Nationwide assessment of practice variability in the utilization of hysteropexy at laparoscopic apical suspension for uterine prolapse.

BACKGROUND: Although hysteropexy has been used to preserve the uterus during uterine prolapse surgery for a long time, there is a scarcity of data that describe the nationwide patterns of use of this surgical procedure. OBJECTIVE: This study aimed to examine the national-level use and characteristics of hysteropexy at the time of laparoscopic apical suspension surgery for uterine prolapse in the United States. STUDY DESIGN: This cross-sectional study used data from the Healthcare Cost and Utilization Project's Nationwide Ambulatory Surgery Sample. The study population included 55,608 patients with a diagnosis of uterine prolapse who underwent laparoscopic apical suspension surgery from 2016 to 2019. Patients who had a hysterectomy were assigned to the hysterectomy group, and those who did not have a hysterectomy were assigned to the hysteropexy group. The main outcome was clinical characteristics associated with hysteropexy, assessed using a multivariable binary logistic regression model. A classification tree was further constructed to assess the use pattern of hysteropexy during laparoscopic apical suspension procedures. The secondary outcome was surgical morbidity, including urinary tract injury, intestinal injury, vascular injury, and hemorrhage. RESULTS: A hysteropexy was performed in 6500 (11.7%) patients. In a multivariable analysis, characteristics associated with increased use of a hysteropexy included (1) patient factors, such as older age, Medicare coverage, private insurance, self-pay, and medical comorbidity; (2) pelvic floor dysfunction factor of complete uterine prolapse; and (3) hospital factors, including medium bed capacity center and location in the Southern United States (all P<.05). Conversely, (1) the patient factor of higher household income; (2) gynecologic factors such as uterine myoma, adenomyosis, and benign ovarian pathology; (3) pelvic floor dysfunction factor with stress urinary incontinence; and (4) hospital factors including Midwest and West United States regions and rural setting center were associated with decreased use of a hysteropexy (all P<.05). A classification tree identified a total of 14 use patterns for hysteropexies during laparoscopic apical suspension procedures. The strongest factor that dictated the use of a hysteropexy was the presence or absence of uterine myomas; the rate of hysteropexy use was decreased to 5.6% if myomas were present in comparison with 15% if there were no myomas (P<.001). Second layer factors were adenomyosis and hospital region. Patients who did not have uterine myomas or adenomyosis and who underwent surgery in the Southern United States had the highest rate of undergoing a hysteropexy (22.6%). Across the 14 use patterns, the percentage rate difference between the highest and lowest uptake patterns was 22.0%. Patients who underwent a hysteropexy were less likely to undergo anteroposterior colporrhaphy, posterior colporrhaphy, and sling procedures (all P<.05). Hysteropexy was associated with a decreased risk for measured surgical morbidity (3.0 vs 5.4 per 1000 procedures; adjusted odds ratio, 0.57; 95% confidence interval, 0.36-0.90). CONCLUSION: The results of these current, real-world practice data suggest that hysteropexies are being performed at the time of ambulatory laparoscopic apical suspension surgery for uterine prolapse. There is substantial variability in the application of hysteropexy based on patient, gynecologic, pelvic floor dysfunction, and hospital factors. Developing clinical practice guidelines to address this emerging surgical practice may be of use.

Reconstructive Surgery at Hysterectomy for Patients With Uterine Prolapse and Gynecologic Malignancy.

In this cross-sectional study examining 211,708 patients with a diagnosis of uterine prolapse who underwent hysterectomy between 2016 and 2019 identified in the Healthcare Cost and Utilization Project's Nationwide Ambulatory Surgery Sample, co-diagnosis of gynecologic malignancy was reported in 2,398 (1.1%) patients, and they were less likely to receive reconstructive surgery at hysterectomy (odds ratio [OR] 0.90, 95% CI 0.84-0.96). This absence of reconstructive surgery was most pronounced among patients with complete uterine prolapse and gynecologic malignancy (OR 0.68, 95% CI 0.57-0.81). The association was also consistent in coexisting gynecologic premalignancy (n=3,357 [1.6%]). In conclusion, this national-level assessment suggests that patients with uterine prolapse and coexisting gynecologic malignancy or premalignancy may be less likely to receive reconstructive surgery for pelvic floor dysfunction at hysterectomy.

Rates of unanticipated premalignant and malignant lesions at the time of hysterectomy performed for pelvic organ prolapse in an underscreened population.

BACKGROUND: The rate of unanticipated premalignant or malignant pathology at the time of hysterectomy performed for pelvic organ prolapse has been previously reported to be 0.2%. It is not known whether this rate is similar in patients with limited access to regular medical care. OBJECTIVE: This study aimed to describe the rates of unanticipated premalignancy and malignancy at the time of hysterectomy performed for pelvic organ prolapse in an underscreened population and to determine the risk factors for unanticipated pathology. STUDY DESIGN: Hysterectomies performed for pelvic organ prolapse at a large public hospital between July 2007 and July 2019 were reviewed. Patients undergoing surgery for malignancy or premalignancy were excluded. Medical records were reviewed for demographic information, medical history, preoperative workup, and final pathology. Frequencies of abnormal pathologies were calculated. Demographic and screening factors were correlated with pathologic findings using the Fisher exact test or Mann-Whitney U test, as appropriate. This study was approved by the institutional review board. RESULTS: Between 2007 and 2019, 759 cases of pelvic organ prolapse were identified. Of 759 patients, 667 (87.9%) self-identified as Hispanic. The median age was 57 years old, and 505 of 759 patients (66.5%) were in the postmenopausal stage. Abnormal uterine bleeding history was present in 217 of 759 patients (28.6%). Of 759 patients, 493 (65.4%) underwent preoperative ultrasonography, and 290 (38.3%) underwent preoperative endometrial biopsy. Of the 744 uterine specimens that had available histology results, there were 2 cases of endometrial hyperplasia and 1 case of endometrial cancer. Of the 729 cervical specimens that were available for review, there was 1 case of intraepithelial neoplasia and 2 cases of cervical cancer. In the 246 patients who underwent oophorectomy, no ovarian malignancy was found. CONCLUSION: For patients undergoing hysterectomy for pelvic organ prolapse in an underscreened population, the rates of endometrial dysplasia or cancer were 0.40% (3/744), and the rates of cervical dysplasia or cancer were 0.42% (3/729). Our results underscore the importance of considering screening history when interpreting preoperative cervical and endometrial cancer screening. Consideration of higher negative predictive value tests, such as cytology with human papillomavirus cotesting and preoperative counseling on the risks and management strategies of unanticipated premalignancy or malignancy within this population may be reasonable.

Incidence, characteristics, and maternal outcomes of pregnancy with uterine prolapse.

BACKGROUND: Gravid uterine prolapse refers to abnormal descent of the uterus during pregnancy. It is a rare pregnancy complication and its clinical characteristics and obstetrical outcomes are not well understood. OBJECTIVE: This study aimed to assess the national-level incidence, characteristics, and maternal outcomes of pregnancies complicated by gravid uterine prolapse. STUDY DESIGN: This retrospective cohort study queried the Healthcare Cost and Utilization Project's National Inpatient Sample. The study population was 14,647,670 deliveries from January 2016 to December 2019. The exposure assignment was the diagnosis of uterine prolapse. The coprimary outcome measures were incidence rate, clinical and pregnancy characteristics, and delivery outcomes of patients with gravid uterine prolapse. The inverse probability of treatment weighting cohort was created to mitigate the difference in prepregnancy confounding factors, followed by adjusting for pregnancy and delivery factors. RESULTS: The incidence of gravid uterine prolapse was 1 in 4209 deliveries (23.8 per 100,000). In a multivariable analysis, older age (≥40 years; adjusted odds ratio, 3.21; 95% confidence interval, 2.70-3.81); age from 35 to 39 years (adjusted odds ratio, 2.66; 95% confidence interval, 2.37-2.99); Black (adjusted odds ratio, 1.48; 95% confidence interval, 1.34-1.63), Asian (adjusted odds ratio, 1.45; 95% confidence interval, 1.28-1.64), and Native American (adjusted odds ratio, 2.17; 95% confidence interval, 1.63-2.88) race/ethnicity; tobacco use (adjusted odds ratio, 1.19; 95% confidence interval, 1.03-1.37); grand multiparity (adjusted odds ratio, 1.78; 95% confidence interval, 1.24-2.55); and history of pregnancy losses (adjusted odds ratio, 2.20; 95% confidence interval, 1.48-3.26) were the patient characteristics associated with increased risk of gravid uterine prolapse. Current pregnancy characteristics associated with gravid uterine prolapse included cervical insufficiency (adjusted odds ratio, 3.25; 95% confidence interval, 1.94-5.45), preterm labor (adjusted odds ratio, 1.53; 95% confidence interval, 1.18-1.97), preterm premature rupture of membranes (adjusted odds ratio, 1.40; 95% confidence interval, 1.01-1.94), and chorioamnionitis (adjusted odds ratio, 1.64; 95% confidence interval, 1.18-2.28). Delivery characteristics associated with gravid uterine prolapse included early-preterm delivery at <34 weeks' gestation (69.1 vs 32.0 per 1000; adjusted odds ratio, 1.86; 95% confidence interval, 1.34-2.59) and precipitate labor (35.2 vs 20.1; adjusted odds ratio, 1.73; 95% confidence interval, 1.22-2.44). Moreover, risks of postpartum hemorrhage (112.1 vs 44.4 per 1000; adjusted odds ratio, 2.70; 95% confidence interval, 2.20-3.32), uterine atony (32.0 vs 15.7; adjusted odds ratio, 2.10; 95% confidence interval, 1.46-3.03), uterine inversion (9.6 vs 0.3; adjusted odds ratio, 31.97; 95% confidence interval, 16.60-61.58), shock (3.2 vs 0.7; adjusted odds ratio, 4.18; 95% confidence interval, 1.41-12.40), blood product transfusion (22.4 vs 11.1; adjusted odds ratio, 2.06; 95% confidence interval, 1.34-3.18), and hysterectomy (7.5 vs 2.3; adjusted odds ratio, 3.02; 95% confidence interval, 1.40-6.51) were increased in the gravid uterine prolapse group compared with the nonprolapse group. Conversely, patients with gravid uterine prolapse were less likely to deliver via cesarean delivery compared with those without gravid uterine prolapse (200.6 vs 322.8 per 1000; adjusted odds ratio, 0.51; 95% confidence interval, 0.44-0.61). CONCLUSION: This nationwide analysis suggests that pregnancy with gravid uterine prolapse is uncommon but associated with several high-risk pregnancy characteristics and adverse delivery outcomes.

Endometrial safety of low-dose vaginal estrogens.

ABSTRACT: It is estimated that up to 50% to 90% of postmenopausal women may experience genitourinary syndrome of menopause (GSM), which may have a detrimental impact on quality of life. One of the most effective modes of treatment of GSM is low-dose vaginal estrogens. Numerous studies have addressed the safety of these estrogens using endometrial biopsy and/or endometrial thickness on ultrasound. Based on these studies, the consensus is that low-dose vaginal estrogens do not substantially increase the risk of endometrial hyperplasia or cancer; however, the data are severely limited by short duration of follow-up. Although long-term trials are warranted, they are difficult to carry out, costly, and will not yield data for years. More immediate information regarding endometrial safety may be obtained from studies measuring endometrial tissue and serum concentrations of estradiol, estrone, and relevant equine estrogens after administration of different estrogen formulations and doses. This would allow us to understand better the metabolism of estrogens by the vagina and endometrium, and how much estrogen is reaching the endometrium. Here, we discuss metabolism, receptor binding, and signaling of estrogens in vaginal and endometrial tissue, and summarize the existing studies on the endometrial impact of low-dose vaginal estrogen treatment in postmenopausal women.

Quantitation of 5α-androstanedione in normal women and women with PCOS.

In vitro studies show that 5α-androstane-3,17-dione (5α-A) is an important intermediate in the formation of dihydrotestosterone (DHT) from androstenedione (A) in women and men. Many studies involving hyperandrogenism, hirsutism, and polycystic ovary syndrome (PCOS) have measured A, testosterone (T), and DHT, but not 5α-A due to lack of a readily available assay to quantify this androgen. We have developed a specific and sensitive radioimmunoassay to measure 5α-A levels, together with A, T, and DHT, in both serum and genital skin. The present study involves 2 cohorts. Cohort 1 included 23 mostly postmenopausal women who provided both serum and genital skin to measure those androgens. In cohort 2, serum androgen levels were compared between women with PCOS and non-PCOS controls. Tissue-to-serum ratios were significantly higher for 5α-A and DHT as compared to A and T. None of the androgens showed a significant correlation between serum and genital tissue. In serum, 5α-A was significantly correlated with A, T, and DHT. In cohort 2, A, T, and DHT were significantly higher in the PCOS group compared to the control group. In contrast, 5α-A levels were similar between the 2 groups. Our findings support the view that 5α-A is an important intermediate in DHT formation in genital skin. Also, the relatively low levels of 5α-A in PCOS women suggest that it may play a more important intermediate role in the conversion of A to androsterone glucuronide.

Estimated costs of preoperative evaluation of postmenopausal hysterectomy for prolapse at a safety-net hospital: an observational descriptive study.

BACKGROUND: In practice, preoperative evaluation prior to hysterectomy varies. Unnecessary preoperative evaluation may add cost and risk with little benefit to the patient. OBJECTIVE: This study aimed to describe practice patterns and the associated costs related to preoperative evaluations before hysterectomy for prolapse at a safety-net hospital. STUDY DESIGN: This was a retrospective cohort study of postmenopausal women who underwent a hysterectomy for prolapse. Nonfacility-associated cost data were obtained from the Centers for Medicare Services. The biopsy cost was estimated to be $172.55 and $125.23 for ultrasounds. RESULTS: A total of 505 postmenopausal cases were identified. Of those, 155 (31%) underwent a preoperative biopsy, 305 (60%) had an ultrasound, and 124 (25%) had both. Of those, 72.9% had an indication for a biopsy. A total of 64 biopsies and 216 ultrasounds lacked clear indication. Of those, 56 biopsies were performed for bleeding in cases with an endometrial thickness of <4 mm. The total cost of nonvalue-added testing was $42,576. CONCLUSION: Adherence to a strict preoperative algorithm would have saved $38,092 over the study period, although 0.50% of these biopsies would potentially have detected endometrial cancer preoperatively. These results underscore the value of clinical algorithms at teaching institutions.

Opioid Consumption After Urogynecologic Surgery: A Prospective Multicenter Observational Study Using a Text-Messaging Survey Tool.

IMPORTANCE: Understanding postoperative opioid consumption is key to reducing opioid misuse. OBJECTIVE: The aim of the study was to quantify the amount of outpatient opioids consumed after urogynecologic surgery. STUDY DESIGN: This is a prospective multicenter cohort study sponsored by the American Urogynecologic Society Fellow's Pelvic Research Network. Women undergoing pelvic organ prolapse or urinary incontinence surgery between May 2019 and January 2021 were included. Patients used text messaging to report daily opioid consumption, pain levels, and nonopioid analgesic consumption 2 weeks postoperatively. Demographic and perioperative factors associated with high opioid use (>75th percentile) were identified. RESULTS: Two hundred sixty-one patients were included from 9 academic centers. The median (interquartile range) morphine milligram equivalents (MME) consumed were 28 (0-65) and prescribed were 75 (50-113). The median ibuprofen and acetaminophen tablets consumed were 19 (10-34) and 12 (4-26). The median pain level was 2.7 of 10 (1.7-4.4). Factors associated with high MME use (>65 MME) included body mass index greater than 30 ( P < 0.01), chronic pain ( P < 0.01), elevated baseline pain score ( P < 0.01), elevated blood loss ( P < 0.01), longer operating time ( P < 0.01), and southern region ( P < 0.01). High MME consumers more frequently underwent perineorrhaphy ( P = 0.03), although this was not significant on multivariate analysis. CONCLUSIONS: Urogynecology patients consume a median of 28 MME (3-4 oxycodone 5-mg tablets) after surgery, and surgeons prescribe 3 times this amount (75 MME, 10 oxycodone tablets). In addition, there are several factors that can be used to identify patients who will require greater numbers of opioids. These data may be used to enhance existing prescribing guidelines.

Effect of prunes on gastrointestinal function after benign gynecological surgery: a randomized control trial.

OBJECTIVE: To investigate the effect of postoperative prune consumption on time to first bowel movement after benign gynecologic surgery. MATERIALS AND METHODS: In this randomized, open label, controlled trial, 77 adult women who had benign gynecologic surgery that required at least one night in the hospital were enrolled from July 2018 to April 2019. Participants were randomized in a 1:1 ratio to one of two groups using a randomization assignment: 4 oz prunes daily plus docusate sodium 100 g twice daily versus docusate alone. The study's primary objective was time to first bowel movement (BM). Secondary outcomes were pain associated with first BM, stool consistency using Bristol stool scale, and patient satisfaction with bowel regimen and surgery experience. RESULTS: Postoperative survey data was available for 68.4% of participants (n = 52). There was no difference in time to first BM between the two groups (p = 0.29); however, consumption of > 12 prunes was associated with an increased likelihood of having a BM in the study period. Among women who consumed at least 12 prunes, hospital discharge was earlier, and there was a not statistically significant greater satisfaction with postoperative bowel regimen. CONCLUSIONS: The addition of prunes to postoperative bowel regimen of docusate sodium may be a beneficial adjunct to postoperative bowel regimen. CLINICAL TRIAL: The Institutional Review Board at the University of Southern California approved the study, and the study was registered at clinicaltrials.gov (ID: NCT03523715).

Acceptability of Text Messaging and Disparities in Mobile Health Access in Women's Health Care: A Survey Study.

Objective: Few studies in women's health care have utilized text messaging as a data collection tool. Our aims were to (1) determine the willingness of Obstetrics and Gynecology (Ob/Gyn) patients to participate in text message surveys, (2) determine the patient-preferred mode of survey distribution, (3) compare preferences between a low-resource and university population, and (4) review the practical aspects of implementing text message surveys. Methods: Paper surveys were distributed to Ob/Gyn clinic patients at two academic centers. English and Spanish speakers were included. Questions assessed sociodemographic data, survey preferences, and text messaging preferences. Appropriate tests were used to look for associations between demographics and survey preferences. Results: One hundred eighty-two participants completed the survey. Respondents were seen at either a university (42%) or a safety net (58%) clinic. Most owned a mobile phone (94%), used text messaging everyday (88%), and had an unlimited data plan (83%). Of the respondents willing to participate in a survey, text messaging was the preferred survey method (70%), followed by phone (14%) and mobile applications (8%). Fifty-six percent of respondents were willing to participate in a daily text message survey. There were no associations between socioeconomic status and survey preferences or willingness to participate in text message surveys. Survey preference was associated with age (p < 0.01). Respondents of all age groups preferred text message surveys; however, those aged 31-60 years were most likely to prefer text messaging (odds ratio: 8.3, confidence interval: 2.6-29.8). Conclusions: Most Ob/Gyn patients are willing and able to participate in text message surveys, and text messaging is the most preferred survey method across sociodemographic categories.

Lavender Aromatherapy for Anxiety and Pain During Multichannel Urodynamics: A Randomized Controlled Pilot Trial.

OBJECTIVE: Our objective was to determine if there is a difference in anxiety during urodynamics in women given lavender aromatherapy (lavender) versus placebo. METHODS: This was a randomized, controlled trial of women scheduled for urodynamic testing with baseline anxiety. Participants rated their anxiety and pain immediately before the examination and then were randomized to lavender or placebo. Anxiety and pain were assessed immediately after catheter placement and 15 minutes after termination of the study. RESULTS: Data for 40 women who received lavender and 38 women who received placebo were available for analysis. Decrease in anxiety from baseline to catheter placement (-2 vs -0.5, P = 0.01) and 15 minutes post procedure was significantly greater in the lavender group. Postprocedure anxiety was lower in the lavender group compared with controls (0 vs 0.5, P = 0.001). No differences were seen in pain. CONCLUSIONS: Lavender aromatherapy reduces anxiety during urodynamics.

Translation and linguistic validation of the Female Genitourinary Pain Index in Spanish.

INTRODUCTION AND HYPOTHESIS: We sought to develop a Spanish translation of the Female Genitourinary Pain Index (GUPI) and to validate this instrument in US Latina women. METHODS: Translation back-translation was performed to create the initial Spanish version. Bilingual women with pelvic and/or genitourinary pain were recruited from clinical sites and social media. Participants reported demographics and completed the Female GUPI in both English and Spanish. Agreement was assessed for each item, subscale and total score. Additionally, we performed cognitive debriefing interviews to further test face validity. A consensus group of bilingual physicians and healthcare personnel utilized comments from the interviews to create a final Spanish version. RESULTS: Thirty-four participants completed the questionnaire. Their average age was 33 years, 80% reported attending some college, and 20% reported an undergraduate degree or higher. Most were born in mainland USA (57%) or Mexico (27%). Agreement for the pain, urinary and quality of life subscales between the English and Spanish versions of the measure were excellent (0.91, 0.89 and 0.92, respectively) with 0.96 agreement for the measure as a whole. Despite favorable psychometrics, preferences for alternate wording were reported over 50 times. Based on that feedback, a consensus group was formed, which recommended changes to 13 of the 15 items, 3 of which required complete rewriting. CONCLUSIONS: The Spanish Female GUPI is strongly correlated with the English original; however, participants reported the language was overly complex. Translation and validation should include review of the measure and feedback by the target audience for optimal clarity and readability.

Does Obtaining a Diagnosis of Interstitial Cystitis/Bladder Pain Syndrome Improve Symptoms or Quality of Life? A Cross-sectional Questionnaire-Based Study.

OBJECTIVES: The aim of this study was to investigate whether receiving a clinical diagnosis of interstitial cystitis (IC) or bladder pain syndrome (BPS) improves patients' symptoms, health-related quality of life (HRQOL), or ability to cope with their symptoms. METHODS: In this cross-sectional study, participants with self-reported IC/BPS completed an online questionnaire recalling their perceived change in symptoms after diagnosis and treatment. The questionnaire included demographic information, overall HRQOL measured on a visual analog scale (VAS), O'Leary-Sant Interstitial Cystitis Problem Index, the Urinary Impact Questionnaire, and questions regarding patient beliefs about diagnosis. HRQOL and symptom impact scales were compared before and after diagnosis and treatment. Demographic data, symptom data, and beliefs were examined for correlation with improvement in quality of life after diagnosis. RESULTS: A total of 1052 participants initiated the survey and were included in the analysis; most of them identified as female, non-Hispanic, and white (90%). Before symptom onset, median VAS HRQOL score was 87 (interquartile range [IQR], 77-95). Median scores nadired at 34 (IQR, 20-59) after symptom onset before diagnosis, but improved to 61 after diagnosis and treatment (IQR, 38-74; all P < 0.001). Scores remained stable after diagnosis and initiation of treatment with a median score of 65 at the time of survey (IQR, 37-80; P > 0.05). Age, insurance type, and improvement in scores on the symptom impact scale predicted improvement in HRQOL after diagnosis and treatment in the multivariable model. CONCLUSIONS: Participants reported improvements on global and symptom-specific quality of life measures after diagnosis and treatment for IC/BPS.

The Effect of a Diagnosis on Patients With Interstitial Cystitis/Bladder Pain Syndrome: A Qualitative Approach.

INTRODUCTION: Interstitial cystitis/bladder pain syndrome (IC/BPS) is a chronic pain condition that significantly affects patient quality of life. We investigated whether receiving a formal medical diagnosis of IC/BPS was perceived by patients to improve symptoms and disease-specific quality of life. METHODS: Participants with self-reported IC/BPS completed publicly available online surveys. Surveys included demographic information, validated questionnaires, and a free-text response. Participants were asked to comment on the utility of obtaining a diagnosis. Investigators coded the responses and analyzed the results using grounded theory methodology. RESULTS: Six hundred seventy-three participants who responded to the free-text were analyzed. The mean age of respondents was 52 years, with an average of 10 years since IC/BPS diagnosis. The IC/BPS pain syndrome diagnosis had wide ranging effects on both symptoms and coping. These effects were often mediated by improvements in perceived control and empowerment after diagnosis. Although most participants noted benefit after diagnosis of IC/BPS, some reported harmful effects ranging from stigmatization by providers to desperation when told that there was not a cure. CONCLUSIONS: A formal medical diagnosis of IC/BPS has a significant effect on patients who experience the condition. Although diagnosis usually improves symptoms and coping, a universal experience was not described by all IC/BPS patients. Given that most patients report improvement, more work is needed to expedite diagnosis. In addition, we must better understand factors associated with lack of symptom and quality of life improvement after an IC/BPS diagnosis has been made by medical providers.

Route-specific association of progestin therapy and concurrent metformin use in obese women with complex atypical hyperplasia.

INTRODUCTION: Previous studies have suggested that metformin use may enhance the therapeutic effect of progestin therapy for endometrial hyperplasia or malignancy. However, it is not known how the impact of concurrent metformin may be altered by route of progestin therapy, either locally via an intrauterine device or systemically. This study examined the effectiveness of concurrent metformin use and progestin therapy for women with complex atypical hyperplasia stratified by progestin route (systemic vs local). METHODS: This single-institution retrospective study examined consecutive women with complex atypical hyperplasia who received progestin therapy from 2003 to 2018. Time-dependent analyses for complete response rate were performed comparing concurrent metformin users versus non-users in the oral progestin group and in the levonorgestrel-releasing intrauterine device group. RESULTS: Across the study cohort (n=245), there were 137 (55.9%) women who responded to progestin therapy. In the oral progestin group (n=176), the median age and body mass index were 36 years and 37.7 kg/m2, respectively. 36 (20.5%) of women on oral progestins also took metformin. After controlling for diabetes status, women taking both oral progestins and metformin had a complete response rate similar to those not taking metformin (6 month cumulative rates, 23.1% vs 27.8%, adjusted hazard ratio (aHR) 0.71, 95% confidence interval (95% CI) 0.36 to 1.41). In the levonorgestrel-releasing intrauterine device group (n=69), the median age and body mass index were 35 years and 39.9 kg/m2, respectively. There were 15 (21.7%) women who took metformin in addition to the levonorgestrel-releasing intrauterine device. After controlling for diabetes status, women who had the levonorgestrel-releasing intrauterine device and took metformin had a significantly higher complete response rate compared with those not taking metformin (6 month cumulative rates, 86.7% vs 58.9%, aHR 2.31, 95% CI 1.09 to 4.89). CONCLUSION: In a predominantly obese population, concurrent metformin may possibly offer treatment benefit when used with the levonorgestrel-releasing intrauterine device.

Progestin therapy for obese women with complex atypical hyperplasia: levonorgestrel-releasing intrauterine device vs systemic therapy.

BACKGROUND: Though hysterectomy remains the standard treatment for complex atypical hyperplasia, patients who desire fertility or who are poor surgical candidates may opt for progestin therapy. However, the effectiveness of the levonorgestrel-releasing intrauterine device compared to systemic therapy in the treatment of complex atypical hyperplasia has not been well studied. OBJECTIVE: We sought to examine differences in treatment response between local progestin therapy with the levonorgestrel-releasing intrauterine device and systemic progestin therapy in women with complex atypical hyperplasia. METHODS: This single-institution retrospective study examined women with complex atypical hyperplasia who received progestin therapy between 2003 and 2018. Treatment response was assessed by histopathology on subsequent biopsies. Time-dependent analyses of complete response and progression to cancer were performed comparing the levonorgestrel-releasing intrauterine device and systemic therapy. A propensity score inverse probability of treatment weighting model was used to create a weighted cohort that differed based on treatment type but was similar with respect to other characteristics. An interaction-term analysis was performed to examine the impact of body habitus on treatment response, and an interrupted time-series analysis was employed to assess if changes in treatment patterns correlated with outcomes over time. RESULTS: A total of 245 women with complex atypical hyperplasia received progestin therapy (levonorgestrel-releasing intrauterine device n = 69 and systemic therapy n = 176). The mean age and body mass index were 36.9 years and 40.0 kg/m2, respectively. In the patient-level analysis, women who received the levonorgestrel-releasing intrauterine device had higher rates of complete response (78.7% vs 46.7%; adjusted hazard ratio, 3.32; 95% confidence interval, 2.39-4.62) and a lower likelihood of progression to cancer (4.5% vs 15.7%; adjusted hazard ratio, 0.28; 95% confidence interval, 0.11-0.73) compared to those who received systemic therapy. In particular, women with class III obesity derived a higher relative benefit from levonorgestrel-releasing intrauterine device therapy in achieving complete response compared to systemic therapy: class III obesity, adjusted hazard ratio 4.72, 95% confidence interval 2.83-7.89; class I-II obesity, adjusted hazard ratio 1.83, 95% confidence interval 1.09-3.09; and nonobese, adjusted hazard ratio 1.26, 95% confidence interval 0.40-3.95. In the cohort-level analysis, the obesity rate increased during the study period (77.8% to 88.2%, 13.4% relative increase, P = .033) and levonorgestrel-releasing intrauterine device use significantly increased after 2007 (6.3% to 82.7%, 13.2-fold increase, P < .001), both concomitant with a higher proportion of women achieving complete response (32.9% to 81.4%, 2.5-fold increase, P = .005). CONCLUSION: Our study suggests that local therapy with the levonorgestrel-releasing intrauterine device may be more effective than systemic therapy for women with complex atypical hyperplasia who opt for nonsurgical treatment, particularly in morbidly obese women. Shifts in treatment paradigm during the study period toward increased levonorgestrel-releasing intrauterine device use also led to improved complete response rates despite increasing rates of obesity.

Effectiveness of progestin-based therapy for morbidly obese women with complex atypical hyperplasia.

OBJECTIVE: While progestins can effectively treat women with complex atypical hyperplasia (CAH), the impact of body habitus on treatment outcome is not well studied. We examine the association between body mass index (BMI) and progestin treatment outcomes. METHODS: We conducted a retrospective cohort study of patients diagnosed with hyperplasia between 2003 and 2011. Demographics, past medical history, BMI, hormonal therapy, and histologic treatment response were abstracted. Patients with CAH who received progestin therapy were examined, and rates of regression were assessed. RESULTS: Of 623 patients identified, 117 had CAH and satisfied the inclusion criteria. Median age was 34, and nearly, two-thirds (64%) were nulliparous. Mean BMI was 40.2, and 81% were obese (BMI 30-39.9: 36%, BMI ≥ 40: 45%). 103 patients (88%) received systemic progestin therapy and 14 patients (12%) received levonorgestrel-releasing intrauterine devices (LNG-IUS). 47 patients (40%) had a complete response to progestin-based therapy. BMI had no effect on the rate of complete response. The proportions of CAH patients with complete regression after hormonal therapy were BMI < 30: 39%, 30-39.9: 40%, and ≥ 40: 36% (P = 0.73). Women treated with LNG-IUS displayed higher rates of complete regression than those receiving systemic therapy (62% versus 38%, P = 0.096), and those with class III obesity were more likely than non-obese patients to receive LNG-IUS although neither reached statistical significance (< 40: 6.7% versus ≥ 40: 17%, P = 0.09). CONCLUSION: In this morbidly obese population, response to progestin therapy was generally low; body habitus did not impact treatment outcome for CAH, but local therapy may be more effective than systemic therapy.

Randomized controlled trial of 2% lidocaine gel versus water-based lubricant for multi-channel urodynamics.

INTRODUCTION AND HYPOTHESIS: The purpose of the study was to determine if there is a difference in pain during and after multichannel urodynamic testing in women when using 2% lidocaine gel versus water-based lubricant. METHODS: This was a randomized, controlled, double-blinded study. Women scheduled to undergo urodynamic testing were invited to participate. Participants were randomized to lidocaine 2% gel or water-based lubricant for use during testing. Both participant and examiner were blinded to the type of gel. Pain was assessed by the Wong-Baker pain scale from 0 to 10 at four points during the examination. After testing, participants completed a questionnaire to assess their expectations of pain and embarrassment with urodynamic testing. The examiner also completed a questionnaire to assess his/her impression of the participant's pain during the procedure. RESULTS: The women in the lidocaine group had lower pain scores after the cotton tipped swab test (1.3 vs 3.6, lidocaine vs lubricant respectively, p < 0.001) and after placement of urodynamic catheters (1.4 vs 3.9, lidocaine vs lubricant, respectively, p < 0.001). Mean pain scores 30 min post-completion of the study were similar between groups (0.7 vs 1.2, 1.4 vs 3.9, lidocaine vs lubricant respectively, p = 0.19). Participants reported that pain during the study was better than expected in both groups. Physician perception of the participant's pain during testing was lower in the lidocaine group (2 vs 3, lidocaine vs lubricant respectively p = 0.008). CONCLUSION: Use of 2% lidocaine gel during in and out catheterization, cotton-tipped swab test, and urodynamic testing decreases pain during these procedures.

Effect of pessary use on hydronephrosis in women with advanced pelvic organ prolapse: a self-selected interventional trial.

INTRODUCTION AND HYPOTHESIS: The purpose of this study was to determine the proportion of women who demonstrate improvement in hydronephrosis after pessary placement for advanced pelvic organ prolapse (POP). METHODS: This was a planned subset analysis of a prospective study on the prevalence of hydronephrosis in women with advanced POP. Women with anterior or apical POP ≥1 cm past the hymenal remnant were enrolled and screened for hydronephrosis. All were offered expectant management, pessary placement or surgery. Participants self-selecting pessary placement were compared with those with expectant management during the study period. A follow-up ultrasound scan was performed after >3 weeks of treatment. The proportions of participants demonstrating cure/improvement were compared using Fisher's exact test. RESULTS: Of 180 participants enrolled, 55 had hydronephrosis for a prevalence of 30.6% (95% CI 24.3-37.6%). Of those with hydronephrosis, 39 (70.8%) chose pessary placement while 16 (30.2%) declined. A follow-up ultrasound scan was performed in 89% of participants at a median of 77 days (interquartile range 49-99 days). Intention-to-treat analysis showed no difference in improvement or resolution of hydronephrosis between women who accepted and those who declined pessary placement (p = 0.43). However, of 22 women successfully using a pessary, 77.3% showed improvement or cure, compared with 29.6% of 27 women not using a pessary (p = 0.003). CONCLUSIONS: Successful pessary use improved hydronephrosis in over 75% of women with advanced POP. Approximately 39% of women with prolapse did not comply with pessary use and did not demonstrate hydronephrosis improvement.