193 results on '"Ferrando, Cecile A."'
Search Results
152. Adverse Events After Concurrent Procedures for Gynecologic Malignancies and Pelvic Floor Disorders.
- Author
-
Sheyn, David, Mahajan, Sangeeta T., Ferrando, Cecile A., and Bretschneider, C. Emi
- Published
- 2018
- Full Text
- View/download PDF
153. Retrospective review of changes in testosterone dosing and physiologic parameters in transgender and gender-diverse individuals following hysterectomy with and without oophorectomy.
- Author
-
Grimstad, Frances W, Fraiman, Elad, Garborcauskas, Garrett, and Ferrando, Cecile A
- Subjects
- *
TRANSGENDER people , *OVARIECTOMY , *HYSTERECTOMY , *TESTOSTERONE , *GENDER affirmation surgery , *FERTILITY preservation , *HEMATOCRIT - Abstract
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. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
154. Management of breakthrough bleeding in transgender and gender diverse individuals on testosterone.
- Author
-
Grimstad FW, Boskey ER, Clark RS, and Ferrando CA
- Subjects
- Humans, Female, Retrospective Studies, Male, Adult, Young Adult, Adolescent, Metrorrhagia, Algorithms, Amenorrhea etiology, Androgens therapeutic use, Hormone Replacement Therapy, Hysterectomy, Testosterone therapeutic use, Testosterone blood, Transgender Persons
- Abstract
Background: While many transgender and gender diverse individuals rapidly achieve amenorrhea on testosterone, emerging data have identified that breakthrough bleeding can occur in up to one-third of individuals with long-term use. Breakthrough bleeding can worsen dysphoria and patients may seek management to reattain amenorrhea. Because of this, there is a need to assess efficacy of management approaches., Objective: The primary aim of the study was to evaluate methods used by patients and their providers to manage breakthrough bleeding which arises after 1 year of testosterone use. Secondary aims included describing the diagnostic approaches to breakthrough bleeding, and proposing an algorithm for classification and management of breakthrough bleeding in this patient population., Study Design: This was an institutional review board-approved single tertiary center, retrospective chart review of transgender and gender diverse individuals on testosterone gender affirming hormone therapy who experienced breakthrough bleeding after 1 year of use. Charts were reviewed to determine patient characteristics, testosterone use, and breakthrough bleeding management approaches., Results: Of the 96 individuals who had been on testosterone for 1 year and experienced breakthrough bleeding, 97% (n=93) engaged in at least 1 approach to management. The mean age at initiation of testosterone was 21.9 (standard deviation 5.4) and the median duration of time on testosterone was 54.5 months (interquartile range 33.5, 82). Only 16% (n=15) were using menstrual suppression at the time of their breakthrough bleeding episode. Breakthrough bleeding was successfully managed in 77 (79%), following between 1 and 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% and 100%. Other than hysterectomy, which was fully successful at managing breakthrough bleeding, 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, 1 did so in part as a first line approach to manage breakthrough bleeding., Conclusion: In this study, use of medical management methods was not found to be superior to observation alone in the management of breakthrough bleeding. In the absence of data supporting superiority of any method, we recommend tailoring method attempts to patients' goals., (Copyright © 2024 Elsevier Inc. All rights reserved.)
- Published
- 2024
- Full Text
- View/download PDF
155. Virtual Compared With In-Office Postoperative Visits After Urogynecologic Surgery: A Randomized Controlled Trial.
- Author
-
Lua-Mailland LL, Nowacki AS, Paraiso MFR, Park AJ, Wallace SL, and Ferrando CA
- Subjects
- Humans, Female, Middle Aged, Aged, Urinary Incontinence, Postoperative Care methods, Telemedicine, Patient Satisfaction, Pelvic Organ Prolapse surgery, Office Visits, Gynecologic Surgical Procedures
- Abstract
Objective: To compare patient satisfaction, health care resource utilization, and adverse events among patients receiving a virtual video compared with in-office postoperative visit after urogynecologic surgery. We hypothesized that virtual video visits would be noninferior to in-office visits., Methods: This was a randomized noninferiority clinical trial of patients undergoing surgery for pelvic organ prolapse and urinary incontinence at a single academic tertiary referral center. Participants were randomized to receive either a virtual video postoperative visit or a standard in-office postoperative visit. The primary outcome was patient satisfaction measured by the validated PSQ-18 (Patient Satisfaction Questionnaire-18) (noninferiority margin 5 points) at the 6-week postoperative visit. Secondary outcomes included PSQ-18 domain scores (noninferiority margin 0.5 points) and composite health care resource utilization and adverse events after the 6-week postoperative visit up to 12 weeks after surgery (noninferiority margin 10%). A sample size of 100 participants (50 per group) would allow 80% power to assess a 5-point noninferiority margin on the total PSQ-18 with an SD of 10 and α=0.05., Results: From January 2023 to September 2023, 265 patients were screened for eligibility, and 104 were randomized. A total of 100 participants (50 per arm) completed the study and were included in the analysis. The mean±SD age of all participants was 57.0±13.2 years. The mean±SD PSQ-18 total score was 75.18±8.15 in the virtual group and 75.14±8.7 in the in-office group. The mean PSQ-18 total score was 0.04 points higher (ie, greater degree of satisfaction) in the virtual group, with a 95% CI of -2.75 to 2.83, which met the criterion for noninferiority. Between-group differences for all PSQ-18 domain scores likewise met criterion for noninferiority. Composite health care resource utilization was 14.0% lower in the virtual group than in the in-office group (20.0% vs 34.0%, 95% CI, -28.0% to 1.0%). For composite adverse events, the between-group difference was 2.0% (2.0% in virtual group vs 0.0% in in-office group, 95% CI,-3.0% to 8.0%)., Conclusion: Virtual video postoperative visits were noninferior to in-office visits with regard to patient satisfaction, health care resource utilization, and adverse events and can be offered as an alternative to in-office visits for postoperative follow-up after urogynecologic surgery., Clinical Trial Registration: ClinicalTrials.gov , NCT05641077., Competing Interests: Financial Disclosure Marie Fidela R. Paraiso reported receiving grants from Coloplast and Caldera and consultant fees from Boston Scientific outside the submitted work. She has also received royalties from UpToDate. Amy J. Park reported receiving royalties from UpToDate outside the submitted work. Cecile A. Ferrando reported receiving royalties from UpToDate and Elsevier outside the submitted work. The other authors did not report any potential conflicts of interest., (Copyright © 2024 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)
- Published
- 2024
- Full Text
- View/download PDF
156. Pelvic Floor Dysfunction Among Persons With Marfan and Loeys-Dietz Syndrome.
- Author
-
Akesson C, Richards EG, Yao M, Ross J, Grima J, May L, Roversi G, and Ferrando CA
- Subjects
- Humans, Female, Cross-Sectional Studies, Adult, Middle Aged, Prevalence, Young Adult, Surveys and Questionnaires, Severity of Illness Index, Adolescent, Aged, Marfan Syndrome epidemiology, Marfan Syndrome complications, Marfan Syndrome physiopathology, Loeys-Dietz Syndrome epidemiology, Loeys-Dietz Syndrome genetics, Pelvic Floor Disorders epidemiology, Pelvic Floor Disorders etiology
- Abstract
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., Competing Interests: C.A.F. received authorship royalties from UpToDate and Elsevier. All other authors have declared they have no conflicts of interest., (Copyright © 2024 American Urogynecologic Society. All rights reserved.)
- Published
- 2024
- Full Text
- View/download PDF
157. Persistent and De Novo Stress Urinary Incontinence After Minimally Invasive Sacrocolpopexy.
- Author
-
Sinha A, Yao M, and Ferrando CA
- Subjects
- Humans, Female, Middle Aged, Aged, Suburethral Slings adverse effects, Incidence, Gynecologic Surgical Procedures adverse effects, Pelvic Organ Prolapse surgery, Urinary Incontinence, Stress epidemiology, Urinary Incontinence, Stress surgery, Urinary Incontinence, Stress etiology, Minimally Invasive Surgical Procedures adverse effects, Postoperative Complications epidemiology, Postoperative Complications etiology
- Abstract
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., Competing Interests: The other authors have declared they have no conflicts of interest., (Copyright © 2024 American Urogynecologic Society. All rights reserved.)
- Published
- 2024
- Full Text
- View/download PDF
158. Classification and treatment of vaginal strictures at the donor-recipient anastomosis after uterus transplant.
- Author
-
Johannesson L, Humphries LA, Porrett PM, Testa G, Anderson S, Walter JR, Rush M, Ferrando CA, O'Neill K, and Richards EG
- Subjects
- Female, Humans, Adult, Constriction, Pathologic, Prospective Studies, Risk Factors, Postoperative Complications etiology, Postoperative Complications diagnosis, Postoperative Complications therapy, Postoperative Complications epidemiology, Postoperative Complications surgery, Treatment Outcome, Young Adult, 46, XX Disorders of Sex Development surgery, 46, XX Disorders of Sex Development diagnosis, Severity of Illness Index, Organ Transplantation adverse effects, Organ Transplantation methods, Middle Aged, Incidence, Tissue Donors, Graft Survival, Congenital Abnormalities, Mullerian Ducts abnormalities, Uterus surgery, Vagina surgery, Vagina pathology, Anastomosis, Surgical adverse effects
- Abstract
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)., Competing Interests: Declaration of Interests L.Z. has nothing to disclose. L.A.H. has nothing to disclose.P.M.P. G.T. has nothing to disclose. S.A. has nothing to disclose. J.R.W. has nothing to disclose. M.R. has nothing to disclose. C.A.F. has nothing to disclose. K.O. has nothing to disclose. E.G.R. has nothing to disclose., (Copyright © 2024 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)
- Published
- 2024
- Full Text
- View/download PDF
159. Dynamic Changes of the Genital Hiatus at the Time of Prolapse Surgery: 1-Year Follow-Up Study.
- Author
-
Chang OH, Ferrando CA, Paraiso MFR, and Propst K
- Abstract
Importance: The genital hiatus (GH) has been identified as a predictor of pelvic organ prolapse. An enlarged preoperative GH is a risk factor for recurrent prolapse after surgery., Objective: The objective of this study was to determine the changes in preoperative and postoperative GH size compared with the intraoperative resting GH at 6 weeks and 12 months after native-tissue pelvic organ prolapse surgery., Study Design: This was a descriptive analysis of a prospective cohort study of women undergoing native-tissue prolapse repair with apical suspension. Resting GH was obtained at the start and conclusion of surgery. Measurements were obtained preoperatively, and 6 weeks and 12 months postoperatively under Valsalva maneuver. Comparisons were made using paired t tests for the following time points: (1) preoperative measurements under Valsalva maneuver to resting presurgery measurements under anesthesia, and (2) resting postsurgery measurements under anesthesia to 6 weeks and 12 months postoperatively under Valsalva maneuver., Results: Sixty-seven patients were included, with a median age of 66 years and median body mass index (calculated as weight in kilograms divided by height in meters squared) of 29.1. There was no significant difference in GH when measured preoperatively to resting presurgical measurements under anesthesia (P = 0.60). For all, the median GH was 3.0 cm at the conclusion of surgery and remained at 3.0 cm at 6 weeks and 12 months postoperatively. In patients who had a concurrent posterior colporrhaphy, the median resting postsurgery GH was 3.0 cm, then decreased to 2.5 cm at 6 weeks then 3.5 cm at 12 months under Valsalva., Conclusions: Preoperative GH size under Valsalva maneuver and resting under anesthesia were comparable. For all patients undergoing native-tissue pelvic organ prolapse repair, the genital hiatus size remains the same from the intraoperative final resting measurements to the 6-week and 12-month measurements under Valsalva maneuver., Competing Interests: The authors have declared they have no conflicts of interest., (Copyright © 2024 American Urogynecologic Society. All rights reserved.)
- Published
- 2024
- Full Text
- View/download PDF
160. Same-day Discharge Following Vaginal Hysterectomy and Native-tissue Apical Repair for Uterovaginal Prolapse: A Prospective Cohort Study.
- Author
-
Casas-Puig V, Paraiso MFR, Park AJ, and Ferrando CA
- Subjects
- Humans, Female, Prospective Studies, Middle Aged, Aged, Patient Discharge statistics & numerical data, Postoperative Complications epidemiology, Postoperative Complications etiology, Treatment Outcome, Pain, Postoperative etiology, Pain, Postoperative epidemiology, Hysterectomy, Vaginal adverse effects, Hysterectomy, Vaginal methods, Patient Satisfaction, Uterine Prolapse surgery
- Abstract
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., (© 2024. The International Urogynecological Association.)
- Published
- 2024
- Full Text
- View/download PDF
161. Healthcare Resource Utilization Following Minimally Invasive Sacrocolpopexy: Impact of Concomitant Rectopexy.
- Author
-
Lua-Mailland LL, Stanley EE, Yao M, Paraiso MFR, Wallace SL, and Ferrando CA
- Subjects
- Humans, Female, Retrospective Studies, Middle Aged, Aged, Patient Acceptance of Health Care statistics & numerical data, Rectum surgery, Postoperative Complications etiology, Postoperative Complications epidemiology, Patient Readmission statistics & numerical data, Sacrum surgery, Pelvic Organ Prolapse surgery, Minimally Invasive Surgical Procedures, Gynecologic Surgical Procedures statistics & numerical data, Gynecologic Surgical Procedures methods
- Abstract
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., (© 2024. The International Urogynecological Association.)
- Published
- 2024
- Full Text
- View/download PDF
162. Patient Perspectives Following Obstetric Anal Sphincter Injury.
- Author
-
Nutaitis AC, Ferrando CA, and Propst K
- Abstract
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., Competing Interests: C.A.F. received authorship royalties from UpToDate and Elsevier. The remaining authors report no conflicts of interest., (Copyright © 2024 American Urogynecologic Society. All rights reserved.)
- Published
- 2024
- Full Text
- View/download PDF
163. Breast Cancer Screening Referral Patterns and Compliance in Transgender Male Patients.
- Author
-
Tewari S and Ferrando CA
- Abstract
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., Competing Interests: The authors declare no conflicts of interest., (Copyright 2024, Mary Ann Liebert, Inc., publishers.)
- Published
- 2024
- Full Text
- View/download PDF
164. Incidence of breakthrough bleeding in transgender and gender-diverse individuals on long-term testosterone.
- Author
-
Grimstad FW, Boskey ER, Clark RS, and Ferrando CA
- Subjects
- Adult, Female, Adolescent, Humans, Young Adult, Testosterone therapeutic use, Incidence, Retrospective Studies, Transgender Persons, Metrorrhagia
- Abstract
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., (Copyright © 2024 Elsevier Inc. All rights reserved.)
- Published
- 2024
- Full Text
- View/download PDF
165. Does the setting for intradetrusor onabotulinumtoxinA injection for management of overactive bladder matter?
- Author
-
Ross JH, Abrams M, Vasavada SP, Mangel JM, and Ferrando CA
- Abstract
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., Competing Interests: There are no conflicts of interest., (Copyright: © 2024 Indian Journal of Urology.)
- Published
- 2024
- Full Text
- View/download PDF
166. Patient Outcomes After Robotic Ventral Rectopexy With Sacrocolpopexy.
- Author
-
Ross JH, Yao M, Wallace SL, Paraiso MFR, Vogler SA, Propst K, and Ferrando CA
- Subjects
- Humans, Retrospective Studies, Treatment Outcome, Robotic Surgical Procedures adverse effects, Rectal Prolapse surgery, Intussusception etiology, Pelvic Organ Prolapse surgery
- Abstract
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., Competing Interests: The authors have declared they have no conflicts of interest., (Copyright © 2023 American Urogynecologic Society. All rights reserved.)
- Published
- 2024
- Full Text
- View/download PDF
167. Urinary Reconstruction in Genital Gender-Affirming Surgery: Checking Our Surgical Complication Blind Spots.
- Author
-
Blasdel G, Dy GW, Nikolavsky D, Ferrando CA, Bluebond-Langner R, and Zhao LC
- Subjects
- Humans, Female, Constriction, Pathologic etiology, Vagina surgery, Retrospective Studies, Systematic Reviews as Topic, Sex Reassignment Surgery methods, Transgender Persons
- Abstract
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., (Copyright © 2023 by the American Society of Plastic Surgeons.)
- Published
- 2024
- Full Text
- View/download PDF
168. Urinary microbiome community types associated with urinary incontinence severity in women.
- Author
-
Carnes MU, Siddiqui NY, Karstens L, Gantz MG, Dinwiddie DL, Sung VW, Bradley M, Brubaker L, Ferrando CA, Mazloomdoost D, Richter HE, Rogers RG, Smith AL, and Komesu YM
- Subjects
- Humans, Female, Middle Aged, Cross-Sectional Studies, Urinary Incontinence microbiology, Adult, Urine microbiology, Aged, RNA, Ribosomal, 16S, Urinary Incontinence, Stress microbiology, Urinary Incontinence, Urge microbiology, Microbiota, Vagina microbiology, Severity of Illness Index
- Abstract
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., (Copyright © 2023. Published by Elsevier Inc.)
- Published
- 2024
- Full Text
- View/download PDF
169. Restrictive opioid prescribing after surgery for prolapse and incontinence: a randomized, noninferiority trial.
- Author
-
Yuan AS, Propst KA, Ross JH, Wallace SL, Paraiso MFR, Park AJ, Chapman GC, and Ferrando CA
- Subjects
- Humans, Female, Pain, Postoperative drug therapy, Practice Patterns, Physicians', Oxycodone therapeutic use, Analgesics, Opioid therapeutic use, Pelvic Organ Prolapse surgery
- Abstract
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., (Copyright © 2023 Elsevier Inc. All rights reserved.)
- Published
- 2024
- Full Text
- View/download PDF
170. Prevalence of Polycystic Ovarian Syndrome in Young and Adolescent Transmasculine Patients Presenting for Gender-Affirming Care.
- Author
-
Rangi SK, Rehmer J, and Ferrando CA
- Subjects
- Female, Humans, Adolescent, Retrospective Studies, Prevalence, Gender-Affirming Care, Polycystic Ovary Syndrome complications, Polycystic Ovary Syndrome epidemiology, Polycystic Ovary Syndrome diagnosis, Hyperandrogenism complications
- Abstract
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., Competing Interests: Conflicts of Interest Cecile Ferrando, MD, discloses royalties from UpToDate and Elsevier. Sabrina Rangi, MD, and Jenna Rehmer, MD, have no disclosures., (Copyright © 2023. Published by Elsevier Inc.)
- Published
- 2024
- Full Text
- View/download PDF
171. Transgender women's perspectives on mental health care related to vaginoplasty for gender affirmation.
- Author
-
Marra EE, Mabel H, Feldman S, Mercer MB, Altinay M, and Ferrando CA
- Subjects
- Female, Humans, Gender Identity, Mental Health, Mental Health Services, Sex Reassignment Surgery methods, Transgender Persons psychology, Transsexualism surgery, Vagina surgery
- Abstract
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., (© 2023. The Author(s).)
- Published
- 2024
- Full Text
- View/download PDF
172. Characterization of Pain Associated With Pelvic Organ Prolapse: Is Surgery the Answer?
- Author
-
Yuan AS, Ferrando CA, and Hickman LC
- Abstract
Importance: Data on the incidence of pelvic organ prolapse (POP)-related pain, risk factors for its development, and treatment effects of surgery remain sparse., Objectives: The aims of the study were to evaluate the incidence and characteristics of POP-related pain in patients presenting with POP and assess the outcome of pain after surgery., Study Design: This was a retrospective study of patients presenting for initial evaluation of POP from May 2019 to May 2020. Using a standardized questionnaire, patients were asked "Do you have pain associated with your prolapse (not pressure or fullness)?" and to indicate pain severity and location(s). Patients who underwent surgery were asked postoperatively if their POP-related pain resolved. Patient and perioperative characteristics were obtained from the medical record and used to evaluate relationships between the presence and resolution of POP-related pain., Results: Of the 795 patients who met inclusion criteria, 106 (13.3%) reported POP-related pain. The mean age of all patients was 59.9 years, 38.1% had stage 3 or greater POP, and 52.1% were sexually active. Women with POP-related pain reported a median severity of 5 of 10. The most common pain locations were the vagina (46.6%), lower abdomen (27.4%), and back (9.6%). Fifty-seven women with pain (53.8%) underwent surgery, and 40 (70.2%) reported postoperative pain resolution. Of those who did not have resolution, pain improved or remained stable in severity. No patients reported worsening pain after surgery., Conclusions: Pain is a symptom experienced by more than 1 in 8 women presenting with POP, with 70% reporting resolution of their pain postoperatively., Competing Interests: The authors have declared they have no conflicts of interest., (Copyright © 2023 American Urogynecologic Society. All rights reserved.)
- Published
- 2023
- Full Text
- View/download PDF
173. Comparing endometrial biopsy results with hysteroscopic pathology in women presenting with abnormal and postmenopausal uterine bleeding.
- Author
-
Ferrando CA, Lintel MK, and Bradley LD
- Subjects
- Humans, Female, Hyperplasia, Postmenopause, Retrospective Studies, Uterine Hemorrhage complications, Biopsy, Uterine Diseases complications, Uterine Diseases diagnosis, Uterine Diseases surgery, Uterine Neoplasms diagnosis
- Abstract
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/m
2 . 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., Competing Interests: Declaration of Competing Interest Dr. Ferrando receives authorship royalties from UpToDate and Elsevier; Dr. Bradley receives authorship royalties from UpToDate, Wolters Kluwer, and Elsevier., (Copyright © 2023. Published by Elsevier Masson SAS.)- Published
- 2023
- Full Text
- View/download PDF
174. 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.
- Author
-
Ferrando CA, Mishra K, Grimstad FW, Weigand NW, and Pikula C
- Subjects
- Female, Humans, Pelvic Floor surgery, Pelvic Pain therapy, Physical Therapy Modalities, Standard of Care, Adult, Male, Transgender Persons
- Abstract
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/m
2 . 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., (© 2023. The International Urogynecological Association.)- Published
- 2023
- Full Text
- View/download PDF
175. Is there an association between 6-month genital hiatus size and 24-month composite prolapse recurrence following minimally invasive sacrocolpopexy?
- Author
-
Casas-Puig V, Yao M, Propst KA, and Ferrando CA
- Abstract
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., (© 2023. The International Urogynecological Association.)
- Published
- 2023
- Full Text
- View/download PDF
176. Postoperative adverse events following gender-affirming vaginoplasty: an American College of Surgeons National Surgical Quality Improvement Program study.
- Author
-
Mishra K and Ferrando CA
- Subjects
- Humans, Female, Male, United States epidemiology, Adult, Retrospective Studies, Quality Improvement, Gender Identity, Postoperative Complications epidemiology, Risk Factors, Surgical Wound Infection epidemiology, Surgeons
- Abstract
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., (Copyright © 2023 Elsevier Inc. All rights reserved.)
- Published
- 2023
- Full Text
- View/download PDF
177. Intention matters: Success rate of bilateral salpingo-oophorectomy at the time of vaginal hysterectomy for pelvic organ prolapse.
- Author
-
Messingschlager C, Ferrando CA, and Chang OH
- Subjects
- Humans, Female, Salpingo-oophorectomy methods, Hysterectomy methods, Retrospective Studies, Intention, Ovariectomy methods, Hysterectomy, Vaginal methods, Pelvic Organ Prolapse surgery, Pelvic Organ Prolapse etiology
- Abstract
Objective: The objective of this study was to determine the incidence of successful bilateral salpingo-oophorectomy at the time of vaginal hysterectomy for pelvic organ prolapse and to evaluate associated factors and success rate over time., Study Design: This was a retrospective chart review of all women who underwent vaginal hysterectomy for pelvic organ prolapse who were consented for bilateral salpingo-oophorectomy "if possible" and "including extraordinary measures" between 2014 and 2019 at a tertiary medical center. Baseline demographic data along with prolapse stage, operative findings, operative time, and complications were recorded. Univariate analysis using the Pearson's chi-square test, the student's t-test or Mann Whitney U test when appropriate and multivariable logistic regression was performed to determine predictors of successful vaginal bilateral salpingo-oophorectomy., Results: A total of 453 eligible patients were included. 420 patients (92.7 %) were consented for bilateral salpingo-oophorectomy "if possible" and 33 patients (7.3 %) were consented for "including extraordinary measures". The success rate of vaginal bilateral salpingo-oophorectomy in all patients was 57.9 % (n = 262). Of the patients consented for extraordinary measures, the success rate was 93.9 % (n = 31), compared to a success rate of 55 % (n = 231) in the "if possible" group. A concurrent posterior repair was found to have higher odds of successful bilateral salpingo-oophorectomy (adjOR 1.75 [95 % CI = 1.17-2.61]). Successful bilateral salpingo-oophorectomy extended operative time by 14 min (154 min vs 140 min, p < 0.001). Compared to patients in the unsuccessful group, the successful group had a higher proportion of the following indications: a family history of ovarian cancer, personal breast cancer history or patient request for definitive removal., Conclusion: When the pre-operative intention to perform bilateral salpingo-oophorectomy at the time of vaginal hysterectomy for pelvic organ prolapse is high, the success rate is nearly 40% higher when compared to an opportunistic procedure. This suggests that success is closely linked to the surgeon's determination to complete this procedure vaginally., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier B.V. All rights reserved.)
- Published
- 2023
- Full Text
- View/download PDF
178. Determining the Ideal Intraoperative Resting Genital Hiatus Size-Balancing Surgical and Functional Outcomes.
- Author
-
Chang OH, Yao M, Ferrando CA, Paraiso MFR, and Propst K
- Subjects
- Female, Humans, Middle Aged, Prospective Studies, Pelvic Floor, Vagina, Vulva, Pelvic Organ Prolapse
- Abstract
Importance: The intraoperative resting genital hiatus (GH) size can be surgically modified but its relationship to prolapse recurrence is unclear., Objectives: The objective of this study was to identify the optimal intraoperative resting GH size as it relates to prolapse recurrence and functional outcomes at 1 year., Study Design: This prospective cohort study was conducted at 2 hospitals from 2019 to 2021. Intraoperative measurements of the resting GH, perineal body, and total vaginal length were collected. The composite primary outcome consisted of anatomic recurrence, subjective recurrence, and/or conservative or surgical retreatment at 1 year. Comparisons of anatomic, functional, and sexual outcomes were compared between patients stratified by the optimal intraoperative GH size identified by receiver operating characteristic curve analysis., Results: Sixty-eight patients (median age of 63 years) underwent surgery, with 59 (86.8%) presenting for follow-up at 1 year. Based on the 13 patients (22%) with composite recurrence, receiver operating characteristic curve analysis demonstrated an intraoperative resting GH size of 3 cm, had 76.9% sensitivity (confidence interval [CI], 54-99.8%), and 34.8% specificity (CI, 21.0-48.5%) for composite recurrence at 1 year (area under curve = 0.61). Nineteen patients had an intraoperative GH less than 3 cm (32.2%) and 40 had a GH of 3 cm or greater (67.8%). The intraoperative resting GH size was significantly larger in patients with prolapse beyond the hymen at 1 year (4 cm [3.0, 4.0]) compared with those with prolapse at or proximal to the hymen (3.0 cm [2.5, 3.5], P = 0.009)., Conclusions: Intraoperative GH size may not reliably predict composite prolapse recurrence at 1 year, although there was an association between intraoperative resting GH size with prolapse beyond the hymen., Competing Interests: The authors have declared they have no conflicts of interest., (Copyright © 2022 American Urogynecologic Society. All rights reserved.)
- Published
- 2022
- Full Text
- View/download PDF
179. Postoperative pain and the need for intervention after sacrospinous ligament hysteropexy compared to colpopexy: a retrospective cohort study.
- Author
-
Yuan AS, Propst KA, and Ferrando CA
- Subjects
- Buttocks, Female, Humans, Ligaments surgery, Ligaments, Articular, Pain, Postoperative epidemiology, Pain, Postoperative etiology, Retrospective Studies, Treatment Outcome, Gynecologic Surgical Procedures adverse effects, Pelvic Organ Prolapse etiology, Pelvic Organ Prolapse surgery
- Abstract
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., (© 2022. The International Urogynecological Association.)
- Published
- 2022
- Full Text
- View/download PDF
180. Intermediate term outcomes after transvaginal uterine-preserving surgery in women with uterovaginal prolapse.
- Author
-
Hickman LC, Tran MC, Paraiso MFR, Walters MD, and Ferrando CA
- Subjects
- Adult, Aged, Cross-Sectional Studies, Female, Gynecologic Surgical Procedures methods, Humans, Middle Aged, Retrospective Studies, Treatment Outcome, Pelvic Organ Prolapse surgery, Uterine Prolapse surgery
- Abstract
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., (© 2021. The International Urogynecological Association.)
- Published
- 2022
- Full Text
- View/download PDF
181. Defining mechanisms of recurrence following apical prolapse repair based on imaging criteria.
- Author
-
Bowen ST, Moalli PA, Abramowitch SD, Lockhart ME, Weidner AC, Ferrando CA, Nager CW, Richter HE, Rardin CR, Komesu YM, Harvie HS, Mazloomdoost D, Sridhar A, and Gantz MG
- Subjects
- Aged, Female, Gynecologic Surgical Procedures adverse effects, Humans, Hysterectomy, Vaginal adverse effects, Imaging, Three-Dimensional, Middle Aged, Recurrence, Magnetic Resonance Imaging, Pelvis diagnostic imaging, Treatment Failure, Uterine Prolapse diagnostic imaging, Uterine Prolapse surgery
- Abstract
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., (Copyright © 2021 Elsevier Inc. All rights reserved.)
- Published
- 2021
- Full Text
- View/download PDF
182. Risk factors for ureteral obstruction and the diagnostic value of the "cysto-under-tension" technique at the time of uterosacral colpopexy.
- Author
-
Chang OH, Tewari S, Sun JY, and Ferrando CA
- Subjects
- Aged, Cohort Studies, Female, Humans, Ligaments, Retrospective Studies, Risk Factors, Ureteral Obstruction epidemiology, Ureteral Obstruction etiology, Ureteral Obstruction surgery
- Abstract
Introduction and Hypothesis: The objective is to determine the incidence of ureteral obstruction and delayed ureteral injury and to identify risk factors for ureteral obstruction following uterosacral colpopexy. The secondary objective is to evaluate the diagnostic value of the "cysto-under-tension" technique, when a cystoscopy is performed prior to vaginal cuff closure with the uterosacral sutures on tension., Methods: This was a retrospective review of patients undergoing uterosacral ligament colpopexy between 2007 and 2012 with a nested case-control analysis. Patients with documented ureteral obstruction on cystoscopy or a delayed ureteral injury were identified. Cases were defined as patients with a ureteral obstruction on cystoscopy and controls as those who did not; a multivariable regression analysis was performed., Results: A total of 551 patients underwent uterosacral ligament colpopexy. Twenty-four (4.3% [95% CI = 2.94-6.40]) patients had a ureteral obstruction on cystoscopy, and two (0.4% [95% CI = 0.09-1.31]) patients experienced a delayed ureteral injury. The "cysto-under-tension" technique was used in 40 (7.3%) cases, with a sensitivity of 50.0% (CI = 1.26-98.74) and specificity of 97.4% (CI = 86.2-99.9) to detect ureteral obstruction. On logistic regression for the case-control analysis, increased age remained associated with increased odds of ureteral obstruction (adjOR 1.06, 95% CI = 1.02-1.11) and a higher BMI had lower odds (adjOR 0.89, 95% CI = 0.79-0.98)., Conclusions: In this large cohort study, older age was associated with higher odds of obstruction at the time of colpopexy while a higher BMI might have been protective. The "cysto-under-tension" technique overall may not be that useful in detecting ureteral obstructions but has high negative predictive value., (© 2020. The International Urogynecological Association.)
- Published
- 2021
- Full Text
- View/download PDF
183. Preoperative Pain Symptoms and the Incidence of Endometriosis in Transgender Men Undergoing Hysterectomy for Gender Affirmation.
- Author
-
Ferrando CA, Chapman G, and Pollard R
- Subjects
- Female, Humans, Hysterectomy adverse effects, Incidence, Infant, Newborn, Male, Pelvic Pain epidemiology, Pelvic Pain etiology, Pelvic Pain surgery, Retrospective Studies, Endometriosis epidemiology, Endometriosis surgery, Laparoscopy adverse effects, Transgender Persons
- Abstract
Study Objective: To describe the incidence of pelvic pain in transgender men undergoing hysterectomy for gender affirmation and to describe the incidence of endometriosis found at the time of surgery., Design: Retrospective chart review of transgender men presenting for gender-affirming hysterectomy between 2010 and 2019. Patients were identified by Current Procedural Terminology codes and documented male gender in the medical record, which was queried for perioperative data., Setting: All patients underwent minimally invasive hysterectomy under general anesthesia by 2 surgeons at 2 institutions., Patients: Patients were individuals assigned female at birth identifying as male who met the criteria for gender-affirming hysterectomy., Interventions: Hysterectomy performed using preferred techniques by the surgeons in this study., Measurements and Main Results: Sixty-seven (N = 67) patients underwent hysterectomy: 98.5% (66) total laparoscopic with salpingo-oophorectomy and 1.5% (1) total laparoscopic with ovarian preservation. Mean age and body mass index were 29(±8) years and 28.6(±6.7) kg/m
2 , respectively. Of the patients, 89.5% (60) were on testosterone for a median of 36 (12-300) months: 59.7% (40) were amenorrheic, 43.2% (29) had dysmenorrhea, 17.9% (12) reported heavy menses, and 14.9% had irregular menses. Furthermore, 50.7% (34) complained of pelvic pain (35.3% constant, 64.7% cyclic). Intraoperative endometriosis was diagnosed in 26.9% (18) of the patients: in 32.3% of the patients who reported pelvic pain and in 21.9% of the patients without pain. There were no differences between patients with endometriosis compared with those without endometriosis except for those with endometriosis were more likely to report irregular bleeding (27.8% vs 8.3%, p = .04) and were also more likely to complain of heavy menses (66.7% vs 35.4%, p = .03)., Conclusion: Of the transgender men who presented for hysterectomy, 50% reported pelvic pain, but only 1 in 3 with pain had findings of endometriosis. Patients found to have endometriosis were more likely to report irregular bleeding and/or heavy menses., (Copyright © 2021 AAGL. Published by Elsevier Inc. All rights reserved.)- Published
- 2021
- Full Text
- View/download PDF
184. Assessment of Cardiovascular Risk in Transgender Patients Presenting for Gender-Affirming Care.
- Author
-
Denby KJ, Cho L, Toljan K, Patil M, and Ferrando CA
- Subjects
- Adult, Female, Health Services for Transgender Persons, Humans, Male, Retrospective Studies, Risk Assessment, Young Adult, Cardiovascular Diseases complications, Cardiovascular Diseases epidemiology, Heart Disease Risk Factors, Transsexualism complications
- Abstract
Background: The transgender population is rapidly growing in the United States and abroad. Transgender men and women are marginalized as a result of their transgender status, with resultant health repercussions. This and other factors such as increased substance use, mental health disorders, violence, and chronic stress may place transgender individuals at higher risk for cardiovascular disease. Additionally, many transgender patients pursue gender-affirming hormone therapy, which has been linked to increased rates of some cardiovascular events such as metabolic syndrome, venous thromboembolism, and stroke. Despite the likelihood of elevated cardiovascular risk in this population, there is a paucity of published data about the cardiovascular risk of this population., Methods: We present baseline cardiovascular data from a transgender population at a large tertiary care center prior to the initiation of hormone therapy., Results: The described transgender population had much higher rates of mental health disorders and substance use than the general population. Furthermore, there were high rates of undiagnosed and untreated comorbidities, such as hypertension and dyslipidemia, that increase risk for cardiovascular disease. Baseline risk assessment using the ASCVD (Atherosclerotic Cardiovascular Disease) and QRISK3 calculators showed higher-than-expected cardiovascular risk, particularly given the young age of our patient population., Conclusions: Transgender individuals are at high baseline cardiovascular risk. These data help fill some important knowledge gaps in this patient subgroup, and provide us with much-needed data to help guide our management and counseling of individuals seeking this type of care., (Copyright © 2021 Elsevier Inc. All rights reserved.)
- Published
- 2021
- Full Text
- View/download PDF
185. A prospective randomized trial comparing Restorelle® Y mesh and flat mesh for laparoscopic and robotic-assisted laparoscopic sacrocolpopexy: 24-month outcomes.
- Author
-
Ferrando CA and Paraiso MFR
- Subjects
- Female, Gynecologic Surgical Procedures, Humans, Prospective Studies, Surgical Mesh, Treatment Outcome, Laparoscopy, Pelvic Organ Prolapse surgery, Robotic Surgical Procedures
- Abstract
Objective: To compare prolapse recurrence and the incidence of mesh exposure between Restorelle® Y mesh and dual flat mesh., Methods: A randomized trial of women undergoing laparoscopic (LSC) or robotic (RSC) sacrocolpopexy for post-hysterectomy vaginal prolapse. Subjects were randomized to either Y mesh or dual flat mesh. Subjects underwent a pelvic examination with POP-Q and evaluation of any mesh exposure, and the PFDI-20 was administered at 6, 12 and 24 months postoperatively. Subjective recurrence was defined by symptomatic vaginal bulge. All subjects underwent pelvic examination with POP-Q at 6, 12 and 24 months. Objective recurrence was defined by descent of the apex > 1/3 into the vaginal canal, anterior or posterior vaginal descent beyond the hymen, or retreatment for prolapse., Results: Sixty-two patients were enrolled, and 59 patients were implanted with mesh: 30 Y mesh (17 LSC, 13 RSC) and 29 flat mesh (18 LSC, 11 RSC). There were no differences in patient characteristics between the groups. At 24 months, data were available for 44 (74.5%) patients. There were no mesh exposures for all subjects. PFDI-20 scores improved significantly for all subjects with no differences in mean improvement by mesh configuration. There were no differences in subjective and objective recurrence rates between the groups. Four patients (9.1%) complained of subjective vaginal bulge symptoms while nine (20.5%) patients had an objective recurrence (77.8% [7] examination only and 22.2% [2] reoperation). There were no apical recurrences. Of those patients who had a recurrence on examination only (n = 7), 85.7% (6) were asymptomatic., Conclusions: At 24 months, there were no differences in subjective outcomes and prolapse recurrence in patients who underwent sacrocolpopexy with the Restorelle® Y mesh versus dual flat mesh. One in five patients experienced an objective recurrence; however, there were no apical recurrences and the majority were asymptomatic.
- Published
- 2021
- Full Text
- View/download PDF
186. Outcomes of labiaplasty in women with labial hypertrophy.
- Author
-
Propst K and Ferrando CA
- Subjects
- Adolescent, Adult, Cross-Sectional Studies, Female, Humans, Hypertrophy, Patient Satisfaction, Retrospective Studies, Vulva surgery, Young Adult, Quality of Life, Plastic Surgery Procedures
- Abstract
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/m
2 . 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.- Published
- 2021
- Full Text
- View/download PDF
187. Occult Uterine Malignancy at the Time of Sacrocolpopexy in the Context of the Safety Communication on Power Morcellation by the FDA.
- Author
-
Chang OH and Ferrando CA
- Subjects
- Communication, Female, Humans, Hysterectomy adverse effects, Retrospective Studies, United States epidemiology, United States Food and Drug Administration, Laparoscopy adverse effects, Morcellation adverse effects, Uterine Neoplasms epidemiology, Uterine Neoplasms surgery
- Abstract
Study Objective: The objective of this study was to determine the incidence of occult uterine malignancy at the time of sacrocolpopexy with concurrent hysterectomy, in the context of practice pattern changes as a result of the 2014 Food and Drug Administration (FDA) power morcellation safety communication., Design: Retrospective chart review., Setting: Tertiary care referral center in the United States., Patients: A total of 839 patients who underwent sacrocolpopexy from January 2004 to December 2018., Interventions: All patients received a concurrent hysterectomy without a diagnosis of suspected or confirmed gynecologic malignancy before surgery. Trends of surgeries were compared before and after the 2014 FDA power morcellation safety communication., Measurements and Main Results: Demographic and perioperative data were collected from the system-wide electronic medical record. Operative and pathology reports were reviewed to determine the method of specimen retrieval and specimen pathology results. A total of 238 patients (28.4%) had a hysterectomy at the time of sacrocolpopexy. There were no cases of occult uterine malignancy (0%, 95% CI 0%-1.6%). There was 1 case of borderline tumor of the ovary. The most common mode of hysterectomy over the 15-year period was laparoscopic hysterectomy (n = 84, 35.3%), followed by vaginal hysterectomy (n = 63, 26.5%). After the FDA communication, the most common form of hysterectomy changed significantly to vaginal hysterectomy (n = 35, 55.6%; p <.001). When comparing the first 2 years after the announcement (2014-2016) to the subsequent 2 years (2017-2018), there was again a significant increase in the use of laparoscopic hysterectomy in the latter time period (7.3% vs 40.9%; p <.001)., Conclusion: In this cohort of patients undergoing sacrocolpopexy with concurrent hysterectomy, the incidence of occult uterine malignancy was low. After the FDA safety communication, practice patterns with regard to the mode of hysterectomy changed, but the magnitude of these changes were transient., (Copyright © 2020 AAGL. Published by Elsevier Inc. All rights reserved.)
- Published
- 2021
- Full Text
- View/download PDF
188. Pelvic organ prolapse recurrence in young women undergoing vaginal and abdominal colpopexy.
- Author
-
Hickman LC, Tran MC, Davidson ERW, Walters MD, and Ferrando CA
- Subjects
- Adult, Cross-Sectional Studies, Female, Humans, Pessaries, Retrospective Studies, Treatment Outcome, Vagina surgery, Pelvic Organ Prolapse epidemiology, Pelvic Organ Prolapse surgery
- Abstract
Introduction and Hypothesis: While pelvic organ prolapse (POP) recurrence is believed to increase over time, outcomes of young women who undergo POP surgery are unclear. We hypothesized POP recurrence incidence among women <49 years would be higher after vaginal versus abdominal colpopexy., Methods: This is a retrospective cohort study with a cross-sectional survey of women 18-49 years who underwent primary POP surgery from January 2003 to September 2013. Patients were identified by CPT codes for vaginal and abdominal colpopexy. POP recurrence was defined as vaginal bulge symptoms, POP retreatment (pessary or surgery) or both. Validated questionnaires were used to assess pelvic floor symptoms, patient satisfaction and improvement., Results: Three hundred thirty-three women met the criteria. Mean age was 43 (+ 5.3) years; 29.1% (97) had an abdominal colpopexy and 70.9% (236) had a vaginal colpopexy. The recurrence incidence overall was 32.0% (31) in the abdominal group and 24.2% (57) in the vaginal group (p = 0.15), with a 10.3% (10) retreatment incidence in the abdominal group and 5.9% (14) in the vaginal group (p = 0.16). Forty-five percent (149) responded to the survey at a median time of 7.9 (3.1-15.2) years since surgery. The overall recurrence incidence in respondents was 13.7% (7) in the abdominal group and 15.3% (15) in the vaginal group (p = 0.80), with a retreatment incidence of 5.9% (3) in the abdominal and 5.2% (5) in the vaginal group (p = 0.85)., Conclusions: One in four young women experienced subjective POP recurrence and/or retreatment, but only 5-10% underwent retreatment. There does not appear to be a difference in the incidence of recurrence between vaginal and abdominal colpopexy.
- Published
- 2020
- Full Text
- View/download PDF
189. Clinical needs for transgender men in the gynecologic oncology setting.
- Author
-
Stenzel AE, Moysich KB, Ferrando CA, and Starbuck KD
- Subjects
- Female, Genital Neoplasms, Female therapy, Gynecology statistics & numerical data, Health Services Needs and Demand statistics & numerical data, Humans, Male, Mass Screening organization & administration, Medical Oncology statistics & numerical data, Quality Improvement, Social Stigma, United States, Vulnerable Populations, Genital Neoplasms, Female diagnosis, Gynecology organization & administration, Healthcare Disparities statistics & numerical data, Medical Oncology organization & administration, Transgender Persons statistics & numerical data
- Abstract
Transgender men remain at risk for gynecologic malignancies, but are an underserved population. Members of the transgender community experience discrimination and have experiences that contribute to health disparities, including in gynecology and oncology. While efforts have been made within the United States to reduce inequalities experienced by members of this community, many needs in the clinical setting remain. Increased education and training among providers and healthcare professionals, and general improvements towards understanding barriers to health screening and health resource uptake may reduce some disparities. Additional research towards screening and cancer surveillance among this community will be necessary to understand any potential additional risks and survival disparities experienced by transgender men. This review focuses on barriers and clinical needs for transgender men in the gynecologic oncology setting, and suggestions for moving forward to improve care for this patient population., Competing Interests: Declaration of Competing Interest Dr. Ferrando reports annual royalties from UpToDate on the subject of LGBTQ+ health., (Copyright © 2020 Elsevier Inc. All rights reserved.)
- Published
- 2020
- Full Text
- View/download PDF
190. Does concurrent posterior repair for an asymptomatic rectocele reduce the risk of surgical failure in patients undergoing sacrocolpopexy?
- Author
-
Chang OH, Davidson ERW, Thomas TN, Paraiso MFR, and Ferrando CA
- Subjects
- Constipation, Cross-Sectional Studies, Female, Gynecologic Surgical Procedures adverse effects, Humans, Retrospective Studies, Surgical Mesh, Treatment Outcome, Pelvic Organ Prolapse surgery, Rectocele surgery
- Abstract
Purpose: To determine if a concurrent posterior repair for an asymptomatic rectocele at the time of sacrocolpopexy reduces the incidence of surgical failure., Methods: This is a retrospective chart review with a cross-sectional follow-up survey of all patients who underwent sacrocolpopexy from 2004 to 2014. Demographic and operative data were collected from the medical record. For the cross-sectional portion, patients were contacted to obtain information on symptoms and retreatment after surgery. In this study, we included patients with an asymptomatic rectocele on examination, defined as Ap or Bp ≥ -1 on POP-Q without defecatory dysfunction, which was defined as constipation based on the Rome III criteria, dyschezia, excessive straining and/or splinting to have a bowel movement. The primary outcome was a composite score of subjective bulge symptoms or retreatment for prolapse., Results: Three hundred forty-four patients met the inclusion criteria: 185 (53.8%) had a sacrocolpopexy only (SCP) and 159 (46.2%) had a concurrent posterior repair (SCP + PR). The composite failure rate was 10.2% (95% CI = 7.4-13.8%), with a 13.5% (25) failure rate in the SCP group compared with 6.3% (10) in the SCP + PR group (p = 0.03). On multivariable logistic regression, the adjusted odds of failure was 2.79 in the SCP compared with the SCP + PR group (CI 1.25-6.23; P = 0.01). The rates of de novo defecatory dysfunction following surgery were low (SCP = 5.6% vs. SCP + PR = 7.5%, p = 0.55)., Conclusions: For patients with asymptomatic rectoceles, a concurrent posterior repair at the time of sacrocolpopexy reduces the odds of composite patient-centered failure without an increased rate of dyspareunia or de novo defecatory dysfunction.
- Published
- 2020
- Full Text
- View/download PDF
191. Long-term pelvic organ prolapse recurrence and mesh exposure following sacrocolpopexy.
- Author
-
Thomas TN, Davidson ERW, Lampert EJ, Paraiso MFR, and Ferrando CA
- Subjects
- Cross-Sectional Studies, Female, Gynecologic Surgical Procedures adverse effects, Humans, Prospective Studies, Retrospective Studies, Surgical Mesh adverse effects, Treatment Outcome, Laparoscopy, Pelvic Organ Prolapse surgery
- Abstract
Introduction and Hypothesis: Large, long-term studies are needed to compare pelvic organ prolapse (POP) recurrence and mesh exposure following all modes of sacrocolpopexy (open, robotic, and laparoscopic). We hypothesized that the prevalence of recurrent POP and mesh exposure does not differ between modes of sacrocolpopexy., Methods: This is a retrospective cohort study with a cross-sectional, prospective survey. Participants were surveyed regarding complications, retreatments, and symptoms following sacrocolpopexy. Baseline characteristics, POP recurrence, mesh exposure, and survey responses were compared., Results: A total of 709 participants met the criteria. Median time from sacrocolpopexy to last follow-up for all participants was 0.5 years (2 days to 13.4 years). 15.0% experienced recurrent stage 2 or greater POP or underwent retreatment (open 11.7% [95% CI 7.8-17.2%]; robotic 21.1% [95% CI 15.6-27.9%]; laparoscopic 13.8% [95% CI 10.6-17.9%]; p = 0.03). After adjusting for baseline differences there was no significant difference among groups (p = 0.30). 5.3% experienced mesh and/or suture exposure (mesh n = 19, suture n = 10, mesh and suture n = 8) with no significant difference among groups (open 7.7% [95% CI 4.6-12.5%]; robotic 3.6% [95% CI 1.7-7.6%]; laparoscopic 4.9% [95% CI 3.1-7.7%]; p = 0.20). Median time from sacrocolpopexy to survey completion was 6.5 (1.6-13.4) years. 9.2% reported evaluation or treatment for recurrent POP (open 6.3% [95% CI 2.1-16.8%]; robotic 12.5% [95% CI 6.9-21.5%]; laparoscopic 8.5% [5.1-13.8%]; p = 0.44). 6.9% reported evaluation or treatment for mesh exposure (open 6.0% [95% CI 2.1-16.2%]; robotic 3.9% [95% CI 1.3-10.7%]; laparoscopic 8.6% [5.2-13.9%]; p = 0.38)., Conclusions: Objective and patient-reported long-term prevalence of POP recurrence and mesh exposure are low following all modes of sacrocolpopexy.
- Published
- 2020
- Full Text
- View/download PDF
192. Ovarian Histopathology in Transmasculine Persons on Testosterone: A Multicenter Case Series.
- Author
-
Grimstad FW, Fowler KG, New EP, Ferrando CA, Pollard RR, Chapman G, Gray M, and Gomez Lobo V
- Subjects
- Adult, Androgens, Female, Humans, Retrospective Studies, Young Adult, Ovary pathology, Testosterone, Transgender Persons
- Abstract
Background: As transmasculine persons utilize androgen gender affirming hormone therapy as a part of transition, guidance has been lacking on the effects of the therapy on the ovaries, especially for those who may desire retention., Aim: To describe the ovarian histopathology of transmasculine persons on testosterone therapy following oophorectomy at the time of hysterectomy performed for gender affirmation., Methods: This was a multicenter case series study of transmasculine patients on testosterone therapy who underwent hysterectomy with oophorectomy for gender affirmation between January 2015 and December 2017 at 5 tertiary care referral centers. Patients were identified by their current procedural and International Classification of Diseases codes., Outcomes: Pre-, perioperative, and pathologic data were obtained from the electronic medical records and ovarian tissue descriptions from pathology reports were grouped into the following classifications: (i) simple/follicular cysts; (ii) polycystic ovaries; (iii) complex cysts; (iv) endometriomas; (v) other masses; (vi) atrophy; and (vii) normal., Results: 85 patients were included in the study. At the time of oophorectomy, the mean age and body mass index of the cohort were 30.4 ± 8.4 years and 30.2 ± 7.3 kg/m
2 , respectively, and the average interval from the initiation of testosterone to oophorectomy was 36 0.3 ± 37.9 months. On examination of ovarian histopathology, 49.4% (42) of specimens were found to have follicular/simple cysts, 5.9% (5) were polycystic, and 38.8% (33) had normal pathology. For those specimens with volume documented (n = 41), the median volume was 9.6 (range 1.5-82.5) cm3 . There was no association between the duration of testosterone therapy or body mass index and the presence of cysts in the ovaries., Clinical Implications: The results of this study reported benign histopathology in ovaries of a large cohort of transmasculine persons on testosterone which should be included when counseling patients on ovarian retention, as transmasculine patients may choose to retain their ovaries while on testosterone for a variety of reasons (including no desire to undergo surgery, desire for backup sex steroids, and potential use for future fertility)., Strengths & Limitations: This is a large multicenter study seeking to address the uncertainty in present counseling surrounding ovarian conservation in transmasculine persons on testosterone therapy. Its limitations included its retrospective nature and inability to address ovarian function after testosterone discontinuance., Conclusion: In this cohort of transmasculine patients on testosterone therapy undergoing hysterectomy with oophorectomy for gender affirmation, ovarian histopathology was benign in all the specimens. Grimstad FW, Fowler KG, New EP, et al. Ovarian Histopathology in Transmasculine Persons on Testosterone: A Multicenter Case Series. J Sex Med 2020;17:1807-1818., (Copyright © 2020 International Society for Sexual Medicine. All rights reserved.)- Published
- 2020
- Full Text
- View/download PDF
193. Cost-Effectiveness of Sacral Neuromodulation versus OnabotulinumtoxinA for Refractory Urgency Urinary Incontinence: Results of the ROSETTA Randomized Trial.
- Author
-
Harvie HS, Amundsen CL, Neuwahl SJ, Honeycutt AA, Lukacz ES, Sung VW, Rogers RG, Ellington D, Ferrando CA, Chermansky CJ, Mazloomdoost D, and Thomas S
- Subjects
- Botulinum Toxins, Type A administration & dosage, Cost-Benefit Analysis, Dose-Response Relationship, Drug, Female, Follow-Up Studies, Humans, Lumbosacral Plexus, Male, Middle Aged, Prospective Studies, Time Factors, Transcutaneous Electric Nerve Stimulation methods, Treatment Outcome, Urinary Incontinence, Urge economics, Urinary Incontinence, Urge physiopathology, Botulinum Toxins, Type A economics, Health Care Costs, Transcutaneous Electric Nerve Stimulation economics, Urinary Incontinence, Urge therapy, Urination physiology
- Abstract
Purpose: Sacral neuromodulation and intradetrusor onabotulinumtoxinA injection are therapies for refractory urgency urinary incontinence. Sacral neuromodulation involves surgical implantation of a device that can last 4 to 6 years while onabotulinumtoxinA therapy involves serial office injections. We assessed the cost-effectiveness of 2-stage implantation sacral neuromodulation vs 200 units onabotulinumtoxinA for the treatment of urgency urinary incontinence., Materials and Methods: Prospective economic evaluation was performed concurrent with the ROSETTA (Refractory Overactive Bladder: Sacral NEuromodulation vs. BoTulinum Toxin Assessment) randomized trial of 386 women with 6 or more urgency urinary incontinence episodes on a 3-day diary. Analysis is from the health care system perspective with primary within-trial analysis for 2 years and secondary 5-year decision analysis. Costs are in 2018 U.S. dollars. Effectiveness was measured in quality adjusted life-years (QALYs) and reductions in urgency urinary incontinence episodes per day. We generated incremental cost-effectiveness ratios and cost-effectiveness acceptability curves., Results: Two-year costs were higher for sacral neuromodulation than for onabotulinumtoxinA ($35,680 [95% CI 33,920-37,440] vs $7,460 [95% CI 5,780-9,150], p <0.01), persisting through 5 years ($36,550 [95% CI 34,787-38,309] vs $12,020 [95% CI 10,330-13,700], p <0.01). At 2 years there were no differences in mean reduction in urgency urinary incontinence episodes per day (-3.00 [95% CI -3.38 - -2.62] vs -3.12 [95% CI -3.48 - -2.76], p=0.66) or QALYs (1.39 [95% CI 1.34-1.44] vs 1.41 [95% CI 1.36-1.45], p=0.60). The probability that sacral neuromodulation is cost-effective relative to onabotulinumtoxinA is less than 0.025 for all willingness to pay values below $580,000 per QALY at 2 years and $204,000 per QALY at 5 years., Conclusions: Although both treatments were effective, the high cost of sacral neuromodulation is not good value for treating urgency urinary incontinence compared to 200 units onabotulinumtoxinA.
- Published
- 2020
- Full Text
- View/download PDF
Catalog
Discovery Service for Jio Institute Digital Library
For full access to our library's resources, please sign in.