Is size in the eye of the beholder? Visual estimation of penis size among transgender and cisgender people and implications for genital gender-affirming surgery and sexual medicine.

BACKGROUND: Transgender men (TM) seeking gender-affirming phalloplasty and transgender women (TW) seeking vaginoplasty and desiring insertive intercourse must consider penis size. Evidence has shown that, at least among cisgender men (CM), penile dimensions tend to be poorly estimated. In transgender patients desiring gender-affirming surgery, inaccuracy in estimation of penis dimensions may lead to unnecessary morbidity: for TW, trauma to the neovagina; for TM with excess girth, an inability to insert. Studies on the accuracy with which transgender and cisgender patients estimate penis size are limited. AIM: To assess the degree of accuracy with which CM and CW, as well as TM and TW, visually estimate the size of the human penis, including length, width, and girth. METHODS: There were 142 participants included (25 TM, 47 TW, 30 CM, and 40 CW; net mean ± SD age, 36.6 ± 11.2 years). Participants were shown these models and asked to estimate length, width, and midshaft girth by visual inspection of 6 realistic models of a penis and scrotum of varying lengths and widths. We evaluated the accuracy of the visual measurements by comparing mean perceived dimensions with the actual dimensions of each model. OUTCOMES: We used a multivariate model of all 3 bias dimensions to test for differences in average bias among gender groups (CM, CW, TM, and TW). RESULTS: TM significantly overestimated length across the longest models. TW significantly overestimated length in the longer 3 models. All groups except for TM significantly underestimated girth in at least 1 model. No groups significantly underestimated width. CM, CW, and TM significantly overestimated width in all 6 models. CLINICAL IMPLICATIONS: When transgender patients use numbers to express penis size (either in neophallus or vaginal depth based on perceived partner size), the result is likely to be larger than expected. Use of realistic penis models as a decision-making tool may help manage patient expectations and surgery decision making preoperatively and improve postoperative patient satisfaction and safety. STRENGTHS AND LIMITATIONS: To our knowledge, this is the first study to assess visual estimation in penis size in TM and CM, as well as TW and CW. The penile models in our study were shown side by side and in the flaccid state despite having dimensions more consistent with an erect penis, which may have influenced estimations across all dimensions. CONCLUSION: Men and women (cisgender and transgender) tend to significantly overestimate penis length and width.

Shallow-depth vaginoplasty: preoperative goals, postoperative satisfaction, and why shallow-depth vaginoplasty should be offered as a standard feminizing genital gender-affirming surgery option.

BACKGROUND: Shallow-depth vaginoplasty (SDV), also referred to as vaginoplasty without creation of a vaginal canal, is an understudied alternative to full-depth vaginoplasty (FDV), or vaginoplasty with creation of a vaginal canal. SDV is associated with fewer short- and long-term risks and shorter recovery, and does not require a lifelong commitment to vaginal dilation and douching. AIM: To describe a surgical technique for SDV that creates a dimpled introitus, together with clinical outcomes, decision-making prioritization, and satisfaction data. We hypothesize that SDV patients prioritize comparable appearance and sexual function to FDV over shorter-term risk factors, and experience high satisfaction. METHODS: We describe (1) a surgical technique for SDV; (2) the proportion of patients who underwent SDV vs. FDV, with SDV complication rates; and (3) the results of an anonymous, electronic questionnaire administered via Qualtrics that assessed SDV patient demographics, terminology preferences, prioritization of decision-guiding factors for choosing SDV over FDV, and postoperative satisfaction across various domains. OUTCOMES: A total of 110 patients underwent primary feminizing genital gender-affirming surgery at a single institution between April 2017 and July 2022: 35 (32%) of 110 underwent SDV and 75 (68%) underwent FDV. The 35 SDV patients were invited to answer the study questionnaire, of which 29 (83%) completed it (mean age 51.9 ± 16.7 years, mean body mass index 27.3 ± 5.3 kg/m2). RESULTS: All but one survey respondent met one or more of the following characteristics: (1) ≥40 years of age, (2) exclusively feminine-identifying sexual partners, and/or (3) significant aversion to performing long-term vaginal dilation and douching. Ranking of 8 decision-guiding factors revealed prioritization of long-term over short-term outcomes. Postoperatively, patients reported high satisfaction across all 3 domains. When asked if they had to choose between SDV and FDV over again, 86% reported that they would choose SDV. While 14% would choose FDV, all but one reported new interest in receptive vaginal intercourse due to finding masculine-identifying partners post-SDV surgery. A total of 27% of SDV patients experienced complications that required additional surgeries; 82% of complications were related to urinary spraying. CLINICAL IMPLICATIONS: SDV is a lower-risk alternative to FDV and is associated with reduced postoperative maintenance and high postoperative satisfaction. STRENGTHS AND LIMITATIONS: This study describes the clinical outcomes of the largest documented cohort of patients to undergo SDV to date. Limitations include recall bias due to the retrospective survey and use of nonvalidated questions attributed to the paucity of validated gender-affirming surgery questionnaires. CONCLUSION: SDV's appeal to a large subset of patients (32% in this study), low complication rate, high satisfaction, and low decisional regret suggests that this surgical option should be offered to all patients seeking feminizing genital gender-affirming surgery.

Frailty as predictor of complications in patients undergoing percutaneous nephrolithotomy (PCNL).

INTRODUCTION & OBJECTIVE: Surgical complications are difficult to predict, despite existing tools. Frailty phenotype has shown promise estimating postoperative risk among the elderly. We evaluate the use of frailty as a predictive tool on patients undergoing percutaneous renal surgery. METHODS: Frailty was prospectively analyzed using the Hopkins Frailty Index, consisting of 5 components yielding an additive score: patients categorized not frail, intermediate, or severely frail. Primary outcomes were complications during admission and 30-day complication rate. Secondary outcomes included overall hospital length of stay (LOS) and discharge location. RESULTS: A total of 100 patients recruited, of whom five excluded as they did not need the procedure. A total of 95 patients analyzed; 69, 10, and 16 patients were not frail, intermediate, and severely frail, respectively. There were no differences in blood loss, number of dilations, presence of a staghorn calculus, laterality, or location of dilation. Severely frail patients were likely to be older and have a higher American Society of Anesthesiologists score and Charlson comorbidity index. Patients of intermediate or severe frailty were more likely to exhibit postoperative fevers, bacteremia, sepsis, and require ICU admissions (P < 0.05). Frail patients had a longer LOS (P < 0.001) and tended to require skilled assistance when discharge (p < 0.0001). CONCLUSIONS: Frailty assessment appears useful stratifying those at risk of extended hospitalization, septic complications, and need for assistance following percutaneous renal surgery. Risks of sepsis, bacteremia, and post-operative hemorrhage may be higher in frail individuals. Preoperative assessment of frailty phenotype may give insight into treatment decisions and represent a modifiable marker allowing future trials exploring the concept of "prehabilitation".

Blood Dehydroepiandrosterone and Dehydroepiandrosterone Sulfate as Pathophysiological Correlates of Chronic Pain: Analyses Using a National Sample of Midlife Adults in the United States.

OBJECTIVE: Identifying biomarkers is a priority in translational chronic pain research. Dehydroepiandrosterone (DHEA) and its sulfated form, DHEA-S, are adrenocortical steroids in the blood with neuroprotective properties that also produce sex hormones. They may capture key sex-specific neuroendocrine mechanisms of chronic pain. DESIGN: Cross-sectional study. METHODS: Using data from 1,216 community-dwelling adults aged 34-84 from the Midlife in the United States (MIDUS) cohort, we examined blood DHEA and DHEA-S levels in association with chronic pain in men and women, adjusting for demographics, chronic diseases, medications including opioids, and psychosocial factors. If an association was found, we further explored dose-response relationships by the number of pain locations and the degree of pain interference. RESULTS: In women, chronic pain was associated with 0.072 lower (95% confidence interval [CI], -0.127 to -0.017) log10 DHEA-S µg/dL, with pain in one to two locations associated with 0.068 lower (95% CI, -0.131 to -0.006) and in three or more locations 0.071 lower (95% CI, -0.148 to 0.007) log10 DHEA-S (P for trend = 0.074). Furthermore for women, low-interference pain was associated with 0.062 lower (95% CI, -0.125 to -0.000), whereas high-interference pain was associated with 0.138 lower (95% CI, -0.233 to -0.043) log10 DHEA-S (P for trend = 0.004). Chronic pain was not associated with DHEA or DHEA-S levels in men or DHEA levels in women. CONCLUSIONS: Chronic pain and its functional interference correspond to lower blood DHEA-S levels in women.

Association between dysmenorrhea and chronic pain: a systematic review and meta-analysis of population-based studies.

OBJECTIVE: The objective of the study was to synthesize the epidemiological findings for the associations between dysmenorrhea, including primary dysmenorrhea and endometriosis-associated dysmenorrhea and any chronic pain conditions, including chronic pelvic pain, and chronic nonpelvic pain. DATA SOURCES: The data sources included PubMed, Embase, and CINAHL from inception to December 2019. STUDY ELIGIBILITY CRITERIA: The study criteria included observational population-based studies in which the relationship between dysmenorrhea and the presence or severity of chronic pain was examined. STUDY APPRAISAL AND SYNTHESIS METHODS: Each study was double coded and evaluated for bias based on the modified Newcastle and Ottawa Scale. Random-effect meta-analyses were conducted to quantify the associations between dysmenorrhea and the presence of chronic pelvic and nonpelvic pain. RESULTS: Out of 9452 records, 32 studies were included, with 14 reporting associations between dysmenorrhea and chronic pelvic pain, and 20 for dysmenorrhea and chronic nonpelvic pain. Primary dysmenorrhea and endometriosis-associated dysmenorrhea were examined in 7 studies, respectively. More than 30% of the studies were categorized as poor quality, 56% as moderate, and 12.5% as high. Dysmenorrhea was positively associated with both the presence and severity of chronic pelvic and nonpelvic pain conditions. Based on 6689 women from 8 studies, those with chronic pelvic pain had 2.43 (95% confidence interval, 1.98-2.99, I2, 42%) times the odds of having dysmenorrhea compared with those without. Based on 3750 women from 11 studies, those with chronic nonpelvic pain had 2.62 (95% confidence interval, 1.84-3.72, I2, 72%) times the odds of having dysmenorrhea compared with those without. Overall, dysmenorrhea was associated with 2.50 (95% confidence interval, 2.02-3.10) times the odds of chronic pain, which did not differ by chronic pelvic vs chronic nonpelvic pain, community vs clinical populations, or different geographical regions. CONCLUSIONS: Dysmenorrhea may be a general risk factor for chronic pain, although whether primary dysmenorrhea increases the risk for chronic pain is unclear. Given that adolescence is a sensitive period for neurodevelopment, elucidating the role of primary dysmenorrhea in pain chronicity in future longitudinal studies is important for preventing both chronic pelvic and nonpelvic pain.

Sustained correction of FVII deficiency in dogs using AAV-mediated expression of zymogen FVII.

Factor VII (FVII) deficiency is a rare autosomal recessive bleeding disorder treated by infusion of fresh-frozen plasma, plasma-derived FVII concentrates and low-dose recombinant activated FVII. Clinical data suggest that a mild elevation of plasma FVII levels (>10% normal) results in improved hemostasis. Research dogs with a G96E missense FVII mutation (FVII-G96E) have <1% FVII activity. By western blot, we show that they have undetectable plasmatic antigen, thus representing the most prevalent type of human FVII deficiency (low antigen/activity). In these dogs, we determine the feasibility of a gene therapy approach using liver-directed, adeno-associated viral (AAV) serotype 8 vector delivery of a canine FVII (cFVII) zymogen transgene. FVII-G96E dogs received escalating AAV doses (2E11 to 4.95E13 vector genomes [vg] per kg). Clinically therapeutic expression (15% normal) was attained with as low as 6E11 vg/kg of AAV and has been stable for >1 year (ongoing) without antibody formation to the cFVII transgene. Sustained and supraphysiological expression of 770% normal was observed using 4.95E13 vg/kg of AAV (2.6 years, ongoing). No evidence of pathological activation of coagulation or detrimental animal physiology was observed as platelet counts, d-dimer, fibrinogen levels, and serum chemistries remained normal in all dogs (cumulative 6.4 years). We observed a transient and noninhibitory immunoglobulin G class 2 response against cFVII only in the dog receiving the highest AAV dose. In conclusion, in the only large-animal model representing the majority of FVII mutation types, our data are first to demonstrate the feasibility, safety, and long-term duration of AAV-mediated correction of FVII deficiency.

Content validity of symptom-based measures for diabetic, chemotherapy, and HIV peripheral neuropathy.

INTRODUCTION: No treatments for axonal peripheral neuropathy are approved by the United States Food and Drug Administration (FDA). Although patient- and clinician-reported outcomes are central to evaluating neuropathy symptoms, they can be difficult to assess accurately. The inability to identify efficacious treatments for peripheral neuropathies could be due to invalid or inadequate outcome measures. METHODS: This systematic review examined the content validity of symptom-based measures of diabetic peripheral neuropathy, HIV neuropathy, and chemotherapy-induced peripheral neuropathy. RESULTS: Use of all FDA-recommended methods to establish content validity was only reported for 2 of 18 measures. Multiple sensory and motor symptoms were included in measures for all 3 conditions; these included numbness, tingling, pain, allodynia, difficulty walking, and cramping. Autonomic symptoms were less frequently included. CONCLUSIONS: Given significant overlap in symptoms between neuropathy etiologies, a measure with content validity for multiple neuropathies with supplemental disease-specific modules could be of great value in the development of disease-modifying treatments for peripheral neuropathies. Muscle Nerve 55: 366-372, 2017.

A cis-element in the Notch1 locus is involved in the regulation of gene expression in interneuron progenitors.

Interneurons comprise approximately one third of the total cortical neurons in the mammalian cerebral cortex. Studies have revealed many details in the generation of this cell type. However, the mechanism that defines interneuron-lineage specific gene expression is not well understood. Gene regulatory elements, e.g., promoters, enhancers, and trans-acting factors, are essential for the proper control of gene expression. Here, we report that a novel evolutionarily conserved cis-element in the second intron of the Notch1 locus plays an important role in regulating gene expression in interneuron progenitors. The spatiotemporal activity of the cis-element in the developing central nervous system (CNS) was determined by both transient reporter expression in the developing chick and a transgenic mouse model. Its activity is well correlated with neurogenesis in both the chick and mouse and restricted to neural progenitor cells in the ganglionic eminence that are fated to differentiate into GABAergic interneurons of the neocortex. We further demonstrate that the cis-element activity requires the binding motif for trans-acting factors Gsh1/Barx2/Brn3. Deletion of this binding motif abolishes reporter gene expression. Together, these data provide new insights into the regulatory mechanisms of interneuron development in the vertebrate CNS.

Effects of Gender-affirming Hormone Therapy on Orgasm Function of Transgender Men and Women: A Long Term Follow Up.

OBJECTIVE: To assess the reported changes in orgasm quality and function of transgender men (TM) and transgender women (TW) after commencing gender-affirming hormone therapy (GAHT). METHODS: We queried potential changes in orgasm function before and after commencing GAHT (minimum 1 year) among 130 consecutive TW and 33 TM. We queried the following domains under a uniform condition (masturbation): (1) Lead-time to reach orgasm, (2) Duration of orgasm, (3) Body location of orgasm sensation, (4) Description of orgasm as either a single or multiple-peak event, (5) Duration of post-orgasm refractory period, and (6) Overall satisfaction with orgasm quality. RESULTS: Within groups by gender, TW and TM reported similar responses to our inventory before starting GAHT. After commencing GAHT, TW reported notable changes in orgasm function: increase in lead-time necessary to reach orgasm, orgasm duration, and overall orgasm satisfaction. Similarly, TM reported an increase in duration of orgasm and increased overall satisfaction with orgasm quality. Over half of the TW reported experiencing orgasms in new/additional body locations. Additionally, prior to commencing GAHT, the majority of TM and TW patients reported their orgasms as a short, single-peak event but following GAHT these same patients reported longer and protracted multiple-peak orgasms. CONCLUSIONS: GAHT has the potential to positively improve orgasm quality for transgender patients undergoing gender transition. It is important to share such data with patients prospectively before treatments.

A Proposed Inventory to Assess Changes in Orgasm Function of Transgender Patients Following Gender Affirming Treatments: Pilot Study.

INTRODUCTION: While providers generally counsel patients about possible effects of gender affirming treatments, such as gender affirming hormone therapy (GAHT) and gender affirming surgery (GAS), on sexual function - the effects of these treatments on orgasm function and quality are not well understood. AIM: To develop a gender transition orgasm quality inventory based on orgasm function domains transgender patients communicated were important to them. METHODS: We conducted a series of interviews in which we asked transgender patients to describe which factors related to orgasm (ie, orgasm quality and orgasm-related sexual function) were most important to them. This work generated a list of 6 domains which we incorporated into a survey instrument. The 6 domains that our work generated are: (1) Lead-time to reach orgasm, (2) Duration of orgasm, (3) Body location of orgasm sensation; (4) Description of orgasm as either a single or multiple-peak event, (5) Duration of postorgasm refractory period, and (6) Overall satisfaction with orgasm quality. Using this new questionnaire, we queried potential changes in orgasm function before and after commencing GAHT (minimum 1 year) among 130 consecutive transgender women (TW) and 33 transgender men (TM) as a pilot study. RESULTS: Within groups by gender, TW and TM cohorts reported similar responses to our inventory before starting GAHT. After commencing GAHT, TW reported notable changes in orgasm function: increase in lead-time necessary to reach orgasm, orgasm duration, and overall orgasm satisfaction; and decrease in post-orgasm refractory period. Similarly, TM reported an increase in duration of orgasm and increased overall satisfaction with orgasm quality; and a decrease in post-orgasm refractory period. Over half of the TW reported experiencing orgasms in new/additional body locations. Additionally, prior to commencing GAHT, the majority of TM and TW patients reported their orgasms as a short, single-peak event but following GAHT these same patients reported longer and protracted multiple-peak orgasms. CONCLUSION: We have developed a novel questionnaire with the purpose of assessing patient self-reported changes in orgasm function following gender affirming treatments. Findings from our pilot study shows that GAHT has the potential to positively improve sexual function and orgasm quality for transgender patients undergoing gender transition. We encourage future studies to utilize our novel questionnaire to assess potential changes in orgasm function related to various gender affirming procedures. Zaliznyak M, Lauzon M, Stelmar J, et al. A Proposed Inventory to Assess Changes in Orgasm Function of Transgender Patients Following Gender Affirming Treatments: Pilot Study. Sex Med 2022;10:100510.

'Modified Phallourethroplasty' as a Surgical Alternative to Phalloplasty With Urethral Lengthening: Technique, How We Present This Option to Patients, and Clinical Outcomes.

BACKGROUND: Most complications after masculinizing genital gender-affirming surgery (gGAS) are associated with urethral lengthening (+UL). While many transmasculine patients desire +UL for standing urination, not all patients prioritize this benefit over the significantly increased risk of complications. Currently, phalloplasty without UL (-UL) appears to be seldom offered, and previous -UL techniques create genital anatomy that is visibly different from the anatomy created by phallourethroplasty+UL (P+UL). AIM: To describe a novel surgical technique to create a normal-appearing phallus tip, scrotum, and perineal urethral opening that avoids urethral complications associated with +UL. METHODS: We describe our surgical technique and approach to patient counseling. We report patient satisfaction outcomes from the first cohort of patients to undergo this 'modified phallourethroplasty' (-UL) approach to date. OUTCOMES: Among patients who elected phalloplasty over metoidioplasty, 13/40 (32.5%) patients elected P-UL. Prior to 1/2020, before we standardized how we presented this option to patients, 17.4% elected this option. Of the patients that elected P-UL, 8 have completed first-stage and 7 have completed second-stage surgeries. RESULTS: All patients that have undergone P-UL have expressed satisfaction with body image and urinary function. Among patients asked to rank which of 14 preoperative factors were most important (1 = most important, 14 = least important), having a normal-appearing phallus (mean rank 4.14) and minimizing complications (mean rank 8.14) were ranked more highly than ability to urinate in a standing position (mean rank 9.14). When asked what factors most influenced their choice to have -UL (ranked from 1 to 9), elimination of risks was rated the most important (mean rank 2.71) and expected decrease in risk of needing revision surgery was rated the second most important (mean rank 3.57). CLINICAL IMPLICATIONS: The significant reduction in +UL-related complications decrease morbidity, urgent revision surgeries, and cost to our healthcare system. STRENGTHS AND LIMITATIONS: Strengths include a novel technique that provides a surgical alternative to P+UL that eliminates the majority of phalloplasty related postoperative complications. Limitations include the small number of patients who have completed first and second stage surgery, and short follow up time. CONCLUSION: It is important to understand what factors drive individual patients' choices. Patients considering masculinizing gGAS should be offered both +UL and -UL options. The costs and benefits of each option should be presented objectively and in the context of each patient's unique priorities and needs. Smith SM, Yuan N, Lee G, et al. 'Modified Phallourethroplasty' as a Surgical Alternative to Phalloplasty With Urethral Lengthening: Technique, How We Present This Option to Patients, and Clinical Outcomes. Sex Med 2022;10:100495.

Penile and Scrotal Skin Measurements to Predict Final Vaginal Depth With Penile Inversion Vaginoplasty.

INTRODUCTION: No nomogram exists to predict maximum achievable neovaginal depth before penile inversion vaginoplasty (PIV) based on available penile & scrotal skin (SS). Maximal depth is important to patients and is determined by available skin and available anatomic space within the pelvis and varies with surgical technique. AIM: We endeavored to create a nomogram to predict expected postoperative vaginal depth. METHODS: Retrospective review of all patients undergoing primary PIV at a single institution from June 2017 to February 2020 (n = 60). Pre-op: Dorsal penile and midline scrotal skin length were measured. Intra-op: Tubularized scrotal skin length measured on a dilator. Immediate post-op: Final vaginal depth measured with a dilator. OUTCOMES: The amount of available penile and scrotal skin was not associated with vaginal depth. The only variable that did significantly increase depth was the use of penile + scrotal skin, as compared to penile skin alone. (P < .001) RESULTS: In patients who underwent PIV-SS, the final vaginal depth (13.3 ± 1.9 cm) was 87% of pre-op measured penile skin length (15.3 ±- 3.0 cm). In patients who underwent PIV+SS, pre-op penile skin length was 11.1 ± 4.7±cm and pre-op midline scrotal length was 22.8 ± 2.6 cm. with a final post-op vaginal canal depth of 15.2 ± 1.3 cm. In 45/46 (98%) surgeries utilizing SS grafts, SS tube length exceeded the length necessary to achieve maximal vaginal depth, and required trimming and discard. Given that in most cases there was an excess of SS, final post-op depth equaled the maximal vaginal depth that could be surgically dissected, and was not limited by the amount of available skin. CLINICAL IMPLICATIONS: Our findings suggest that for most patients it should not be necessary to include additional tissue sources (eg, peritoneum) to create a vaginal canal during primary vaginoplasty. STRENGTHS AND LIMITATIONS: Any penile skin that was discarded due to poor quality (eg, tight phimosis, poor viability) was not measured and accounted for. This likely resulted in a slight overestimation of the contribution of the penile skin to the final vaginal depth, but did not change the overall finding that final depth was not limited by available skin. CONCLUSION: SS grafts, when harvested and tubularized using optimized technique, supplied an excess of skin necessary to line a vaginal canal space of maximal achievable depth. We found that additional tissue sources can, instead, be reserved for future salvage surgery if it becomes necessary to augment depth. Smith SM, Yuan N, Stelmar J, et al. Penile and Scrotal Skin Measurements to Predict Final Vaginal Depth With Penile Inversion Vaginoplasty. Sex Med 2022;10:100569.

Procedures Never Explained in Textbooks: How to Correctly Convert a Closed-Suction Drain to a Closed-Gravity Drain, and How to Correctly Remove a Closed-Suction Drain Off Suction.

Objective: To describe a novel method to convert a closed-system suction drain to a highly efficient closed-system gravity-dependent drain and demonstrate its efficacy in an ex-vivo model. Methods: We reviewed the 5 top-selling urology and surgery text/reference books for information on drainage systems. An ex-vivo model was designed with a reservoir of fluid connected to a Jackson-Pratt bulb drain. We measured the volume of fluid drained from the reservoir into the bulb while on-suction and off-suction. This was repeated using a novel modified bulb, where the bulb's outflow stopper was replaced with a one-way valve oriented to allow release of pressure from the bulb. Results: With the bulb on-suction, drainage was maintained regardless of the height of the drain relative to the reservoir. With the bulb off-suction, closed passive gravity-dependent drainage occurred only when the drain was below the fluid reservoir; drainage ceased at minimal volumes. With addition of a one-way valve and maintenance of the bulb below the level of the reservoir, drainage proceeded to completion. Conclusion: How surgical drains work is not described in the leading urology and general surgery textbooks/reference books. Closed-system suction drains cannot be used to achieve passive gravity-dependent drainage without allowing release of displaced air from the bulb-lumen. The novel modified drain we describe affords reversible closed-system suction and passive drainage.

Use of Voice Recordings in the Consultation of Patients Seeking Genital Gender-Affirming Surgery: An Opportunity for Broader Application Throughout Surgery?

Introduction: It has been demonstrated that patient memory for medical information is often poor and inaccurate. The use of audio recordings for patient consultation has been described; however, to our knowledge this is the first reported use of audio recordings in consultation for gender-affirming surgery. Our aim was to determine whether, and specifically how, audio recording the consultation of patients presenting for genital gender-affirming surgery would be of benefit to patients. Materials and Methods: We began to offer all new patients the opportunity to have their consultations recorded. At the end of the consultation the recording was uploaded to a USB, which was given to the patient to keep. We then surveyed all patients who had received a copy of their recorded consultation to query the utility of having access to an audio recording of their consultation. Results: 71/72 (98.6%) patients who were given the option to have their consultation recorded chose to do so. 50/71 (70%) of patients who had their consultation recorded responded to our survey. Patients reported that having access to a voice recording of their consultation was beneficial and was viewed overwhelmingly positively. Conclusions: Routine audio recording of patient consultations is highly beneficial to patients, with little cost to providers, and should be considered as a valuable addition to the new patient consultation. This approach may have applications in broader clinical contexts where patients face numerous, complex, and nuanced management options. The study would benefit from continued application and a larger (multi-center, international) sample.

An Alternative Option for Gender-Affirming Revision Vaginoplasty: The Tubularized Urachus-Peritoneal Hinge Flap.

INTRODUCTION: Gender-affirming peritoneal vaginoplasty has been described, and previous descriptions are modifications of the Davydov technique. AIM: To describe our alternative technique for gender-affirming peritoneal vaginoplasty (PV) using a single-pedicled, urachus-peritoneal hinge flap, discussing proposed advantages. METHODS: Retrospective review of all consecutive transfeminine patients with neovaginal shortening after prior penile inversion vaginoplasty (PIV) who underwent our PV technique from May 2019 to July 2022.  PV was performed via combined transperineal and laparoscopic (robot-assisted) approaches. After spatulation of the neovaginal remnant, a midline, inferiorly based urachus-peritoneal hinge flap was elevated craniocaudally from the umbilicus to the mid-posterior bladder. The free end of the flap was flipped posteriorly and sutured to posterior edge of the open canal remnant, forming a peritoneal pouch. The lateral edges of the pouch were sutured together for water-tight closure. Patients resumed dilation on POD 6 and douching on POD 10. MAIN OUTCOME MEASURES: Ten transfeminine patients underwent PV, with good outcomes. We measured: Pre-op penile and scrotal skin lengths, intra-op tubularized scrotal skin length, pre and post-op vaginal depth and width (immediate and at last follow-up). RESULTS: Pre-op: mean neovaginal depth was 9.2cm (SD 1.5); width was 12cm. Immediate post-op: mean depth was 15.1 cm (SD 2.2 cm, mean net increase: 5.9 cm). At mean follow-up of 18.3 months, mean depth was 12.5 cm (SD 2.1 cm, mean net increase: 3.3 cm) and width was 12 cm. There were no immediate post-op complications. Eight (80%) of the 10 patients report satisfactory vaginal receptive intercourse. The other 2 have not yet attempted vaginal receptive intercourse. CLINICAL IMPLICATIONS: Advantages of the proposed technique over existing techniques include no tension on peritoneal suture lines and total exclusion of the rectum. STRENGTHS AND LIMITATIONS: Strengths include a short learning curve for urologic surgeons with robotic experience.  The study is limited by small sample size. CONCLUSIONS: Our PV technique is a safe and effective option for salvage peritoneal vaginoplasty after primary PIV. Smith SM, Yuan N, Stelmar J, et al. An Alternative Option for Gender-Affirming Revision Vaginoplasty: The Tubularized Urachus-Peritoneal Hinge Flap. Sex Med 2022;10:100572.

Clinical outcome assessment in clinical trials of chronic pain treatments.

Clinical outcome assessments (COAs) measure outcomes that are meaningful to patients in clinical trials and are critical for determining whether a treatment is effective. The objectives of this study are to (1) describe the different types of COAs and provide an overview of key considerations for evaluating COAs, (2) review COAs and other outcome measures for chronic pain treatments that are recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) or other expert groups, and (3) review advances in understanding pain-related COAs that are relevant to clinical trials. The authors reviewed relevant articles, chapters, and guidance documents from the European Medicines Agency and U.S. Food and Drug Administration. Since the original core set of outcome measures were recommended by IMMPACT 14 years ago, several new advancements and publications relevant to the measurement or interpretation of COAs for chronic pain trials have emerged, presenting new research opportunities. Despite progress in the quality of measurement of several outcome domains for clinical trials of chronic pain, there remain some measurement challenges that require further methodological investigation.

Research approaches for evaluating opioid sparing in clinical trials of acute and chronic pain treatments: Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials recommendations.

ABSTRACT: Randomized clinical trials have demonstrated the efficacy of opioid analgesics for the treatment of acute and chronic pain conditions, and for some patients, these medications may be the only effective treatment available. Unfortunately, opioid analgesics are also associated with major risks (eg, opioid use disorder) and adverse outcomes (eg, respiratory depression and falls). The risks and adverse outcomes associated with opioid analgesics have prompted efforts to reduce their use in the treatment of both acute and chronic pain. This article presents Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) consensus recommendations for the design of opioid-sparing clinical trials. The recommendations presented in this article are based on the following definition of an opioid-sparing intervention: any intervention that (1) prevents the initiation of treatment with opioid analgesics, (2) decreases the duration of such treatment, (3) reduces the total dosages of opioids that are prescribed for or used by patients, or (4) reduces opioid-related adverse outcomes (without increasing opioid dosages), all without causing an unacceptable increase in pain. These recommendations are based on the results of a background review, presentations and discussions at an IMMPACT consensus meeting, and iterative drafts of this article modified to accommodate input from the co-authors. We discuss opioid sparing definitions, study objectives, outcome measures, the assessment of opioid-related adverse events, incorporation of adequate pain control in trial design, interpretation of research findings, and future research priorities to inform opioid-sparing trial methods. The considerations and recommendations presented in this article are meant to help guide the design, conduct, analysis, and interpretation of future trials.

Outcomes and Complications After Intervention for Postradiation Prostatic Urethral Stenosis.

OBJECTIVE: To study and report on treatment outcomes after surgical intervention for postradiation prostatic urethral stenosis. METHODS: A retrospective chart review was performed, identifying all patients treated at our institution from July 2014-June 2018 with the ICD-10 code N42.89 for prostatic urethral stenosis. RESULTS: Twenty-two patients were identified with the diagnosis of prostatic urethral stenosis. Patients who had less than 3 months of follow up or etiologies other than postradiation were excluded from analysis. 16 patients were included in the final analysis with an average follow up of 2.6 years (range 3 months to 6.8 years). Average age was 74 years (range 63-84). The average number of interventions performed before referral to a reconstructive urologist was 2.2 (range 0-6). Following referral, an additional 1.2 procedures were performed. Transurethral resection of prostate was the most common intervention, performed in 11 patients; urethroplasty was performed in 2 and the remainder underwent endoscopic incision or dilation. None of the urethroplasty patients required any further intervention for recurrent stenosis. Five patients became severely incontinent and required placement of an artificial urinary sphincter. CONCLUSION: Prostatic urethral stenosis is a rare complication occurring after radiotherapy for prostate cancer. Endoscopic management can be successful in stabilizing patients, while urethroplasty can be feasibly performed in patients with short prostatic apical strictures.

Adherence to Consolidated Standards of Reporting Trials (CONSORT) Guidelines for Reporting Safety Outcomes in Trials of Medical Cannabis and Cannabis-based Medicines for Chronic Noncancer Pain: A Systematic Review.

OBJECTIVE: Current treatments for chronic pain have limited effectiveness and tolerability. With growing interest in the potential of cannabinoids, there is a need to inform risk-benefit considerations. Thus, this focused systematic review assesses the quality of safety assessment and reporting in chronic noncancer pain cannabinoid trials. METHODS: The protocol for this review has been published, and, registered in PROSPERO. We searched MEDLINE, Embase, The Cochrane Library, Scopus, and PsychINFO for double-blind, placebo-controlled, randomized controlled trials of cannabinoids for chronic pain, with a primary outcome related to pain. The primary review outcome is adherence to the 2004 Consolidated Standards of Reporting Trials (CONSORT) Harms extension. Secondary outcomes included type, reporting method, frequency and severity of adverse events (AEs), trial participant withdrawals, and reasons for withdrawals. RESULTS: In total, 43 studies (4436 participants) were included. Type of cannabinoid (number of studies) included nabiximols (12), dronabinol (8), nabilone (7), oral cannabis extract preparations (5), smoked tetrahydrocannabinol (5), vaporized tetrahydrocannabinol (3), novel synthetic cannabinoids (2), sublingual cannabis extract preparations (1). The median CONSORT score was 7. On average, 3 to 4 recommendations of the CONSORT guidelines were not being met in trials. Seventeen trials did not provide their method of AE assessment, 14 trials did not report on serious AEs and, 7 trials provided no quantitative data about AEs. DISCUSSION: Better harms assessment and reporting are needed in chronic pain cannabinoid trials. Improvements may be achieved through: expanded education/knowledge translation increased research regulation by ethics boards, funding agencies and journals, and greater emphasis on safety assessment and reporting throughout research training.

Interpretation of chronic pain clinical trial outcomes: IMMPACT recommended considerations.

Interpreting randomized clinical trials (RCTs) is crucial to making decisions regarding the use of analgesic treatments in clinical practice. In this article, we report on an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) consensus meeting organized by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks, the purpose of which was to recommend approaches that facilitate interpretation of analgesic RCTs. We review issues to consider when drawing conclusions from RCTs, as well as common methods for reporting RCT results and the limitations of each method. These issues include the type of trial, study design, statistical analysis methods, magnitude of the estimated beneficial and harmful effects and associated precision, availability of alternative treatments and their benefit-risk profile, clinical importance of the change from baseline both within and between groups, presentation of the outcome data, and the limitations of the approaches used.