A prospective study to assess the effectiveness and safety of the BlueWind System in the treatment of patients diagnosed with urgency urinary incontinence.

BACKGROUND: Overactive bladder (OAB) affects one in six adults in Europe and the United States and impairs the quality of life of millions of individuals worldwide. When conservative management fails, third-line treatments including tibial neuromodulation (TNM) is often pursued. TNM has traditionally been accomplished percutaneously in clinic. OBJECTIVE: A minimally invasive implantable device activated by a battery-operated external wearable unit has been developed for the treatment of urgency urinary incontinence (UUI), mitigating the burden of frequent clinic visits and more invasive therapies that are currently commercially available. METHODS: A prospective, multicenter, single-arm, open-label, pivotal study evaluated the safety and effectiveness of the device in adult females with UUI (i.e., wet OAB) (BlueWind Implantable Tibial Neuromodulation [iTNM] system; IDE number #G200013; NCT03596671). Results with the device were previously published under the name RENOVA iStim, which has been since renamed as the Revi™ System. Approximately 1-month post-implantation of the device, participants delivered therapy at their convenience and completed a 7-day voiding diary before visits 6- and 12-months post-treatment initiation. The primary efficacy and safety endpoints were the proportion of responders to therapy ( ≥ 50% improvement on average number of urgency-related incontinence episodes) and incidence of adverse events from implantation to 12-month post-activation. RESULTS: A total of 151 participants, mean age 58.8 (SD: 12.5), were implanted; 144 and 140 completed the 6- and 12-month visits, respectively. The participants demonstrated mean baseline of 4.8 UUI/day (SD 2.9) and 10 voids/day (SD 3.3). Six and 12-months post-activation, 76.4% and 78.4% of participants, respectively, were responders to therapy in an intent-to-treat analysis. Of the 139 participants with completed 12-month diaries, 82% were responders, 50% were classified as "dry" (on at least 3 consecutive diary days), and 93.5% of participants reported that their symptoms improved. No implanted participant experienced an SAE related to the procedure or device. CONCLUSIONS: iTNM, delivered and powered by a patient-controlled external wearable communicating with an implant, demonstrated clinically meaningful and statistically significant improvement in UUI symptoms and a high safety profile. This therapy highlights the value of patient-centric therapy for the treatment of UUI.

Telemedicine follow-up is safe and efficacious for synthetic midurethral slings: a randomized, multi-institutional control trial.

INTRODUCTION AND HYPOTHESIS: The objective was to assess whether telemedicine-based follow-up is equivalent to office-based follow-up in the early postoperative period after routine synthetic midurethral sling placement. METHODS: This is a prospective, international, multi-institutional, randomized controlled trial. Patients undergoing synthetic midurethral sling placement were randomized to 3-week postoperative telemedicine versus office-based follow-up. The primary outcome was the rate of unplanned events. Secondary outcomes included patient satisfaction, crossover from telemedicine to office-based follow-up, and compliance with 3- to 5-month office follow-up. RESULTS: We included 238 patients (telemedicine: 121 vs office: 117). No differences in demographics or medical comorbidities were noted between the study groups (p = 0.09-1.0). No differences were noted in unplanned events: hospital admission, emergency department visit, or unplanned office visit or call (14% vs 12.9%, p = 0.85) or complications (9.9% vs 8.6%, p = 0.82). Both groups were equally "very satisfied" with their surgical outcomes (71.1% vs 69%, p = 0.2). Telemedicine patients were more compliant with 3- to 5-month office follow-up (90.1% vs 79.3%, p = 0.04). CONCLUSIONS: After synthetic midurethral sling placement, telemedicine follow-up is a safe patient communication option in the early postoperative period. Telemedicine patients reported no difference in satisfaction compared with office-based follow-up but had greater compliance with 3- to 5-month follow-up.

What Is the Role of Additional Pharmacotherapy and Neuromodulation in Patients with Marginal Benefit from Botulinum Toxin Injection?

PURPOSE OF REVIEW: Third-line therapies for patients with overactive bladder (OAB) can improve symptoms for those who have failed conservative therapies. Options include percutaneous tibial nerve stimulation (PTNS), cystoscopic injection of onabotulinumtoxinA (BTX-A), and sacral neuromodulation (SNM). This paper aims to review the current literature on the treatment of patients with idiopathic OAB who have undergone BTX-A injections and have not responded or have undesirable side effects from the therapy. RECENT FINDINGS: There are no randomized control trials examining the role of concurrent medical therapy and BTX-A; rather, there are observational studies in the neurogenic population. Furthermore, there are two observational studies on the role of SNM in BTX-A refractory idiopathic OAB patients demonstrating its safety and efficacy. There are many options available to the patient who fails BTX-A. Further research in this specific patient population is necessary to determine why patients have suboptimal responses and to delineate the next step in treatment.

Prevention of iatrogenic ureteral injuries during robotic gynecologic surgery: a review.

Iatrogenic ureteral injuries, more than half of which occur during gynecologic surgery, may have devastating consequences for both patients and physicians. Gynecologists have employed various techniques such as cystoscopy, ureteral stents, and lighted ureteral stents to prevent ureteral injuries. The emergence and increasing prevalence of robotic surgery necessitates that we not only reevaluate the utility of these techniques, but also develop new ones specific for the robotic modality. In the robotic setting, the surgeon lacks tactile feedback and must rely primarily on visual cues. The use of intraureteral indocyanine green and subsequent visualization under near-infrared fluorescence appears to be a promising technique to primarily and secondarily prevent ureteral injuries during robotic gynecologic surgery.

Two-year Pivotal Study Analysis of the Safety and Efficacy of Implantable Tibial Nerve Stimulation With eCoin for Urgency Urinary Incontinence.

OBJECTIVE: To evaluate the continued effectiveness and safety of the eCoin Implantable Tibial Nerve Stimulator system (ITNS) for urgency urinary incontinence (UUI) in patients with overactive bladder (OAB). The 1-year pivotal study was extended through 2 years. The ITNS is a novel and recently FDA-approved therapy. METHODS: A prospective, multicenter, single-arm trial was conducted on 137 subjects with refractory UUI to evaluate eCoin ITNS therapy. A 3-day voiding diary was collected along with the OAB questionnaire, Patient Global Impression of Improvement, and a custom Likert scale on subject satisfaction. The primary efficacy measure was the proportion of subjects who achieved at least 50% reduction from baseline in number of UUI episodes. The primary safety measure was device-related adverse events (AEs). RESULTS: Seventy-two subjects completed the 96-week evaluation. Around 78% (95% CI: 67%-87%) experienced at least 50% reduction in UUI episodes; 48% (95% CI, 36%-60%) experienced at least 75% reduction, and 22% (95% CI, 13%-33%) were dry on a 3-day diary. Subjects reported a decrease from baseline in their UUI episodes/day of 2.61 (SD 2.97) and 2.97 (SD 2.64) at 48 weeks and 96 weeks, respectively. Around 91.3% did not require additional medications for OAB. No serious or unanticipated AEs were reported in this extension phase. CONCLUSION: The eCoin ITNS demonstrated consistent continuing effectiveness and safety in treating OAB patients with UUI. The findings support it as an excellent treatment option for refractory patients.

New developments in the diagnosis and treatment of chronic prostatitis/chronic pelvic pain syndrome.

PURPOSE OF REVIEW: To describe new developments in the diagnosis and treatment of chronic prostatitis/chronic pelvic pain syndrome (CPPS). RECENT FINDINGS: Symptoms in men with chronic prostatitis/CPPS appear to cluster into a group with primarily pelvic or localized disease, and a group with more systemic symptoms. Several other chronic pain conditions can be associated with chronic prostatitis/CPPS, including irritable bowel syndrome, fibromyalgia, and chronic fatigue syndrome. Markers of neurologic inflammation and autoimmune disease parallel changes in symptoms after treatment. Treatment options include new alpha-blockers, psychological intervention, and prostate-directed therapy. The areas of acupuncture and pelvic floor physical therapy/myofascial release have received increased recent attention and appear to be good options in these patients. Future therapy may include antibodies to mediators of neurogenic inflammation and even treatment of bacteria in the bowel. SUMMARY: The diagnosis of chronic prostatitis/CPPS must include conditions traditionally outside the scope of urologic practice but important for the care of men with chronic pelvic pain. The treatment is best done using multiple simultaneous therapies aimed at the different aspects of the condition.

Safety of Intradetrusor OnabotulinumtoxinA (BTX-A) Injection in the Asymptomatic Patient With a Positive Urine Dip.

OBJECTIVE: To evaluate differences in adverse events (AE) in asymptomatic patients with a positive urine dip (UD) at time of intradetrusor onabotulinumtoxinA (BTX-A) injection vsthose with a defined negative UD. MATERIALS AND METHODS: All intradetrusor BTX-A injections were retrospectively reviewed at a single institution between 2016 and 2018. Exclusion criteria included an indwelling catheter, recent positive urine culture, recent antibiotic course, or absence of UD on the day of injection. A positive UD was defined using 7 different definitions with varying combinations of any level of positive blood, leukocyte esterase, or nitrite. Negative UDs were defined those excluded from the positive UD group. We compared multiple positive UD-defined groups to their respective negative UD cohorts with regards to outcomes and demographics. RESULTS: A total of 212 patients underwent 335 cycles of BTX-A injections over a 2-year period. The average age was 65 years (range: 21-90). The majority received 100 units (73%) of BTX-A for a non-neurogenic diagnosis (73%). The overall rate of AEs, urinary tract infection, and urinary retention was 14.6%, 9%, and 3%, respectively. In all groups, the most common AE was urinary tract infection followed by urinary retention. There were no major Clavien-Dindo-defined complications. There was no statistically significant difference in the total or categorical AE rates between positive and negative UD groups using all 7 definitions of a positive UD (P = .05-1.0). CONCLUSION: These data do not support the practice of obtaining a preprocedure UD in asymptomatic patients undergoing intradetrusor BTX-A injection for any indication; test results are unable to predict outcomes or AEs.

Management of the Exposed or Perforated Midurethral Sling.

The synthetic midurethral sling has become the gold standard for treatment of stress urinary incontinence since its introduction more than 20 years ago. With its utilization, the incidence of mesh-related complications has also increased. Mesh exposure and perforation are 2 common mesh complication scenarios that pelvic floor surgeons should be prepared to treat. This article highlights preoperative, perioperative, and postoperative factors to minimize the chance of vaginal wall mesh exposure or perforation of mesh into the lower urinary tract. It also summarizes common presenting symptoms, suggested evaluation and a range of treatment options.

Association of Low Socioeconomic Status With Adverse Prostate Cancer Pathology Among African American Men Who Underwent Radical Prostatectomy.

BACKGROUND: We tested for associations between socioeconomic status (SES) and adverse prostate cancer pathology in a population of African American (AA) men treated with radical prostatectomy (RP). PATIENTS AND METHODS: We retrospectively reviewed data from 2 institutions for AA men who underwent RP between 2010 and 2015. Household incomes were estimated using census tract data, and patients were stratified into income groups relative to the study population median. Pathologic outcomes after RP were assessed, including the postsurgical Cancer of the Prostate Risk Assessment (CAPRA-S) score and a definition of adverse pathology (stage ≥ pT3, Gleason score ≥ 4+3, or positive lymph nodes), and compared between income groups. RESULTS: We analyzed data of 347 AA men. Median household income was $37,954. Low-SES men had significantly higher prostate-specific antigen values (mean 10.2 vs. 7.3; P < .01) and CAPRA-S scores (mean 3.4 vs. 2.5; P < .01), more advanced pathologic stage (T3-T4 31.8% vs. 21.5%; P = .03), and higher rates of seminal vesicle invasion (17.3% vs. 8.2%; P < .01), positive surgical margins (35.3% vs. 22.1%; P < .01), and adverse pathology (41.4% vs. 30.1%; P = .03). Linear and logistic regression showed significant inverse associations of SES with CAPRA-S score (P < .01) and adverse pathology (P = .03). CONCLUSION: In a population of AA men who underwent RP, we observed an independent association of low SES with advanced stage or aggressive prostate cancer. By including only patients in a single racial demographic group, we eliminated the potential confounding effect of race on the association between SES and prostate cancer risk. These findings suggest that impoverished populations might benefit from more intensive screening and early, aggressive treatment of prostatic malignancies.

An evaluation of the pharmacotherapy for interstitial cystitis.

INTRODUCTION: Interstitial cystitis (IC) and bladder pain syndrome (BPS) are chronic conditions that can be debilitating for patients. There is no consensus as to their etiology, and there are many proposed treatment algorithms. Oftentimes multimodal therapy, such as combining behavioral modification and physical therapy alongside pharmacotherapies, will be utilized. With the various treatment options available to patients and providers, there is an ever-growing need to implement evidence-based therapies. AREAS COVERED: The authors explore the different pharmacotherapies as commonly recommended in the American Urological Association (AUA) and European Association of Urology (EAU) multitiered guidelines for IC/BPS treatment as well as other investigational therapies. Pharmacotherapies targeting bladder, pelvic, and/or systemic factors in the overall treatment of IC/BPS are discussed with a particular focus on evidence-based guideline therapies. This article also looks at emerging therapies of interest. EXPERT OPINION: IC/BPS is a syndrome that requires a multimodal approach, including clinical phenotyping and directed therapy based on the patient's symptoms. The AUA and EAU provide guidelines for practitioners to follow, but adequate treatment requires the therapy to be targeted toward the patient's phenotypic domain.

Multi-institution analysis of racial disparity among African-American men eligible for prostate cancer active surveillance.

There is a significant controversy on whether race should be a factor in considering active surveillance for low-risk prostate cancer. To address this question, we analyzed a multi-institution database to assess racial disparity between African-American and White-American men with low risk prostate cancer who were eligible for active surveillance but underwent radical prostatectomy. A retrospective analysis of prospectively collected clinical, pathologic and oncologic outcomes of men with low-risk prostate cancer from seven tertiary care institutions that underwent radical prostatectomy from 2003-2014 were used to assess potential racial disparity. Of the 333 (14.8%) African-American and 1923 (85.2%) White-American men meeting active surveillance criteria, African-American men were found to be slightly younger (57.5 vs 58.5 years old; p = 0.01) and have higher BMI (29.3 v 27.9; p < 0.01), pre-op PSA (5.2 v 4.7; p < 0.01), and maximum percentage cancer on biopsy (15.1% v 13.6%; p < 0.01) compared to White-American men. Univariate and multivariate analysis demonstrated similar rates of upgrading, upstaging, positive surgical margin, and biochemical recurrence between races. These results suggest that single institution studies recommending more stringent AS enrollment criteria for AA men with a low-risk prostate cancer may not capture the complete oncologic landscape due to institutional variability in cancer outcomes. Since all seven institutions demonstrated no significant racial disparity, current active surveillance eligibility should not be modified based upon race until a prospective study has been completed.

Use of indocyanine green during robot-assisted ureteral reconstructions.

BACKGROUND: Although there are reports of robot-assisted ureteral reconstructions (RURs) with excellent safety and efficacy, the procedures remain technically challenging. In the robotic setting the surgeon must rely on visual cues in the absence of tactile feedback. Indocyanine green (ICG) is a dye that can be visualized under near-infrared fluorescence (NIRF). OBJECTIVE: To describe our novel technique, which utilizes intraureteral injection of ICG and subsequent visualization under NIRF to facilitate RUR, and report our outcomes after these procedures. DESIGN, SETTING, AND PARTICIPANTS: This is a retrospective review of 25 patients who underwent 26 RURs for various ureteral pathologies between June 2012 and October 2013. SURGICAL PROCEDURE: After full disclosure, all patients consented to off-label use of ICG. A ureteral catheter and/or percutaneous nephrostomy tube were used to inject 10ml of ICG into the diseased ureter, above and below the stricture. Intraoperatively, NIRF was activated to assist in identification of the ureter and to localize the margins of ureteral strictures. MEASUREMENTS: Postoperatively, RURs were assessed for clinical success (absence of symptoms attributable to ureteral pathology) and radiological success (absence of a ureteral stricture on imaging). RESULTS AND LIMITATIONS: Our technique provided visual cues and aided in successful performance of 26 RURs in 25 patients. The procedures included ureterolysis (n=4), pyeloplasty (n=8), ureteroureterostomy (n=9), and ureteroneocystostomy (n=5). There were no perioperative complications attributable to ICG use. At a mean overall follow-up of 12 mo, all procedures were clinically and radiologically successful. This study is limited by the small sample size and short-term follow-up. CONCLUSIONS: Intraureteral injection of ICG and subsequent visualization under NIRF facilitates RUR by aiding in rapid and accurate identification of the ureter, and precise localization of the proximal and distal ureteral stricture margins. In our experience, our technique is safe, easy to perform, and reproducible. PATIENT SUMMARY: In this report, we describe a new technique to facilitate robot-assisted ureteral reconstructions using intraureteral injection of ICG and subsequent visualization under near-infrared fluorescence. More specifically, our technique allows for rapid and accurate identification of the ureter, and precise localization of ureteral strictures.