More than 2000 posters, abstracts, and videos were presented at the 2019 American Urological Association (AUA) Annual Meeting, held in Chicago, IL, from May 3 to 6, 2019. The editors of Reviews in Urology have culled an enormous volume of information from this premier source and present the findings that are most relevant to the practicing urologist.
Dr. Ananias Diokno, at a late-breaking abstract plenary session on Sunday, May 5, 2019, presented exciting interim data on a novel treatment for patients with underactive bladder (UAB).1 UAB affects >15% of the population yet the only consensus treatment is catheterization. This was the first regulatory-approved clinical trial of a 2-year, prospective, open-label study assessing the safety and efficacy of intradetrusor injected autologous muscle-derived cells (AMDC) treatment for UAB (NCT02463448).
Underactive bladder is a common problem with great unmet medical needs. Detrusor underactivity and increased post-void residual volume (PVR) are associated with aging. It has been previously reported that between 11% and 22% of men and women over age 60 years in the community had difficulties with bladder emptying, whereas 66% of incontinent institutionalized elderly have detrusor underactivity (often to impaired contractility).
Twenty non-neurogenic UAB patients were treated and 15 had at least a 1-month visit. Baseline evaluation included history, physical examination, voiding diary, multi-channel urodynamic testing, and endoscopy to confirm no obstruction. Key inclusions included difficult bladder emptying symptoms, Underactive Bladder Questionnaire Score of 3+ or being on total clean intermittent catheterization (CIC), unresponsive to therapy, PVR of 150 mL or more, and no evidence of obstruction. Key exclusions included neurological impairment, pelvic organ cancers, pelvic radiation therapy, and being on medications affecting the bladder.
Approximately 150 mg of quadriceps femoris muscle was collected using a spirotome 8-ga needle, sent to Cook MyoSite (Pittsburgh, PA) for processing, and, upon reaching a final concentration of 62.5 million AMDC/mL, the patient received 30 intradetrusor injections of 0.5 mL delivered to the bladder, for a total of 15 mL. The procedure was performed utilizing a flexible cystoscope under direct vision using topical local anesthesia. Follow-up assessments included adverse events and efficacy at 1, 3, 6, and 12 months post-injection. Optional second injection was offered at the end of the 6-month visit.
The study enrolled 20 patients, 15 men and 5 women. Ages ranged from 41 to 82 years with a median of 65 years. Etiology included 7 men with benign prostatic hyperplasia (BPH) post–transurethral resection of the prostate (TURP) and 7 women and men with idiopathic UAB. AMDC were injected once in 15 patients and injected twice in 12 patients. Bladder function at baseline included clean intermittent catheterization (CIC) only in 7 patients, voiding only in 1 patient, and mixed CIC/voiding in 7 patients.
To date, results on 15 patients, based on participants’ report collaborated by voiding diary, showed a gradual increase in the number of responders with regards to bladder function responsiveness over time, 27%, 31%, 58%, and 80% at 1-, 3-, 6-, and 12-month follow-up visit, respectively. No serious procedure- or treatment-related adverse events (AEs) occurred. No AEs related to AMDC product were reported. All biopsy and injection-related AEs were expected complications, and either self-resolved or were easily treated.
Dr. Diokno concluded that interim analysis up to 18 months revealed encouraging improvement in bladder function and safety with intradetrusor AMDC for UAB. Cellular therapy may be a promising novel treatment for underactive bladder and a multi-center, controlled trial is needed.
[Michael B. Chancellor, MD]
Dr. Chancellor, a William Beaumont Hospital Urologist working on this study, was one of the inventors of this stem cell process. Dr. Chancellor receives royalty payments for the stem cell process and payments for consulting from Cook-Myosite, the sponsor of the study.
There were several fine presentations regarding the pathophysiology, epidemiology, evaluation, prevention, and treatment of patients with kidney stones at the 2019 AUA meeting.
Calcium oxalate kidney stone formation is due to a complex set of events that are still being defined. The presence of oxalate in urine is a prerequisite. The non-enzymatic breakdown of vitamin C contributes to the urinary oxalate pool. Liu and associates2 demonstrated in a murine model that the androgen receptor (AR) augments oxalate excretion and increased oxidative stress because of accumulating calcium oxalate crystals. Another group, Zhu and colleagues,3 demonstrated in a murine model of hyperoxaluria that when AR is selectively knocked out in renal tubular cells M2 macrophage (anti-inflammatory) recruitment is stimulated and renal interstitial calcium oxalate crystal deposition is reduced. This is thought to be due to increased macrophage crystal clearance. The composition of the fecal microbiome is thought to influence kidney stone formation. Wang and associates4 reported that the fecal microbiome of single time and recurrent kidney stones differs from non-stone formers. They found that at the genus level the abundance of bacterial species producing short chain fatty acids (SCFAS) was significantly lower in stone formers. A potential link to the development of stones is that one of these SCFAS, butyrate, augments the integrity of the bowel mucosal surface, which could impact transport of chemicals, involved in kidney stone formation. Urinary oxalate excretion is increased in obese patients. The reasons for this have previously not been defined clearly. Boyd and colleagues5 reported the results of a carefully performed metabolic study in humans that endogenous oxalate synthesis appears to be enhanced in obesity. Insulin resistance is increased in obesity and this could be playing a role in the relationship. Ando and associates6 demonstrated in a prospective cohort trial that insulin resistance was significantly associated with the risk of developing a kidney stone in men but not in women.
The prevalence of kidney stones has been increasing in the United States and other countries. There is a paucity of data on kidney stone incidence. Tundo and associates7 used the Medical Expenditure Panel Survey to estimate stone incidence in the United States in 2005 and 2015. It was 0.6% in 2005 increasing to 0.9% in 2015 (P < 0.01). There was no change in gender representation and the majority of those afflicted resided in southern states in both years.
CT remains the most commonly utilized imaging study to evaluate patients with suspected renal colic. Although there has been a push to use ultrasonography as the initial study in the emergency room (ER) environment to limit radiation exposure, its adaptation has been quite slow. Bowen and colleagues8 reported that in South Carolina (1996-2017) even in patients who had prior CT imaging in an ER for a stone event nearly all underwent another CT during subsequent visits (90% for same ER, 93.9% for different ER). There is no question that most patients in the latter groups could be evaluated with initial renal ultrasonography at the time of subsequent ER visits.
A reduction in urinary oxalate excretion could reduce the risk of developing further kidney stone formation. Quintero and associates9 performed a prospective, randomized, double-blind crossover study in normal patients to assess the ability of an orally administered oxalate decarboxylase agent to reduce urinary oxalate excretion. Patients were on a controlled high oxalate, low calcium diet. There was approximately a 25% reduction in urinary oxalate excretion when oxalate decarboxylase was administered. Type 1 primary hyperoxaluria (PH1) is a rare monogenic disorder associated with excessive urinary oxalate excretion, stone formation, and a significant risk of developing end-stage renal disease (ESRD). Most of the latter are treated with combined renal/hepatic transplantation. Fishberg and colleagues10 presented results of a phase 1/2 randomized multicenter trial of the administration of lumasiran to patients with PH1 and an estimated glomerular filtration rate (eGFR) > 45 mL/min/1.73 m2. This is an siRNA to glycolate oxidase (GO) that is targeted to the liver, the primary site of endogenous oxalate synthesis. GO is the enzyme that catalyzes the conversion of glycolate to glyoxylate, the immediate precursor to oxalate. The agent was administered subcutaneously either at a dose of 1 mg/kg for 3 monthly doses or 3 mg/kg at quarterly intervals. The mean maximum reduction in urinary oxalate excretion was 75%. This agent and others in the pipeline could revolutionize the treatment of PH1.
Many studies have utilized patient reported outcomes regarding passage of ureteral stones. McClarty and associates11 compared radiographic evidence of stone passage with patients’ perception of stone passage or resolution of pain. Only 77.7% of those who believed that they passed the stone had radiographic evidence of stone passage. Similarly, 79.7% who had cessation of pain were demonstrated to pass their stones on imaging. These findings have an impact of future study design, and clinical practice.
Kidney stone patients perhaps compose most urologic patients impacted by the opioid crisis. Shoag and colleagues12 performed an analysis of date from the National Health and Nutrition Examination Survey (NHANES). Current opioid use was significantly greater among those who had a kidney stone, 10.9% versus 6.1%. Opioid utilization was higher amongst those with recurrent stones. Vollstedt and associates13 queried the Medical Expenditure Panel Survey (2005-2015) to determine repeated and prolonged opioid use in kidney stone formers. Amongst stone formers receiving an initial opioid prescription, 50.1% got another within 6 months. In addition, 20% of those receiving an opioid prescription were administered such prescriptions 1 year later. Said and colleagues14 reported that amongst 50,249 opioid-naive patients (Truven Market Scan) who filled an opioid prescription in the perioperative period after a stone-removing procedure, 8.1% continued to do so 90 to 180 days after surgery. These highlighted studies clearly indicate that reducing opioid utilization amongst stone patients should be a major goal. Portis and associates15 reported on the utility of a structured educational program for ER physicians in their system to foster the utilization of acetaminophen and ketorolac for the management of renal colic. This resulted in an increase in the utilization of these agents for first-line therapy of renal colic from 35% to 51%.
There were several papers comparing the in vitro effectiveness of newer laser lithotripsy modalities. Chew and colleagues16 compared a super pulse thulium fiber laser (SPTF) to a 120W holmium laser. The SPTF had superior fragmentation and dusting efficiency. Chiron and associates17 reported that the SPTF had better fragmentation and dusting efficiency than a 30W holmium laser. Traxer and colleagues18 compared the SPTF and holmium/Moses laser (short- and long-pulse duration). Retropulsion was lower with the SPTF when comparing the holmium for all three modes (short pulse, long pulse, Moses). Stone ablation for the SPTF was superior to the holmium for all three modes. Although the SPTF appears to perform better in the lab, this does not always predict a clinical advantage/benefit.
This review demonstrates novel advancements in the understanding of mechanisms of stone formation, promising new treatments for stone prevention, and improvements in technology to facilitate stone removal. Thus, the overall field is accelerating, and this should result in improvement in patient care.
[Dean G. Assimos, MD]
Multiparametric magnetic resonance imaging (mpMRI) has become more widespread for prostate cancer diagnosis, a pattern supported by recent high-level evidence and guidelines statements.19-21 In light of this trend, researchers are investigating novel methods of utilizing mpMRI to enhance its prognostic value. At the 2019 AUA meeting in Chicago, there was a surge in abstracts featuring mpMRI in the diagnostic setting.
As with any diagnostic study, mpMRI for prostate cancer diagnosis has well-documented limitations including significant interobserver variability,22,23 a limited positive predictive value (PPV),24 and an imperfect negative predictive value (NPV).24 Much of the research at the AUA meeting that featured mpMRI was aimed at addressing these inadequacies with a recognition of the additive benefit of mpMRI when combined with other biomarkers, genomic tests, and clinicopathologic features.
Building off the work from the AUA 2018 meeting in San Francisco, many abstracts focused on combining mpMRI with serum biomarkers such as prostate-specific antigen (PSA) derivatives or the 4Kscore Test (OPKO Health, Inc, Elmwood Park, NJ) during initial diagnosis to find ways to reduce unnecessary biopsies.
When deciding which patients can safely avoid biopsy, much of the attention has focused on patients with a negative mpMRI. Although it remains a point of debate, a significant proportion of patients with a negative mpMRI harbor clinically significant prostate cancer (csPCa), defined as grade group (GG) ≥2. A systematic review and meta-analysis of 24 studies with 3903 patients cited a pooled negative predictive value (NPV) of 91.7%.25 Lauwers and colleagues, in a study of 297 patients with a negative mpMRI, found that prostate-specific antigen density (PSAD) was an independent predictor of csPCa and could be useful to decide who requires a biopsy.26 A similar study in patients with a negative mpMRI found an enhanced NPV of 96% for csPCa when using a PSAD cutoff of 0.1 ng/mL/cc compared with mpMRI alone, which had a NPV of 85%.27
Biomarkers may also help solve the diagnostic dilemma of whether to target Prostate Imaging Reporting and Data System (PI-RADS) 3 lesions. Wood and colleagues showed that using both PSAD and %free PSA yielded additive benefit to determine whether these lesions harbored csPCa.28 Impressively, no csPCa was detected when applying the cutoffs of <0.1 ng/mL/cc and 20%, respectively. Additionally, a separate multicenter study also recognized that PSAD was a significant predictor of csPCa in PI-RADS 3 lesions.29
Additive value was also identified when combining mpMRI and 4Kscore Test results at initial biopsy. Lubin and colleagues demonstrated that patients with a 4K score <20% and PI-RADS score <3 had a high NPV of 96% for csPCa.30 Although their numbers were small with only 138 patients, using their algorithm could avoid 67.3% of prostate biopsies while only missing 2.8% of csPCa.30 In another larger study of 407 men, using both 4Kscore Test results and mpMRI in combination achieved only a 92.2% NPV, similar to the NPV of using 4Kscore Test alone (92.1%).31 Although this could obviate the need for 41% of prostate biopsies, there would be a higher rate of missed csPCa (3.2%).
Although the benefits of mpMRI and traditional biomarkers used together have been well documented, the relationship between mpMRI and prostate cancer genomic studies is less understood.
The Decipher Prostate Cancer Test (GenomeDx Biosciences, San Diego, CA), when performed in patients with low and favorable intermediate-risk prostate cancer, showed no significant difference in median Decipher score with increasing PI-RADS scores32 Additionally, a high-risk Decipher score (≥0.45) was associated with a higher likelihood of Gleason grade (GG) 2 versus GG1 disease (75% vs 11.1%; P = 0.01) in patients with a PI-RADS 5 lesions. These findings suggest that Decipher scores are both prognostic for higher-grade disease and independent of PI-RADS scores, implying that Decipher could be combined with mpMRI or used in a clinical decision-making model. Purysko and colleagues, also using Decipher, presented data that seemingly contradicts these findings, demonstrating a positive correlation between increasing Decipher scores and increasing PI-RADS scores (r = 0.54).33 They also shed light on MRI-invisible lesions, which have significantly lower Decipher scores and lower rates of higher-grade pathology than MRI-visible lesions, providing evidence that MRI-invisible lesions are more likely lower-grade and genetically lower-risk prostate cancers.33
ConfirmMDx for Prostate Cancer (MDxHealth, Irvine, CA), a tissue DNA hypermethylation field effect assay that has a high NPV for prostate cancer, was also used with mpMRI in patients with prior negative biopsies. In a study of 113 patients with a negative biopsy and a negative ConfirmMDx result, 89.3% of patients also had a either a negative mpMRI or PI-RADS score <4. These results suggest that a negative ConfirmMDx result is strongly associated with both benign pathology and an absence of higher PI-RADS lesions.34 Additionally, Witthaus and colleagues investigated ConfirmMDx in patients with a PI-RADS ≥3 lesion and a prior negative targeted biopsy and found that DNA hypermethylation was more likely present outside the lesion region of interest (ROI) than within (31.8% vs 15.9%), suggesting that a systematic biopsy may be a more effective means of detecting prostate cancer in this population compared with re-targeting the ROI.35
As the role of mpMRI becomes more ubiquitous in the diagnosis of prostate cancer, more research will be dedicated to finding ways to enhance its prognostic value. Presentations at AUA 2019 underscored this effort to find the right combination of diagnostic testing, utilizing both traditional serum biomarkers and genomic studies, to overcome the limitations of mpMRI for prostate cancer diagnosis.
[Zeyad R. Schwen MD, Alan W. Partin MD, PhD]
The AUA and the Society of Pediatric Urology (SPU) held their joint annual meeting on May 3-5, 2019, in Chicago. The scientific program covered a wide range of topics including urinary tract infection (UTI), reflux, disorders of sexual development, hypospadias, testis, endourology, minimally invasive surgery (MIS), stone disease, imaging, tumors, testis, and transplant. In addition, there were debates on the best approach to bladder exstrophy (John P. Gearhart [staged] and Pramod Reddy [complete primary]) and the best surgical approach to hypospadias (Warren Snodgrass and Mark Zaontz). A very timely update from the Differences of Sex Development (DSD) Task Force was presented by Dr. Lane Palmer and there were continued sessions on congenitalism by Rosalia Misseri.
Two lectures were especially meaningful and memorable. The Meredith Campbell Lecture was delivered by Dr. Alberto Pena and was entitled “Anorectal Malformations: Reflections of a Career of Innovation and Collaboration.” This was truly an inspiring presentation. The second outstanding lecture was the Society for Pediatric Urology Lecture by Dr. N. Scott Adzick that highlighted his illustrious career in fetal intervention—past, present, and future.
The Sunday Pediatric Urology Plenaries are always excellent, well-prepared presentations by well-respected colleagues. The surgical approach to ureteral reimplantation was debated and the open (Linda Baker and Gil Rushton) versus robotic approach (Richard Yu and Mohan Gundeti) appeared to be best. An unusual pediatric plenary on stones entitled “Tips and Tricks: A 7-year-old Male with a 9-mm Lower Pole Stone” was also discussed.
Dr. Stuart Bauer presented the John Duckett Memorial Lecture entitled “The Neurogenic Bladder: Where We Were, Where We Are, and Where We Are Going.”
This review focuses on the best of the clinical research abstracts and other clinical abstracts of interest to the practicing urologist. All abstracts can be viewed at http://spuonline.org/abstracts/2019.
Randomized Blinded Placebo Controlled Trial of Continuous Antibiotic Prophylaxis for Febrile UTIs In Infants With Prenatal Hydronephrosis: The Alpha Study. It has been the practice of most pediatricians that infants with prenatally diagnosed hydronephrosis who do not have reflux do not need continuous antibiotic prophylaxis (CAP) instituted or continued following a negative study. This very important study from Hospital for Sick Children examines whether CAP versus placebo affect the incidence if febrile urinary tract infection (fUTI) in prenatal hydronephrosis (PHN) within the first 18 months of life.36
The study involved 146 infants ages 0 to 7 months with pre- and postnatal HN (Society for Fetal Urology [SFU] grade III/IV HN with/without ureteral dilation >7 mm) and no vesicoureteral reflux (VUR) on voiding cystourethrogram (VCUG) in A superiority, parallel, randomized, blinded, placebo-controlled trial using trimethoprim (TMP) or placebo. A catheter specimen for fUTIs and bacterial resistance patterns were assessed. Renal sonograms were performed quarterly for 1 year. fUTI developed in 6% (9/146), 8 in the placebo arm versus 1 (TMP-resistant bacteria) in CAP TMP arm (11% vs 1.4%; P = 0.03). Of note, 8 of the fUTIs were in an uncircumcised boy and 1 occurred in a girl. In addition, hydroureteronephrosis in primary obstructed megaureter had a significantly higher fUTI rate compared with those with hydronephrosis (UPJ) alone (14% vs 3%; P = 0.02). In all, 21 infants had UTIs treated and multi-drug resistance was noted in 42% receiving placebo versus 22% of those on TMP (P = 0.3). Infants receiving placebo were 10 times more likely to develop a fUTI than those on TMP CAP. This study suggests that CAP will benefit uncircumcised boys with high-grade PHN and those with primary obstructed megaureters for the first 6 months of life due to their higher risk of fUTI.
One of the many important institutional reviews from Children’s Hospital of Philadelphia (CHOP) at this meeting examined duration of follow-up in complication detection after pediatric hypospadias repair. Many patients who undergo hypospadias are seen at intervals during the first 6 months and follow-up is often suggested to parents after potty training. It is unusual for patients to be followed beyond the 6-month interval. The surgeon assumes they are doing well. The investigators at CHOP hypothesize that surgical complications occur much beyond the first 12 months after surgery and are not being detected.37 The CHOP investigators examined primary repairs over almost two decades (2000-2018). Complications were defined by additional surgical procedures. Of the 1290 patients that were included (981 distal [dHR], 68.9%; 64 mid-shaft [mHR], 4.9%; and 245 proximal [pHR], 18.8%), the complication rates were 10.8%, 18.8%, and 54.3% (P < 0.0001) for dHR, mHR, and pHR, respectively, with 47.2%, 100%, and 42.9% of dHR, mHR, and pHR, respectively, presenting within 12 months of surgery. Surprisingly and unfortunately, 8% of complications in distal and proximal hypospadias repairs occur 5 years after surgery.
The authors concluded that complications 3 years postoperatively, usually at the time of potty training, are found in 26% of dHR and 18% of pHR repairs. Follow-up beyond the first 5 years postoperatively shows complications in an additional 8% of these difficult surgical patients.
A study by Koepsell and the investigators at CHOP examined the unique composition and gene products of the gut microbiome of children and adolescents with calcium oxalate kidney stones.38 The study included 88 patients, ages 4 to 18 years, half of whom had calcium stones with >50% oxalate and half who were age-, sex-, and race-matched controls. Bacterial taxa and gene products of the microbiome of stool samples were determined using shotgun metagenomic sequencing.
Less gut microbiome diversity was found in kidney stone formers, especially those ages 9 to 14 years, than in the control group. The authors identified 60 bacterial taxa that produce butyrate, a short-chain fatty acid and found them to be less abundant among the case group compared with the control group, including Ruminococcus, Oscillibacter, and Roseburia (1% of all bacteria present in the microbiome). In addition, bacterial genes for butyrl-coA dehydrogenase, a key enzyme in the butyrate production pathway, were found to be less abundant in stone formers than in the control group. This study is the first to show that absence of butyrate-producing bacteria that degrade oxalates that act synergistically to increase intestinal absorption and urinary excretion of oxalate, may have a key role in calcium oxalate stone formation.
[Ellen Shapiro, MD, FACS, FAAP]
The 2019 AUA meeting delivered several fascinating presentations related to female urology/incontinence and urodynamics. Over 100 abstracts were included, multiple courses focusing on bladder neck management and incontinence, as well as updates to the overactive bladder guideline and a new guideline on recurrent uncomplicated urinary tract infections in women. Attendance and interest in functional urology, female pelvic medicine and reconstructive surgery (FPMRS), incontinence, and urodynamics was extremely high.
Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU) held a half-day meeting on May 3, 2019; the central theme was lower urinary tract symptoms (LUTS) in women. The SUFU meeting was put together by Arthur Mourtinos and Polina Reyblat. Some of the highlights included an update to the Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium by Dr. Elizabeth Mueller and Symptoms of Lower Urinary Tract Dysfunction Research Network by Dr. Anne Cameron. An important panel discussion about bladder neck obstruction in women was led by Dr. Benjamin Brucker. He started the panel discussion by defining female bladder neck obstruction and put it into clinical context. The next panelist, Dr. Doreen Chung, reviewed strategies to diagnose this rare condition and Dr. Lara MacLachlan introduced nonsurgical treatment options. Finally, surgical management was reviewed by Dr. Priya Padmanabhan, and there was then a lively discussion surrounding two case presentations. Another exciting case discussion, led by Dr. Kathleen Kobashi, was of 55-year-old woman with moderate cystocele and persistent LUTS after a mid-urethral sling placement. In addition, Dr. Alvaro Lucioni gave a timely talk discussing the current state of vaginal mesh on the heels of the April 16, 2019 US Food and Drug Administration (FDA) announcement ceasing distribution of transvaginal mesh for prolapse. The FDA distinguishes transvaginal mesh for pelvic organ prolapse repair from that used for sacrocolpopexy and slings. The FDA will reconsider this decision once 36-month follow-up data becomes available.
Considering the new uncomplicated recurrent UTI guideline released by the AUA, the SUFU meeting also included a moderated discussion on recurrent UTIs entitled, “Another UTI? What Do Experts Say?” moderated by Dr. Toby Chai. The attendees were active during the session, asking questions and sharing experiences, demonstrating that clinicians have different points of view on this topic and the importance of this new guideline.
Dr. Jennifer Anger presented highlights of the new recurrent UTI guideline. In addition to methodology for the diagnosis and treatment of uncomplicated recurrent UTIs, the presentation highlighted the need for antibiotic stewardship and the importance of urine cultures. In addition, the AUA makes a clear recommendation that asymptomatic bacteriuria should not be treated.
In addition, a new update to the overactive bladder (OAB) guideline crafted by AUA and SUFU was highlighted by Dr. Sandip Vasavada. This update comes after a 2018 literature review that determined numerous studies demonstrated improved efficacy of combination therapy of antimuscarinics with beta-3 agonists for patients that are refractory to monotherapy of either medication. In addition, what was previously called “Additional Treatments” was renamed “Fourth-Line Treatment,” which includes “augmentation cystoplasty or urinary diversion for severe, refractory, complicated OAB patients.”39
Exciting new data on a novel oral treatment of overactive bladder symptoms was presented by Dr. David Staskin.40 Dr. Staskin presented a late-breaking abstract discussing the EMPOWUR trial, which is a phase 3, double-blind, placebo- and active- (tolterodine) controlled study to determine the safety and efficacy of vibegron in patients with OAB symptoms. A total of 1518 patients were enrolled and randomized to vibegron, 75 mg; placebo; or extended-release tolterodine, 4 mg. Primary endpoints included average number of urge urinary incontinence (UUI) episodes daily in those with 1 or more episodes per day. Data analysis showed a statistically significant reduction (P < 0.0001) in UUI episodes and the number of voids per day (P < 0.001) on vibegron compared with placebo. In addition, only 8% of patients on vibegron had a treatment-emergent AEs compared with 10% of patients on tolterodine. These promising data demonstrate that vibegron is efficacious in improving OAB and is well tolerated with minimal AEs.
There continued to be interest in the management of mesh-related complications; one highlight was an abstract from Dr. Chughtai and colleagues.41 The abstract presented results from a systematic review of 100 articles evaluating a total of 177 patients to determine safety and efficacy of different outcomes of surgical excision techniques. They compared resolution of symptoms based on surgical approach. Abdominal and transvaginal approach to mesh removal appeared to be more successful than cystoscopic approaches. When the urethra is involved in the mesh erosion, their systematic review determined that the transvaginal approach was favored.
Another topic covered with interest at the annual meeting was bladder pain and interstitial cystitis. Here the MAPP Research Network presented data demonstrating predictors of female sexual dysfunction in those suffering from interstitial cystitis (IC)/bladder pain syndrome (BPS) and other chronic pain conditions.42 Dr. Rodriguez found that female sexual dysfunction (FSD) was higher in the IC/BPS (65%) group versus positive controls (35.7%) and healthy controls (14.7%) (P = 0.001). In addition, psychosocial factors such as depression, anxiety, personality traits, stress, and overall pain and urinary severity were associated with FSD in univariate analysis and continued to be associated after adjusting for age, spouse, ethnicity, number of genital sites with pain, and employment status. The authors concluded that FSD is impacted by various psychosocial risk factors and genital pain. They suggest the importance of targeting treatment of these modifiable risk factors may improve sexual function and quality of life in these patients.
Dr. Larissa Bresler and her colleagues presented data from a prospective, randomized, single-blind study comparing electro-acupuncture (EA) to minimal acupuncture (MA) in women with IC/BPS.43 Twenty-one patients were randomized to EA (n = 11) or MA (n = 10) for 6 weeks. Both groups showed statistically significant improvement in worst pain at end of treatment with a decrease of —2.91 ± 0.59 (P = 0.007) and —2.09 ± 0.68 (P < 0.001) for EA and MA, respectively, with no difference between the groups (P = 0.37). EA group had greater improvement in quality of life (pain interference) at the end of treatment, —3.28 ± 0.51 versus —21.67 ± 0.58 (P = 0.049). Ultimately, the authors found that EA had greater improvement in quality of life (pain interference) and pelvic floor muscle tenderness with continuing effects on pain scores at 12 weeks compared with MA.
The meeting also saw work presented by Dr. Laurent Wagner on the results of a multicenter randomized trial comparing robot-assisted sacrocolpopexy (RAS) to laparoscopic sacrocolpopexy (LS) for pelvic organ prolapse.44 Sixteen centers were included from July 2011 to October 2016. Primary objectives were to compare 30-day complication rates with secondary objectives including comparisons of technical data, anatomical correction, recurrence, incontinence, quality of life, and medico-economic data between arms, during 5 years follow-up. Three hundred and forty-five patients were randomly assigned (170 RAS, 175 LS). Twenty patients in the RAS group (11.76%) and 27 in the LS group (15.43%) had nonsurgical complications (P = 0.3213). Surgical complications occurred in 6 RAS patients (3.5%) and 16 LS patients (9.1%) (P = 0.04). Length of stay, anesthesia, and hospital stay were similar between groups. The authors concluded that RAS and LS had similar rates of perioperative complications and length of stay, but the RAS group had fewer surgical complications. They determine that less surgical complications, despite less experienced surgeons, might suggest that the robotic approach provides at least similar surgical outcomes with a shorter learning curve.
Finally, Dr. Christina Escobar and colleagues45 discussed whether urodynamic criteria can be used to predict outcomes for women with sling revisions for bladder outlet obstruction (BOO) and storage symptoms. The investigators conducted a retrospective chart review of all female patients with sling revisions between 2010 and 2018. Thirty-three patients who had revision of anti-incontinence procedures and videourodynamics were included in the study, 15.1% of whom had subjectively reported complete resolution of symptoms, 48.5% of whom reported improvement, 27.3% of whom were unchanged, and 9.1% of whom reported worsening symptoms. Five contemporary criteria for BOO in women were analyzed, but there was no significant evidence to support that one of these criteria outperformed the other in the ability to predict favorable outcomes in patients with clinical obstruction and storage symptoms. Its suggested that future studies are needed to determine and establish more objective predictors of favorable outcomes in this patient population.
[Benjamin M. Brucker, MD, Gregory Vurture, MS4]
Dr. Brucker serves as an advisor for Watkin-Conti Products, an investigator/speaker for Allergan, an investigator for Boston Scientific, and an advisor for Urogant.
Reviewed by Michael B. Chancellor, MD, Oakland University William Beaumont School of Medicine, Royal Oak, MI; Dean G. Assimos, MD, University of Alabama at Birmingham School of Medicine, Birmingham, AL; Zeyad R. Schwen, MD, Alan W. Partin, MD, PhD, Johns Hopkins Medical Institutions, Baltimore, MD; Ellen Shapiro, MD, FACS, FAAP, New York University School of Medicine, New York, NY; Benjamin M. Brucker, MD, Gregory Vurture, MS4, New York University School of Medicine, New York, NY.