Long-Term Outcomes Following Surgical Management of Urethral Catheter Injuries in Men With Spinal Cord Injury

Objective: To evaluate the outcomes of surgical management of men with spina cord injury (SCI) with subsequent catheter damage to the urethra that prevents clean intermittent catheterization (CIC). Methods: We performed a retrospective analysis of male SCI individuals on CIC with catheter-induced urethral injuries who had undergone an operative intervention in the last 30 years at our institution. The offered surgical managements were direct vision internal urethrotomy (DVIU) or urethroplasty (UP). Continent diversion (CDIV) was indicated when reconstruction was not possible. Results: A total of 43 male SCI patients were identified. Median age was 50 years (IQR 41 to 57), and follow-up was 69 months (IQR 34 to 125). Inability to perform CIC was due to urethral stricture (25), false passages (11), fistula (4), diverticulum (2), and urethral erosion (1) . Primary intervention techniques were DVIU, UP, and CDIV. Overall primary success, defined by the ability to return to continent CIC, was 25/43 (58%); secondary surgery (10 CDIV, 3 UP, 1 DVIU) rescued 14/18 failures for a final 91% success rate. Conclusion: Urethral injuries in men with SCI are complex, but individualized continued surgical management can be successful in up to 90% of patients. Therefore, reconstruction should be considered in this population to restore continent intermittent catheterization.

Urethral erosion developed after implantation of artificial urinary sphincter

The case report presents a clinical observation of urethral erosion that developed after a long-term presence of a urethral catheter in a patient after implantation of an artificial bladder sphincter. The stages of the patients surgical treatment are described. The frequency of such complications in patients with an established artificial bladder sphincter according to literature data is presented.

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OBJECTIVES/SPECIFIC AIMS: Stress urinary incontinence (SUI) significantly affects quality of life and occurs in 60% of men after radical prostatectomy, with 5% requiring surgical treatment. The artificial urinary sphincter (AUS) offers these patients excellent control of their post-prostatectomy SUI. The device contains 3 parts: the pump, urethral cuff, and pressure regulating balloon. Despite the effectiveness of AUS, up to 50% of patients require surgical revision after initial placement due to recurring SUI. Thus far, literature is heterogeneous regarding the causes of mechanical AUS failure and appropriate surgical management. Our study aims to characterize the most common reasons of AUS failure requiring surgical revision and the survival of each AUS component. METHODS/STUDY POPULATION: We report a series of 48 patients who received AUS placement and/or revision by 1 surgeon from 2010 to 2013. Upon presenting for revision, intraoperatively, the surgeon systematically evaluated the device for failure of the balloon, cuff and pump as well as urethral erosion and atrophy. In patients not requiring revision all device components were presumed functional. We conducted retrospective chart review to collect baseline characteristics, intraoperative findings, and postoperative outcomes. Using Kaplan-Meier estimates, we calculated incidence rates of component failure for the cuff, pump, and balloon. To identify risk factors for AUS failure, Cox regression was performed for univariate and multivariable testing. Multivariable modeling included those variables considered biologically plausible and significant in univariate testing. RESULTS/ANTICIPATED RESULTS: In total, 48 patients were studied with median follow up of 4.25 years. All patients received an AMS 800 device with a 61–70 mL balloon filled with 27 cc of isotonic contrast. Cuff sizes ranged from 3.5 to 5.5 cm, with 4.5 cm selected in 33/48 cases (68.8%); 19 of the patients required AUS correction (41.7%). Balloon leak constituted 57.9% (11/19) of failures, followed by cuff failure/urethral atrophy (21.1%), urethral erosion (10.5%), and individual cases of infection and pump failure. Median time to mechanical failure due to balloon leak was 3.67 years (IQR 2.17, 5.33); median time to failure for nonballoon causes was 0.54 years (IQR 0.25, 1.83). Survival of the balloon, cuff, and pump was 100%, 95.7%, and 97.9% at 1 year and 76.9%, 91.0%, and 97.9% at 5 years, respectively. DISCUSSION/SIGNIFICANCE OF IMPACT: Our study identifies fluid leakage from the balloon as the most common cause of AUS failure, particularly in patients presenting between 1 and 5 years after initial placement. For such patients, interrogating the balloon first can decrease infection risk and surgical morbidity as it can avoid manipulation of the urethral cuff. Furthermore, simply replacing lost fluid saves cost and allows for immediate reactivation of the AUS device.

Multicentre Experience with ZSI 375 Artificial Urinary Sphincter for the Treatment of Stress Urinary Incontinence in Men

Objectives The aim of this study was to evaluate the safety and efficacy of the artificial urinary sphincter ZSI 375 device in male patients with stress urinary incontinence (SUI) at 10 centres. Methods This was a retrospective, nonrandomised, multicentre study. From January 2012 to December 2014, and follow-up to February 2016, men with SUI were treated with the ZSI 375 device. The primary outcome was continence. The secondary outcome was complications rate. Results A total of 147 patients with moderate-to-severe stress incontinence and mean age of 70.67 (26-85) years underwent implantation of the ZSI 375 device at 10 centres. The most common indication for placement was incontinence after radical prostatectomy (121 patients: 82.31%). The ZSI 375 device was considered successful in 86.40% of cases after 12 months follow-up, 83.52% after 24 months follow-up and 78.26% after 36 months follow-up. The infection rate was 6.12%, urethral erosion was 12.92% and mechanical failure was limited to 3.40% leading to ZSI 375 improvement. Conclusions This study confirmed safety and efficacy of ZSI 375 device to treat moderate-to-severe SUI in men.

Urinary Artificial Sphincter ZSI 375 for Treatment of Stress Urinary Incontinence in Men: 5 and 7 Years Follow-Up Report

Study Design This is a retrospective, non-randomised study. Objectives The aim of this study was to evaluate safety and efficacy of artificial urinary sphincter ZSI 375 inserted in male patients with stress urinary incontinence (SUI). Methods Between May 2009 and January 2017, 45 men with SUI underwent ZSI 375 device insertion. Operations were performed in two French centres by one surgeon. Complications and pad used to manage continence were recorded. Results From May 2009 to January 2012, 45 patients with a mean age of 70.42 years underwent placement of the ZSI 375 device in France. The most common cause for incontinence was radical prostatectomy (RP, 33/45 ­patients, 73.33%). The minimal period of incontinence was 6 months. Twenty-seven out of 45 patients (60.00%) had a severe incontinence (at least four pads per day), 13 patients (28.89%) had moderate incontinence (three pads per day) and five patients (11.11%) had two pads per day. With a long follow-up, the ZSI 375 device was considered to be successful in 73.33% patients after 5 years (60 months) and 72% of patients after 7 years (84 months). The infection rate was 2.2 % affecting one in 45 patients. Six out of 45 patients presented a urethral erosion (13.33%). Mechanical failure with a revision occurred in three patients (6.67%). Conclusions The ZSI 375 device is a safe and effective device to treat severe SUI in men.