Iltamiocel Autologous Cell Therapy for the Treatment of Female Stress Urinary Incontinence: A Double-Blind, Randomized, Stratified, Placebo-Controlled Trial.

AIMS: This study aimed to determine the efficacy and safety of iltamiocel investigational autologous muscle cell therapy in females with stress urinary incontinence (SUI). METHODS: Adult females were randomized 2:1 to iltamiocel (150 × 106 cells) or placebo and stratified by severity and prior SUI surgery. The primary objective was efficacy based on the frequency of stress incontinence episodes (SIE) recorded in a 3-day diary at 12 months posttreatment. After 12 months, placebo participants could elect to receive open-label iltamiocel. Efficacy and safety analyses were performed using all patients as treated populations. RESULTS: The study enrolled 311 patients, 297 were randomized to either iltamiocel (n = 199) or placebo (n = 98). Of the 295 participants that completed 12 months blinded follow-up, the proportion achieving the primary endpoint of ≥ 50% SIE reduction was not statistically different between treatment groups (52% vs. 53.6%; p = 0.798). A significantly greater proportion of iltamiocel participants in the prior SUI surgery stratum group achieved ≥ 75% SIE reduction compared with placebo, (40% vs. 16%; p = 0.037). Treatment response was maintained at 24 months in 78.4% and 64.9% of iltamiocel participants who achieved ≥ 50% and ≥ 75% SIE reduction, respectively, at Month 12. Adverse events related to the treatment were reported in 19 (9.5%) iltamiocel participants and 6 (6.1%) placebo participants. CONCLUSION: The study did not meet its primary endpoint however, iltamiocel cell therapy is safe and may be ideally suited to female patients who have undergone prior surgery for SUI. Additional study in this group of patients with high unmet medical needs is warranted. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01893138; EudraCT number: 2014-002919-41.

Comparison of Times to Ureteral Efflux after Administration of Sodium Fluorescein and Phenazopyridine.

PURPOSE: There is currently a national shortage of indigo carmine. In efforts to identify the most efficient aid for visualizing ureteral efflux intraoperatively we investigated the time to excretion of phenazopyridine vs a newly identified alternative, sodium fluorescein. MATERIALS AND METHODS: We analyzed prospectively collected data on a cohort of women who underwent pelvic reconstructive surgery in 2015. Per provider preference patterns a number of patients were administered 200 mg phenazopyridine orally with a sip of water 1 hour prior to the start of operative time. Other patients were given 0.5 ml 10% sodium fluorescein intravenously in the operating room. In all cases time was measured between the administration of the agent and the visualization of color changes consistent with agent efflux in an indwelling catheter, which was placed at the start of the operation. Differences in excretion times between the groups were compared with the Wilcoxon rank sum test. RESULTS: Seven women received phenazopyridine and 5 received sodium fluorescein. Mean excretion time was significantly longer in the phenazopyridine group compared to the sodium fluorescein group (81.9 vs 5.1 minutes, p = 0.0057). Median excretion time for phenazopyridine was 70 minutes (range 59 to 127) and for sodium fluorescein it was 5 minutes (range 3 to 9). CONCLUSIONS: Sodium fluorescein is excreted significantly faster in the operating room compared to phenazopyridine. Depending on the cost of these agents at an institution, in addition to the desire to decrease operative time, this may impact practice patterns and agent selection.

Descending perineum syndrome: a review of the presentation, diagnosis, and management.

INTRODUCTION AND HYPOTHESIS: Defecatory dysfunction is a relatively common and challenging problem among women and one that practicing pelvic reconstructive surgeons and gynecologists deal with frequently. A subset of defecatory dysfunction includes obstructed defecation, which can have multiple causes, one of which is descending perineum syndrome (DPS). METHODS: A literature search was performed to identify the pathophysiology, diagnosis, and management of DPS. RESULTS: Although DPS has been described in the literature for many decades, it is still uncommonly diagnosed and difficult to manage. A high index of suspicion combined with physical examination consistent with excess perineal descent, patient symptom assessment, and imaging in the form of defecography are required for the diagnosis to be accurately made. Primary management options of DPS include conservative measures consisting of bowel regimens and biofeedback. Although various surgical approaches have been described in limited case series, no compelling evidence can be demonstrated at this point to support surgical intervention. CONCLUSIONS: Knowledge of DPS is essential for the practicing pelvic reconstructive surgeon to make a timely diagnosis, avoid harmful treatments, and initiate therapy early on.

Cosmetic Appearance of Port-site Scars 1 Year After Laparoscopic Versus Robotic Sacrocolpopexy: A Supplementary Study of the ACCESS Clinical Trial.

STUDY OBJECTIVE: To prospectively measure trocar site appearances 1 year after surgery in women participants in the Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies Trial, a 2-center randomized surgical trial (NCT01124916). DESIGN: Supplementary analysis of a surgical trial that randomized women to robotic or laparoscopic sacrocolpopexy (Canadian Task Force classification I). SETTING: Operative trial. PATIENTS: Women undergoing clinically indicated sacrocolpopexy for symptomatic stage ≥II pelvic organ prolapse were randomized to laparoscopic abdominal sacrocolpopexy (LASC) or robotic abdominal sacrocolpopexy (RASC). Trocar skin incision closure was standardized by using Dermabond (Ethicon, Somerville, NJ). MEASUREMENTS AND MAIN RESULTS: Photographs of all incision sites were taken at baseline (immediately), 6 weeks, 6 months, and 1 year after surgery. Study coordinators scored each incision with the validated Stony Brook Evaluation Scale (SBES), a 5-point wound evaluation scale. We calculated the average of all scars scores per case to determine the percent of optimal wound healing (0%-100%) for each case as well as the proportion of cases meeting 100% wound repair scoring. Wound repair scores across groups were tested with the Wilcoxon rank sum test. The overall proportion of cases in each group meeting "optimal" wound recovery (scores of 100%) was tested with the Fisher exact test. Seventy-eight women with a mean age of 59 years (range, 26-79 years) were randomized to LASC (n = 38) or RASC (n = 40). We did not detect significant differences in baseline characteristics or rates of dropout between the 2 study groups (5 in LASC and 7 in RASC, p = .60). Pain in the initial postoperative period was higher in the robotic arm although groups were similar at 2 weeks. Nearly all cases (75/78) contributed wound repair data (36 laparoscopic and 39 robotic). Laparoscopic surgeries require significantly fewer incisions (median = 4; range, 4-6) than robotic surgeries (median = 5; range, 4-6; p < .001). SBES scores at 6 weeks were not different for LASC and RASC (p = .426). By 6 months, the scores were better in the LASC group (84.8% ± 8.8% vs 78.5% ± 7.2%, p = .031), and this finding remained at 1 year (93.4% ± 7.2% vs 85.9% ± 8.8%, p = .001). The proportion of cases with optimal wound repair (score of 100%) was higher in the laparoscopic arm at 1 year after surgery (12/27 vs 4/33, p = .008). INTERVENTIONS: Women were randomized to robotic assisted laparoscopy or laparoscopy. CONCLUSION: Wound appearance using the SBES was better in the LASC group, suggesting that there may be alterations in the mechanism for wound initiation and/or healing based on the minimally invasive route used for sacrocolpopexy.

Video-based peer feedback through social networking for robotic surgery simulation: a multicenter randomized controlled trial.

OBJECTIVE: To examine the feasibility and outcomes of video-based peer feedback through social networking to facilitate robotic surgical skill acquisition. BACKGROUND: The acquisition of surgical skills may be challenging for novel techniques and/or those with prolonged learning curves. METHODS: Randomized controlled trial involving 41 resident physicians performing the Tubes (Da Vinci Intuitive Surgical, Sunnyvale, CA) simulator exercise with versus without peer feedback of video-recorded performance through a social networking Web page. Data collected included simulator exercise score, time to completion, and comfort and satisfaction with robotic surgery simulation. RESULTS: There were no baseline differences between the intervention group (n = 20) and controls (n = 21). The intervention group showed improvement in mean scores from session 1 to sessions 2 and 3 (60.7 vs 75.5, P < 0.001, and 60.7 vs 80.1, P < 0.001, respectively). The intervention group scored significantly higher than controls at sessions 2 and 3 (75.5 vs 59.6, P = 0.009, and 80.1 vs 65.9, P = 0.019, respectively). The mean time (seconds) to complete the task was shorter for the intervention group than for controls during sessions 2 and 3 (217.4 vs 279.0, P = 0.004, and 201.4 vs 261.9, P = 0.006, respectively). At the study conclusion, feedback subjects were more comfortable with robotic surgery than controls (90% vs 62%, P = 0.021) and expressed greater satisfaction with the learning experience (100% vs 67%, P = 0.014). Of the intervention subjects, 85% found that peer feedback was useful and 100% found it effective. CONCLUSIONS: Video-based peer feedback through social networking appears to be an effective paradigm for surgical education and accelerates the robotic surgery learning curve during simulation.

Management of genitourinary fistula.

PURPOSE OF REVIEW: To review current literature on the management of genitourinary fistulae, specifically, the techniques for diagnosis, timing to repair, surgical approach and recent advancements in surgical technique. RECENT FINDINGS: Recent advancement in minimally invasive surgery has prompted surgeons to perform fistula repairs with laparoscopic or robotic-assisted laparoscopic techniques. Whereas there is a role for transabdominal fistula closure, the majority of fistulae are still best approached via a transvaginal route. SUMMARY: Genitourinary fistulae from obstetric trauma have received increased attention and funding to treat and prevent this devastating condition in developing countries. Despite multiple classification systems, a standardized classification that accurately identifies predictors of successful repair is lacking. In industrialized nations, genitourinary fistulae are rare and are most frequently associated with pelvic surgery, pelvic radiation, cancer or trauma. Surgical techniques to repair these fistulae have shifted from transabdominal laparotomy to minimally invasive laparoscopic procedures. Vascularized tissue flaps can play an important role in successful closure of complex fistulae. Despite advancements in surgical technology, overarching principles of fistula closure remain. The majority of fistulae can be closed through a transvaginal approach, with a tension-free, watertight, multilayer closure.

Comparison of Pelvic Floor Physical Therapy Attendance Based on Referring Provider Specialty.

OBJECTIVE: The objective of this study was to determine whether pelvic floor physical therapy (PFPT) attendance differs based on referring provider specialty and identify factors related to PFPT initiation and completion. METHODS: This was an institutional review board-approved retrospective cohort study examining referrals from female pelvic medicine and reconstructive surgery (FPMRS) and non-FPMRS providers at a single academic medical center to affiliated PFPT clinics over a 12-month period. Demographics, referring specialty and diagnoses, prior treatment, and details regarding PFPT attendance were collected. Characteristics between FPMRS and non-FPMRS referrals were compared and multivariate logistic regression analyses were performed to identify factors associated with PFPT initiation and completion. RESULTS: A total of 497 referrals were placed for PFPT. Compared with non-FPMRS referrals, FPMRS referrals were for patients who were older (54.7 years vs 35.6 years), and had higher parity; more were postmenopausal (56% vs 18%) and had Medicare insurance (22% vs 10%) (all P < 0.001). Most FPMRS referrals were for patients with urinary incontinence (69% vs 31%), whereas non-FPMRS referrals were for patients with pelvic pain (70% vs 27%) (both P < 0.0001). Pelvic floor physical therapy attendance was similar in both groups when comparing rates of initiation (47% vs 45%) and completion (13% vs 16%). In multivariate analysis, factors associated with initiation were age 65 years or older, additional therapy provided at referring visit, private insurance, Asian race, pregnant or postpartum at time of referral, and more than 1 referring diagnosis (all P < 0.05). No factors were associated with completion. CONCLUSIONS: Less than half of the patients referred to PFPT initiate therapy, and only 15% complete PFPT. The populations referred by FPMRS and non-FPMRS providers are different, but ultimately PFPT utilization is similar.

Now Anyone Can Kegel: One-Time Office Teaching of Pelvic Floor Muscle Exercises.

OBJECTIVE: In women with pelvic floor disorders, we sought to determine time-to-teach (TTT) correct pelvic floor muscle (PFM) contraction, prevalence of inappropriate muscle contractions, and the association between TTT with PFM strength (PFMS). METHODS: From August 2017 to April 2018, patients from 2 pelvic floor disorder clinics participated in a prospective study examining PFMS. Assessment of PFMS was performed to obtain TTT, inappropriate accessory muscle, and Modified Oxford Grading Scale scores for pelvic floor muscle contractions 1 to pelvic floor muscle contractions 2. RESULTS: Of 100 women, 77 were from low-resource setting and 23 from high-resource setting. Mean TTT overall was 64.1 seconds (±26.0; range, 9-160 seconds), and mean TTT between settings was not significant. Mean overall TTT was significantly less than 90 seconds. Seventy-one women (71%) demonstrated at least 1 inappropriate accessory muscle, and of those, up to 50% of patients contracting 2 accessory muscle groups with abdominal muscles most frequently contracted at baseline. Thirty-nine percent of patients had a PFM contraction of at least 3 at baseline compared with 82% of patients upon completion of teaching, with 60% of women with scores of 4 or 5. The mean difference overall between baseline and pelvic floor muscle contractions 3 was 1.27 (confidence interval, 1.08-1.46; P < 0.001), and this increase was significant. CONCLUSIONS: One-time PFMS teaching can be done in a time-proficient fashion and is translatable across high-resource and low-resource settings. Most patients show improvement in PFMS immediately and can quickly acquire this learned skill for proper home practice.

All Levels of Providers Can Effectively and Efficiently Teach Pelvic Floor Strength Assessment at Time of Pelvic Examination.

OBJECTIVE: In women who undergo provider-guided vaginal biofeedback of pelvic floor muscle strength, we sought to determine whether the level of the provider correlates with the patient's ability to achieve adequate pelvic floor muscle contractions (PFMCs). METHODS: From August 2017 to April 2018, patients from 2 urogynecology clinics were recruited to participate in an institutional review board-approved, prospective study examining PFMCs. Pelvic examination and teaching session were done by providers who had specific training on how to assess pelvic floor muscle strength using the validated, modified Oxford scale. Patients were asked to perform a baseline PFMC during a 2-digit pelvic examination. Thereafter, patients were counseled to relax their muscles, identify the levator ani muscles during provider teaching, and perform 3 consecutive provider-guided PFMCs. The strength of each PFMC was measured, and the time-to-teach (TTT) was recorded. The level of provider and TTT were correlated with PFMC1 to PFMC3 using Spearman correlation coefficient. RESULTS: One hundred women participated. Obstetrics/gynecology (OB/GYN) residents (post-graduate years 1-4) evaluated 20 patients; female pelvic medicine and reconstructive surgery fellowship trainees (post-graduate years 5-7), 38 patients; OB/GYN nurse practitioners, 18 patients; generalist OB/GYN faculty, 9 patients; and female pelvic medicine and reconstructive surgery faculty, 15 patients. There was no correlation between level of provider and TTT or between level of provider and strength of PFMC1, PFMC2, or PFMC3. CONCLUSIONS: At the time of pelvic floor muscle assessment, the level of provider does not impact teaching time or PFMC1 to PFMC3. Teaching pelvic floor muscle exercise is a cost-effective, low-resource tool to improve patient care, and providers of any level should be encouraged to teach pelvic floor muscle exercise to patients at the time of office examination.

Vaginal Dehiscence and Evisceration After Robotic-assisted Radical Cystectomy: A Case Series and Review of the Literature.

OBJECTIVE: To describe a rare complication in 5 women who had vaginal prolapse, dehiscence, and/or evisceration after having undergone robotic-assisted radical cystectomy with creation of ileal conduit urinary diversion. Radical cystectomy is the standard of care in the extirpative treatment for muscle invasive urothelial carcinoma. Anterior exenteration in the female patient requires removal of the anterior vaginal wall, urethra, uterus, and adnexa which results in significant changes to the pelvic floor. METHODS: Retrospective identification of all women having undergone robotic-assisted radical cystectomy for urothelial carcinoma who ultimately represented with vaginal prolapse, dehiscence, and/or evisceration between January 2012 and April 2019. We identified patient characteristics detailing their presentation. A review of the available literature highlighted the lack of available information in this uncommon cohort. RESULTS: Five women with vaginal dehiscence and/or evisceration who had previously undergone robotic-assisted radical cystectomy, anterior vaginectomy with urethrectomy, pelvic lymph node dissection, and creation of ileal conduit by 4 surgeons were identified. Mean interval time to initial presentation of prolapse or dehiscence was 44.4 weeks (range 11-120). In the 2 patients that eviscerated prior to repair, this occurred at 5 and 25 weeks after initial outpatient consultation. All reconstructive efforts were approached transvaginally. Two patients underwent 2 or more repairs. Management options included expectant management, pessary, and immediate vs delayed transvaginal surgical repair. CONCLUSION: Our case series describes the unique and potentially devastating complication of vaginal dehiscence and bowel evisceration in women with history of robotic-assisted radical cystectomy.

Assessing Resident Surgical Volume Before and After Initiation of a Female Pelvic Medicine and Reconstructive Surgery Fellowship.

OBJECTIVES: The effect of fellowship programs on resident training for gynecologic surgery volume has not been clearly defined. The purpose of our study is to assess resident surgical volume for laparoscopic and vaginal hysterectomy before and after initiation of a female pelvic medicine and reconstructive surgery (FPMRS) fellowship. DESIGN: A retrospective review of Accreditation Council for Graduate Medical Education Resident Case Logs of obstetrics and gynecology residents who graduated in the 3 years before and after initiation of a FPMRS fellowship was performed. Mean values of vaginal and laparoscopic hysterectomies were compared using two-tailed t-tests with statistical significance set at p < 0.05. SETTING: Obstetrics and gynecology resident case logs at the Ronald Reagan University of California Los Angeles (UCLA) Medical Center were assessed. The UCLA Medical Center, located in Los Angeles, CA, is a tertiary referral center with a graduating class of 7 obstetrics and gynecology residents yearly. PARTICIPANTS: Obstetrics and gynecology residents who graduated from residency 3 years before and after imitation of a FPMRS fellowship were included. In the 3 years before the start of the fellowship, 20 residents graduated, whereas 21 residents graduated after the start of the fellowship. RESULTS: Residents who graduated in the 3 years after the start of the FPMRS fellowship, finished with 4.6 less vaginal hysterectomies compared with residents who graduated before the fellowship (p = 0.022). Residents who graduated in the 3 years after the start of the FPMRS fellowship finished with 3.2 more laparoscopic hysterectomies compared with residents who graduated before the fellowship although this was not significant (p = 0.25). CONCLUSIONS: Resident surgical volume was significantly decreased for vaginal hysterectomy after the initiation of a FPMRS fellowship, whereas laparoscopic hysterectomy volume was not significantly changed. Longer follow-up and a national assessment are necessary to determine the broader effect of fellowship training on resident surgical experience.

The Relationship of Anterior Vaginal and Apical Position to Postvoid Residual Urine.

OBJECTIVE: The aim of the study was to investigate the association between severity of anterior vaginal or apical prolapse and postvoid residual volume (PVR). METHODS: The charts of all women who presented to Urogynecology Clinic at Olive View-UCLA Medical Center for a 2-year period were reviewed. Demographic data, the degree of prolapse pelvic organ prolapse quantification points Aa, Ba, and C, and PVR were recorded. Patients with incomplete pelvic organ prolapse quantification assessment or improperly measured PVR were excluded. RESULTS: Three hundred fifty-two patients were included. Median age was 54 years (range, 26-80). Mean gravidity and parity were 4.4 and 3.7, respectively. Mean body mass index was 29.9 kg/m. One hundred forty-nine women had previous pelvic surgery. Median PVR was 25 mL, and 40 patients (11.4%) had a PVR of 100 mL or greater.Considering 15 potential PVR predictors, we found that the position of apex/cervix (point C) significantly correlated with an increase in PVR and also after controlling for the other significant covariates (rate of change b = 4.7% increase in PVR/cm, P = 0.0007). The other significant (P < 0.05) covariates were gravidity (5.7% per pregnancy), postmenopausal status (32.4%), and vaginal surgical history (61.4%). This was not true, however, for the anterior vaginal position (points Aa, Ba; P > 0.15). There was no difference in mean PVR in patients with versus without a hysterectomy (P = 0.236). CONCLUSIONS: Elevated PVR values have long been linked with prolapse of the anterior vaginal wall. We found that there is a linear association between PVR and the anatomic position of the apex. There was no association of PVR with the position of the anterior vaginal wall.

National Assessment of Advancing Age on Perioperative Morbidity and Length of Stay Associated With Minimally Invasive Sacrocolpopexy.

OBJECTIVE: The aim of the study was to assess the impact of age on 30-day perioperative complications and length of stay (LOS) for minimally invasive sacrocolpopexy (MISC) using a national database. METHODS: We performed an institutional review board-exempt retrospective analysis of prospectively collected data, using the National Surgical Quality Improvement Program database to analyze MISC performed at participating hospitals from 2010 to 2013. Age was stratified into the following 5 categories: younger than 60, 60 to 64, 65 to 69, 70 to 74, and 75 years or older. Complications were tabulated on the basis of available categories and were assessed using logistic multivariate regression. Length of stay was deemed abnormal if 3 days or more. RESULTS: A total of 1201 patients were identified as having undergone MISC. Mean (SD) patients age was 61.3 (11.1) years. Most patients had an American Society of Anesthesiologists (ASA) class of 2 (68.3%) or an ASA class of 3 (23.6%). Older patients had a significantly higher ASA class and lower body mass index. The most common complications were urinary tract infection (3.4%), readmission (2.7%), and return to the operating room (1.5%). Urinary tract infection (P = 0.93), readmission (P = 0.38), and return to the operating room (P = 0.17) were not significantly different between age groups. Older patients did not have greater odds of having an LOS of 3 days or more versus 1 day or 0 to 2 days. CONCLUSIONS: Returns to the operating room, readmission, and urinary tract infection were the most common adverse events and did not differ between age groups. Older patients did not have greater odds of having an increased LOS. Minimally invasive sacrocolpopexy seems to be safe among appropriately selected elderly patients.

The impact of trocar-cannula design and simulated operative manipulation on incisional characteristics: a randomized trial.

OBJECTIVE: To evaluate the hypothesis that abdominal muscular and fascial defects associated with 12-mm blunt conical trocar-cannula system will be similar to those associated with 8-mm pyramidal trocar-cannula system, both with and without simulated operative movements. METHODS: A randomized trial was performed in an animal (white swine) model. Four trocar-cannula system groups were evaluated: group A, 12-mm blunt conical system, no operative manipulations; group B, 12-mm blunt conical system, standardized operative manipulation; group C, 8-mm pyramidal system, no operative manipulations; group D, 8-mm pyramidal system with standardized operative manipulation. These 4 groups were randomly assigned across 8 animals and 6 locations for a total of 48 insertions. After the cannulas were removed, the skin and subcutaneous tissues were dissected to expose the fascial wounds. Maximal incisional length, wound area, and muscle damage score were determined for each defect. RESULTS: Mean wound area was 8.58 mm(2) in group A, 9.71 mm(2) in group B, 9.83 mm(2) in group C, and 9.63 mm(2) in group D. Incisional length was 9.16 mm in group A, 9.61 mm in group B, 9.14 mm in group C, and 8.52 mm in group D. There were no statistically significant differences between any 2 groups. Mean muscle injury scores were also similar for all groups. CONCLUSIONS: Twelve-millimeter conical trocar-cannula systems create fascial defects similar to those of 8-mm pyramidal systems, both immediately after insertion and after simulated operative manipulations. Given the historical low risk of wound dehiscence and hernia associated with pyramidal devices less than 10-mm in outside diameter, fascial closure of wounds created by conical systems may be unnecessary.

Women seeking second opinion for symptomatic uterine leiomyoma: role of comprehensive fibroid center.

OBJECTIVE: The objective of the study was to describe our early experience with a comprehensive uterine fibroid center and report our results in women seeking a second opinion for management of symptomatic uterine leiomyoma. METHODS: We performed a HIPAA-complaint, IRB-approved retrospective study of women seeking second opinion for management of uterine fibroids at our multidisciplinary fibroid treatment center in a tertiary care facility from July 2008 to August 2011. After a review of patients' history, physical examination, and magnetic resonance imaging (MRI) findings, treatment options were discussed which included conservative management, uterine-preserving options, and hysterectomy. We performed Fisher's exact test for categorical variables between the cohort that did or did not undergo a uterine-preserving treatment. Differences were considered significant at p < 0.05. RESULTS: The mean age of the 205 patient study cohort was 43.8 years (SD 7.5). One hundred sixty-two (79.0%) patients had no prior therapy. Based on MRI, one or more fibroids were detected in 178/205 (86.8%), adenomyosis in 8/205 (3.9%), and a combination of fibroid and nonfibroid condition (i.e., adenomyosis, endometrial polyp) in 18/205 (8.8%). In those who desired to transition their care to our institution (n = 109), 85 patients underwent 90 interventions: 39 MRgFUS (magnetic resonance-guided high-intensity focused ultrasound surgery), 14 UAE (uterine artery embolization), 25 myomectomies, 8 hysterectomies, 3 polypectomies, and 1 endometrial ablation. Five patients had two procedures. Intramural and subserosal fibroids were most commonly treated with MRgFUS followed by myomectomy and then UAE; in contrast, pedunculated fibroids were frequently managed with myomectomy. CONCLUSIONS: Multidisciplinary fibroid evaluation may facilitate the increase use of less invasive options over hysterectomy for symptomatic fibroid treatment.

Robotic compared with laparoscopic sacrocolpopexy: a randomized controlled trial.

OBJECTIVE: Laparoscopic and robotic sacrocolpopexy are widely used for pelvic organ prolapse (POP) treatment. Evidence comparing outcomes and costs is lacking. We compared costs and clinically relevant outcomes in women randomized to laparoscopic sacrocolpopexy compared with robotic sacrocolpopexy. METHODS: Participants with symptomatic stage POP II or greater, including significant apical support loss, were randomized to either laparoscopic or robotic sacrocolpopexy. We compared surgical costs (including costs for robot, initial hospitalization) and rehospitalization within 6 weeks. Secondary outcomes included postoperative pain, POP quantification, symptom severity and quality of life, and adverse events. RESULTS: We randomized 78 women (mean age 59 years): laparoscopic (n=38) and robotic (n=40). The robotic sacrocolpopexy group had higher initial hospital costs ($19,616 compared with $11,573, P<.001) and over 6 weeks, hospital costs remained higher for robotic sacrocolpopexy ($20,898 compared with $12,170, P<.001). When we excluded costs of robot purchase and maintenance, we did not detect a statistical difference in initial day of surgery costs of robotic compared with laparoscopic ($12,586 compared with $11,573; P=.160) or hospital costs over 6 weeks ($13,867 compared with $12,170; P=.060). The robotic group had longer operating room times (202.8 minutes compared with 178.4 minutes, P=.030) and higher pain scores 1 week after surgery (3.5±2.1 compared with 2.6±2.2; P=.044). There were no group differences in symptom bother by Pelvic Floor Distress Inventory, POP stage, or rate of adverse events. CONCLUSION: Costs of robotic sacrocolpopexy are higher than laparoscopic, whereas short-term outcomes and complications are similar. Primary cost differences resulted from robot maintenance and purchase costs. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, www.clinicaltrials.gov, NCT01124916. LEVEL OF EVIDENCE: I.

Patterns of pessary care and outcomes for medicare beneficiaries with pelvic organ prolapse.

OBJECTIVES: Using a national data set, we sought to assess patterns of pessary care in older women with pelvic organ prolapse (POP) and subsequent outcomes, including rates of complications and surgical treatment of POP. METHODS: Public use files from the US Centers for Medicare and Medicaid Services were obtained for a 5% random national sample of beneficiaries from 1999 to 2000. Diagnostic and procedural codes (International Classification of Diseases, Ninth Revision, Clinical Modification and Current Procedural Terminology, 4th Edition) were used to identify women with POP and those treated with pessary. Individual subjects were followed longitudinally for 9 years. Across this duration, patient care and outcomes (eg, return clinic visits, repeated pessary placements, complications, and rate of surgical treatment of prolapse) were assessed. RESULTS: Of 34,782 women with a condition diagnosed as POP, 4019 women (11.6%) were treated with a pessary. In the initial 3 months after pessary placement, 40% underwent a follow-up visit with the provider who had placed the pessary, and through 9 years after the initial fitting, 69% had such a visit. During this period, 3% of the subjects developed vesicovaginal or rectovaginal fistulas, and 5% had a mechanical genitourinary device complication. Twelve percent of women underwent surgery for POP by 1 year; with 24% by 9 years. CONCLUSIONS: Pessary can be effectively used for the management of POP in older women. Despite this, a low percentage of Medicare beneficiaries undergo pessary fitting. Lack of continuity of care is associated with a small but unacceptable rate of vaginal fistulas.

Health literacy and disease understanding among aging women with pelvic floor disorders.

OBJECTIVES: Few studies on health literacy and disease understanding among women with pelvic floor disorders have been published. We conducted a pilot study to explore the relationship between disease understanding and health literacy, age, and diagnosis type among women with urinary incontinence and pelvic organ prolapse. METHODS: The study subjects were recruited from urology and urogynecology specialty clinics based on a chief complaint suggestive of urinary incontinence or pelvic prolapse. Subjects completed questionnaires to assess symptom severity, and health literacy was measured using the Test of Functional Health Literacy in Adults. Patient-physician interactions were audiotaped during the office visit. Immediately afterward, patients were asked to describe diagnoses and treatments discussed by the physician and record them on a checklist, with follow-up phone call, where the same checklist was administered 2 to 3 days later. RESULTS: A total of 36 women with pelvic floor disorders, aged 42 to 94 years, were enrolled. We found that health literacy scores decreased with increasing age. However, all patients had low percentage recall of their pelvic floor diagnoses and poor understanding of their pelvic floor condition despite high health literacy scores. Patients with pelvic prolapse seemed to have worse recall and disease understanding than patients with urinary incontinence. CONCLUSIONS: High health literacy as assessed by the Test of Functional Health Literacy in Adults may not correlate with patients' ability to comprehend complex functional conditions such as pelvic floor disorders. Lack of understanding may lead to unrealistic treatment expectations, inability to give informed consent for treatment, and dissatisfaction with care. Better methods to improve disease understanding are needed.