Urinary Incontinence Treatment Network Research Articles

Representation of Minority Groups in Key Pelvic Floor Disorder Trials.

Multicenter randomized clinical trials on pelvic floor disorders (PFDs) support evidence-based care. However, many of these studies include homogenous study populations lacking diversity. Heterogeneous sampling allows for greater generalizability while increasing knowledge regarding specific subgroups. The racial/ethnic makeup of key pelvic floor disorder (PFD) trials has not been examined. This study aimed to investigate racial/ethnic representation in major PFD clinical trials in comparison to racial/ethnic distribution of PFD in the National Health and Nutritional Examination Survey (NHANES). Demographic data were extracted from completed PFD Network (PFDN) and Urinary Incontinence Treatment Network studies, which have resulted in nearly 200 publications. Prevalence of PFD by race/ethnicity was obtained from the NHANES. A representative index (Observed "n" by PFD study/Expected "n" based on the NHANES-reported prevalence) was calculated as a measure of representation. Meta-analyses were performed for each outcome and overall with respect to race/ethnicity. Eighteen PFDN/Urinary Incontinence Treatment Network studies were analyzed. White women comprised 70%-89% of PFD literature; Black women, 6%-16%; Hispanic women, 9%-15%; Asians, 0.5%-6%; and American Indians, 0%-2%. Representation of White women was higher in 13 of 18 PFDN studies compared with the NHANES prevalence data. Representation of Black women was either decreased or not reported in 10 of 18 index studies compared with the NHANES prevalence data. Hispanic women were absent or underrepresented in 7 of 18 PFDN studies compared with the prevalence data. Our examination of PFDN and other landmark trials demonstrates inconsistent reporting of minority subgroups, limiting applicability with respect to minority populations. Our study suggests that PFD research would benefit from targeted sampling of minority groups.

PD33-03 IMPACT OF FEMALE STRESS URINARY INCONTINENCE SURGERY ON PRE-OP OVERACTIVE BLADDER SYMPTOMS

You have accessJournal of UrologyUrodynamics/Incontinence/Female Urology: Female Urology I1 Apr 2014PD33-03 IMPACT OF FEMALE STRESS URINARY INCONTINENCE SURGERY ON PRE-OP OVERACTIVE BLADDER SYMPTOMS Halina Zyczynski, Michael Albo, Hae-Young Kim, Maude Carmel, Clifford Wai, Peggy Norton, Linda Brubaker, Larry Sirls, R.E. Varner, Howard Goldman, and Urinary Incontinence Treatment Network Halina ZyczynskiHalina Zyczynski More articles by this author , Michael AlboMichael Albo More articles by this author , Hae-Young KimHae-Young Kim More articles by this author , Maude CarmelMaude Carmel More articles by this author , Clifford WaiClifford Wai More articles by this author , Peggy NortonPeggy Norton More articles by this author , Linda BrubakerLinda Brubaker More articles by this author , Larry SirlsLarry Sirls More articles by this author , R.E. VarnerR.E. Varner More articles by this author , Howard GoldmanHoward Goldman More articles by this author , and Urinary Incontinence Treatment Network More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2014.02.2286AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Persistence of overactive bladder (OAB) symptoms decreases satisfaction with stress urinary incontinence (SUI) surgery. We assessed the impact of SUI surgery on OAB symptoms up to 5 years post-op and identified predictors of OAB symptom change. METHODS We analyzed data from 2 multicenter SUI surgical trials of women with stress predominant mixed urinary incontinence conducted by the UITN: SISTEr (Burch v. autologous fascial sling) and TOMUS (retropubic v. transobturator midurethral sling). The primary outcome was improvement of ≥70% from baseline in symptoms measured by irritative subscale of the Urinary Distress Inventory (UDI-I) and MESA Urge Index. Differences in procedure outcomes were compared within the trial. Regression models used 12 and 60 month data. RESULTS At 12 months, most women (60-76%) reported OAB symptom improvement (Figure 1). Symptom improvement was similar between TOMUS sling groups at 1 year(70.3% RMUS vs 72.9% TMUS, p=0.70) and 5 years. More women reported symptom improvement in the Burch group compared to the sling (71% vs 59.6%, p=0.01) at 1 year; this difference was sustained at 5 years. Similar, significant improvements from baseline urgency incontinence were observed for each group in SISTEr and TOMUS without significant group differences. The % of women with symptom improvement declined significantly in each group, though at 5 years, 49%-67% continued to report improvement. Predictors of symptom change in TOMUS included concomitant surgery (decreased odds of improvement at 12 months) and greater baseline symptom severity (increased odds of improvement). Variables not predictive of symptom change included pre-operative anticholinergics, urodynamic detrusor overactivity, bladder volumes at first desire, strong desire or maximum cystometric capacity. Greater symptom improvement at 12 months occurred in SISTEr participants who were menopausal(on HRT), who were not obese, and with greater baseline OAB symptoms; conversely, increasing parity reduced the odds of symptom improvement. CONCLUSIONS Most women with stress predominant mixed urinary incontinence experienced significant improvement in OAB wet and dry symptoms after SUI surgery although initial improvement diminishes over time. Urodynamic parameters are not prognostic of change in baseline OAB symptoms. © 2014FiguresReferencesRelatedDetails Volume 191Issue 4SApril 2014Page: e841-e842 Advertisement Copyright & Permissions© 2014MetricsAuthor Information Halina Zyczynski More articles by this author Michael Albo More articles by this author Hae-Young Kim More articles by this author Maude Carmel More articles by this author Clifford Wai More articles by this author Peggy Norton More articles by this author Linda Brubaker More articles by this author Larry Sirls More articles by this author R.E. Varner More articles by this author Howard Goldman More articles by this author Urinary Incontinence Treatment Network More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Effect of Aging on Storage and Voiding Function in Women with Stress Predominant Urinary Incontinence

We investigated age related changes in urodynamic parameters in 2 large cohorts of women planning stress urinary incontinence surgery. Using a standardized protocol we obtained urodynamic parameters for participants in SISTEr (Stress Incontinence Surgical Treatment Efficacy Trial) and TOMUS (Trial of Mid-Urethral Slings) undergoing baseline noninvasive flow followed by filling cystometrogram and pressure flow study. The bladder contractility index (defined as detrusor pressure at maximum flow+5×maximum flow) and detrusor hypocontractility (defined as detrusor pressure at maximum flow less than 10 cm H2O) were also characterized. Patients excluded from analysis had undergone prior stress urinary incontinence surgery or had prolapse stage greater than II. Propensity score analysis controlled for the potential bias of combining participants from 2 clinical trials. Linear and logistic regression analysis adjusting for propensity score quintile was done to assess the association of age and an age cutoff (less than 65 vs 65 or greater years) with urodynamic parameters. A total of 945 women (468 in SISTEr and 477 in TOMUS) were included in analysis. Mean age was 50 years in SISTEr (range 27 to 75) and 51 years (range 24 to 82) in TOMUS. Noninvasive maximum urinary flow decreased significantly with age (26.2 vs 22 ml per second, p=0.002). Noninvasive flow voiding time increased 2.7 seconds for each 10-year age increment and detrusor pressure at maximum flow decreased 2.1 cm H2O for each 10-year increase in age (each p=0.003). Hypocontractility was more likely in women 65 years old or older (OR 2.89, 95% CI 1.59, 5.27). The bladder contractility index was inversely related to age, decreasing a mean±SD of 7.68±1.96 cm H2O for each 10-year age increase (p<0.001). In these 2 cohorts the observed changes in voiding parameters suggest that detrusor contractility and efficiency decrease with age.

Repeat post‐op voiding trials: An inconvenient correlate with success

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 versus 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 post-operative result.

Rectus fascia pubovaginal sling for recurrent stress urinary incontinence after failed synthetic mid-urethral sling: Letter.

We were very interested to read the recent study by Welk and Herschorn, and the related commentary by Steele, regarding the role of autologous rectus fascial slings for complex recurrent female stress urinary incontinence (SUI).1,2 The authors report that, on medium-term follow-up of 33 women with previous failed continence surgery, pubovaginal sling was associated with a significant reduction in pad usage and good patient satisfaction rates.1 In 2010, we reviewed the published literature on therapeutic options for managing women with recurrent SUI after failed synthetic mid-urethral sling (MUS).3 At that time, no studies reporting outcomes after PVS for a previous failed MUS had been reported and thus, the data reported by Welk and Herschorn are particularly welcome. We also recently collected data on women undergoing rectus fascial PVS for complex recurrent SUI in our tertiary urogynecology unit. Preoperative video-urodynamics was performed in all women considering PVS. The surgical technique used was very similar to that by Welk and Herschorn,1 with a 13 × 2-cm strip of rectus fascia harvested. All cases were seen in the clinic at 6 weeks and 12 months postoperatively and at variable follow-up periods thereafter. At follow-up visits, uroflowmetry and post-void residual volume were performed and subjective cure of SUI was assessed. We identified 7 women who underwent PVS after a previously failed MUS, who were contacted by telephone to complete the ICIQ-SF questionnaire4 and to ascertain cure (Table 1). Women had a median age of 61 (range: 41–73) years and were a complex group, with a median of 2 (range: 1–4) prior continence surgeries. All women completed the telephone survey and the median interval since the PVS was 5 years (range: 0.5–9 years). The long-term failure rate following PVS for recurrent SUI in our population was 14% (1/7). This patient had preoperative voiding dysfunction and was still requiring self-catheterizing 4.5 years after the PVS. A second patient required self-catheterization for de novo voiding dysfunction but was dry. Table 1. Overall, 71% (5/7) of women were completely cured and 86% (6/7) were satisfied. The rate of de novo OAB in women with a stable bladder preoperatively was 80% (4/5). One woman, with a history of known thrombophilia, suffered a large pulmonary embolus on postoperative day 12 but recovered fully. We agree with the comments of Steele that autologous PVS still has a role as a salvage procedure in complex recurrent female SUI. We found that PVS was associated with a low failure rate, but a high rate of de novo OAB at 5 years in a small population of women with previous failed synthetic MUS. Although the case of pulmonary embolus in our population raises some concern, previous work from the Urinary Incontinence Treatment Network reported a low rate (0.3%) of venous thromboembolism after PVS, which is reassuring.5

Re: Comments on “A randomized trial of urodynamic testing before stress‐incontinence surgery” (N Engl J Med. 2012 May 24;366(21):1987–1997) From the Italian Society of Urodynamics

Neurourology and UrodynamicsVolume 32, Issue 3 p. 303-304 Letter to the Editor Re: Comments on “A randomized trial of urodynamic testing before stress-incontinence surgery” (N Engl J Med. 2012 May 24;366(21):1987–1997) From the Italian Society of Urodynamics†‡ Charles W. Nager, Corresponding Author Charles W. Nager cnager@ucsd.edu Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Reproductive Medicine, UC San Diego Health Care System, San Diego, CaliforniaDivision of Female Pelvic Medicine and Reconstructive Surgery, Department of Reproductive Medicine, UC San Diego Health Care System, San Diego, CA.Search for more papers by this authorfor the Urinary Incontinence Treatment Network (UITN), for the Urinary Incontinence Treatment Network (UITN)Search for more papers by this author Charles W. Nager, Corresponding Author Charles W. Nager cnager@ucsd.edu Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Reproductive Medicine, UC San Diego Health Care System, San Diego, CaliforniaDivision of Female Pelvic Medicine and Reconstructive Surgery, Department of Reproductive Medicine, UC San Diego Health Care System, San Diego, CA.Search for more papers by this authorfor the Urinary Incontinence Treatment Network (UITN), for the Urinary Incontinence Treatment Network (UITN)Search for more papers by this author First published: 21 September 2012 https://doi.org/10.1002/nau.22323Citations: 6 † Conflict of interest: none. ‡ Christopher Chapple led the peer-review process as the Associate Editor responsible for the paper. Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat No abstract is available for this article.Citing Literature Volume32, Issue3March 2013Pages 303-304 RelatedInformation

The Fellows’ Pelvic Research Network (FPRN) 5 years later: an update

IntroductionFive years agoaninitiative was launchedduring the meetingof the American Urogynecologic Society (AUGS) by thepresident of the Society of Gynecological Surgeons (SGS),the head of the research committee of the SGS, and a fellowof the society: to establish a research network for fellows inurogynecology and female urology. The agenda of the net-work was published in this journal [1] and included thefollowing objectives: “Create an environment for fellowsto participate in collaborative research and conduct multi-center studies as primary investigators”. The main purposeof the network was to enhance fellows’ knowledge andskills in study design, implementation of multicenter stud-ies, data management, and statistical analysis. It was alsohoped that the network would provide an environment forfellows to develop long-term professional relationships.This initiative was inspired by acknowledgement of majordifferences in clinical research and mentoring opportunities forfellows from different programs throughout the USA. In addi-tion to didactic research training for fellows, the network wasenvisioned to enable the conduct of large scale studies withparticipants from across the USA. This was believed to beparticularly important for the investigation of rare conditionsand regional differences in clinical practice and outcomes.WemodeledthisnewnetworkonthetwoNationalInstitutesofHealth(NIH)-sponsoredmulticenterclinicaltrialnetworksinurogynecology that were being conducted in the USA at thattime: (1) the Urinary Incontinence Treatment Network, whichincluded urologists and urogynecologists from nine centersacrossthecountry;and(2)thePelvicFloorDisordersNetwork,whichincludedsevencenters. Our networkdiffered from theseNIH networks in two main ways: (a) we operate on a very lowbudget, which is allocated by the SGS, (b) we have no restric-tions or limitations on initial me mbership. Participation in thenetwork was extended to all fellows in female urology andurogynecology programs in the USA.First scientific meetingOn April 2007, 18 fellows from 18 different urogynecologyand female urology programs across the USA attended thefirst meeting of the Fellows’ Pelvic Research Network(FPRN) at the annual SGS scientific conference. An advi-sory board consisting of six senior urogynecologists – asubgroup of the SGS Research Committee – volunteeredto mentor the fellows and assist in establishment of thenetwork. Three fellows were elected to the FPRN SteeringCommittee, in the roles of chair, secretary, and treasurer. Atthe first meeting two multicenter clinical research trials werechosen as the first projects. These were selected from nineprojects that had been submitted by fellows. One of theadvisory board members was selected to oversee the

Evaluation of Stress Predominant Urinary Incontinence

Urodynamic studies (UDS) have been used to objectively characterize a patient’s complaint of urinary incontinence. Presumably, the clinician can utilize the UDS data to guide treatment options. It is even hoped that UDS can help predict which treatments should be utilized to produce the most effective outcomes. However, is this currently the case? The Urinary Incontinence Treatment Network (UITN) has completed four large randomized clinical trials related to treatments for urinary incontinence. Two trials compared outcomes of different surgeries for stress urinary incontinence (SUI) in which standardized UDS protocols were used. Secondary analyses of these UDS data showed that UDS were neither prognostic of treatment outcomes nor correlative with severity of UI symptoms, suggesting limited utility of UDS in the evaluation and management of the uncomplicated SUI patient. A third trial was designed to answer whether a basic office examination is not noninferior to UDS in affecting SUI surgical outcomes. The results of this study are currently in press. A fourth trial examined treatment of urgency urinary incontinence (UUI). Because UDS was not part of this trial, the utility of UDS in management and treatment of UUI could not be assessed. In summary, UDS will need to undergo further refinements to increase its clinical effectiveness in the area of urinary incontinence.

Lessons Learned from a Decade of Multicenter Cooperative Clinical Trials in Stress Urinary Incontinence

Stress urinary incontinence (SUI) is estimated to affect 12 % to 55 % of women at some point in their life. Furthermore, 15 % to 35 % of adult American women report that their quality of life is altered by urinary incontinence. In addition to the toll SUI takes on patient lives—physically, socially and psychologically—it also comes at a significant cost to health care systems. In 1999, as an initiative of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the National Institute of Child Health and Human Development (NICHD), the Urinary Incontinence Treatment Network (UITN) was born, with the primary task of developing trials to evaluate treatment of urinary incontinence in women. The purpose of this article is to review the SUI trials conducted and challenges faced, and to highlight the lessons learned from a decade of UITN work.

Biofeedback for the Treatment of Stress Urinary Incontinence: A Viable option for Select Patients.

This is an interesting retrospective study assessing the use of biofeedback for the treatment of stress urinary incontinence (SUI) using ICIQ-SF scores and urodynamics (UDS) parameters as outcome measures (1). The authors concluded that women with SUI improved with biofeedback (BF) techniques. Furthermore, UDS may not be necessary in patients who elect to have BF to manage their SUI, since no UDS changes were noted after BF. We congratulate and commend the authors on their manuscript, as this is a challenging and important topic in our field. The authors indicated that all of their patients had “genuine stress incontinence.” We feel that this term, although sufficient for this manuscript, should be defined more precisely. “Genuine SUI” can mean many different things to different people, and it is imperative that we understand what “genuine SUI” means. SUI should be defined by both the presence and severity of symptoms (2). The presence of SUI can be identified through a physical exam or UDS while the severity of leakage can be determined by a voiding diary, pad weight test or validated questionnaires. Defining a cure for SUI remains a challenge and is based on the outcome measure(s) selected at the outset of the trial (3). There needs to be an understanding and agreement on a definition of SUI. We feel it is crucial to accurately and subjectively define and quantify SUI prior to any discussion of treatment. Similarly, when performing UDS testing, we recommend and advocate testing based on ICS standards, which do not appear to have been used in this particular study. There is published level I evidence from the Urinary Incontinence Treatment Network (UITN) (an NIh funded group to research urinary incontinence) on the importance of using a standard protocol when performing UDS. Specifically, the UITN developed a UDS protocol for women with stress predominant SUI that included specific details for annotation, patient positioning, equipment, calibration and data recording (4). Additionally, they published interpretation guidelines to allow central reviewing of the UDS tracings (5, 6). Employing these guidelines would ensure uniformity and accuracy in performing and interpreting UDS for patients with SUI before and after their biofeedback sessions. We acknowledge the difficulty in asking patients to perform biofeedback exercises when not under the direct supervision of trained physical therapists. however, providing patients with a “workout regimen”, such as how many times per day to perform certain daily exercises and for how long provides a minimum number of exercises for the patient to perform. We have found that advising patients to perform exercises on their own can be confusing and sometimes frustrating for patients. lastly, we agree with the authors on the utility and convenience of using the ICIQ-SF to assess symptoms and quality of life. however, to eliminate recall bias, questionnaires should be administered at the same interval for each patient after completion of their biofeedback treatment. The results, nonetheless, are encouraging and provide important data to our field. We hope this manuscript motivates other investigators to further expand upon this study or at the very least re-confirm the lack of UDS impact in women treated with BF for bothersome SUI. Truthfully, a multicenter study would be ideal to reproduce these findings and make them more generalizable.

History and Future of Multi-Institutional Clinical Trials in Urinary Incontinence

History and Future of Multi-Institutional Clinical Trials in Urinary Incontinence

Mixed incontinence: comparing definitions in non-surgical patients.

We aimed to explore operational definitions of mixed urinary incontinence (MUI) for use in incontinence outcomes research for non-surgical patient populations. A secondary analysis of women with urge incontinence or urge predominant MUI enrolled in the Urinary Incontinence Treatment Network BE-DRI randomized clinical trial was performed. Subjects were characterized at baseline for urinary incontinence severity and incontinence subtype (stress or urge) using the Medical, Epidemiologic, and Social Aspects of Aging (MESA) questionnaire, the Urogenital Distress Inventory, and a 7-day urinary diary. Various different definitions of MUI, ranging from low to high threshold, were created using a combination of these baseline incontinence measures. Prevalence of MUI based on each definition was described and compared to treatment response. Logistic regression analysis was used to estimate the association between the study outcomes and the different definitions of MUI. The 307 participants in the BE-DRI study had a mean age of 56.9 (± 13.9) years with a mean total MESA score of 21.7 (± 8.9) and a mean total UDI score of 120.5 (± 49.6). The proportion of women diagnosed with MUI varied significantly by definition ranging from 63.5% to 96.4%. Low threshold symptom-based definitions resulted in nearly universal diagnosis of MUI. No strict cut-off value for these baseline measures was identified to predict clinical outcomes. Current MUI definitions do not adequately categorize clinically relevant UI subgroups. For research purposes we believe it necessary to describe the severity of each incontinence subtype separately in subjects with MUI.

Challenges in designing a pragmatic clinical trial: the mixed incontinence -- medical or surgical approach (MIMOSA) trial experience.

Mixed urinary incontinence (MUI) is a common, bothersome condition in women. In MUI, the two subtypes of urinary incontinence that coexist are treated differently; stress urinary incontinence (SUI) is primarily treated surgically while urge urinary incontinence (UUI) is primarily treated medically. There is no evidence to guide the treatment for women with significant bother from both incontinence subtypes. Therefore, investigators of the Urinary Incontinence Treatment Network (UITN) designed and initiated a randomized clinical trial comparing outcomes for two distinct initial treatment approaches for women with mixed urinary incontinence (MUI): therapy initiated with surgery versus therapy initiated with nonsurgical treatment. The aim of this manuscript is to describe the challenges in planning and implementing this randomized clinical trial. The mixed incontinence: medical or surgical approach (MIMOSA) trial was designed as a practical or pragmatic clinical trial to establish the relative efficacy of two specific treatment approaches. The design presented many challenging decisions including: (1) selection of practical paradigm; (2) refining inclusion/ exclusion criteria to offer equipoise; (3) selection of feasibility sample size; (4) recruitment challenges for two divergent treatment approaches (medical vs. surgical), and (5) resolution of ethical and methodological issues. MIMOSA recruitment was planned in two phases, starting with a 5-month pilot and feasibility phase followed by a full trial contingent on the outcome of the first phase. The feasibility portion of the MIMOSA trial started in November 2008. 1198 subjects were screened and approached for study enrollment, but only 27 consented to randomization. The feasibility study was halted due to lack of enrollment in March 2009. The challenges of this trial included a lack of information from subjects who did not enroll, increasing the difficulty of interpreting the feasibility phase. Successful recruitment to a randomized trial that compares significantly different treatment approaches poses a challenge.

Complications in Women Undergoing Burch Colposuspension Versus Autologous Rectus Fascial Sling for Stress Urinary Incontinence

We determined the clinicodemographic factors associated with complications of continence procedures, the impact of concomitant surgery on the complication rate and the relationship between the incidence of cystitis and the method of postoperative bladder drainage. We reviewed serious adverse events and adverse events in the Stress Incontinence Surgical Efficacy Trial, a randomized trial comparing Burch colposuspension to the autologous rectus fascial sling. Clinicodemographic variables were analyzed to determine those associated with adverse events using logistic regression analysis. Complications were stratified based on the presence or absence of concomitant surgery. Differences in complication rates (controlling for concomitant surgery) and cystitis rates (controlling for the bladder emptying method) were compared using Fisher's exact test. Blood loss (p = 0.0002) and operative time (p <0.0001) were significantly associated with an adverse event. Patients who underwent concomitant surgery had a significantly higher serious adverse event rate (14.2% vs 7.3%, p = 0.01) and adverse event rate (60.5% vs 48%, p <0.01) than patients who underwent continence surgery alone. Cystitis rates were higher in the sling vs the Burch group up to 6 weeks postoperatively regardless of concomitant surgery status (p <0.01). Intermittent self-catheterization increased the cystitis rate by 17% and 23% in the Burch and sling groups, respectively. Concomitant surgery at continence surgery increased the risk of complications. Sling surgery was associated with a higher risk of cystitis within the first 6 weeks postoperatively. Intermittent self-catheterization increased the risk of cystitis in each group. Complications were associated with surgical factors and not with patient related factors.

Associated factors and the impact of fecal incontinence in women with urge urinary incontinence: from the Urinary Incontinence Treatment Network's Behavior Enhances Drug Reduction of Incontinence study

The objective of the study was to determine the prevalence, risk factors, and impact on quality-of-life (QOL) that fecal incontinence (FI) symptoms have on women seeking treatment for urge urinary incontinence (UUI). Baseline sociodemographic, history, physical examination, and validated questionnaire data were analyzed in 307 women enrolled in the Behavior Enhances Drug Reduction of Incontinence study for associations with FI. FI was defined as loss of liquid/solid stool occurring at least monthly. Multivariable logistic regression models compared women with FI and UUI with women with only UUI. Prevalence of monthly FI was 18%, liquid stool (12%), and solid stool (6%). In multivariable analysis, FI was associated with vaginal delivery, posterior vaginal wall prolapse, higher body mass index, and UUI symptoms. QOL was worse in women with FI/UUI than isolated UUI. Women seeking treatment for UUI have high rates of monthly FI with a negative impact on QOL.

Challenges of conducting multi-center, multi-disciplinary urinary incontinence clinical trials: experience of the urinary incontinence treatment network.

The Urinary Incontinence Treatment Network (UITN) was established in 2000 as a multi-disciplinary, multi-institutional network by the National Institute for Diabetes, Digestive, and Kidney Diseases (NIDDK) to investigate treatments for urinary incontinence in women. Over 8 years this network composed of urologists, urogynecologists, geriatricians, behavioral psychologists, physical therapists, nurses, epidemiologists, social scientists and statisticians from nine academic sites and a Data Coordinating Center has been effective in designing and completing prospective randomized clinical trials for treatments of urinary incontinence in women. Two major clinical trials have been completed and a third has completed recruitment. The focus of the completed trials was a comparison of surgical methods to treat stress urinary incontinence whereas the third examined the potential benefit of combined behavioral intervention and antimuscarinic drug therapy to eliminate the need for long-term use of drug therapy alone to manage urge urinary incontinence. The scientific output of the network measured by abstracts, original papers and presentations demonstrates the productivity of the network. Many unique challenges are posed by a multi-disciplinary team located at sites across the United States undertaking several clinical trials. This review presents some of the logistics, barriers, tactics, and strategies used to create this successful clinical trials network focused on urinary incontinence.

A critical overview of the evidence base for the contemporary surgical management of stress incontinence

The purpose of this article is to evaluate the evidence base for surgical management of stress urinary incontinence in women between July 2006 and December 2007. The Urinary Incontinence Treatment Network and Pelvic Floor Diseases Network have contributed level 1 evidence in the management of stress urinary incontinence with multicentric randomized controlled trials. Pubovaginal sling has a higher success rate than the Burch at the expense of a higher morbidity. A prophylactic Burch procedure at the time of an abdominal sacrocolpopexy can reduce secondary stress urinary incontinence and urge urinary incontinence. Suburethral tapes have a higher cure rate for patients with predominant stress urinary incontinence and can safely be placed at the time of concomitant pelvic surgery. The tension-free vaginal tape has a higher rate of lower urinary tract injury and voiding dysfunction when compared with transobturator tape. The Burch and pubovaginal sling have a high success rate for treating stress urinary incontinence. Prospective randomized trials are needed to assess the long-term results of suburethral slings. There is still no consensus on outcome measures when reporting on surgical management for stress urinary incontinence.

Predictors of Fecal Incontinence in Women with Urge Urinary Incontinence: From the Urinary Incontinence Treatment Network’s BEDRI Study

Predictors of Fecal Incontinence in Women with Urge Urinary Incontinence: From the Urinary Incontinence Treatment Network’s BEDRI Study

The Fellows’ Pelvic Research Network (FPRN)

Clinical trials are crucial to the practice and advancement of medicine. Research studies are designed to answer specific questions about new drugs, devices, and therapies and to identify new ways of using known treatments. During the last decade, multicenter studies have become more common. Networks have been established in various fields to facilitate collaborative efforts to develop and perform clinical trials related to specific disorders, allowing more timely recruitment and completion of studies as well as increasing the generalizability of the results. In urogynecology, the National Institutes of Health has dedicated funds to two active multicenter clinical trial networks: (1) the Urinary Incontinence Treatment Network includes urologists and urogynecologistsfrom ninecentersacrosstheUSA; and(2)thePelvic Floor Disorders Network, which includes seven US centers. Participating sites were competitively selected, and both networks are in the second 5-year cycle. Through highquality research trials, both networks have successfully

Predictors of Success With Postoperative Voiding Trials After a Mid Urethral Sling Procedure

We identified predictors of passing a voiding trial after incontinence surgery with a mid urethral sling and examined if successful performance on a voiding trial was maintained. A total of 89 women scheduled for incontinence surgery were enrolled from July 2005 until April 2006. Voiding trials were performed the day of discharge from the hospital, with a two-thirds volume void after a 300 ml fill considered passing. Those who passed underwent a second voiding trial 3 hours later. Of the participants 60 (67.4%) underwent tension-free vaginal tape surgery, 29 underwent transobturator tape (32.6%) and 64 (71.9%) underwent concurrent vaginal repairs. A total of 59 (67.0%) participants passed the first voiding trial. Univariate analysis identified 12 potential predicting variables for passing the first voiding trial. From these 12, model building via backward stepwise logistic regression found maximum flow on preoperative uroflowmetry to be the only significant predictive variable (p = 0.0002). Of the 59 women who passed the initial voiding trial 9 (16.4%) failed the second voiding trial. None of the 11 participants who had maximal flow rates greater than 30 cc per second failed the first or second voiding trial, whereas 17 of 22 subjects (77.3%) who had maximal flow rates less than 15 cc per second failed either of these trials. Maximum flow rates on preoperative uroflowmetry were the best predictor of passing an initial voiding trial after undergoing a mid urethral sling procedure for incontinence. However, the ability to maintain performance on a second voiding trial, even only 3 hours after passing an initial trial, is not assured.