Management of Breakthrough Bleeding in Transgender and Gender Diverse Individuals on Testosterone.

BACKGROUND: While many transgender and gender diverse individuals rapidly achieve amenorrhea on testosterone, emerging data has identified that breakthrough bleeding (BTB) can occur in up to one third of individuals with long term use. BTB can worsen dysphoria and patients may seek management to reattain amenorrhea. Because of this, there is a need to assess efficacy of management approaches. OBJECTIVES: The primary aim of the study was to evaluate methods used by patients and their providers to manage BTB which arises after one year of testosterone use. Secondary aims included describing the diagnostic approaches to BTB, and proposing an algorithm for classification and management of BTB in this patient population. STUDY DESIGN: This was an IRB-approved single tertiary center, retrospective chart review of transgender and gender diverse individuals on testosterone gender affirming hormone therapy who experienced BTB after one year of use. Charts were reviewed to determine patient characteristics, testosterone use, and BTB management approaches. RESULTS: Of the 96 individuals who had been on testosterone for one year and experienced BTB, 97% (n=93) engaged in at least one approach to management. The mean age at initiation of testosterone was 21.9 (SD 5.4) and the median duration of time on testosterone was 54.5 months (IQR 33.5,82). Only 16% (n=15) were using menstrual suppression at the time of their BTB episode. BTB was successfully managed in 77 (79%), following between 1-4 attempted approaches. More than half of management attempts (63%) were successful on the first try. When management approaches were analyzed independently, the range of success associated with any particular approach was between 33-100%. Other than hysterectomy, which was fully successful at managing BTB, no approach was significantly better than no intervention. This was true both for individuals who did and did not bleed with missed testosterone doses. Regardless of what approach was used, after a failed attempt, the next attempt was successful in more than half of individuals. Of the 16 who underwent hysterectomy, one did so in part as a first line approach to manage BTB. CONCLUSION: In this study, use of medical management methods was not found to be superior to observation alone in the management of BTB. In the absence of data supporting superiority of any method, we recommend tailoring method attempts to patients' goals.

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.

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.

Urinary microbiome community types associated with urinary incontinence severity in women.

BACKGROUND: Urinary microbiome (urobiome) studies have previously reported on specific taxa and community differences in women with mixed urinary incontinence compared with controls. Therefore, a hypothesis was made that higher urinary and vaginal microbiome diversity would be associated with increased urinary incontinence severity. OBJECTIVE: This study aimed to test whether specific urinary or vaginal microbiome community types are associated with urinary incontinence severity in a population of women with mixed urinary incontinence. STUDY DESIGN: This planned secondary, cross-sectional analysis evaluated associations between the urinary and vaginal microbiomes and urinary incontinence severity in a subset of Effects of Surgical Treatment Enhanced With Exercise for Mixed Urinary Incontinence trial participants with urinary incontinence. Incontinence severity was measured using bladder diaries and Urinary Distress Inventory questionnaires collected at baseline. Catheterized urine samples and vaginal swabs were concurrently collected before treatment at baseline to assess the urinary and vaginal microbiomes. Of note, 16S rRNA V4 to V6 variable regions were sequenced, characterizing bacterial taxa to the genus level using the DADA2 pipeline and SILVA database. Using Dirichlet multinomial mixtures methods, samples were clustered into community types based on core taxa. Associations between community types and severity measures (Urinary Distress Inventory total scores, Urinary Distress Inventory subscale scores, and the number of urinary incontinence episodes [total, urgency, and stress] from the bladder diary) were evaluated using linear regression models adjusted for age and body mass index. In addition, alpha diversity measures for richness (total taxa numbers) and evenness (proportional distribution of taxa abundance) were analyzed for associations with urinary incontinence episodes and community type. RESULTS: Overall, 6 urinary microbiome community types were identified, characterized by varying levels of common genera (Lactobacillus, Gardnerella, Prevotella, Tepidimonas, Acidovorax, Escherichia, and others). The analysis of urinary incontinence severity in 126 participants with mixed urinary incontinence identified a Lactobacillus-dominated reference group with the highest abundance of Lactobacillus (mean relative abundance of 76%). A community characterized by fewer Lactobacilli (mean relative abundance of 19%) and greater alpha diversity was associated with higher total urinary incontinence episodes (2.67 daily leaks; 95% confidence interval, 0.76-4.59; P=.007) and urgency urinary incontinence episodes (1.75 daily leaks; 95% confidence interval, 0.24-3.27; P=.02) than the reference group. No significant association was observed between community type and stress urinary incontinence episodes or Urogenital Distress Inventory total or subscores. The composition of vaginal community types and urinary community types were similar but composed of slightly different bacterial taxa. Vaginal community types were not associated with urinary incontinence severity, as measured by bladder diary or Urogenital Distress Inventory total and subscale scores. Alpha diversity indicated that greater sample richness was associated with more incontinence episodes (observed genera P=.01) in urine. Measures of evenness (Shannon and Pielou) were not associated with incontinence severity in the urinary or vaginal microbiomes. CONCLUSION: In the urobiome of women with mixed urinary incontinence, a community type with fewer Lactobacilli and more diverse bacteria was associated with more severe urinary incontinence episodes (total and urgency) compared with a community type with high predominance of a single genus, Lactobacillus. Whether mixed urinary incontinence severity is due to lesser predominance of Lactobacillus, greater presence of other non-Lactobacillus genera, or the complement of bacteria consisting of urobiome community types remains to be determined.

Same-day Discharge Following Vaginal Hysterectomy and Native-tissue Apical Repair for Uterovaginal Prolapse: A Prospective Cohort Study.

INTRODUCTION AND HYPOTHESIS: The safety and feasibility of same-day discharge (SDD) has been consistently reported across the benign and gynecologic oncology literature. However, outcomes of SDD in the urogynecology population are sparse. The objectives of this study were to describe the success of SDD following vaginal hysterectomy and native-tissue colpopexy, and to compare the incidence of postoperative adverse events in patients discharged same-day versus postoperative day 1 (POD1). Further objectives were to compare pain, quality of recovery (QoR), and satisfaction between the groups. METHODS: This was a single-center, prospective cohort study of patients with planned SDD. A standardized ERAS protocol was utilized. The QoR-40 questionnaire was administered at baseline, POD2, and the 6-week postoperative visit. Pain scores were captured similarly, and a satisfaction survey was administered at 6 weeks. The primary outcome was composite adverse events defined as any postoperative adverse event and/or health care utilization, excluding telephone calls, and urinary tract infection. RESULTS: A total of 101 patients were enrolled in the study; the primary outcome was available for 99. SDD was achieved for 76 patients (77.0%); 23 patients stayed overnight (23.2%). The overall incidence of composite adverse events was 20.2% (95% CI, 13.5-29.2), and was not different between the groups (26.1% vs 18.4%, p = 0.42). Additionally, there were no differences in the QoR-40 or pain scores on POD2 and at 6 weeks. Patient satisfaction was high and similar between the groups. CONCLUSIONS: Successful SDD was achieved in 77.0% of the patients. SDD following vaginal hysterectomy and native-tissue colpopexy appears to be safe, feasible, and associated with good QoR and a high degree of patient satisfaction.

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.

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.

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.

Postoperative adverse events following gender-affirming vaginoplasty: an American College of Surgeons National Surgical Quality Improvement Program study.

BACKGROUND: As a part of gender-affirming care, many transgender women undergo vaginoplasty surgery, which is increasingly being performed in the United States. There are considerable knowledge gaps about adverse events associated with vaginoplasty as most published articles report single-center results. OBJECTIVE: This study aimed to describe severe and overall 30-day adverse events after gender-affirming vaginoplasty using a large multicenter database. STUDY DESIGN: This was a retrospective cohort study of transgender women who underwent vaginoplasty between 2011 and 2019 using the American College of Surgeons National Surgical Quality Improvement Program database. Cases were initially identified by diagnosis codes for gender identity disorders and procedure codes for male-to-female vaginoplasty. Adverse events at 30 days were identified, including unplanned reoperation or readmission, blood transfusion, wound dehiscence, surgical site infections, thromboembolic disease, sepsis, cerebrovascular or cardiac events, and urinary tract infection. Surgical procedures were further stratified by Clavien-Dindo grade, a standardized classification system for registering surgical complications. A score of 0 is given if there is no adverse event, whereas scores of 1 and 2 refer to deviations from the normal postoperative course, which may include additional pharmacologic treatment, bedside-managed wound complications, and blood transfusions. Clavien-Dindo grades of 3 to 4 include surgical interventions or life-threatening complications requiring intensive care unit management. A Clavien-Dindo grade of 5 is given for any complication resulting in death. RESULTS: A total of 488 cases were eligible for inclusion in this study. The mean age of the cohort was 37.5 years, and race distribution was as follows: 71.1% White, 15.2% Black, 5.5% Asian or Pacific Islander, and 8.2% other. Of the cohort, 18.6% were Hispanic. Surgeries were performed by plastic surgeons (87.9%), urologists (8.6%), gynecologists (1.8%), and other specialists (1.6%). Concurrent nongenital surgery was performed in 17% of cases. The median operative time for all cases was 271 minutes (interquartile range, 214-344). There was no reported death in the 30-day period (Clavien-Dindo grade 5), and 27 cases (5.5%) had a Clavien-Dindo grade of 3 to 4. On multivariate analysis, body mass index and higher American Society of Anesthesiologists class were associated with higher odds of having a Clavien-Dindo grade of 3 to 4 (adjusted odds ratios, 2.9 [95% confidence interval, 1.32-4.21; P=.01] and 1.23 [95% confidence interval, 0.56-2.57; P=.05], respectively). Wound dehiscence, superficial surgical site infection, or deep surgical site infection occurred in 46 cases (9.0%). The readmission rate was 4.3% (n=21). Several preoperative factors had higher odds of readmission: body mass index (adjusted odds ratio, 9.81; 95% confidence interval, 1.77-22.13; P=.005), higher American Society of Anesthesiologists class (adjusted odds ratio, 3.23; 95% confidence interval, 1.23-9.03; P=.003), diabetes mellitus (adjusted odds ratio, 5.39; 95% confidence interval, 1.42-20.45; P=.006), and hypertension (adjusted odds ratio, 3.63; 95% confidence interval, 1.26-10.47; P=.01). The reoperation rate was 4.7% (n=23), with no significant patient factor associated with this complication. Of the reoperations, 68.2% of cases were due to wound problems, vaginal bleeding, or hematoma. CONCLUSION: In transgender women undergoing vaginoplasty for gender affirmation, severe postoperative complications were rare, occurring in 1 of 20 patients. Most patients experienced minor complications or no complication after surgery.

Retrospective review of changes in testosterone dosing and physiologic parameters in transgender and gender-diverse individuals following hysterectomy with and without oophorectomy.

BACKGROUND: As more transgender and gender-diverse patients undergo hysterectomy, gaps in knowledge remain about how testosterone dosing or other physiologic parameters change following surgery and how these are influenced by concomitant oophorectomy. AIM: The aims of this study were to determine the incidence of testosterone dosing change after gender-affirming hysterectomy and to compare this incidence between patients who underwent oophorectomy and ovarian preservation. METHODS: This multicenter retrospective cohort study consisted of transmasculine patients who underwent hysterectomy for gender affirmation. OUTCOMES: Outcome measures included testosterone dosing changes at least 3 months following hysterectomy, as identified by clinical documentation, as well as clinical and laboratory parameters assessed for a change after hysterectomy: free and total testosterone, estradiol, hemoglobin, hematocrit, total cholesterol, weight, and blood pressure. RESULTS: Of the 50 patients, 32 (64%) underwent bilateral oophorectomy, 10 (20%) unilateral oophorectomy, and 8 (16%) maintained both ovaries. Eight percent (n = 4) changed testosterone dosing following hysterectomy. Those who underwent bilateral oophorectomy were no more likely to change their testosterone dose than those who did not (P = .09). Those who also used menstrual suppression were 1.31 times more likely to change doses of testosterone after hysterectomy (95% CI, 1.09-1.82; P = .003). For those who had pre- and posthysterectomy laboratory and clinical values, the majority saw no clinically significant change. However, among patients who underwent bilateral oophorectomy, the calculated free testosterone increased by 90.1 ± 288.4 ng/dL (mean ± SD), and estradiol dropped by 20.2 ± 29.0 pg/mL. CLINICAL IMPLICATIONS: In a field where access to care can be a significant barrier, there is unlikely to be a need for routine reassessment of testosterone dose or laboratory parameters following hysterectomy, whether or not a bilateral oophorectomy occurs. STRENGTHS AND LIMITATIONS: Limitations of the study include its retrospective nature and the lack of consistent clinical laboratory testing, which resulted in limited data about any given hormonal change. The heterogeneity of our population limited the number of patients undergoing or not undergoing oophorectomy; however, it allowed our study to more truly reflect a clinical environment. CONCLUSION: In a multisite cohort of individuals who underwent hysterectomy for gender affirmation, few patients changed testosterone dosing after surgery. In addition, dosing change was not associated with the presence or absence of bilateral oophorectomy, and most measured laboratory values remained consistent following hysterectomy.

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.

Updates on feminizing genital affirmation surgery (vaginoplasty) techniques.

Vaginoplasty is a gender affirming surgery performed for transgender women who desire feminizing genital reconstruction. Over the last decade, access to surgical care has improved for patients, and vaginoplasty has been increasingly performed. Several vaginoplasty techniques exist, many of which are modifications of the traditional penile inversion vaginoplasty. In this paper, we review the penile inversion vaginoplasty, the intestinal segment vaginoplasty and the peritoneal flap vaginoplasty. An overview of the techniques employed to perform these procedures is provided, as well as an update on their published outcomes and complications.

Is there an association between 6-month genital hiatus size and 24-month composite prolapse recurrence following minimally invasive sacrocolpopexy?

INTRODUCTION AND HYPOTHESIS: Although an enlarged postoperative genital hiatus (GH) size has been identified as a predictor of recurrence following pelvic organ prolapse (POP) surgery, the protective role of concurrent level III support procedures to reduce the GH size at the time of minimally invasive sacrocolpopexy (MI-SCP) remains unclear. The objective of this study was to compare 24-month composite prolapse recurrence following MI-SCP between patients with a 6-month postoperative GH measurement of <3 cm versus ≥3 cm; and to explore the impact of concurrent level III support procedures on prolapse recurrence, bowel, and sexual function. METHODS: This was a secondary analysis of two randomized controlled trials of women who underwent MI-SCP from 2014 to 2020. Our primary outcome was composite prolapse recurrence defined as retreatment with either pessary or surgery, and/or subjective bothersome vaginal bulge. A receiver operating characteristic (ROC) curve was generated to identify a 6-month GH cutoff point associated with 24-month composite recurrence. RESULTS: Of the 108 women who met the inclusion criteria, 13 (12%) had composite prolapse recurrence at 24 months: 12 patients (11.1%) reported a bothersome vaginal bulge, and 3 patients (2.8%) underwent retreatment with surgery. A ROC curve demonstrated that a 6-month postoperative GH size of 3 cm had 84.6% sensitivity to predict vaginal bulge and/or retreatment at 24 months (area under curve = 0.52). There was no difference in the composite prolapse recurrence between the groups; however, only patients with a 6-month GH >3 cm underwent retreatment. CONCLUSIONS: Twenty-four-month composite prolapse recurrence does not differ based on 6-month GH size; however, surgical failure may be more common in those with a GH size greater than 3 cm.

Postoperative void trial failure and same-day discharge following apical pelvic organ prolapse surgery: a retrospective matched case-control study.

INTRODUCTION AND HYPOTHESIS: Robust data comparing the timing of voiding trials following prolapse surgery are lacking. Filling in these knowledge gaps would be helpful in counseling patients preoperatively about the concerns regarding same-day discharge. We aimed to compare the rate of a failed void trial after apical pelvic organ prolapse (POP) repair between patients who were discharged on the day of surgery versus those discharged on postoperative day 1. METHODS: This was a retrospective matched case-control study of women who underwent either a laparoscopic/robotic or transvaginal apical POP surgery with or without concurrent hysterectomy. Patients who were discharged on postoperative day 0 (POD0) were identified as cases and matched to control patients discharged on postoperative day 1 (POD1). Patients were matched 1:1 based on age and surgical approach. RESULTS: A total of 59 patients in each group met the inclusion criteria. Of the entire cohort, 34 (28.8%) patients failed their void trial, with no statistically significant difference between those who were discharged on POD0 versus POD1 (33.9% vs 23.7%, p=0.47). Patients who were discharged on POD0 were more likely to be diagnosed with a urinary tract infection (22.0% vs 8.4%, p=0.041) during the postoperative period. CONCLUSIONS: In patients undergoing surgery for apical prolapse, there was no difference in the rate of void trial failure in those who had a catheter removal on the day of surgery compared with those who experienced removal the following day.

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.

Postoperative pain and the need for intervention after sacrospinous ligament hysteropexy compared to colpopexy: a retrospective cohort study.

OBJECTIVES: To compare postoperative pain between patients undergoing sacrospinous ligament colpopexy (SSLF) and hysteropexy (SSLH). METHODS: This was a retrospective cohort study of all patients undergoing native tissue SSLF and SSLH between January 2013 and March 2020. The electronic medical record was queried for demographic and perioperative data until the postoperative visit. The primary outcome was a composite incidence of any of the following: telephone calls, urgent office visits, additional analgesic prescriptions and need for intervention for pain in the buttocks, posterior thigh or perirectal area. Secondary outcomes were the incidence of persistent pain at the postoperative visit and perioperative risk factors associated with reported pain. RESULTS: A total of 406 patients met inclusion criteria (308 SSLF, 98 SSLH). The composite pain outcome was seen in 99 patients (24.4%; 95% CI 20.5%-28.8%), and there was no statistical difference between cohorts. Persistent pain was seen in 15.6% and 13.3% of SSLF and SSLH patients at 6 weeks (p = 0.58). Twelve patients (3.0%) underwent interventions for pain, including physical therapy (2), trigger point injections (5) and suture release (5). Compared to SSLF patients, SSLH patients were more likely to need interventions (7 [7.1%] vs. 5 [1.6%], p = 0.005) and office visits (14 [14.3%] vs. 13 [4.2%], p = 0.0005) for pain. CONCLUSIONS: There was no difference in the overall incidence of postoperative pain between patients who underwent SSLF or SSLH. However, patients who underwent hysteropexy were more likely to need intervention and office evaluation for postoperative pain.

Intermediate term outcomes after transvaginal uterine-preserving surgery in women with uterovaginal prolapse.

INTRODUCTION AND HYPOTHESIS: There is growing interest in and performance of uterine-preserving prolapse repairs. We hypothesized that there would be no difference in pelvic organ prolapse (POP) recurrence 2 years following transvaginal uterosacral ligament hysteropexy (USLH) and sacrospinous ligament hysteropexy (SSLH). METHODS: This is a retrospective cohort study with a cross-sectional survey of women who underwent transvaginal uterine-preserving POP surgery from May 2016 to December 2017. Patients were included if they underwent either USLH or SSLH. POP recurrence was defined as a composite of subjective symptoms and/or retreatment. A cross-sectional survey was used to assess pelvic floor symptoms and patient satisfaction. RESULTS: A total of 47 women met the criteria. Mean age was 52.8 ± 12.5 years, and all had a preoperative POP-Q stage of 2 (55.3%) or 3 (44.7%). Thirty (63.8%) underwent SSLH and 17 (36.2%) underwent USLH. There were no differences in patient characteristics or perioperative data. There was no difference in composite recurrence (26.7% [8] vs 23.5% [4]) and retreatment (6.7% [2] vs 0%) retrospectively between SSLH and USLH groups at 22.6 months. Survey response rate was 80.9% (38) with a response time of 30.7 (28.0-36.6) months. The majority of patients (84.2%) reported POP symptom improvement, and both groups reported great satisfaction (89.5%). In respondents, 13.2% (5) reported subjective recurrence and 5.3% (2) underwent retreatment, with no differences between hysteropexy types. There were no differences in other pelvic floor symptoms. CONCLUSIONS: Although 1 in 4 women experienced subjective POP recurrence after transvaginal uterine-preserving prolapse repair and <5% underwent retreatment at 2 years, our results must be interpreted with caution given our small sample size. No differences in outcomes were identified between hysteropexy types; however, additional studies should be performed to confirm these findings. Both hysteropexy approaches were associated with great patient satisfaction.

The Effect of Preoperative Gender-Affirming Hormone Therapy Use on Perioperative Adverse Events in Transmasculine Individuals Undergoing Masculinizing Chest Surgery for Gender Affirmation.

BACKGROUND: Many providers require cessation of gender-affirming hormone therapy (GAHT) for transgender patients prior to undergoing masculinizing chest surgery (MCS) due to concerns about increased adverse events in the presence of exogenous hormones. Evidence has suggested that continuation of GAHT for certain patients may be safe for gender-affirming procedures. OBJECTIVES: The aim of this study was to compare adverse event rates for GAHT cessation vs GAHT continuation in patients undergoing MCS. METHODS: This multicenter, retrospective study included patients at the Cleveland Clinic and MetroHealth System who underwent MCS between 2016 and 2020. RESULTS: There were 236 patients who met the inclusion criteria. Of these, 172 (72.9%) discontinued testosterone GAHT prior to surgery and 64 (27.1%) continued the therapy. Mean [standard deviation] age at surgery was 25 [8] years, and mean BMI was 29.5 [6.6] kg/m.2 The median duration of testosterone therapy was 18 months (range, 0-300 months). There was no significant difference in tobacco use (P = 0.73), diabetes (P = 0.54), thrombophilia (P = 0.97), or history of thromboembolism (P = 0.39). Most patients underwent the double-incision free nipple graft technique (77.9%). There was no significant difference in surgical time (P = 0.12), intraoperative complications (P = 0.54), or postoperative complications (P = 0.34). The most common complication was postoperative bleeding/hematoma (7.2%). Other complications included seroma (2.1%), infection (1.3%), and nipple graft failure (0.4%). There were no thromboembolic complications. CONCLUSIONS: There is no significant difference in the incidence of perioperative adverse events for patients who continue GAHT preoperatively vs patients who stop GAHT prior to MCS.

Defining mechanisms of recurrence following apical prolapse repair based on imaging criteria.

BACKGROUND: Prolapse recurrence after transvaginal surgical repair is common; however, its mechanisms are ill-defined. A thorough understanding of how and why prolapse repairs fail is needed to address their high rate of anatomic recurrence and to develop novel therapies to overcome defined deficiencies. OBJECTIVE: This study aimed to identify mechanisms and contributors of anatomic recurrence after vaginal hysterectomy with uterosacral ligament suspension (native tissue repair) vs transvaginal mesh (VM) hysteropexy surgery for uterovaginal prolapse. STUDY DESIGN: This multicenter study was conducted in a subset of participants in a randomized clinical trial by the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Overall, 94 women with uterovaginal prolapse treated via native tissue repair (n=48) or VM hysteropexy (n=46) underwent pelvic magnetic resonance imaging at rest, maximal strain, and poststrain rest (recovery) 30 to 42 months after surgery. Participants who desired reoperation before 30 to 42 months were imaged earlier to assess the impact of the index surgery. Using a novel 3-dimensional pelvic coordinate system, coregistered midsagittal images were obtained to assess study outcomes. Magnetic resonance imaging-based anatomic recurrence (failure) was defined as prolapse beyond the hymen. The primary outcome was the mechanism of failure (apical descent vs anterior vaginal wall elongation), including the frequency and site of failure. Secondary outcomes included displacement of the vaginal apex and perineal body and change in the length of the anterior wall, posterior wall, vaginal perimeter, and introitus of the vagina from rest to strain and rest to recovery. Group differences in the mechanism, frequency, and site of failure were assessed using the Fisher exact tests, and secondary outcomes were compared using Wilcoxon rank-sum tests. RESULTS: Of the 88 participants analyzed, 37 (42%) had recurrent prolapse (VM hysteropexy, 13 of 45 [29%]; native tissue repair, 24 of 43 [56%]). The most common site of failure was the anterior compartment (VM hysteropexy, 38%; native tissue repair, 92%). The primary mechanism of recurrence was apical descent (VM hysteropexy, 85%; native tissue repair, 67%). From rest to strain, failures (vs successes) had greater inferior displacement of the vaginal apex (difference, -12 mm; 95% confidence interval, -19 to -6) and perineal body (difference, -7 mm; 95% confidence interval, -11 to -4) and elongation of the anterior vaginal wall (difference, 12 mm; 95% confidence interval, 8-16) and vaginal introitus (difference, 11 mm; 95% confidence interval, 7-15). CONCLUSION: The primary mechanism of prolapse recurrence following vaginal hysterectomy with uterosacral ligament suspension or VM hysteropexy was apical descent. In addition, greater inferior descent of the vaginal apex and perineal body, lengthening of the anterior vaginal wall, and increased size of the vaginal introitus with strain were associated with anatomic failure. Further studies are needed to provide additional insight into the mechanism by which these factors contribute to anatomic failure.

Outcomes of labiaplasty in women with labial hypertrophy.

INTRODUCTION AND HYPOTHESIS: High-quality data are lacking to understand outcomes in women who undergo labiaplasty for labial hypertrophy and whether there is an association with body dismorphic disorder (BDD). METHODS: This was a cross-sectional study of a retrospective cohort of women who underwent labiaplasty for labial hypertrophy at a tertiary care referral center. Women were identified by CPT codes and were included if the procedure was performed by a urogynecologist. The health record was queried for demographic, pre-, intra-, and postoperative data. For the cross-sectional component of the study, participants were contacted to complete a survey. RESULTS: Thirty-six women met study inclusion criteria; 21 participated in the survey, and retrospective data were available for 20. At the time of labiaplasty, the women had a mean age of 30 ± 12 years and mean BMI of 23.9 ± 4.4 kg/m2. The most common preoperative motivation for undergoing labiaplasty, based on the medical record, was pain (85.0% 17/20). Complications were uncommon and minor. No women met criteria for BDD. Participant survey-reported primary motivation for undergoing partial simple vulvectomy was "pinching" in 10 (47.6%), "pain" in 4 (19.0%), and "appearance" in 7 (33.3%). The majority of women reported that labiaplasty achieved their preoperative goal (20/21, 95.2%). CONCLUSIONS: Women who underwent labiaplasty were primarily motivated by functional concerns, and outcomes indicate a high satisfaction with genital appearance postoperatively as well as a positive effect on body image and quality of life. We recommend that surgeons work to understand what motivates women to pursue surgical intervention by asking about cosmetic concerns.