Defining success after surgical treatment of stress urinary incontinence.

BACKGROUND: A consensus standardized definition of success after stress urinary incontinence surgical treatment is lacking, which precludes comparisons between studies and affects patient counseling. OBJECTIVE: This study aimed to identify optimal patient-centric definition(s) of success after stress urinary incontinence surgical treatment and to compare the identified "more accurate" treatment success definitions with a commonly used composite definition of success (ie, no reported urine leakage, negative cough stress test result, and no retreatment). STUDY DESIGN: We evaluated 51 distinct treatment success definitions for participants enrolled in a previously conducted randomized trial of stress urinary incontinence treatments concomitantly performed with sacrocolpopexy (NCT00934999). For each treatment success definition, we calculated the mean (SD) of participant-assessed symptom improvement and participant-assessed surgical success scores with an 11-point Likert scale among those achieving success and failure. The "more accurate" treatment success definition(s) were identified by measuring the magnitude of the mean difference of participant assessments with Hedges g values. The treatment success definitions with the highest Hedges g values were considered "more accurate" treatment success definitions and were then compared with the composite definition of success. RESULTS: The percentage of participants who had treatment success (6.4% to 97.3%) and Hedges g values (-4.85 to 1.25) varied greatly according to each treatment success definition. An International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form score ≤5, Urogenital Distress Inventory-6 score ≤33.3, and a no/mild stress urinary incontinence response on Urogenital Distress Inventory-6 question 3 had the highest Hedges g values and were considered the top 3 "more accurate" treatment success definitions. Paradoxically, treatment success definitions that required a negative cough stress test result or no persistent urinary leakage greatly reduced the ability to differentiate between participant-assessed symptom improvement and surgical success. When the "more accurate" treatment success definitions were compared with the composite definition, patients with failed treatment according to the composite definition had lower Urinary Impact Questionnaire-7 scores and a higher proportion of survey responses indicating complete satisfaction or some level of satisfaction and very good/perfect bladder condition. In addition, the composite definition had considerably fewer favorable outcomes for participants than did the top 3 "more accurate" treatment success definitions. CONCLUSION: Successful outcomes of stress urinary incontinence surgical treatments for women undergoing concurrent sacrocolpopexy varied greatly depending on the definition used. However, stringent definitions (requiring complete dryness) and objective testing (negative cough stress test result) had decreased, rather than increased, participant-assessed symptom improvement and surgical success scores. The "more accurate" treatment success definitions better differentiated between participant-assessed symptom improvement and surgical success than the composite definition. The composite definition disproportionately misidentified participants who reported minor symptoms or complete/partial satisfaction with their outcome as having treatment failures and yielded a considerably lower proportion of women who reported favorable outcomes than did the top 3 "more accurate" treatment success definitions.

A bundle of opioid-sparing strategies to eliminate routine opioid prescribing in a urogynecology practice.

BACKGROUND: Current evidence supports that many patients do not use prescribed opioids following reconstructive pelvic surgery, yet it remains unclear if it is feasible to eliminate routine opioid prescriptions without a negative impact on patients or providers. OBJECTIVE: To determine if there is a difference in the proportion of patients discharged without opioids after implementing a bundle of opioid-sparing strategies and tiered prescribing protocol compared to usual care after minimally invasive pelvic reconstructive surgery (transvaginal, laparoscopic, or robotic). Secondary objectives include measures of patient-perceived pain control and provider workload. STUDY DESIGN: The bundle of opioid-sparing strategies and tiered prescribing protocol intervention was implemented as a division-wide evidence-based practice change on August 1, 2022. This retrospective cohort compares a 6-month postintervention (bundle of opioid-sparing strategies and tiered prescribing protocol) cohort to 6-month preintervention (usual care) of patients undergoing minimally invasive pelvic reconstructive surgery. A 3-month washout period was observed after bundle of opioid-sparing strategies and tiered prescribing protocol initiation. We excluded patients <18 years, failure to consent to research, combined surgery with other specialties, urge urinary incontinence or urinary retention procedures alone, and minor procedures not typically requiring opioids. Primary outcome was measured by proportion discharged without opioids and total oral morphine equivalents prescribed. Pain control was measured by pain scores, postdischarge prescriptions and refills, phone calls and visits related to pain, and satisfaction with pain control. Provider workload was demonstrated by phone calls and postdischarge prescription refills. Data were obtained through chart review on all patients who met inclusion criteria. Primary analysis only included patients prescribed opioids according to the bundle of opioid-sparing strategies and tiered prescribing protocol protocol. Two sample t tests compared continuous variables and chi-square tests compared categorical variables. RESULTS: Four hundred sixteen patients were included in the primary analysis (207 bundle of opioid-sparing strategies and tiered prescribing protocol, 209 usual care). Baseline demographics were similar between groups, except a lower proportion of irritable bowel syndrome (13% vs 23%; P<.01) and pelvic pain (15% vs 24.9%; P=.01), and higher history of prior gynecologic surgery (69.1% vs 58.4%; P=.02) in the bundle of opioid-sparing strategies and tiered prescribing protocol cohort. The bundle of opioid-sparing strategies and tiered prescribing protocol cohort was more likely to be discharged without opioids (68.1% vs 10.0%; P<.01). In those prescribed opioids, total oral morphine equivalents on discharge was significantly lower in the bundle of opioid-sparing strategies and tiered prescribing protocol cohort (48.1 vs 81.8; P<.01). The bundle of opioid-sparing strategies and tiered prescribing protocol cohort had a 20.6 greater odds (confidence interval 11.4, 37.1) of being discharged without opioids after adjusting for surgery type, arthritis/joint pain, IBS, pelvic pain, and contraindication to nonsteroidal anti-inflammatory drugs. The bundle of opioid-sparing strategies and tiered prescribing protocol cohort was also less likely to receive a rescue opioid prescription after discharge (1.4% vs 9.5%; P=.03). There were no differences in opioid prescription refills (19.7% vs 18.1%; P=.77), emergency room visits for pain (3.4% vs 2.9%; P=.76), postoperative pain scores (mean 4.7 vs 4.0; P=.07), or patient satisfaction with pain control (81.5% vs 85.6%; P=.21). After bundle of opioid-sparing strategies and tiered prescribing protocol implementation, the proportion of postoperative phone calls for pain also decreased (12.6% vs 21.5%; P=.02). Similar results were identified when nonadherent prescribing was included in the analysis. CONCLUSION: A bundle of evidence-based opioid sparing strategies and tiered prescribing based on inpatient use increases the proportion of patients discharged without opioids after minimally invasive pelvic reconstructive surgery without evidence of uncontrolled pain or increased provider workload.

Assessing the impact of procedure-specific opioid prescribing recommendations on opioid stewardship following pelvic organ prolapse surgery.

BACKGROUND: Nationally, there is increasing concern regarding the volume of opioid medications prescribed postoperatively and the rate of prescription opioid-related adverse events. In evaluation of this, several reports have identified significant variability in postoperative opioid-prescribing patterns, including quantities exceeding patient's needs, especially after minor surgical procedures. However, data regarding patient's postoperative opioids needs following surgery for pelvic organ prolapse are sparse. OBJECTIVE: To design procedure-specific opioid-prescribing recommendations for pelvic organ prolapse surgeries and evaluate their impact on opioid stewardship. STUDY DESIGN: We prospectively evaluated opioid-prescribing patterns, patient use, medication refills, and patient satisfaction in women undergoing prolapse surgery (ie, vaginal, abdominal, or robotic) during an 8-month time period. Two cohorts of women, stratified by whether they had surgery before or after implementation of procedure-specific opioid-prescribing recommendations, were evaluated. Postoperative opioid usage (assessed via pill count), medication refills, and satisfaction with pain management after hospital dismissal were evaluated by telephone call 2 weeks after surgery. Postoperative opioid prescribing and use were recorded after conversion to oral morphine equivalents. RESULTS: Overall, 96 women were included, 57 in the initial baseline cohort, and 39 following implementation of the prescribing recommendations. In the initial cohort, 32.8% of the prescribed oral morphine equivalents (3607/11,007 mg) were consumed. Following implementation of the prescribing recommendations, median oral morphine equivalents prescribed decreased from 200 mg oral morphine equivalents (interquartile range 150, 225) to 112.5 mg oral morphine equivalents (interquartile range 22.5, 112.5; P<.0001). The total oral morphine equivalents prescribed decreased by 45% when compared with the volume that would have been prescribed before implementing the recommendations. The amount of leftover opioids per patient significantly decreased as well (P<.0001). Pain medication refills increased after the intervention (18% vs 3.5%; P=.03), whereas satisfaction scores were similar in both cohorts (P=.87). CONCLUSIONS: By using procedure-specific opioid prescribing recommendations, we decreased the number of opioids prescribed at hospital dismissal by roughly one half. Decreased opioid prescribing did not adversely impact patient satisfaction.

Randomized controlled trial of silver-alloy-impregnated suprapubic catheters versus standard suprapubic catheters in assessing urinary tract infection rates in urogynecology patients.

INTRODUCTION AND HYPOTHESIS: Catheter-associated urinary tract infections (UTI) are the most common health-care-related infections. We aimed to compare the UTI rate among women undergoing urogynecological procedures with a silver-alloy suprapubic catheter (SPC) and a standard SPC, and identify the risk factors predisposing patients to UTI. METHODS: Patients who were to undergo placement of an SPC as part of pelvic organ prolapse surgery were enrolled between 1 August 2011 and 30 August 2017, and randomized to either standard SPC or silver-alloy SPC. Follow-up was performed at a postoperative visit or via a phone call at 6 weeks. The primary outcome was UTI. RESULTS: Of the 288 patients who were randomized, 127 with standard SPC and 137 with silver-alloy SPC were included in the analysis. Twenty-nine out of 123 women with standard SPC (23.6%) and 24 out of 131 (18.3%) with silver-alloy SPC were diagnosed with UTI within 6 weeks postoperatively (p = 0.30). In univariate analysis, non-white race (odds ratio [OR] 5.36, 95% CI 1.16-24.73) and diabetes (OR 2.80, 95% CI 1.26-6.23) were associated with increased risk of UTI. On multivariate analysis, only diabetes remained an independent risk factor. Comparisons between groups were evaluated using two-sample t test for age, Chi-squared tests for diabetes, and Wilcoxon rank sum test for all other variables. CONCLUSION: There was only a 5% difference in 6-week UTI rates between those who received standard vs silver-alloy SPC; the study was not powered to detect such a small difference. Diabetes was identified as a risk factor for SPC-associated UTI in women undergoing pelvic reconstructive surgeries.

Long-term outcomes and predictors of failure after surgery for stage IV apical pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to compare outcomes after uterosacral ligament suspension (USLS) or sacrocolpopexy for symptomatic stage IV apical pelvic organ prolapse (POP) and evaluate predictors of prolapse recurrence. METHODS: The medical records of patients managed surgically for stage IV apical POP from January 2002 to June 2012 were reviewed. A follow-up survey was sent to these patients. The primary outcome, prolapse recurrence, was defined as recurrence of prolapse symptoms measured by validated questionnaire or surgical retreatment. Survival time free of prolapse recurrence was estimated using the Kaplan-Meier method, and Cox proportional hazards models evaluated factors for an association with recurrence. RESULTS: Of 2633 women treated for POP, 399 (15.2%) had stage IV apical prolapse and were managed with either USLS (n = 355) or sacrocolpopexy (n = 44). Those managed with USLS were significantly older (p < 0.001) and less likely to have a prior hysterectomy (39.7 vs 86.4%; p < 0.001) or prior apical prolapse repair (8.2 38.6%; p < 0.001). Median follow-up was 4.3 years [interquartile range (IQR) 1.1-7.7]. Survival free of recurrence was similar between USLS and sacrocolpopexy (p = 0.43), with 5-year rates of 88.7 and 97.6%, respectively. Younger age [adjusted hazard ratio (aHR) 1.55, 95% confidence interval (CI) 1.12-2.13; p = 0.008] and prior hysterectomy (aHR 2.8, 95% CI 1.39-5.64; p = 0.004) were associated with the risk of prolapse recurrence, whereas type of surgery approached statistical significance (aHR 2.76, 95% CI 0.80-9.60; p = 0.11). CONCLUSIONS: Younger age and history of prior hysterectomy were associated with an increased risk of recurrent prolapse symptoms. Notably, excellent survival free of prolapse recurrence were obtained with both surgical techniques.

The effect of sacral neuromodulation on pregnancy: a systematic review.

INTRODUCTION AND HYPOTHESIS: To evaluate the effects of sacral neuromodulation (SNM) on pregnancy and the impact of delivery on SNM function. METHODS: A systematic search was conducted through January 2016. We selected studies including women who had SNM and a subsequent pregnancy. RESULTS: Out of 2,316, eight studies were included, comprising 22 patients (26 pregnancies). SNM indications were Fowler's syndrome in 11, urinary retention in 6, fecal incontinence in 1, fecal and urinary urgency in 1, overactive bladder in 1, intractable interstitial cystitis in 1, and myelodysplasia in 1. SNM stayed on in 8 pregnancies. In the remaining 18 pregnancies in which the device was deactivated, 7 had recurrent urinary tract infections, including 1 with pyelonephritis and 2 who requested reactivation owing to recurrent symptoms. Outcomes were reported in 25 pregnancies, 16 had Cesarean section (CS) and 9 had vaginal delivery, including 2 operative deliveries. Out of 25, two infants had pilonidal sinus and motor tic disorder (exhibited at the age of 2 years), both from the same mother. After delivery, SNM was functioning in 15 (60%), 4 required reprogramming, and 3 required replacement (1 had recurrence of fecal incontinence after her operative delivery with evidence of displaced leads and 1 patient reported decreased SNM effects after her two CS), and 3 decided to remove the device (2 out of 3 patients were free of symptoms after SNM deactivation and requested removal). CONCLUSION: Within the current limited evidence, the decision regarding SNM activation or deactivation should be individualized. A registry for those patients is recommended.

Predictors of vaginal mesh exposure after midurethral sling placement: a case-control study.

INTRODUCTION AND HYPOTHESIS: Female stress urinary incontinence is highly prevalent, and synthetic midurethral sling placement is the most common type of anti-incontinence surgery performed in the USA. We aimed to identify risk factors associated with surgery used to treated vaginal mesh exposure after midurethral sling placement for stress urinary incontinence. METHODS: We identified women who underwent anti-incontinence procedures from January 2002 through December 2012. Patients with vaginal mesh exposure undergoing surgical repair after midurethral sling placement were compared with a control group without mesh exposure in a 1:3 ratio. Patients with ObTape sling placement (Mentor Corporation) were excluded. Logistic regression models were used to evaluate associations between clinical risk factors and vaginal mesh exposure. RESULTS: Overall, 2,123 patients underwent primary sling placement, with 27 (1.3 %) having vaginal mesh exposure necessitating surgical repair. Patients with mesh exposure were more likely to have undergone previous bariatric surgery (P = 0.008), hemoglobin <13 g/dL (P = 0.006), premenopausal status (P = 0.008), age <50 years (P = 0.001), and the retropubic approach to sling placement (P = 0.03). Multivariate analysis identified these risk factors: previous bariatric surgery (odds ratio [OR], 7.0; 95 % CI, 1.1-61.4), retropubic approach (OR, 5.7; 95 % CI, 1.1-107.0), preoperative hemoglobin <13 g/dL (OR, 2.8; 95 % CI, 1.1-7.5), and premenopausal status (OR, 2.6; 95 % CI, 1.0-7.3). Among postmenopausal patients, those with mesh exposure were significantly more likely to receive preoperative estrogen therapy (OR, 12.4; 95 % CI, 2.7-57.8). CONCLUSIONS: Previous bariatric surgery, retropubic approach, premenopausal status, and lower preoperative hemoglobin were associated with a significantly increased risk of surgery for vaginal mesh exposure after midurethral sling placement. Recognizing these factors can improve preoperative patient counseling.

Evaluation of the local carcinogenic potential of mesh used in the treatment of female stress urinary incontinence.

INTRODUCTION AND HYPOTHESIS: To evaluate the carcinogenic potential of implanted synthetic mesh midurethral slings in the treatment of female stress urinary incontinence. METHODS: We identified female patients undergoing implantation of mesh materials for stress urinary incontinence at our institution from 1 January 2002 to 31 December 2012. This was accomplished by querying the medical records for CPT code 57288 ("sling operation for stress incontinence") and a subsequent chart review to identify patients who underwent synthetic mesh sling placement. Medical records were then evaluated for the documentation of bladder, urethral, vaginal, cervical, uterine or ovarian cancers via the International Classification of Disease (ninth edition) coding. A chart review of patients with a cancer diagnosis was performed for verification of the diagnosis and evaluation of the temporal relationship with sling placement. RESULTS: During the study period, 2,474 patients underwent polypropylene midurethral sling placement. The median age was 57 years (IQR 47, 69) and the median follow-up was 60 months (IQR 23.3, 94.9). Overall, 51 patients also had a cancer diagnosis (8 bladder cancers, 7 vaginal malignancies, 8 ovarian carcinomas, 26 endometrial cancers, 2 cervical malignancies); however, only 2 cancers (0.08 %, 2 out of 2,474) developed following sling placement (a vaginal melanoma 3 years after sling placement and an ovarian tumor 1 year after sling placement). No cases of sarcoma formation, bladder, urethral or squamous cell carcinomas were identified. CONCLUSIONS: With a median follow-up of 5 years after synthetic midurethral sling placement, development of pelvic malignancy was rare (0.08 %) and unlikely to be secondary to foreign body reaction from the implanted material.

Comparison of graft-reinforced repairs and suture repair using a novel biomechanical test.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to determine the feasibility of a novel biomechanical test for evaluating mesh-reinforced repair compared to suture-reinforced repair using an animal model. We hypothesized that the fatigue life of a mesh reinforced repair would be greater than that of xenograft reinforced repair and suture-only repair. METHODS: Wistar rats were randomly assigned to undergo a ventral hernia repair using sutures or one of the three mesh materials representative of incorporation, encapsulation and resorption host responses (Gynemesh, Pelvisoft and Surgisis®, respectively). All surviving animals were killed at 90 days and specimens containing the prosthesis-tissue interface were exposed to cyclic forces. The number of cycles to failure (fatigue life) was compared between groups using a Cox regression model. RESULTS: Of 40 randomly assigned animals, 11 died before 90 days. After randomizing an additional 5 rats, a total of 34 rats were killed at 90 days. The proportions of specimens that failed before 10,000 cycles were 25% (2/8), 50% (4/8), 62.5% (5/8) and 70% (7/10) in the Gynemesh, Surgisis, Pelvisoft, and suture control groups, respectively. In addition, the median number of cycles to failure was >10,000 in the Gynemesh group, >6,923 in the Surgisis group, 1133 in the Pelvisoft group and 741 in the control group. After adjustment for cross-sectional area, the risk of failure in the suture control group was higher than in all of the reinforced repair groups combined with an adjusted hazard ratio of 2.58 (95% CI 0.96 - 6.97), and was statistically significantly higher than in the Gynemesh group with an adjusted hazard ratio of 6.67 (95% CI 1.30 - 34.48). CONCLUSION: We present a novel biomechanical test that can be used to compare mesh materials in an animal model prior to use in humans. In this animal model, after adjusting for cross-sectional area, suture reinforced repair has a higher risk of failure than graft reinforced repair.

Assessing the learning curve of robotic sacrocolpopexy.

INTRODUCTION AND HYPOTHESIS: The aim was to evaluate the learning curve of robotic sacrocolpopexy, adjusted for surgical risk. METHODS: The charts of 145 robotic sacrocolpopexies performed by urogynecologists at Mayo Clinic, Rochester, MN, USA, from 2007 to 2013, were reviewed. Outcomes of interest included operative time, intraoperative complications, and postoperative complications with a Clavien-Dindo grade 2 or higher. Risk-adjusted cumulative summation analysis was performed by comparing a calculated complication risk score with observed patient outcomes, and then cumulatively recalculating the rate of expected vs observed complications after each procedure. Proficiency was defined as the point at which the surgeon's complication rates were better than expected, given the patient's risk factors. RESULTS: The median operative time decreased significantly, from 5.3 to 3.6 h, during the 7-year period, and plateaued after the first 60 cases. A higher ASA classification was associated with an increased risk of intraoperative complications (p = 0.02), and a higher Charlson comorbidity index was associated with an increased risk of intraoperative or postoperative complications (p = 0.01). In risk-adjusted CUSUM analyses, accounting for these factors, and for body-mass index and vaginal parity, proficiency was identified at 55 cases for intraoperative complications and 84 cases for intraoperative or postoperative complications. CONCLUSIONS: Operative time plateaued after the first 60 cases, whereas complication rates continued to decrease beyond this. Proficiency, as determined by a risk-adjusted CUSUM analysis for complication rates, was achieved after approximately 84 cases. Evaluation of postoperative complications in addition to intraoperative complications, in a risk-adjusted model, is critical in depicting the surgical learning curve.

Perioperative complications of robotic sacrocolpopexy for post-hysterectomy vaginal vault prolapse.

INTRODUCTION AND HYPOTHESIS: Open abdominal sacrocolpopexy has been the preferred treatment for post-hysterectomy vaginal vault prolapse. In light of the rise in popularity of less invasive robotic sacrocolpopexy, our objective was to compare perioperative complications of robotic vs open sacrocolpopexy. METHODS: This was a single-institution, retrospective cohort study of robotic and open sacrocolpopexies. Robotic sacrocolpopexies performed between 1 January 2007 and 31 December 2009 were compared with open cases performed between 1 January 2002 and 31 December 2006. Baseline and intraoperative variables of the groups were compared. Complications were compared univariately and in a multivariable logistic regression model to adjust for prior transabdominal surgery. RESULTS: A total of 50 robotic and 87 open sacrocolpopexies were analyzed. Baseline characteristics were similar, but patients in the open group had more prior transabdominal surgeries. The robotically assisted group had decreased estimated blood loss (median, 100 mL vs 150 mL; P = 0.002) and hospital stay (median, 2 days vs 3 days; P < 0.001), but increased operative time (median, 4.6 vs 2.9 h; P < 0.001), cystotomy (10.0 % [5 out of 50] vs 1.1 % [1 out of 87]; P = 0.02), and vaginotomy (24.0 % [12 out of 50] vs 5.7 % [5 out of 87]; P = 0.003). Two patients in the robotically assisted group had postoperative hernia. There were no differences in rates of ureteral or bowel injury, urinary tract infection, ileus, bowel obstruction, or overall complications. CONCLUSIONS: Overall complication rates of robotic and open sacrocolpopexy were not significantly different. The robotically assisted group experienced shorter hospital stay but increased operative times and increased incidence of cystotomy and vaginotomy, possibly reflecting the learning curve of robotic sacrocolpopexy.

A cohort study comparing a single-incision sling with a retropubic midurethral sling.

INTRODUCTION AND HYPOTHESIS: Despite established comparable efficacy between retropubic midurethral (RMUS) and transobturator slings, there are conflicting data regarding single-incision mini-slings (SIMS). This study tests the null hypothesis that the MiniArc® Single-Incision Sling is equivalent to the ALIGN® Urethral Support System for treatment of stress urinary incontinence (SUI). METHODS: Women who underwent a sling for SUI from 1 January 2008 through 31 December 2009 were identified (N = 324). A follow-up survey was mailed. Primary outcomes were treatment failure, defined as International Consultation on Incontinence Questionnaire (ICIQ) score >0 or additional anti-incontinence procedure, and stress-specific incontinence (SSI). Secondary outcomes included Patient Global Impression of Severity and Improvement (PGI-SI), satisfaction, de novo urge, and complications. RESULTS: The study included 202 women who returned the survey. The SIMS group had higher body mass index (BMI) (30.7 ± 6.5 vs 28.9 ± 6.0 kg/m(2), P = 0.052) and shorter follow-up (18.6 ± 11.5 vs 22.9 ± 14.6 months, P = 0.019). Treatment failure was higher in SIMS compared with RMUS (76.3 % vs 64.2 %) with adjusted odds ratio of 1.84 (95 % CI, 1.0, 3.5). The SIMS group was more likely to have postoperative SSI, with adjusted OR of 2.4 (95 % CI; 1.3-4.5). The RMUS group reported more improvement and satisfaction. Incidence of de novo urge and complications were similar between groups. Reoperation for mesh erosion was more likely in the RMUS group, while the SIMS had a higher reoperation rate for SUI. CONCLUSIONS: Compared with retropubic ALIGN® Slings, MiniArc® Single-Incision Slings are less effective, with more postoperative incontinence, less patient-reported improvement, satisfaction, and higher reoperation rates for SUI.

Evaluating the Long-term Impact of Implementing Standardized Postoperative Opioid Prescribing Recommendations Following Pelvic Organ Prolapse Surgery.

IMPORTANCE: Improving opioid stewardship is important, given the common use of opioids and resultant adverse events. Evidence-based prescribing recommendations for surgeons may help reduce opioid prescribing after specific procedures. OBJECTIVE: The aim of this study was to assess longitudinal prescribing patterns for patients undergoing pelvic organ prolapse surgery in the 2 years before and after implementing evidence-based opioid prescribing recommendations. STUDY DESIGN: In December 2017, a 3-tiered opioid prescribing recommendation was created based on prospective data on postoperative opioid use after pelvic organ prolapse surgery. For this follow-up study, prescribing patterns, including quantity of opioids prescribed (in oral morphine equivalents [OMEs]) and refill rates, were retrospectively compared for patients undergoing prolapse surgery before (November 2015-November 2017; n = 238) and after (December 2017-December 2019; n = 361) recommendation implementation. Univariate analysis was performed using the Wilcoxon rank sum and χ2 tests. Cochran-Armitage trend tests and interrupted time-series analysis tested for significance in the change in OMEs prescribed before versus after recommendation implementation. RESULTS: After recommendation implementation, the quantity of postoperative opioids prescribed decreased from median 225 mg OME (interquartile range, 225, 300 mg OME) to 71.3 mg OME (interquartile range, 0, 112.5 mg OME; P < 0.0001). Decreases also occurred within each subgroup of prolapse surgery: native tissue vaginal repair ( P < 0.0001), robotic sacrocolpopexy ( P < 0.0001), open sacrocolpopexy ( P < 0.0001), and colpocleisis ( P < 0.003). The proportion of patients discharged following prolapse surgery without opioids increased (4.2% vs 36.6%; P < 0.0001), and the rate of opioid refills increased (2.1% vs 6.0%; P = 0.02). CONCLUSIONS: With 2 years of postimplementation follow-up, the use of procedure-specific, tiered opioid prescribing recommendations at our institution was associated with a significant, sustained reduction in opioids prescribed. This study further supports using evidence-based recommendations for opioid prescribing.

The Impact of an Overactive Bladder Care Pathway on Longitudinal Patient Management.

IMPORTANCE: Implementation of an overactive bladder (OAB) care pathway may affect treatment patterns and progression. OBJECTIVES: This study aimed to assess the effect of OAB care pathway implementation on treatment patterns for women with OAB. STUDY DESIGN: This retrospective cohort study evaluated women with OAB, before (January 1, 2015-December 31, 2017) and after (January 1, 2019-December 31, 2021) care pathway initiation. Care pathway use included standardized counseling, early introduction of therapy, and close follow-up. Primary outcomes included OAB medication use, follow-up visits, third-line therapy, and time to third-line therapy. RESULTS: A total of 1,349 women were included: 1,194 before care pathway implementation and 155 after. Patients after implementation were more likely to have diabetes mellitus (P = 0.04) and less likely to smoke (P = 0.01). Those managed via a care pathway were more likely to use any medication or third-line therapy within 1 year after consultation (61.3% vs 25.0%; P < 0.001). This included higher proportions receiving a medication (50.3% [95% confidence interval (CI), 41.8%-57.6%] vs 23.3% [95% CI, 20.9%-25.7%]; P < 0.001) and progressing to third-line therapy (22.6% [95% CI, 15.7%-28.9%] vs 2.9% [95% CI, 2%-3.9%]; P < 0.001). Among those who underwent third-line treatment, care pathway use was associated with shorter time to third-line therapy (median, 10 days [interquartile range, 1-56 days] vs 29 days [interquartile range, 7-191 days]; P = 0.013). Those managed via a care pathway were less likely to have additional clinic visits for OAB within 1 year after initial consultation (12.3% vs 23.9%; P < 0.001). CONCLUSIONS: Use of an OAB care pathway was associated with higher rates of oral medication and third-line therapy yet decreased follow-up office visits. Use of an OAB care pathway may promote consistent and efficient care for women with OAB.

Abdominal and robotic sacrocolpopexy costs following implementation of enhanced recovery after surgery.

OBJECTIVE: To compare perioperative costs and morbidity between open and robotic sacrocolpopexy after implementation of enhanced recovery after surgery (ERAS) pathway. METHODS: The present retrospective cohort study of patients undergoing open or robotic sacrocolpopexy (January 1, 2014, through November 30, 2017) used an ERAS protocol with liposomal bupivacaine infiltration of laparotomy incisions. Primary outcomes were costs associated with index surgery and hospitalization, determined with Medicare cost-to-charge ratios and reimbursement rates and adjusted for variables expected to impact costs. Secondary outcomes included narcotic use, length of stay (LOS), and complications from index hospitalization to postoperative day 30. RESULTS: For the total of 231 patients (open cohort, 90; robotic cohort, 141), the adjusted mean cost of robotic surgery was $3239 higher compared with open sacrocolpopexy (95% confidence interval [CI] $1331-$5147; P < 0.001). Rates were not significantly different for intraoperative complications (robotic, 4.3% [6/141]; open, 5.6% [5/90]; P = 0.754), 30-day postoperative complications (robotic, 11.4% [16/141]; open, 16.7% [15/90]; P = 0.322), or readmissions (robotic, 5.7% [8/141]; open, 3.3% [3/90]; P = 0.535). The percentage of patients dismissed on postoperative day 1 was greater in the robotic group (89.4% [126/141] vs. 48.9% [44/90], P < 0.001). CONCLUSIONS: Decreased LOS associated with ERAS provided significant cost savings with open sacrocolpopexy versus robotic sacrocolpopexy without adverse impacts on perioperative complications or readmissions.

Ureteral injury during vaginal mesh excision: role of prevention and treatment options.

Vaginal mesh kits are increasingly used in vaginal prolapse repair. Mesh erosion, infection, and pain may necessitate removal, which can lead to urinary tract injury. We describe 2 cases of ureteral injury at the time of mesh excision. Surgeons must recognize the possibility of ureteral injury and treatment modalities available.

A three-incision approach to treat persistent vaginal exposure and sinus tract formation related to ObTape mesh insertion.

Mentor Corporation's ObTape has been associated with considerable morbidity. An unacceptably high exposure rate has been noted, and in some cases, multiple procedures may be necessary for complete mesh removal. We evaluated a patient who had prior ObTape placement complicated with persistent vaginal discharge and granulation tissue formation related to persistent mesh exposure (3Bc-T2-S2) followed by sinus tract formation (6Cd-T3-S3) according to the International Urogynecological Association Classification. We performed a three-incision approach (abdominal, vaginal, and groin) for the complete removal of the retained portion of the transobturator tape. This three-incision technique represents a viable option for removal of transobturator tape causing persistent clinical issues.

A three-incision approach to treat persistent vaginal exposure and sinus tract formation related to ObTape mesh insertion.

Mentor Corporation's ObTape has been associated with considerable morbidity. An unacceptably high exposure rate has been noted, and in some cases, multiple procedures may be necessary for complete mesh removal.We evaluated a patient who had prior ObTape placement complicated with persistent vaginal discharge and granulation tissue formation related to persistent mesh exposure (3Bc-T2-S2) followed by sinus tract formation (6Cd-T3-S3) according to the International Urogynecological Association Classification. We performed a three-incision approach (abdominal, vaginal, and groin) for the complete removal of the retained portion of the transobturator tape. This three-incision technique represents a viable option for removal of transobturator tape causing persistent clinical issues.

Introduction to Machine Learning in Obstetrics and Gynecology.

In the digital age of the 21st century, we have witnessed an explosion in data matched by remarkable progress in the field of computer science and engineering, with the development of powerful and portable artificial intelligence-powered technologies. At the same time, global connectivity powered by mobile technology has led to an increasing number of connected users and connected devices. In just the past 5 years, the convergence of these technologies in obstetrics and gynecology has resulted in the development of innovative artificial intelligence-powered digital health devices that allow easy and accurate patient risk stratification for an array of conditions spanning early pregnancy, labor and delivery, and care of the newborn. Yet, breakthroughs in artificial intelligence and other new and emerging technologies currently have a slow adoption rate in medicine, despite the availability of large data sets that include individual electronic health records spanning years of care, genomics, and the microbiome. As a result, patient interactions with health care remain burdened by antiquated processes that are inefficient and inconvenient. A few health care institutions have recognized these gaps and, with an influx of venture capital investments, are now making in-roads in medical practice with digital products driven by artificial intelligence algorithms. In this article, we trace the history, applications, and ethical challenges of the artificial intelligence that will be at the forefront of digitally transforming obstetrics and gynecology and medical practice in general.

Cost-effectiveness Analysis of Early Sling Loosening Versus Delayed Sling Lysis in the Management of Voiding Dysfunction After Midurethral Sling Placement.

OBJECTIVE: The aim of this study was to perform a cost-effectiveness analysis comparing the management for ongoing voiding dysfunction after midurethral sling placement, including early sling loosening and delayed sling lysis. METHODS: A Markov model was created to compare the cost-effectiveness of early sling loosening (2 weeks) versus delayed sling lysis (6 weeks) for the management of persisting voiding dysfunction/retention after midurethral sling placement. A literature review provided rates of resolution of voiding dysfunction with conservative management, complications, recurrent stress urinary incontinence, or ongoing retention, as well as quality-adjusted life years (QALYs). Costs were based on 2020 Medicare reimbursement rates. Incremental cost-effectiveness ratios were compared using a willingness-to-pay threshold of $100,000/QALY. One-way and probabilistic sensitivity analyses were performed. RESULTS: At 1 year, early sling loosening resulted in increased costs ($3,575 vs $1,836) and higher QALYs (0.948 vs 0.925) compared with delayed sling lysis. This translated to early sling loosening being the most cost-effective strategy, with an incremental cost-effectiveness ratio of $74,382/QALY. The model was sensitive to multiple variables on our 1-way sensitivity analysis. For example, delayed sling lysis became cost-effective if the rate of voiding dysfunction resolution with conservative management was greater than or equal to 57% or recurrent stress urinary incontinence after early loosening was greater than or equal to 9.6%. At a willingness-to-pay threshold of 100,000/QALY, early sling loosening was cost-effective in 82% of microsimulations in probabilistic sensitivity analysis. CONCLUSIONS: Early sling loosening represents a more cost-effective management method in resolving ongoing voiding dysfunction after sling placement. These findings may favor early clinical management in patients with voiding dysfunction after midurethral sling placement.