Retrospective Cohort Study of Recovery From Sacrocolpopexy Versus Nonmesh Prolapse Repair.

IMPORTANCE: Providing recovery expectations for prolapse surgery is an important part of patient counseling and aids in patient-centered decision making. OBJECTIVES: The purpose of this study was to determine if postoperative recovery from minimally invasive sacrocolpopexy (MISCP) is noninferior to that of native tissue repair. STUDY DESIGN: Recovery at 2 and 6 weeks was quantified using the Postdischarge Surgical Recovery 13 scale, where higher scores indicate greater patient-perceived recovery. A 2:1 MISCP to native tissue repair ratio was used. The study population was created from 3 prior studies involving patients who underwent prolapse surgery between 2013 and 2021.Independent-samples t test was used for normally distributed data, Mann-Whitney U tests for nonnormally distributed data, and the χ2 test for population proportions. A parsimonious linear regression analysis was performed to determine if the surgical group independently predicted postdischarge surgical recovery at 2 and 6 weeks, after controlling for significant confounders identified during bivariate analysis. RESULTS: The study population included 476 patients: 352 underwent MISCP and 124 underwent native tissue repair.Postdischarge Surgical Recovery 13 scores for patients who underwent MISCP compared with native tissue repair were higher at 2 weeks (mean, 58.4 ± 18.2 vs 54.4 ± 18.7; P = 0.04) and at 6 weeks postoperatively (mean, 77.2 ± 15.6 vs 73.7 ± 18.7; P = 0.1). CONCLUSIONS: Our findings indicate that recovery after MISCP is noninferior to that of native tissue repair. This information is important for delivering patient-centered care during preoperative counseling.

Predictors of Recovery Expectancy in Preparation for Pelvic Reconstructive Surgery in Women With Pelvic Organ Prolapse: A Prospective Cohort Study.

IMPORTANCE: Recovery expectancy is a modifiable predictor of actual recovery after surgery. Identifying predictors of recovery expectancy will allow clinicians to preoperatively modify recovery expectancy and optimize actual recovery. OBJECTIVES: The primary objective was to identify patient characteristics that predict a patient's recovery expectancy. The secondary objective was to validate previous research demonstrating that recovery expectancy predicted actual recovery. STUDY DESIGN: This is a prospective cohort study of women undergoing pelvic reconstructive surgery. Patients completed a preoperative survey to collect data on potential sociodemographic, clinical, and psychosocial, including investment in life roles, predictors of recovery expectancies. Actual recovery was measured at postoperative weeks 2 and 6. Predictors of recovery expectancy were identified. RESULTS: Two hundred one women were recruited with 174 included in the final analysis. Variables significantly associated with recovery expectancy during bivariate analysis ( P < 0.05) were education level, total prior surgical procedures, pelvic pain, back pain, bodily pain, sick role investment, optimism, satisfaction with participation in social roles, overall social support, job satisfaction, and professionalism. Sick role investment was the only independent predictor of recovery expectancy (F = 3.46, df = 13, P < 0.001). Greater sick role investment was associated with increased probability of prolonged recovery. Patients with low recovery expectancies had less actual recovery compared with patients with high recovery expectancies ( P = 0.014). CONCLUSIONS: This study confirmed prior work that recovery expectancy predicts actual recovery after reconstructive pelvic surgery and may establish recovery expectancy as a mediator between sick role investment and actual postdischarge surgical recovery.

Enhanced Recovery Protocol Enhances Postdischarge Recovery After Laparoscopic Sacrocolpopexy.

OBJECTIVE: The objective of this study is to determine if an ERAS (enhanced recovery after surgery) protocol enhanced the patient-perceived postdischarge recovery after laparoscopic sacrocolpopexy. METHODS: In this prospective cohort study, patients exposed to an ERAS protocol completed a preoperative survey that included established predictors of postdischarge recovery. Postoperatively, they completed the validated Postdischarge Surgical Recovery 13 (PSR-13) scale at 7, 14, and 42 days. A historical cohort of non-ERAS patients who completed similar surveys were included for comparisons. Characteristics between the 2 cohorts were analyzed using the χ2 test, Student t tests, and Mann-Whitney U tests where appropriate. A mixed-design analysis of variance model was constructed to determine if our ERAS protocol affected recovery as measured by the PSR-13 scale. RESULTS: Eighty-nine ERAS patients were compared with 169 non-ERAS controls. There were no differences in established predictors of recovery between the groups. Length of hospital stay was shorter in the ERAS cohort (33±13.1 hours vs 44.2±25.9 hours; mean difference, 11.2; 95% confidence interval [CI], 6.44-16.0). Postdischarge recovery significantly improved with time (7 days: 52.7; 95% CI, 50.1-55.2; 14 days: 63.4; 95% CI, 60.9-65.8; 42 days: 80.1, 95% CI, 78.1-82.1). The ERAS cohort reported greater postdischarge recovery than the non-ERAS cohort (as measured by the PSR-13 scale) at postoperative days 7, 14, and 42 days (68.4 vs 62.3; mean difference, 6.1; 95% CI, 2.04-10.16). CONCLUSIONS: Enhanced recovery after surgery protocols reduce length of hospital stay and enhance patient-perceived postdischarge recovery.

Early and Consistent Improvements in Urinary Symptoms and Quality of Life With OnabotulinumtoxinA in Patients With Overactive Bladder and Urinary Incontinence: Results From a Randomized, Placebo-controlled, Phase IV Clinical Trial.

OBJECTIVES: This randomized, multicenter, placebo-controlled, phase IV study assessed the efficacy and tolerability of onabotulinumtoxinA in patients with overactive bladder. METHODS: Patients were randomized 1:1 to onabotulinumtoxinA 100 U or placebo. Assessments over 12 weeks included: change from baseline in urinary incontinence (UI) episodes/day; proportions of patients who achieved 100% and 50% or greater reductions in UI episodes/day; proportion of patients using no incontinence pads in the previous 24 hours; and changes from baseline in micturition frequency, nocturia, urgency UI, Incontinence-Quality of Life, King's Health Questionnaire, International Consultation on Incontinence Questionnaire-UI Short Form scores and time to request retreatment. RESULTS: Significant reductions in UI episodes/day were seen with onabotulinumtoxinA versus placebo within week 1 posttreatment (-2.9 vs -2.0, P = 0.005) through week 12 (coprimary endpoint: -3.5 vs -1.6, P < 0.001). Significantly more onabotulinumtoxinA-treated patients achieved 100% (coprimary endpoint) and 50% or greater reductions in UI episodes/day. Decreases in other urinary symptoms were also seen within 1 week with onabotulinumtoxinA that continued through at least week 12. More onabotulinumtoxinA-treated versus placebo-treated patients required no incontinence pads at weeks 1 to 12, and greater improvements in quality of life measurements were seen. Time to request retreatment was significantly longer with onabotulinumtoxinA versus placebo (30.0 weeks vs 13.1 weeks; P < 0.001). No unexpected safety signals were observed. Urinary tract infection was the most commonly observed adverse event. CONCLUSIONS: Urinary symptom and quality of life improvements were observed with onabotulinumtoxinA within 1 week of treatment and were sustained for at least 12 weeks.

Economic Burden of Illness in Adult Patients with Nocturia.

BACKGROUND: Nocturia is considered to be a very bothersome lower urinary tract disorder. Yet, to date, the economic burden attributable to this poor health condition remains less well known. OBJECTIVE: To compare differences in health care resource utilization (HCRU), health care costs, and work productivity in adult patients with differing frequencies of nocturia episodes (i.e., < 2 vs. ≥ 2 nocturia episodes per night). METHODS: Adult patients with nocturia enrolled in an integrated proprietary database were recruited to complete a survey on their demographics, nocturia characteristics, and work productivity. Using patients' survey data and health care claims from the previous 6 months, those with < 2 (n = 197; 21.9%) versus ≥ 2 (n = 702; 78.1%) nocturia episodes per night were compared for differences in HCRU, health care costs, and work productivity after adjusting for potential confounders. HCRU was reported as the mean number per patient per month (PPPM) for outpatient visits (all types), physician office visits, and prescriptions filled and the proportion of patients with ≥1 hospitalization or emergency department visit in the previous 6 months. Health care costs were reported as mean PPPM. Work productivity was assessed via patient survey and reported as a mean percentage for absenteeism, presenteeism, overall work impairment, and activity impairment during the past week. RESULTS: 899 adult patients (mean age = 71.4 years; 57.2% men) were enrolled and analyzed. Compared with patients with <2 nocturia episodes per night, patients with ≥ 2 nocturia episodes had more outpatient health care visits (unadjusted mean visits PPPM: 2.1 vs. 1.6; P < 0.001; adjusted mean visits PPPM: 2.1 vs. 1.6; P = 0.017), office visits (unadjusted and adjusted mean visits PPPM: 0.9 vs. 0.7; P < 0.001), and prescriptions filled (unadjusted mean prescription fills PPPM: 3.1 vs. 2.1; P < 0.001; adjusted mean prescription fills PPPM: 3.2 vs. 2.2; P = 0.027). Patients with ≥ 2 nocturia episodes per night also displayed significantly higher outpatient health care costs (unadjusted mean PPPM costs: $676 vs. $516; P = 0.028; adjusted mean PPPM costs: $678 vs. $506; P = 0.017). In terms of work productivity impairment, patients with ≥ 2 nocturia episodes per night experienced higher rates of unadjusted (20% vs. 10%; P = 0.002) and adjusted presenteeism (20% vs. 10%; P = 0.004) and unadjusted (20% vs. 10%; P = 0.002) and adjusted overall work impairment (20% vs. 10%; P = 0.001). CONCLUSIONS: Study findings demonstrate that nocturia was associated with higher outpatient encounters and related costs in the presence of a greater occurrence of nocturic episodes. DISCLOSURES: This study was funded by Allergan plc, Dublin, Ireland. Neither honoraria nor payments were provided for authorship. Dmochowski is a consultant and speaker for Allergan plc and a consultant for Serenity Pharmaceuticals. Brucker is a consultant and speaker for Allergan plc, a consultant for Watkins-Conti and Avadel, and an investigator for Medtronic and Ipsen. Cole is a consultant for Allergan plc and an employee of Sharp Rees-Stealy Medical Group. Kawahara and Pulicharam are full-time employees of DaVita Medical Group. Burk is a consultant for Allergan plc and a health outcomes consultant. Tung is an employee of Allergan plc. Hale has served as a consultant/advisor to and has received research funding from Allergan plc. The data from this manuscript were previously presented in poster format by Steve Kawahara at the Academy of Managed Care & Specialty Pharmacy Annual Meeting; April 19-22, 2016; San Francisco, CA.

Posterior Compartment Surgery Provides No Differential Benefit for Defecatory Symptoms Before or After Concomitant Mesh-Augmented Apical Suspension.

OBJECTIVES: The aim of this study was to determine the value of posterior compartment surgery during concomitant mesh-augmented apical suspension by comparing obstructed defecatory symptoms after laparoscopic sacrocolpopexy (LSC) with LSC with posterior repair (LSC + PR) and laparoscopic sacrocolpoperineopexy (LSCP) procedures. METHODS: This was a retrospective cohort study of women who underwent LSC, LSC + PR, and LSCP between July 2007 and July 2016 at a tertiary referral center in Indianapolis, Ind. Our primary outcome was differential change in Colorectal-Anal Distress Inventory (CRADI-8) and Colorectal-Anal Impact Questionnaire (CRAIQ-7) scores between the groups including patient-specific symptoms of splinting, straining, incomplete emptying, and pain with defecation. Our secondary outcomes were the rates of postoperative persistent, new, and resolved obstructed defecation symptoms. Anatomic outcomes were also compared between the groups as measured by change in Pelvic Organ Prolapse Quantification System points Ap, GH, and PB. RESULTS: A total of 312 women were included in the study (47 LSC, 133 LSC + PR, and 132 LSCP), with a median follow-up time of 366 days. The majority of patients who underwent surgery had stage III pelvic organ prolapse (61%). Baseline demographics were similar between groups, including preoperative CRADI-8 and CRAIQ-7 scores. All surgical groups demonstrated improvement in CRADI-8 and CRAIQ-7 scores postoperatively (P < 0.001). However, despite differential change in Pelvic Organ Prolapse Quantification System points Ap, GH, and PB, there was no change in CRADI-8 and CRAIQ-7 scores or rates of persistent, new, and resolved symptoms of splinting to defecate, incomplete emptying, and pain with defecation between the groups. The only factor that seemed to be differentially improved by the addition of a posterior compartment repair was postoperative straining. There was a greater rate of de novo straining in the LSC group compared with LSCP (P = 0.01) (LSC + PR v LSCP, P = NS, for both). CONCLUSIONS: We cannot recommend posterior compartment surgery as providing any patient-centered benefit beyond improved cosmesis because the addition of perineal body stabilization either before (LSCP) or posterior repair after (LSC + PR) concomitant mesh-augmented apical suspension did not differentially affect bowel symptoms compared with LSC alone.

Suprapubic versus transurethral bladder drainage following reconstructive pelvic surgery: a comparison of patient satisfaction and quality of life.

INTRODUCTION AND HYPOTHESIS: To assess the differences in patient-reported, catheter-specific satisfaction and quality of life with either suprapubic or transurethral postoperative bladder drainage following reconstructive pelvic surgery. METHODS: This was a prospective study of all eligible women who were scheduled to undergo reconstructive surgery requiring bladder drainage during the study period November 2013 to March 2015. Women who did not undergo the planned procedure(s) or did not require bladder drainage were excluded. The primary outcome was patient-reported quality of life using catheter-specific instruments including the Catheter-related Quality of Life (CIQOL) instrument, and a modified version of the Intermittent Self-Catheterization Questionnaire (ISC-Q), designed to evaluate aspects of catheter-related quality of life and satisfaction specific to the needs of the individual. RESULTS: A total of 178 women were analyzed, 108 in the transurethral catheter group and 70 in the suprapubic group. Women with suprapubic bladder drainage had higher quality of life and satisfaction scores than women with transurethral bladder drainage as measured by the ISC-Q (68.31 ± 16.87 vs. 54.04 ± 16.95, mean difference 14.27, 95 % CI 9.15 - 19.39). There was no difference in quality of life by the CIQOL. After regression analysis, women with suprapubic bladder drainage were more satisfied with their catheter-specific needs despite longer duration of catheter use, more concurrent continence surgery, and higher trait anxiety. CONCLUSIONS: Differences in catheter-specific quality of life and patient satisfaction scores favoring suprapubic bladder drainage support its continued use in appropriately selected women for treatment of temporary postoperative urinary retention after reconstructive pelvic surgery.

If you could see what we see, would it bother you?

OBJECTIVE: The purpose of our study was to determine whether the anatomic threshold for pelvic organ prolapse (POP) diagnosis and surgical success remains valid when the patient sees what we see on exam. METHODS: Two hundred participants were assigned, by computer-generated block randomization, to see one of four videos. Each video contained the same six clips representative of various degrees of anterior vaginal wall support. Participants were asked questions immediately after each clip. They were asked: "In your opinion, does this patient have a bulge or something falling out that she can see or feel in the vaginal area?" Similarly, they were asked to give their opinion on surgical outcome on a 4-point Likert scale. RESULTS: The proportion of participants who identified the presence of a vaginal bulge increased substantially at the level of early stage 2 prolapse (1 cm above the hymen), with 67 % answering yes to the question regarding bulge. The proportion of participants who felt that surgical outcome was less desirable also increased substantially at early stage 2 prolapse (1 cm above the hymen), with 52 % describing that outcome as "not at all" or "somewhat" successful. CONCLUSION: Early stage 2 POP (1 cm above the hymen) is the anatomic threshold at which women identify both a vaginal bulge and a less desirable surgical outcome when they see what we see on examination.

Patient satisfaction and regret with decision differ between outcomes in the composite definition of success after reconstructive surgery.

INTRODUCTION AND HYPOTHESIS: To evaluate patient satisfaction and regret with their decision for reconstructive surgery, and determine if they valued each item equally in the composite definition of success after making the decision for surgery. METHODS: A list was created including all patients who underwent laparoscopic sacral colpopexy or laparoscopic uterosacrocolpopexy. Patients were placed in mutually exclusive outcome categories (retreatment, symptomatic failure, anatomic failure, and surgical success). Retreatment included any postoperative treatment for urinary incontinence, pelvic organ prolapse including pessary use, or surgery for mesh complications. The validated modified Decision Regret Scale (DRS) and the Satisfaction Decision Scale (SDS) questionnaires were administered by telephone. Higher DRS scores indicate greater regret and higher SDS scores indicate greater satisfaction with the decision for surgery. RESULTS: Of 715 patients, 197 were successfully contacted by telephone following reconstructive surgery and surveyed as study participants. Composite surgical outcomes were available for 150. Information on the need for retreatment was available for all the study participants. Surgery was successful in 101 (67.3 %) of the study participants. Anatomic failure occurred in 14, symptomatic failure occurred in 10, and retreatment was required in 25 of the study participants. Overall, the study participants were more satisfied than regretful with their decision for reconstructive surgery. Regret and satisfaction with their decision differed between outcomes in the composite definition of success after reconstructive surgery. CONCLUSIONS: Surgeons and patients should focus on retreatment rates during preoperative outcome discussions because retreatment will result in the least satisfaction and greatest regret with the decision for reconstructive surgery.

Impact of a Novel Vaginal Bowel Control System on Bowel Function.

BACKGROUND: Bowel dysfunction, including frequency, fecal urgency, stool consistency, and evacuation symptoms, contributes to fecal incontinence. OBJECTIVE: The purpose of this study was to examine the impact of a vaginal bowel control system on parameters of bowel function, including frequency, urgency, stool consistency, and evacuation. DESIGN: This was a secondary analysis of a multicenter, prospective clinical trial. SETTINGS: This study was conducted at 6 sites in the United States, including university hospitals and private practices in urogynecology and colorectal surgery. PATIENTS: A total of 56 evaluable female subjects aged 19 to 75 years with 4 or more fecal incontinence episodes on a 2-week bowel diary were included. INTERVENTIONS: The study intervention was composed of the vaginal bowel control system, consisting of a vaginal insert and pressure-regulated pump. MAIN OUTCOME MEASURES: Subjects completed a 2-week baseline diary of bowel function before and after treatment completed at 1 month. Fecal urgency, consistency of stool (Bristol score), and completeness of evacuation were recorded for all bowel movements. RESULTS: Use of the insert was associated with an improvement in bowel function across all 4 categories. Two thirds (8/12) of subjects with a high frequency of daily stools (more than 2 per day) shifted to a normal or low frequency of stools. Analysis of Bristol stool scale scores demonstrated a significant reduction in the proportion of all bowel movements reported as liquid (Bristol 6 or 7), from 36% to 21% (p = 0.0001). On average, 54% of stools were associated with urgency at baseline compared with 26% at 1 month (p < 0.0001). Incomplete evacuations with all bowel movements were reduced from 39% to 26% of subjects at 1 month (p = 0.0034). LIMITATIONS: The study follow-up period was 1 month (with an optional additional 2 months). CONCLUSIONS: The vaginal bowel control system was associated with an improvement in bowel symptoms and function, including reduced bowel movement frequency, less fecal urgency, increased solid consistency, and improved evacuation in patients with significant fecal incontinence.

Consistently inconsistent, the posterior vaginal wall.

Posterior vaginal wall prolapse is one of the most common prolapses encountered by gynecological surgeons. What appears to be a straightforward condition to diagnose and treat surgically for physicians has proven to be frustratingly unpredictable with regard to symptom relief for patients. Functional disorders such as dyssynergic defecation and constipation are often attributed to posterior vaginal wall prolapse. Little scientific evidence supports this assumption, emphasizing that structure and function are not synonymous when treating posterior vaginal wall prolapse. Rectoceles, enteroceles, sigmoidoceles, peritoneoceles, rectal and intraanal intussusception, rectal prolapse, and descending perineal syndrome are all conditions that have an impact on the posterior vaginal wall. All too often these different anatomic conditions are treated with the same surgical approach, addressing a posterior vaginal wall bulge with a traditional posterior colporrhaphy. Studies that examine the correlation between stage of posterior wall prolapse and patient symptoms have failed to reliably do so. Surgical outcomes measured by prolapse staging appear successful, yet patient expectations are often not met. As increasing attention is being placed on patient satisfaction outcomes concerning surgical treatments, this fact will need to be addressed. Surgeons will have to clearly communicate what can and what cannot be expected with surgical repair of posterior vaginal wall prolapse.

Obliterative Surgery for the Treatment of Pelvic Organ Prolapse: A Patient Survey on Reasons for Surgery Selection and Postoperative Decision Regret and Satisfaction.

OBJECTIVES: To identify patient-reported reasons for selecting obliterative surgery for the purpose of predicting decision regret and satisfaction. METHODS: We created a deidentified database of patients who underwent an obliterative procedure for prolapse from 2006 to 2013. Patients were excluded if they declined study participation, were deceased, or had dementia. Participants completed a survey regarding reasons for selecting obliterative surgery and a modified version of validated questionnaires on decision regret (Decision Regret Scale-Pelvic Floor Disorder) and satisfaction (Satisfaction with Decision Scale-Pelvic Floor Disorder). Parsimonious multivariate linear regression models were constructed to determine if any of the reasons given for choosing obliterative surgery were independent predictors of decision regret and satisfaction after controlling for significant sociodemographic, clinical, and surgical outcome data identified by bivariate analysis. RESULTS: Seventy-seven women completed the surveys. "To follow my doctor's recommendations" and "no longer sexually active," and/or "did not plan to be" as reasons for selecting obliterative surgery made the most difference; however, these reasons were not identified as independent predictors of decision regret or satisfaction after controlling for confounders. The regret linear regression models identified preoperative sexual activity rather than the patient-reported reason "no longer sexually active and/or did not plan to be," as the only independent predictor of more decision regret after obliterative surgery (B coefficient 1.68, P < 0.01). The satisfaction linear regression models identified reoperation for any reason as an independent predictor of lower satisfaction (ß, -0.24; P = 0.04) and the patient-reported reason for choosing obliterative surgery "not interested in pessary" as a predictor of higher satisfaction (ß, 0.30, P = 0.01). CONCLUSIONS: This study advances our knowledge about the obliterative surgical decision making process. Behavioral and educational interventions directed at improving patient and physician communications concerning the dynamics of sexual health issues in an aging population will likely decrease regret when obliterative surgery is chosen. Minimizing reoperation after obliterative surgery through increased experience, knowledge, and improved surgical skills and patient validation when pessary is declined will likely improve satisfaction when obliterative surgery is chosen.

Balloon expulsion testing for the diagnosis of dyssynergic defecation in women with chronic constipation.

INTRODUCTION AND HYPOTHESIS: Dyssynergic defecation can be difficult to diagnose. Anorectal manometry and defecography are often used to make this diagnosis. However, these tests are expensive and require expertise. Balloon expulsion testing may be a simple alternative. We compared balloon expulsion to anorectal manometry and defecography for diagnosing dyssynergia in women with chronic constipation. METHODS: We conducted a retrospective review. All women presenting for evaluation of chronic constipation who underwent concurrent balloon testing, manometry, and defecography were included. A diagnosis of dyssynergic defecation was established by either defecography revealing prolonged/incomplete rectal evacuation and/or by manometry revealing paradoxical contraction/inadequate relaxation of the pelvic floor. Inability to expel a 50-ml balloon defined dyssynergic defecation by balloon testing. Sensitivity, specificity, and predictive values were calculated. RESULTS: A total of 61 women met inclusion criteria. Mean age was 50 years. There were 36 women (59 %) who met Rome III criteria for dyssynergic defecation on defecography and/or manometry. Only 12 of these 36 (33 %) were similarly diagnosed by balloon testing. The sensitivity and positive predictive value of balloon testing for dyssynergia were 33 and 71 %, respectively. Of the 25 (41 %) women who did not meet Rome III criteria for dyssynergia on defecography and/or manometry, 20 (80 %) also had negative balloon testing. Thus, the specificity and negative predictive value of balloon testing for diagnosing dyssynergia were 80 and 50 %, respectively. CONCLUSIONS: In our population, balloon expulsion was not an ideal screening test for dyssynergic defecation in women with constipation. Multimodal testing is necessary for more accurate diagnosis.

A vaginal bowel-control system for the treatment of fecal incontinence.

OBJECTIVE: To evaluate the effectiveness and safety of a vaginal bowel-control device and pump system for fecal incontinence treatment. METHODS: Women with a minimum of four fecal incontinence episodes over 2 weeks were fit with the intravaginal device. Treatment success, defined as a 50% or greater reduction of incontinent episodes, was assessed at 1 month. Participants were invited into an optional extended-wear period of another 2 months. Secondary outcomes included symptom improvement measured by the Fecal Incontinence Quality of Life, Modified Manchester Health Questionnaire, and Patient Global Impression of Improvement. Adverse events were collected. Intention-to-treat analysis included participants who were successfully fit entering treatment. Per protocol, analysis included participants with a valid 1-month treatment diary. RESULTS: Sixty-one of 110 (55.5%) participants from six clinical sites were successfully fit and entered treatment. At 1 month, intention-to-treat success was 78.7% (48/61, P<.001); per protocol success, 85.7% (48/56, P<.001) and 85.7% (48/56) considered bowel symptoms "very much better" or "much better." There was significant improvement in all Fecal Incontinence Quality of Life (P<.001) and Modified Manchester (P≤.007) subscales. Success rate at 3 months was 86.4% (38/44; 95% confidence interval 73-95%). There were no serious adverse events; the most common study-wide device-related adverse event was pelvic cramping or discomfort (25/110 participants [22.7%]), the majority of events (16/25 [64%]) occurring during the fitting period. CONCLUSION: In women successfully fit with a vaginal bowel-control device for nonsurgical treatment for fecal incontinence, there was significant improvement in fecal incontinence by objective and subjective measures. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01655498. LEVEL OF EVIDENCE: : II.

Documentation of specific mesh implant at the time of midurethral sling surgery in women with stress incontinence.

OBJECTIVE: We aimed to assess documentation completeness of the operative record for mesh implanted at the time of midurethral sling surgery and to identify modifiable predictors of documentation completeness. METHODS: A retrospective cross-sectional study of women with stress incontinence who underwent midurethral sling placement between January 2009 and December 2011 was conducted. Data from the dictated operative note and nursing operative record were extracted to determine if the specific mesh implanted during surgery was documented. The primary outcome was the rate of documentation of mesh implanted in the physician's dictated operative note and in the nursing record. Logistic regression was used to determine if any characteristics were associated with the rate of documentation while accounting for correlation of patients from the same dictating surgeon. RESULTS: There were 816 surgeries involving the implantation of a midurethral sling during the study period. All surgeries were performed at 6 Indiana University hospitals. Fifty-two surgeons of varying specialties and levels of training dictated the operative notes. A urogynecologist dictated 71% of the operative notes. The rate of documentation completeness for mesh implanted in the physician's note was 10%. The rate of documentation completeness for mesh implanted in the nursing operative record was 92%. Documentation of mesh implanted in the physician's note was not significantly associated with the level of training, specialty, or year of surgery. CONCLUSIONS: Documentation completeness for specific mesh implant in the physician's note is low, independent of specialty and level of training. Nursing documentation practices are more rigorous. Postmarket surveillance, currently mandated by the Food and Drug Administration, may not be feasible if only the physician's note is available or if nursing practices are inconsistent. Development of documentation guidelines for physicians would improve the feasibility of surveillance.

Pudendal neuralgia.

Pudendal neuralgia is a painful condition affecting the nerve distribution of the pudendal nerve. The Nantes criteria give some structure for making this diagnosis. A step-ladder approach to therapy, as described, is suggested when treating these patients.

Recurrence of prolapse after transvaginal mesh excision.

OBJECTIVE: Recurrence of pelvic organ prolapse (POP) is a potential complication after mesh removal. We evaluated anatomical and functional outcomes preoperatively and postoperatively in patients undergoing mesh excision. MATERIALS AND METHODS: We conducted a retrospective cohort analysis of consecutive patients who underwent mesh excision from years 2005 to 2009. Anatomical outcomes were evaluated using the POP quantification (POP-Q) system. Recurrence of prolapse was defined as stage II or higher-stage prolapse on the POP-Q system, reoperation for prolapse, or postoperative use of a pessary for prolapse reduction. Functional outcomes were assessed using the pelvic floor distress inventory and pelvic floor impact questionnaire scores. RESULTS: Data were analyzed from 71 patients who underwent either partial or complete mesh excision. Most (44/70 [63%]) of the patients underwent partial mesh excision, and 26 patients (37%) underwent total mesh removal. Nineteen patients (26.7%) had preoperative prolapse and 27 (38.0%) of the 71 patients underwent concomitant native tissue prolapse repair. Overall change in POP-Q stage in women who underwent partial removal (median, 0 [-1 to 2]) was less advanced than in women with total excision. (median, -1 [-3 to 0]; P = 0.006) at 1 year postoperatively. Four patients prolapsed to the hymen, with all patients having defects in the anterior compartment. No patients required a second surgery, and one patient was treated with a pessary.Total pelvic floor distress inventory and pelvic floor impact questionnaire scores before mesh excision were significantly improved 6 months after mesh removal (P < 0.05). Dyspareunia improved significantly after mesh excision (P = 0.034). CONCLUSION: In our patient population, total and partial mesh excision is associated with re-treatment of POP in 1.4% of the patients. Patient functional outcomes significantly improved after mesh removal.