Cost Effectiveness of Additional Preoperative Telephone Call to Increase Surgical Preparedness: Analysis of a Randomized Clinical Trial.

INTRODUCTION AND HYPOTHESIS: There is a need for cost effective interventions that increase surgical preparedness in urogynecology. METHODS: We performed an ancillary prospective economic evaluation of the Telehealth Intervention to Increase Patient Preparedness for Surgery (TIPPS) Trial, a randomized multicenter trial that evaluated the impact of a preoperative telehealth call on surgical preparedness in women undergoing urogynecologic surgery. A within-trial analysis from the health care sector and societal perspective was performed. Cost-effectiveness was computed from health care sector and societal perspectives, with an 8-week time horizon. RESULTS: A total of 126 women were included in our analysis. QALYs gained were similar between groups (telehealth 0.1414 + 0.0249; usual care 0.1409 + 0.0179). The cumulative mean per-person costs at 8 weeks from the healthcare sector perspective were telehealth call: $8696 +/- 3341; usual care: $8473 +/- 3118 (p = 0.693) and from the societal perspective were telehealth call: $11,195 + 5191; usual care: $11,213 +/- 4869 (p = 0.944). The preoperative telehealth call intervention was not cost effective from the health care sector perspective with an ICER of $460,091/QALY (95%CI -$7,382,608/QALY, $7,673,961) using the generally accepted maximum willingness to pay threshold of $150,000/QALY (Neumann et al. N Engl J Med. 371(9):796-7, 2014). From the societal perspective, because incremental costs per QALY gained were negative $-35,925/QALY (95%CI, -$382,978/QALY, $317,226), results suggest that preoperative telehealth call dominated usual care. CONCLUSIONS: A preoperative telehealth call is cost effective from the society perspective. CLINICAL TRIAL REGISTRATION: Registered with http://ClinicalTrials.gov . Date of registration: March 26, 2019 Date of initial participant enrollment: June 5, 2019 URL: https://clinicaltrials.gov/ct2/show/record/NCT03890471 Clinical trial identification number: NCT03890471.

A telehealth intervention to increase patient preparedness for surgery: a randomized trial.

INTRODUCTION AND HYPOTHESIS: Methods to increase surgical preparedness in urogynecology are lacking. Our objective was to evaluate the impact of a preoperative provider-initiated telehealth call on surgical preparedness. METHODS: This was a multicenter randomized controlled trial. Women undergoing surgery for pelvic organ prolapse and/or stress urinary incontinence were randomized to either a telehealth call 3 (± 2) days before surgery plus usual preoperative counseling versus usual preoperative counseling alone. Our primary outcome was surgical preparedness, as measured by the Preoperative Prepardeness Questionnaire. The Modified Surgical Pain Scale, Pelvic Floor Distress Inventory-20, Patient Global Impressions of Improvement, Patient Global Impressions of Severity, Satisfaction with Decision Scale, Decision Regret Scale, and Clavien-Dindo scores were obtained at 4-8 weeks postoperatively and comparisons were made between groups. RESULTS: Mean telehealth call time was 11.1 ± 4.11 min. Women who received a preoperative telehealth call (n = 63) were significantly more prepared for surgery than those who received usual preoperative counseling alone (n = 69); 82.5 vs 59.4%, p < 0.01). A preoperative telehealth call was associated with greater understanding of surgical alternatives (77.8 vs 59.4%, p = 0.03), complications (69.8 vs 47.8%, p = 0.01), hospital-based catheter care (54 vs 34.8%, p = 0.04) and patient perception that nurses and doctors had spent enough time preparing them for their upcoming surgery (84.1 vs 60.9%, p < 0.01). At 4-8 weeks, no differences in postoperative and patient reported outcomes were observed between groups (all p > 0.05). CONCLUSIONS: A short preoperative telehealth call improves patient preparedness for urogynecological surgery.

Better together: multidisciplinary approach improves adherence to pelvic floor physical therapy.

INTRODUCTION AND HYPOTHESIS: To determine whether consultation with pelvic floor physical therapy (PFPT) at the time of initial urogynecologic evaluation increases adherence to PFPT and to identify factors associated with PFPT attendance and completion. METHODS: We performed a retrospective chart review of all patients evaluated for new urogynecology consultation at our institution in a 1-year period, abstracting data about demographics, diagnoses, and PFPT referral, attendance, and completion. Descriptive analyses compared patients who were referred to, attended, and completed PFPT, stratified by whether they saw PFPT the same day as their initial urogynecologic consultation. Logistic regression identified factors associated with PFPT attendance, completion, and referral. RESULTS: PFPT referral was made for 35% (335/958), of whom 67% attended and 42% completed PFPT. Patients who saw PFPT the same day as their first urogynecology visit were significantly more likely to attend PFPT than those who did not (91% vs. 61%, p < 0.001), but completion rates did not differ (49% vs. 41%, p = 0.15). PFPT attendance was higher among women who saw a PFPT the same day as their initial urogynecology appointment (p < 0.001) and among those aged ≥ 65 years (p = 0.015). Age ≥ 65 years and white, non-Hispanic race/ethnicity were associated with PFPT completion. Patients with a diagnosis of pelvic organ prolapse or urinary incontinence and those seen in multidisciplinary clinic were more likely to be referred to PFPT. CONCLUSIONS: PFPT consultation at the time of initial urogynecologic evaluation improves attendance of initial PFPT appointment, but does not improve completion rates.

Preemptive Analgesia in Minimally Invasive Gynecologic Surgery.

Preemptive analgesia is an intervention provided before initiating painful stimuli that may reduce or prevent subsequent pain. This systematic review examines the evidence supporting the practice of preemptive analgesia in minimally invasive gynecologic surgery (MIGS). We searched PubMed, Cochrane Register for Controlled Trials, and Embase from inception through February 26, 2018. The search was limited to human and English language studies. A total of 324 studies were identified. The abstracts were screened for relevance for minimally invasive gynecologic surgery (MIGS) and preemptive analgesia. The final trials reviewed were restricted to randomized controlled trials of preemptive medications given before the completion of MIGS surgery. Preemptive blocks (including paracervical, triple antibiotic paste, and pudendal) appear to have the most consistently beneficial effect on postoperative pain in MIGS with an excellent cost-benefit ratio, with the exception of liposomal bupivacaine, which requires further evaluation to determine if its added cost delivers better outcomes. Preemptive anticonvulsants, ketamine, and dexmedetomidine have a positive effect on postoperative pain and opioid use but are limited by side effects. Preemptive dexamethasone, acetaminophen, and nonsteroidal anti-inflammatory drugs have a modest effect on postoperative pain control. Despite these findings, additional quality work is needed to find more definitive methods of preemptive pain control for MIGS.

Evaluation of a Structured Female Pelvic Medicine and Reconstructive Surgery Resident Rotation Curriculum.

IMPORTANCE: Residency education is moving toward competency-based learning, which requires novel educational methods. One solution is structured learning through a formalized curriculum. OBJECTIVE: The purpose of this study is to evaluate the educational aspects of a novel structured curriculum in female pelvic medicine and reconstructive surgery. STUDY DESIGN: This was a prospective cohort study of third-year obstetrics and gynecology residents who rotated on the female pelvic medicine and reconstructive surgery service. The curriculum was organized into 7 specific topics with weekly required reading, key specialty articles, and reviewed quizzes on subspecialty topics adapted from the American Board of Obstetrics and Gynecology Guide to Learning. A prerotation and postrotation self-assessment of pelvic anatomy and pelvic floor dysfunction content comprehension was assessed using a Likert scale (0-10) for each domain. RESULTS: Obstetrics and gynecology residents from 4 academic years resulted in a total of 17 paired assessments for analysis. Each of the 7 domains showed significant improvement among all academic years, with a mean increase of 4.9 ± 0.8 points ( P < 0.001). The 2 domains that showed the greatest improvement were stress urinary incontinence (5.5 ± 1.3, P < 0.001) and pelvic organ prolapse (5.5 ± 1.9, P < 0.001). There was no significant association between score improvement and the number of previous surgical rotations or having the rotation in the first or second half of the academic year. CONCLUSIONS: This study demonstrated that a structured curriculum in female pelvic medicine and reconstructive surgery was associated with significant improvement in self-assessed perceived resident knowledge during the subspecialty rotation. This approach could be applied to other rotations and direct education curriculum development.

Updated Prevalence of Urinary Incontinence in Women: 2015-2018 National Population-Based Survey Data.

OBJECTIVES: This study aimed to update estimates of urinary incontinence (UI) prevalence and associated risk factors for adult women in the United States, using the National Health and Nutrition Examination Survey (NHANES). METHODS: We used descriptive analysis of 2015-2018 NHANES weighted data for women to estimate prevalence and characterize UI types and severity. Logistic regression modeling determined adjusted associations with UI. RESULTS: Complete data were available for 5,006 women. In weighted analyses, 61.8% had UI, corresponding to 78,297,094 adult U.S. women, with 32.4% of all women reporting symptoms at least monthly. Of those with UI, 37.5% had stress urinary incontinence, 22.0% had urgency urinary incontinence, 31.3% had mixed symptoms, and 9.2% had unspecified incontinence. The prevalence of moderate or more severe UI by Sandvik Severity Index was 22.1%, corresponding to 28,454,778 adult U.S. women. In multivariate models, increasing age, body mass index ≥25, prior vaginal birth, anxiety, depression, functional dependence, and non-Hispanic White ethnicity and race were associated with any and moderate UI. Urinary incontinence was not associated with diabetes, education level, prior hysterectomy, smoking status, physical activity level, or current pregnancy status. CONCLUSIONS: More than 60% of community-dwelling adult women in the United States experience any UI and an increase from prior estimates (38%-49%) using NHANES data from 1999 to 2004; more than 20% experience moderate or more severe UI. Increases in UI prevalence may be related to population aging and increasing obesity prevalence. Age greater than 70 years, body mass index >40, and vaginal birth had the strongest association with UI in multivariate modeling.

Redefining the Spectrum of Pentosan Polysulfate Retinopathy: Multimodal Imaging Findings from a Cross-Sectional Screening Study.

PURPOSE: There is growing evidence of a direct association between pentosan polysulfate (PPS) therapy and the development of macular changes. Using standardized visual acuity (VA) testing and multimodal imaging, we investigated the impact of PPS therapy on vision and described an expanded spectrum of imaging findings among PPS users. DESIGN: Cross-sectional screening study. PARTICIPANTS: Thirty-nine patients who were current or recent users of PPS. METHODS: The participants underwent a brief eye examination and answered a comprehensive medical and ophthalmic history questionnaire. Color fundus photography, fundus autofluorescence (FAF), and spectral-domain OCT (SD-OCT) were performed. The images were evaluated by expert graders at Wisconsin Reading Center. Abnormalities were categorized as definite toxicity (DT) if seen on both FAF and SD-OCT and as questionable toxicity (QT) if seen on either FAF or SD-OCT. MAIN OUTCOME MEASURES: ETDRS and Snellen VA, the dosage and duration of PPS exposure, and the prevalence of retinal toxicity on imaging. RESULTS: The mean ETDRS and Snellen VA of the study cohort were 85 letters and 20/22, respectively. The mean PPS daily dose was 282 mg (range, 88-400 mg), whereas the mean cumulative dose was 915 g (range, 19-3650 g) over a mean period of 8.8 years (range, 2 months-25 years). There was evidence of retinopathy in 41% of the eyes; DT was identified in 24 eyes (31%) and QT in 8 eyes (10%). Retinal pigment epithelium (RPE) abnormalities (thickening or thinning or both) were present in all eyes with DT. Retinal pigment epithelium atrophy was seen in 7 eyes (9%). In addition to well-established findings, the unique SD-OCT features of this cohort included interdigitation zone abnormalities and the presence of a flying saucer-type defect. Fundus autofluorescence abnormalities were seen in 24 eyes (30.8%), with 20 (66.7%) of these exhibiting abnormalities located outside the central subfield and extending beyond the arcades. CONCLUSIONS: Findings from the masked grading of multimodal imaging at a centralized reading center suggest a wider phenotypic spectrum of structural abnormalities among patients taking PPS. Macular changes selectively involve the RPE and outer retina, with a range of findings often seen beyond the arcades. The subtle and atypical findings in this cohort should prompt clinicians to consider lowering the threshold for diagnosing PPS retinopathy.

Robotic transperitoneal infrarenal aortic lymphadenectomy: technique and results.

INTRODUCTION: This study was designed to evaluate the feasibility and the results of robotic transperitoneal infrarenal aortic lymphadenectomy. METHODS: Development of a technique of robotic transperitoneal infrarenal aortic lymphadenectomy in female cadavers and review of the results in 33 patients who underwent the newly developed technique as part of the surgical treatment of gynecologic malignancies. RESULTS: The mean console time was 42 minutes (range, 19-64 minutes). The mean number of nodes was 12.9 (range, 2-27); the mean number of positive nodes was 2.6 (range, 0-8). There was 1 conversion to laparotomy. CONCLUSIONS: Robotic transperitoneal infrarenal aortic lymphadenectomy can be performed adequately and safely with the robotic column at the patient's head. Operating table rotation and additional trocar sites are needed when used in conjunction with robotic pelvic surgery.

Robotic-assisted sacrocolpopexy: technique and learning curve.

BACKGROUND: Laparoscopic sacrocolpopexy (LSCP) offers a minimally invasive approach for treating vaginal vault prolapse. The Da Vinci robotic surgical system may decrease the difficulty of the procedure. The objective of this study was to describe the surgical technique of robotic-assisted sacrocolpopexy (RASCP) and evaluate its feasibility, safety, learning curve, and perioperative complications. METHODS: Eighty patients underwent RASCP between November 2004 and June 2007. Robotic dissection of the planes between the bladder and vagina anteriorly and between the vagina and rectum posteriorly was performed. A peritoneal incision was made to expose the sacral promontory and extended down to the vaginal apex. A Y-shaped mesh was sutured to the anterior and posterior surfaces of the vagina. The tail end of the mesh was sutured to the sacral promontory. Intracorporeal knot tying was used in all sutures. The peritoneal incision was closed to cover the mesh using a running suture. RESULTS: Mean operative time was 197.9 [standard deviation (SD) 66.8] min. After completion of the first ten cases, mean operative time decreased by 25.4% [64.3 min, 95% confidence interval (CI) 16.1-112.4 min, p < 0.01]. Two (2.5%) patients had injury to the bladder, one (1.2%) patient had a small bowel injury, and one (1.2%) patient had a ureteric injury. Postoperatively, five (6%) patients developed vaginal mesh erosion, one (1.2%) patient developed a pelvic abscess, and one (1.2%) patient had postoperative ileus. Four (5%) cases were converted to laparotomy. Mean follow-up period was 4.8 months (range 1-24 months). CONCLUSIONS: RASCP is a feasible procedure with acceptable complication rates and short learning curve.

Open laparoscopic access technique: review of 2010 patients.

OBJECTIVE: We assessed safety and efficacy of an open laparoscopic entry technique. METHODS: A retrospective review of all patients undergoing laparoscopy via open laparoscopic access over an 8-year period from January 1, 1998 to December 31, 2006 is presented. RESULTS: During the study period, 2010 consecutive subjects underwent laparoscopy. Recorded intraoperative complications include enterotomy (0.1%) and failure to enter (0.1%). There were no instances of vascular injury related to entry. Recorded postoperative complications include hernia (0.9%), infection (2.5%), hematoma (0.05%), and noncosmetic healing (0.4%). A statistically significant association existed between obesity and postoperative hernia, and between previous abdominal surgery and postoperative infection. CONCLUSION: Though typically straightforward, initial entry is one of the most common causes of injury in laparoscopy. The predominant entry method of entry in gynecologic surgery remains a closed technique. This technique has unfortunately been demonstrated in multiple series to have the potential for visceral and vascular injury due to its blind insertion of Veress needles and trocars. The open laparoscopic technique is a safe and effective method of obtaining access to the abdominal cavity with no associated vascular injury.

Suprapubic-vaginocutaneous fistula 18 years after a bladder-neck suspension.

BACKGROUND: Several complications are associated with healing after pelvic reconstructive surgery for stress urinary incontinence. These include infection, hemorrhage, erosion, and fistula formation. CASE: A 67-year-old woman presented with simultaneously draining vaginal and suprapubic sinuses. Examination revealed a vagino-abdominal fistula. Surgical excision found an abscess around synthetic material from a previous bladder-neck suspension. CONCLUSION: Unusual fistulation can occur remotely from anti-incontinence surgery, especially when graft materials are used.

The efficacy of viewing an educational video as a method for the acquisition of basic laparoscopic suturing skills.

STUDY OBJECTIVE: To estimate the efficacy of viewing an educational video in the acquisition of laparoscopic suturing skills. DESIGN: A prospective observational study (Canadian Task Force classification II-2). SETTING: Tertiary care academic medical institution. SUBJECTS: Twelve candidates interviewing for the female pelvic medicine and reconstructive surgery fellowship position at our institution. INTERVENTIONS: Candidates were evaluated in the laparoscopy laboratory before and after watching a 6-minute educational video on the basic principles of laparoscopic suturing. Each candidate evaluation included the following tasks: (1) introduction of a needle through a trocar (timed in seconds); (2) load and position a needle for suturing with a laparoscopic needle holder (evaluated by number of movements); (3) running continuous suture with 2 passes (timed in seconds); (4) intracorporeal knot tying with 2 throws (timed in seconds); and (5) extracorporeal knot tying with 2 knots (timed in seconds). MEASUREMENTS AND MAIN RESULTS: Wilcoxon signed rank test was used for the statistical comparison of the candidates' performance before and after viewing the video. After viewing the teaching video, the total median time to perform all timed tasks improved by 20% (115.5 seconds, p = .009). Significant improvement occurred in the median time of introducing the needle through a trocar, continuous suturing, and extracorporeal knot tying (p = .02, p = .01, and p = .003, respectively). CONCLUSION: The use of an educational video appears to be an effective method for the acquisition of basic laparoscopic suturing skills.