Efficacy and safety of adjustable balloons (Proact™) to treat male stress urinary incontinence after prostate surgery: Medium and long-term follow-up data of a national multicentric retrospective study.

AIMS: Male stress urinary incontinence (SUI) represents a complication after radical prostatectomy or benign prostatic obstruction surgery. The artificial urinary sphincter is considered the standard treatment but interest on minimally invasive devices, such as adjustable balloons, has recently increased. Aim of this study is to evaluate the efficacy and safety of the ProACT system. METHODS: In this multicentric retrospective study, we reported the data from nine centers. Patients with SUI who underwent a ProACT device implantation for postoperative SUI and had a minimum follow-up of 24 months were included. Efficacy was evaluated at the maximum available follow-up and was assessed utilizing a 24-hour pad test. Patients were considered: "Dry" if presenting a urine leak weight lower than 8 g at the 24-hour pad test; "Improved" if presenting a reduction of urine leak higher than 50% (but >8 g/24 hours); "Failure" if presenting a reduction in urine leak lower than 50%. The evaluation included a record of intraoperative and long-term complications. RESULTS: Safety and efficacy results are reported on 240 patients. 29.6% of patients were dry at 24 months, 37.5% were improved and 32.9% of patients were considered failures. The baseline mean pad weight of 367 g was reduced to 123 g at 24 months. Five-year follow-up on 152 patients showed similar efficacy. The complication rate was 22.5%, with the top complication being long-term balloon failure. CONCLUSIONS: ProACT implantation represents a safe and efficacious treatment for male postoperative SUI at both medium and long-term follow up. 67.1% of patients were dry or improved at 24 months. The majority of complications are low grade.

Efficacy and safety of artificial urinary sphincter (AUS): Results of a large multi-institutional cohort of patients with mid-term follow-up.

AIMS: To assess efficacy and safety as well as predictive factors of dry rate and freedom from surgical revision in patients underwent AUS placement. The artificial urinary sphincter (AUS) is still considered the standard for the treatment of moderate to severe post-prostatectomy stress urinary incontinence (SUI). However, data reporting efficacy and safety from large series are lacking. METHODS: A multicenter, retrospective study was conducted in 16 centers in Europe and USA. Only primary cases of AUS implantation in non-neurogenic SUI after prostate surgery, with a follow-up of at least 1 year were included. Efficacy data (continence rate, based on pad usage) and safety data (revision rate in case of infection and erosion, as well as atrophy or mechanical failure) were collected. Multivariable analyses were performed in order to investigate possible predictors of the aforementioned outcomes. RESULTS: Eight hundred ninety-two men had primary AUS implantation. At 32 months mean follow-up overall dry rate and surgical revision were 58% and 30.7%, respectively. Logistic regression analysis showed that patients without previous incontinence surgery had a higher probability to be dry after AUS implantation (OR: 0.51, P = 0.03). Moreover institutional case-load was positively associated with dry rate (OR: 1.18; P = 0.005) and freedom from revision (OR: 1.51; P = 0.00). CONCLUSIONS: The results of this study showed that AUS is an effective option for the treatment of SUI after prostate surgery. Moreover previous incontinence surgery and low institutional case-load are negatively associated to efficacy and safety outcomes.

Argus-T Sling in 182 Male Patients: Short-term Results of a Multicenter Study.

OBJECTIVE: To evaluate the short-term results with Argus-T sling in patients with post-prostatectomy incontinence (PPI). MATERIALS AND METHODS: A total of 182 patients with PPI were treated with Argus-T sling at 5 urologic centers from June 2008 to March 2013. The preoperative evaluation included medical history, pad count (1-2 pads: mild PPI; 3-5 pads: moderate PPI; >5 pads: severe PPI), visual analog scale on continence, quality of life score scale, physical examination, cystoscopy, and urodynamic evaluation. Postoperative evaluation was performed 6 weeks postoperatively, and late follow-up was achieved in April 2013. We considered a successful result when patients were cured (0-1 pads/24 hours) and or improved (1-2 pads/24 hours or a reduction in pad per day usage greater than 50%). RESULTS: Twenty-one (11.8%), 96 (52.7%), and 65 (35.7%) patients have mild, moderate, and severe incontinence, respectively. At the median follow-up of 22 months, the overall success rate was 86.2%. We obtained successful results of 95% in mild incontinence, 78% in moderate incontinence and 70% in severe incontinence. In cured and improved patients, we observed a statistically significant amelioration of quality of life (P <.0001). Sling regulation was carried out in 42.9% of cases, whereas its removal occurred in 9.3% of cases. Postoperative complications were reported in 14.3% of patients. In patients with previous radiotherapy, we observed a successful result in 61.2% of cases. CONCLUSION: This study represents the first report that shows short-term results of Argus-T positioning in a large population. Argus-T seems to offer good outcomes in patients with mild and moderate PPI.

Long-Term Outcomes of the Implant of a Periurethral Constrictor for Stress Urinary Incontinence Following Radical Prostatectomy.

OBJECTIVES: To assess morbidity, effectiveness and quality of life (QoL) of implant of Silimed periurethral constrictor (PC) in a consecutive series of patients who had stress urinary incontinence following radical prostatectomy. MATERIAL AND METHODS: A prospective non-randomized study designed on patients who underwent implant of Silimed PC. Primary end point was postoperative morbidity and secondary end points were effectiveness of implant and QoL. We performed a sub-analysis of men who received previous radiation and we compared the subpopulation with radiation-naïve patients. RESULTS: Nineteen patients (31.6%) received pelvic radiation therapy prior implant. All procedures were completed successfully with median operative time of 55 (IQR 50-62.5) min. We recorded 47 (78.3%) postoperative complications in 30 men. Twenty-three men (38.3%) developed urethral erosion at median follow-up of 27.5 (IQR 21-35) months, and 1 man (1.9%) had rectourethral fistula at 2 months. Risk of urethral erosion increased significantly among patients who received radiation (63.1 vs. 26.8%; p < 0.001). In 12 cases (20%), we recorded malfunctioning of the reservoir requiring replacement. CONCLUSION: The implant of Silimed device is not safe due to a high risk of urethral erosion. Careful patient selection and detailed counseling are mandatory when considering the implant of PC in adult patients.

Sacral neuromodulation for urinary retention in a kidney-transplant patient.

Bladder outlet obstruction can negatively affect renal function in the kidney transplant population. Functional obstruction represents a clinical challenge as conventional treatments are either ineffective or not recommended. Sacral neuromodulation was successfully used in functional voiding dysfunction in a kidney transplant patient. This is the first case to be reported in the literature.