A randomized trial of retropubic vs single-incision sling among patients undergoing vaginal prolapse repair.

BACKGROUND: The choice of midurethral sling type may impact efficacy and complications in women undergoing transvaginal native tissue repair of pelvic organ prolapse. OBJECTIVE: The primary aim was to determine if the single-incision sling is noninferior to retropubic sling for the management of stress urinary incontinence among patients undergoing reconstructive or obliterative native tissue vaginal repair. The secondary aims were to compare adverse events and surgeon ease of use with sling assignment. STUDY DESIGN: A multicenter, noninferiority, randomized trial of women with ≥ stage II pelvic organ prolapse and objectively confirmed stress urinary incontinence undergoing reconstructive or obliterative vaginal repair was performed. Women were randomized to concomitant single-incision (Altis sling, Coloplast Minneapolis, MN) with suprapubic sham incisions or retropubic slings. The primary dichotomous outcome was abnormal lower urinary tract function within 12 months postsurgery, defined as bothersome stress urinary incontinence symptoms (>1 Pelvic Floor Distress Inventory question no. 17); retreatment for stress urinary incontinence or treatment for urinary retention. Secondary outcomes were adverse events, Patient Global Impression of Improvement of bladder function, and surgeon ease of use (1, worst; 10, best). All subjects completed validated questionnaires and underwent a Pelvic Organ Prolapse Quantification, cough stress test, and postvoid residual preoperatively, at 6 weeks and 12 months postoperatively. Assuming a subjective cure rate for retropubic of 82%, 80% power, and 1-sided 5% significance level, we estimated that 127 patients in each arm were needed to declare noninferiority of the single-incision sling if the upper bound of the 95% confidence interval for the between-group difference per protocol in abnormal bladder function was <12%. Assuming a 10% loss to follow-up, the total enrollment goal was 280. RESULTS: Between December 2018 and January 2023, 280 subjects were enrolled across 7 sites, and 255 were randomized: 126 were for single-incision, and 129 were for retropubic sling. There were no preoperative or operative characteristic differences between groups. Overall, 81% had reconstructive, and 19% had obliterative native tissue repairs. The primary outcome, abnormal lower urinary tract function at 12 months, occurred in 29 (25%) of single-incision vs 24 (20%) of the retropubic sling group (risk difference, 0.04472 [95% confidence interval, -0.03 to 0.1133]; P=.001 for noninferiority). Bothersome stress urinary incontinence occurred in 20% vs 17% (P=.27) and was retreated in 4% vs 2% (P=.44) of single-incision vs retropubic groups, respectively. Adverse events were reported in 24 (16%) of single-incision vs 14 (9%) of the retropubic group (95% confidence interval, 0.95-3.29; P=.70) and included de novo or worsening urgency incontinence symptoms, urinary tract infection, mesh exposure, need for prolonged catheter drainage, and de novo pain, without differences between groups. Patient Global Impression of Improvement (very satisfied and satisfied) was 71% vs 67% (P=.43), and median surgeon ease of sling use was 8 (7-10) vs 9 (8-10), P=.03 in single-incision vs retropubic, respectively. CONCLUSION: For women undergoing vaginal repair, single-incision was noninferior to retropubic sling for stress urinary incontinence symptoms, and complications, including treatment for urinary retention, did not differ.

Comprehensive pelvic muscle assessment: Developing and testing a dual e-Learning and simulation-based training program.

OBJECTIVE: The Prevention of Lower Urinary Tract Symptoms (PLUS) research consortium launched the RISE FOR HEALTH (RISE) national study of women's bladder health which includes annual surveys and an in-person visit. For the in-person exam, a standardized, replicable approach to conducting a pelvic muscle (PM) assessment was necessary. The process used to develop the training, the products, and group testing results from the education and training are described. METHODS: A comprehensive pelvic muscle assessment (CPMA) program was informed by literature view and expert opinion. Training materials were prepared for use on an electronicLearning (e-Learning) platform. An in-person hands-on simulation and certification session was then designed. It included a performance checklist assessment for use by Clinical Trainers, who in collaboration with a gynecology teaching assistant, provided an audit and feedback process to determine Trainee competency. RESULTS: Five discrete components for CPMA training were developed as e-Learning modules. These were: (1) overview of all the clinical measures and PM anatomy and examination assessments, (2) visual assessment for pronounced pelvic organ prolapse, (3) palpatory assessment of the pubovisceral muscle to estimate muscle integrity, (4) digital vaginal assessment to estimate strength, duration, symmetry during PM contraction, and (5) pressure palpation of both myofascial structures and PMs to assess for self-report of pain. Seventeen Trainees completed the full CPMA training, all successfully meeting the a priori certification required pass rate of 85% on checklist assessment. CONCLUSIONS: The RISE CPMA training program was successfully conducted to assure standardization of the PM assessment across the PLUS multicenter research sites. This approach can be used by researchers and healthcare professionals who desire a standardized approach to assess competency when performing this CPMA in the clinical or research setting.

Healthy bladder storage and emptying functions in community-dwelling women measured by a 2-day bladder health diary.

INTRODUCTION: The prevalence of healthy bladder storage and emptying function in community-dwelling women is not well established. METHODS: A planned secondary analysis of a US cross-sectional study designed to validate a bladder health instrument was conducted in women aged ≥18 years. A subset was invited to complete the novel 2-day bladder health diary capturing bladder storage and emptying experiences. Overall healthy bladder function was defined as ≤8 waking/daytime voids and ≤1 void during sleeping/nighttime; along with the absence of leakage, urgency, emptying difficulties (initiation, flow, efficacy, relief of urge sensation) and pain. Descriptive statistics of healthy bladder functions and regression models of factors associated with healthy function are reported. RESULTS: Of the 383 invited, 237 (62%) eligible women returned complete dairies. Of these, 12% (29/237) met criteria for overall healthy bladder function. Most (96%) denied pain, 74% had healthy daytime and 83% had healthy nighttime voiding frequency, 64% were continent, 36% reported healthy emptying and 30% denied any urgency episodes. Middle income (odds ratio [OR]:95% confidence interval [CI] = 11.4:1.9-67.4 for $75k-$99 999 vs. $25 000-$49 999), Graduate education (4.8:1.4-17) and previously seeking treatment for bladder problems (OR:95%CI = 0.1; 0-0.9) were associated with overall healthy function. CONCLUSION: The prevalence of overall healthy bladder function was very low based on our strict definition of health as measured on a 2-day diary. However, most women had healthy voiding frequency and denied pain or urinary leakage. Postvoid dribbling and urgency most commonly contributed to an overall unhealthy bladder. Further investigation is needed to determine whether these diary derived measures are meaningful for patient-oriented bladder health research.

Development and validation of models predicting treatment patterns in women with urinary urgency and/or urgency incontinence: A Symptoms of Lower Urinary Tract Dysfunction Research Network observational cohort study.

PURPOSE: To develop a tool to predict a woman's treatment pattern for bothersome urinary urgency (UU) and/or UU incontinence over 1 year after presenting for care at urology or urogynecology clinics. METHODS: The Symptoms of Lower Urinary Tract Dysfunction Research Network observational cohort study enrolled adult women with bothersome UU and/or UU incontinence using the lower urinary tract symptoms (LUTS) Tool who were seeking care for LUTS. Treatments for UU and/or urgency incontinence were ordered from least to most invasive. Ordinal logistic and Cox proportional hazard regression models were fit to predict the most invasive level of treatment during follow-up and overactive bladder (OAB) medication discontinuation, respectively. Binary logistic regression was performed to predict sling treatment during the study follow-up. Clinical tools were then created using the models listed above to predict treatment pattern over 12 months. RESULTS: Among 349 women, 281 reported UU incontinence, and 68 reported UU at baseline. The highest level of treatment during the study was as follows: 20% no treatment, 24% behavioral treatments, 23% physical therapy, 26% OAB medication, 1% percutaneous tibial nerve stimulation, 3% onabotulinumtoxin A, and 3% sacral neuromodulation. Slings were placed in 10% (n = 36) of participants before baseline and in 11% (n = 40) during study follow-up. Baseline factors associated with predicting the most invasive level of treatment included baseline level of treatment, hypertension, UU incontinence severity, stress urinary incontinence (SUI) severity, and anticholinergic burden score. Less severe baseline depression and less severe UU incontinence were associated with OAB medication discontinuation. UU and SUI severity were associated with sling placement during the study period. Three tools are available to predict: (1) highest level of treatment; (2) OAB medication discontinuation; and (3) sling placement. CONCLUSIONS: OAB treatment prediction tools developed in this study can help providers individualize treatment plans and identify not only patients at risk for treatment discontinuation but also patients who may not be escalated to potentially beneficial OAB treatments, with the goal to improve clinical outcomes for patients suffering from this chronic and often debilitating condition.

Surgical versus nonsurgical treatment selection patterns among Asian American patients with pelvic floor disorders: a matched cohort study.

INTRODUCTION AND HYPOTHESIS: The objective was to determine if Asian racial identity was associated with the selection of surgical versus nonsurgical treatments for pelvic floor disorders (PFDs). Secondarily, we aimed to determine if there were other demographic or clinical characteristics associated with treatment selection patterns. METHODS: This was a retrospective matched cohort study that examined new patient visits (NPVs) of Asian patients at an academic urogynecology practice in Chicago, IL, USA. We included NPVs with primary diagnoses of anal incontinence, mixed urinary incontinence, stress urinary incontinence, overactive bladder, or pelvic organ prolapse. We identified Asian patients with self-identified racial identity recorded in the electronic medical records. Every Asian patient was age matched to white patients in a 1:3 ratio. The primary outcome was surgical versus nonsurgical treatment selection for their primary PFD diagnosis. Comparison of demographic and clinical variables between the two groups and multivariate logistic regression models were performed. RESULTS: A total of 53 Asian patients and 159 white patients were included in this analysis. Asian patients were less likely to be English speaking (92% vs 100%, p=0.004), endorse history of anxiety (17% vs 43%, p<0.001), and report history of any pelvic surgery (15% vs 34%, p=0.009) than white patients. When controlling for race, age, history of anxiety, depression, prior pelvic surgery, sexual activity, Pelvic Organ Prolapse Distress Inventory, Colorectal-Anal Distress Inventory, and Urinary Distress Inventory scores, Asian racial identity (adjusted odds ratio 0.36 [95% CI 0.14-0.85]) was independently associated with decreased likelihood of choosing surgical treatments for PFDs. CONCLUSIONS: Asian patients with PFDs were less likely than white patients to undergo surgical treatment for their PFDs despite similar demographic and clinical characteristics.

Comparing clinical bladder diaries and recalled patient reports for measuring lower urinary tract symptoms in the symptoms of Lower Urinary Tract Dysfunction Research Network (LURN).

PURPOSE: Bladder diaries are a key source of information about lower urinary tract symptoms (LUTS); however, many patients do not complete them as instructed. Questionnaire-based patient-reported outcome measures (PROMs) are another option for reporting LUTS but may have recall bias. We assessed the strength of the associations between PROMs and a 3-day bladder diary. MATERIALS AND METHODS: Symptomatic adults from 6 tertiary care sites completed a 3-day paper bladder diary and 3-, 7-, and 30-day electronic PROMs. We assessed the linear associations between mapped pairs of diary variables and responses to PROM items using biserial and polyserial correlation coefficients with 95% confidence intervals. RESULTS: Of 290 enrolled participants, 175 (60%) completed the bladder diary as instructed and at least one corresponding PROM. Linear associations were strongest between the diary and 3-day recall of daytime frequency (r = 0.75) and nighttime frequency (r = 0.69), followed by voids with urgency sensations (r = 0.62), and an item reporting any incontinence (r = 0.56). Linear associations between bladder diary and specific incontinence variables (e.g., stress, urgency) were low to negligible (ranging from r = 0.16-0.39). Linear associations were consistent across the 3-, 7-, and 30-day recall periods. CONCLUSIONS: Missing and unusable bladder diary data were common, highlighting the patient burden associated with this method of data collection. A questionnaire-based PROM is a reasonable alternative to a diary for reporting voiding frequency and may offer an easier option for reporting some symptoms.

Neuromuscular urethral function and urethral urodynamic parameters between urgency and stress incontinence do not differ.

INTRODUCTION AND HYPOTHESIS: To describe and compare urethral neuromuscular function using concentric needle electromyography (CNEMG) and urodynamic (UDS) parameters between stress incontinent (SUI) and urge incontinent (UUI) women. METHODS: Incontinent women were recruited from a urogynecology clinic if they answered "sometimes" or "always" to one of the items on the Medical, Epidemiologic, and Social Aspects of Aging questionnaire. Participants were categorized by MESA scores into stress (SUI) or urgency (UUI) incontinence groups. Participants underwent CNEMG of the striated urethral sphincter at three insertion sites using Medtronic multiple motor unit action potential analysis. UDS was performed with Laborie microtip catheters: urethral pressure profiles were obtained at baseline and 300 ml. Data were analyzed in SPSS. Continuous variables were compared with independent t-test or Mann-Whitney U, categorical variables with chi-square test. A logistic regression was performed to control for variables found to be significant on univariate analysis. RESULTS: Fifty-six women (37 SUI, 19 UUI) with mean ± SD age of 53 ± 13 years participated. At baseline, patients with SUI were younger, more likely to be premenopausal and had lower BMIs. There were no differences in urethral EMG or UDS parameters between UUI and SUI women except lower maximum cystometric capacity in women with UUI. When controlling for age, BMI and MCC on logistic regression, there remained no differences between SUI and UUI groups on EMG or UDS parameters. CONCLUSIONS: Women with UUI and DO show similar evidence of denervation-reinnervation injury to the striated urethral sphincter muscle as women with SUI.

Mesh complications after total vs supracervical laparoscopic hysterectomy at time of minimally invasive sacrocolpopexy.

INTRODUCTION AND HYPOTHESIS: Our objective was to compare mesh exposure rates (4 months and 1 year) after total (TLH) vs supracervical (SLH) laparoscopic hysterectomy at time of minimally invasive sacrocolpopexy (SCP). Secondary outcomes included 30-day complications and midurethral mesh exposure rates. METHODS: This a retrospective cohort study at a tertiary care referral center from 2011 to 2018. Subjects were identified using Current Procedural Terminology codes. Demographics, operative characteristics, and perioperative complications were abstracted from medical records. RESULTS: Four hundred three women met the inclusion criteria: 91 SLH+SCP and 312 TLH+SCP. Median follow-up was 52 weeks with an overall mesh exposure rate of 1.5%. Follow-up was available for 90% of patients at 4 months and 51% at 1 year. Half of patients had lightweight mesh (n = 203), and half had ultralightweight mesh (n = 200). Vaginal mesh fixation was performed with permanent suture in 86% (n = 344) and delayed absorbable suture in 14% (n = 56) of patients. At 4 months, vaginal mesh exposure rates did not differ between groups (0% SLH vs 1% TLH, p = 1.00). All mesh exposures in the study period occurred with lightweight mesh in the TLH arm. No differences were noted in 1-year mesh exposure rates, 30-day perioperative complications (p = 0.57), or midurethral mesh exposure rates at 4 months (p = 0.35) and 1 year (p = 1.00) between groups. CONCLUSIONS: Short-term mesh exposure following SCP with ultralightweight and lightweight polypropylene mesh is rare regardless of type of hysterectomy and much lower than reported in earlier studies with heavier weight mesh. These data suggest TLH at the time of SCP is a safe option in appropriately counseled patients.

The Leadership Landscape: The Role of Gender in Current Leadership Positions in Obstetrics and Gynecology Departments.

STUDY OBJECTIVE: To describe the proportion of female faculty in departmental administrative and educational leadership roles in Obstetrics and Gynecology departments. DESIGN: Cross-sectional observational study (II-3). SETTING: Accredited Obstetrics and Gynecology residency programs. PARTICIPANTS: A total of 288 accredited residency programs were identified from 2019 to 2020 with 1237 individuals in leadership positions. INTERVENTIONS: Similar to a 2012 to 2013 survey by Hofler et al, residency program websites and corresponding fellowships (Maternal Fetal Medicine, Female Pelvic Medicine and Reconstructive Surgery, Reproductive Endocrinology and Infertility, and Gynecologic Oncology), departmental websites, and divisional websites were queried for those in administrative and educational leadership positions. Information regarding gender (as determined by the surrogates of name and photographic gender expression), medical and academic degrees, academic rank, and subspecialty certification was abstracted. MEASUREMENTS AND MAIN RESULTS: Within administrative leadership roles, women comprised 29% of chairs, 46% of vice chairs, and 47% of division directors, all significantly lower than men in administrative leadership (p <.001). In educational leadership, women made up 71% of medical school clerkship directors, 58% of residency directors, and 50% fellowship directors. Women were more likely to hold educational leadership positions (56% vs 40%; p <.001), although men were more likely to hold administrative leadership positions (68% vs 52%; p <.001). Among subspecialties, there was greatest gender equity within Female Pelvic Medicine and Reconstructive Surgery. Female leaders were more likely to have received additional academic degrees (e.g. MBA, MPH) than their male counterparts (19% vs 13%; p = .002). CONCLUSION: Women continue to be underrepresented in administrative leadership positions. Compared with 2012 to 2013, there is only a 9% increase in proportion of women chairing and 10% vice chairing Obstetrics and Gynecology departments; however, the increase is more substantial in other positions, such as division directors (17%). Our findings demonstrate ongoing gender disparity in the highest levels of departmental leadership and the need to further improve on diversity and gender equity within leadership roles.

Is there an Association between Vaginal Birth after Cesarean Prediction and Obstetric Anal Sphincter Injury?

OBJECTIVE: This study aimed to estimate whether there is an association between the predicted probability of vaginal birth after cesarean delivery (VBAC) and the occurrence of obstetric anal sphincter injuries (OASIS). STUDY DESIGN: This was a single-site retrospective cohort study of all women with a singleton vaginal birth after a previous cesarean section between January 2011 and December 2016. Women were divided into four ordinal groupings by the predicted probability of achieving vaginal birth after cesarean using the Maternal-Fetal Medicine Units Network VBAC calculator (less than 41%, 40.1-60%, 60.1-80%, and greater than 80%). The primary outcome was OASIS, defined as a 3rd or 4th degree perineal laceration. Bivariable and multivariable analyses were used to examine the association between predicted VBAC probability and OASIS. RESULTS: In total, 1,411 women met inclusion criteria and 73 (5.2%) sustained OASIS. The median predicted probability of VBAC was lower in women with OASIS compared with those without OASIS (60% [interquartile range {IQR}: 48-70%] vs. 66% (IQR: 52-80%), p = 0.02]. On bivariable and multivariable logistic regression, predicted probability of VBAC was associated with increased odds of OASIS (less than 41% probability: adjusted odds ratio [aOR]: 3.18, 95% confidence interval [CI]: 0.90-11.21; 41-60% probability: aOR: 3.76, 95% CI: 1.34-10.57; 61-80% probability aOR: 3.47, 95% CI: 1.25-9.69) relative to women with a predicted probability of VBAC of greater than 80%. CONCLUSION: Having a lower predicted probability of VBAC is associated with an increased risk of OASIS at the time of a VBAC relative to those with greater than 80% predicted probability. Incorporation of this aspect of maternal morbidity may inform risk-stratification at the time of trial of labor after cesarean, as well as the choice of performing an operative vaginal delivery. KEY POINTS: · Predicted probability of VBAC is associated with OASIS.. · Low predicted probability of VBAC is associated with increased odds of OASIS.. · Forceps delivery was associated with the highest odds of OASIS..

Ultrasound-Measured Urethral Length Does Not Change following Minimally Invasive Sacrocolpopexy for Pelvic Organ Prolapse.

OBJECTIVES: To compare urethral length (UL), as measured by three-dimenstional transvaginal ultrasound, before and after minimally invasive sacrocolpopexy (SCP). METHODS: Secondary analysis of a prospective cohort study of women undergoing SCP for prolapse beyond the hymen with or without a concomitant anti-incontinence procedure. Participants underwent ultrasound at baseline and 14 weeks postoperatively. UL was measured in a reconstructed sagittal plane from the bladder neck to the urethral meatus. All of the participants underwent multichannel urodynamics preoperatively. Data were analyzed in SPSS using independent or paired t tests as indicated for continuous variables and the McNemar test for paired dichotomous variables. Correlations including nonparametric data are reported as Spearman rho. RESULTS: A total of 28 participants, with a mean ± standard deviation age of 56 ± 10 years and median (interquartile range) preoperative prolapse stage of 3 (3-3), were analyzed. There was no change in UL between the baseline and 14-week visits (29.8 ± 11.0 mm vs 29.3 ± 10.0 mm, P = 0.83). There was no difference in baseline UL (29.4 ± 11.8 mm vs 30.9 ± 8.9 mm, P = 0.74) in those with and without preoperative stress urinary incontinence (SUI), nor was there a difference in baseline functional UL on multichannel urodynamics between these groups. In total, 21 participants (75%) had preoperative SUI and 19 (90%) underwent a concomitant anti-incontinence procedure. UL at 14 weeks was similar in those with and without SUI symptoms (26.5 ± 10.9 mm vs 31.1 ± 11.3 mm, P = 0.32) when controlling for those who underwent anti-incontinence procedures. CONCLUSION: UL does not change following suspension of the anterior vaginal wall with SCP.

Timing of diagnosis of complex lower urinary tract injury in the 30-day postoperative period following benign hysterectomy.

BACKGROUND: Complex lower urinary tract injury resulting from hysterectomy is a rare but highly morbid complication. Although intraoperative recognition reduces the risk of serious sequelae, observational studies have shown that most complex lower urinary tract injuries are recognized in the postoperative period. To date, limited research exists describing the timing of diagnosis of complex lower urinary tract injury or risk factors associated with complex lower urinary tract injury diagnosed in the postoperative period. OBJECTIVE: This analysis aimed to describe the time to diagnosis of complex lower urinary tract injury among women undergoing benign hysterectomy. We also aimed to identify the intraoperative risk factors for differences in type and timing of complex lower urinary tract injury in the 30-day postoperative period using a large prospective national surgical database. STUDY DESIGN: This was a retrospective analysis using the National Surgical Quality Improvement Program hysterectomy data set from 2014 to 2018. All benign hysterectomies were included. Sociodemographic factors, health status, surgeon type, and other operative characteristics were extracted. A complex lower urinary tract injury was defined as at least 1 ureteral obstruction, ureteral fistula, or bladder fistula diagnosed within the first 30 days following surgery. Bivariate and multivariate logistic regression and cox proportional hazards assessed differences in odds of and time until diagnosis of complex lower urinary tract injury. Proportional hazard assumptions were evaluated with martingale residuals and supremum tests. Significance thresholds were 0.05 for all analyses. RESULTS: In this study, 100,823 women met the inclusion criteria. Median time to diagnosis of complex lower urinary tract injury was 10 days (interquartile range, 3-19) and varied significantly based on type of injury (P<.01) with ureteral obstruction (6; interquartile range, 2-16) recognized earlier than ureteral fistula (12; interquartile range, 7-21) and bladder fistula (14; interquartile range, 4-23). In addition, 8.65% of complex lower urinary tract injury were diagnosed on the day of surgery. Total laparoscopic hysterectomy had the lowest rate of complex lower urinary tract injury in unadjusted and adjusted analysis, with abdominal hysterectomy (adjusted odds ratio, 2.02; 95% confidence interval, 1.21-3.36) and vaginal hysterectomy (adjusted odds ratio, 2.05; 95% confidence interval, 1.16-3.62) having greater odds of ureteral obstruction, whereas laparoscopic assisted vaginal hysterectomy had the greatest odds of fistula (adjusted odds ratio, 2.10; 95% confidence interval, 1.26-3.48). Concomitant apical suspension was associated with a 6-day reduction in median time to diagnosis (P=.01), and surgery with a gynecologic oncologist was associated with a 9.5-day increase in median time to diagnosis (P=.01). Cox proportional hazards analysis confirmed these findings when controlling for confounders. CONCLUSION: Greater than 91% of complex lower urinary tract injury diagnoses in the National Surgical Quality Improvement Program hysterectomy database were diagnosed after the day of surgery. Route of hysterectomy, concomitant apical suspension, and primary surgeon specialty are associated with differences in both type of injury and time until diagnosis. These intraoperative risk factors should be considered when assessing for complex lower urinary tract injury in the 30-day postoperative period.

Satisfaction with a rechargeable sacral neuromodulation system-A secondary analysis of the ARTISAN-SNM study.

AIM: To describe factors associated with satisfaction with the Axonics sacral neuromodulation (SNM) System at 1 year. METHODS: This was a secondary analysis of data collected in the ARTISAN-SNM study-a single arm, prospective, multicenter trial of the Axonics r-SNM System™. ARTISAN-SNM recruited participants with urgency urinary incontinence (UUI) to undergo a single, nonstaged implant of the lead and rechargeable neurostimulator. Participants were considered therapy responders if they had ≥50% reduction in UUI episodes in a 3-day period at 1-month post-implant. Bladder diaries and satisfaction (7-point Likert scale) were assessed at 1 year. RESULTS: In all, 124 participants (110 "responders" and 14 "non-responders") had complete data at baseline, 1 month and 1 year following implant. Most participants were satisfied with Axonics at 1 year: 68.5% were "very satisfied," 25.8% were "moderately satisfied," and 2.4% were "slightly satisfied." At 1 year, treatment efficacy, as measured by electronic bladder diaries, was significantly associated with satisfaction. Participants who were "very satisfied" had a larger reduction in voids per day (p = .01), leaks per day (p = .004), urgent leaks per day (p = .04), and voids in which the urgency was desperate per day (p = .03) compared to those less satisfied. Twelve of the 14 "non-responders" continued to see improvements in symptom reduction from 1 month to 1 year; 9/14 (64%) were "responders" at 1 year with six reporting being "very satisfied" and one reporting being "moderately satisfied." CONCLUSION: Satisfaction 1 year after implantation of Axonics SNM is extremely high and correlates with the degree of symptom improvement, which increases over time.

Prevalence of childhood trauma and its association with lower urinary tract symptoms in women and men in the LURN study.

AIMS: To describe the association between childhood traumas (death of a family member, severe illness, sexual trauma, parental separation) reported by women and men and lower urinary tract symptoms (LUTS). METHODS: In this secondary analysis of the Lower Urinary Tract Research Network Observational Cohort Study, participants completed the LUTS tool, childhood trauma events scale (CTES), PROMIS depression and anxiety and perceived stress scale. LUTS tool responses were combined to quantify urinary urgency, frequency, incontinence, and overall LUTS severity. Multivariable linear regression tested associations between trauma and LUTS; mental health scores were tested for potential mediation. RESULTS: In this cohort (n = 1011; 520 women, 491 men), more women reported experiencing at least one trauma (75% vs. 64%, p < .001), greater than three traumas (26% vs. 15%, p < .001), and childhood sexual trauma (23% vs. 7%, p < .001), and reported higher impact from traumatic events compared with men (median [interquartile rnage] CTES score = 10 [5-15] vs. 6 [4-12], p < .001). The number of childhood traumatic events was not associated with severity of overall LUTS (p = .79), urinary frequency (p = .75), urgency (p = .61), or incontinence (p = .21). Childhood sexual trauma was significantly associated with higher incontinence severity (adjusted mean difference 4.5 points, 95% confidence interval= 1.11-7.88, p = .009). Mental health was a mediator between trauma and LUTS among those with at least one childhood trauma. CONCLUSION: Although total childhood trauma is not associated with LUTS, childhood sexual trauma is associated with urinary incontinence severity. For patients with childhood trauma, half of the effect of CTE Impact score on overall LUTS severity is mediated through the association between trauma and the patient's mental health.

Cost-effectiveness Analysis of Universal Cystoscopy at the Time of Benign Laparoscopic Hysterectomy.

STUDY OBJECTIVE: To estimate the rate of lower urinary tract injury (LUTI) and percentage of LUTI needing to be recognized intraoperatively to make universal cystoscopy cost-effective and cost-saving during laparoscopic hysterectomy. DESIGN: A decision tree model was used to estimate the costs and quality-adjusted life years associated with delayed or intraoperative recognition of LUTI at the time of laparoscopic hysterectomy. Probabilities and utilities were estimated from published literature. Costs were estimated from Medicare national reimbursement schedules. Threshold analyses estimated the LUTI rate and cystoscopy sensitivity that would make universal cystoscopy cost-effective or cost-saving. Monte Carlo simulations were performed. SETTING: US healthcare system. PATIENTS: Individuals undergoing laparoscopic hysterectomy for benign indications. INTERVENTIONS: Theoretic implementation of a universal cystoscopy policy. MEASUREMENTS AND MAIN RESULTS: The total direct medical costs of laparoscopic hysterectomy under usual care were $8831 to $9149 and under universal cystoscopy were $8944 to $9068. When low LUTI rates (0.44%; estimated using sample-weighted estimates of retrospective and prospective data) were assumed, universal cystoscopy was only cost-effective in 17.1% of the simulations; the incremental cost was estimated to be $111 to $131. With median LUTI rates (2.3%) or high LUTI rates (4.0%; estimated using only prospective data with universal screening), the universal cystoscopy strategy was cost-effective in 93.9% and 99.6% of the simulations, respectively, and potentially cost-saving if the sensitivity of intraoperative cystoscopy for ureteral injury exceeded 65% or 31%, respectively. The estimated potential savings were $18 to $95 per hysterectomy. In threshold analysis assuming the average cystoscopy sensitivity rate, universal cystoscopy is estimated to be cost-effective when the LUTI rate exceeds 0.80%. CONCLUSION: In our model, universal cystoscopy is the preferred approach for laparoscopic hysterectomy and is estimated to be cost-effective in contemporary clinical settings where the LUTI rate is estimated to be 1.8% and potentially cost-saving among higher-risk populations, including those with endometriosis or pelvic organ prolapse. If the LUTI rates are less than 0.75%, the estimated incremental costs are modest-up to $131 per case. Administrators and providers should consider the local LUTI rates and practice patterns when planning implementation of a universal cystoscopy policy.

Truth or Myth: Intra-abdominal Pressure Increases in the Lithotomy Position.

STUDY OBJECTIVE: To determine if there were differences in intra-abdominal pressure (IAP) in the supine, low lithotomy, and high lithotomy positions. DESIGN: Prospective cohort study. SETTING: University medical center. PATIENTS: Twenty-nine women undergoing surgery for prolapse or stress incontinence. INTERVENTIONS: Relevant medical history, including the pelvic organ prolapse quantification stage, body mass index, and airway grade (Mallampati score), was abstracted from patients' medical charts. IAP was measured in centimeters of water (cmH2O) on the day of their surgery before induction of general or intravenous anesthesia using a T-doc air charged urodynamic catheter (Laborie Aquarius; Ontario, Canada) placed in a patient's vagina (for patients with incontinence) or rectum (for patients with prolapse). MEASUREMENTS AND MAIN RESULTS: IAP was measured in 3 positions: supine (legs at 0°), low lithotomy (legs in Yellowfin stirrups at 45°; Allen Medical, Acton, MA), and high lithotomy (legs at 90°). The means ± SDs IAP for the groups were as follows: in the supine position, 18.6 cmH2O ± 7.6; low lithotomy, 17.7 cmH2O ± 6.6; and high lithotomy, 17.1 cmH2O ± 6.3. In the same women, there was a significant decrease in IAP from the supine to high lithotomy positions, with a mean difference of 1.4 cmH2O ± 3.7, p = .05. Similarly, there was a significant, though smaller, decrease in mean IAP when moving from the supine to low lithotomy positions in these same women (mean decrease of 0.9 cmH2O ± 1.5, p = .004). Neither change is clinically significant based on previous research that suggests 5 cmH2O is a clinically significant change. CONCLUSION: Placing patients' legs in a low or high lithotomy position does not result in a clinically significant increase in IAP. Therefore, surgeons and anesthesiologists can consider positioning patients' lower extremities in stirrups while patients are awake to minimize discomfort and possibly reduce the risk of nerve injuries.

Minimizing Risks in Minimally Invasive Surgery: Rates of Surgical Site Infection Across Subtypes of Laparoscopic Hysterectomy.

STUDY OBJECTIVE: To compare the 30-day incidence of deep or organ-space and/or superficial incisional surgical site infections (SSIs) by the subtype of laparoscopic hysterectomy and to report on additional risk factors for SSIs following laparoscopic hysterectomy. DESIGN: Retrospective cohort study. SETTING: American College of Surgeons National Surgical Quality Improvement Program Database. PATIENTS: Women undergoing laparoscopic hysterectomy from 2012 to 2014. INTERVENTIONS: Women were stratified into 3 groups by the type of hysterectomy: total laparoscopic hysterectomy (TLH), laparoscopic-assisted vaginal hysterectomy (LAVH), and laparoscopic supracervical hysterectomy (LSCH). Demographic and clinical characteristics were compared for the 3 groups using the Kruskal-Wallis test or 1-way analysis of variance, where appropriate, for continuous variables and the chi-square or Fisher's exact test for categoric variables. Post hoc analyses were performed for multiple comparisons. Univariate analyses to examine the association with SSI were performed using the t test or Wilcoxon rank sum test as appropriate for continuous variables and the chi-square test or Fisher's exact test as appropriate for categoric variables. Significant variables on univariate analysis were included in a stepwise, backward multivariable logistic regression to identify the independent risk factors of SSI. MEASUREMENTS AND MAIN RESULTS: In total, 46 755 women underwent laparoscopic hysterectomy. Most were classified as TLH (26 009, 56%), followed by LAVH (13 884, 30%), and LSCH (6862, 14%). The overall rate of 30-day deep or organ-space SSI was 1.8% (n = 445). Thirty-day deep or organ-space SSI was lower in women who underwent LSCH (0.6%) than in women who underwent TLH (1.0%) or LAVH (1.1%; p = .001), but there was no difference in the incidence of superficial incisional SSI (0.8%, 0.8%, and 0.8% for TLH, LAVH, and LSCH, respectively; p = .75). On multivariate regression analysis, LSCH remained independently associated with a decreased risk of deep or organ-space SSI (adjusted odds ratio, 0.60; 95% confidence interval, 0.43-0.84; p = .003). In addition, relative to the women who were discharged on the same day, women admitted for >24 hours had 2-fold increased odds of deep or organ-space SSI. Asian race, smoking, perioperative transfusion, dirty or infected cases, and American Society of Anesthesiologist class 3 were associated with increased odds for deep or organ-space SSI. Length of stay >24 hours and Native Hawaiian/Pacific Islander race were associated with increased odds of superficial incisional SSI. CONCLUSION: LSCH is associated with a decreased risk of deep or organ-space SSI compared with other subtypes of laparoscopic hysterectomy. Same-day discharge after laparoscopic hysterectomy is associated with decreased odds of SSI.

Recovering sexual satisfaction after prolapse surgery: a secondary analysis of surgical recovery.

INTRODUCTION AND HYPOTHESIS: We compared pre- and postoperative sexual function scores in sexually active women undergoing pelvic organ prolapse (POP) surgery. METHODS: Planned secondary analysis of women enrolled in the Restricted Convalescence: Outcomes Following Urogynecologic Procedures study, a randomized trial of postoperative activity after POP surgery. All participants could return to sexual activity at 6 weeks. Participants completed the Pelvic Floor Distress Inventory (PFDI), the Patient-Reported Outcomes Measurement Information System (PROMIS) profile, and the Golombok Rust Inventory of Sexual Satisfaction (GRISS) questionnaires at baseline and 3 months. GRISS is a validated 28-item survey for heterosexual couples that contains seven subscales to assess sexual function. Higher scores represent worse sexual function. RESULTS: Thirty-seven sexually active women were assessed. Mean age ± standard deviation (SD) was 56 ± 11, most of whom (92%) were Caucasian; 78% had undergone minimally invasive sacrocolpopexy, and the remainder had native tissue vaginal repairs. GRISS scores improved 3 months after surgery [4.5 ± 2.6 to 3.6 ± 2.2, p < 0.001; mean decrease of 0.9, 95% confidence interval (CI) 0.36-1.36]. PFDI scores improved from 122 ± 53 at baseline to 28 ± 31 at 3 months (p < 0.001). Higher GRISS scores were correlated with higher PFDI scores (Spearman's rho = 0.35, p = 0.03) at baseline and 3 months (Spearman's rho = 0.31, p = 0.03). Several GRISS subscales improved after surgery: partner avoidance (p = 0.01), vaginismus (p = 0.02), noncommunication (p = 0.01), dissatisfaction (p = 0.03), and anorgasmia (p = 0.001). However, sexual infrequency (p = 0.08) and nonsensuality (p = 0.4) did not change. Fifty-one percent had sexual dysfunction before surgery, which decreased to 32% after surgery (p = 0.04). CONCLUSION: Sexual function and satisfaction are significantly improved 3 months following POP surgery. Improved sexual function is correlated with improved pelvic floor symptoms.

All the darkness we don't see.

Trafficking of women and children for sexual exploitation is the fastest growing criminal enterprise in the world. This is a public health crisis; as physicians who have direct contact with victims, we have a unique opportunity to intervene. The authors developed a specialty clinic for survivors of sex trafficking in 2013 at an academic medical center in New York City. Twenty of the 24 women seen in the Survivor Clinic saw a physician while being trafficked. Sex trafficking violates basic human rights, which include the rights to bodily integrity, dignity, health, and freedom from violence and torture. The stories of the patients seen in the Survivor Clinic bear witness to the health consequences of commercial sexual exploitation and reinforce the previous literature on the rates of physical and psychologic harms of trafficking. Health consequences of trafficking include traumatic brain injuries, drug addiction, depression, and neglect of chronic health conditions. All physicians, but gynecologists especially, need more education about the prevalence and dynamics of trafficking and how to assess and intervene on behalf of survivors.

Vestibulodynia: A Multifactorial Syndrome: A Case Report.

BACKGROUND: Vulvodynia is a difficult-to-treat, chronic, multifactorial malady that drastically lowers the quality of life of afflicted patients. CASE: A 68-year-old woman, who had been treated successfully for vulvodynia years before with medication, returned with a recurrence of vulvodynia symptoms that this time did not respond to treatment. She now had biopsy-confirmed lichen sclerosis and was found to have markedly elevated serum testosterone levels. An imaging study detected an ovarian lesion that, on removal, proved to be afibrothecoma. Postoperatively the testosterone rapidly dropped to normal levels. What was unexpected and unusual was that the vulvar pain disappeared and the lichen sclerosis markedly regressed. CONCLUSION: This case demonstrates a hormonal trigger for the development of vulvodynia.