Liberal vs. restricted opioid prescribing following midurethral sling dataset.

Postoperative opioid prescribing has historically lacked information critical to balancing the pain control needs of the individual patient with our professional responsibility to judiciously prescribe these high-risk medications. This data evaluates pain control, satisfaction with pain control, and opioid utilization among patients undergoing isolated mid-urethral sling (MUS) randomized to one of two different opioid prescribing regimens. This study was registered on clinicaltrials.gov (NCT04277975). Women undergoing isolated MUS by a Female Pelvic Medicine and Reconstructive Surgery physician at a Penn State Health hospital from June 1, 2020 to November 22, 2021 were offered enrollment into this prospective, randomized, open-label, non-inferiority clinical trial. Participants gave informed consent and were enrolled by a member of the study team. Allocation was concealed to patient and study personnel until randomization on the day of surgery. Preoperatively, all participants completed baseline demographic and pain surveys including CSI-9, PCS, and Likert pain score (scale 0-10). Participants were randomized to either receive a standard prescription of ten 5 mg tablets oxycodone provided preoperatively (standard) or opioid prescription provided only upon patient request postoperatively (restricted). Randomization was performed by the study team surgeon using the REDCap randomization module on the day of surgery. Following MUS, subjects completed a daily diary for 1 week, i.e., postoperative day (POD) 0 through 7. Within the dairy, subjects provided the following information: average daily pain score, opioid use and amount of opioid utilized, other forms of pain management, satisfaction with pain control, perception of the amount of opioid prescribed, and need for pain management hospital/clinic visits. The online Prescription Drug Monitoring Program (PDMP) was queried for all patients to determine if prescriptions for opioids were filled during the postoperative period. The primary outcome was average postoperative day 1 pain score and an a priori determined margin of non-inferiority was set at 2 points. Secondary outcomes included whether subject filled an opioid prescription (indicated by the online PDMP), opioid use (yes/no), satisfaction with pain control (on a scale of 1= "much worse" to 5= "much better" than expected), and how subjects felt about the amount of opioid prescribed (on a scale of 1="prescribed far more" to 3="prescribed the right amount" to 5="prescribed far less" opioid than needed). 82 participants underwent isolated MUS placement and met inclusion criteria; 40 were randomized to the standard arm and 42 to the restricted group. Within this manuscript, we detail the data obtained from this randomized clinical trial and the methods utilized.

A randomized trial of standard vs restricted opioid prescribing following midurethral sling.

BACKGROUND: Postoperative opioid prescribing has historically lacked information crucial to balancing the pain control needs of the individual patient with our professional responsibility to judiciously prescribe these high-risk medications. OBJECTIVE: This study aimed to evaluate pain control, satisfaction with pain control, and opioid use among patients undergoing isolated midurethral sling randomized to 1 of 2 different opioid-prescribing regimens. STUDY DESIGN: Patients who underwent isolated midurethral sling placement from June 1, 2020, to November 22, 2021, were offered enrollment into this prospective, randomized, open-label, noninferiority clinical trial. Participants were randomized to receive either a standard prescription of ten 5-mg oxycodone tablets provided preoperatively (standard) or an opioid prescription provided only during patient request postoperatively (restricted). Preoperatively, all participants completed baseline demographic and pain surveys, including the 9-Question Central Sensitization Index, Pain Catastrophizing Scale, and Likert pain score (scale 0-10). The participants completed daily surveys for 1 week after surgery to determine the average daily pain score, number of opioids used, other forms of pain management, satisfaction with pain control, perception of the number of opioids prescribed, and need to return to care for pain management. The online Prescription Drug Monitoring Program was used to determine opioid filling in the postoperative period. The primary outcome was average postoperative day 1 pain score, and an a priori determined margin of noninferiority was set at 2 points. RESULTS: Overall, 82 patients underwent isolated midurethral sling placement and met the inclusion criteria: 40 were randomized to the standard arm, and 42 were randomized to the restricted group. Concerning the primary outcome of average postoperative day 1 pain score, the restricted arm (mean pain score, 3.9±2.4) was noninferior to the standard arm (mean pain score, 3.7±2.7; difference in means, 0.23; 95% confidence interval, -∞ to 1.34). Of note, 23 participants (57.5%) in the standard arm vs 8 participants (19.0%) in the restricted arm filled an opioid prescription (P<.001). Moreover, 18 of 82 participants (22.0%) used opioids during the 7-day postoperative period, with 10 (25.0%) in the standard arm and 8 (19.0%) in the restricted arm using opioids (P=.52). Of participants using opioids, the average number of tablets used was 3.4±2.3, and only 3 participants used ≥5 tablets. On a scale of 1="prescribed far more opioids than needed" to 5="prescribed far less opioids than needed," the means were 1.9±1.0 in the standard arm and 2.7±1.0 in the restricted arm (P<.001). CONCLUSION: Restricted opioid prescription was noninferior to standard opioid prescription in the setting of pain control and satisfaction with pain control after isolated midurethral placement. Participants in the restricted arm filled fewer opioid prescriptions than participants in the standard arm. On average, only 3.4 tablets were used by those that filled prescriptions in both groups. Restrictive opioid-prescribing practices may reduce unused opioids in the community while achieving similar pain control.

Early Resumption of Sexual Intercourse after First Childbirth and Unintended Pregnancy within Six Months.

OBJECTIVE: We aimed to evaluate factors associated with early resumption of sexual intercourse after first childbirth and assess whether early intercourse is associated with unprotected intercourse, subsequent pregnancy, and unintended pregnancy over 6 months. METHODS: This secondary analysis used data from the First Baby Study, a prospective study of women aged 18-35 years with singleton pregnancies who delivered at 76 hospitals in Pennsylvania. At 1 and 6 months postpartum, women were asked about intercourse and the use of birth control since childbirth. We compared women who resumed intercourse in the first month after childbirth (early resumption) with those who resumed intercourse later, via multivariable logistic regression models. RESULTS: In our cohort, 261 of 2,643 women (9.9%) reported first intercourse within the first postpartum month (7-31 days). Women who resumed intercourse early were less educated, younger, and less likely to breastfeed, have had a perineal laceration, or have had an episiotomy than those who resumed intercourse later. In addition, they were more likely to have unprotected intercourse in at least one of the first 6 months after first childbirth (adjusted odds ratio [aOR], 2.33; 95% confidence interval [CI], 1.76-3.09); to be pregnant by 6 months postpartum (aOR, 3.03; 95% CI, 1.48-6.20); and to report that pregnancy as unintended (aOR, 3.32; 95% CI, 1.50-7.36). CONCLUSIONS: Nearly 10% of women resumed intercourse in the first month after childbirth. Because early resumption of intercourse was associated with a greater likelihood of unprotected intercourse and unintended pregnancy within 6 months of first childbirth, clinicians should focus efforts on comprehensive family planning and contraception counseling beginning in the prenatal period.

Opioid Prescribing and Utilization Following Isolated Mid-Urethral Sling.

INTRODUCTION: Overprescribing by providers is a leading contributor to the opioid crisis. Despite available information regarding the role that physician prescribing plays in the community availability of opioids, guidelines for the management of acute pain remain sparse. This project aims to evaluate opioid prescribing, opioid usage patterns, and postoperative pain control in patients undergoing isolated mid-urethral sling (MUS) placement. METHODS: Patients who underwent isolated MUS placement from March 19, 2019 through March 19, 2020 were contacted by telephone in May 2020 and asked a series of questions examining opioid usage, postoperative pain, what they did with unused opioids, and whether they had received education on disposal techniques. A chart review was utilized to determine the amount of opioid prescribed, the presence of any operative complications, and medical and demographic characteristics of subjects. RESULTS: A total of 53 subjects met inclusion criteria, of which 31 participated in a phone interview. Of the 53 subjects, 54.7% received a postoperative opioid prescription, and all but two of these subjects filled their prescription. Of the interviewed subjects, only 66.6% who filled a prescription reported using opioids Fifty percent (n=6) of patients that required oxycodone reported use of four tablets (30 morphine milligram equivalents (MMEs)) or less and used for 1-2 days postoperatively. No patient reported using opioids beyond five days. Only 22.2% reported receiving instruction on opioid disposal, and 16.7% returned unused opioids to a disposal center. 87.1% of subjects rated postoperative pain as "better" or "much better" than expected. CONCLUSION: Patients undergoing isolated MUS placement require limited amounts of postoperative opioids, if any are needed at all, to achieve satisfactory pain control. Excess prescribed opioids, along with inadequate patient education on proper disposal techniques, may contribute towards opioids that are at risk of diversion for nonmedical use.

Natural history of urinary incontinence from first childbirth to 30-months postpartum.

PURPOSE: The objectives of this study were to determine the incidence of UI in a large cohort of primiparous women before and during pregnancy and over the course of 30-months postpartum, and to identify risk factors for UI during and after pregnancy. METHODS: Nulliparous women aged 18-35 years with singleton pregnancies were interviewed in their third trimester and asked about urinary incontinence before and during pregnancy (n = 3001). After delivery these women were interviewed at 1, 6, 12, 18, 24 and 30-months postpartum and asked about urinary incontinence occurring in the month prior to each interview. Multivariable logistic regression models identified risk factors for UI during pregnancy and during the follow-up period. RESULTS: Overall, 4% reported having urinary incontinence before pregnancy and 36.8% during pregnancy. The strongest predictor of urinary incontinence during pregnancy was urinary incontinence before pregnancy (adjusted OR 13.11, 95% CI 7.43-23.13). Among the women with no subsequent pregnancies, the rate of urinary incontinence increased from 12.5% at 6-months postpartum to 27.4% at 30-months postpartum, 52.1% reported UI at one or more postpartum data collection stages, and the strongest predictors of postpartum UI were UI before pregnancy (adjusted OR 3.95 (95% CI 1.60-9.75) and during pregnancy (adjusted OR 4.36, 95% CI 3.24-5.87). CONCLUSION: Our findings suggest that primiparous women who report UI before and during pregnancy should be monitored for the continuation or worsening of UI over the course of the first 2-3 years postpartum, and treatment options discussed.

Postoperative Opioid Filling Patterns in Women Undergoing Midurethral Sling Placement.

OBJECTIVE: To evaluate postoperative opioid filling patterns for patients undergoing isolated midurethral sling placement. METHODS: Patients undergoing midurethral sling placement from 2005 to 2016 were identified in the Truven Health MarketScan database. We determined whether sling placement was an isolated procedure or performed in conjunction with other benign gynecologic procedures. All outpatient prescription drug claims for opioids were extracted from 28 days before surgery to 28 days after surgery. We identified the number of prescriptions filled and calculated morphine milligram equivalents (MMEs) in the allotted perioperative windows. The proportion of patients with opioid prescription claims and cumulative MMEs were compared for multiple versus isolated procedures using χ2 and Wilcoxon tests, respectively. RESULTS: The cohort included 153,631 patients, with 79,069 (51.5%) having an isolated procedure and 74,562 (48.5%) having multiple benign procedures. Seventy-two percent of the patients undergoing isolated midurethral sling placement received at least 1 opioid prescription in the study period compared with 79% of those undergoing combined procedures (P < 0.001). The median cumulative MMEs for isolated midurethral sling and midurethral sling + multiple procedures were 150 and 225 MMEs, respectively (P < 0.001). Across the years under study, the proportion of patients filling opioid prescription claims increased, but the median cumulative MME was unchanged. CONCLUSIONS: Patients undergoing isolated midurethral sling placement filled a median of 150 cumulative MMEs, and the proportion of patients filling perioperative opioid prescriptions increased over the study period.

Pelvic Organ Prolapse Severity and Genital Hiatus Size With Long-Term Pessary Use.

OBJECTIVES: To evaluate the association between pessary use more than 1 year and change in prolapse severity. METHODS: This is a secondary analysis of a previously published randomized controlled trial of women undergoing office management of pessaries for management of symptomatic pelvic organ prolapse and incontinence. Primary outcome was change in pelvic organ prolapse quantification measurement genital hiatus (GH). Secondary outcomes included change in prolapse stage, type of pessary, size of pessary, number of pessary changes, and duration of use. Baseline data were collected from the earliest documented examination within the hospital record before pessary placement and compared with their final study visit. Demographics were analyzed using descriptive statistics. Student t test and Mann-Whitney tests were used for categorical comparisons. Pearson and Spearman correlation coefficients were used to evaluate change over time. RESULTS: The cohort was 132 predominantly non-Hispanic White (75%) women with symptomatic prolapse >stage 2 (70.5%). All were postmenopausal. Median duration of pessary use was 39.5 months (interquartile range, 17-64.5 months). Genital hiatus (P = 0.014) and prolapse stage (P = 0.001) decreased as duration of pessary use increased. Those with baseline stages ≥3 had a significant decrease in GH as duration of pessary use increased compared with stages <3 (-0.5 cm vs 0 cm, P < 0.001). There was no difference in change in GH when comparing women with baseline GH less than 3 to 3 cm or greater. CONCLUSIONS: Pessary use by women with pelvic organ prolapse causes a change in vaginal anatomy over time as seen by decreasing stage and point GH.

Evaluating Postoperative Morbidity in Patients Undergoing Pelvic Reconstructive Surgery Using the American College of Surgeons National Surgical Quality Improvement Program Surgical Risk Calculator.

OBJECTIVE: The aim of this study was to evaluate the ability of the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) surgical risk calculator to predict surgical morbidity in patients undergoing pelvic reconstructive surgery. METHODS: This was a retrospective study of patients who underwent pelvic reconstructive surgery from 2014 to 2017. Preoperative risk factors were abstracted from medical records and entered into the ACS NSQIP surgical risk calculator. The Current Procedural Terminology code that produced the largest risk was used and compared with actual patient outcomes. Demographic, clinical, and surgical characteristics were analyzed descriptively. Logistic regression evaluated significant factors associated with each outcome; prediction capability of the risk calculator was assessed. RESULTS: Seven hundred thirty-one surgical cases were reviewed. The cohort was predominantly younger than 65 years (58.7%), white (77.4%), multiparous (81.1%), and overweight (64.7%); 76.3% were American Society of Anesthesiologists class 2, and 70.2% had vaginal surgery. There was no difference in median risk scores between those with and without postoperative event. Two hundred twenty-one (30.3%) experienced "any serious complication," with 89% of these due to urinary tract infection. Incidence of urinary tract infection was 27%; readmission was 3.2%, and 3.6% returned to the operating room. Decreasing age was predictive of return to the operating room (P < 0.001), and increasingly worse functional status predicted discharge to nursing or skilled rehabilitation facility (P < 0.001). CONCLUSIONS: The ACS NSQIP surgical risk calculator is an overall poor predictor of actual outcomes in a sample of patients who underwent pelvic reconstructive surgery, perhaps because of low prevalence of serious events. A more accurate surgical risk calculator is needed for this patient population.

A Comparison of Two Methods of Catheter Management After Pelvic Reconstructive Surgery: A Randomized Controlled Trial.

OBJECTIVE: To compare effects on activity between two catheter management systems after failed voiding trial after pelvic reconstructive surgery. METHODS: Women with a failed postoperative voiding trial after reconstructive pelvic surgeries were randomized to plug-unplug or continuous drainage catheters. The primary outcome was a mean activity assessment scale score. Secondary outcomes included urinary tract infection (UTI), time to passing outpatient voiding trial, and patient satisfaction. Enrollees who passed the voiding trial were assigned to a "Reference" arm. Ninety participants (30 per arm) provided more than 80% power to detect an effect size of 0.33 in the primary outcome, using a two-sided alpha of 0.05. RESULTS: Sixty-three patients were randomized (32 plug-unplug, 31 continuous drainage). The first 30 participants discharged without a catheter comprised the reference arm. There was no difference in postoperative activity assessment scale scores (total: plug-unplug 70.3, continuous drainage 67.7, reference arm 79.4; P=.090) between arms. Women in the continuous drainage arm noted more difficulty compared with the plug-unplug arm when managing the catheter "during the day" (P=.043) and "all the time" (P=.049) and felt the catheter impeded activities (P=.012) and wearing clothes (P=.005). The catheter arms had significantly higher rates of culture-positive UTI compared with the reference arm (58.7% vs 6.7%, P<.001). However, rate of UTI did not differ between catheter arms (plug-unplug, 68.8% vs continuous drainage, 48.4%, P=.625). The majority of patients passed their outpatient voiding trials at the initial postoperative visit (plug-unplug 71.9%, continuous drainage 58.1%, P=.250). There was no difference in patient satisfaction, with the majority reporting they were "very satisfied" (plug-unplug 78.1%, continuous drainage 80.0%, reference 66.7%, P=.202). CONCLUSION: Postoperative activity does not differ in patients discharged with plug-unplug or continuous drainage catheters, but those with plug-unplug perceive easier management and ability to complete activities of daily living. The plug-unplug method is an acceptable alternative to traditional catheterization after pelvic reconstructive surgery. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03071211.

Postoperative Catheter Management After Pelvic Reconstructive Surgery: A Survey of Practice Strategies.

OBJECTIVE: The aim of this study was to evaluate practice preferences in catheter management after a failed inpatient voiding trial after pelvic reconstructive surgery. METHODS: This is a cross-sectional study of postoperative catheter management after pelvic reconstructive surgery after failed voiding trial. Physicians practicing at ACGME-accredited residencies and fellowships in Obstetrics and Gynecology (Ob/Gyn), Urology, and Female Pelvic Medicine and Reconstructive Surgery (FPMRS) within the United States completed a Web-based questionnaire in March 2017. Respondents were asked about voiding trial protocols, definitions of abnormal postvoid residual (PVR), type of catheterization used after failed voiding trials, and antibiotic use. Primary outcome was type of catheterization after failure of an inpatient voiding trial. Data were analyzed using χ statistical tests. RESULTS: One hundred five respondents had a mean age of 36.5 years (range, 36 years). A total of 45.9% of participants practiced in FPMRS, 36.5% in Ob/Gyn, and 17.6% in Urology. Catheters were discontinued most frequently by postoperative day 1 after all procedures. Distribution of catheterization by specialty differed. Clean-intermittent straight catheterization had the greatest prevalence in all specialties and was the highest, by percentage, in Urology (33% Ob/Gyn, 40.6% FPMRS, and 69% Urology); P = 0.026. Type of catheterization differed significantly between Ob/Gyn and FPMRS respondents (P = 0.045). A total of 77.7% measured PVR by ultrasound and 22.3% performed catheterization. This distribution was similar across the specialties (70% Ob/Gyn, 79% FPMRS, and 100% Urology; P = 0.092). Abnormal PVR was defined most frequently as 150 mL or greater (30.5%). A minority of respondents routinely administer antibiotics during catheterization (17.1%). Duration and time until repeat voiding trial varied from 1 day to 2 weeks. CONCLUSIONS: Practice variability in catheterization after pelvic reconstructive and incontinence surgery is high. Distribution of catheterization type by specialty varies significantly, with clean-intermittent straight catheterization most prevalent. Future studies are necessary to establish a consensus on optimal catheterization management technique for patients with acute postoperative voiding dysfunction.

Use of the Pelvic Organ Quantification System (POP-Q) in published articles of peer-reviewed journals.

INTRODUCTION AND HYPOTHESIS: The Pelvic Organ Quantification (POP-Q) system is a standardized technique used for staging POP. This study aimed to examine POP-Q use in peer-reviewed publications. METHODS: Nine journals representative of urogynecology were reviewed for articles describing POP staging from January to December 2012 and 2015. Review articles, editorials, letters and articles with or without retractions in manuscript form were excluded. The primary outcome was frequency of POP-Q use. Secondary outcomes were POP-Q use by journal specialty, specialty of primary author, country of origin, and an anatomic definition of failure. Data were evaluated using chi-square tests. Results yielding p < 0.05 were deemed statistically significant. RESULTS: Two hundred and nineteen articles were reviewed. POP-Q was used in 88.4% in 2012 and 80% in 2015(not significant; p = 0.296). Urologists used the POP-Q least frequently, although its use was greater in 2015 (63.6%) than in 2012 (50%). In 2012, a definition for anatomic failure was present in 27% of articles; 23% of authors in the 2012 time frame reported using the POP-Q, and 17.8% used a specific POP-Q point. Between 2012 and 2015, the use of a specific point significantly decreased (17.8 vs. 7.8%, p = 0.033). CONCLUSION: POP-Q is the most common staging system used in published articles across studied subgroups. When used as an outcome measure, a greater number of authors use the recommended staging system rather than specific points.