Does the setting for intradetrusor onabotulinumtoxinA injection for management of overactive bladder matter?

Introduction: Intradetrusor onabotulinumtoxinA (Botox) injections, to treat idiopathic overactive bladder (OAB), can be performed in the office setting under local analgesia alone or in the operating room (OR) under local and/or sedation. The objective of this study was to compare the symptomatic improvement in patients with OAB who underwent treatment with intradetrusor onabotulinumtoxinA injections in an in-office versus the OR setting. Methods: We performed a multicenter retrospective cohort study of women with the diagnosis of refractory non-neurogenic OAB who elected to undergo treatment with intradetrusor onabotulinumtoxinA injections between January 2015 and December 2020. The electronic medical records were queried for all the demographic and peri-procedural data, including the report of subjective improvement post procedure. Patients were categorized as either "in-office" versus "OR" based on the setting in which they underwent their procedure. Results: Five hundred and thirty-nine patients met the inclusion criteria: 297 (55%) in the in-office group and 242 (45%) in the OR group. A total of 30 (5.6%) patients reported retention after their procedure and it was more common in the in-office group (8.1%) versus the OR group (2.5%), (P = 0.003). The rate of urinary tract infection within 6 months of the procedure was higher in the OR group (26.0% vs. 16.8%, P = 0.009). The overall subjective improvement rate was 77% (95% confidence interval: 73%-80%). Patients in the OR group had a higher reported improvement as compared to the in-office group (81.4% vs. 73.3%, P = 0.03). Conclusions: In this cohort study of patients with OAB undergoing intradetrusor onabotulinumtoxinA injections, post procedural subjective improvement was high regardless of the setting in which the procedure was performed.

Patient Perspectives Following Obstetric Anal Sphincter Injury.

IMPORTANCE: An obstetric anal sphincter injury can significantly affect patients. Support for these patients is both limited and not well understood. OBJECTIVE: The aim of this study was to describe patient experiences after an obstetric anal sphincter injury. STUDY DESIGN: This is a prospective cross-sectional qualitative study of patients who experienced an obstetric anal sphincter injury within a tertiary care network between May and June of 2022. Demographic data, clinical data regarding the delivery, and the Edinburgh Postnatal Depression Scale were collected. Prospective semistructured interviews were conducted approximately 5-12 weeks postpartum to address opportunities to improve obstetric anal sphincter injury care. Qualitative analysis was performed using a grounded theory approach. RESULTS: Fifteen women with a mean age of 31 (±3.93) years participated. The majority identified as White (93.3%) and non-Hispanic (100%). All participants identified as being married to men and completing undergraduate education; 9 (60%) also received postgraduate education. Five participants (33.3%) screened positive (score of 10 or greater) for postnatal depression on the Edinburgh Postnatal Depression Scale. Thematic saturation was reached with 3 major themes identified: (1) pain control, (2) desire for multifactorial support, and (3) obstetric anal sphincter injury knowledge and awareness. CONCLUSIONS: Experiencing an obstetric anal sphincter injury represents a great unknown to most women. This study identifies opportunities for improved postpartum care through education, pain control, and patient support. Interventions are needed to improve the postpartum experience for women who experience an obstetric anal sphincter injury with childbirth.

Breast Cancer Screening Referral Patterns and Compliance in Transgender Male Patients.

Purpose: Screening guidelines for breast cancer (BC) in transgender male (TM) patients are not well defined. This study describes referral patterns and compliance with referral for BC screening among TM patients receiving care at a tertiary care center. Methods: This was a retrospective cohort study of TM patients, 40-74 years of age, presenting for care between 2017 and 2020. The electronic medical record was queried for medical history and cancer screening data. Compliance with referral and screening was defined as occurring within 2 years of when screening would be expected. Results: Of the 266 patients identified, 45 met inclusion criteria. One (2.2%) had a history of BC, 0 (0%) had hereditary BC risk, and 11 (24.4%) had a family history of BC. Of the patients, 18 (40%) were referred for BC screening, of whom 13 (72.2%) were compliant with screening. Ten (55.6%) were referred by a primary care provider, 2 (11.1%) were referred by a transgender medicine specialist, and 6 (33.3%) were referred by both. Of the cohort, 27 (60%) had undergone masculinizing mastectomy. Six (22.2%) of these patients were referred for screening, of whom 0 (0%) had pre-screening clinical findings indicating need for screening. Of the 18 (40%) patients who had not undergone masculinizing mastectomy, 12 (66.7%) were referred for BC screening. Conclusions: There was heterogeneity in referral patterns for BC screening between TM patients who had undergone masculinizing mastectomy and those who had not. BC screening guidelines should be established for TM patients who have undergone masculinizing mastectomy.

Classification and treatment of vaginal strictures at the donor-recipient anastomosis after uterus transplant.

OBJECTIVE: To describe the incidence and management of vaginal stricture after uterus transplantation (UTx) in the US, to propose a grading system to classify stricture severity, and to identify risk factors for stricture formation. DESIGN: Prospective cohort study. SETTING: University Hospital. PATIENTS: Recipients undergoing UTx from 2016-2023 at Baylor University Medical Center in Dallas, Cleveland Clinic, the University of Pennsylvania, and the University of Alabama at Birmingham were monitored postoperatively with regular pelvic examinations. Stricture was defined as vaginal narrowing of <3 cm in patients with graft survival of at least 7 days. INTERVENTION: Demographic and surgery characteristics. MAIN OUTCOME MEASURES: Stricture development and severity (grade 1 for diameter 2-<3 cm, grade 2 for 1-<2 cm, or grade 3 for <1 cm). RESULTS: Of the 45 UTx from 2016-2023 (16 deceased donors and 29 living donors), 3 were excluded from the analysis because of graft loss within 7 days. Of the 42 remaining recipients, 39 (92.9%) had Mayer-Rokitansky-Küster-Hauser syndrome and 3 (7.1%) had a prior hysterectomy. Twenty-eight (66.7%) UTx recipients developed postoperative vaginal strictures with a median time to stricture of 33 days (interquartile range 19-53 days). Most strictures were of moderate severity, with 4 (14.3%) strictures categorized as grade 1, 19 (67.9%) as grade 2, and 5 (17.9%) as grade 3. History of Mayer-Rokitansky-Küster-Hauser syndrome and preoperative recipient vaginal length were significant risk factors for stricture, after adjustment for donor and recipient age and body mass index, anastomosis technique, total ischemia time, center, and year. Patients with longer preoperative vaginal length had a lower risk of stricture (hazard ratio 0.45, 0.29-0.70). The severity grading of the stricture was associated with the effectiveness of a nonoperative treatment approach (grade 1 vs. grade 3). No patients with grade 3 strictures improved with self-dilation alone; all required surgical repair and/or dilation under anesthesia. Conversely, for grade 1 or 2 strictures, self-dilation alone was successful in 47.8% (11/23), and no grade 1 strictures required surgical repair. CONCLUSIONS: Vaginal stricture is a common postoperative complication after UTx, affecting >65% of recipients. Short preoperative vaginal length and history of müllerian agenesis in the recipient are significant risk factors. Vaginal self-dilation was effective for some mild to moderate strictures, although dilation under anesthesia or surgical repair was required in most cases. CLINICAL TRIAL REGISTRATION NUMBERS: Dallas UtErus Transplant Study (DUETS) at Baylor University Medical Center (NCT02656550), Uterine transplantation for the treatment of uterine factor infertility at the Cleveland Clinic (NCT02573415), The University of Pennsylvania Uterus Transplant for Uterine Factor Infertility Trial (UNTIL) (NCT03307356).

Pelvic Floor Dysfunction Among Persons With Marfan and Loeys-Dietz Syndrome.

IMPORTANCE: Connective tissue disorders are proposed in the literature to be predisposing risk factors for pelvic floor disorders. Prior data characterizing the prevalence of and symptom burden related to pelvic floor disorders are limited for individuals with Marfan syndrome and are nonexistent for those with Loeys-Dietz syndrome. OBJECTIVE: The objective of this study was to determine the prevalence and severity of symptoms related to pelvic floor disorders among individuals with Marfan syndrome and Loeys-Dietz syndrome using the Pelvic Floor Distress Inventory-20 (PFDI-20). STUDY DESIGN: In this cross-sectional study, a survey including the PFDI-20 was administered to biologically female individuals older than 18 years with a confirmed diagnosis of Marfan syndrome or Loeys-Dietz Syndrome. Respondents were solicited through the websites, email lists, and social media forums of The Marfan Foundation and The Loeys-Dietz syndrome Foundation. RESULTS: A total of 286 respondents were included in the final analysis, 213 with Marfan syndrome and 73 with Loeys-Dietz syndrome. The median PFDI-20 score of the cohort was 43.8. Individuals with Loeys-Dietz syndrome had higher PFDI-20 scores and were more likely to have established risk factors for pelvic floor disorders that correlated with their PFDI-20 scores compared with those with Marfan syndrome. CONCLUSIONS: Respondents with Marfan syndrome and Loeys-Dietz syndrome experience a high burden of symptoms related to pelvic floor disorders. Despite the similar pathophysiology and clinical manifestations of these disorders, there were differences in PFDI-20 responses that may suggest that these diseases differ in the ways they affect the pelvic floor.

Healthcare Resource Utilization Following Minimally Invasive Sacrocolpopexy: Impact of Concomitant Rectopexy.

INTRODUCTION AND HYPOTHESIS: Combined surgical procedures with sacrocolpopexy (SCP) and rectopexy (RP) are more commonly being performed for treatment of multicompartment pelvic organ prolapse. This study aimed to compare healthcare resource utilization (HRU) within 6 weeks following combined surgery (SCP-RP) versus SCP alone (SCP-only). We hypothesized that concomitant RP does not impact HRU. METHODS: A retrospective cohort study of patients who underwent minimally invasive SCP from 2017 to 2022 was conducted at a tertiary referral center. Patients were grouped based on the performance of concomitant RP. HRU was defined as a composite of unscheduled office visits, emergency department visits, and readmissions before the 6-week postoperative visit. HRU was compared in the SCP-RP and SCP-only groups. Multivariable regression analysis was performed to identify factors associated with HRU. RESULTS: There were 144 patients in the SCP-RP group and 405 patients in the SCP-only group. Patient characteristics were similar between the two groups, with the following exceptions: the SCP-RP group was older, more likely to have comorbid conditions, and live >60 miles from the hospital. Of the 549 patients, 183 (33.3%) had ≥1 HRU encounter within 6 weeks after surgery. However, there was no difference between the SCP-RP and SCP-only groups in composite HRU (34.0% vs 33.1%, p = 0.84). The most common reasons for HRU were pain, urinary tract infection symptoms, and wound issues. Concomitant mid-urethral sling was associated with a two-fold increased risk of HRU after surgery. CONCLUSIONS: One in 3 patients undergoing minimally invasive SCP had at least one unanticipated encounter within 6 weeks after surgery. Concomitant RP was not associated with increased postoperative HRU.

Incidence of breakthrough bleeding in transgender and gender-diverse individuals on long-term testosterone.

BACKGROUND: Little is known about the maintenance of amenorrhea among transgender and gender-diverse individuals with uteri who are using long-term testosterone gender-affirming hormone therapy. Emerging data describe breakthrough bleeding among adolescents on long-term testosterone therapy and among adults who are seeking a gender-affirming hysterectomy. More studies are needed to better understand breakthrough bleeding patterns among transgender and gender-diverse individuals with uteri who are using testosterone, including the frequency, timing, and etiology of bleeding and how these patterns may differ between adults and younger populations. OBJECTIVE: The primary aim of this study was to characterize the incidence and patterns of breakthrough bleeding in a cohort of transgender and gender-diverse individuals who had been on testosterone for longer than 12 months and who had uteri in situ. Secondary aims included identifying the time to first bleed for those who experienced breakthrough bleeding and the risk factors associated with breakthrough bleeding while on testosterone therapy. STUDY DESIGN: This was an institutional review board-approved, single tertiary center, retrospective chart review of transgender and gender diverse individuals who had been on testosterone for at least 1 year. A primary survival analysis that evaluated the incidence of bleeding was combined with descriptive analyses and an evaluation of the factors associated with bleeding. RESULTS: Of the 279 patients included in the analysis, the median age of testosterone initiation was 22 years (interquartile range, 19-41), and the median follow-up time was 34 months (range, 12-278). The absolute proportion of individuals who ever experienced breakthrough bleeding on testosterone was 34% (n=96; 95% confidence interval, 29-40). Patients who experienced breakthrough bleeding initiated testosterone at a younger age (20.5 vs 22.0 years; P=.04), had lower mean serum testosterone levels (389.14 vs 512.7 ng/dL; P=.001), were more likely to have a mean testosterone level <320 ng/dL (52% vs 48%; P=.001), and had higher mean estradiol levels (62% vs 49%; P=.003). Survival analyses estimated a breakthrough bleeding incidence rate of 0.09 per year (95% confidence interval, 0.07-1.0). Although 58 people underwent a hysterectomy during the follow-up period, 64% of the cohort who maintained a uterus eventually experienced breakthrough bleeding. The median time to the initial bleeding episode was 22 months (interquartile range, 12-201) after testosterone initiation. CONCLUSION: These results suggest that a substantial fraction of transgender and gender-diverse individuals who are using testosterone will experience at least 1 episode of breakthrough bleeding even after their initial year of testosterone use. We recommend that clinicians inform all patients that breakthrough bleeding is a common occurrence even after the first year on testosterone therapy.

Persistent and De Novo Stress Urinary Incontinence After Minimally Invasive Sacrocolpopexy.

IMPORTANCE: Data on stress urinary incontinence (SUI) after minimally invasive sacrocolpopexy (SCP) with or without midurethral sling placement are limited. OBJECTIVE: The aim of the study was to determine the incidence of SUI after minimally invasive sacrocolpopexy. STUDY DESIGN: This was a secondary analysis of 2 randomized clinical trials of participants undergoing SCP. Participants completed symptom assessment and urodynamic testing. Participants underwent SCP with or without midurethral sling placement. Preoperatively, participants were defined as having symptomatic SUI, occult SUI, or no SUI. Participants completed the Pelvic Floor Distress Inventory-20 at 6 and 12 months postoperatively and were categorized as having persistent SUI in the setting of symptomatic or occult SUI or de novo SUI. RESULTS: Eighty-one participants were included. Sixty-one participants met inclusion criteria for the persistent SUI analysis: 42 participants with symptomatic SUI and 19 participants with occult SUI. There were 20 participants in the de novo SUI group. The overall incidence of persistent SUI was 26.2% (95% confidence interval [CI], 15.8%-39.1%) with 33.3% (95% CI, 19.6%-49.6%) of symptomatic and 10.5% (95% CI, 1.5%-33.1%) of occult participants. Bothersome symptoms were defined as "moderately" or "quite a bit" bothered postoperatively. Of participants with symptomatic SUI, 14.3% participants were bothered and no participants underwent retreatment. No patient with occult SUI was bothered; however, 1 patient underwent retreatment. The incidence of de novo SUI was 45% (95% CI, 23.1%-68.5%). No patient in the de novo SUI group was bothered or underwent SUI treatment. CONCLUSIONS: Approximately 1 in 4 participants reported persistent SUI. Almost 50% reported de novo SUI. However, few participants were bothered or underwent treatment.

Transgender women's perspectives on mental health care related to vaginoplasty for gender affirmation.

PURPOSE: This study aimed to describe patient experiences and attitudes about the role of the mental health professional as it relates to pursuing gender affirmation surgery. METHODS: This was a mixed-models study with semi-structured interviews. Participants who presented for gender affirming vaginoplasty and had completed pre-surgical requirements but had not yet had the procedure were invited to participate in the study. Semi-structured phone interviews were conducted from November 2019 and December 2020 until saturation of themes was achieved at a sample size of 14. Interviews were then transcribed verbatim and coded by theme. Qualitative analysis was performed using a grounded theory approach. RESULTS: Almost half of the patients did not identify any barriers to obtaining mental health care, but a majority brought up concerns for less advantaged peers, with less access to resources. Some patients also felt that there was benefit to be obtained from the mental health care required before going through with surgery, while others felt the requirements were discriminatory. Finally, a large proportion of our participants reported concerns with the role of mental health care and the requirements set forth by the World Professional Association for Transgender Health (WPATH), and patients gave suggestions for future improvements including decreasing barriers to care while rethinking how guidelines impact patients. CONCLUSION: There are many competing goals to balance when it comes to the guidelines for gender affirmation surgery, and patients had differing and complex relationships with mental health care and the pre-surgical process.

Gynecologic Care of Transgender and Gender-Diverse People.

The visibility and care of transgender and gender-diverse (TGD) people is an important component of gynecology. Transmasculine individuals require routine gynecologic and preventative care. Guidelines can be extrapolated from the cisgender female population, and using affirming language, acknowledging the challenges patients face with pelvic examination, and discussing individual gynecologic needs are important components of care. Transmasculine patients may seek hysterectomy for gender affirmation from gynecologists. Unique nuances exist in the considerations needed when preparing for hysterectomy, and patients should be thoroughly counseled with regard to concurrent vaginectomy or oophorectomy or both. Transfeminine patients often seek gynecologic care after gender-affirming surgery, and, unlike transmasculine patients, the gynecology visit is often very affirming and welcomed by patients. Becoming familiar with the perioperative and delayed postoperative care needs of transfeminine patients undergoing vaginoplasty can help improve the care provided by gynecologists. In general, prospective data on the outcomes of gender-affirming care in large cohorts of TGD patients are limited, but the body of literature is growing. Gynecologists remain central to the care of TGD patients, the academic advancement of the field of transgender health, and the advocacy needed to support this vulnerable patient population.

Urinary Reconstruction in Genital Gender-Affirming Surgery: Checking Our Surgical Complication Blind Spots.

BACKGROUND: Urologic complications in genital gender-affirming surgery are imperfectly measured, with existing evidence limited by "blind spots" that will not be resolved through implementation of patient-reported outcomes alone. Some blind spots are expected in a surgical field with rapidly expanding techniques, and they may be exacerbated by factors related to transgender health. METHODS: The authors provide a narrative review of systematic reviews published in the past decade to describe the current options for genital gender-affirming surgery and surgeon-reported complications, as well as contrasting peer-reviewed sources with data not reported by the primary surgeon. In combination with expert opinion, these findings help estimate complication rates. RESULTS: Eight systematic reviews describe complications in patients undergoing vaginoplasty, including 5% to 16.3% mean incidence of meatal stenosis and 7% to 14.3% mean incidence of vaginal stenosis. Compared with surgeon-reported cohorts, patients undergoing vaginoplasty or vulvoplasty in other reports had higher rates of voiding dysfunction (47% to 66% versus 5.6% to 33%), incontinence (23% to 33% versus 4% to 19.3%), or misdirected urinary stream (33% to 55% versus 9.5% to 33%). Outcomes in six reviews of phalloplasty and metoidioplasty included urinary fistula (14% to 25%), urethral stricture or meatal stenosis (8% to 12.2%), and ability to stand to void (73% to 99%). Higher rates of fistula (39.5% to 56.4%) and stricture (31.8% to 65.5%) were observed in alternate cohorts, along with previously unreported complications such as vaginal remnant requiring reoperation. CONCLUSIONS: The literature does not completely describe urologic complications of genital gender-affirming surgery. In addition to standardized, robustly validated patient-reported outcome measures, future research on surgeon-reported complications would benefit from using the IDEAL (idea, development, exploration, assessment, and long-term study) framework for surgical innovation.

Patient Outcomes After Robotic Ventral Rectopexy With Sacrocolpopexy.

IMPORTANCE: As few studies exist examining postoperative functional outcomes in patients undergoing robotic sacrocolpopexy and ventral rectopexy, results from this study can help guide surgeons in counseling patients on their outcomes. OBJECTIVE: The aim of the study was to evaluate functional outcomes and overall postoperative satisfaction as measured by the Pelvic Floor Disability Index 20 (PFDI-20), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), and Patient Global Impression of Improvement Scale (PGI-I) in patients who underwent combined robotic ventral rectopexy and sacrocolpopexy for concomitant pelvic organ prolapse (POP) and rectal prolapse or intussusception (RP/I). METHODS: This was a retrospective cohort and survey study of patients with combined POP and RP/I who underwent the previously mentioned surgical repair between January 2018 and July 2021. Each patient was contacted to participate in a survey evaluating postoperative symptoms related bother, sexual function, and overall satisfaction using the PFDI-20, PISQ-12, and PGI-I. RESULTS: A total of 107 patients met study inclusion criteria with 67 patients completing the surveys. The mean age and body mass index were 63.7 ± 11.5 years and 25.0 ± 5.4, respectively. Of the patients, 19% had a prior RP repair and 23% had a prior POP repair. Rectal prolapse or intussusception recurrence was reported in 10.4% of patients and objective POP recurrence was found in 7.5% of patients. Sixty-seven patients (62%) completed the surveys. The median time to survey follow-up was 18 (8.8-51.8) months. At the time of survey, the mean PFDI-20 score was 95.7 ± 53.7. The mean PISQ-12 score for all patients was 32.8 ± 7.2 and the median PGI-I score was 2.0 (interquartile range, 1.0-3.0). CONCLUSIONS: In this cohort of patients who underwent a combined robotic ventral rectopexy and sacrocolpopexy, patient-reported postoperative symptom bother was low, sexual function was high, and their overall condition was much improved.

Prevalence of Polycystic Ovarian Syndrome in Young and Adolescent Transmasculine Patients Presenting for Gender-Affirming Care.

STUDY OBJECTIVE: To determine the incidence of polycystic ovarian syndrome (PCOS) and hyperandrogenism among adolescent transmasculine patients presenting to a tertiary care referral center for gender-affirming care METHODS: This was a retrospective study of adolescent transmasculine patients presenting to Cleveland Clinic for gender-affirming hormone therapy. The diagnostic criteria were adolescent-specific as defined by the international evidence-based guideline for PCOS management and included oligomenorrhea and/or anovulation with clinical and/or biochemical hyperandrogenism after exclusion of other androgen excess disorders. RESULTS: The described transgender population had a prevalence of PCOS of 23.8%. The transmasculine patients who met the criteria for PCOS had both higher levels of androgens and higher body mass indexes when compared with the patients without PCOS. Additionally, the patients with PCOS had higher rates of dyslipidemia. CONCLUSION: The prevalence of PCOS among transmasculine patients may be higher compared with the general population. Transmasculine patients with PCOS should be counseled regarding the long-term health implications associated with PCOS and screened appropriately to minimize risks.

Outcomes in Women With Pelvic Organ Prolapse Presenting With Pessary-Related Complications.

IMPORTANCE: There is currently a paucity of data describing the outcomes of women with pelvic organ prolapse (POP) and/or urinary incontinence (UI) who present with pessary-related complications. OBJECTIVE: This study aimed to describe outcomes in women with POP and UI managed with a pessary who present with pessary-related complications. STUDY DESIGN: This was a retrospective cohort study of women with POP and/or UI who elected for management with a pessary from January 1, 2016, to December 31, 2020. Patients were included if they had used a pessary for at least 1 year and had a documented pessary-related complication. Complications were defined a priori, and patient charts were abstracted using International Classification of Diseases, Ninth and Tenth Revisions codes associated with pessary use. RESULTS: Of 2,088 of women receiving pessary care, 444 (21%) experienced a complication. Of 154 of women, 34.6% experienced 2 pessary-related complications during the study period, whereas 12.6% (56) experienced 3, 4.5% (20) experienced 4, and 1.8% (8) experienced 5. One hundred fifty-two patients (34.2%) underwent surgery during the study period to manage their POP and/or UI. Patients who were older were less likely to have surgery (adjusted odds ratio, 0.70 [95% confidence interval, 0.20-0.90]; P = 0.002), and patients who had an indication of pessary use for both POP and UI were more likely to undergo surgery during the study period (adjusted odds ratio, 2.12 [95% confidence interval, 1.29-3.48]; P = 0.003). CONCLUSIONS: Our results suggest that 1 in 5 patients has a documented complication associated with pessary use of greater than 1 year. Of these patients, one third will eventually undergo surgery for management of their POP and/or UI.

Restrictive opioid prescribing after surgery for prolapse and incontinence: a randomized, noninferiority trial.

BACKGROUND: Opioids are routinely prescribed for postoperative pain control after gynecologic surgery with growing evidence showing that most prescribed opioids go unused. Restrictive opioid prescribing has been implemented in other surgical specialties to combat the risk for opioid misuse and diversion. The impact of this practice in the urogynecologic patient population is unknown. OBJECTIVE: This study aimed to determine if a restrictive opioid prescription protocol is noninferior to routine opioid prescribing in terms of patient satisfaction with pain control after minor and major surgeries for prolapse and incontinence. STUDY DESIGN: This was a single-center, randomized, noninferiority trial of opioid-naïve patients who underwent minor (eg, colporrhaphy or mid-urethral sling) or major (eg, vaginal or minimally invasive abdominal prolapse repair) urogynecologic surgery. Patients were excluded if they had contraindications to all multimodal analgesia and if they scored ≥30 on the Pain Catastrophizing Scale. Subjects were randomized on the day of surgery to the standard opioid prescription protocol (wherein patients routinely received an opioid prescription upon discharge [ie, 3-10 tablets of 5 mg oxycodone]) or to the restrictive protocol (no opioid prescription unless the patient requested one). All patients received multimodal pain medications. Participants and caregivers were not blinded. Subjects were asked to record their pain medication use and pain levels for 7 days. The primary outcome was satisfaction with pain control reported at the 6-week postoperative visit. We hypothesized that patient satisfaction with the restrictive protocol would be noninferior to those randomized to the standard protocol. The noninferiority margin was 15 percentage points. Pain level scores, opioid usage, opioid prescription refills, and healthcare use were secondary outcomes assessed for superiority. RESULTS: A total of 133 patients were randomized, and 127 (64 in the standard arm and 63 in the restrictive arm) completed the primary outcome evaluation and were included in the analysis. There were no statistically significant differences between the study groups, and this remained after adjusting for the surgery type. Major urogynecologic surgery was performed in 73.6% of the study population, and minor surgery was performed in 26.4% of the population. Same-day discharge occurred for 87.6% of all subjects. Patient satisfaction was 92.2% in the standard protocol arm and 92.1% in the restrictive protocol arm (difference, -0.1%; P=.004), which met the criterion for noninferiority. No opioid usage in the first 7 days after hospital discharge was reported by 48.4% of the patients in the standard protocol arm and by 70.8% in the restrictive protocol arm (P=.009). Opioid prescription refills occurred in 8.5% of patients with no difference between the study groups (9.4% in the standard arm vs 6.7% in the restrictive arm; P=.661). No difference was seen in the rate of telephone calls and urgent visits for pain control between the study arms. CONCLUSION: Among women who underwent minor and major surgery for prolapse and incontinence, patient satisfaction rates were noninferior after restrictive opioid prescribing when compared with routine opioid prescribing.

Comparison of Morbidity and Retreatment After Urethral Bulking or Midurethral Sling at the Time of Pelvic Organ Prolapse Repair.

OBJECTIVE: To compare postprocedure retreatment rates for stress incontinence in patients who underwent either midurethral sling or urethral bulking at the time of concomitant repair of pelvic organ prolapse (POP). METHODS: This was a retrospective cohort study using data from the Premier Healthcare Database. Using Current Procedural Terminology codes, we identified patients who were undergoing POP repair and concomitant urethral bulking or midurethral sling between the years 2001 and 2018. Patients who underwent concomitant nongynecologic surgery, Burch urethropexy, or oncologic surgery, and those who did not undergo concomitant POP and anti-incontinence surgery, were excluded. Additional data collected included patient demographics, hospital characteristics, surgeon volume, and comorbidities. The primary outcome was a repeat anti-incontinence procedure at 2 years, and the secondary outcome was the composite complication rate. RESULTS: Over the study period, 540 (0.59%) patients underwent urethral bulking, and 91,005 (99.41%) patients underwent midurethral sling. The rate of a second procedure within 2 years was higher for urethral bulking, compared with midurethral sling (9.07% vs 1.11%, P <.001); in the urethral bulking group, 4.81% underwent repeat urethral bulking and 4.81% underwent midurethral sling. In the midurethral sling group, 0.77% underwent repeat midurethral sling and 0.36% underwent urethral bulking. After adjusting for confounders, midurethral sling was associated with a decreased odds of a repeat anti-incontinence procedure at 2 years (adjusted odds ratio 0.11, 95% CI 0.08-0.16). The probability of any complication at 2 years was higher with urethral bulking (23.0% vs 15.0%, P <.001). CONCLUSION: Urethral bulking at the time of POP repair is associated with a higher rate of repeat procedure and postoperative morbidity up to 2 years after surgery.

Prevalence of pelvic pain in transgender individuals on testosterone.

BACKGROUND: Pelvic pain has been reported in transmasculine individuals taking testosterone. There is a need for further investigation to increase understanding of the prevalence and risk factors of this pain. AIM: We sought to determine the prevalence of pelvic pain reported by transmasculine individuals who had both a uterus and ovaries and were taking testosterone. METHODS: We conducted an institutional review board-approved retrospective study of all transmasculine individuals who had been taking testosterone for at least 1 year and had a uterus and ovaries at the time of testosterone initiation. Charts of participating patients were reviewed to determine patient characteristics, testosterone use, and pelvic pain symptoms both before and after initiation of testosterone. OUTCOMES: Patients reported experiences of pelvic pain while on testosterone. RESULTS: Of 280 individuals who had been on testosterone for at least 1 year, 100 (36%) experienced pelvic pain while on testosterone. Of those patients, 71% (n = 71) had not experienced pelvic pain prior to starting testosterone. There were 42 patients (15%) who had pelvic pain prior to starting testosterone, 13 (31%) of whom no longer experienced pain once starting testosterone. The median (IQR) age at initiation of testosterone was 22 (19-41) years and duration of testosterone treatment was 48 (27-251) months.Those patients who experienced pelvic pain while on testosterone were significantly more likely to have also reported pelvic pain prior to starting testosterone (29% vs 7%, P < .001). These patients were also more likely to have a pre-existing diagnosis of dysmenorrhea (27% vs 7%, P < .001), endometriosis (6% vs 2%, P = .049), or ovarian cysts and/or masses (12% vs 2% P < .001). Patients with pelvic pain were also more likely to have been on a menstrual suppression agent prior to and overlapping testosterone initiation (22% vs 12%, P = .03) and to have used menstrual suppression for longer durations (median [IQR] 18 [6-44] vs 8 [4-15] months, P = .04). CLINICAL IMPLICATIONS: Pelvic pain is common in transmasculine individuals who are initiating testosterone treatment, although testosterone has both positive and negative effects on pelvic pain in different individuals. STRENGTHS AND LIMITATIONS: The major strengths of this study included large numbers of patients, ability to assess for documentation of pelvic pain prior to testosterone, and ability to determine an actual prevalence of pelvic pain. Major limitations included the study being a retrospective analysis in a single tertiary care center, the limitations of clinical documentation, and the lack of a standard pelvic pain evaluation process. CONCLUSION: More than one-third of transmasculine patients with a uterus and ovaries had pelvic pain while on testosterone, with the majority reporting onset of pain after initiating testosterone.

Comparing endometrial biopsy results with hysteroscopic pathology in women presenting with abnormal and postmenopausal uterine bleeding.

OBJECTIVE: To compare pathology results after office-based blind endometrial biopsy and pathology results from hysteroscopy in women presenting with abnormal uterine bleeding (AUB). METHODS: A retrospective cohort study of biologic women presenting with AUB at a tertiary care referral care center. Patients were included if they underwent evaluation with blind endometrial biopsy performed in the office followed by hysteroscopy within one year. Hysteroscopic findings and pathology were correlated with index endometrial biopsy findings. RESULTS: 689 patients met inclusion criteria. The mean age and BMI were 49 (±10) years and 31 (±8) kg/m2. The median duration of bleeding leading up to presentation was of 3.5 (1.5-9) months. Of the patients who had operative hysteroscopic pathology demonstrating endometrial polyp, 30.6 % (81) had a polyp detected on office endometrial biopsy. Of the patients who had hysteroscopic pathology demonstrating intracavitary fibroids, 0 % (0) were detected on endometrial biopsy. Of the patients who had hyperplasia without atypia on hysteroscopy, 28.6 % (4) were detected or suspected on endometrial biopsy. Of the patients who had hyperplasia with atypia on hysteroscopy, 5.9 % (1) were detected or suspected on endometrial biopsy. There were 12 cases of confirmed or suspected malignancy on hysteroscopy, of which 8.3 % (1) were detected on endometrial biopsy. CONCLUSION: Concordance between focal findings on office hysteroscopy and endometrial biopsy is low. Endometrial biopsy when malignancy is suspected has been shown to be of benefit, but in the setting of suspected benign focal pathology, blind assessment of the endometrial cavity for definitive diagnosis should be abandoned. In women with symptomatic uterine bleeding, hysteroscopic visualization is associated with increased sensitivity in identifying intrauterine pathology.

A randomized trial comparing perioperative pelvic FLOor physical therapy to current standard of care in transgender Women undergoing vaginoplasty for gendER affirmation: the FLOWER Trial.

INTRODUCTION AND HYPOTHESIS: There are sparse data on the use of postoperative pelvic floor physical therapy (PFPT) in patients undergoing vaginoplasty. The primary objective of this study was to compare the impact of PFPT on the ease of vaginal dilation after vaginoplasty in transgender women. We hypothesized that patients undergoing PFPT would report better ease of vaginal dilation following surgery. METHODS: This was a randomized trial of transgender women undergoing vaginoplasty. Patients were randomized to either no PFPT or PFPT 3 and 6 weeks following surgery. Subjects completed the Pelvic Floor Disorders Inventory and the Pelvic Floor Impact Questionnaire at baseline and at 12 weeks. At 12 weeks, subjects underwent vaginal length measurement and completed the Patient Global Impression of Improvement and a visual analogue scale (0-10) for ease of vaginal dilation and pain with dilation. A total of 17 subjects in each arm were needed to detect a significant difference in ease of dilation between the two groups. RESULTS: Forty-one subjects were enrolled and 12-week data were available for 37 subjects (20 PFPT, 17 no PFPT). Mean age and BMI were 31 ± 13 years and 24.9 (± 4.0) kg/m2. Subjects were on hormone therapy for a median of 39 (20-240) months and 5 (13.5%) patients had undergone previous orchiectomy. At 12 weeks, the median vaginal length was 12.5 (10-16) cm, reported mean ease of dilation was 7.3 (± 1.6), and pain with dilation was 2.4 (± 1.7). There were no differences in these outcomes or in pelvic floor symptoms between the groups. CONCLUSIONS: In this study, routine postoperative PFPT did not improve outcomes in patients undergoing vaginoplasty.