Management of female stress urinary incontinence with single-incision mini-sling (Altis®): 36 month multicenter outcomes.

PURPOSE: To assess noninferiority of the safety and effectiveness of the Altis® Single Incision Sling (SIS) with standard midurethral transobturator and/or retropubic slings through 36 months in a prospective, longitudinal, nonrandomized US Food and Drug Administration (FDA) 522 cohort study. MATERIALS AND METHODS: Adult females with confirmed predominant stress urinary incontinence (UI) through cough stress test (CST) or urodynamics and failed two noninvasive incontinence therapies. Effectiveness endpoints included objective dryness, negative CST, adverse events, and revision/resurgery through 36 months. The primary effectiveness endpoint was reduction from baseline in 24-h pad weight of ≥50% at 6 months, as requested by the FDA, and is included as a study point in this paper. Primary safety endpoint was rate of related serious adverse events (SAE) through 36 months. Noninferiority margins of 15% and 10% were prespecified for the effectiveness and safety endpoints. Due to the observational nature of the cohort study, a propensity methodology was conducted to assess the effect of potential confounding variables on the primary endpoints between groups. RESULTS: Three hundred fifty-five women underwent the sling procedure (n = 184 Altis; n = 171 Comparator). One hundred fourty (76%) Altis subjects and 101 (59%) Comparator subjects completed follow-up through 36 months. At 36 months, for the effectiveness endpoint, the difference in proportions of -0.005 for Altis versus Comparator (95% confidence interval [CI]: -0.102 to 0.092) was statistically significant (p = 0.002), supporting the hypothesis that Altis is noninferior to Comparator. Furthermore, both groups demonstrated high objective efficacy; in the Altis arm n = 99 (81.8%) subjects were a success, and in the Comparator arm, n = 79 (82.3%) subjects were a success. Additionally, regarding the CST, Altis was found to be noninferior to the Comparator at every study visit, and the rate of negative CST remained above 80% for both groups (p < 0.001). At 36 months, Altis (n = 2; 1.1%) and Comparator (n = 4; 2.3%) subjects experienced a device and/or procedure-related SAE. The difference in proportions of 0.013 for Altis versus Comparator (95% CI: -0.023 to 0.048) was statistically significant (p < 0.001), demonstrating that Altis is noninferior to Comparator with respect to the primary safety endpoint throughout the study. There were 62 (36.3%) retropubic midurethral slings (RMUS), 96 (56.1%) transobturator midurethral slings (TMUS), and 13 (7.6%) SIS slings in the Comparator group. For the 36 month effectiveness endpoint, assessing the noninferiority of Altis versus RMUS and Altis versus TMUS, 99 (81.8%) Altis and 37 (90.2%) RMUS were a success, trending toward statistical significance, however, it cannot be determined to be noninferior (p = 0.092). Ninty-nine (81.8%) Altis and 33 (71.7%) TMUS were a success; this was statistically significant (p < 0.001), demonstrating Altis was noninferior to TMUS. Rates of negative CST were 122 (87.1%) Altis, 40 (93.0%) RMUS (p < 0.001), and 44 (91.7%) TMUS (p < 0.001). CST demonstrated that Altis was noninferior to RMUS and Altis was noninferior to TMUS at 36 months. CONCLUSION: Altis single-incision sling was noninferior to standard midurethral sling for treatment of stress UI, throughout the study and at 36 months. Furthermore, adverse event rates were low.

A Multicenter Prospective Study Evaluating Efficacy and Safety of a Single-incision Sling Procedure for Stress Urinary Incontinence.

STUDY OBJECTIVE: The aim of the Altis 522 study was to compare the safety and efficacy of the Altis Single-Incision Sling System (SIS) (Coloplast, Minneapolis, MN) with standard midurethral transobturator and/or retropubic slings through 36 months. In this report, we present data through 12 months of follow-up. DESIGN: Postmarket, prospective, multicenter, nonrandomized cohort design. SETTING: The study was performed at 23 hospitals in the United States and Canada. PATIENTS: Adult female patients with stress urinary incontinence (SUI) clinically indicated for an incontinence sling were treated (n = 355). INTERVENTIONS: Altis SIS was compared with any Food and Drug Administration-cleared transobturator or retropubic sling. MEASUREMENTS AND MAIN RESULTS: Collected measures included device- and/or procedure-related serious adverse events, relevant nonserious and all adverse events, and revision surgery. Objective efficacy measures included 24-hour pad weight, dryness (defined as pad weight ≤4.0 g), and cough stress test. Subjective outcome measures included patient global impression of improvement, urogenital distress inventory, Incontinence Impact Questionnaire-Short Form, Surgical Satisfaction Questionnaire, and visual analog scale for pain. At 12 months, 24-hour pad weight success (≥50% reduction), negative cough stress test, patient global impression of improvement, urogenital distress inventory, and Incontinence Impact Questionnaire-Short Form appeared similar between groups. Through 12 months, 2 subjects in the Altis group and 3 subjects in the comparator group experienced a serious device- and/or procedure-related adverse event. In the Altis group, 1 subject (0.5%) experienced a device revision, and 1 subject (0.5%) had the device explanted. In the comparator group, 7 subjects (4.1%) experienced a device revision, and 1 device (0.6%) was explanted before the 12-month visit. The occurrence of relevant nonserious procedure and/or device-related adverse events was similar between groups. CONCLUSION: At 12-months follow-up, safety and efficacy appeared similar between Altis SIS and standard transobturator and retropubic midurethral slings.

Recurrent pelvic organ prolapse: International Urogynecological Association Research and Development Committee opinion.

INTRODUCTION AND HYPOTHESIS: This committee opinion paper summarizes available evidence about recurrent pelvic organ prolapse (POP) to provide guidance on management. METHOD: A working subcommittee from the International Urogynecological Association (IUGA) Research and Development Committee was formed. The literature regarding recurrent POP was reviewed and summarized by individual members of the subcommittee. Recommendations were graded according to the 2009 Oxford Levels of Evidence. The summary was reviewed by the Committee. RESULTS: There is no agreed definition for recurrent POP and evidence in relation to its evaluation and management is limited. CONCLUSION: The assessment of recurrent POP should entail looking for possible reason(s) for failure, including persistent and/or new risk factors, detection of all pelvic floor defects and checking for complications of previous surgery. The management requires individual evaluation of the risks and benefits of different options and appropriate patient counseling. There is an urgent need for an agreed definition and further research into all aspects of recurrent POP.

Sexual function in women with anal incontinence using a new instrument: the PISQ-IR.

INTRODUCTION: Anal incontinence (AI) has been associated with sexual complaints. The Pelvic Organ Prolapse/Incontinence Sexual Questionnaire-IUGA Revised (PISQ-IR) has been validated to measure sexual function in sexually active (SA) and non-SA (NSA) women with pelvic floor disorders (PFD) including AI. We describe symptoms in women with PFDs including AI using this instrument. METHODS: This was a planned secondary analysis of data collected for the validation of the PISQ-IR. SA and NSA women with symptoms of pelvic organ prolapse, urinary incontinence (UI) and/or AI at 12 US and 5 UK sites were recruited. The Female Sexual Function Index (FSFI) and PISQ-IR were completed in addition to the Pelvic Floor Distress Inventory (PFDI), and other measures. RESULTS: Of 872 women enrolled, 90 (10%) reported AI. Compared with women without AI, women with AI were more likely to report stress UI (p = 0.007), urgency UI (p < 0.001), mixed UI (p < 0.001), diabetes (p = 0.036) and depression (p < 0.001), and to show larger genital hiatus measurements (p = 0.005) and more underactive pelvic floor muscles (p = 0.011). Furthermore, scores on the PFDI showed greater bother (p = 0.013), particularly the colorectal subscale (p < 0.001). While sexual activity was similar between the groups, FSFI desire (p = 0.016), PISQ-IR 'condition-specific' (p = 0.03) and 'global quality' (p = 0.046) domains were worse in women with AI. In logistic regression analysis, only the PISQ-IR 'condition-specific' domain was associated with AI when controlling for other confounders (OR 0.27, 95% CI 0.10 - 0.72, p = 0.009). CONCLUSIONS: Women with AI have similar rates of sexual activity but poorer sexual function than women without AI. The PISQ-IR may be most appropriate to characterize these conditions.

Randomized controlled trial comparing two procedures for anterior vaginal wall prolapse.

OBJECTIVE: To compare success rates between anterior colporrhaphy and abdominal paravaginal defect repair for treatment of anterior vaginal wall prolapse. METHODS: This was a prospective randomized controlled trial comparing anterior colporrhaphy plus polyglactin 910 mesh (vaginal) to paravaginal defect repair (abdominal) in women with symptomatic anterior vaginal wall prolapse. Pelvic organ prolapse quantification staging (POP-Q), pelvic floor distress inventory, pelvic floor impact questionnaire, and pelvic organ prolapse/urinary incontinence sexual questionnaires were administered pre and post-operatively. Women were followed up to 2 years. The primary outcome was anterior POP-Q stage, with failure defined as ≥stage II. RESULTS: We enrolled 70 patients, 35 in each group. Demographic and most peri-operative characteristics were similar between the groups. Mean anterior vaginal wall prolapse repair time (39 min) was shorter for vaginal versus abdominal repair (60 min; P < 0.001), with more concurrent hysterectomies in the vaginal (71%) versus abdominal group (42%), P = 0.01. At 2 years, objective failure rates for the vaginal and abdominal groups were 32% and 40%, respectively, P = 0.56. Subjective failure rates were lower and similar for both groups. Patient satisfaction rates were 88% for the vaginal and 73% for the abdominal group, P = 0.11. Quality of life questionnaires showed significant improvement from baseline but no difference between the groups (P = 0.12). CONCLUSIONS: At 2 years follow-up, anterior colporrhaphy with polyglactin 910 mesh and abdominal paravaginal defect repair have similar success rates, with most objective failures being asymptomatic.

The PISQ-IR: considerations in scale scoring and development.

INTRODUCTION: This paper provides a detailed discussion of the psychometric analysis and scoring of a revised measure of sexual function in women with pelvic floor disorders (PFD): the Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR). METHODS: Standard tools for evaluating item distributions, relationships, and psychometric properties were used to identify sub-scales and determine how the sub-scales should be scored. The evaluation of items included a nonresponse analysis, the nature of missingness, and imputation methods. The minimum number of items required to be answered and three different scoring methods were evaluated: simple summation, mean calculation, and transformed summation. RESULTS: Item nonresponse levels are low in women who are sexually active and the psychometric properties of the scales are robust. Moderate levels of item nonresponse are present for women who are not sexually active, which presents some concerns relative to the robustness of the scales. Single imputation for missing items is not advisable and multiple imputation methods, while plausible, are not recommended owing to the complexity of their application in clinical research. The sub-scales can be scored using either mean calculation or transformed summation. Calculation of a summary score is not recommended. CONCLUSION: The PISQ-IR demonstrates strong psychometric properties in women who are sexually active and acceptable properties in those who are not sexually active. To score the PISQ-IR sub-scales, half of the items must be answered, imputation is not recommended, and either mean calculation or transformed sum methods are recommended. A summary score should not be calculated.

Childhood dysfunctional voiding is differentially associated with urinary incontinence subtypes in women.

PURPOSE: To estimate the relationship between the history of childhood dysfunctional voiding and urinary incontinence (UI) in adult women with and without clinical UI and to estimate its relationship with stress, urge, and mixed UI. MATERIALS AND METHODS: Using a case-control study, we surveyed adult women with or without UI using a validated dysfunctional voiding questionnaire. Cases were clinically classified as stress, urge, or mixed UI. Patient characteristics were compared using Student's t-test, chi-square test, and Fisher's exact test. Confounders were controlled through logistic regression. We compared the history of childhood dysfunctional voiding status among the three UI subtypes using multinomial logistic regression. RESULTS: We recruited 267 cases (120 stress, 37 urge, 98 mixed, and 12 other UI) and 107 controls. Mean age of cases and controls were 58 and 52 years and BMI 26 and 23 kg/m², respectively. Fifty-six percent of cases (48% stress, 65% urge, and 62% mixed UI) had a prevalence of childhood dysfunctional voiding compared to controls (40%) (P = 0.06). After adjusting for confounders, women with adult UI had a twofold increased odds (95% CI = 1.2-3.4, P = 0.006) of childhood dysfunctional voiding compared with controls. The highest prevalence of dysfunctional voiding was with urge UI (OR = 4.4, 95% CI = 1.8-10.7) followed by mixed UI (OR = 2.7, 95% CI = 1.5-5.2), and finally stress UI (OR = 1.4, 95% CI = 0.8-2.5). CONCLUSION: Childhood dysfunctional voiding may predict adult bladder control problems. This association is strongest in women with urge UI followed by mixed UI, but not different between women with stress UI and controls.

Multicenter inter-examiner agreement trial for the validation of simplified POPQ system.

INTRODUCTION AND HYPOTHESIS: The primary aim of this study was to evaluate the inter-examiner agreement of a previously described simplified pelvic organ prolapse quantification (S-POP) system in a multicenter, prospective, randomized, blinded fashion. Pelvic organ prolapse quantification (POPQ) system's use in daily practice is hampered due to perceived complexity and difficulty of use. The S-POP was introduced in order to make the POPQ user-friendly and increase its usage (Swift et al. in Int Urogynecol J 17(6):615-620, 2006). METHODS: Five hundred eleven subjects underwent two separate pelvic exams in random order by two blinded examiners employing the S-POP at 12 centers around the world. Data were compared using weighted kappa statistics. RESULTS: The weighted kappa statistics for the inter-examiner reliability of the S-POP were 0.87 for the overall stage, 0.89 and 0.81 for the anterior and posterior vaginal walls, 0.82 for the apex/cuff 0.89, and 0.84 for the cervix and vaginal fornix, respectively. CONCLUSION: There is an almost perfect inter-examiner agreement of the S-POP system for the overall stage and each point within the system.

Robotic telepresence: profit analysis in reducing length of stay after laparoscopic gastric bypass.

BACKGROUND: With the continuing rise of health-care costs, lowering inpatient length of stay can help managers and hospital administrators cope with the financial pressures and challenges of anticipated unfavorable operating margins. The goal of this study was to assess the financial impact of postoperative robotic telerounding on length of stay of all patients undergoing noncomplicated laparoscopic gastric bypass operations. STUDY DESIGN: We retrospectively reviewed 376 patients who underwent laparoscopic gastric bypass for morbid obesity from January 2004 to July 2006. The first 284 patients (group A) were assessed by bedside visits alone during the postoperative period. The second group (group B) consisted of 92 patients assessed by robotic telepresence combined with regular bedside visits before their discharge. Eleven patients were excluded from the study because they suffered from postoperative complications during the same admission. RESULTS: After robotic rounds, 71 patients (77%) were discharged on postoperative day 1 (group B) and 218 patients (77%) assessed exclusively by bedside rounds were discharged on day 2 (group A). Mean length of stay was reduced from 2.33 days for group A to 1.26 days for group B. Early discharge created capacity for an additional 71 patient/days, although only 54 beds (76%) were reoccupied by new patients, representing a total financial gain of $219,578. Additionally, total room and board savings of $14,378 were realized as early discharge. Readmission rates within 7 days after discharge were 2% for group A and 1% for group B. CONCLUSIONS: Robotic telerounding substantially reduces length of stay of patients undergoing noncomplicated laparoscopic gastric bypass operation. Telepresence technology applied in these settings had a substantial financial impact by reducing variable cost and creating capacity for growth and income.

Bilateral bladder erosion of a transobturator tape mesh.

BACKGROUND: The transobturator tape procedure is reported to be an effective procedure with low complication rates. CASE: A 45-year-old woman underwent surgery for prolapse and incontinence. The surgery included transobturator tape. Intraoperative cystoscopy was not performed. Postoperatively, a mesh erosion into the bladder on the left side and a large cystocele were diagnosed. The patient underwent a combined transurethral and suprapubic mesh resection. Six months later, she had another mesh erosion on the contralateral side. This time, a complete vaginal resection of the mesh was performed. CONCLUSION: Intraoperative cystoscopy should be considered after a transobturator tape procedure. Bilateral mesh erosion may result from motion of a cystocele against a fixed transobturator tape. Concurrent repair of the cystocele to prevent future mesh erosions may be warranted.

Spontaneous bladder rupture following cystoscopy with hydrodistention and biopsy in a female patient with interstitial cystitis.

We report a case of remote spontaneous rupture of urinary bladder following cystourethroscopy with hydrodistention and a bladder biopsy in a patient with interstitial cystitis. This required abdominal exploration with cystorrhaphy. This case emphasizes a unique and dangerous complication of this procedure in a patient with interstitial cystitis.

Effects of castration on female rabbit bladder physiology and morphology.

OBJECTIVES: To determine the effect of ovariectomy on bladder blood flow and oxygen tension. Women are subject to bladder dysfunctions that occur less frequently in men. These include interstitial cystitis (syndrome of urgency, frequency, and pain on distension), incontinence, and bladder infections. It is believed that alterations in female sex hormones play a major role in mediating these abnormalities. We believe that alterations in estrogen can have marked effects on the blood flow to the bladder. METHODS: We divided 20 female rabbits into two equal groups: ovariectomized and sham operated. Six weeks later, the bladder of each rabbit was evaluated for bladder capacity, compliance, permeability, blood flow, tissue hypoxia, morphology, and smooth muscle contraction. RESULTS: Ovariectomy resulted in decreased bladder compliance; decreased blood flow to the bladder mucosa and uterus, a smaller decrease in blood flow to the bladder smooth muscle, and mucosal hypoxia; and statistically significant thinning of the bladder mucosa and increased mucosal permeability. CONCLUSIONS: Ovariectomy resulted in decreased blood flow and hypoxia to the bladder mucosa and a mildly decreased blood flow to the smooth muscle. The decreased blood flow and hypoxia may be related to the age-related uropathologic findings in postmenopausal women.