Ectopic Prostatic Tissue in Female Urethral Diverticulum.

BACKGROUND: Ectopic prostatic tissue in female patients is rare. It is theorized that the presence of prostatic tissue in female patients is likely a Wolffian remnant or transformation of hormonally mediated tissue of the uterus, cervix, Skene's gland, and, rarely, periurethral tissue. Due to the increase in the use of testosterone and gender-affirming therapies, it is important to understand the role of testosterone in mediating the presence of ectopic prostatic tissue. CASE: We present a case of ectopic prostatic tissue in a urethral diverticulum in a female patient with exposure to testosterone hormone therapy and review the literature on this finding. CONCLUSION: Although rare, ectopic prostatic tissue should be considered in the differential diagnosis of anterior vaginal cysts, especially in the setting of testosterone supplementation.

Adherence to Perioperative Behavioral Therapy With Pelvic Floor Muscle Training in Women Receiving Vaginal Reconstructive Surgery for Pelvic Organ Prolapse.

OBJECTIVE: The objective of this study was to describe adherence to behavioral and pelvic floor muscle training in women undergoing vaginal reconstructive surgery for organ prolapse and to examine whether adherence was associated with 24-month outcomes. METHODS: Participants were women ≥18 years of age, with vaginal bulge and stress urinary incontinence symptoms, planning to undergo vaginal reconstructive surgery for stages 2 to 4 vaginal or uterine prolapse. They were randomized to either sacrospinous ligament fixation or uterosacral ligament suspension and to perioperative behavioral and pelvic floor muscle training or usual care. Measurements included anatomic failure, pelvic floor muscle strength, participant-reported symptoms, and perceived improvement. Analyses compared women with lower versus higher adherence. RESULTS: Forty-eight percent of women performed pelvic floor muscle exercises (PFMEs) daily at the 4- to 6-week visit. Only 33% performed the prescribed number of muscle contractions. At 8 weeks, 37% performed PFMEs daily, and 28% performed the prescribed number of contractions. No significant relationships were found between adherence and 24-month outcomes. CONCLUSION: Adherence to a behavioral intervention was low following vaginal reconstructive surgery for pelvic organ prolapse. The degree of adherence to perioperative training did not appear to influence 24-month outcomes in women undergoing vaginal prolapse surgery. IMPACT: This study contributes to the understanding of participant adherence to PFMEs and the impact that participant adherence has on outcomes at 2, 4 to 6, 8, and 12 weeks and 24 months postoperatively. It is important to educate women to follow up with their therapist or physician to report new or unresolved pelvic symptoms.

Natural history of lower urinary tract symptoms in treatment-seeking women with pelvic organ prolapse; the Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN).

BACKGROUND: The association of pelvic organ prolapse with overactive bladder and other lower urinary tract symptoms, and the natural history of those symptoms are not well characterized. Previous cross-sectional studies demonstrated conflicting relationships between prolapse and lower urinary tract symptoms. OBJECTIVE: This study primarily aimed to determine the baseline association between lower urinary tract symptoms and prolapse and to assess longitudinal differences in symptoms over 12 months in women with and without prolapse. Secondary aims were to explore associations between lower urinary tract symptoms and prolapse treatment. We hypothesized that: (1) prolapse is associated with the presence of lower urinary tract symptoms, (2) lower urinary tract symptoms are stable over time in patients with and without prolapse, and (3) prolapse treatment is associated with lower urinary tract symptom improvement. STUDY DESIGN: Women enrolled in the Symptoms of Lower Urinary Tract Dysfunction Research Network Observational Cohort Study with adequate 12-month follow-up data were included. Prolapse and lower urinary tract symptom treatment during follow-up was guided by standard of care. Outcome measures included the Lower Urinary Tract Symptoms Tool total severity score (in addition to overactive bladder, obstructive, and stress urinary incontinence subscales) and Urogenital Distress Inventory-6 Short Form. Prolapse (yes or no) was defined primarily when Pelvic Organ Prolapse Quantification System points Ba, C or Bp were >0 (beyond the hymen). Mixed-effects models with random effects for patient slopes and intercepts were fitted for each lower urinary tract symptom outcome and prolapse predictor, adjusted for other covariates. The study had >90% power to detect differences as small as 0.4 standard deviation for less prevalent group comparisons (eg, prolapse vs not). RESULTS: A total of 371 women were analyzed, including 313 (84%) with no prolapse and 58 (16%) with prolapse. Women with prolapse were older (64.6±8.8 vs 55.3±14.1 years; P<.001) and more likely to have prolapse surgery (28% vs 1%; P<.001) and pessary treatment (26% vs 4%; P<.001) during the study. Average baseline Lower Urinary Tract Symptoms Tool total severity scores were lower (fewer symptoms) for participants with prolapse compared with those without (38.9±14.0 vs 43.2±14.0; P=.036), but there were no differences in average scores between prolapse groups for other scales. For all urinary outcomes, average scores were significantly lower (improved) at 3 and 12 months compared with baseline (all P<.05). In mixed-effects models, there were no statistically significant interactions between pelvic organ prolapse measurement and visit and time-dependent prolapse treatment groups (P>.05 for all regression interaction coefficients). The Lower Urinary Tract Symptoms Tool obstructive severity score had a statistically significant positive association with Pelvic Organ Prolapse Quantification System Ba, Bp, and point of maximum vaginal descent. The Lower Urinary Tract Symptoms Tool total severity scale had a statistically significant negative association with Pelvic Organ Prolapse Quantification System Ba and point of maximum vaginal descent. No other associations between prolapse and lower urinary tract symptoms were significant (P>.05 for all regression coefficients). Symptom differences between prolapse groups were small: all regression coefficients (interpretable as additive percentage change in each score) were between -5 and 5 (standard deviation of outcomes ranged from 14.0-32.4). CONCLUSION: Among treatment-seeking women with urinary symptoms, obstructive symptoms were positively associated with prolapse, and overall lower urinary tract symptom severity was negatively associated with prolapse. Lower Urinary Tract Symptoms Tool scores improved over 12 months regardless of prolapse status, including in those with treated prolapse, untreated prolapse, and without prolapse.

Development and Validation of a Model for Predicting Surgical Site Infection After Pelvic Organ Prolapse Surgery.

IMPORTANCE: Surgical site infection (SSI) is a common and costly complication. Targeted interventions in high-risk patients may lead to a reduction in SSI; at present, there is no method to consistently identify patients at increased risk of SSI. OBJECTIVE: The aim of this study was to develop and validate a model for predicting risk of SSI after pelvic organ prolapse surgery. STUDY DESIGN: Women undergoing surgery between 2011 and 2017 were identified using Current Procedural Terminology codes from the Centers for Medicare and Medicaid Services 5% Limited Data Set. Surgical site infection ≤90 days of surgery was the primary outcome, with 41 candidate predictors identified, including demographics, comorbidities, and perioperative variables. Generalized linear regression was used to fit a full specified model, including all predictors and a reduced penalized model approximating the full model. Model performance was measured using the c-statistic, Brier score, and calibration curves. Accuracy measures were internally validated using bootstrapping to correct for bias and overfitting. Decision curves were used to determine the net benefit of using the model. RESULTS: Of 12,334 women, 4.7% experienced SSI. The approximated model included 10 predictors. Model accuracy was acceptable (bias-corrected c-statistic [95% confidence interval], 0.603 [0.578-0.624]; Brier score, 0.045). The model was moderately calibrated when predicting up to 5-6 times the average risk of SSI between 0 and 25-30%. There was a net benefit for clinical use when risk thresholds for intervention were between 3% and 12%. CONCLUSIONS: This model provides estimates of probability of SSI within 90 days after pelvic organ prolapse surgery and demonstrates net benefit when considering prevention strategies to reduce SSI.

Development and Validation of a Model for Opioid Prescribing Following Gynecological Surgery.

Importance: Overprescription of opioid medications following surgery is well documented. Current prescribing models have been proposed in narrow patient populations, which limits their generalizability. Objective: To develop and validate a model for predicting outpatient opioid use following a range of gynecological surgical procedures. Design, Setting, and Participants: In this prognostic study, statistical models were explored using data from a training cohort of participants undergoing gynecological surgery for benign and malignant indications enrolled prospectively at a single institution's academic gynecologic oncology practice from February 2018 to March 2019 (cohort 1) and considering 39 candidate predictors of opioid use. Final models were internally validated using a separate testing cohort enrolled from May 2019 to February 2020 (cohort 2). The best final model was updated by combining cohorts, and an online calculator was created. Data analysis was performed from March to May 2020. Exposures: Participants completed a preoperative survey and weekly postoperative assessments (up to 6 weeks) following gynecological surgery. Pain management was at the discretion of clinical practitioners. Main Outcomes and Measures: The response variable used in model development was number of pills used postoperatively, and the primary outcome was model performance using ordinal concordance and Brier score. Results: Data from 382 female adult participants (mean age, 56 years; range, 18-87 years) undergoing gynecological surgery (minimally invasive procedures, 158 patients [73%] in cohort 1 and 118 patients [71%] in cohort 2; open surgical procedures, 58 patients [27%] in cohort 1 and 48 patients [29%] in cohort 2) were included in model development. One hundred forty-seven patients (38%) used 0 pills after hospital discharge, and the mean (SD) number of pills used was 7 (10) (median [IQR], 3 [0-10] pills). The model used 7 predictors: age, educational attainment, smoking history, anticipated pain medication use, anxiety regarding surgery, operative time, and preoperative pregabalin administration. The ordinal concordance was 0.65 (95% CI, 0.62-0.68) for predicting 5 or more pills (Brier score, 0.22), 0.65 (95% CI, 0.62-0.68) for predicting 10 or more pills (Brier score, 0.18), and 0.65 (95% CI, 0.62-0.68) for predicting 15 or more pills (Brier score, 0.14). Conclusions and Relevance: This model provides individualized estimates of outpatient opioid use following a range of gynecological surgical procedures for benign and malignant indications with all model inputs available at the time of procedure closing. Implementation of this model into the clinical setting is currently ongoing, with plans for additional validation in other surgical populations.

Quantifying the Added Value of 2 Common Frailty Measures for Predicting Adverse Outcomes After Elective Hysterectomy.

IMPORTANCE: Although frailty is predictive of adverse outcomes in predominantly male general and orthopedic surgical populations, the utility of American College of Surgeons National Surgical Quality Improvement Program-based frailty measurement for hysterectomy is unclear. OBJECTIVES: The objective of this study was to measure the added contribution of the modified frailty index (mFI) and Risk Analysis Index (RAI) for predicting adverse outcomes after hysterectomy. STUDY DESIGN: A secondary analysis of the 2011 to 2014 American College of Surgeons National Surgical Quality Improvement database was conducted. Benign elective hysterectomy by any route was included. The primary outcome was readmission within 30 days of surgery. Secondary outcomes were major (Clavien-Dindo grade ≥3) and minor (grade 1-2) complications. The fraction of new prognostic information attributable to each frailty measure was estimated by the ratio of model likelihood-ratio χ 2 values compared with a baseline model, including American Society of Anesthesiologists classification, age, body mass index (BMI), smoking status, and surgical route. RESULTS: Among 70,649 cases, 3.0% (95% confidence interval [CI], 2.9-3.1) were readmitted within 30 days and 2.8% (95% CI, 2.7-2.9) and 5.2% (95% CI, 5.0-5.4) had major and minor complications, respectively. The RAI provided a greater fraction of new prognostic information than the mFI when predicting readmission (4.8 vs 2.7%) and major complications (4.8 vs 2.3%). Interaction analysis showed a stronger association of frailty and outcomes among individuals undergoing abdominal hysterectomy and with BMI of 40 of higher or less than 20. CONCLUSIONS: The RAI and mFI provided modest improvement in the ability to predict adverse outcomes, which limits its clinical utility. Surgeons may consider selective utilization among those individuals undergoing abdominal hysterectomy or with BMI of 40 of higher or less than 20.

Trends in Performance of Anti-Incontinence Treatment at the Time of Pelvic Organ Prolapse Repair From 2011 to 2019.

IMPORTANCE: There are no publications on national trends in performance of concomitant stress urinary incontinence (SUI) treatment with pelvic organ prolapse surgery over the past decade. OBJECTIVES: The objective of this study was to describe trends in the performance and type of concomitant SUI treatment from 2011 to 2019. STUDY DESIGN: Surgical procedures for pelvic organ prolapse and coding for prolapse repair were identified from the American College of Surgeons National Surgical Quality Improvement Program database. An autoregressive interrupted time series model estimated temporal trends in concomitant SUI treatment associated with 3 consequential events: U.S. Food and Drug Administration's (FDA) requirement for postmarketing studies from mesh manufacturers (January 2012), publication of the Outcomes following Vaginal Prolapse Repair and Midurethral Sling (OPUS) trial (June 2012), and the FDA's reclassification of vaginal mesh as a high-risk device (January 2016). RESULTS: There were 43,370 cases identified. The rate of concomitant SUI treatment decreased from 46.1% to 35.7% across the analysis period. No significant trend before postmarketing studies (-0.2%; 95% confidence interval [CI], -0.8 to 1.1) was observed. After postmarketing studies, there was a downward deflection of -2.0% per quarter (95% CI, -3.6 to -0.4). After OPUS, we observed a flattening of the trend to -0.2% (95% CI, -0.8 to 0.4) that persisted after FDA reclassification. Sling procedures remained predominant (96.2% of SUI procedures) and performance of urethropexy decreased across the analysis period (-0.1%; 95% CI, -0.08 to -0.2). CONCLUSIONS: After the FDA's order for postmarketing studies, rates of concomitant SUI treatment significantly decreased. Rates stabilized after the OPUS trial at around 35% and did not subsequently change. Rates of nonmesh concomitant SUI treatment decreased during the analysis period.

Changes in Performance of Apical Suspension at the Time of Surgery for Prolapse: Assessment of the Influence of the American Urogynecologic Society and American College of Obstetricians and Gynecologists Practice Bulletin.

OBJECTIVES: To assess the association of publication of the American Urogynecologic Society (AUGS)/American College of Obstetricians and Gynecologists (ACOG) Practice Bulletin on pelvic organ prolapse and performance of an apical suspension at the time of surgery for pelvic organ prolapse. METHODS: Surgical procedures performed with a primary diagnosis of uterovaginal or female genital prolapse, cystocele, or enterocele were isolated from the 2011 to 2019 American College of Surgeons National Surgical Quality Improvement Program Database. An autoregressive interrupted time series regression estimated the overall temporal trend in performance of an apical suspension and assessed for a change in trend associated with publication of the AUGS/ACOG Practice Bulletin in April 2017. A stratified analysis was also performed depending on performance of a concomitant hysterectomy, and sensitivity analysis was performed using only diagnoses of uterovaginal or vaginal vault prolapse. RESULTS: There were 72,194 individuals identified; 83.4% had a diagnosis of uterovaginal or female genital prolapse, 15.2% cystocele and 1.4% enterocele. Only 36.6% of cases had an apical suspension. Prior to the practice bulletin publication, performance of an apical suspension grew at 0.19% per quarter (95% confidence interval [CI], 0.07-0.31), with a trend toward increased utilization (+0.12%; 95% CI, -0.06 to 0.30) after publication. The increase was greater among cases with a concomitant hysterectomy (+0.35%; 95% CI, 0.08-0.62). Sensitivity analyses found similar changes in trend. CONCLUSIONS: Performance of apical suspensions during surgery for prolapse remains low and is increasing at less than 1% per year. The AUGS/ACOG practice guidelines were associated with minimal changes in this pattern. Incentives or other strategies may be needed to further encourage standard of care management of prolapse.

Subgroups of failure after surgery for pelvic organ prolapse and associations with quality of life outcomes: a longitudinal cluster analysis.

BACKGROUND: Treatment outcomes after pelvic organ prolapse surgery are often presented as dichotomous "success or failure" based on anatomic and symptom criteria. However, clinical experience suggests that some women with outcome "failures" are asymptomatic and perceive their surgery to be successful and that other women have anatomic resolution but continue to report symptoms. Characterizing failure types could be a useful step to clarify definitions of success, understand mechanisms of failure, and identify individuals who may benefit from specific therapies. OBJECTIVE: This study aimed to identify clusters of women with similar failure patterns over time and assess associations among clusters and the Pelvic Organ Prolapse Distress Inventory, Short-Form Six-Dimension health index, Patient Global Impression of Improvement, patient satisfaction item questionnaire, and quality-adjusted life-year. STUDY DESIGN: Outcomes were evaluated for up to 5 years in a cohort of participants (N=709) with stage ≥2 pelvic organ prolapse who underwent surgical pelvic organ prolapse repair and had sufficient follow-up in 1 of 4 multicenter surgical trials conducted by the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Surgical success was defined as a composite measure requiring anatomic success (Pelvic Organ Prolapse Quantification system points Ba, Bp, and C of ≤0), subjective success (absence of bothersome vaginal bulge symptoms), and absence of retreatment for pelvic organ prolapse. Participants who experienced surgical failure and attended ≥4 visits from baseline to 60 months after surgery were longitudinally clustered, accounting for similar trajectories in Ba, Bp, and C and degree of vaginal bulge bother; moreover, missing data were imputed. Participants with surgical success were grouped into a separate cluster. RESULTS: Surgical failure was reported in 276 of 709 women (39%) included in the analysis. Failures clustered into the following 4 mutually exclusive subgroups: (1) asymptomatic intermittent anterior wall failures, (2) symptomatic intermittent anterior wall failures, (3) asymptomatic intermittent anterior and posterior wall failures, and (4) symptomatic all-compartment failures. Each cluster had different bulge symptoms, anatomy, and retreatment associations with quality of life outcomes. Asymptomatic intermittent anterior wall failures (n=150) were similar to surgical successes with Ba values that averaged around -1 cm but fluctuated between anatomic success (Ba≤0) and failure (Ba>0) over time. Symptomatic intermittent anterior wall failures (n=82) were anatomically similar to asymptomatic intermittent anterior failures, but women in this cluster persistently reported bothersome bulge symptoms and the lowest quality of life, Short-Form Six-Dimension health index scores, and perceived success. Women with asymptomatic intermittent anterior and posterior wall failures (n=28) had the most severe preoperative pelvic organ prolapse but the lowest symptomatic failure rate and retreatment rate. Participants with symptomatic all-compartment failures (n=16) had symptomatic and anatomic failure early after surgery and the highest retreatment of any cluster. CONCLUSION: In particular, the following 4 clusters of pelvic organ prolapse surgical failure were identified in participants up to 5 years after pelvic organ prolapse surgery: asymptomatic intermittent anterior wall failures, symptomatic intermittent anterior wall failures, asymptomatic intermittent anterior and posterior wall failures, and symptomatic all-compartment failures. These groups provide granularity about the nature of surgical failures after pelvic organ prolapse surgery. Future work is planned for predicting these distinct outcomes using patient characteristics that can be used for counseling women individually.

Design of a Randomized Controlled Trial of Percutaneous Posterior Tibial Nerve Stimulation for the Treatment of Refractory Fecal Incontinence in Women: The NeurOmodulaTion for Accidental Bowel Leakage Study.

OBJECTIVES: High-level evidence for second-line noninvasive treatments for fecal incontinence in women is limited. We present the rationale for and design of the NeuromOdulaTion for Accidental Bowel Leakage trial, a randomized controlled trial of percutaneous tibial nerve stimulation (PTNS) and validated sham stimulation in women with refractory accidental bowel leakage. METHODS: The rationale and goals for a 2-part study with a run-in phase, use of a generic pulse generator for PTNS and sham stimulation, masking, participant inclusion, primary and secondary outcome measures, and adverse event collection are described. A superiority design will be used to compare change from baseline in St. Mark's score after 12 weekly stimulation sessions between PTNS and sham. Responders to initial treatment (PTNS or sham) will be assigned to scheduled or "as needed" intervention for up to 1 year. Secondary outcome measures include incontinence episodes and other bowel events recorded in a 14-day electronic bowel diary, general and condition-specific quality of life instruments, adaptive behavior, global impression of improvement, symptom control, and sexual function. RESULTS: Sample size calculations determined that 165 participants (110 PTNS and 55 sham) would provide 90% power to detect greater than or equal to 4-point difference between PTNS and sham in change from baseline in St. Mark's score at 12 weeks. CONCLUSIONS: The methods for the NeuromOdulaTion for Accidental Bowel Leakage trial will provide high-level evidence of the effectiveness and optimal maintenance therapy schedule of a low-cost PTNS protocol in community-dwelling women seeking second-line intervention for refractory accidental bowel leakage.

Comparison of 100 U With 200 U of Intradetrusor OnabotulinumToxinA for Nonneurogenic Urgency Incontinence.

OBJECTIVES: The objective of this study was to compare efficacy and adverse events between 100 U and 200 U of onabotulinumtoxinA for 6 months in women with nonneurogenic urgency incontinence. METHODS: This is a secondary analysis of 2 multicenter randomized controlled trials assessing efficacy of onabotulinumtoxinA in women with nonneurogenic urgency incontinence; one compared 100 U to anticholinergics and the other 200 U to sacral neuromodulation. Of 307 women who received onabotulinumtoxinA injections, 118 received 100 U, and 189 received 200 U. The primary outcome was mean adjusted change in daily urgency incontinence episodes from baseline over 6 months, measured on monthly bladder diaries. Secondary outcomes included perceived improvement, quality of life, and adverse events. The primary outcome was assessed via a multivariate linear mixed model. RESULTS: Women receiving 200 U had a lower mean reduction in urgency incontinence episodes by 6 months compared with 100 U (-3.65 vs -4.28 episodes per day; mean difference, 0.63 episodes per day [95% confidence interval (CI), 0.05-1.20]). Women receiving 200 U had lower perceptions of improvement (adjusted odds ratio, 0.32 [95% CI, 0.14-0.75]) and smaller improvement in severity score (adjusted mean difference, 12.0 [95% CI, 5.63-18.37]). Upon subanalysis of only women who were treated with prior anticholinergic medications, these differences between onabotulinumtoxinA doses were no longer statistically significant. There was no statistically significant difference in adverse events in women receiving 200 U (catheterization, 32% vs 23%; adjusted odds ratio, 1.4 [95% CI, 0.8-2.4]; urinary tract infection, 37% vs 27%; adjusted odds ratio, 1.5 [95% CI, 0.9-2.6]). CONCLUSIONS: A higher dose of onabotulinumtoxinA may not directly result in improved outcomes, but rather baseline disease severity may be a more important prediction of outcomes.

Reliability of Symptoms and Dipstick for Postoperative Catheter-Associated Urinary Tract Infections.

OBJECTIVE: The aim of the study was to determine the diagnostic reliability of patient symptoms and urine dipstick results, including blood, leukocyte esterase, and nitrite, in diagnosing postoperative catheter-associated urinary tract infections (CAUTIs) after gynecologic surgery. METHODS: A prospective cohort study of patients undergoing gynecologic surgeries who required short-term (>24 hours) postoperative catheterization was conducted. Patients completed a questionnaire regarding symptoms. Urine dipstick analysis was completed on catheterized urine samples and urine was sent for culture for all patients. Positive likelihood ratios (LRs) were used to examine diagnostic reliability of patient symptoms and urine dipstick results in diagnosing postoperative CAUTIs. RESULTS: Fifty-seven patients with postoperative short-term indwelling catheterization were recruited, 25 (44%) of whom had CAUTIs diagnosed by urine culture at recruitment and 32 (56%) of whom did not have CAUTIs. Urine dipstick parameters were found to successfully diagnose CAUTIs, with positive LRs of 1.44 (95% confidence interval [CI], 1.04-1.99), 6.77 (95% CI, 2.23-20.52), and 9.47 (95% CI, 1.23-72.69) for blood, leukocyte esterase, and nitrite, respectively. The combination of leukocyte esterase and nitrite yielded a positive LR of 9.48 (95% CI, 2.62-34.25). Individual symptoms, alone or in combination, did not successfully diagnose positive urine culture (positive LRs <1.8). CONCLUSIONS: Urine dipstick parameters are reliable diagnostic tests for diagnosing postoperative CAUTIs after gynecologic surgery, particularly when in combination. Patient symptoms have little diagnostic value for positive urine cultures in catheterized patients after gynecologic surgery.

Success and failure are dynamic, recurrent event states after surgical treatment for pelvic organ prolapse.

BACKGROUND: The ideal measure of success after surgery for pelvic organ prolapse has long been debated. Historically, strict definitions based on anatomic perfection have dominated the literature. However, the importance of patient-centered perception of outcomes is equally or more important when comparing the success of various prolapse surgeries. Understanding the limitations of existing outcome definitions will guide surgical outcome reporting and comparisons of pelvic organ prolapse surgeries. OBJECTIVE: This study aimed to describe the relationships and overlap among the participants who met the anatomic, subjective, and retreatment definitions of success or failure after pelvic organ prolapse surgery; demonstrate rates of transition between success and failure over time; and compare scores from the Pelvic Organ Prolapse Distress Inventory, Short-Form Six-Dimension health index, and quality-adjusted life years among these definitions. STUDY DESIGN: Definitions of surgical success were evaluated at 3 or 6, 12, 24, 36, 48, and 60 months after surgery for ≥stage II pelvic organ prolapse in a cohort of women (N=1250) from 4 randomized clinical trials conducted by the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Surgical failure was defined by a composite measure requiring 1 or more of (1) anatomic failure (Pelvic Organ Prolapse Quantification point Ba, Bp, or C of >0), (2) subjective failure (presence of bothersome vaginal bulge symptoms), or (3) pessary or surgical retreatment for pelvic organ prolapse. Pelvic Organ Prolapse Distress Inventory, Short-Form Six-Dimension health index, and quality-adjusted life years were compared among participants who met a variety of definitions of success and failure including novel "intermittent" success and failure over time. RESULTS: Among the 433 of 1250 women (34.6%) who had surgical failure outcomes at ≥1 time point, 85.5% (370 of 433) met only 1 component of the composite outcome at the assessment of initial failure (anatomic failure, 46.7% [202 of 433]; subjective failure, 36.7% [159 of 433]; retreatment, 2.1% [9 of 433]). Only 12.9% (56 of 433) met the criteria for both for anatomic and subjective failure. Despite meeting the criteria for failure in primary study reporting, 24.2% of these (105 of 433) transitioned between success and failure during follow-up, of whom 83.8% (88 of 105) met the criteria for success at their last follow-up. There were associations between success or failure classification and the 1- and 2-year quality-adjusted life years and a time-varying group effect on Pelvic Organ Prolapse Distress Inventory and Short-Form Six-Dimension health index scores. CONCLUSION: True failure rates after prolapse surgery may be overestimated in the current literature. Only 13% of clinical trial subjects initially met both subjective and objective criteria for failure. Approximately one-quarter of failures were intermittent and transitioned between success and failure over time, with most intermittent failures being in a state of "surgical success" at their last follow-up. Current composite definitions of success or failure may result in the overestimation of surgical failure rates, potentially explaining, in part, the discordance with low retreatment rates after pelvic organ prolapse surgery.

Reference data on in vitro anatomy and indentation response of tissue layers of musculoskeletal extremities.

The skin, fat, and muscle of the musculoskeletal system provide essential support and protection to the human body. The interaction between individual layers and their composite structure dictate the body's response during mechanical loading of extremity surfaces. Quantifying such interactions may improve surgical outcomes by enhancing surgical simulations with lifelike tissue characteristics. Recently, a comprehensive tissue thickness and anthropometric database of in vivo extremities was acquired using a load sensing instrumented ultrasound to enhance the fidelity of advancing surgical simulations. However detailed anatomy of tissue layers of musculoskeletal extremities was not captured. This study aims to supplement that database with an enhanced dataset of in vitro specimens that includes ultrasound imaging supported by motion tracking of the ultrasound probe and two additional full field imaging modalities (magnetic resonance and computed tomography). The additional imaging datasets can be used in conjunction with the ultrasound/force data for more comprehensive modeling of soft tissue mechanics. Researchers can also use the image modalities in isolation if anatomy of legs and arms is needed.

Association between adjuvant posterior repair and success of native tissue apical suspension.

BACKGROUND: Posterior repairs and perineorrhaphies are often performed in prolapse surgery to reduce the size of the genital hiatus. The benefit of an adjuvant posterior repair at the time of sacrospinous ligament fixation or uterosacral ligament suspension is unknown. OBJECTIVE: We aimed to determine whether an adjuvant posterior repair at transvaginal apical suspension is associated with improved surgical success. MATERIALS AND METHODS: This secondary analysis of Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) trial compared 24-month outcomes in 190 participants who had a posterior repair (posterior repair group) and 184 who did not (no posterior repair group) at the time of sacrospinous ligament fixation or uterosacral ligament suspension. Concomitant posterior repair was performed at the surgeon's discretion. Primary composite outcome of "surgical success" was defined as no prolapse beyond the hymen, point C ≤ -2/3 total vaginal length, no bothersome bulge symptoms, and no retreatment at 24 months. The individual components were secondary outcomes. Propensity score methods were used to build models that balanced posterior repair group and the no posterior repair group for ethnographic factors and preoperative Pelvic Organ Prolapse Quantification values. Adjusted odds ratios were calculated to predict surgical success based on the performance of a posterior repair. Groups were also compared with unadjusted χ2 analyses. An unadjusted probability curve was created for surgical success as predicted by preoperative genital hiatus. RESULTS: Women in the posterior repair group were less likely to be Hispanic or Latina, and were more likely to have had a prior hysterectomy and to be on estrogen therapy. The groups did not differ with respect to preoperative Pelvic Organ Prolapse Quantification stage; however, subjects in the posterior repair group had significantly greater preoperative posterior wall prolapse. There were no group differences in surgical success using propensity score methods (66.7% posterior repair vs 62.0% no posterior repair; adjusted odds ratio, 1.07; 95% confidence interval, 0.56-2.07; P = 0.83) or unadjusted test (66.2% posterior repair vs 61.7% no posterior repair; P = 0.47). Individual outcome measures of prolapse recurrence (bothersome bulge symptoms, prolapse beyond the hymen, or retreatment for prolapse) also did not differ by group. Similarly, there were no differences between groups in anatomic outcomes of any individual compartment (anterior, apical, or posterior) at 24 months. There was high variation in performance of posterior repair by surgeon (interquartile range, 15-79%). The unadjusted probability of overall success at 24 months, regardless of posterior repair, decreased with increasing genital hiatus, such that a genital hiatus of 4.5 cm was associated with 65.8% success (95% confidence interval, 60.1-71.1%). CONCLUSION: Concomitant posterior repair at sacrospinous ligament fixation or uterosacral ligament suspension was not associated with surgical success after adjusting for baseline covariates using propensity scores or unadjusted comparison. Posterior repair may not compensate for the pathophysiology that leads to enlarged preoperative genital hiatus, which remains prognostic of prolapse recurrence.

Recruitment and retention: A randomized controlled trial of video-enhanced versus standard consent processes within the E-OPTIMAL study.

BACKGROUND/AIMS: In this study, we compared two research consent techniques: a standardized video plus usual consent and usual consent alone. METHODS: Individuals who completed 24-month outcomes (completers) in the Operations and Pelvic Muscle Training in the Management of Apical Support Loss study were invited to participate in an extended, longitudinal follow-up study (extended Operations and Pelvic Muscle Training in the Management of Apical Support Loss). Potential participants who were (1) able to provide consent and (2) not in long-term care facilities were randomized 1:1 to a standardized video detailing the importance of long-term follow-up studies of pelvic floor disorders followed by the usual institutional consent process versus the usual consent process alone. Randomization, stratified by site, used randomly permuted blocks. The primary outcome was the proportion of participants who enrolled in the extended study and completed data collection events 5 years after surgery. Secondary outcomes included the proportion enrolled in the extended study, completion of follow-up at each study year, completion of data collection points, completion of in-person visits, and completion of quality of life calls. Motivation and barriers to enrollment (study-level and personal-level) and satisfaction with the study consent process were measured by questionnaire prior to recruitment into extended Operations and Pelvic Muscle Training in the Management of Apical Support Loss. Groups were compared using an intention-to-treat principle, using unadjusted Student's t-test (continuous) and chi-square or Fisher's exact (categorical) test. A sample size of 340 (170/group) was estimated to detect a 15% difference in enrollment and study completion between groups with p < 0.05. RESULTS: Of the 327 Operations and Pelvic Muscle Training in the Management of Apical Support Loss completers, 305 were randomized to the consent process study (153 video vs 152 no video). Groups were similar in demographics, surgical treatment, and outcomes. The overall rate of extended study enrollment was high, without significant differences between groups (video 92.8% vs no video 94.1%, p = 0.65). There were no significant differences in the primary outcome (video 79.1% vs no video 75.7%, p = 0.47) or in any secondary outcomes. Being "very satisfied" overall with study information (97.7% vs 88.5%, p = 0.01); "strong agreement" for feeling informed about the study (81.3% vs 70.8%, p = 0.06), understanding the study purpose (83.6% vs 71.0%, p = 0.02), nature and extent (82.8% vs 70.2%, p = 0.02), and potential societal benefits (82.8% vs 67.9%, p = 0.01); and research coordinator/study nurse relationship being "very important" (72.7% vs 63.4%, p = 0.03) were better in the video compared to the no video consent group. CONCLUSION: The extended study had high enrollment; most participants completed most study tasks during the 3-year observational extension, regardless of the use of video to augment research consent. The video was associated with a higher proportion of participants reporting improved study understanding and relationship with study personnel.

Validation of a Model Predicting De Novo Stress Urinary Incontinence in Women Undergoing Pelvic Organ Prolapse Surgery.

OBJECTIVE: To validate a previously developed prediction model for de novo stress urinary incontinence (SUI) after undergoing vaginal surgery for pelvic organ prolapse (POP). METHODS: Model performance was determined using a cohort of women who participated in two, 14-center randomized trials in the Netherlands that evaluated whether postoperative SUI 1 year after surgery was reduced with or without concomitant midurethral sling at the time of surgery for symptomatic women who had at least stage 2 POP. Age, number of previous vaginal births, urine leakage associated with urgency, history of diabetes, body mass index, preoperative stress test result, and placement of a midurethral sling were used to calculate the predicted probability of an individual developing de novo SUI. Predicted probabilities were compared with outcomes and quantitated using the concordance index and calibration curves. Model accuracy was compared with and without the preoperative stress test, and net reclassification improvement was measured using probability cutoffs of 0.2, 0.3, and 0.4. RESULTS: Of 239 participants who did not report preoperative SUI and underwent surgery, 152 were eligible for analysis with complete baseline and outcome data. Model discrimination was acceptable and consistent with performance in the original development cohort when the preoperative stress test result was included (concordance index 0.63; 95% CI 0.52-0.74) and had lower discrimination than when the stress test variable was not included (concordance index 0.57; 95% CI 0.46-0.67, P=.048). The model that included the stress test variable was most accurate when predicted probabilities of de novo SUI were between 0 and 50%, and it correctly reclassified upward 5.9% (95% CI -14.8 to 26.8) of participants with de novo SUI and correctly reclassified downward 16.9% (95% CI 6.6-27.7) of participants without de novo SUI. CONCLUSION: On external validation, the model was predictive of de novo SUI after vaginal prolapse surgery and may facilitate decision making regarding concomitant sling placement. CLINICAL TRIAL REGISTRATION: Nederlands Trial Register, NTRR 1197 en 1070.

Gaining the patient perspective on pelvic floor disorders' surgical adverse events.

BACKGROUND: The Institute for Healthcare Improvement defines an adverse event as an unintended physical injury resulting from or contributed to by medical care that requires additional monitoring, treatment, or hospitalization or that results in death. The majority of research has focused on adverse events from the provider's perspective. OBJECTIVE: The objective of this qualitative study was to describe patient perceptions on adverse events following surgery for pelvic floor disorders. STUDY DESIGN: Women representing the following 3 separate surgical populations participated in focus groups: (1) preoperative (women <12 weeks prior to surgery); (2) short-term postoperative (women up to 12 weeks after surgery); and (3) long-term postoperative (women 1-5 years after surgery). Deidentified transcripts of audio recordings were coded and analyzed with NVivo 10 software to identify themes, concepts, and adverse events. Women were asked to rank patient-identified and surgeon-identified adverse events in order of perceived severity. RESULTS: Eighty-one women participated in 12 focus groups. Group demographics were similar between groups, and all groups shared similar perspectives regarding surgical expectations. Women commonly reported an unclear understanding of their surgery and categorized adverse events such as incontinence, constipation, nocturia, and lack of improvement in sexual function as very severe, ranking these comparably with intensive care unit admissions or other major surgical complications. Women also expressed a sense of personal failure and shame if symptoms recurred. CONCLUSION: Women consider functional outcomes such as incontinence, sexual dysfunction, and recurrence of symptoms as severe adverse events and rate them as similar in severity to intensive care unit admissions and death.

The impact of surgeon volume on perioperative adverse events in women undergoing minimally invasive hysterectomy for the large uterus.

BACKGROUND: There are currently sparse data on the relationship between surgeon- and patient-related factors and perioperative morbidity in the setting of elective hysterectomy for the larger uterus. OBJECTIVE: We sought to evaluate the impact of surgeon case volume on perioperative adverse events in women undergoing minimally invasive hysterectomy for uteri >250 g. STUDY DESIGN: This is a retrospective cohort study of all women who underwent total vaginal, total laparoscopic, laparoscopic-assisted vaginal, or robotic-assisted total laparoscopic hysterectomy from January 2014 through July 2016. Hysterectomy was performed for: fibroids, pelvic pain, abnormal uterine bleeding, or prolapse. Patients were identified by Current Procedural Terminology codes and the systemwide electronic medical record was queried for demographic and perioperative data. Perioperative adverse events were defined a priori and classified using the Clavien-Dindo scale. Surgeon case volume was defined as the mean number of minimally invasive hysterectomy cases performed per month by each surgeon during the study period. RESULTS: In all, 763 patients met inclusion criteria: 416 (54.5%) total laparoscopic hysterectomy, 196 (25.7%) robotic-assisted total laparoscopic hysterectomy, 90 (11.8%) total vaginal hysterectomy, and 61 (8%) laparoscopic-assisted vaginal hysterectomy. Mean (±SD) age was 47.3 ± 6.1 years, and body mass index was 31.1 ± 7.4 kg/m2. In all, 66 surgeons performed minimally invasive hysterectomy for uteri >250 g during the study period, and the median rate of minimally invasive hysterectomy cases for large uteri per month was 3.4 (0.4-3.7) cases/month. The median (IQR) uterine weight was 409 (308-606.5) g. The rate of postoperative adverse events Dindo grade >2 was 17.8% (95% confidence interval, 15.2-20.7). The overall rate of intraoperative adverse events was 4.2% (95% confidence interval, 2.9-5.9). The rate of conversion to laparotomy was 5.5% (95% confidence interval, 4.0-7.4). There was no significant difference in adverse event rates between the routes of minimally invasive hysterectomy cases (25.6% vs 17.5% vs 18.0% vs 14.8% for total laparoscopic hysterectomy, robotic-assisted laparoscopic hysterectomy, total vaginal hysterectomy, and laparoscopic-assisted vaginal hysterectomy, respectively, P = .2). In a logistic regression model controlling for age, body mass index, uterine weight, operating time, and history of laparotomy, higher monthly minimally invasive hysterectomy volume was significantly associated with the likelihood that a patient would experience a postoperative adverse event (adjusted odds ratio, 1.1 for each additional minimally invasive hysterectomy case for large uteri per month; 95% confidence interval, 1.0-1.3). When controlling for the same variables, a higher incidence of intraoperative complications was significantly associated with monthly minimally invasive hysterectomy case volume (adjusted odds ratio, 1.5 for each additional minimally invasive hysterectomy case for large uteri per month; 95% confidence interval, 1.20-2.08). Increasing age was associated with a lower incidence of complications (adjusted odds ratio, 0.9 for each additional year; 95% confidence interval, 0.8-0.9). Higher monthly minimally invasive hysterectomy volume was associated with a lower rate of conversion from a minimally invasive approach to laparotomy (adjusted odds ratio, 0.4 for each additional minimally invasive hysterectomy case for large uteri per month; 95% confidence interval, 0.2-0.5). CONCLUSION: The overall rate of serious adverse events associated with minimally invasive hysterectomy for uteri >250 g was low. Higher monthly minimally invasive hysterectomy case volume was associated with a higher rate of intraoperative and postoperative adverse events but was associated with a lower rate of conversion to laparotomy.