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Objective: To describe the psychometric properties of existing patient-reported outcome measures for women with prolapse using the COSMIN (Consensus-Based Standards for the Selection of Health Measurement Instruments) framework. Additional objectives were to describe the patient-reported outcome scoring method or interpretation, methods of administration, and to compile a list of the non-English languages in which the patient-reported outcomes are reportedly validated., Data Sources: PubMed and EMBASE was searched through September 2021. Study characteristics, patient-reported outcome details, and psychometric testing data were extracted. Methodologic quality was assessed with COSMIN guidelines., Methods of Study Selection: Studies reporting the validation of a patient-reported outcome in women with prolapse (or women with pelvic floor disorders that included a prolapse assessment) and reporting psychometric testing data on English-language patient-reported outcome for at least one measurement property per COSMIN and the U.S. Department of Health and Human Services definitions were included, as well as studies reporting the translation of an existing patient-reported outcome into another language, a new method of patient-reported outcome administration, or a scoring interpretation. Studies reporting only pretreatment and posttreatment scores, only content or face validity, or only findings for nonprolapse domains of the patient-reported outcome were excluded., Tabulation, Integration, and Results: Fifty-four studies covering 32 patient-reported outcomes were included; 106 studies assessing translation into a non-English language were excluded from the formal review. The number of validation studies per patient-reported outcome (one version of one questionnaire) ranged from 1 to 11. Reliability was the most reported measurement property, and most measurement properties received an average rating of sufficient. The condition-specific patient-reported outcomes had on average more studies and reported data across more measurement properties compared with adapted and generic patient-reported outcomes., Conclusion: Although measurement property data vary on patient-reported outcomes for women with prolapse, most data were of good quality. Overall, condition-specific patient-reported outcomes had more studies and reported data across more measurement properties., Systematic Review Registration: PROSPERO, CRD42021278796., Competing Interests: Financial Disclosure Jon F. Pennycuff reports receiving payment from Corneille Law, LLC. Rebecca G. Rogers reports receiving royalties from UpToDate, IUGA, and ABOG. The other authors did not report any potential conflicts of interest., (Copyright © 2023 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Objective: To evaluate the effects of old age and frailty on complication rates after surgery for pelvic organ prolapse., Methods: The American College of Surgeons' National Surgical Quality Improvement Program database was used to identify patients who underwent surgery for prolapse from 2010 to 2017. We compared our control group (45-64 years, index population) to those aged 65-79 years (elderly) and 80 years and older (very elderly). Frailty was assessed using the National Surgical Quality Improvement Program Modified Frailty Index-5. The primary outcome was the composite rate of serious complications and mortality., Results: We analyzed 27,403 patients in the index population, 20,567 in the elderly group, and 3,088 in the very elderly group. The composite rate of serious complications in the index population was 4.5%, compared with 4.7% in the elderly group (odds ratio [OR] 1.0, 95% CI 0.9-1.1) and 9.0% in the very elderly group (OR 2.1, 95% CI 1.8-2.4). Compared with the index group, the very elderly group had notably elevated risks of cardiac complications (OR 11.9, 95% CI 6.2-23.0), stroke (OR 26.6, 95% CI 5.4-131.8), and mortality (OR 39.9, 95% CI 8.6-184.7). On multivariate logistic regression, the only age group independently associated with serious complications was the very elderly group (adjusted odds ratio [aOR] 2.01, 95% CI 1.8-2.3). The Modified Frailty Index-5 score was independently predictive of complications (aOR 1.4, 95% CI 1.1-2.0). Stratified analysis using interaction terms revealed the Modified Frailty Index-5 score to be predictive of complications in the elderly age group (aOR 2.5, 95% CI 1.3-4.6), but not in the very elderly group., Conclusion: Serious complications surrounding prolapse surgery increase substantially in the cohort of patients older than 80 years of age, independent of frailty and medical or surgical risk factors.

Objective: To develop and externally validate a prediction model for anticholinergic response in patients with overactive bladder (OAB)., Methods: A machine learning model to predict the likelihood of anticholinergic treatment failure was constructed using a retrospective data set (n=559) of female patients with OAB who were treated with anticholinergic medications between January 2010 and December 2017. Treatment failure was defined as less than 50% improvement in frequency, urgency, incontinence episodes, and nocturia, and the patient's subjective impression of symptomatic relief. Patients were stratified by age (younger than 40 years, 40-60 years, and older than 60 years), and number of previously failed medications. K-fold stratified cross-validation was performed on each stratum using machine learning algorithms. Of these, the random forest model was the most accurate. This model was refined using internal cross validation within each stratum. The area under the curve (AUC) was calculated for each stratum and used to identify the optimal operating points for prediction of treatment failure. The random forest model was then externally validated using a prospectively collected data set (n=82) of women treated with anticholinergic medications at a different clinical site between January 2018 and December 2018., Results: The global accuracy of the final model was 80.3% (95% CI 79.1-81.3), and the AUC was 0.77 (95% CI 0.74-0.79). Using the external validation data set, the model's sensitivity and specificity was 80.4% (95% CI 66.5-89.7%) and 77.4% (95% CI 58.6-89.7%), respectively. The model performed best in women aged younger than 40 years (AUC 0.84, 95% CI 0.81-0.84) and worst in women aged older than 60 years who had previously failed medication (AUC 0.71, 95% CI 0.67-0.75)., Conclusion: Our externally validated machine learning prediction model can predict anticholinergic treatment failure during the standard 3-month treatment trial period with greater than 80% accuracy. The model can be accessed at https://oabweb.herokuapp.com/app/pre/.

Objective: To compare the reoperation rates for recurrent stress urinary incontinence (SUI) after retropubic and transobturator sling procedures., Methods: We conducted a retrospective cohort study of all women who underwent midurethral sling procedures at a single institution for primary SUI between 2002 and 2012. To minimize bias, women in the two groups were matched on age, body mass index, isolated compared with combined procedure, and preoperative diagnosis. The primary outcome was defined as reoperation for recurrent SUI. Secondary outcomes included intraoperative complications and mesh-related complications requiring reoperation after the index sling procedure., Results: We identified 1,881 women who underwent a sling procedure for primary SUI-1,551 retropubic and 330 transobturator. There was no difference between groups in any of the evaluated baseline variables in the covariate-matched cohort of 570 with retropubic slings and 317 with transobturator slings; results herein are based on the covariate-matched cohort. Women undergoing a transobturator sling procedure had an increased risk of reoperation for recurrent SUI compared with women undergoing a retropubic sling procedure (hazard ratio 2.42, 95% CI 1.37-4.29). The cumulative incidence of reoperation for recurrent SUI by 8 years was 5.2% (95% CI 3.0-7.4%) in the retropubic group and 11.2% (95% CI 6.4-15.8%) in the transobturator group. Women in the retropubic group had a significantly higher rate of intraoperative complications compared with women in the transobturator group (13.7% [78/570] vs 4.7% [15/317]; difference=9.0%, 95% CI for difference 5.3-12.6%); the majority of this difference was due to bladder perforation (7.0% [40/570] vs 0.6% [2/317]; difference=6.4%, 95% CI for difference 4.1-8.7%). The cumulative incidence of sling revision for urinary retention plateaued at 3.2% and 0.4% by 5 years in the two groups., Conclusion: Women with primary SUI treated with a retropubic sling procedure have significantly lower cumulative incidence of reoperation for recurrent SUI compared with women who were treated with a transobturator sling procedure. Retropubic slings were associated with a higher risk of sling revision for urinary retention.

This month we focus on current research in chronic pelvic pain. Dr. El-Nashar discusses four recent publications, which are concluded with a "bottom-line" that is the take-home message. A complete reference for each can be found on on this page along with direct links to abstracts.

Objective: To report rates and identify risk factors for urinary tract infection (UTI) after hysterectomy for benign conditions or combined with pelvic reconstructive surgery., Methods: This is a cohort study that included women who underwent hysterectomy either for benign gynecologic conditions or hysterectomy combined with pelvic reconstructive surgery from January 1, 2012, through June 30, 2014, at a single institution. The primary outcome was UTI within 8 weeks of surgery. Logistic regression modeling was used to develop a model for predicting UTI after surgery., Results: Of 1,156 women included in the study, 136 (11.8%, 95% CI 10.0-13.8) developed UTI within 8 weeks. Women who underwent hysterectomy for a benign gynecologic condition that was not combined with pelvic reconstructive surgery had an overall UTI rate of 7.3% (95% CI 5.6-9.3) vs 21.7% (95% CI 17.6-26.4) after hysterectomy combined with pelvic reconstructive surgery. After adjusting for hormone therapy use, the following were independent variables associated with postoperative UTI: premenopausal status with an adjusted odds ratio (OR) of 1.80 (95% CI 1.11-2.99), anterior vaginal wall prolapse with an adjusted OR of 4.39 (95% CI 2.77-6.97), and postvoid residual greater than 150 mL with an adjusted OR of 2.38 (95% CI 1.12-4.36). Using this model, postoperative UTI rates ranged from 4.3% to 59.4% with high postvoid residual and presence of anterior prolapse having the strongest association., Conclusion: There are wide variations in the rate of UTI after hysterectomy for begin disease including pelvic reconstructive surgery. These variations can be explained with a model based on available preoperative data.

Objective: To estimate whether the cost of hysterectomy varies by geographic region., Methods: This was a cross-sectional, population-based study using the 2013 Healthcare Cost and Utilization Project National Inpatient Sample of women older than 18 years undergoing inpatient hysterectomy for benign conditions. Hospital charges obtained from the National Inpatient Sample database were converted to actual costs using cost-to-charge ratios provided by the Healthcare Cost and Utilization Project. Multivariate regression was used to assess the effects that demographic factors, concomitant procedures, diagnoses, and geographic region have on hysterectomy cost above the median., Results: Women who underwent hysterectomy for benign conditions were identified (N=38,414). The median cost of hysterectomy was $13,981 (interquartile range $9,075-29,770). The mid-Atlantic region had the lowest median cost of $9,661 (interquartile range $6,243-15,335) and the Pacific region had the highest median cost, $22,534 (interquartile range $15,380-33,797). Compared with the mid-Atlantic region, the Pacific (adjusted odds ratio [OR] 10.43, 95% confidence interval [CI] 9.44-11.45), South Atlantic (adjusted OR 5.39, 95% CI 4.95-5.86), and South Central (adjusted OR 2.40, 95% CI 2.21-2.62) regions were associated with the highest probability of costs above the median. All concomitant procedures were associated with an increased cost with the exception of bilateral salpingectomy (adjusted OR 1.03, 95% CI 0.95-1.12). Compared with vaginal hysterectomy, laparoscopic and robotic modes of hysterectomy were associated with higher probabilities of increased costs (adjusted OR 2.86, 95% CI 2.61-3.15 and adjusted OR 5.66, 95% CI 5.11-6.26, respectively). Abdominal hysterectomy was not associated with a statistically significant increase in cost compared with vaginal hysterectomy (adjusted OR 1.01, 95% CI 0.91-1.09)., Conclusion: The cost of hysterectomy varies significantly with geographic region after adjusting for confounders.

Objective: To compare the long-term risks associated with salpingo-oophorectomy with ovarian conservation at the time of benign hysterectomy., Data Sources: MEDLINE, ClinicalTrials.gov, and the Cochrane Central Register of Controlled Trials were searched from inception to January 30, 2015. We included prospective and retrospective comparative studies of women with benign hysterectomy who had either bilateral salpingo-oophorectomy (BSO) or conservation of one or both ovaries., Methods of Study Selection: Reviewers double-screened 5,568 citations and extracted eligible studies into customized forms. Twenty-six comparative studies met inclusion criteria. Studies were assessed for results, quality, and strength of evidence., Tabulation, Integration, and Results: Studies were extracted for participant, intervention, comparator, and outcomes data. When compared with hysterectomy with BSO, prevalence of reoperation and ovarian cancer was higher in women with ovarian conservation (ovarian cancer risk of 0.14-0.7% compared with 0.02-0.04% among those with BSO). Hysterectomy with BSO was associated with a lower incidence of breast and total cancer, but no difference in the incidence of cancer mortality was found when compared with ovarian conservation. All-cause mortality was higher in women younger than age 45 years at the time of BSO who were not treated with estrogen replacement therapy (hazard ratio [HR] 1.41, 95% confidence interval [CI] 1.04-1.92). Coronary heart disease (HR 1.26, 95% CI 1.04-1.54) and cardiovascular death were higher among women with BSO (HR 1.84, 95% CI 1.27-2.68), especially women younger than 45 years who were not treated with estrogen. Finally, there was an increase in the prevalence of dementia and Parkinson disease among women with BSO compared with conservation, especially in women younger than age 50 years. Clinical practice guidelines were devised based on these results., Conclusion: Bilateral salpingo-oophorectomy offers the advantage of effectively eliminating the risk of ovarian cancer and reoperation but can be detrimental to other aspects of health, especially among women younger than age 45 years., Competing Interests: Financial Disclosure The authors did not report any potential conflicts of interest.

Objective: To identify independent risk factors for cesarean delivery after induction of labor and to develop a nomogram for predicting cesarean delivery among nulliparous women undergoing induction of labor at term., Methods: This is a retrospective cohort study including nulliparous women with singleton, term (37 0/7 weeks of gestation or greater), cephalic pregnancies undergoing induction of labor from July 1, 2006, through May 31, 2012, at a tertiary care academic center. Inductions were identified using International Classification of Diseases, 9th Revision codes. Demographic, delivery, and outcome data were abstracted manually from the medical record. Women with a contraindication to vaginal delivery (malpresentation, abnormal placentation, prior myomectomy) were excluded. Independent risk factors for cesarean delivery were identified using logistic regression., Results: During the study period, there were 785 nulliparous inductions that met study criteria; 231 (29.4%) underwent cesarean delivery. Independent risk factors associated with an increased risk of cesarean delivery included older maternal age, shorter maternal height, greater body mass index, greater weight gain during pregnancy, older gestational age, hypertension, diabetes mellitus, and initial cervical dilation less than 3 cm. A nomogram was constructed based on the final model with a bias-corrected c-index of 0.709 (95% confidence interval 0.671-0.750)., Conclusion: We identified independent risk factors that can be used to predict cesarean delivery among nulliparous women undergoing induction of labor at term. If validated in other populations, the nomogram could be useful for individualized counseling of women with a combination of identifiable antepartum risk factors., Level of Evidence: II.

Objective: To evaluate the accuracy of hysterosalpingography (HSG) in patients who underwent concomitant radiofrequency endometrial ablation and hysteroscopic sterilization., Methods: This historical cohort study was conducted at a midwestern academic medical center. A total of 186 women (94 with combined procedure and 92 with sterilization alone) were identified as having undergone intervention between January 1, 2003, and June 30, 2011. Two reviewers blinded to the surgical procedure interpreted the standard clinically indicated HSGs in each group., Results: The primary outcome assessed was the inability to rely on the microinserts for contraception based on HSG interpretation using manufacturers' guidelines (unsatisfactory HSG). Position of the devices and occlusion of tubes were assessed on all 3-month and, when available, all 6-month repeat HSGs. At the 3-month HSG, 5 of 76 (6.6%, 95% confidence interval [CI] 2.2-14.7%) in the sterilization-only group had unsatisfactory HSG compared with 13 of 71 (18.3%, 95% CI 10.1-29.3%) in the combined group (P=.03). After accounting for the seven patients who underwent repeat HSG at 6 months, 3 of 76 (3.95%, 95% CI 0.8-11.1%) in the sterilization-only group had unsatisfactory HSG compared with 13 of 71 (18.31%, 95% CI 10.1-29.3%) in the combined group (P=.005)., Conclusion: After completing all clinically indicated HSGs, patients who undergo concomitant radiofrequency endometrial ablation and hysteroscopic sterilization have an approximate fivefold increase (odds ratio 5.45, 95% CI 1.48-20.0) in the rate of unsatisfactory HSG for purposes of documenting tubal occlusion., Level of Evidence: II.

Objective: To systematically review the literature on the proportion of emergent cesarean deliveries accomplished within 30 minutes, the mean time from decision-to-incision or delivery, and differences in neonatal outcomes in deliveries accomplished within 30 minutes compared to beyond 30 minutes., Data Sources: Electronic databases (Ovid MEDLINE and EMBASE and www.clinicaltrials.gov) were searched from inception to January 2013., Methods of Study Selection: Eligible studies reported decision-to-incision time or delivery time intervals for nonelective cesarean deliveries. Both emergent and urgent deliveries (also known as category 1 and category 2 deliveries) were included. Two reviewers independently identified studies for inclusion., Tabulation, Integration, and Results: Out of 737 reports identified in the primary search, 34 studies (22,936 women) met eligibility criteria. Seventy-nine percent (95% confidence interval [CI] 61-97%) of category 1 deliveries and 36% (95% CI 24-48%) of category 2 deliveries were achieved within 30 minutes, with significantly shorter time in category 1 compared to category 2 deliveries (21.2 compared with 42.6 minutes; P<.001). In the 13 studies that included neonatal outcomes, there was a higher risk of overall 5-minute Apgar score less than 7 (odds ratio [OR] 3.10; 95% CI 1.93-4.96) and umbilical artery pH level less than 7.10 (OR 3.40; 95% CI 2.38-4.87) in cases involving shorter delivery intervals. However, analyses limited to category 1 deliveries did not show a statistically greater risk of Apgar score less than 7 (OR 0.69; 95% CI 0.11-4.51) or umbilical artery pH level less than 7.10 (OR 1.10; 95% CI 0.28-4.40) with shorter delivery intervals. There was no difference by delivery interval in admission to neonatal intensive care units or special newborn units (OR 1.23; 95% CI 0.90-1.68)., Conclusion: Delivery within 30 minutes was not achieved in a substantial proportion of cases. The clinical significance of failing to achieve this standard remains uncertain.

Objective: To determine factors predictive of bowel complications after gynecologic surgery and establish the added utility of computed tomography (CT) in the diagnostic process., Methods: Patients who underwent gynecologic surgery between January 2, 2008, and December 30, 2010, who had CT scans of the abdomen, pelvis, or abdomen and pelvis within 42 days for a suspected bowel complication were identified. Logistic regression analysis was used to identify factors predictive of bowel-related complications. The diagnostic accuracy of CT was compared among patient risk groups based on clinical suspicion (pretest probability) of bowel complications., Results: Among 205 eligible patients, 38 (18.5%) patients had a bowel-related complication. Mean time from surgery to CT was 12.4 (10.1) days. Clinical characteristics were used to develop a clinical model that included unexpected drainage from the drain, wound, or stoma (adjusted odds ratio [OR] 26.3, 95% confidence interval [CI] 3.1-224.4, P=.003), coronary artery disease (OR 10.7, CI 1.4-80.9, P=.022), laparotomy (compared with minimally invasive surgery) (OR 4.4, CI 1.1-17.2, P=.032), and age older than 45 years (OR 2.4, CI 0.7-8.8, P=.18). Addition of CT to clinical evaluation increased the predictive ability of the model (area under the curve) from 0.73 to 0.99. Among 57 low-risk patients, three with confirmed bowel-related complications would have been missed if CT was not performed. Among 13 high-risk patients, CT sensitivity was 70%, and it was negative for bowel complications in three patients subsequently confirmed to have serious complications (one anastomotic leak, two bowel perforations)., Conclusions: In patients who have undergone gynecologic surgery and have a high clinical probability of a postoperative bowel-related complication, CT alone may fail to accurately identify patients with serious complications., Level of Evidence: : II.

Objective: To evaluate intraoperative hypothermia as a predictor for morbidity after open abdominal surgery for ovarian cancer., Methods: This cohort study included 146 women with stage IIIC and IV ovarian cancer who underwent debulking surgery at our institution from January 1, 2001, through December 31, 2003. Hypothermia was defined as end operative temperature lower than 36°C. Early complications (occurring within 30 days of surgery) included: mortality, infectious morbidities, cardiovascular events, venous thromboembolic (VTE) events, anastomotic leak, readmission, and reoperation. Survival was also evaluated. Logistic regression models were used to adjust for known confounders., Results: The mean age was 63.9 ± 11.7 years; 46 (32%) patients had a body mass index higher than 30; mean operative time was 239 ± 85 minutes. There were five deaths perioperatively, all in the hypothermic group. Hypothermia was associated with an increased risk of any early complications (34 [42.0%] compared with 11 [16.9%]) with an adjusted odds ratio (OR) of 3.40 (95% confidence interval [CI] 1.48-8.33). For individual complications, hypothermic patients were at higher risk for VTE events with an adjusted OR of 3.53 (95% CI 1.02-16.44); infectious morbidity with an adjusted OR of 2.99 (95% CI 0.97-11.35); and reoperation with an adjusted OR of 4.96 (95% CI 0.80-95.7). The overall survival was shorter in hypothermic group with a median of 34 compared with 45 months (P=.045); this remained significant for an optimally resected subgroup with a median overall survival of 40 compared with 48 months (P=.049)., Conclusion: Surgical hypothermia is an independent predictor of early perioperative complications and overall survival after cytoreductive surgery for ovarian cancer. This is a critically important finding, because maintaining normothermia is an inexpensive modifiable factor, which could result in reduced morbidity.

Objective: To report rates of amenorrhea and treatment failure after global endometrial ablation and to estimate the association between patient factors and these outcomes by developing and validating prediction models., Methods: From January 1998 through December 2005, 816 women underwent global endometrial ablation with either a thermal balloon ablation or radio frequency ablation device; 455 were included in a population-derived cohort (for model development), and 361 were included in a referral-derived cohort (for model validation). Amenorrhea was defined as cessation of bleeding from immediately after ablation through at least 12 months after the procedure. Treatment failure was defined as hysterectomy or reablation for patients with bleeding or pain. Logistic and Cox proportional hazard regression models were used in model development and validation of potential predictors of outcomes., Results: The amenorrhea rate was 23% (95% confidence interval [CI] 19-28%) and the 5-year cumulative failure rate was 16% (95% CI 10-20%). Predictors of amenorrhea were age 45 years or older (adjusted odds ratio [aOR] 2.6, 95% CI 1.6-4.3); uterine length less than 9 cm (aOR 1.8, 95% CI 1.1-3.1); endometrial thickness less than 4 mm (aOR 2.7, 95% CI 1.2-6.3); and use of radio-frequency ablation instead of thermal balloon ablation (aOR 2.8, 95% CI 1.7-4.9). Predictors of treatment failure included age younger than 45 years (adjusted hazard ratio [aHR] 2.6, 95% CI 1.3-5.1); parity of 5 or greater (aHR 6.0, 95% CI 2.5-14.8); prior tubal ligation (aHR 2.2, 95% CI 1.2-4.0); and history of dysmenorrhea (aHR 3.7, 95% CI 1.6-8.5). After global endometrial ablation, 23 women (5.1%, 95% CI 3.2-7.5%) had pelvic pain, three (0.7%, 95% CI 0.1-1.9%) were pregnant, and none (95% CI 0-0.8%) had endometrial cancer., Conclusion: Population-derived rates and predictors of treatment outcomes after global endometrial ablation may help physicians offer optimal preprocedural patient counseling., Level of Evidence: II.

Objective: To evaluate the efficacy of global endometrial ablation in women with bleeding disorders who presented with menorrhagia., Methods: A records-linkage system was used to construct a retrospective cohort of 41 women with bleeding disorders (coagulopathy) and a reference group of 111 randomly selected women without bleeding disorders from a pool of 943 women who underwent global endometrial ablation (with thermal balloon ablation technology or bipolar radiofrequency ablation technology) for menorrhagia at Mayo Clinic (Rochester, Minnesota) from January 1995 through December 2005. Demographic data, type of global endometrial ablation therapy and reablation, and hysterectomy data were extracted from the database., Results: There was no significant difference in baseline age, parity, body mass index, uterine size, type of global endometrial ablation therapy, or duration of follow-up between the groups. Two women (5%) in the coagulopathy group had hysterectomy or reablation, compared with 8 (7%) in the reference group (Fisher exact test, P=.728). A Kaplan-Meier plot showed no difference in the time to treatment failure between the groups (log-rank test, P=.534). Procedural-related complications were generally minor and infrequent (9 of 152 [6%]). Complications were equally distributed in the coagulopathy (4 of 41) and reference groups (6 of 111) (Fisher exact test, P=.267)., Conclusion: Global endometrial ablation is an effective treatment choice for women with coagulopathy presenting with menorrhagia.