Colpopexy And Urinary Reduction Efforts Research Articles

The role of conventional pelvic floor reconstructive surgeries in obstructed defecation symptoms change: CARE and OPTIMAL trials sub-analysis of 2-year follow-up data.

The current study was aimed at addressing two questions: first, is any conventional vaginal prolapse repair effective in curing obstructed defecation symptoms, and second, is there evidence to suggest that a sacrocolpopexy will increase the risk of worsening or new-onset obstructed defecation symptoms? This is a sub-analysis of two major clinical trials performed by the Pelvic Floor Disorders Network: the Colpopexy and Urinary Reduction Efforts (CARE) trial and the Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) trial. Two-year follow-up data were included. Demographics, pelvic organ prolapse quantification examination, and symptoms were compared between first, two surgical arms in the OPTIMAL study and second, CARE and OPTIMAL datasets using Chi-squared test for categorical variables and Student's t test or Mann-Whitney U test for continuous variables. A total of 353 subjects form the OPTIMAL study and 279 subjects from the CARE study met the inclusion criteria. Regardless of trial, obstructed defecation symptoms were present in more than half of the patients at the initial visit before the surgical intervention, and interestingly, about one third of the patients were symptomatic at the 24-month follow-up in all surgical groups. The conventional vaginal prolapse surgeries, with or without posterior vaginal wall repair, improved obstructed defecation symptoms by 50%, but about 35% of patients were suffering from at least one of the aspects of obstructed defecation at the 24-month follow-up. It is also important to note that about a quarter of the patients experienced persisting or worsening of their obstructed defecation symptoms in the absence of anatomical failure.

Does the Degree of Cystocele Predict De Novo Stress Urinary Incontinence After Prolapse Repair? Further Analysis of the Colpopexy and Urinary Reduction Efforts Trial.

Cystoceles may cause urethral obstruction by altering the vesicourethral angle. Restoration of normal anatomy after pelvic organ prolapse (POP) repair can relieve this obstruction but may unmask stress urinary incontinence (SUI). The association between the severity of cystocele and developing de novo SUI after prolapse repair, however, is poorly understood. We hypothesized that, in women undergoing prolapse repair, increasing degrees of bladder prolapse would be associated with increasing rates of postoperative de novo SUI. We performed a secondary analysis of the Colpopexy and Urinary Reduction Efforts (CARE) trial data. Using the control arm (women undergoing prolapse repair without a prophylactic SUI procedure), we identified de novo SUI using a composite definition based on original trial criteria. We performed logistic regression to evaluate the relationship between the degree of cystocele and the development of new SUI. Of the 164 women who underwent abdominal sacrocolpopexy alone, 54% developed de novo postoperative SUI. Stratifying by the degree of anterior prolapse (point Ba), we found a linear increase in the rate of SUI with worsening preoperative cystocele. The incidence of de novo SUI based on the POP Quantification stage of anterior prolapse was 41.3%, 52.5%, and 66.1%, for stage 2, early stage 3, and advanced stage 3 or stage 4, respectively. Point Ba was found to be significantly associated with de novo SUI on both univariate (odds ratio = 1.17, P = 0.015) and multivariate analysis (odds ratio = 1.16, P = 0.04). The incidence of de novo SUI after prolapse repair directly correlates to the degree of cystocele on preoperative examination. This simple yet novel relationship should further guide discussions about potential postoperative incontinence.

MP10-10 DOES THE DEGREE OF CYSTOCELE PREDICT DE-NOVO STRESS URINARY INCONTINENCE AFTER PROLAPSE REPAIR? FURTHER ANALYSIS OF THE CARE TRIAL

You have accessJournal of UrologyUrodynamics/Lower Urinary Tract Dysfunction/Female Pelvic Medicine: Pelvic Prolapse1 Apr 2016MP10-10 DOES THE DEGREE OF CYSTOCELE PREDICT DE-NOVO STRESS URINARY INCONTINENCE AFTER PROLAPSE REPAIR? FURTHER ANALYSIS OF THE CARE TRIAL Michael Davenport, Eric Sokol, and Christopher Elliott Michael DavenportMichael Davenport More articles by this author , Eric SokolEric Sokol More articles by this author , and Christopher ElliottChristopher Elliott More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2016.02.2340AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Cystoceles may cause urethral obstruction by altering the vesico-urethral angle. Restoration of normal anatomy after vaginal prolapse repair can relieve this urethral “kink”, but may unmask stress incontinence (SUI). The association between the severity of cystocele and developing de-novo SUI after prolapse repair however, is poorly understood. We hypothesized that in women undergoing prolapse repair, increasing degrees of bladder prolapse would be associated with increasing rates of post-operative de-novo SUI. METHODS We performed a secondary analysis of the Colpopexy and Urinary Reduction Efforts (CARE) trial data. Using the control arm (women undergoing prolapse repair without a prophylactic SUI procedure), we identified de-novo SUI using a composite definition based on original trial criteria, including 1) new symptoms of SUI, 2) new physical exam findings of SUI and 3) any treatment for SUI within one year of prolapse repair. We performed logistic regression to evaluate the relationship between the degree of cystocele and the development of new SUI. RESULTS Of the 168 women who underwent abdominal sacrocolpopexy alone, 53% developed de-novo post-operative SUI. Stratifying by the degree of anterior prolapse (point Ba), we found a linear increase in the rate of SUI with worsening preoperative cystocele. The incidence of de-novo SUI based on tertile of anterior prolapse from least to most severe, was 41.7%, 53.3% and 63.3%, respectively (Table 1). Point Ba was found to be significant for predicting de-novo SUI on both univariate (OR=1.17 3, p-value 0.015), and multivariate analysis (OR=1.16, p-value 0.04). CONCLUSIONS The incidence of de-novo SUI after prolapse repair directly correlates to the degree of cystocele on preoperative exam. This simple yet novel relationship should further guide discussions about potential post-operative incontinence with women undergoing prolapse repair. © 2016FiguresReferencesRelatedDetails Volume 195Issue 4SApril 2016Page: e105-e106 Advertisement Copyright & Permissions© 2016MetricsAuthor Information Michael Davenport More articles by this author Eric Sokol More articles by this author Christopher Elliott More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

MP10-11 WHAT IS THE ROLE OF PREOPERATIVE URODYNAMICS FOR WOMEN UNDERGOING PROLAPSE SURGERY?

“kink”, but may unmask stress incontinence (SUI). The association between the severity of cystocele and developing de-novo SUI after prolapse repair however, is poorly understood. We hypothesized that in women undergoing prolapse repair, increasing degrees of bladder prolapse would be associated with increasing rates of post-operative de-novo SUI. METHODS: We performed a secondary analysis of the Colpopexy and Urinary Reduction Efforts (CARE) trial data. Using the control arm (women undergoing prolapse repair without a prophylactic SUI procedure), we identified de-novoSUI using a composite definition based onoriginal trial criteria, including1) newsymptomsofSUI, 2) newphysical exam findings of SUI and 3) any treatment for SUI within one year of prolapse repair. We performed logistic regression to evaluate the relationship between the degree of cystocele and the development of new SUI. RESULTS: Of the 168 women who underwent abdominal sacrocolpopexy alone, 53% developed de-novo post-operative SUI. Stratifying by the degree of anterior prolapse (point Ba), we found a linear increase in the rate of SUI with worsening preoperative cystocele. The incidence of de-novo SUI based on tertile of anterior prolapse from least to most severe, was 41.7%, 53.3% and 63.3%, respectively (Table 1). Point Ba was found to be significant for predicting de-novo SUI on both univariate (OR1⁄41.17 3, p-value 0.015), and multivariate analysis (OR1⁄41.16, p-value 0.04). CONCLUSIONS: The incidence of de-novo SUI after prolapse repair directly correlates to the degree of cystocele on preoperative exam. This simple yet novel relationship should further guide discussions about potential post-operative incontinence with women undergoing prolapse repair.

Comparing operations for POP: the importance of standardization of surgical technique

In the past decade, scientific literature regarding surgical treatment for pelvic organ prolapse (POP) has been overwhelmingly about the use of meshes, which has gained credibility after recent publications that report good anatomical outcomes. Nevertheless, results must be considered taking into account the increasing number of reported postoperative complications that have led to some important, cautious reviews and warnings, such as the ones included in the updated US Food and Drug Administration (FDA) communication in 2011 [1]. In this scenario, it is appropriate to review previous studies in order to balance safety and efficacy of surgical therapeutic options. Different types of operations should be carefully reappraised and given their appropriate place in POP management. Special attention should be given to potential conclusion biases inherent to the methodological inconsistencies regarding criteria for population inclusion, cure/failure, and outcomes when various studies addressing a surgical technique are analyzed together. In fact, those points have been raised by some authors [2, 3]. Another aspect, but no less important, is the one related to the lack of standardization of surgical techniques when evaluating the supposed “same operation.” Several types of operations have been described to support apical prolapse [4]. Recently published, the extended Colpopexy and Urinary Reduction Efforts (CARE) trial brought some important issues to the forefront in respect of surgical management of the apical compartment [5]. Despite the unexpected recurrence rate observed over time, abdominal sacrocolpopexy is considered the most durable technique for restoring the prolapsed vaginal apex to a normal anatomic position [4]. However, in the absence of well-controlled and designed studies, definitive conclusion about a gold standard procedure shall be considered merely a matter of speculation. Even if randomized controlled trials and/or meta-analyses are undertaken in the future, questions on appropriate interpretation of results would be subject of criticism and debate due to intraand interobserver variations. In fact, surgeries and surgeons are basically impossible to ideally control for in such circumstances [6]. A good example is the number of technical variations of the McCall culdoplasty and uterosacral ligament suspensions (USLS). Those techniques have undergone diverse technical modifications over the years, including anatomic landmarks, surgical route, and type and exact position of sutures. Physicians should clarify and inform their readers what they mean by “modified McCall” or “high McCall”. Everyone speaks a unique language when attempting to reach a possible common conclusion. The best approach is, of course, another subject of numerous debates. Many surgeons advocate that the procedure performed by laparoscopy seems to have important advantages over the abdominal and vaginal approaches, allowing proper dissection in critical areas, correct identification of uterosacral ligaments and both ureters, as well as placing sutures in a more cranial position, which might positively impact treatment results. As a natural consequence of the lack of standardization among procedures, each being potentially “different” from each other, crucial questions emerge from this discussion: Shall we separately analyze the results obtained from each technique modification, or shall we put them all in the same pocket? In contrast to the time when vaginal mesh kits were perceived as making surgical skill redundant, surgeons must G. Favero Department of Gynecology, Instituto do Câncer do Estado de Sao Paulo, Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil

Sacrocolpopexy for Pelvic Organ Prolapse: Nothing Lasts Forever . . .

Initial results of the Colpopexy and Urinary Reduction Efforts (CARE) trial (JW Womens Health 2006 Jun 6) showed that, at 2 years, open abdominal

Long-term Outcomes Following Abdominal Sacrocolpopexy for Pelvic Organ Prolapse

More than 225 000 surgeries are performed annually in the United States for pelvic organ prolapse (POP). Abdominal sacrocolpopexy is considered the most durable POP surgery, but little is known about safety and long-term effectiveness. To describe anatomic and symptomatic outcomes up to 7 years after abdominal sacrocolpopexy, and to determine whether these are affected by concomitant anti-incontinence surgery (Burch urethropexy). Long-term follow-up of the randomized, masked 2-year Colpopexy and Urinary Reduction Efforts (CARE) trial of women with stress continence who underwent abdominal sacrocolpopexy between 2002 and 2005 for symptomatic POP and also received either concomitant Burch urethropexy or no urethropexy. Ninety-two percent (215/233) of eligible 2-year CARE trial completers were enrolled in the extended CARE study; and 181 (84%) and 126 (59%) completed 5 and 7 years of follow-up, respectively. The median follow-up was 7 years. Symptomatic POP failure requiring retreatment or self-reported bulge; or anatomic POP failure requiring retreatment or Pelvic Organ Prolapse Quantification evaluation demonstrating descent of the vaginal apex below the upper third of the vagina, or anterior or posterior vaginal wall prolapse beyond the hymen. Stress urinary incontinence (SUI) with more than 1 symptom or interval treatment; or overall UI score of 3 or greater on the Incontinence Severity Index. By year 7, the estimated probabilities of treatment failure (POP, SUI, UI) from parametric survival modeling for the urethropexy group and the no urethropexy group, respectively, were 0.27 and 0.22 for anatomic POP (treatment difference of 0.050; 95% CI, -0.161 to 0.271), 0.29 and 0.24 for symptomatic POP (treatment difference of 0.049; 95% CI, -0.060 to 0.162), 0.48 and 0.34 for composite POP (treatment difference of 0.134; 95% CI, -0.096 to 0.322), 0.62 and 0.77 for SUI (treatment difference of -0.153; 95% CI, -0.268 to 0.030), and 0.75 and 0.81 for overall UI (treatment difference of -0.064; 95% CI, -0.161 to 0.032). Mesh erosion probability at 7 years (estimated by the Kaplan-Meier method) was 10.5% (95% CI, 6.8% to 16.1%). During 7 years of follow-up, abdominal sacrocolpopexy failure rates increased in both groups. Urethropexy prevented SUI longer than no urethropexy. Abdominal sacrocolpopexy effectiveness should be balanced with long-term risks of mesh or suture erosion. clinicaltrials.gov Identifier: NCT00099372.

Emerging concepts for pelvic organ prolapse surgery: What is cure?

The objective of this review is to discuss emerging concepts in pelvic organ prolapse, in particular, “What is cure?” In a post-trial data analysis of the CARE (Colpopexy and Urinary Reduction Efforts) trial, treatment success varied tremendously depending on the definition used (19.2%–97.2%). Definitions that included the absence of vaginal bulge symptoms had the strongest relationships with the patients’ assessment of overall improvement and treatment success. As demonstrated by this study, there are several challenges in defining cure in prolapse surgery. Additionally, the symptoms of prolapse are variable. The degree of prolapse does not correlate directly with symptoms. There are many surgical approaches to pelvic organ prolapse. Multiple ways to quantify prolapse are used. There is a lack of standardized definition of cure. The data on prolapse surgery outcomes are heterogeneous. The goal of surgical repair is to return the pelvic organs to their original anatomic positions. Ideally, we have four main goals: no anatomic prolapse, no functional symptoms, patient satisfaction, and the avoidance of complications. The impact of transvaginal mesh requires thoughtful investigation. The driving force should be patient symptoms in defining cure of prolapse.

Prophylactic Burch colposuspension at the time of abdominal sacrocolpopexy: a survey of current practice patterns

The purpose of this study was to determine the utilization of the prophylactic Burch procedure with abdominal sacrocolpopexy since the publication of the Colpopexy and Urinary Reduction Efforts (CARE) trial. Using an Internet survey, 1,134 members of the American Urogynecological Society (AUGS) were contacted in May 2008 and questioned regarding their practice patterns to prevent de novo stress incontinence after sacrocolpopexy. Two hundred sixty-six responses were obtained for a 23% response rate. Of the 235 respondents actively performing sacrocolpopexies, 133 (57%) would not perform a prophylactic Burch colposuspension at the time of sacrocolpopexy in a woman without symptoms of stress urinary incontinence. Respondents were more likely to perform a prophylactic Burch if it had been more than 6 years since they completed residency or fellowship training. Prophylactic Burch colposuspension at the time of abdominal sacrocolpopexy has not been uniformly implemented into clinical practice by AUGS members since the publication of the CARE Trial.

Obesity and outcomes after sacrocolpopexy

The purpose of this study was to compare outcomes after sacrocolpopexy (SC) between obese and healthy-weight women. Baseline and postoperative data were analyzed from the Colpopexy And Urinary Reduction Efforts (CARE) randomized trial of SC with or without Burch colposuspension in stress continent women with stages II-IV prolapse. Outcomes and complications were compared between obese and healthy-weight women. CARE participants included 74 obese (body mass index >/=30 kg/m(2)), 122 overweight (25-29.9 kg/m(2)), and 125 healthy-weight (18.5-24.9 kg/m(2)) women, and 1 underweight (< 18.5 kg/m(2)) woman. Compared to healthy-weight women, obese women were younger (59.0 +/- 9.9 vs 62.1 +/- 10.3 yrs; P = .04), more likely to have stage II prolapse (25.7% vs 11.2%; P = .01), and had longer operative times (189 +/- 52 vs 169 +/- 58 min; P = .02). Two years after surgery, stress incontinence, prolapse, symptom resolution, and satisfaction did not differ between the obese and healthy-weight groups. Most outcomes and complication rates after SC are similar in obese and healthy-weight women.

Two-Year Outcomes After Sacrocolpopexy With and Without Burch to Prevent Stress Urinary Incontinence

To report anatomic and functional outcomes 2 years after sacrocolpopexy in stress-continent women with or without prophylactic Burch colposuspension. In the Colpopexy and Urinary Reduction Efforts (CARE) trial, stress-continent women undergoing sacrocolpopexy were randomized to receive or not receive a Burch colposuspension. Outcomes included urinary symptoms, other pelvic symptoms, and pelvic support. Standardized pelvic organ prolapse quantification examinations and validated outcome measures including the Pelvic Floor Distress Inventory and the Pelvic Floor Impact Questionnaire were completed before surgery and at several postoperative intervals, including at 2 years. This analysis is based on 322 randomized participants; certain analyses were done with a subset based on data availability. Most were Caucasian (94%), with a mean age of 62±10 years (mean±standard deviation). Two years after surgery, 41.8% and 57.9% of women in the Burch and control groups, respectively, met the stress incontinence endpoint (presence of symptoms or positive cough stress test or interval treatment for stress incontinence, P=.020). The apex was well supported (point C within 2 cm of total vaginal length) in 95% of women, and this was not affected by concomitant Burch (P=.18). There was a trend toward fewer urgency symptoms in the Burch group (32.0% versus 44.5% no Burch, P=.085). Twenty participants experienced mesh or suture erosions. The early advantage of prophylactic Burch colposuspension for stress incontinence that was seen at 3 months remains at 2 years. Apical anatomic success rates are high and not affected by concomitant Burch. (www.clinicaltrials.gov), ClinicalTrials.gov, NCT00065845. I.

The Role of Pre-Operative Urodynamic Testing in Stress Continent Women Undergoing Sacrocolpopexy: The Colpopexy and Urinary Reduction Efforts (CARE) Randomized Surgical Trial

The Role of Pre-Operative Urodynamic Testing in Stress Continent Women Undergoing Sacrocolpopexy: The Colpopexy and Urinary Reduction Efforts (CARE) Randomized Surgical Trial

The correlation of voiding variables between non‐instrumented uroflowmetery and pressure‐flow studies in women with pelvic organ prolapse

To (1) correlate peak and maximum flow rates from non-instrumented flow (NIF) and pressure-flow studies (PFS) in women with pelvic organ prolapse (POP); (2) measure the impact of voided volume and degree of prolapse on correlations. We compared four groups of women with stages II-IV POP. Groups 1 and 2 were symptomatically stress continent women participating in the colpopexy and urinary reduction efforts (CARE) trial; during prolapse reduction before sacrocolpopexy, Group 1 (n = 67) did not have and Group 2 (n = 84) had urodynamic stress incontinence (USI). Group 3 (n = 74) and Group 4 participants (n = 73), recruited specifically for this study, had stress urinary incontinence (SUI) symptoms. Group 3 planned sacrocolpopexy. Group 4 planned a different treatment option. Participants completed standardized uroflowmetry and pressure voiding studies. Subjects' median age was 61 years; median parity 3% and 80% had stage III or IV POP. Based on the Blaivas-Groutz nomogram, 49% of all women were obstructed. NIF and PFS peak and average flow rates had low correlations with one another (0.31, P < 0.001 and 0.35, P < 0.001, respectively). When NIF and PFS voided volumes were within 25% of each other, the peak and average flow rate correlations improved (0.52, P < 0.001 and 0.57, P < 0.001, respectively). As vaginal prolapse increased, correlations between NIF and PFS peak and average flow rates decreased. Peak and average flow rates are highly dependent on voided volume in women with prolapse. As the prolapse stage increases, correlations between NIF and PFS variables decrease.

Enhancing Participation of Older Women in Surgical Trials

Older participants are often excluded from clinical trials, precluding a representative sample. Using qualitative and quantitative methods, we examined recruitment and retention of older women with pelvic organ prolapse in two surgical trials: the randomized Colpopexy And Urinary Reduction Efforts (CARE) study and the Longitudinal Pelvic Symptoms and Patient Satisfaction After Colpocleisis cohort study. Using focus groups, we developed a questionnaire addressing factors facilitating and impeding the recruitment and retention of older study participants and administered it to research staff. Enrollment-to-surgery ratios, missed visit rates, and dropout rates for older and younger participants were compared using Fisher's exact test, with cut-points of 70 and 80 years for the CARE and Colpocleisis studies, respectively. Questionnaires were completed by 23 physician investigators and 11 nurses or coordinators (92% response rate). Respondents indicated it was more difficult to recruit older research participants (32%), obtain informed consent (56%), and retain participants to study completion (50%). Challenges to recruitment included caregiver involvement in the decision to participate and participant comorbidities. Perceived barriers to retention were transportation, caregiver availability, and participant fatigue. Data quality was challenged by sensory and cognitive impairment, resulting in a change from telephone interviews to in-person visits in the Colpocleisis study. Older participants did not have higher dropout rates than younger participants. There were no differences in missed in-person visits or telephone interview rates between age groups. Strategies, albeit unstudied, could assist investigators in planning surgical trials that successfully enroll and retain older women.

Optimism in Women Undergoing Abdominal Sacrocolpopexy for Pelvic Organ Prolapse

Although studies suggest that optimism can predict health outcomes, the relationship has not been tested in women with pelvic organ prolapse (POP). This study sought to explore the relationship between optimism, prolapse severity, and symptoms before operation; and examine whether optimism predicts postsurgical functional status, treatment satisfaction, and treatment success. Data from the randomized Colpopexy and Urinary Reduction Efforts (CARE) study, in which stress continent women undergoing sacrocolpopexy to repair stage II to IV POP completed a baseline assessment of optimism and validated symptom and quality-of-life measures at baseline and 24 months. Relationships between optimism and demographics, clinical status, and functional and quality-of-life outcomes were assessed. Of 322 Colpopexy and Urinary Reduction Efforts study participants, 305 (94.7%) completed 24-month followup interviews. At baseline, there were no notable differences in optimism with respect to POP stage or history of earlier operations for prolapse or urinary incontinence. At baseline, women with greater optimism reported markedly better physical and mental functioning (p <or= 0.001) and less symptom distress (p <or= 0.01). Two years after operation, the difference in symptom experience across the three optimism categories narrowed; all women reported improved health status, fewer symptoms, and less impact on daily activities. Satisfaction with treatment and perception of treatment success were not associated with optimism. In women planning operation for POP, optimism is related to pelvic symptom severity, but is not associated with satisfaction with treatment or treatment success. Abdominal sacrocolpopexy resulted in substantial improvements in quality of life and functional outcomes that were not notably influenced by optimism.

The role of preoperative urodynamic testing in stress-continent women undergoing sacrocolpopexy: the Colpopexy and Urinary Reduction Efforts (CARE) randomized surgical trial

The aim of this study is to describe results of reduction testing in stress-continent women undergoing sacrocolpopexy and to estimate whether stress leakage during urodynamic testing with prolapse reduction predicts postoperative stress incontinence. Three hundred twenty-two stress-continent women with stages II-IV prolapse underwent standardized urodynamics. Five prolapse reduction methods were tested: two at each site and both performed for each subject. Clinicians were masked to urodynamic results. At sacrocolpopexy, participants were randomized to Burch colposuspension or no Burch (control). P-values were computed by two-tailed Fisher's exact test or t-test. Preoperatively, only 12 of 313 (3.7%) subjects demonstrated urodynamic stress incontinence (USI) without prolapse reduction. More women leaked after the second method than after the first (22% vs. 16%; p = 0.012). Preoperative detection of USI with prolapse reduction at 300ml was pessary, 6% (5 of 88); manual, 16% (19 of 122); forceps, 21% (21 of 98); swab, 20% (32 of 158); and speculum, 30% (35 of 118). Women who demonstrated preoperative USI during prolapse reduction were more likely to report postoperative stress incontinence, regardless of concomitant colposuspension (controls 58% vs. 38% (p = 0.04) and Burch 32% vs. 21% (p = 0.19)). In stress-continent women undergoing sacrocolpopexy, few women demonstrated USI without prolapse reduction. Detection rates of USI with prolapse reduction varied significantly by reduction method. Preoperative USI leakage during reduction testing is associated with a higher risk for postoperative stress incontinence at 3 months. Future research is warranted in this patient population to evaluate other treatment options to refine predictions and further reduce the risk of postoperative stress incontinence.

Does urethral competence affect urodynamic voiding parameters in women with prolapse?

To (1) compare voiding parameters and (2) correlate symptoms and urodynamic findings in women with pelvic organ prolapse (POP) and varying degrees of urethral competence. We compared three groups of women with stages II-IV POP. Groups 1 and 2 were symptomatically stress continent women participating in the Colpopexy and Urinary Reduction Efforts (CARE) trial; during prolapse reduction before sacrocolpopexy, Group 1 (n = 67) did not have and Group 2 (n = 84) had urodynamic stress incontinence (USI) during prolapse reduction. Group 3 participants (n = 74), recruited specifically for this study, had stress urinary incontinence (SUI) symptoms and planned sacrocolpopexy. Participants completed standardized uroflowmetry, pressure voiding studies, and validated symptom questionnaires. Subjects' median age was 61 years, median parity 3 and 87% had stage III or IV POP. Fourteen percent of women in Group 3 demonstrated USI without, and 70% with, prolapse reduction. Women in Groups 2 and 3 had more detrusor overactivity (DO) than Group 1 (17 and 24% vs. 6%, P = 0.02) and detrusor overactivity incontinence (DOI) (15 and 8% vs. 0%, P = 0.004). Based on the Blaivis-Groutz nomogram, 60% of all women were obstructed. Post-void residual volume (PVR), peak flow rate, detrusor pressure at peak flow, voiding mechanisms, voiding patterns, obstruction and urinary retention did not differ among groups. Women in Group 3 had higher irritative and obstructive symptom scores than Group 1 or 2; neither score differed by presence of DO nor obstruction, respectively. Women with POP have significant rates of urodynamic obstruction and retention, independent of their continence status. Symptoms of obstruction and retention correlate poorly with urodynamic findings.

Prolapse severity, symptoms and impact on quality of life among women planning sacrocolpopexy

Objectives: To explore the relationship between severity of pelvic organ prolapse (POP), symptoms of pelvic dysfunction and quality of life using validated measures. Method: Baseline data from 314 participants in the Colpopexy And Urinary Reduction Efforts (CARE) trial were analyzed. Pelvic symptoms and impact were assessed using the Pelvic Floor Distress Inventory (PFDI) and the Pelvic Floor Impact Questionnaire (PFIQ). PFDI and PFIQ scores were compared by prolapse stage and history of incontinence or POP surgery. Regression analyses were performed to identify other predictors of symptoms and impact. Results: Women were predominantly (90%) Caucasian and had mean age of 61 years. Women with stage II POP, especially those with prior surgery, reported more symptoms and impact than women with more advanced POP. There were no other significant predictors of symptoms or life impact. Conclusions: Women planning sacrocolpopexy with stage II prolapse and prior pelvic surgery reported more symptoms and quality of life impact than those with more advanced prolapse.

ORAL PRESENTATION 17: The Role of Pre-Operative Urodynamic Testing in Stress Continent Women Undergoing Sacrocolpopexy: The Colpopexy and Urinary Reduction Efforts (CARE) Randomized Surgical Trial

ORAL PRESENTATION 17: The Role of Pre-Operative Urodynamic Testing in Stress Continent Women Undergoing Sacrocolpopexy: The Colpopexy and Urinary Reduction Efforts (CARE) Randomized Surgical Trial

A randomized trial of colpopexy and urinary reduction efforts (CARE): design and methods

The primary aim of this randomized clinical trial is to evaluate whether a standardized modified Burch colposuspension, when added to planned abdominal sacrocolpopexy for the treatment of pelvic organ prolapse, improves the rate of urinary stress continence in subjects without preoperative symptoms of stress urinary incontinence. Secondary aims include comparison of immediate and short-term complications, overall urinary tract function, and other aspects of pelvic health between subjects with and without a concomitant Burch. The value of preoperative urodynamic testing with prolapse reduction will also be compared between subjects with and without a concomitant Burch. This trial is performed through the Pelvic Floor Disorders Network, which is funded by the National Institutes of Health–National Institute of Child Health and Human Development. Subjects will be enrolled at seven clinical centers across the United States and data will be analyzed by the central data coordinating center. Standardized questionnaires and physical observations and measurements will be obtained. The surgical team is masked to the preoperative urodynamic findings, and the patient and research coordinator are masked to treatment assignment. The primary outcome will be determined at 3 months after surgery. Stress continence is defined as absence of stress incontinence symptoms by questionnaire, a negative standardized stress test, and no treatment for stress incontinence other than the study intervention. Additional follow-up occurs at 6, 12, and 24 months. Accrual began in April 2002 and is projected to take 3 years. As of March 6, 2003, 91 patients have been randomized. This article highlights the scientific aspects of trial design for this pivotal clinical trial. The optimal approach to the urinary tract in women treated surgically for prolapse is not known. This trial is designed to provide pelvic surgeons and their patients with scientific data regarding the utility of urodynamics with and without prolapse reduction and the role of colposuspension with sacrocolpopexy.