean age, 56 years [SD, 11]) with untreated incontinence for an average of 7 years (SD, 7) and a broad range of incontinence severity.Measurements: All participants included in the analyses answered the 3IQ questionnaire, and a urologist or urogynecologist who was blinded to the responses performed the extended evaluation. Sensitivity, specificity, and likelihood ratios were determined for the 3IQ.Results: For classification of urge incontinence and with the extended evaluation as the gold standard, the 3IQ had a sensitivity of 0.75 (95% CI, 0.68 to 0.81), a specificity of 0.77 (CI, 0.69 to 0.84), and a positive likelihood ratio of 3.29 (CI, 2.39 to 4.51). For classification of stress incontinence, the sensitivity was 0.86 (CI, 0.79 to 0.90), the specificity was 0.60 (CI, 0.51 to 0.68), and the positive likelihood ratio was 2.13 (CI, 1.71 to 2.66).Limitations: Participants were enrolled by urologists and urogynecologists at academic medical centers.Conclusions: The 3IQ questionnaire is a simple, quick, and noninvasive test with acceptable accuracy for classifying urge and stress incontinence and may be appropriate for use in primary care settings. Similar studies are needed in other populations. We also need a clinical trial comparing the outcomes of treatments based on the 3IQ and the extended evaluation. [ABSTRACT FROM AUTHOR]

OBJECTIVE: The purpose of this study was to assess a cohort of patients who underwent a colpocleisis procedure more than 1 year post operation to determine: 1) the proportion of patients who regretted having the procedure, 2) patient satisfaction with the procedure, and 3) changes in symptom severity after surgery. STUDY DESIGN: Using the University of Alabama at Birmingham (UAB) Genitourinary Disorders Center database, a prospective analysis was performed on 54 patients who underwent colpocleisis between August 1996 and April 2003. From August to October of 2004, participants were contacted by an investigator not involved with the surgery and were asked 1) 'do you regret having your surgery, and, if so, why?,' 2) 'how satisfied are you with your progress (completely, somewhat, or not)?,' and 3) to repeat the short form Incontinence Impact Questionnaire/Urogenital Distress Inventory (IIQ-7/UDI-6). RESULTS: Fifty-nine percent (32/54) of potential candidates participated in the study. Nine percent (3/32) of patients regretted having colpocleisis performed. Fifty-seven percent (16/28) were completely satisfied, 29% (8/28) somewhat satisfied, and 14% (4/28) not satisfied. Mean IIQ score improved significantly from 40.9 (+/-31.7) at baseline to 14.1 (+/-26.7) at last interview (P = .003). Mean UDI score improved significantly from 63.1 (+/-24.3) at baseline to 24.2 (+/-26.7) at last interview (P = .001). There was a negative correlation between change in UDI scores with time since procedure (r = -.397, P = .055) and age (r = -.435, P = .034). CONCLUSION: Few patients reported regret after partial colpocleisis. There was a high rate of patient satisfaction and significant symptom improvement more than a year post surgery. Stable but smaller improvements were reported with longer time from surgery and increasing age. [ABSTRACT FROM AUTHOR]

Controversy surrounds the association between bacterial vaginosis (BV) and pelvic inflammatory disease (PID). Women (N = 1,140) were ascertained at five US centers, enrolled (1999-2001), and followed up for a median of 3 years. Serial vaginal swabs were obtained for Gram's stain and cultures. PID was defined as 1) histologic endometritis or 2) pelvic pain and tenderness plus oral temperature >38.8 degrees C, leukorrhea or mucopus, erythrocyte sedimentation rate >15 mm/hour, white blood cell count >10,000, or gonococcal/chlamydial lower genital infection. Exploratory factor analysis identified two discrete clusters of genital microorganisms. The first correlated with BV by Gram's stain and consisted of the absence of hydrogen peroxide-producing lactobacillus, Gardnerella vaginalis, Mycoplasma hominis, anaerobic gram-negative rods, and, to a lesser degree, Ureaplasma urealyticum. The second, unrelated to BV by Gram's stain, consisted of Enterococcus species and Escherichia coli. Being in the highest tertile in terms of growth of BV-associated microorganisms increased PID risk (adjusted rate ratio = 2.03, 95% confidence interval: 1.16, 3.53). Carriage of non-BV-associated microorganisms did not increase PID risk. Women with heavy growth of BV-associated microorganisms and a new sexual partner appeared to be at particularly high risk (adjusted rate ratio = 8.77, 95% confidence interval: 1.11, 69.2). When identified by microbial culture, a combination of BV-related microorganisms significantly elevated the risk of acquiring PID. [ABSTRACT FROM AUTHOR]

Objective: This study was undertaken to assess the cure rate of stress urinary incontinence, long-term effects on other lower urinary tract symptoms, and quality of life in a cohort of patients who underwent pubovaginal sling procedures for treatment of incontinence related to intrinsic sphincteric deficiency and urethral hypermobility. Study Design: This was a retrospective analysis of 57 patients with 90% follow-up who underwent pubovaginal autologous fascial sling procedures for stress urinary incontinence related to urethral hypermobility and intrinsic sphincteric deficiency. Objective postoperative urodynamic evaluation was performed in 34 (60%) of the cases. Telephone interviews to assess quality-of-life parameters were performed in all cases. Results: The mean follow-up period was 42 months and the median follow-up period was 34 months, with a range of 0.5 to 134 months. The age at the time of the sling procedure ranged from 18 to 84 years, with a median parity of 3.0 (range, 0-6). Preoperative body mass index ranged from 19.5 to 39.1 kg/m(2). Five percent of patients had detrusor instability before the operation. Forty-one percent (41%) of the patients who underwent postoperative urodynamic evaluation had voiding dysfunction. The postoperative objective cure rate for stress urinary incontinence was 97%. Of all patients 88% indicated that the sling had improved the quality of life, 84% indicated that the sling relieved the incontinence in the long-term, and 82% would choose to undergo the procedure again. Conclusion: Construction of a pubovaginal sling is an effective technique for relief of severe stress urinary incontinence. Voiding dysfunction is a common side effect. Despite this problem, a significant number of patients would elect to undergo the procedure again. [ABSTRACT FROM AUTHOR]

Background and Objectives: Vaginal acidification has been suggested as a means of normalizing the vaginal flora.Goal: The purpose of this study was to determine the effectiveness of an acetic acid-based vaginal gel in the treatment of bacterial vaginosis (BV).Study Design: Forty-four patients with BV were enrolled in a randomized, double-blind clinic trial. Of these, 29 were evaluable. Patients were randomized to receive either 5 mL acetic acid gel (n = 14) or placebo gel (n = 15) intravaginally twice daily for 7 days. Clinical criteria and vaginal Gram stain scores were compared between the initial visit and at 2 weeks after initiating therapy.Results: No significant differences were noted when comparing drug and placebo in terms of subjective or clinical improvement or improvement in Gram stain smears for bacterial vaginosis.Conclusion: Vaginal acidification with an acetic acid gel formulated to pH 3.9 to 4.1 was ineffective therapy for bacterial vaginosis. [ABSTRACT FROM AUTHOR]

Abstract Background Neuropathic pain must be correctly diagnosed for optimal treatment. The questionnaire named Neuropathic Pain Symptom Inventory (NPSI) was developed in its original French version to evaluate the different symptoms of neuropathic pain. We hypothesized that the NPSI might also be used to differentiate neuropathic from non-neuropathic pain. Methods We translated the NPSI into German using a standard forward-backward translation and administered it in a case-control design to patients with neuropathic (n = 68) and non-neuropathic pain (headache and osteoarthritis, n = 169) to validate it and to analyze its discriminant properties, its sensitivity to change, and to detect neuropathic pain subgroups with distinct profiles. Results Using a sum score (the NPSI-G score), we found sensitivity to change (r between 0.37 and 0.5 for pain items of the graded chronic pain scale) and could distinguish between neuropathic and other pain on a group basis, but not for individual patients. Post hoc development of a discriminant score with optimized diagnostic properties to distinguish neuropathic pain from non-neuropathic pain resulted in an instrument with high sensitivity (91%) and acceptable specificity (70%). We detected six different pain profiles in the patient group with neuropathic pain; three profiles were found to be distinct. Conclusions The NPSI-G potentially combines the properties of a diagnostic tool and an instrument to identify subtypes of neuropathic pain.

Abstract Background The determination of Intraepidermal Nerve Fiber Density (IENFD) in skin biopsy is a useful method for the evaluation of different types of peripheral neuropathies. To allow a reliable use of the method it is necessary to determine interobserver reliability. Previous studies dealing with this topic used limited suitable statistical methods. Methods In the present study three observers determined the IENFD and estimated the staining quality of the basement membrane for an adequate quantity of 120 skin biopsies (stained with indirect immunofluorescence technique) from 68 patients. More adequate statistical methods like intraclass correlation coefficient and Bland Altman Plot were chosen to estimate interobserver reliability. Results We found an unexpected significant difference in IENFD between the observers (p < 0.05) and so the results of this study are not in line with the high interobserver reliability reported before (intraclass correlation coefficient: 0.73). The Bland Altmann Plot showed a variance growing with rising mean. The difference in IENFD between the observers and the resulting low interobserver reliability is likely caused by different interpretations of the standard counting rules. There was no significant difference in IENFD between observers for biopsies with a well-defined basement membrane. Thus skin biopsies with an inexactly defined basement membrane should not be used diagnostically for the determination of IENFD. Conclusion These results emphasise that standardisation of the method is extremely important and at least two observers should analyse skin biopsies with critical IENFD near the cut-off values.