Thorough QT/QTc study to evaluate the effect of a single supratherapeutic dose of islatravir on QTc interval prolongation in healthy adults.

Islatravir is a deoxynucleoside analog being developed for the treatment of HIV-1 infection. Clinical studies are being conducted to evaluate islatravir, administered in combination with other antiretroviral therapies, at doses of 0.25 mg once daily and 2 mg once weekly. In multiple previous clinical studies, islatravir was generally well tolerated, with no clear trend in cardiac adverse events. A trial was conducted to evaluate the effect of islatravir on cardiac repolarization. A randomized, double-blind, active- and placebo-controlled phase 1 trial was conducted, in which a single dose of islatravir 0.75 mg, islatravir 240 mg (supratherapeutic dose), moxifloxacin 400 mg (active control), or placebo was administered. Continuous 12-lead electrocardiogram monitoring was performed before dosing through 24 hours after dosing. QT interval measurements were collected, and safety and pharmacokinetics were evaluated. Sixty-three participants were enrolled, and 59 completed the study. Fridericia's QT correction for heart rate was inadequate; therefore, a population-specific correction was applied (QTcP). The placebo-corrected change from baseline in QTcP (ΔΔQTcP) interval at the observed geometric mean maximum plasma concentration associated with islatravir 0.75 mg and islatravir 240 mg was <10 ms at all time points. Assay sensitivity was confirmed because the use of moxifloxacin 400 mg led to a ΔΔQTcP >10 ms. The pharmacokinetic profile of islatravir was consistent with that of previous studies, and islatravir was generally well tolerated. Results from the current trial suggest that single doses of islatravir as high as 240 mg do not lead to QTc interval prolongation.

A randomized trial of retropubic vs single-incision sling among patients undergoing vaginal prolapse repair.

BACKGROUND: The choice of midurethral sling type may impact efficacy and complications in women undergoing transvaginal native tissue repair of pelvic organ prolapse. OBJECTIVE: The primary aim was to determine if the single-incision sling is noninferior to retropubic sling for the management of stress urinary incontinence among patients undergoing reconstructive or obliterative native tissue vaginal repair. The secondary aims were to compare adverse events and surgeon ease of use with sling assignment. STUDY DESIGN: A multicenter, noninferiority, randomized trial of women with ≥ stage II pelvic organ prolapse and objectively confirmed stress urinary incontinence undergoing reconstructive or obliterative vaginal repair was performed. Women were randomized to concomitant single-incision (Altis sling, Coloplast Minneapolis, MN) with suprapubic sham incisions or retropubic slings. The primary dichotomous outcome was abnormal lower urinary tract function within 12 months postsurgery, defined as bothersome stress urinary incontinence symptoms (>1 Pelvic Floor Distress Inventory question no. 17); retreatment for stress urinary incontinence or treatment for urinary retention. Secondary outcomes were adverse events, Patient Global Impression of Improvement of bladder function, and surgeon ease of use (1, worst; 10, best). All subjects completed validated questionnaires and underwent a Pelvic Organ Prolapse Quantification, cough stress test, and postvoid residual preoperatively, at 6 weeks and 12 months postoperatively. Assuming a subjective cure rate for retropubic of 82%, 80% power, and 1-sided 5% significance level, we estimated that 127 patients in each arm were needed to declare noninferiority of the single-incision sling if the upper bound of the 95% confidence interval for the between-group difference per protocol in abnormal bladder function was <12%. Assuming a 10% loss to follow-up, the total enrollment goal was 280. RESULTS: Between December 2018 and January 2023, 280 subjects were enrolled across 7 sites, and 255 were randomized: 126 were for single-incision, and 129 were for retropubic sling. There were no preoperative or operative characteristic differences between groups. Overall, 81% had reconstructive, and 19% had obliterative native tissue repairs. The primary outcome, abnormal lower urinary tract function at 12 months, occurred in 29 (25%) of single-incision vs 24 (20%) of the retropubic sling group (risk difference, 0.04472 [95% confidence interval, -0.03 to 0.1133]; P=.001 for noninferiority). Bothersome stress urinary incontinence occurred in 20% vs 17% (P=.27) and was retreated in 4% vs 2% (P=.44) of single-incision vs retropubic groups, respectively. Adverse events were reported in 24 (16%) of single-incision vs 14 (9%) of the retropubic group (95% confidence interval, 0.95-3.29; P=.70) and included de novo or worsening urgency incontinence symptoms, urinary tract infection, mesh exposure, need for prolonged catheter drainage, and de novo pain, without differences between groups. Patient Global Impression of Improvement (very satisfied and satisfied) was 71% vs 67% (P=.43), and median surgeon ease of sling use was 8 (7-10) vs 9 (8-10), P=.03 in single-incision vs retropubic, respectively. CONCLUSION: For women undergoing vaginal repair, single-incision was noninferior to retropubic sling for stress urinary incontinence symptoms, and complications, including treatment for urinary retention, did not differ.

Long-Term Costs of Minimally Invasive Sacral Colpopexy Compared to Native Tissue Vaginal Repair With Concomitant Hysterectomy.

STUDY OBJECTIVE: To determine the long-term costs of hysterectomy with minimally invasive sacrocolpopexy (MISCP) versus uterosacral ligament suspension (USLS) for primary uterovaginal prolapse repair. DESIGN: A hospital-based decision analysis model was built using TreeAge Pro (TreeAge Software Inc, Williamstown, MA). Those with prolapse were modeled to undergo either vaginal hysterectomy with USLS or minimally invasive total hysterectomy with sacrocolpopexy (MISCP). We modeled the chance of complications of the index procedure, prolapse recurrence with the option for surgical retreatment, complications of the salvage procedure, and possible second prolapse recurrence. The primary outcome was cost of the surgical strategy. The proportion of patients living with prolapse after treatment was the secondary outcome. SETTING: Tertiary center for urogynecology. PATIENTS: Female patients undergoing surgical repair by the same team for primary uterovaginal prolapse. INTERVENTIONS: Comparison analysis of estimated long-term costs was performed. MEASUREMENTS AND MAIN RESULTS: Our primary outcome showed that a strategy of undergoing MISCP as the primary index procedure cost $19 935 and that undergoing USLS as the primary index procedure cost $15 457, a difference of $4478. Furthermore, 21.1% of women in the USLS group will be living with recurrent prolapse compared to 6.2% of MISCP patients. Switching from USLS to MISCP to minimize recurrence risk would cost $30 054 per case of prolapse prevented. Additionally, a surgeon would have to perform 6.7 cases by MISCP instead of USLS in order to prevent 1 patient from having recurrent prolapse. CONCLUSION: The higher initial costs of MISCP compared to USLS persist in the long term after factoring in recurrence and complication rates, though more patients who undergo USLS live with prolapse recurrence.

Tibial Nerve Stimulation for Urge Urinary Incontinence and Overactive Bladder: Narrative Review of Randomized Controlled Trials and Applicability to Implantable Devices.

The tibial nerve is an established target for neuromodulation in the management of overactive bladder (OAB) and its associated symptoms, including urge urinary incontinence (UUI). Technologies are currently available to deliver tibial nerve stimulation (TNS) through percutaneous devices or through implantable devices. The benefits and safety of percutaneous TNS have led to it as a guideline-recommended therapy. However, patient compliance is limited by the burden of weekly office visits and the need for maintenance treatments. Further, insurance often only covers a limited number of lifetime visits for percutaneous TNS. These factors and others have led to the development, study, and utilization of implantable TNS devices. Implantable TNS devices deliver the same therapeutic mechanism of action for nerve stimulation with a permanent implanted device that provides at-home stimulation rather than in-office therapy delivery. Additionally, there is an added potential for dynamic and patient-centered stimulation. There is a large body of high-quality evidence published for TNS, including numerous randomized controlled trials published on percutaneous TNS which have consistently demonstrated superior efficacy to sham and similar efficacy to that of anticholinergic medications. Percutaneous TNS also performs better than conservative therapy including pelvic floor muscle training. The percutaneous and implantable approaches deliver nerve stimulation to the same target nerve, using the same mechanism of action. Therefore, data from randomized trials of percutaneous TNS are informative for implantable TNS devices. At the time of this article's publication, at least two implantable TNS devices have received marketing authorization from the Food and Drug Administration (FDA). The objective of this review is to discuss the mechanism of action for TNS and summarize the published literature from clinical trials of percutaneous TNS as a foundation of high-quality evidence for implantable devices targeting the tibial nerve.

Specialty-Specific Trends in Surgery for Apical Pelvic Organ Prolapse Post Vaginal Mesh.

IMPORTANCE: Since transvaginal mesh (VM) kits for apical pelvic organ prolapse (APOP) were labeled "high-risk" in 2016 and subsequently banned in 2019 by the U.S. Food and Drug Administration, the most common remaining surgical options include abdominal mesh-augmented sacrocolpopexy (AS) and transvaginal native tissue suspension (VN). OBJECTIVE: The objective of this study was to determine temporal trends in APOP procedures for urologists and gynecologists. STUDY DESIGN: Between 2011 and 2020, the American College of Surgeons National Surgical Quality Improvement Program database was queried for AS, VM, and VN. RESULTS: There were 26,477 cases of APOP repair (32% AS, 6% VM, 62% VN) included, 9% by urologists. Urologists operated on older (65 vs 61 years) patients with more medical comorbidities. Urologists performed significantly higher proportion of AS (65% vs 29%) and VM (8% vs 6%) relative to VN (27% vs 65%) than gynecologists ( P < 0.0001). Transvaginal mesh utilization has decreased over time for both specialties ( P < 0.05); nonsignificant trends toward increasing AS ( P = 0.1646) in urologists and VN ( P = 0.0913) in gynecologists concurrently occurred. Significant independent predictors of the operating surgeon being a urologist were surgery being performed in the latter half of the cohort (2016-2020; odds ratio [OR], 1.22), non-White patient race (OR < 1 for all), a concomitant sling being placed (OR = 0.89), the surgery being VM (OR = 2.95) or AS (OR = 4.36), the patient being older (OR > 1 for each age range), and having a higher frailty index score (OR = 1.16). CONCLUSIONS: Significant differences in APOP repair choices exist between specialties. Urologists operate on older, more medically complex patients while demonstrating a strong preference for mesh-augmented compared with transvaginal native tissue repairs.

Long-Term Mesh Exposure 5 Years Following Minimally Invasive Total Hysterectomy and Sacrocolpopexy.

INTRODUCTION AND HYPOTHESIS: The objective was to assess long-term mesh complications following total hysterectomy and sacrocolpopexy. METHODS: In this second extension study, women from a multicenter randomized trial were followed for more than 36 months after surgery. Owing to COVID-19, participants were assessed through either in-person visits or telephone questionnaires. The primary outcome was the incidence of permanent suture or mesh exposure. Secondary outcomes included surgical success and late adverse outcomes. RESULTS: Out of the 200 initially enrolled participants, 82 women took part in this second extension study. Among them, 46 were in the permanent suture group, and 36 in the delayed absorbable group. The mean follow-up duration was 5.3 years, with the cumulative mesh or suture exposure of 9.9%, involving 18 cases, of which 4 were incident cases. Surgical success after more than 5 years stood at 95%, with few experiencing bothersome bulge symptoms or requiring retreatment. No serious adverse events occurred, including mesh erosion into the bladder or bowel. The most common adverse events were vaginal pain, bleeding, dyspareunia, and stress urinary incontinence, with no significant differences between suture types. CONCLUSION: The study found that mesh exposure risk gradually increased over time, reaching nearly 10% after more than 5 years post-surgery, regardless of suture type. However, surgical success remained high, and no delayed serious adverse events were reported.

The impact of verbal goal setting on operating room turnover time: a randomized trial.

INTRODUCTION AND HYPOTHESIS: Operating room turnover times are highly variable, with longer times having a significant negative impact on hospital costs, surgeon volume, and satisfaction. The primary aim of this randomized trial was to examine the impact of a verbalized time goal on the likelihood of meeting institutional goals. METHODS: This is a prospective, single-blind, randomized study conducted across four operative sites: inpatient main campus and three outpatient centers. Sequential cases for the same surgeon in the same room were randomized to receive a verbal prompt versus usual care, in which no goal setting was verbalized. Multivariate and univariate statistical analyses were performed. RESULTS: From July through October 2022, five attending surgeons randomized 88 cases (44 verbal prompt, 44 usual care). Of these, 30 were at the main inpatient hospital. The case mixture included 36% vaginal, 27% endoscopy, 8% open, 10% robotic, and others. Average turnover time was 51.7 and 35.3 min for inpatient and outpatient cases respectively. Overall, only 39.8% of cases hit the institutional turnover time goal. Verbal prompting did not significantly increase the likelihood of achieving the institutional goal (38.4% vs 43.4% p = 0.352) except for in minor surgery (64.0 vs 39.0%, p = 0.0477). A verbal prompt reduced turnover time in major surgery (59.7 vs 47.8 min, p = 0.0445). CONCLUSION: Our academic center achieved goal turnover times in only 39.8% of cases. Although verbal prompting did not significantly improve the likelihood of meeting institutional goals in the group as a whole, some subgroups were significantly improved.

Injection site number and outcomes of intradetrusor onabotulinumtoxinA for refractory overactive bladder syndrome: a randomized clinical trial.

INTRODUCTION AND HYPOTHESIS: The optimal number of onabotulinumtoxinA injections for the treatment of refractory overactive bladder syndrome is unknown. Our primary objective was to determine whether 10-injections sites with 100 units of onabotulinumtoxinA each were associated with less pain than 20-injections sites. METHODS: In a single-blinded randomized trial, 100 units of onabotulinumtoxinA was administered, either as 10 × 1 ml or as 20 × 0.5 ml injections following the instillation of 30 ml of bupivacaine and 5 ml of NaHCO3 solution for 15 min. The primary outcome was procedural pain, as measured on an 11-point Numerical Pain Rating Scale (NPRS) immediately following the procedure. A power calculation estimated that 16 subjects in each arm were needed to detect a mean difference of 1 with a standard deviation of 1, on the NPRS score between the two treatment groups, with α 0.05 and power 80%. To adjust for an estimated 20% dropout rate, the final sample size was planned for 20 patients per group. RESULTS: From October 2020 to November 2022, a total of 56 patients were approached and 40 were enrolled and randomized to two groups (21 in the 10-injections group and 19 in 20-injections group). The difference in the median pain score between the group was not statistically significant (4 [1.5-5] for 10 injections vs 3 [1-4] for 20 injections, p=0.823). CONCLUSION: Patients' perception of pain, efficacy, and adverse events did not significantly differ between patients receiving 10 and those receiving 20 injections of 100 units of onabotulinumtoxinA.

Anterior approach sacrospinous hysteropexy: native tissue compared with mesh-augmented repair for primary uterovaginal prolapse management.

INTRODUCTION AND HYPOTHESIS: Anterior sacrospinous hysteropexy (SSH) was popularized by transvaginal mesh kits. Following mesh-kit market withdrawal, we hypothesized similar efficacy through native-tissue reattachment of the pubocervical fascia with fixation of the anterior cervix to the sacrospinous ligament. Few analyses for anterior native-tissue versus mesh-augmented SSH exist. METHODS: A retrospective analysis of women who underwent transvaginal anterior SSH between 01 January 2016 and 31 December 2022 was performed. Women who underwent a mesh-augmented (Uphold Lite Vaginal Support System™) versus native-tissue repair were compared. Composite success was defined as no bulge symptoms, no retreatment, and no recurrence beyond the hymen with apex nondescended > one third of the total vaginal length. Descriptive and bivariate statistics were obtained as indicated. RESULTS: Of 223 women screened, inclusion criteria were met by 124 (40 mesh-augmented; 84 native-tissue). There was no difference in pre-operative characteristics between groups. Composite success was demonstrated in 95.2% of women with a median follow-up of 224 days (range: 30-988). Two women in the mesh-augmented group reported bulge symptoms and underwent re-treatment with a pessary. Four women in the native-tissue group reported bulge symptoms; 3 underwent re-treatment (2 pessary, 1 surgery). There were no differences in composite success rates between groups (p=0.954). There were additionally no differences in intra-operative (p=0.752) or post-operative (p=0.292) complication rates between the groups. There were no mesh-related complications, including exposure or chronic pelvic pain. CONCLUSIONS: Ninety-five percent of women achieved surgical success and the use of mesh augmentation did not confer added benefit in terms of efficacy or complications when compared with native tissue. Further long-term data are needed to continue our assessment of native-tissue anterior SSH.

Long-Term Pain After Minimally Invasive Total Hysterectomy and Sacrocolpopexy.

IMPORTANCE: There are limited long-term data on patient-reported pain after surgical treatment of uterovaginal prolapse. OBJECTIVE: This study aimed to evaluate pain in women undergoing minimally invasive total hysterectomy and sacrocolpopexy with a lightweight polypropylene Y-mesh (Upsylon) >2 years after surgery. STUDY DESIGN: This is a planned secondary analysis of a 5-site randomized trial comparing permanent versus absorbable suture for vaginal attachment of a lightweight polypropylene Y-mesh during total laparoscopic hysterectomy and sacrocolpopexy in women with stage ≥2 uterovaginal prolapse. Our primary outcome was patient-reported pain or dyspareunia at >2 years. RESULTS: Of the 185 participants eligible for enrollment in the e-PACT study, 106 enrolled; 98 participants (96%) completed either in-person examinations or study questionnaires regarding pain and are included in this analysis. At >2 years, 28% reported any pain: 14% reported dyspareunia on questionnaires, 5% reported pelvic pain on questionnaires, and 14% of those who had an in-person examination reported pain. Of participants who reported pain or dyspareunia at baseline before surgery, 59% reported resolution of their symptoms >2 years. On multiple logistic regression controlling for age and baseline pain or dyspareunia, baseline pain or dyspareunia was associated with a nearly 3-fold increased risk of reporting any pain >2 years (adjusted odds ratio, 2.7; 95% confidence interval, 1.1-6.9). No women had repeat surgical intervention for pain. CONCLUSIONS: Although 60% of women report pain resolution >2 years after surgery, de novo pain was present in 1 of 5 women. Baseline history of pain or dyspareunia is the only factor associated with an increased likelihood of experiencing pain >2 years after surgery.

Differences in Surgical Practice Patterns of Vaginal Native Tissue Repair for Pelvic Organ Prolapse Between Urologists and Gynecologists.

IMPORTANCE: Surgeon specialty training may influence the combination of transvaginal procedures for pelvic organ prolapse (POP) repair. Isolated transvaginal anterior compartment repair (AR) without concurrent apical suspension (ApS) is a known risk factor for POP recurrence. OBJECTIVES: Our primary aim was to compare the prevalence of isolated AR between urologists versus gynecologists. Our secondary aim was to compare associated postoperative complications. STUDY DESIGN: We queried the American College of Surgeons National Surgical Quality Improvement Program for vaginal POP repair procedures (Current Procedural Terminology codes 57240, 57260, 57265, 57268, 57282, 57283) over a 5-year period by designated surgical specialty. We analyzed the relationships between specialty, vaginal repair type, operative details, and 30-day postoperative complications. RESULTS: Between January 2015 and December 2019, we included 16,093 women who underwent transvaginal POP repair, 90% performed by gynecologists and 10% by urologists. Urologists were more likely to perform an isolated AR without concurrent ApS (56% vs 47%, P < 0.0001). Gynecologists performed more isolated ApS (11% vs 9%) and combined AR with ApS (43% vs 35%, P < 0.0001). Overall, concurrent urethral sling placement was performed in 27% of cases, regardless of POP repair type, with no difference between specialties (P > 0.05). There were no differences in 30-day reoperations, readmissions, surgical site infections, urinary tract infections, or hospital stay lengths between specialties (P > 0.05). CONCLUSIONS: Urologists perform a minority of vaginal POP repairs and were more likely to perform isolated AR than gynecologists. The absence of concurrent ApS may increase the likelihood of prolapse recurrence. Immediate complication rates for each procedure did not differ.

Financial analysis of minimally invasive sacrocolpopexy compared with native tissue vaginal repair with concomitant hysterectomy.

INTRODUCTION: Minimally invasive sacrocolpopexy (MISCP) is increasingly used for uterovaginal prolapse, but comparative cost data of MISCP versus native tissue vaginal repair (NTR) are lacking. The objective was to determine the cost difference, from a hospital perspective, between MISCP and NTR performed with hysterectomy for uterovaginal prolapse. METHODS: This was a retrospective cohort study at a tertiary care center of women who underwent NTR or MISCP with concomitant hysterectomy in 2021. Hospital charges, direct and indirect costs, and operating margin (revenue minus costs) were obtained from Strata Jazz and compared using SPSS. RESULTS: A total of 82 women were included, 33 MISCP (25 robotic, 8 laparoscopic) versus 49 NTR. Demographic and surgical data were similar, except that MISCP had younger age (50.5 vs 61.1 years, p<0.01). Same-day discharge and estimated blood loss were similar, but operative time was longer for MISCP (204 vs 161 min, p<0.01). MISCP total costs were higher (US$17,422 vs US$13,001, p<0.01). MISCP had higher direct costs (US$12,354 vs US$9,305, p<0.01) and indirect costs (US$5,068 vs US$3,696, p<0.01). Consumable supply costs were higher with MISCP (US$4,429 vs US$2,089, p<0.01), but the cost of operating room time and staff was similar (US$7,926 vs US$7,216, p=0.07). Controlling for same-day discharge, anti-incontinence procedures and smoking, total costs were higher for MISCP (adjusted beta = US$4,262, p<0.01). Mean charges (US$102,060 vs US$97,185, p=0.379), revenue (US$22,214 vs US$22,491, p=0.929), and operating margin (US$8,719 vs US$3,966, p=0.134) were not statistically different. CONCLUSION: Minimally invasive sacrocolpopexy had higher costs than NTR; however, charges, reimbursement, and operating margins were not statistically significantly different between the groups.

Detection of Bacteria in Bladder Mucosa of Adult Females.

PURPOSE: Interstitial cystitis/bladder pain syndrome is a chronic urological condition diagnosed in nearly 8 million females in the United States. Whether urinary microbiota play an etiological role remains controversial. Most studies assessed the microbiota of interstitial cystitis/bladder pain syndrome patients with voided or catheterized urine as a proxy for bladder urothelium; however, urine may not be a true reflection of the bladder microbiota. Bladder biopsy tissue may provide a more accurate, and thus more clinically relevant, picture of bladder microbiota. MATERIALS AND METHODS: Bladder biopsy tissues were obtained from: (1) 30 females with interstitial cystitis/bladder pain syndrome (18-80 years old) via cystoscopically guided cold-cup biopsy following therapeutic bladder hydrodistention, and (2) 10 non-interstitial cystitis/bladder pain syndrome females undergoing pelvic organ prolapse repair. To detect bacteria, technical duplicates of each RNAlater-preserved biopsy were subjected to 16S rRNA gene sequencing. To visualize bacteria, paraformaldehyde-fixed, paraffin-embedded biopsies were subjected to a combined multiplexed fluorescence in situ hybridization and fluorescence immunohistochemistry assay and confocal microscopy. RESULTS: Bacteria were detected by 16S rRNA gene sequencing in at least 1 technical duplicate of most biopsies. The most abundant genus was Staphylococcus, followed by Lactobacillus; Escherichia was common but not abundant. There was no significant difference between interstitial cystitis/bladder pain syndrome patients and controls (P > .05). Combined fluorescence in situ hybridization and immunohistochemistry reproducibly detected 16S rRNA in epithelial cells and shed cells in the urothelium and lesioned areas and capillary walls in the lamina propria of human bladder biopsy tissue. CONCLUSIONS: We conclude that urothelial and urinary microbiota are similar but not identical in adult females.

Long-term mesh exposure after minimally invasive total hysterectomy and sacrocolpopexy.

INTRODUCTION AND HYPOTHESIS: The objective was to evaluate total and incident mesh exposure rates at least 2 years after minimally invasive total hysterectomy and sacrocolpopexy. Secondary aims were to evaluate surgical success and late adverse events. METHODS: This extension study included women previously enrolled in the multicenter randomized trial of permanent vs delayed-absorbable suture with lightweight mesh for > stage II uterovaginal prolapse. Owing to COVID-19, women were given the option of an in-person (questionnaires and examination) or telephone visit (questionnaires only). The primary outcome was total and incident suture or mesh exposure, or symptoms suggestive of mesh exposure in women without an examination. Secondary outcomes were surgical success, which was defined as no subjective bulge, no prolapse beyond the hymen, and no pelvic organ prolapse retreatment, and adverse events. RESULTS: A total of 182 out of 200 previously randomized participants were eligible for inclusion, of whom 106 (58%) women (78 in-person and 28 via questionnaire only) agreed to the extension study. At a mean of 3.9 years post-surgery, the rate of mesh or suture exposure was 7.7% (14 out of 182) of whom only 2 were incident cases reported after 1-year follow-up. None reported vaginal bleeding or discharge, dyspareunia, or penile dyspareunia. Surgical success was 93 out of 106 (87.7%): 13 out of 94 (13.8%) failed by bulge symptoms, 2 out of 78 (2.6%) by prolapse beyond the hymen, 1 out of 85 (1.2%) by retreatment with pessary, and 0 by retreatment with surgery. There were no serious adverse events. CONCLUSIONS: The rate of incident mesh exposure between 1 and 3.9 years post-surgery was low, success rates remained high, and there were no delayed serious adverse events.

An assessment of urethral radiation exposure in the treatment of endometrial and rectal cancers.

INTRODUCTION AND HYPOTHESIS: Female survivors of endometrial and rectal cancers have increased risk of urinary incontinence. Survivors with prior radiation therapy are counseled against mesh incontinence surgery. We hypothesize that urethral radiation dose varies based on modality which may influence surgical risks. We aimed to demonstrate urethral radiation dose differences between vaginal brachytherapy (VBT) and external beam radiation therapy (EBRT). METHODS: This is a retrospective cohort study of women exposed to VBT for endometrial cancer and EBRT for rectal cancer. The urethra was contoured on CT imaging to calculate radiation doses in centigray (cGy). The primary outcome was the percent of treatment radiation dose estimated to be received by the urethra based on the volume dose to 0.2 cc of urethra. Secondary outcomes were point doses to the bladder neck, mid-urethra, and total mean urethral dose. Descriptive statistics described demographic characteristics. Bivariate analyses compared urethral radiation dose based on radiation modality. RESULTS: Between 2014-2017, 32 women treated were included: 18 with VBT and 14 with EBRT. Mean ± SD urethral volume doses were lower in VBT (1266 cGy ± 533, 42.2% of prescribed treatment dose) compared to EBRT (5051 cGy ± 192, 100.2% of prescribed treatment dose), p < 0.0001. VBT also had significantly lower mean total urethral dose and point doses to bladder neck and mid- urethra compared to EBRT (p < 0.0001). CONCLUSIONS: The female urethra is exposed to significantly less radiation in VBT compared to EBRT. These data highlight that modality of pelvic radiation should be considered in treatment counseling on urinary incontinence in women.

Small-Fiber Polyneuropathy Is Prevalent in Patients With Interstitial Cystitis/Bladder Pain Syndrome.

IMPORTANCE: The pathophysiology of interstitial cystitis/bladder pain syndrome (IC/BPS) is imperfectly understood. Recent studies reported that small-fiber polyneuropathy (SFPN) is common in fibromyalgia, a condition commonly comorbid with IC/BPS. OBJECTIVE: The objective of this study was to determine the prevalence of SFPN in a large cohort of IC/BPS patients. METHODS: Adults diagnosed with IC/BPS scheduled to undergo either therapeutic hydrodistention (n = 97) or cystectomy with urinary diversion (n = 3) were prospectively recruited to this study. A skin biopsy obtained from the lower leg was used for intraepidermal nerve fiber density measurement. Small-fiber polyneuropathy (+/-) status was determined by comparing linear intraepidermal nerve fiber density (fibers/mm2) with normative reference values. Demographic information, medical history, and diagnoses for 14 conditions (both urologic and nonurologic) known to co-occur with IC/BPS were documented from self-report and electronic medical record. RESULTS: In this large cohort of patients with IC/BPS, 31% (31/100) were positive for SFPN. Intraepidermal nerve fiber density was below the median for age and sex in 81% (81/100) of patients. Approximately one-third (31%) of SFPN+ patients reported co-occurring chronic fatigue syndrome, compared with 10.6% of the SFPN- group (P = 0.034). Small-fiber polyneuropathy-positive patients reported significantly fewer allergies than SFPN- patients (37.9% vs 60.6%; P = 0.047). There were no significant differences in bladder capacity or Hunner lesion status between the SFPN+ and SFPN- subgroups. CONCLUSIONS: Small-fiber polyneuropathy is a common finding in patients with IC/BPS, and SFPN status is significantly correlated with co-occurring chronic fatigue syndrome and negatively correlated with the presence of allergies in this population.

An analysis of diversity within academic urology leadership.

INTRODUCTION: Women, underrepresented minorities, and international medical graduates are underrepresented in urology. We sought to compare demographics of leaders in academic urology to urology faculty and academic medical faculty. MATERIALS AND METHODS: The Association of American Medical Colleges provided academic medical faculty demographics. Women, underrepresented minorities, and international medical graduates in leadership roles (department/division chair or full professor) were identified. Fisher's exact tests were performed to compare proportions of those groups in urology leadership to academic urology, academic medicine leadership, and academic medicine. RESULTS: In 2019, there were 179,105 faculty in academic medicine with 41,766 in leadership and 1,614 faculty in urology with 567 in leadership. Significantly fewer women were in urology leadership compared to academic urology (7.4% vs. 22.0%, p < 0.0001), academic medical leadership (7.4% vs. 25.0%, p < 0.0001), and academic medicine (7.4% vs. 42.0%, p < 0.0001). Significantly fewer underrepresented minorities were in urology leadership compared to academic medicine (6.9% vs. 9.4%, p = 0.04) with no significant difference when compared to urology faculty (6.9% vs. 8.1%, p = 0.4) or medical faculty leadership (6.9% vs. 6.4%, p = 0.6). Significantly more international medical graduates were in urology leadership compared to across academic urology, (32% vs. 24%, p = 0.0006), but significantly fewer than those in leadership across all medical specialties (32% vs. 40%, p = 0.0001). CONCLUSIONS: Women and underrepresented minorities are significantly underrepresented in academic urologic leadership while international medical graduates are statistically overrepresented. Considering calls for diversity, equity, and inclusion, these data highlight a need for increased representation in leadership positions in academic urology.

Examining the Role of Nonsurgical Therapy in the Treatment of Geriatric Urinary Incontinence.

OBJECTIVE: To examine the role of physical function impairments on the change in urinary incontinence (UI) symptoms after pelvic floor muscle training in older women. METHODS: This is a prospective cohort study of 70 community-dwelling participants, older than age 70 years, with at least moderate incontinence symptoms. A comprehensive pelvic floor and physical function assessment was done at baseline. Individualized pelvic floor muscle training prescriptions with behavioral management strategies to reduce incontinence episodes were provided for 12 weeks. Baseline physical function was determined using the SPPB (Short Physical Performance Battery). A total score of 9 or lower out of 12 indicated impaired physical function, and scores higher than 9 indicated normal physical function. A 3-day bladder diary established daily incontinence episodes. The between-group difference in the change in number of UI episodes, from baseline to 6 weeks, was our primary outcome. Descriptive analyses compared important demographic and clinical characteristics. Longitudinal mixed model linear regression analyses determined the change in incontinence episodes and estimates of improvement based on the presence of impaired physical function and adjusted for age, race, and body mass index (BMI). RESULTS: Participants' mean±SD age was 76.9±5.4 years, and 15.7% identified as African American, with no significant differences in age or race between groups. Participants with impaired physical function had higher mean±SD BMI (33.6±14.5 vs 27.4±5.8; P=.03) and more baseline incontinence episodes (4.5±2.9 vs 2.7±2.1 episodes per day; P=.005) than in women without functional impairment. After 6 weeks of pelvic floor exercises, the change in number of incontinence episodes per day was not different between participants with physical functional impairment compared with women with normal physical function (mean [95% CI] -1.2 [-2.0 to -0.5] vs -0.4 [-1.1 to 0.3], P=.31). Overall, after 12 weeks of pelvic floor muscle training, complete satisfaction with incontinence symptom improvement was low for both groups (41.8% with physical function impairments vs 44.8% with normal physical function; P=.90). CONCLUSION: Behavioral therapy including pelvic floor muscle training may not significantly decrease UI symptoms to a degree that is satisfactory in women who are older than 70 years and are seeking treatment for UI, regardless of the presence of physical function impairments. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03057834.