Optilume drug-coated balloon for anterior urethral stricture: 2-year results of the ROBUST III trial.

Objective: The aim of this study is to report the updated 2-year results of the intervention arm of the ROBUST III randomized trial evaluating the safety and efficacy of the Optilume drug-coated balloon (DCB) versus standard endoscopic management of recurrent male anterior urethral stricture. Materials and Methods: Eligible patients included men with recurrent anterior urethral stricture ≤3 cm in length and ≤12Fr in diameter, International Prostate Symptom Score (IPSS) ≥11 and peak flow rate (Qmax) <15 mL/s. Patients were randomized to treatment with the Optilume DCB or standard-of-care endoscopic management. Primary efficacy endpoints measured at 2 years included freedom from re-intervention and changes in IPSS, Qmax and post-void residual (PVR). Secondary endpoint was impact on sexual function using the International Index of Erectile Function (IIEF). Primary safety endpoint was freedom from serious procedure- or device-related adverse events (AEs). Results: A total of 127 patients enrolled at 22 sites in the United States and Canada (48 randomized to standard-of-care dilation and 79 to DCB dilation). Seventy-five patients in the DCB arm entered the open-label phase after 6 months. Participants averaged 3.2 prior endoscopic interventions (range 2-10); most (89.9%) had bulbar strictures with an average stricture length of 1.63 cm (SD 0.76). Significant improvements in IPSS, average Qmax and PVR were maintained at 2 years. Freedom from repeat intervention was significantly higher in the Optilume DCB arm at 2 years versus the Control arm at 1 year (77.8% vs. 23.6%, p < 0.001). During the follow-up period, there were 15 treatment failures and two non-study-related deaths. Treatment-related AEs were rare and generally self-limited (haematuria, dysuria and urinary tract infection). Conclusion: The Optilume DCB shows sustained improvement in both objective and subjective voiding parameters at 2-year follow-up. Optilume appears to provide a safe and effective endoscopic treatment alternative for short recurrent anterior urethral strictures among men who wish to avoid or delay formal urethroplasty.

One-Year Results for the ROBUST III Randomized Controlled Trial Evaluating the Optilume® Drug-Coated Balloon for Anterior Urethral Strictures.

PURPOSE: The Optilume® drug-coated balloon (DCB) is a urethral dilation balloon with a paclitaxel coating that combines mechanical dilation for immediate symptomatic relief with local drug delivery to maintain urethral patency. The ROBUST III study is a randomized, single-blind trial evaluating the safety and efficacy of the Optilume DCB against endoscopic management of recurrent anterior urethral strictures. MATERIALS AND METHODS: Eligible patients were adult males with anterior strictures ≤12Fr in diameter and ≤3 cm in length, at least 2 prior endoscopic treatments, International Prostate Symptom Score ≥11 and maximum flow rate <15 ml per second. A total of 127 subjects were enrolled at 22 sites. The primary study end point was anatomical success (≥14Fr by cystoscopy or calibration) at 6 months. Key secondary end points included freedom from repeat treatment, International Prostatic Symptom Score and peak flow rate. The primary safety end point included freedom from serious device- or procedure-related complications. RESULTS: Baseline characteristics were similar between groups, with subjects having an average of 3.6 prior treatments and average length of 1.7 cm. Anatomical success for Optilume DCB was significantly higher than control at 6 months (75% vs 27%, p <0.001). Freedom from repeat intervention was significantly higher in the Optilume DCB arm. Immediate symptom and urinary flow rate improvement was significant in both groups, with the benefit being more durable in the Optilume DCB group. The most frequent adverse events included urinary tract infection, post-procedural hematuria and dysuria. CONCLUSIONS: The results of this randomized controlled trial support that Optilume is safe and superior to standard direct vision internal urethrotomy/dilation for the treatment of recurrent anterior urethral strictures <3 cm in length. The Optilume DCB may serve as an important alternative for men who have had an unsuccessful direct vision internal urethrotomy/dilation but want to avoid or delay urethroplasty.

International Continence Society best practice statement for use of sacral neuromodulation.

AIMS: Sacral neuromodulation (SNM) is an accepted therapy for a variety of conditions. However, despite over 20 years of experience, it remains a specialized procedure with a number of subtleties. Here we present the recommendations issued from the International Continence Society (ICS) SNM Consensus Panel. METHODS: Under the auspices of the ICS, eight urologists, three colorectal surgeons and two urogynecologists, covering a wide breadth of geographic and specialty interest representation, met in January 2017 to discuss best practices for neuromodulation. Suggestions for statements were submitted in advance and specific topics were assigned to committee members, who prepared and presented supporting data to the group, at which time each topic was discussed in depth. Best practice statements were formulated based on available data. This document was then circulated to multiple external reviewers after which final edits were made and approved by the group. RESULTS: The present recommendations, based on the most relevant data available in the literature, as well as expert opinion, address a variety of specific and at times problematic issues associated with SNM. These include the use of SNM for a variety of underlying conditions, need for pre-procedural testing, use of staged versus single-stage procedures, screening for success during the trial phase, ideal anesthesia, device implantation, post-procedural management, trouble-shooting loss of device function, and future directions for research. CONCLUSIONS: These guidelines undoubtedly constitute a reference document, which will help urologists, gynecologists, and colorectal surgeons optimize their use of SNM for refractory urinary urgency and frequency, UUI, NOR, and FI.

Sacral Neuromodulation in Urological Practice.

Sacral neuromodulation (SNM) is a minimally invasive, restorative treatment to improve voiding and elimination functions. We give a historical perspective of SNM and explore the evidence for the use of this therapy for Food and Drug Administration-approved pathologies as well as disease processes that are being treated internationally. Ensuring optimal lead placement increases the potential of a comfortable, durable, and efficacious response. The future of SNM aims to maximize its potential benefit, refine its use, and minimize its risks and cost. Evolution of the therapy includes better device options, better software for patient and clinician use, more programming capabilities, and new nerve targets.

Detailed Cost Analysis of Robotic Sacrocolpopexy Compared to Transvaginal Mesh Repair.

OBJECTIVE: To evaluate the hospital-realized cost difference between transvaginal mesh prolapse repair and robot-assisted sacrocolpopexy. METHODS: Consecutive transvaginal mesh prolapse surgery and robot-assisted sacrocolpopexy cases from January 2012 to December 2013 were evaluated. Patient clinical and operative data were recorded. The total institutional costs (direct and indirect) for each procedure were obtained and subcategorized by area. Independent sample t tests and chi-squared analysis were performed. RESULTS: One hundred twenty women underwent transvaginal mesh repair whereas 106 underwent robotic sacrocolpopexy. Body mass index was similar between groups (28.1 vs 27.5) as was midurethral sling placement (50% vs 59%). Robotic patients were younger (61 years vs 67 years., P < .001) and more likely to undergo concomitant hysterectomy (58.5% vs 26.7%). There were similar rates for additional compartment repairs. Amortized costs for robotic purchase and maintenance were included with all depreciated equipment and realized by all patients undergoing surgery. Overall mean robotic operative time was longer with and without hysterectomy (279 minutes vs 174 minutes, P < .001 and 201 minutes vs 91 minutes, P < .001). Mean total costs were higher with robotic technique ($9675 vs $6718, P < .001), primarily driven by anesthesia ($1141 vs $675, P < .001), and operative ($6883 vs $4487, P < .001) costs. No differences for total costs were seen in laboratory fees, recovery room, or inpatient nursing. CONCLUSION: Transvaginal prolapse repair is less costly than robotic sacrocolpopexy. Length of surgery and additional robotic supplies drive the majority of increased operative costs. Costs attributed to robot purchase and maintenance do not uniquely factor into the procedure costs.

Percutaneous tibial nerve stimulation and sacral neuromodulation: an update.

Neuromodulation is an important treatment modality for a variety of pelvic floor disorders. Percutaneous tibial nerve stimulation (PTNS) and sacral neuromodulation (SNM) are currently the two approved methods for delivering this therapy. Percutaneous tibial nerve stimulation is a minimally invasive office-based procedure that has shown efficacy in the treatment of overactive bladder, fecal incontinence, and pelvic pain. It has the advantage of minimal side effects but is limited by the need for patients to make weekly office visits to receive the series of treatments. Sacral neuromodulation uses an implanted device that stimulates the S3 nerve root and can improve symptoms of overactive bladder, non-obstructive urinary retention, fecal incontinence, and pelvic pain. This paper will review the most recent literature regarding this topic and discuss their advantages and limitations and recent innovations in their use.

Social Media and Online Communication: Clinical Urology Practice in the 21st Century.

INTRODUCTION: Social media use by urologists is common with more than 66% reporting an active account. Most of this is for personal use or at urological conferences, although it can be a powerful tool for patient education and engagement. Patients and care givers are increasingly using online materials to search for health information, although how social media is used is still unclear. For the practicing urologist this review provides an introduction to the use, platforms and risks of social media and other online communication. METHODS: Available social media platforms and their use are reviewed. The unique challenges associated with digital communication are outlined along with suggested ways to post information responsibly. RESULTS: Users should have clear goals when engaging patients online. These may include disease education, practice updates or patient information. Social media accounts should regularly be screened for misuse or harmful comments. Patient confidentiality and professionalism should always be maintained. The widespread sharing and posting of digital content pose unique challenges and advantages for health care professionals. Maintaining the urologist reputation and that of the practice requires all content to be assumed public, even if posted on personal accounts. CONCLUSIONS: Overall the popularity of social media and online communication is increasing. The role in the physician-patient relationship is still evolving. Patient education, disease awareness and expanding the reach of a urologist practice are all possible online and with social media.

Advances in diagnosis and treatment of interstitial cystitis/painful bladder syndrome.

Interstitial cystitis/bladder pain syndrome (IC/BPS) is a prevalent chronic condition that can be challenging not only to diagnose but also to treat. We review recent diagnostic markers and therapies for IC/BPS from non-medication-based therapies, oral therapies, intravesical therapies, and surgical treatments.