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Early real-world experience with Optilume® drug-coated balloon for anterior urethral strictures and posterior urethral stenoses

Patel, Hiren V; Ericksonb, Bradley A; Abbasi, Behzad; Alsikafi, Nejd F; Broghammer, Joshua A; Pandit, Kshitij; Buckley, Jill C; Elliott, Sean P; Daryabari, Seyedeh Sima; Myers, Jeremy B; Smith, Thomas G; Lindekugel, Grady; Voelzke, Bryan B; Vanni, Alex J; Zhao, Lee C; Breyer, Benjamin N
OBJECTIVES/OBJECTIVE:To determine the early experience with paclitaxel-drug coated balloon (DCB) for both anterior urethral stricture disease (aUSD) and posterior urethral stenoses (PUS). METHODS:A retrospective review of patients undergoing Optilume® DCB in the Trauma and Urologic Reconstructive Network of Surgeons (TURNS) database was performed. Both functional (improved subjective voiding without a secondary procedure) and anatomic (open lumen on cystoscopy) success rates were determined. Kaplan Meier estimates were used to determine the risk of failure by LSE classification and LSE Stage. RESULTS:A total of 319 patients were treated with the DCB, of which 260 were for aUSD and 59 were for PUS. Median age was 64 years (Interquartile range [IQR] 48-73). Recurrence was noted in 119 patients (37.3%) at a median follow-up of 5.7 months (IQR 3-12). For aUSD, the 1-year functional recurrence-free survival was 78.4% (95% CI 71.8-85.4) and anatomical recurrence-free survival was 66.4% (95% CI 59.5-74.2). For PUS, the 1-year functional recurrence-free survival was 75.8% (95% CI 61.4-93.7) and anatomical recurrence-free survival was 59.4% (95% CI 44.1-80). Recurrences of any kind were significantly more likely in patients with strictures after hypospadias repair (HR 5.21, 95% CI 1.06-25.6, p=0.042), and use of 24 Fr, 3 cm DCB (HR 3.64, 95% 1.10-12.09, p=0.035). These were also significant predictors of anatomical recurrences. CONCLUSIONS:Multi-institutional utilization of the DCB for aUSD and PUS demonstrates a low effectiveness among high-risk strictures. Recurrence after DCB varies based on stricture characteristics and subtype, which are important for preoperative counseling and postoperative surveillance.
PMID: 41109561
ISSN: 1527-9995
CID: 5955432

Posterior Urethral Reconstruction with Ileal Chimeric Free Flap: A Novel Approach for Management of Radiation-Induced Devastated Bladder Outlet

Sorensen, Thomas J; Elbakry, Amr A; Ratanapornsompong, Wattanachai; Sarawong, Sutthirat; Tran, David; Volk, Angela; Levine, Jamie; Zhao, Lee C
OBJECTIVE:To describes our institutional experience of a case series using a novel multi-segment, chimeric free ileal flap for posterior urethral reconstruction, focusing on surgical technique, perioperative management, and functional outcomes. Complex posterior urethral defects, particularly those resulting from radiation pose a significant reconstructive challenge that is not easily approachable with standard reconstructive techniques. In this case series, we present a novel approach for this complex problem. METHODS:We retrospectively reviewed consecutive patients who underwent posterior urethral reconstruction with a chimeric free ileal flap at our institution. Data were collected via chart review. RESULTS:Six male patients (median age: 61 years range: 59-77) with radiation-associated posterior urethral stenosis and bladder neck pathology underwent reconstruction. One was an active smoker; three had prior failed reconstructions. A 20-cm ileal segment was harvested and designed into a chimeric construct in all cases. The left deep inferior epigastric vessels were used for flap anastomosis. Median operative time was 717 minutes, and median hospital stay was 9 days. Two patients experienced early postoperative complications; none had flap loss. At median follow-up of 204 days, four patients had successful functional outcomes. One had persistent leak, and one required cystectomy for newly diagnosed squamous cell carcinoma found at the bladder neck on final pathology. CONCLUSIONS:Chimeric free ileal flap reconstruction is a novel management option for radiation-associated posterior urethral defects, offering well-vascularized, versatile tissue in patients unsuitable for traditional approaches. However, this approach is complex that requires multidisciplinary collaboration and extensive surgical planning.
PMID: 41106522
ISSN: 1527-9995
CID: 5955322

Vaginoplasty Complications and Revisions

Parker, Augustus; Blasdel, Gaines; Bluebond-Langner, Rachel; Zhao, Lee
Choice of vaginoplasty technique is guided by the patient's natal anatomy, patient goals, and surgeon preference. The biggest distinction among techniques is the choice of lining for the vaginal canal. This chapter provides an overview of current data on the most pertinent complications, both universal and specific to different techniques for gender-affirming vaginoplasty. Clinical pearls for the management of these complications and indications for revision will be reviewed.
PMID: 41093465
ISSN: 1558-0504
CID: 5954862

Robotic upper urinary tract reconstruction for ureteral stricture: a single-center series

Bourillon, Alice; Freton, Lucas; Hascoet, Juliette; Richard, Claire; Haudebert, Camille; Verhoest, Gregory; Mathieu, Romain; Zhao, Lee C; Bensalah, Karim; Peyronnet, Benoit
The surgical approach of ureteral stricture has changed dramatically over the past 15 years with the rise of robotic upper urinary tract reconstruction. This study aimed to evaluate the outcomes of all robotic ureteral reconstructions performed at a single academic center for ureteral stricture and to assess the predictive factors of stricture recurrence. The charts of all patients who underwent robot-assisted ureteral reconstruction between 2013 and 2024 at a single academic center were retrospectively reviewed. Many different surgical techniques were used including non-refluxing reimplantation with or without psoas hitch, refluxing ureteral reimplantation (side-to-side), Boari flap, uretero-ureterostomy, ureterolysis and buccal mucosa graft (BMG) ureteroplasty. The primary outcome was the absence of stricture recurrence, defined as no need for repeat surgery, urinary drainage, or symptomatic upper urinary tract dilation at the last follow-up. Sixty patients, accounting for 63 ureteral reconstructions, were included in the final analysis. Twenty-five patients experienced early postoperative complications (40%), the majority being Clavien-Dindo grade 2. There were only three (5%) major complications (Clavien-Dindo grade 3b). Stricture recurrence occurred in six patients (10%), with a median time to recurrence of 2.5 months postoperatively. Radiotherapy was the only factor significantly associated with an increased risk of stricture recurrence. The present series confirm the overall low morbidity and low recurrence rate of robotic ureteral reconstruction using a variety of surgical techniques. Comparative studies with longer follow-up periods are necessary to evaluate outcomes in comparison to traditional surgical approaches.
PMCID:12414849
PMID: 40914922
ISSN: 1863-2491
CID: 5936422

"Outcomes Following Metoidioplasty and Phalloplasty Gender Affirming Surgery (MaPGAS) with Urethral Lengthening: A Modified Delphi Consensus Study"

Blasdel, Gaines; Chen, Mang L; Berli, Jens; Dy, Geolani; Dugi, Daniel; Djordjevic, Miroslav; Bizic, Marta; Zhao, Lee; Schechter, Loren; Santucci, Richard; Myers, Jeremy B; Goodwin, Isak; Nikolavsky, Dmitriy; Meltzer, Toby; Watt, Andrew; Pariser, Joseph; Figler, Brad; Kuzon, William; Hadj-Moussa, Miriam; McCormick, Benjamin; Brown, Lee K; Nigriny, John F; Moses, Rachel A
OBJECTIVE:To generate surgeon consensus on metoidioplasty and phalloplasty gender-affirming surgery (MaPGAS) outcomes statements using a modified Delphi method. MATERIALS AND METHODS/METHODS:We invited MaPGAS surgeons to anonymously participate in a two-round web-based Delphi survey to generate consensus on patient centered outcome statements generated from surgeon practice patterns, literature review, and patient input. Consensus was predefined as at least 70% agreement. Surgeons were asked to provide open ended feedback on statements which were thematically analyzed and used to revise statements not reaching consensus for a second-round survey. RESULTS:Twenty-one metoidioplasty and phalloplasty surgeons were invited and 16 (76%) reviewed 39 statements in round one and 17/20 (85%) reviewed 10 statements in round two. Following round two, nearly all statements reached consensus: 14/15 (93%) of statements on metoidioplasty, 11/12 (92%) of radial forearm phalloplasty statements and 12/12 (100%) of anterolateral thigh phalloplasty statements. We found that 12/12 (100%) statements on sexual health, 8/8 (100%) statements on non-urinary complications, and 16/18 (89%) statements on urinary outcomes met consensus. CONCLUSIONS:In a modified web-based Delphi survey, surgeons reached consensus on nearly all outcome statements. Variations in surgeon experience, length of follow up, and reporting of outcomes contribute to different definitions of urinary complications. Results from this study will help create decision making tools for individuals considering metoidioplasty and phalloplasty.
PMID: 40780517
ISSN: 1527-9995
CID: 5905512

Exploring the Incidence of Testicular Neoplasms in the Transgender Population: A Case Series

Shanker, Elayna M; Ren, Qinghu; Zhao, Lee C; Bluebond-Langner, Rachel; Deng, Fang-Ming
CONTEXT.—/UNASSIGNED:The use of hormonal therapy and gender-affirming surgery in the transgender community has been rising during the last several years. Although it is generally safe, hormonal therapy's link to testicular cancer remains uncertain. OBJECTIVE.—/UNASSIGNED:To review the incidence of testicular cancer in specimens from gender-affirming orchiectomies at our institution and evaluate the tumors for histologic and genetic alterations. DESIGN.—/UNASSIGNED:Pathology reports for gender-affirming orchiectomies (January 1, 2018, to August 1, 2023) were reviewed for testicular neoplasms, with additional analysis for chromosome 12 abnormalities. Incidence and chromosome variations were compared with those in the general population. RESULTS.—/UNASSIGNED:Among 458 cases during 5.5 years, 5 germ cell neoplasms in 4 patients emerged. Our institution's annual incidence rate (159 per 100 000) is 26.5 times higher than the National Cancer Institute's previous report (6.0 per 100 000). Although they were morphologically no different from germ cell neoplasms in the general population, fluorescence in situ hybridization tests showed no i(12p) in 4 of 5 neoplasms (80%) in our cohort. CONCLUSIONS.—/UNASSIGNED:The cause behind this rise in incidence remains uncertain but may be due to long term pretreatment with hormones or blockers. The lower isochromosome 12p frequency suggests an alternative mechanism driving tumor development, which requires more detailed molecular studies.
PMID: 39522551
ISSN: 1543-2165
CID: 5752422

Bridging the evidence gap in gender-affirming care: urgent research needs

Dolendo, Isabella; Zhao, Lee; Bluebond-Langner, Rachel; Anger, Jennifer T
Gender-affirming care has emerged as a critical component of healthcare, addressing the specific medical and psychosocial needs of transgender and non-binary individuals. In this review article, we address what we see as the most pressing evidence gaps in the gender health literature: long-term effects of pubertal blockers and gender-affirming hormone therapy and the lack of standardised outcome measures of gender-affirming care. Substantial uncertainties persist regarding long-term effects of hormone therapy and the implications of gender-affirming therapy on cancer risk. Though there is some uncertainty about the long-term effects of gender-affirming medical therapy, providers must also consider the potential negative consequences of prolonging a dysphoric experience. Additionally, there is a dearth of validated measures for patient-reported outcomes and a lack of standardisation in the reporting of data that is detrimental to the progress of understanding the impacts of gender-affirming care.
PMID: 40457589
ISSN: 1464-410x
CID: 5862202

Patient-reported symptoms suggestive of vesicoureteral reflux after robotic ureteral reimplantation in adults

Chao, Brian W; Zhao, Kelley; Lee, Matthew; Lin, Jeffery S; Raver, Michael; Stifelman, Michael D; Zhao, Lee C; Eun, Daniel D
Little is known regarding the incidence of symptomatic, de novo vesicoureteral reflux (VUR) after ureteral reimplantation in adults. We sought to characterize this phenomenon in a contemporary cohort. We conducted a retrospective review of a multi-institutional database of robotic ureteral reconstruction (CORRUS, or Collaborative of Reconstructive Robotic Ureteral Surgery). Inclusion criteria were adult patients undergoing robotic ureteral reimplantation with at least 6 months of follow-up. Patients who had no evidence of recurrent ureteral stenosis were asked to complete a questionnaire characterizing their symptoms. The primary outcome was symptoms suggestive of VUR (SS-VUR), defined as flank pain of at least moderate severity that occurred at least weekly and worsened with voiding or a full bladder. We identified 257 patients who underwent robotic reimplantation, of which 97 (37.7%) were free from recurrent ureteral stenosis and responded to the questionnaire. At a median follow-up duration of 35.0 months (IQR 22.0-59.0), 26 patients (27.4%) reported flank pain of any severity on the same side as reimplantation. Nine patients (9.5%) met criteria for SS-VUR. Four patients underwent additional surgical intervention (two endoscopic, two robotic) after radiographic and functional workup confirmed VUR. On multivariable logistic regression, younger age was an independent predictor of SS-VUR (p = 0.041). In our contemporary series of robotic ureteral reimplantation in adults, over one-quarter of patients reported flank pain postoperatively in the absence of ureteral obstruction. A small proportion of patients had more bothersome symptoms particularly suggestive of VUR.
PMID: 40232636
ISSN: 1863-2491
CID: 5827742

Development and Assessment of a Patient-Reported Outcome Instrument for Gender-Affirming Care

Kaur, Manraj N; Rae, Charlene; Morrison, Shane D; Laungani, Alexis; Brassard, Pierre; Mullender, Margriet G; van de Grift, Tim C; Young-Afat, Danny A; Sørensen, Jens Ahm; Poulsen, Lotte; Cornacchi, Sylvie D; Graesser, Jack G; Igbokwe, Michelle Mistry; Satterwhite, Thomas; Pang, John H; Akhavan, Arya A; Hu, Allison; Johnson, Natasha; Cano, Stefan J; Savard, Kinusan; Mundinger, Gerhard S; Capitán-Cañadas, Fermín; Simon, Daniel; Capitán, Luis; Coon, Devin; Brydges, Hilliard T; Bluebond-Langner, Rachel; Rodriguez, Eduardo D; Zhao, Lee C; Armstrong, Kathleen A; Dean, Nicola R; Crittenden, Tamara A; Cannell, Zac A; Lane, Megan; Haley, Caleb A; Hsu, Jessica; Dy, Geolani W; Peters, Blair R; Berli, Jens U; Milano, Christina E; Lava, Christian X; Fan, Kenneth L; Del Corral, Gabriel A; Kaoutzanis, Christodoulos; Kalia, Nargis; Higuchi, Ty; Ganor, Oren; Subedi, Sangeeta; Douglass, Laura M; Hamidian Jahromi, Alireza; Hosseini, Helia C; Ihnat, Jacqueline; Parikh, Neil; Hu, Kevin; Alperovich, Michael; Ray, Edward C; Aref, Youssef; Hassan, Bashar A; Liang, Fan; Mundy, Lily; Chen, Mang L; Pusic, Andrea L; Klassen, Anne F
IMPORTANCE/UNASSIGNED:There is an urgent need for a validated gender-affirming care-specific patient-reported outcome measure (PROM). OBJECTIVE/UNASSIGNED:To field test the GENDER-Q, a new PROM for gender-affirming care, in a large, international sample of transgender and gender diverse (TGD) adults and evaluate its psychometric properties. DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:This international cross-sectional study was conducted among TGD adults aged 18 years and older who were seeking or had received gender-affirming care within the past 5 years at 21 clinical sites across Canada, the United States, the Netherlands, and Spain; participants were also recruited through community groups (eg, crowdsourcing platform, social media). The study was conducted between February 2022 and March 2024. Participants had to be capable of completing the instrument in English, Danish, Dutch, or French-Canadian. Eligible participants accessed an online REDCap survey to complete sociodemographic questions and questions about gender-affirming care they had received or sought (ie, to look, function, or feel masculine, feminine, gender fluid, or another way). MAIN OUTCOME AND MEASURES/UNASSIGNED:Branching logic was used to assign relevant instrument scales. Rasch measurement theory (RMT) analysis was used to examine the fit of the observed data to the Rasch model for each scale. Test-retest reliability and hypothesis-based construct validity of instrument scales were examined. The hypothesis was that instrument scale scores would increase with better outcomes on corresponding categorical questions. RESULTS/UNASSIGNED:A total of 5497 participants (mean [SD] age, 32.8 [12.3] years; 1837 [33.4%] men; 1307 [23.8%] nonbinary individuals; and 2036 [37.0%] women) completed the field test survey. Participants sought or had the following types of gender-affirming care: 2674 (48.6%) masculinizing, 2271 (41.3%) femininizing, and 552 (10.0%) other. RMT analysis led to the development of 54 unidimensional scales and 2 checklists covering domains of health-related quality of life, sexual, urination, gender practices, voice, hair, face and neck, body, breasts, genital feminization, chest, genital masculinization, and experience of care. Test-retest reliability of the scales (intraclass correlation coefficient [average] >0.70) was demonstrated. Only 1 item (phalloplasty donor flap) had an ICC less than 0.70. As hypothesized, scores increased incrementally with better associated self-reported categorical responses. For example, among 661 participants who reported poor psychological well-being, the mean (SD) scale score was 45 (18) points; for those who reported excellent psychological well-being, the mean (SD) scale score was 85 (16) points (P < .001). CONCLUSIONS AND RELEVANCE/UNASSIGNED:In this cross-sectional study of 5497 TGD adults, the instrument demonstrated reliability and validity. The instrument was validated in an international sample and is designed to collect and compare evidence-based outcome data for gender-affirming care from the patients' perspective.
PMCID:12008761
PMID: 40249619
ISSN: 2574-3805
CID: 5829042

Quantifying the Learning Curve in Robotic Peritoneal Flap Vaginoplasty

Hemal, Kshipra; Blasdel, Gaines; Parker, Augustus; Amro, Chris; Dubach-Reinhold, Charlie; Zhao, Lee C; Bluebond-Langner, Rachel
BACKGROUND:The learning curve (LC) is the process of mastering a new technique. This study assesses the LC for robotic-assisted peritoneal flap gender-affirming vaginoplasty (RPGAV). METHODS:A retrospective chart review of all consecutive patients undergoing RPGAV between 09/2017 and 02/2023 at a single center was performed. Operative times (OT) were analyzed to describe the LC. A cutoff point was determined after which OT stabilized, and this was used to compare perioperative and postoperative outcomes. RESULTS:Five hundred RPGAVs were performed. Median OT was 125 (interquartile range 105-181) minutes and decreased significantly over time. The minimum number of cases required to observe a plateau in OT is 300 patients.After adjusting for the LC, 2 variables significantly affected OT: a 1-point increase in body mass index increased OT by 1.4 minutes [95% confidence interval (1.0, 1.9), P < 0.001] and the single port robot decreased OT by 34 minutes [95% CI 1 (-43.1, -25.0), P < 0.001] as compared to the traditional multiport Xi robot.When comparing the first 300 cases (learning phase) to the last 200 (expert phase), length of stay, blood transfusions, and rates of elective revision surgery were lower in the expert phase. CONCLUSIONS:The LC for RPGAV in this large cohort was 300 cases. Patient body mass index causes a dose-response increase in OT and the single port robot dramatically decreases OT. Although OT is just one facet of overall efficiency, differences between learning and expert phases are evident in decreased length of stay, transfusions, and rates of revision surgery.
PMID: 40167061
ISSN: 1536-3708
CID: 5818952