Poster Session 4 - Moderated - FPMRS, Voiding Dysfunction, Transgender Medicine

3:30 - 4:30pm Sunday, 31st October, 2021


Poster Session 4 Vibegron Shows Meaningful Changes in Clinical Endpoints in Patients with Overactive Bladder: Analyses From EMPOWUR

Jeffrey Frankel MD1, David Staskin MD2, Susann Varano MD3, Michael Kennelly MD4, Matt T Rosenberg MD5, Diane K Newman DNP, ANP-BC6, Cynthia J Girman DrPH, FISPE7, Denise Shortino MS8, Rachael A Jankowich RN, MSN8, Paul N Mudd, Jr. PharmD, MBA8
1Seattle Urology Research Center, Seattle, WA, USA. 2Tufts University School of Medicine, Boston, MA, USA. 3Clinical Research Consulting, Milford, CT, USA. 4Carolinas Medical Center, Charlotte, NC, USA. 5Mid-Michigan Health Centers, Jackson, MI, USA. 6Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA. 7CERobs Consulting, LLC, Chapel Hill, NC, USA. 8Urovant Sciences, Irvine, CA, USA

Abstract

Objectives: Reductions in bothersome symptoms of overactive bladder (OAB) are reported to demonstrate improvement in clinical trials, often without interpreting meaningfulness to patients. In the 12-week phase 3 EMPOWUR trial, vibegron significantly reduced micturitions, urgency episodes, and urge urinary incontinence (UUI) episodes vs placebo (P<0.01, each). These analyses used an anchor-based approach to interpret the meaningfulness of symptom reduction with the patient global impression of change (PGI-C).

Methods: Median change from baseline (CFB) at week 12 in micturitions, urgency episodes, and UUI episodes was generated for each PGI-C category, pooled across treatments. Percentages of patients achieving these reductions in symptoms were determined.

Results: Patients who experienced greater CFB at week 12 in each endpoint reported greater improvement in PGI-C. Median reductions from baseline in OAB endpoints pooled across treatment groups were higher than thresholds patients perceived as improved based on PGI-C: ≥15% reduction in micturitions (moderately better), ≥50% reduction in urgency episodes (much better), and ≥90% reduction in UUI episodes (much better; similar to ≥75% reduction seen in EMPOWUR [PGI-C: moderately better]) (Figure). Significantly more patients receiving vibegron vs placebo achieved these reductions (P<0.05, each).

Conclusion: Significantly more patients treated with vibegron vs placebo in EMPOWUR achieved meaningful reductions in micturitions and urgency/UUI episodes that were associated with patient-perceived improvement.

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If funding provided, type in source company / entity name(s):

Urovant Sciences

Poster Session 4 Effects of Vibegron on Ambulatory Blood Pressure in Patients With Overactive Bladder: Results From a Double-Blind Study

Michael A Weber MD1, William B White MD2, Jennifer King PharmD3, Ann Walker MS4, Paul N Mudd, Jr. PharmD, MBA3, Cornelia Haag-Molkenteller MD, PhD3
1State University of New York Downstate College of Medicine, Brooklyn, NY, USA. 2University of Connecticut School of Medicine, Farmington, CT, USA. 3Urovant Sciences, Irvine, CA, USA. 4Apex Biostatistics, Inc, Apex, NC, USA

Abstract

Objectives: Ambulatory blood pressure monitoring (ABPM) is a sensitive method used to determine whether small changes in blood pressure (BP) and heart rate (HR) are induced by new drugs. This randomized, double-blind, placebo-controlled ABPM trial characterized the BP and HR profile of vibegron, a β3-adrenergic receptor agonist, in patients with overactive bladder (OAB).

Methods: Patients were randomized to once-daily vibegron 75 mg or placebo for 28 days. The primary endpoint was change from baseline (CFB) to day 28 in mean daytime (waking hours) ambulatory systolic BP (SBP). Key secondary endpoints were CFB to day 28 in mean daytime ambulatory diastolic BP (DBP) and HR and in mean 24-hour ambulatory SBP, DBP, and HR. Point estimates for treatment group means and treatment differences were presented with a 2-sided 90% confidence interval (CI). For the primary endpoint, the upper limit of the CI was evaluated against a criterion of 3.5 mmHg.

Results: A total of 214 patients with OAB were randomized; of these, 96 in the vibegron group and 101 in the placebo group had evaluable ABPM measurements at baseline and day 28. Mean age was 59.3 years and 74.6% were female; 39.6% and 30.7% of patients receiving vibegron or placebo, respectively, had pre-existing hypertension. The least squares mean difference (LSMD; 90% CI) CFB to day 28 in daytime SBP was 0.81 (‒0.88, 2.49) mmHg for vibegron vs placebo (Table). Changes in daytime DBP and HR were comparable for vibegron and placebo (Table). The 90% CIs include 0, implying no statistically significant differences were seen in mean 24-hour SBP, DBP, or HR (Table). The most commonly reported treatment-emergent adverse event was hypertension (vibegron: n=5 [4.7%, 95% CI=1.6%-10.7%]; placebo: n=4 [3.7%, 95% CI=1.0%-9.2%]); no event of hypertension with vibegron was considered treatment related.

Conclusions: In patients with OAB, once-daily vibegron was not associated with clinically meaningful or statistically significant effects on BP or HR and had a safety profile comparable with placebo.

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If funding provided, type in source company / entity name(s):

Urovant Sciences

Poster Session 4 Online engagement with treatments for benign prostatic hyperplasia: Is interest in Urolift outpacing the gold standard?

Mayra I Lucas BS1, Parris Diaz BS2, Francisco J Escobedo BS1, Bree’va J Limbrick BS1, Kymora B Scotland MD, PhD1
1David Geffen School of Medicine at UCLA, Los Angeles, CA, USA. 2Charles R. Drew University of Medicine and Science, Los Angeles, CA, USA

Abstract

Introduction and Objective: Patients suffering from progressive symptoms of benign prostatic hyperplasia (BPH) increasingly turn to the internet for information on invasive and minimally invasive surgical therapies (MIST). This study aimed to identify online articles accessed by patients seeking guidance on said options and to evaluate the quality of their content.

Methods: Google Trends was used to evaluate search term popularity for BPH procedures from February 2016 to February 2021. The BuzzSumo social media analysis tool was used to identify articles related to procedural treatments for BPH with the most engagements on social media platforms over the same time span. Two individual reviewers rated the quality of the articles based on the average score obtained using the DISCERN tool. Google trends data and DISCERN ratings were analyzed with ANOVA and paired t-test, respectively. 

Results: The top 18 articles obtained from BuzzSumo analyses were selected and accounted for 19,805 total engagements. Thirty-nine percent of identified articles were rated as low quality, 39% as moderate quality, and 22% as high quality using the DISCERN tool, with no significant difference among reviewer ratings. Google Trends data reveal a rising popularity of MIST such as Rezum, Urolift, Aquablation, and PAE in the study period, far exceeding interest in invasive procedures like HoLEP and laser surgery. Urolift interest has specifically increased in the past 6 months. However, transurethral resection of the prostate (TURP) remained popular with no significant difference between MIST and TURP on Google Trends (Figure 1).

Conclusions: Patients are more likely to encounter online sources of low to moderate quality with serious to important shortcomings regarding information on procedural treatments for BPH. Urologists should consider the role of social media platforms when guiding patients to sources of accurate and comprehensive information for BPH treatment, especially with the rise in popularity of MIST.


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Poster Session 4 Short-term Outcomes of Peri-Urethral Injection of Polyacrylamide Hydrogel (Bulkamid®) for Stress Urinary Incontinence with Intrinsic Sphincter Deficiency, Post Mid-Urethral Sling, and Post Mesh Sling Excision

Justina Tam MD, Hannah Koenig MPH, Alvaro Lucioni MD, Kathleen Kobashi MD, Una Lee MD
Virginia Mason Medical Center, Seattle, WA, USA

Abstract

Objectives: Polyacrylamide Hydrogel (PAHG), is a non particle-based urethral bulking agent. PAHG acquired FDA approval in 1/2020, limiting clinical outcomes data in the US. Prior studies demonstrated the efficacy and durability of PAHG in index patients with stress urinary incontinence (SUI). Outcomes following PAHG injection in women with a history of mesh sling excision and/or refractory SUI are lacking. The aim of this study is to examine short-term outcomes of PAGH injection, specifically in women with intrinsic sphincter deficiency (ISD), post mesh sling excision, and/or refractory SUI.

Materials and Methods: Demographics, clinical characteristics, and urodynamic data were collected in women undergoing urethral bulking with PAHG at a single institution. Post-operative assessments (PGI-I, % improvement, overall satisfaction, UDI-6, adverse events, and further SUI treatment) were conducted at 4-6 weeks and 3 months.

Results: Between 5/2020 and 11/2020, 34/48 women treated with PAHG, completed at least 4 week follow up questionnaires. Mean age was 57 (SD 15) and mean BMI was 27.52 (SD 6). Of 20 women who received PAHG as primary treatment for SUI, 10 demonstrated VLPP < 60cm H20. Eleven received PAHG after prior excision of mesh mid-urethral sling, 9 received PAHG with a urethral sling in place, 1 had SUI managed with a non-PAHG bulking agent, and 7 with recurrent SUI after prior urethral sling were previously treated with other urethral bulking agents. Of those with ISD or prior SUI treatment, 17/21 reported much better or very much better post-procedure condition, with 80% median symptom improvement, and 9/10 median satisfaction. Two patients received repeat PAHG injection with 90% improvement after the second injection. (Table 1).

Conclusions: In the subset of women with ISD, refractory SUI after MUS, and post-mesh sling excision, PAHG treatment achieved a median of 80% improvement, and a low rate of complications. Longer term follow-up with a larger cohort is needed to assess the durability of PAHG in non-index and complex patients.

Source of Funding: None

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Poster Session 4 Examination of Information and Misinformation on Urinary Tract Infections on TikTok and YouTube

Justina Tam MD, Emily Porter ., Una Lee MD
Virginia Mason Medical Center, Seattle, WA, USA

Abstract

Objectives: Social media is increasingly used as a resource for health information. YouTube and TikTok videos are highly utilized and are potentially a source of helpful information or misinformation. The objective of this study is to describe and assess the quality and accuracy of the most highly viewed YouTube and TikTok posts related to urinary tract infections (UTIs).

Materials and Methods: From 1/2021 to 2/2021,“UTI” was searched within TikTok and YouTube and the most viewed posts were analyzed for their content and source. Accuracy of scientific information, possible misinformation, credibility, and quality (modified DISCERN) were rated independently by three reviewers. Posts were categorized into educational/informational (EDU), shared experience (EXP), humor/entertainment (HUM), home remedies/alternative therapies (ALT) and number of views, likes, and comments were recorded.

Results: On 50 YouTube and 50 TikTok videos respectively, the median number of views was 49K and 1.4M, the median number of likes was 296 and 58K, and the median number of comments was 50 and 616. On YouTube and TikTok respectively, 94% and 42% were EDU, 4% and 30% were HUM, 6% and 14% were ALTs, and 6% and 20% were EXP. The proportion of female to male presenters on YouTube was equal while 94% were female on TikTok. Overall, YouTube had higher median scores of scientific information, credibility, and less misinformation compared to TikTok. Videos on YouTube with higher views, likes, and comments and those that were categorized as ALT on both platforms tended to have lower scores in all categories and more misinformation (Table 1). On YouTube and TikTok respectively, 66% and 20% of presenters were medical professionals.

Conclusions: Social media allows the sharing of health information and can normalize the UTI experience. YouTube and TikTok generally provided accurate information and did not promote harmful misinformation. Providers should be aware of the potential influence of social media as patients are getting health information from many sources.

Source of Funding: None

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Poster Session 4 Upright Open standing MRI studies of the female bladder and urethra during Yoga postures used in the treatment of female urinary incontinence.

Lynn Stother M.D., Andrew Macnab M.D.
UBC, Vancouver, BC, Canada

Abstract

Background: Yoga is used in treatment of urinary incontinence (UI) in women, but the pathophysiology underlying its benefit is unknown and basic science studies are lacking. NIDDK has called for increased research into the function/dysfunction of the urethra and its role in UI. Objectives: a) develop a protocol for upright open MRI (UO MRI) of the female urethra during yoga; b) identify physical changes in the urethra and bladder neck generated during poses used in RCT’s for UI.

 

Methods: Females with LUTS and controls had UO MRI scans of the pelvis, bladder and urethra using a 0.5 Tesla MRI, while supine, upright and doing yoga; poses included standing triangle/chair/warrior and supine supported bridge. Sagittal and axial images were obtained in 2–5 minute scans using oblique orientation to facilitate urethral measurements and 3D urethral reconstruction. 

 

Results: From N=20 scans, changes in urethral length, width and overall structural shape were evident in individuals when comparing their upright scans to those when supine; urethral widening and foreshortening were observed with upright poses, particularly those with the legs abducted. In the supine bridge position narrowing of the urethra was seen as compared to the widening of the bladder neck region evident when standing upright. Composite Figure 1 shows MRI set up for warrior pose; urethral shape chair pose; urethral shape triangle pose.

 

Conclusions: UO MRI pilot studies demonstrate that changes in urethral anatomy are evident when upright and supine scans are compared and with some Yoga postures. Imaging protocol length varies depending on the plane studied, but 2-5 minutes is sufficient for axial and sagittal plane scans with sufficient resolution for anatomic distinction to be made between changes in the physical characteristics of the urethra related to posture, gravity and yoga. Further UO MRI studies will likely add to our understanding of the role of the urethra in UI related to posture, and possibly help explain the beneficial mechanisms underlying Yoga-related therapies. 

 

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Poster Session 3 Renal Angioembolization Achieves Superior Kidney Salvage Compared to Surgical Repair in Patients with Acute Renal Trauma : Analysis of the National Trauma Databank 2013 – 2018

Nizar Hakam MBBS, Michael J Sadighian MSc, Behnam Nabavizadeh MD, Isabel Elaine Allen PhD, Gregory Amend MD, Deborah M Stein MD, Benjamin N Breyer MD
University of California San Francisco, San Francisco, CA, USA

Abstract

Objective

Contemporary guidelines for renal trauma management recommend conservative management to maximize renal salvage. In patients requiring intervention, angioembolization (AE) and surgical repair (SR) are most common options. We aimed to compare patients who underwent AE vs SR in terms of need for subsequent nephrectomy.

Materials and methods

Using the National Trauma Databank data 2013 - 2018, we identified all patients with renal trauma with AAST grade available, who underwent AE or SR as the initial management. We constructed a propensity score matched cohort by matching AE to SR patients on AAST grade, mechanism of injury (blunt vs penetrating), and hemodynamic instability (SBP < 90). One-to-one propensity score matching was performed using the nearest neighbor match. Post-match logistic regression was performed to assess the association between AE, compared to SR, and nephrectomy. 

Results

Before matching, there were 404 patients in the AE group and 625 in the SR group. Median age was 30 years and 577 (56.1%) had penetrating injuries. Total nephrectomy rate was higher in the SR group vs AE group (8.7% vs 4.5%, p=0.01). Our matched cohort comprised 690 patients who were successfully matched. Post-match adjusted regression revealed that AE, compared to SR, was associated with significantly lower odds of subsequent nephrectomy (OR 0.23, 95% CI 0.06 – 0.82, p = 0.024) (Table 1). 

Conclusion

Renal AE achieved superior kidney salvage compared to SR in this observational cohort from the National Trauma Databank. Our findings inform both clinical practice and future prospective trials. Inherent data limitations, especially patient selection bias, should be acknowledged when interpreting findings. 




Poster Session 4 Pelvic floor muscle oxygen kinetics: a quantifiable measure of pelvic floor muscle function for the assessment and treatment of non-neurogenic and neurogenic lower urinary tract dysfunction.

Lynn Stothers M.D., Andrew Macnab M.D.
UBC, Vancouver, BC, Canada

Abstract

I &O: In the science of sports medicine skeletal muscle function is assessed by measuring changes in oxygenated hemoglobin (HbO2) following an exercise intervention; these data are obtained using an established optical technology, near infrared spectroscopy (NIRS). Although international guidelines recommend pelvic floor muscle (PFM) therapy (PFMT), currently oxygen kinetic measures to quantify training effects are lacking. 

 

Half-recovery time of hemoglobin difference (HbDiff(½RT)) following a sustained maximal voluntary contraction (SMVC), is a validated, NIRS-derived, oxygen kinetic parameter. We studied PFMT training effects using HbDiff(½RT) measurement in women both with NLUTD and non-neurogenic LUTS with control comparisons to quantify metabolic function. 

 

HbO2 reoxygenation after exercise is the time needed for resaturation of deoxyhemoglobin; this reflects the influx of oxygenated blood as well as continued O2 consumption during recovery, and quantifies muscle ‘fitness’

 

M: N = 18 women aged 24-71 years (7 symptomatic, 11 asymptomatic controls) completed 8 weeks of PFMT; HbDiff(½RT) data sets were compared within individuals and between clinical groups. Clinical tools for assessment included: perineometry, bladder diary and clinical questionnaires (Qualiveen & UGDI-6). A vaginal interface (Figure 1) with optical capture rates of 10 Hz was used to capture right and left side PFM NIRS measurements independently to evaluate for differences in sidedness within individuals.  

 

                                    FigureDiagram

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R: Figure 2 shows NIRS data pre and post PMFT from a control subject; following SMVC the slope of reoxygenation recovery allows calculation of HbDiff(½RT) – vertical lines indicate start and end of SMVC. In one subject with NLUTD (incomplete spinal cord injury), no detectable PFM contractile ability was evident on initial assessment, but marked unilateral post-PMFT improvement was detectable using PFM NIRS.

 

                                    Figure 2

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C: Calculation of HbDiff(½RT) following PFM SMVC allows a validated muscle reoxygenation parameter to be applied in evaluation of PFM dysfunction, and to measure training effect from rehabilitation exercise, potentially improving management of UI.




Poster Session 4 Frailty is Associated with an Increased Risk of Complications After Sling Surgery

Michelle E Van Kuiken MD, Shoujun Zhao PhD, John Boscardin PhD, Kenneth Covinsky MD, MPH, Emily Finlayson MD, MS, Anne M Suskind MD, MS
UCSF, San Francisco, CA, USA

Abstract

Purpose:

Sling surgery is the gold standard treatment for stress urinary incontinence in women. While data support the use of sling surgery in younger and middle-aged women, outcomes in older, frail women are largely unknown. The purpose of this study is to examine the risk of complications following sling surgery according to frailty.  

 

Materials and Methods:

Data were examined for all Medicare beneficiaries ≥65 years who underwent sling surgery from 2014 to 2016.  Women were stratified by the Claims-based Frailty Index into four categories of frailty: not frail (CFI <0.15), pre-frail (0.15≤CFI<0.25), mildly frail (0.25≤CFI< 0.35), and moderately-severely frail (CFI ≥0.35). Outcomes included rates and relative risk of 30-day complications, 1-year mortality, and repeat procedures at 1 year for either urinary incontinence or obstructed voiding.

 

Results:

A total of 56,610 women underwent sling surgery during the study period, 5.2% of whom were mildly to moderately-severely frail. Both 30-day complications and 1-year mortality were highest in the moderately-severely frail group, 56.3% and 9.7%, respectively. On multivariate analysis, compared the not frail group, moderately-severely frail women demonstrated an increase in 30-day complications [56.3%, adjusted RR: 2.3 (95% CI: 2.0-2.6)] and 1-year mortality [9.7%, aRR: 6.7 (95% CI: 3.4-11.4)].  Additionally, there was an increase in repeat procedures at 1 year in mildly-severely frail women (6.5%, aRR: 1.5 (95% CI 1.3-1.8)] compared to women who were not frail.

 

Conclusion:

 

As frailty increased, there was an increased relative risk of 30-day complications, 1-year mortality, and need for repeat procedures within 1 year of surgery.  It is important to consider frailty when counseling older women regarding the risks of sling surgery.


If funding provided, type in source company / entity name(s):

NIH-NIA R01AG058616

Poster Session 4 Holmium Laser Enucleation of the Prostate in Renal Transplant Patients

Justin P Campagna MD, Gopal L Narang MD, Jonathan P Moore MD, Scott M Cheney MD, Mitchell R Humphreys MD
Mayo Clinic Arizona, Phoenix, AZ, USA

Abstract

Objectives: Men with benign prostatic hyperplasia (BPH) who undergo renal transplant have a high incidence of post-transplant lower urinary tract symptoms.1,2 Post-transplant BPH has been associated with urinary retention, impaired graft function and urinary tract infection.2,3,4 Gold standard surgical management for bladder outlet obstruction (BOO) from BPH after renal transplant is transurethral resection of the prostate which has been shown to be safe and effective. 4,5,6,7 Little has been published regarding feasibility or efficacy of holmium laser enucleation of the prostate (HoLEP) in this setting. This study examines the safety and efficacy of HoLEP performed before or after renal transplant.

Methods: We retrospectively reviewed patients who underwent both renal transplant and HoLEP between 11/2011–11/2020. Patient demographics, perioperative data, and post-operative outcomes were evaluated.

Results: Our cohort consists of 12 patients; 7 (58%) underwent HoLEP prior to transplant and 5 (42%) underwent HoLEP after transplant. Median age was 69±3.3 and prostate volume was 82±16.5 grams. No patients were oliguric prior to transplant, however 58% of patients were catheter dependent prior to HoLEP. Median procedure time, enucleation time and morcellation time were 128.5±40.3, 69±19 and 10±4 minutes, respectively. Median resection volume was 54±23.9 grams. Median catheter duration was 1.0±1.0 day and blood loss was minimal (median Hgb ∆ 1.5±1.3 g/dL). Two patients required transfusion and one required catheter placement for urinary retention. There was one death nine months after HoLEP. 92% of patients were catheter-free post-HoLEP. Both post-operative Qmax and PVR improved. 92% of patients endorsed subjective happiness with the procedure. Rates of stress urinary incontinence, stricture/bladder neck contracture and second procedure were low at 1 year post-HoLEP (1/12, 1/12, 1/12 respectively) and graft function remained durable.

Conclusions: HoLEP in the setting of renal transplant is a technically feasible and safe procedure for BOO with improved functional outcomes and excellent patient satisfaction. HoLEP may be considered for BOO in the setting of renal transplant.

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Poster Session 4 Analysis of Holmium Laser Enucleation of Prostate (HoLEP) Fixed Operating Room (OR) Times

Laura E Geldmaker B.S., Patrick A Houghton M.D., Daniela A Haehn M.D., Christopher H Hasse FACHE, Abena N Anyane-Yeboah MHA, Mikolaj A Wieczorek B.S., Colleen T Ball M.S., Chandler D Dora M.D., David D Thiel M.D.
Mayo Clinic, Jacksonville, FL, USA

Abstract

OBJECTIVE: HoLEP is a unique endoscopic urology procedure. We aimed to evaluate the efficiency of this procedure in a high-volume tertiary center by analyzing fixed OR times, OR time not associated with surgeon operating time.

METHODS: All urology fixed OR times for HoLEP were prospectively collected for a 24-month period (2019 and 2020). Fixed OR times were defined as: in room time to anesthesia release time (IRAT), anesthesia release time to cut time (ARCT), in room time to cut time (IRCT) (IRAT + ARCT), and close time to wheels out time (CTWO). Variable OR time was defined as cut to close (CTCT). We evaluated variables by comparing morning and afternoon procedures (defined as any surgery that started after noon). We also analyzed the impact of number of certified registered nurse anesthetists (CRNAs) per case on OR efficiency. The Fisher exact test was utilized to compare groups for categorical variables and the Wilcoxon rank sum test was utilized to compare groups for continuous variables. 

RESULTS: Over the 24-month period, 406 HoLEPs were performed. There was not a statistically significant difference in fixed OR times for morning versus afternoon procedures (IRAT P=0.38, ARCT P=0.10, IRCT P=0.39, CTWO P=0.77). Median variable OR time, CTCT, was faster in the afternoon (AM: 88.0 minutes (min), range: 1.0-406.0, vs. PM: 77.0 min, range: 33.0-208.0, P <0.001). Median total OR time (fixed and variable) was faster in the afternoon (AM: 118.0 min, range: 55.0-452.0 vs. PM: 108.0 min, range: 41.0-249.0, P<0.001). Median fixed OR times made up 26.7% (range: 9.9%-98.2%) of the total procedure time in the AM and 28.7% (range: 13.9%-51.7%) in the PM (P=0.005). 78.1% (178/228) of HoLEPs had two or more CRNAs involved in the procedure. Median fixed OR time was not significantly different for procedures with <2 CRNAs versus procedures with ≥2 CRNAs (IRAT: P=0.53, ARCT: P=0.71, IRCT: P=0.26, CTWO: P=0.98).

CONCLUSIONS: Fixed OR time makes up a significant portion of HoLEP procedures and must be considered when evaluating OR efficiency. Neither time of day nor number of anesthesia personnel involved in the case have a statistically significant effect on fixed OR times.


Poster Session 4 Factors that Drive Satisfaction after MIST treatment for BPH: a Sub-Analysis of PUL and Rezum Patients.

William M Schiff MD1, Ronald Tutrone MD2
1Urology Associates of Central California, Fresno, CA, USA. 2Chesapeake Urology Research Associates, Baltimore, MD, USA

Abstract

As utilization of minimally invasive surgical therapies (MISTs) for the treatment of BPH increases, it’s important for physicians and patients to understand not only long-term symptom outcomes, but also what drives high satisfaction during the recovery period. In this new sub-analysis, we assess factors that may influence satisfaction in the early recovery period after undergoing Rezum or PUL (with the UroLift System).

30 PUL and 23 Rezum patients completed a questionnaire detailing their experience within 2 months of their procedure. Highly satisfied patients achieved a pooled score of ≥3 on two questions regarding satisfaction with the effect of the procedure on urinary symptoms and with speed and ease of recovery (for each question, -2=very dissatisfied and +2=very satisfied); dissatisfied patients scored <0. Outcomes were compared between all highly satisfied vs. all dissatisfied patients, and between PUL and Rezum patients.

Highly satisfied patients overall reported significantly better absolute IPSS (8.0 vs. 24.3) and QoL (1.0 vs. 4.6) compared to dissatisfied patients. Catheter duration was shorter for highly satisfied patients (1.9d) than for dissatisfied patients (5.6d). Highly satisfied patients experienced lower rates of interference by urinary symptoms in activities related to sports, entertainment, and community, as well as less of an impact of their recovery on work (p-value = 0.002). Within the timeframe assessed, outcomes associated with increased satisfaction (IPSS, QoL, catheter duration, interference by urinary symptoms with sports, entertainment, and community) were better for PUL vs. Rezum patients (respective p-values: 0.001, 0.04, <0.001, 0.007, 0.01, 0.04).

Better absolute IPSS and QoL scores, less interference of daily activities, and shorter duration of catheterization may be factors that contribute to satisfaction in this population of MIST patients in the early recovery period, and are superior outcomes for PUL patients compared to Rezum.


If funding provided, type in source company / entity name(s):

Neo Tract-Teleflex

Poster Session 4 Analyzing the Information Patients View Online Regarding Benign Prostatic Hyperplasia Supplements.

Jacob Komberg BS1, Sapna Thaker BS2, Karan Thaker BS2, Wayne Brisbane MD2, Kymora Scotland MD2
1FAU CESCOM, Boca Raton, FL, USA. 2UCLA DGSOM, Los Angeles, CA, USA

Abstract

Objectives: Benign Prostatic Hyperplasia (BPH) is one of the most common causes of lower urinary tract symptoms in men. While numerous studies have demonstrated the efficacy of certain lifestyle modifications, medications, and surgeries on symptom management, many patients might still seek alternative therapies like non-prescription supplements, sometimes without the advice of a physician. Patients often seek information on these supplements through online resources. The goal of this study is to identify online sources of information on BPH supplements used by patients and to assess their overall accuracy and scientific basis.

Materials and Methods: The Buzzsumo tool, an online social media analyzer, was used to identify the most viewed resources relating to “prostate supplements” across social media sites. Each source was ranked according to a “total engagement score” (cumulative number of times the article was shared on various social media websites). The top 20 articles over a 5-year period were then evaluated using the DISCERN criteria to determine their reliability and quality. DISCERN utilizes a 16 part assessment with Likert scale of 1-5, with high scores being better (http://www.discern.org.uk/).

Results: The mean “total engagement score” for the top 20 articles over a 5-year period was 2417.5 +/- 4846.91. We also determined that Facebook comprised the vast majority of the “total engagement score” compared to Twitter, Pintrest, Reddit, and other social media sites, with a mean score of 2364.2 +/- 4850.06 (97.80%). Using the DISCERN criteria on these articles, we found that the aggregate mean score for the first 15 questions and 16th question was 3.02 +/- 1.43 and 2.75 +/- 0.97, respectively, which indicate that the average article scored on the low-moderate end of the DISCRERN Criteria scale.

Conclusions: The vast majority of articles regarding BPH supplements on social media come from Facebook and most score in the low-middle range for accuracy and utilization of scientifically proven data. Urologists should engage patients through Facebook in order to improve reliability and quality available within social media.


Poster Session 4 Impact of Botulinum Toxin-A  Add on Pentosan Polysulfate Sodium in Management of Refractory Interstitial Cystitis/Bladder Pain Syndrome

Mohamed Rasheed Professor1, Mohamed Bendary Professor1, Mahmoud Damhougy M.D.2, Mohamed Radwan M.D.3, Salah Nagla M.D.4
1Urology department, Tanta university hospital, Tanta, Gharbeya, Egypt. 2Urology department, Tanta insurance hospital, Tanta, Gharbeya, Egypt. 3Urology department, Tanta university hospital, Tanta, Gharbey, Egypt. 4Urology department, Tanta university hospital, Tabta, Gharbeya, Egypt

Abstract

Objectives:

  Pentosan Polysulfate Sodium (PPS) is the only oral medicine FDA approved for treating pain and discomfort of interstitial cystitisOn the other hand, Botulinum Toxin-A(BTX-A) has fast outcomes in controlling pain symptoms and treating bladder ulcers for patients with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS). The aim of the present study is to evaluate the combination of botulinum toxin-A and oral pentosan polysulfate sodium in the management of interstitial cystitis/bladder pain syndrome.

 

Patients and Method

 Twenty six women with IC/BPS according to the European Society for the Study of Interstitial Cystitis (ESSIC) were enrolled in the current study. Following ethical consent, the cases were divided into two groups 13 cases each. Group (I) women were subjected to single intra-vesical injection of 200 mg BTX-A plus oral 100 mg PPS three times daily for 6 months. While, group (II) cases only received oral 100 mg PPS three times daily for 6 months.

 All cases to fill in the following questionnaires before treatment and at the 3rd and 6th month of treatment. These include, voiding diaries, pelvic pain on visual analogue scale (0-10 VAS), International Cystitis Symptom Index and Problem Index (ICSI & ICPI), as well as, Patient Health Questionnaire-9 (PHQ-9).

 

Results

There is significant Improvement of pelvic pain,  improvement of International Cystitis Symptom Index and Problem Index (ICSI & ICPI), as well as, Patient Health Questionnaire-9 (PHQ-9) in both groups after 3 and 6 months treatment. There was significant lower pain criteria (VAS) among group (I) women (BTX-A + PPS) than group (II) cases (PPS alone) at 3 (p=0.041) and 6 months (p=0.022). Moreover, we reported highly significant improvement of patients quality of life (better PHQ-9) for group (I) women compared to group (II) at 3 (p=0.014) and 6 months (p=0.0005)

 

Conclusion 

Combination of botulinum toxin-A injection with oral pentosan polysulfate sodium in the treatment of refractory interstitial cystitis/bladder pain syndrome seems to give significantly faster, higher and satisfactory pelvic pain relief and significant improvement of quality of life.


Poster Session 4 Outpatient Analgesia Utilization After Implementation of a Standardized Pathway for Gender Affirming Vaginoplasty and Vulvoplasty

Jasper C Bash MD, Chandler Barton MS, Jason Weiss MD, Dorian Scull PA, Daniel D Dugi MD, Geolani Dy MD, Solange Bassale MS, Yiyi Chen PhD, Jyoti Chouhan PharmD, DO
OHSU, Portland, OR, USA

Abstract

Introduction: No significant data exists on outpatient pain management after gender affirming vaginoplasty (GAVa) and vulvoplasty (GAVu). With creation of a neovagina in GAVa and extensive external genital rearrangement in both, significant post-operative pain and opioid use would not be unexpected. We aimed to characterize our patients’ analgesic use and efficacy after implementation of a standardized discharge pathway.

Methods: An IRB-approved analysis was conducted on consecutive patients who underwent GAVa or GAVu by two surgeons from June 2020 to January 2021. Those on chronic narcotics (daily narcotic for ≥ 45 days pre-operatively) were excluded. Tables 1 shows the discharge pathway. Written and verbal post-operative pain management instructions were provided pre-operatively. Patients were evaluated at their first postoperative clinic visit with a surgery-specific survey and the validated Brief Pain Inventory short form.

Results: Of the 13 GAVa and 6 GAVu patients, surveys were available for 8 and 6 of them respectively. 9 GAVa were robotic. Median age 36 (range 19-79, IQR 30-48). 30% of GAVa (n=4) and 50% of GAVu patients (n=3) did not use any post-operative oxycodone. A higher percentage of GAVu patients used acetaminophen (APAP), ibuprofen, and ice packs versus GAVa patients. On the other hand, GAVa patients used oxycodone and lidocaine patches more often. GAVa patients most frequently cited oxycodone as the most effective pain management modality whereas APAP was most frequently cited for GAVu patients. 26% reported using non-pathway cannabinoids for analgesia management. Worst pain in last 24 hours was median 5 out of 10, least pain 2.5, and analgesia provided 50-80% pain relief.

Conclusions: Our data show that GAVa and GAVu patients successfully utilize a multimodal strategy for pain control with a subset of patients requiring no post-discharge narcotics. Lidocaine patch utilization was low and some patients are using alternative therapies.

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If funding provided, type in source company / entity name(s):

Oregon Health & Science University

Poster Session 4 Evaluating the Changes to Serum Estradiol and Testosterone Levels After Oophorectomy in Transmasculine Patients

Sahil Kumar M.Sc1, Elise Bertin B.Sc.2, Cormac O'Dwyer B.A.1, Amir Khorrami B.Sc.1, Richard Wassersug Ph.D.2, Smita Mukherjee Ph.D.2, Marshall Dahl MD FRCPC, Ph.D.3, Krista Genoway MD FRCSC4, Alexander G. Kavanagh MD FRCSC5
1Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada. 2Gender Surgery Program, Vancouver Coastal Health, Vancouver, BC, Canada. 3Division of Endocrinology, Department of Medicine, University of British Columbia, Vancouver, BC, Canada. 4Division of Plastic & Reconstructive Surgery, University of British Columbia, Vancouver, BC, Canada. 5Department of Urologic Sciences, University of British Columbia, Vancouver, BC, Canada

Abstract

Introduction: Following testosterone (T) therapy initiation, transmasculine (TM) patients experience clitoral virilization and lengthening, which facilitates neophallus reconstruction in lower gender-affirming surgeries (GAS; i.e., metoidioplasty or phalloplasty). The ovaries play a major role in the aromatization of T to estradiol (E2). These hormones can act through androgen receptors or estrogen receptors, which are present within clitorophallus tissues. Without good predictors for clitoral growth outcomes or effective salvage therapies in instances of inadequate lengthening, it is important to understand how sex hormone levels change with respect to gonadectomy. Our primary objective is to evaluate the changes to serum T and E2 levels in TM patients before and after bilateral oophorectomy.


Methods: We performed a retrospective chart review of TM patients on T therapy at a single endocrine clinic between 2012 and 2020. Patients who underwent bilateral oophorectomy and had pre-surgical and post-surgical serum data collected were included. We identified matched-control subjects, who were on T therapy and did not undergo oophorectomy during the study period. Each control subject was matched to a case subject by age, an equivalent T dosing regimen, and calculated BMI.


Results: A total of 12 individuals who underwent oophorectomy met the inclusion criteria. There was a statistically significant decrease in the mean E2 levels of case subjects after oophorectomy, when compared to pre-surgical E2 levels (p = 0.02). There was no significant difference between baseline E2 levels between control and case subjects (p = 0.54); however, the difference in E2 levels at follow-up measurements was significant (133.6 ± 17.5 pmol/L vs. 290.1 ± 68.4 pmol/L, p = 0.03). The mean total T levels were not different between case and control subjects at baseline and follow-up.


Conclusions: These results demonstrate that E2 levels in TM patients decreased after oophorectomy. No significant change to E2 was seen in the matched-controls who did not undergo oophorectomy. Thus, oophorectomy may play a significant role in the regulation of E2, despite exogenous T supplementation. These results would warrant further research into the contribution of endocrine hormones to virilization outcomes valuable for lower GAS.

If funding provided, type in source company / entity name(s):

University Of British Columbia

Poster Session 4 Metoidioplasty Patients’ Attitudes toward Using PDE5 inhibitors and Intracavernosal Injections as Erectile Aids

Amir Khorrami MD, Elise Bertin MSC, Sahil Kumar MD, Richard Wassersug PhD, Alexander G Kavanagh MD
UBC, Vancouver, BC, Canada

Abstract

Introduction: Following metoidioplasty, transmasculine patients experience various sexual function challenges. These include difficulties getting sexually aroused, achieving erections and orgasms, and fear of sexual contacts. There are currently no standard treatments offered for these challenges. Phosphodiesterase 5 inhibitors (PDE5is) and intracavernosal injections (ICIs) are used for treatment of erectile dysfunction in cismen. Our objectives are to assess how important erections, orgasms and penetrative intercourse are to metoidioplasty patients. Moreover, we aim to evaluate sexual dysfunction, and to explore the attitudes and experiences of patients toward using PDE5 inhibitors and ICIs as potential erectile aids.

 

Methods: We created an electronic survey consisting of self-constructed questionnaires and the validated Erection Hardness Scale (EHS). All patients who had undergone metoidioplasty at the Gender Surgery Program in Vancouver, British Columbia were recruited. Data were analyzed via t-test and one-way ANOVA.(α = 0.05).  

 

Results: Fourteen patients completed the survey. The average participant was a 35 year old Caucasian transmasculine/male who had undergone metoidioplasty in the past 2 years. The abilities to orgasm and to achieve/maintain erections were ranked significantly more important than penetrative intercourse (p<.001, p=0.012 respectively). The proportion of participants facing challenges with orgasm (36%) was statistically lower than those facing challenges with penetrative intercourse (93%) and erectile function (86%) respectively (p=0.003, p=0.015). On the EHS, 12% of the participants gave their erections a score of 0, 41% a score of 1, 41% a score of 2, and 6% gave it a score of 3. Forty-three percent of the participants had previously tried PDE5Is, but none had used ICIs. Further, 86% and 36% were willing to use PDE5Is and ICIs respectively to improve their erectile function. 

 

Conclusions: These results demonstrate that the ability to orgasm and achieve/maintain erections are more important than penetrative intercourse among metoidioplasty patients. Furthermore, most  patients are facing challenges with penetrative intercourse and their erectile function, while orgasmic function is mostly preserved. While no participants reported achieving a fully rigid erection, the erectile function is partially present post-metoidioplasty. Lastly, metoidioplasty patients are willing to try PDE5is, with the main goal of achieving a better erection.

If funding provided, type in source company / entity name(s):

None

Poster Session 4 A Methodologic and Systematic Approach for Women with Sexual Pain Disorders

Maria Uloko MD, Irwin Goldstein MD
San Diego Sexual Medicine, San Diego, Ca, USA

Abstract

Introduction: There has been an increased interest in urology in the management of female sexual pain disorders.  Sexual pain disorders may result from multiple pathophysiology’s such as dermatologic disorders, inflammatory disorders, high tone pelvic floor disorders, hormonal disorders, clitorodynia, neuroprolifierative vestibulodynia, endometriosis, pudendal neuropathy, cauda equina pathology, etc.  Although  common, It is still misunderstood and under-treated due to a lack of understanding of the vulvar-vestibule-vaginal physical exam including clitoral and vestibular anesthesia testing.

Method: We present our systematic approach to the vulvar-vestibule-vaginal physical exam.  

Results: It is advantageous for providers/patients to visualize their anatomy with a magnified view via vulvoscopy with photography. First, a systematic of the vulva is performed by inspecting the external genitalia, perineum, perianal areas and the mons pubis evaluating for signs of infection, trauma, atrophy, fissures and dermatological changes. The interlabial sulcus is inspected looking for any signs of infection or dermatologic changes. The labia minora is examined assessing labial length, symmetry and resorption which is suggestive of hormonal deficiencies. The glans of the clitoris is examined by reducing the foreskin to assess for clitoral adhesions, size, pain or hypersensitivity. Next, the vestibule is assessed by spreading the labia minora to assess for hyperemia or erythema, and periurethral and peri-vaginal glands with a cotton swab test by palpating the vestibule in 8 anatomical sites in a clock face. A speculum exam with vaginal pH and wet mount are subsequently performed to assess for vaginal pathology.   A digital internal exam is performed for pelvic floor muscle tone.  Clitoral/vestibular anesthesia testing using topical benzocaine-lidocaine-tetracaine (BLT) is performed as indicated based on tenderness.  Significant symptom reduction implies end organ pathology while persistent symptoms implies upstream pathology.

Conclusion: A systematic multidisciplinary approach to the physical exam is key to diagnosis and subsequent treatment of sexual pain disorders in women.  We will present our management paradigm that has successfully treated more than 500 women with distressing sexual pain.


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If funding provided, type in source company / entity name(s):

San Diego Sexual Medicine

Poster Session 4 Advanced Diagnosis using DNA Next-Generation Sequencing for Patients with Complicated Recurrent UTI and Negative Urine Culture Results, A Retrospective Breakdown

Christopher Pulford DO1, Roscoe Nelson MD2
1Creighton Univeristy - Arizona Health Education Alliance, Phoenix, AZ, USA. 2Arizona Urology Specialists, Glendale, AZ, USA

Abstract

Introduction:

 

Urinary tract infections (UTIs) account for over 8 million visits to health care providers every year, leading more than $2 billion spent in health-care costs.1-3 DNA Next generation sequencing (NGS) sequences all microbial and fungal DNA present in a urine sample and the presence of antibiotic resistance genes, helping tailor the treatment for patients with recurrent UTIs (rUTI).1, 4

 

Materials & Methods:

 

The data expands from August 2015 to September 2019. 101 patients met the inclusion criteria of rUTI and samples sent for quantitative real-time polymerase chain reaction (qPCR) and NGS by MicrogenDx. Microscopic analysis and culture and sensitivity was performed on each patient. A PivotTable was generated using Microsoft Excel for incidence breakdown of bacteria. Due to the high sensitivity of the NGS test1, we chose results with >10% DNA present of each bacteria.

 

Results:

 

The ten most reported microbes were Escherichia coli, Enterococcus faecalis, Staphylococcus epidermidis, Klebsiella pneumoniae, Lactobacillus iners, Lactobacillus crispatus, Streptococcus mitis, Streptococcus agalactiae, Staphylococcus haemolyticus, and Pseudomonas aeruginosa. The five most reported polymicrobial combinations and fraction of patients with high bacterial qPCR load were Enterococcus faecalis & Escherichia coli (15/18), Escherichia coli & Klebsiella pneumoniae (13/29), Escherichia coli & Lactobacillus iners (4/18), Enterococcus faecalis & Lactobacillus crispatus (3/12), and Lactobacillus crispatus & Lactobacillus iners (0/13). Eighty eight percent of patients with polymicrobial qPCR had greater than three microbes in their qPCR results. Eleven patients with polymicrobial results had high bacterial load on qPCR with no growth on culture and sensitivity. Only three patients with high bacterial load had culture and sensitivity that matched the microbes in the qPCR. Thirty-six patients with polymicrobial results had more than one resistance gene found on analysis.

 

Conclusions:

In our single practice, we have employed the use of DNA NGS testing in many with complicated UTIs. DNA NGS accurately detects bacteria that do not grow on standard C&S as well as detect low levels of bacteria in patients that have significant UTI Symptom Assessment Questionnaire scores.4 Furthermore, the importance of identifying patients with polymicrobial colonization with proper treatment leads to definitive resolution of symptoms in most patients.



Poster Session 4 COVID-19 vaccine hesitancy linked to increased internet search queries for side effects on fertility potential in the initial rollout phase following Pfizer Emergency Use Authorization

Parris Diaz BS1, Pritika Reddy BS2, Reshna Ramasahayam BS2, Manish Kuchakulla MD2, Rohit Reddy B.S.2, Ranjith Ramasamy MD2
1David Geffen School of Medicine at UCLA/Charles R. Drew University of Medicine and Science, Los Angeles, CA, USA. 2University of Miami Miller School of Medicine, Miami, FL, USA

Abstract

Objectives: The emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine on December 11, 2020 has been met with hesitancy for uptake. Specifically, major concern has been demonstrated regarding vaccine side effects on future fertility potential.  We hypothesized that fertility-related queries would markedly increase during the 48 days following EUA of the coronavirus vaccine. We sought to objectively identify trends in internet search queries on public concerns regarding COVID-19 vaccine side effects on fertility that might impact vaccine uptake. 

 

Methods: We used Google Trends to investigate queries in Google’s Search Engine relating to the coronavirus vaccine and fertility between 10/24/2020 – 1/27/2021. Interest over time for a given keyword was reported as Search Volume Index(SVI) calculated as proportion of keyword searches divided by all searches in a given location and time period. SVI may range from 0-100, with 100 representing the maximum search interest at that time and location selected for a given keyword. SVI and geographical trends in Domestic U.S. and abroad were provided and analyzed via paired T-Test on Microsoft Excel to evaluate whether mean search volume has changed with the arrival of the coronavirus vaccine. 

 

Results: Internet search inquiries related to coronavirus vaccine and fertility significant increased following December 11, 2020 for each key word. The five most queried terms were identified as: ‘COVID Vaccine Fertility’, ‘COVID Vaccine and Infertility’, ‘COVID Vaccine Infertility’, ‘COVID Vaccine Fertility CDC’, and ‘COVID 19 Vaccine Infertility‘ with an increase of 710.471%, 207.56%, 264.35%, 2,943.7%, and 529.26% in search queries following the Pfizer EUA, respectively (all P < .001).

 

Conclusion: This study indicates that there was an increase in online COVID-19 vaccine-related queries regarding fertility side effects coinciding with the emergency use authorization (EUA) of the Pfizer vaccine on December 11, 2020. Our results objectively evidence the increased concern regarding the vaccine and likely demonstrate a major cause for hesitancy in vaccine uptake. Future studies and counseling with patients should be undertaken to help mitigate these concerns.