Evaluation of clinical performance and safety for the rechargeable InterStim Micro device in overactive bladder subjects: 6-month results from the global postmarket ELITE study.

AIMS: Sacral neuromodulation (SNM) is an advanced therapy option for the treatment of overactive bladder (OAB), nonobstructive urinary retention, and fecal incontinence. The aim of this ongoing prospective, multicenter, global, postmarket study is to confirm safety and clinical performance of the InterStimTM Micro system for SNM in all indications. Reported here are the results for the OAB cohort through 6-month follow-up. METHODS: Eligible OAB subjects that had a successful therapy evaluation were enrolled after implant of an InterStim Micro implantable pulse generator (IPG). Subjects completed voiding diaries and the Overactive Bladder Quality of Life questionnaire (OAB-q) at baseline and follow-up visits occurring at 3 months and 6 months postimplant. Safety was evaluated as device-, procedure-, or therapy-related adverse events. The primary objective for the OAB cohort was to demonstrate an improvement in OAB-q Health Related Quality of Life (HRQL) total score at 3 months postimplant compared to baseline. RESULTS: Sixty-eight OAB subjects were enrolled and implanted with an InterStim Micro IPG. Of those, 67 and 66 subjects completed the 3- and 6-month follow-up visits, respectively. The OAB-q HRQL demonstrated a statistically significant improvement from baseline to 3-month follow-up with an average increase of 33 ± 24 points (n = 67, p < 0.001). The change was also observed at 6-months with an average increase of 31 ± 23 points (n = 65) compared to baseline. Eighty-two percent of subjects achieved the minimally important difference in HRQL score at 3- and 6-month, respectively, with a change of 10 points or greater. The majority of subjects reported that their bladder condition was better at 3-month (92.5%, 62/67) and 6-month (89%, 59/66) compared to before they were treated with SNM therapy delivered by the InterStim Micro system. For subjects with urgency urinary incontinence (UUI), the average change from baseline to follow-up in UUI episodes/day was -3.6 (95% CI: -4.7, -2.6; n = 62) at 3-month and -3.7 (95% CI: -4.7, -2.7; n = 61) at 6-month. Among subjects with urgency-frequency (UF), the average change from baseline to follow up in voids/day was -4.5 (95% CI: -6.3, -2.7; n = 52) at 3-months and -4.4 (95% CI: -6.0, -2.7; n = 52) at 6-month. The cumulative incidence of device-, procedure-, or therapy- related adverse events was 7.4% (5/68). Out of these five related adverse events, there was one serious adverse event (1.5%, implant site pain) at the time of database snapshot. CONCLUSIONS: These data confirm the safety and clinical performance of the InterStim Micro device for subjects with OAB by demonstrating a significant improvement in OAB-q HRQL score at 3-month. Similar improvements were observed at 6 months in addition to an incidence of adverse events that is comparable to previously reported rates for SNM.

Assessing comprehension of online information in the United States for third-line treatment of overactive bladder.

INTRODUCTION AND HYPOTHESIS: Overactive bladder (OAB) affects up to 43% of women. Treatment ranges from lifestyle modification to invasive therapies. Nearly 75% of patients report using the internet to gain health information creating a need for interpretable, online resources. This study is aimed at evaluating the readability of online resources for OAB treatment in the US population. METHODS: Google and Bing were queried regarding "sacral neuromodulation," "peripheral tibial nerve stimulation (PTNS)," and "bladder botox." The first 20 results from each search engine were assessed, representing over 90% of accessed search results. Websites were categorized as institutional/reference, commercial, nonprofit, or personal. The Gunning fog (GF), Simple Measure of Gobbledygook (SMOG), and Dale-Chall (DC) validated readability scores were used to assess results. RESULTS: Sacral neuromodulation yielded 27 eligible results. The associated mean readability scores correlated with levels of college senior (GF), high school junior (SMOG), and college level (DC). PTNS yielded 31 eligible results. The associated mean readability scores correlated with levels of college senior (GF), high school senior (SMOG), and college level (DC). Bladder botox yielded 17 eligible results. The associated mean readability scores correlated with levels of college sophomore (GF), high school junior (SMOG), and college level (DC). There was no difference between the therapies regarding readability. Sixty-one percent of websites were institutional/reference, 24% were commercial, 13% were nonprofit, and 2% were personal. CONCLUSIONS: High levels of reading comprehension are required by the general US population to understand OAB information obtained through the internet. These findings highlight a need for simplification of online resources pertaining to OAB.

Assessing the effectiveness of antimicrobial pouch use for infection prevention in sacral neuromodulation.

INTRODUCTION AND HYPOTHESIS: Sacral neuromodulation (SNM) is a commonly performed procedure for various conditions. Infection rates range as high as 10% and often require operative explantation with resultant increased cost and morbidity. Pouches impregnated with antibiotic have been utilized in cardiovascular procedures with decreasing infectious complications. TYRX is an antibiotic pouch utilizing minocycline and rifampin manufactured by Medtronic. The objective of this study is to investigate the utility of antimicrobial pouches for patients undergoing SNM. METHODS: We retrospectively analyzed our patients undergoing SNM using an antimicrobial pouch and compared them with a historic cohort. Additional variables of interest included post-operative infection, diagnosis of diabetes, weight, and revision case or virgin implant. RESULTS: A total of 170 cases were identified, ranging from March 2017 to November 2022. Overall infection rate was 2.9% with 0 in the antimicrobial pouch cohort (0%) versus 5 in the historic cohort (5.5%; p = 0.04). Groups were similar in terms of body habitus. The group receiving an antimicrobial pouch was noted to be older with a higher percentage of female patients. 85 patients received an antimicrobial pouch and 85 did not. Of the infections, 4 occurred in revision cases (6.9%) and 1 in a virgin implant (0.9%; p = 0.03). No difference was noted in infection rate with regard to a diagnosis of diabetes or body habitus. CONCLUSION: The use of antimicrobial pouches in SNM is associated with a decreased rate of infectious complications. Revision cases displayed a higher rate of infectious complications.

The Balance between Open and Robotic Training among Graduating Urology Residents-Does Surgical Technique Need Monitoring?

PURPOSE: A minimum number of index procedures is required for graduation. Without thresholds for surgical technique, it is unclear if robotic and open learning is balanced. We assessed the distribution of robotic and open surgeries performed by residents upon graduation. MATERIALS AND METHODS: Voluntary Accreditation Council for Graduate Medical Education resident case logs from 11 institutions were de-identified and trends in robotic and open major surgeries were compared using Wilcoxon rank sum and 2-sample t-tests. RESULTS: A total of 89,199 major cases were recorded by 209 graduates from 2011 to 2017. The median proportion of robotic cases increased from 2011 to 2017 in reconstruction (4.7% to 15.2%), oncology (27.5% to 54.2%) and pediatrics (0% to 10.9%) (all values p <0.001). Robotic and open cases remained most divergent in reconstruction, with a median of 12 robotic (IQR 9-19) to 70 open cases (IQR 55-106) being performed by residents in 2017. Similar observations occurred in pediatrics. In oncology the number of robotic procedures superseded that of open in 2016 and rose to a median of 148 robotic (IQR 108-214) to 121 open cases (IQR 90-169) in 2017, with the driver being robotic prostatectomy. Substantial differences in surgical technique were observed between institutions and among graduates from the same institution. CONCLUSIONS: Although robotic volume is increasing, the balance of surgical technique and the pace of change differ in reconstruction, oncology and pediatrics, as well as among individual institutions and graduates themselves. This raises questions about whether more specific guidelines are needed to ensure equity and standardization in training.

Carcinogenic potential of polypropylene mid-urethral slings: what do we know so far?

INTRODUCTION AND HYPOTHESIS: Polypropylene (PP) mesh has come under increased scrutiny owing to previous FDA safety communications regarding the risks of mesh in trans-vaginal surgery and ensuing class action litigation for post-operative complications. Additional concerns have been raised regarding a possible link between implanted PP mesh and the long-term development of malignancy. Until recently, no research was specifically committed to the exploration of such a link. Our objective was to provide an overview of the recent literature focusing on any association between the use of PP mesh for midurethral sling procedures and the development of malignancy. METHODS: Multiple online research databases were searched for information related to any possible carcinogenic potential of PP mesh. RESULTS: There was no increased incidence in the development of malignancy after midurethral sling procedures using PP mesh in any of the studies. CONCLUSION: Given the scarcity of evidence suggesting otherwise, the likelihood of PP mesh causing malignancy is exceptionally low. However, with few studies and an unknown latency period between exposure and diagnosis, more observational data would prove useful to exclude causality.

Spermatic cord dedifferentiated liposarcoma presenting as a recurrent inguinal hernia.

Paratesticular sarcomas are a rare entity and provide a unique clinical challenge due to their slow growing, often painless natural course. Adding to this challenge is the complex anatomy of the scrotum that allows these masses to mimic other conditions, including inguinal hernia, cysts, or fluid collections. We report such a case and our approach to an 83-year-old male with dedifferentiated liposarcoma of the spermatic cord with a history of inguinal hernia. In doing so, we highlight the need for thorough evaluation of scrotal masses and the management of these rare, though well-described, tumors.

The Aging Mountaineer: PSA screening in older men--of value or should we skip this test?

The most recent American Urologic Association (AUA) guidelines concerning prostate-specific antigen (PSA) screening have caused much controversy. One particular guideline, in regard to testing elderly men, is the center of intense debate. Currently, the AUA recommends against PSA screening in men aged 70 and older. West Virginia faces the challenge of a population aging at a rate that far exceeds the projected national rate. With such a substantial future proportion of older men, and increased life expectancy within this group, careful consideration of PSA screening in elderly men is warranted. Given the uncertainty surrounding the basis for the AUA guidelines, and the increased quality of life and remaining life expectancy for older men, we propose a view that supports PSA screening in carefully selected elderly men, and offer background to assist clinicians in arriving at a sound clinical decision in concert with the patient.

The Undescended Testicles of West Virginia: A Single Center Experience.

OBJECTIVE: To determine the age of pediatric patients who underwent surgical intervention for undescended testicles (UDT) at our institution. METHODS: We retrospectively reviewed all pediatric patients who underwent orchiopexy and/or diagnostic laparoscopy for undescended or non-palpable testicles with our pediatric urologist from January 2013-March 2014. Patients were separated into those undergoing surgical intervention at 6-12 months, 13-24 months, 25-48 months, and >48 months of age. RESULTS: 70 patients underwent surgical intervention. Only 15 patients (21.4%) underwent surgical intervention within the recommended time period of 6-12 months. Orchiopexy was performed on 21 patients (30.0%) from 13-24 months, 12 patients (17.1%) from 25-48 months, and 22 patients (31.5%) after 48 months of age. CONCLUSIONS: Current American Urologic Association (AUA) recommendations advocate orchiopexy between 6-12 months of age. Improved parent and primary care education and access to pediatric urological evaluation of UDT will hopefully improve the timeliness of intervention within our state.

A review of urinary fistulae in Crohn's disease.

INTRODUCTION: Urinary fistulae develop as abnormal connections between the gastrointestinal (GI) and genitourinary (GU) tracts, and occur in multiple disease processes including diverticulitis, malignancy, and Crohn's disease. Crohn's disease is now the most common cause of fistula formation between the ileum and bladder and the third most common cause of fistulae between the colon and the bladder. Few articles provide a comprehensive review of this process. MATERIALS AND METHODS: We performed a PubMed search using such terms as "fistula" and "Crohn's disease" and/or "enterovesical fistula." We reviewed references from selected papers and relevant articles were used for information-gathering and cited accordingly. RESULTS: Fistulae in Crohn's disease generally occur due to preformed abscess formation or bowel perforation from the development of aphthous ulcers. The most common type of urinary fistula is enterovesical, due to the close proximity of the ileum and bladder dome. Computed tomography and cystoscopy are the most common diagnostic tools utilized. Surgical treatment is usually definitive; however medical treatment has been used with some success as well. CONCLUSION: Urinary fistulae represent an uncommon, yet serious problem to patients with Crohn's disease. Patient symptoms and imaging direct the practitioner to proper diagnosis, with direct visualization via cystoscopy confirming the presence of a urinary fistula. Treatment is aimed at relieving symptoms and may be medical or surgical depending on the clinical presentation.

A Multicenter Study Evaluating the FREquency of Use and Efficacy of a Novel Closed-Loop Wearable Tibial Neuromodulation System for Overactive Bladder and Urgency Urinary Incontinence (FREEOAB).

OBJECTIVE: To evaluate the effectiveness and safety of a novel wearable neuromodulation system incorporating embedded electromyographic evaluation, representing the first closed-loop wearable therapy for bladder control. METHODS: This 12-week, multicenter, open-label, single-arm study of subjects with overactive bladder assessed response of bladder diary parameters and quality of life (QOL) metrics. Subjects used the transcutaneous tibial neuromodulation system, either once or three times weekly, with evaluations at weeks 1, 4, 8, and 12. Enrolled subjects (N = 96) were assessed for changes in urinary frequency, urgency, and urgency urinary incontinence episodes, and QOL changes using various questionnaires. RESULTS: In the intent-to-treat population (N = 96, mean age 60.8 ± 13.0years, 88.5% female), significant reductions in 3-day diary parameters were observed for daily voids, incontinence, and urgency episodes at 12weeks. QOL improvements exceeded the minimal clinically important difference for all QOL questionnaires. Long-term results remained robust at 12months. Device-related adverse events were mild and there were no device-related serious adverse events. Mean therapy compliance at 12weeks was 88.5%. High satisfaction rates were reported for the device overall. CONCLUSION: The Avation device demonstrates promising efficacy in treating adults with overactive bladder and urge urinary incontinence. At 12weeks, both diary parameters and QOL indicators showed significant improvement and remained robust at 12months. The device had a favorable safety profile with high compliance and patient satisfaction. This novel, closed-loop wearable tibial neuromodulation system represents a significant advancement in bladder control therapy, offering a noninvasive, patient-centered alternative with improved accessibility and ease of use.

Gender-based Disparity Exists in the Surgical Experience of Female and Male Urology Residents.

OBJECTIVE: To determine if a discrepancy exists in the number and type of cases logged between female and male urology residents. MATERIALS AND METHODS: ACGME case log data from 13 urology residency programs was collected from 2007 to 2020. The number and type of cases for each resident were recorded and correlated with resident gender and year of graduation. The median, 25th and 75th percentiles number of cases were calculated by gender, and then compared between female and male residents using Wilcoxon rank sum test. RESULTS: A total of 473 residents were included in the study, 100 (21%) were female. Female residents completed significantly fewer cases, 2174, compared to male residents, 2273 (P = .038). Analysis by case type revealed male residents completed significantly more general urology (526 vs 571, P = .011) and oncology cases (261 vs 280, P = .026). Additionally, female residents had a 1.3-fold increased odds of logging a case in the assistant role than male residents (95% confidence interval: 1.27-1.34, P < .001). CONCLUSION: Gender-based disparity exists within the urology training of female and male residents. Male residents logged nearly 100 more cases than female residents over 4years, with significant differences in certain case subtypes and resident roles. The ACGME works to provide an equal training environment for all residents. Addressing this finding within individual training programs is critical.

An atypical presentation of testicular torsion: a case report.

Testicular torsion is an emergent condition requiring prompt surgical intervention to avoid permanent testicular compromise and death. As its symptoms overlap with other disease processes, diagnosis is sometimes difficult. When considering the presenting symptoms, one must be careful not to ignore unusual causes of torsion and misdiagnose the patient. In this case report we describe an unusual etiology of testicular torsion (traumatic) with an atypical patient presentation (mildly painful) which presented many obstacles before proper diagnosis and treatment.

EBV-positive diffuse large B-cell lymphoma presenting as symptomatic masses in the bladder trigone and unilateral kidney.

Diffuse large B-cell lymphoma (DLBCL) of the genitourinary tract is a rare diagnosis. A 66-year-old male with a history of multiple myeloma and prostate cancer presented with gross hematuria and concern for urinary clot retention. Imaging demonstrated an incidental mass in the left kidney and urinary bladder. Resection of the urinary bladder tumor and biopsy of the kidney revealed Epstein-Barr Virus positive DLBCL. Significant lymphadenopathy was found during staging, and this lymphoma was classified as stage IV. The patient was referred to medical oncology, initiated on chemotherapy, and scheduled for follow up with urology for the renal mass.

Open retrieval management of inferior vena cava filter erosion resulting in symptomatic hydroureteronephrosis.

Inferior vena cava filters are effective for the management of thromboembolic disease but can erode into adjacent organ systems in rare instances. Endovascular retrieval of eroded filters has been the preferred management for this complication. We present a case for which endovascular retrieval was not appropriate because of filter orientation and erosion into the ureter and describe successful management using open retrieval of a permanent filter with erosion into the renal collecting system requiring reconstruction. Although minimally invasive retrieval is preferred over open repair, this approach should be considered when filter erosion is not amenable to endovascular retrieval.

Longitudinal Changes in the Operative Experience for Junior Urology Residents.

OBJECTIVE: To evaluate longitudinal trends in surgical case volume among junior urology residents. There is growing perception that urology residents are not prepared for independent practice, which may be linked to decreased exposure to major cases early in residency. METHODS: Retrospective review of deidentified case logs from urology residency graduates from 12 academic medical centers in the United States from 2010 to 2017. The primary outcome was the change in major case volume for first-year urology (URO1) residents (after surgery internship), measured using negative binomial regression. RESULTS: A total of 391,399 total cases were logged by 244 residency graduates. Residents performed a median of 509 major cases, 487 minor cases, and 503 endoscopic cases. From 2010 to 2017, the median number of major cases performed by URO1 residents decreased from 64 to 49 (annual incidence rate ratio 0.90, P < .001). This trend was limited to oncology cases, with no change in reconstructive or pediatric cases. The number of major cases decreased more for URO1 residents than for residents at other levels (P-values for interaction <.05). The median number of endoscopic cases performed by URO1 residents increased from 85 to 194 (annual incidence rate ratio 1.09, P < .001), which was also disproportionate to other levels of residency (P-values for interaction <.05). CONCLUSION: There has been a shift in case distribution among URO1 residents, with progressively less exposure to major cases and an increased focus on endoscopic surgery. Further investigation is needed to determine if this trend has implications on the surgical proficiency of residency graduates.

Testicular trauma resulting in spermatic vessel thrombosis and testicular loss: a case report.

Testicular ischemia is typically seen with cases of testicular torsion. Twisting of the spermatic cord and compromise of testicular blood supply can induce testicular loss if not promptly discovered and treated. Non-torsion causes of testicular ischemia are uncommon with rare citations in the literature. Herein, we present a case of testicular ischemia induced by traumatic thrombosis of the spermatic vessels.

Post-vasectomy pain syndrome: clinical features and treatment options.

INTRODUCTION: Post-vasectomy pain syndrome (PVPS), defined as chronic epididymal pain that is continuous or recurrent in the absence of proven epididymal or testicular infection, has become more common as the number of vasectomies performed rises. With more than four million vasectomies performed annually, the prevention and treatment of this condition becomes more important. Multiple theories have been proposed as a potential etiology of this condition, and along with this have come multiple modalities of treatment. With the uncertainty surrounding the etiology of this syndrome, the aims of treatment are varied and are described and analyzed in this review. MATERIALS AND METHODS: A literature review was conducted to ascertain the various theories explaining the source of the discomfort in this syndrome, along with several treatment modalities, both medical and surgical. CONCLUSIONS: Options for the management of PVPS are rapidly expanding. Among the existing surgical options that include spermatic cord denervation and vasovasostomies, testosterone has emerged as a potential medical therapy with some promising results. Our review of the literature reveals the etiology of PVPS is still uncertain, as multiple theories still prevail. However, progress has been made in the development of additional medical therapies that could provide some relief for patients who are unwilling to accept the risks of surgery. Nevertheless, the importance of counseling patients of the risks of PVPS with vasectomy cannot be overstated. Through review of the pathophysiology of this condition and treatment options including conservative approaches, topical therapies, denervation of the spermatic cord, and surgical approaches, a comprehensive therapeutic approach can be offered to affected patients.

Robotic assisted partial cystectomy with pelvic lymph node dissection for metastatic paraganglioma of the urinary bladder.

Paraganglioma of the urinary bladder is a rare tumor that often presents with hypertensive crisis during micturition. We herein present the unusual case of a 45-year-old female with metastatic paraganglioma treated with robotic assisted partial cystectomy and pelvic lymphadenectomy. We review the literature regarding the evaluation and management of paraganglioma of the bladder.

Sacral nerve stimulation for neuromodulation of the lower urinary tract.

Sacral neuromodulation (SNM) has become a standard treatment option for patients suffering from urinary urge incontinence, urgency-frequency, and/or nonobstructive urinary retention refractory to conservative and pharmacologic treatment. Since its initial development, the manufacturer of InterStim therapy (Medtronic, Inc., Minneapolis, MN, USA), has introduced technical modifications, while surgeons and researchers have adapted and published various innovations and alterations of the implantation technique. In this article, we feature our SNM technique including patient selection, comprehensive dialogue/evaluation, procedure details, and appropriate follow up. Although there is often great variability in patients with lower urinary tract dysfunction, we maintain that great success can be achieved with a systematic and methodical approach to SNM.