Future considerations in prosthetic urology.

Since their popularization, genitourinary prosthetics have remained a gold-standard therapy for the treatment of erectile dysfunction and stress urinary incontinence and in cases of testicular loss or dysfunction. They have also represented an area of significant innovation, which has contributed to excellent long-term outcomes. Given this history, the objective of the current review was to provide a 5-10-year outlook on anticipated trends and developments in the field of genitourinary prosthetics. To accomplish this objective, a PubMed and patent search was performed of topics relating to penile and testicular prostheses and urinary sphincters. In regard to penile prostheses, findings demonstrated several new concepts including temperature-sensitive alloys, automated pumps, devices designed specifically for neophalluses, and improved malleable designs. With artificial urinary sphincters, new concepts include the ability to add or remove fluid from an existing system, two-piece systems, and new mechanisms to occlude the urethra. For testicular prosthetics, future implementations may not only better replicate the feel of a biological testicle but also add endocrinological functions. Beyond device innovation, the future of prosthetics is also one of expanding geographic boundaries, which necessitates variable cost modeling and regulatory considerations. Surgical trends are also changing, with a greater emphasis on nonnarcotic, postoperative pain control, outpatient surgeries, and adjunctive techniques to lengthen the penis and address concomitant stress incontinence, among others. Concomitant with device and surgical changes, future considerations also include a greater need for education and training, particularly given the rapid expansion of sexual medicine into developing nations.

Analysis of cost of component replacement versus entire device replacement during artificial urinary sphincter revision surgery.

AIM: To identify the costs of replacing an entire malfunctioning AUS device versus an individual component at the time of device malfunction. METHODS: Decision analysis was performed by analyzing the costs associated with revising a malfunctioning artificial urinary sphincter using one of two techniques: either individual or entire device replacement. Costs were determined by including actual institutional costs. Model assumptions were based on a summary of published literature and were created based on a time horizon of 0-5 years since the original, primary AUS was placed, and models were created for malfunction of each individual component. Sensitivity analysis was done adjusting for costs of the device and failure rates. RESULTS: Total costs to replace an individual component were $8330 for the pump, $7611 for the cuff, and $5599 for the balloon, while entire device replacement cost $15 069. Over a 5-year time horizon the cost per patient for replacement of a balloon, pump, or cuff were $14 407, $17 491, and $15 212, respectively, versus $18 001 if the entire device was replaced. To be less costly to replace the entire device, balloon, pump, and cuff failure rates would need to be >55%, >25%, or >37.5% during the first 2 years after placement. CONCLUSION: In the event of failure of the artificial urinary sphincter, cost analysis demonstrates that removal and replacement of the entire device is more expensive than replacement of a malfunctioning component at any point up to 5 years after initial AUS placement.

Artificial urinary sphincter for urinary incontinence after radical prostatectomy: a historical cohort from 2004 to 2015

ABSTRACT This study aimed to retrospectively evaluate a cohort of patients with prostate cancer and persistent urinary incontinence after radical prostatectomy. From January 2004 to December 2015, eighty-six individuals were identified to have received an AUS implant, provided by a private nonprofit HMO operating in Belo Horizonte, Brazil. On total, there were 91 AUS implants, with a median interval between radical prostatectomy and AUS implant of 3.6 years (IQR 1.9 to 5.5). The rate of AUS cumulative survival, after a median follow-up of 4.1 years (IQR 1.7-7.2 years), was 44% (n=40). The median survival of AUS implants was 2.9 years (IQR 0.5-7.9 years). Thirty-seven AUS implants (40.7%) resulted in grade III surgical complications. There were 5 deaths at 2.1, 4.7, 5.7, 5.7 and 6.5 years of follow-up, but none due to causes directly associated to the AUS implant. Persistent severe incontinence was documented in 14 (15.3%) additional patients. From the 51 AUS implants which resulted in grade III surgical complications or persistent severe incontinence, 24 (47.1%) underwent surgical revisions. Explantation of the sphincter or its components was observed in 6 cases (25.0%). Mechanical failure, described as fluid loss and/or inability to recycle the AUS device, was observed in 4 devices (16.7%). In conclusion, although AUS implants are recommended as the gold-standard treatment of severe urinary incontinence after prostatectomy, the observed high rates of malfunction and grade III adverse events are a matter of concern warranting further assessment on the safety and efficacy of these devices.

Artificial urinary sphincter for urinary incontinence after radical prostatectomy: a historical cohort from 2004 to 2015.

This study aimed to retrospectively evaluate a cohort of patients with prostate cancer and persistent urinary incontinence after radical prostatectomy. From January 2004 to December 2015, eighty-six individuals were identified to have received an AUS implant, provided by a private nonprofit HMO operating in Belo Horizonte, Brazil. On total, there were 91 AUS implants, with a median interval between radical prostatectomy and AUS implant of 3.6 years (IQR 1.9 to 5.5). The rate of AUS cumulative survival, after a median follow-up of 4.1 years (IQR 1.7-7.2 years), was 44% (n=40). The median survival of AUS implants was 2.9 years (IQR 0.5-7.9 years). Thirty-seven AUS implants (40.7%) resulted in grade III surgical complications. There were 5 deaths at 2.1, 4.7, 5.7, 5.7 and 6.5 years of follow-up, but none due to causes directly associated to the AUS implant. Persistent severe incontinence was documented in 14 (15.3%) additional patients. From the 51 AUS implants which resulted in grade III surgical complications or persistent severe incontinence, 24 (47.1%) underwent surgical revisions. Explantation of the sphincter or its components was observed in 6 cases (25.0%). Mechanical failure, described as fluid loss and/or inability to recycle the AUS device, was observed in 4 devices (16.7%). In conclusion, although AUS implants are recommended as the gold-standard treatment of severe urinary incontinence after prostatectomy, the observed high rates of malfunction and grade III adverse events are a matter of concern warranting further assessment on the safety and efficacy of these devices.

Surgery for stress urinary incontinence due to presumed sphincter deficiency after prostate surgery.

BACKGROUND: Incontinence after prostatectomy for benign or malignant disease is a well-known and often a feared outcome. Although small degrees of incidental incontinence may go virtually unnoticed, larger degrees of incontinence can have a major impact on a man's quality of life.Conceptually, post-prostatectomy incontinence may be caused by sphincter malfunction or bladder dysfunction, or both. Most men with post-prostatectomy incontinence (60% to 100%) have stress urinary incontinence, which is involuntary urinary leakage on effort or exertion, or on sneezing or coughing. This may be due to intrinsic sphincter deficiency and may be treated with surgery for optimal management of incontinence. Detrusor dysfunction is more common after surgery for benign prostatic disease. OBJECTIVES: To determine the effects of surgical treatment for urinary incontinence related to presumed sphincter deficiency after prostate surgery for:- men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) - transurethral resection of prostate (TURP), photo vaporisation of the prostate, laser enucleation of the prostate or open prostatectomy - and- men with prostate cancer - radical prostatectomy (retropubic, perineal, laparoscopic, or robotic). SEARCH METHODS: We searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE in process, ClinicalTrials.gov, and handsearching of journals and conference proceedings (searched 31 March 2014); MEDLINE (January 1966 to April 2014); EMBASE (January 1988 to April 2014); and LILACS (January 1982 to April 2014). We handsearched the reference lists of relevant articles and conference proceedings. We contacted investigators to locate studies. SELECTION CRITERIA: Randomised or quasi-randomised trials that include surgical treatments of urinary incontinence after prostate surgery. DATA COLLECTION AND ANALYSIS: Two authors independently screened the trials identified, appraised quality of papers, and extracted data. MAIN RESULTS: Only one study with 45 participants met the inclusion criteria. Men were divided in two sub-groups (minimal or total incontinence) and each group was randomised to artificial urethral sphincter (AUS) implantation or Macroplastique injection. Follow-up ranged from six to 120 months. In the trial as a whole, the men treated with AUS were more likely to be dry (18/20, 82%) than those who had the injectable treatment (11/23, 46%) (odds ratio (OR) 5.67, 95% confidence interval (CI) 1.28 to 25.10). However, this effect was only statistically significant for the men with more severe ('total') incontinence (OR 8.89, 95% CI 1.40 to 56.57) and the CIs were wide. There were more severe complications in the group undergoing AUS, and the costs were higher. AUS implantation was complicated in 5/22 (23%) men: the implant had to be removed from one man because of infection and in one man due to the erosion of the cuff, in one man the pump was changed due to mechanical failure, in one man there was migration to the intraperitoneal region, and one man experienced scrotal erosion. In the injectable group, 3/23 (13%) men had a complication: one man treated with Macroplastique injection had to be catheterised because of urinary retention and two men developed urinary tract infections. AUTHORS' CONCLUSIONS: The evidence available at present was of very low quality because we identified only one small randomised clinical trial. Although the result was favourable for the implantation of AUS in the group with severe incontinence, this result should be considered with caution due to the small sample size and uncertain methodological quality of the study found.

The impact of an antibiotic coating on the artificial urinary sphincter infection rate.

PURPOSE: In April 2008 InhibiZone® antibiotic coated artificial urinary sphincters were introduced. The antibiotic coating significantly increased the cost of the device by an average of $1,300 per artificial urinary sphincter. To our knowledge, no clinical data to date support the theory that this antibiotic coating decreases the risk of artificial urinary sphincter infection. Therefore, we compared infection rates in our cases before and after the introduction of InhibiZone coated artificial urinary sphincters to determine whether the coating decreased the device infection rate. MATERIALS AND METHODS: We retrospectively reviewed the records of 426 consecutive patients in whom an artificial urinary sphincter was implanted by a single surgeon from January 2005 to June 2012. Patients were divided equally into 213 consecutive males who received an artificial urinary sphincter without the antibiotic coating from January 2005 to March 2008 and 213 consecutive males implanted with the antibiotic coated artificial urinary sphincter from April 2008 to June 2012. Demographics and infection rates were compared. RESULTS: Patient mean age, associated comorbidities and complexity were almost identical in the groups with and without the antibiotic coating, and infection rates were identical at 7 patients (3.3%) per group (p = 0.99). In the more complex patient subgroup with revision the antibiotic coating did not impact the infection rate. Infection developed in 2 of 50 patients (5%) with the antibiotic coated device and in 3 of 38 (6%) with the uncoated device (p = 0.42). CONCLUSIONS: The InhibiZone coating of the artificial urinary sphincters did not alter the infection rate in our study. The added cost of the antibiotic coated artificial urinary sphincters (total of approximately $276,000 more for all 213 coated devices) was of no benefit in our series. Based on this assessment, we will transition to using artificial urinary sphincters without InhibiZone in our practice.

Surgery for stress urinary incontinence due to presumed sphincter deficiency after prostate surgery.

BACKGROUND: Incontinence after prostatectomy for benign or malignant disease is a well known and often a feared outcome. Although small degrees of incidental incontinence may go virtually unnoticed, larger degrees of incontinence can have a major impact on a man's quality of life.Conceptually, postprostatectomy incontinence may be caused by sphincter malfunction and/or bladder dysfunction. The majority of men with post-prostatectomy incontinence (60 to 100%) have stress urinary incontinence, which is the complaint of involuntary urinary leakage on effort or exertion, or on sneezing or coughing. This may be due to intrinsic sphincter deficiency and may be treated with surgery for optimal management of incontinence. Detrusor dysfunction is more common after surgery for benign prostatic disease. OBJECTIVES: To determine the effects of surgical treatment for urinary incontinence related to presumed sphincter deficiency after prostate surgery for either benign LUTS secondary to BPH (transurethral resection of prostate (TURP), photo vaporization of the prostate, laser enucleation of the prostate and open prostatectomy) or radical prostatectomy for prostate cancer (retropubic, perineal, laparoscopic, or robotic). SEARCH STRATEGY: We searched the Cochrane Incontinence Group Specialised Register (searched 28 June 2010), MEDLINE (January 1966 to January 2010), EMBASE (January 1988 to January 2010), LILACS (January 1982 to January 2010) and the reference lists of relevant articles, handsearched conference proceedings and contacted investigators to locate studies. SELECTION CRITERIA: Randomised or quasi-randomised trials that include surgical treatments of urinary incontinence after prostate surgery. DATA COLLECTION AND ANALYSIS: Two authors independently screened the trials identified, appraised quality of papers and extracted data. MAIN RESULTS: Only one study with 45 participants met the inclusion criteria. Men were divided in two subgroups (minimal or total incontinence) and each group was randomized to artificial urethral sphincter (AUS) implantation or Macroplastique injection. Follow-up ranged from six to 120 months. In the trial as a whole, the men treated with AUS were more likely to be dry (18/20, 82%) than those who had the injectable treatment (11/23, 46%) (OR 5.67, 95% CI 1.28 to 25.10). However, this effect was only statistically significant for the men with more severe ('total') incontinence (OR 8.89, 95% CI 1.40 to 56.57) and the confidence intervals were wide. There were more severe complications in the group undergoing AUS, and the costs were higher. AUTHORS' CONCLUSIONS: The evidence available at present is limited because only one small randomised clinical trial was identified. Although the result is favourable for the implantation of AUS in the group with severe incontinence, this result should be considered with caution due to the small sample size and uncertain methodological quality of the study found.

An adjustable continence therapy device for treating incontinence after prostatectomy: a minimum 2-year follow-up.

OBJECTIVE: To evaluate the efficacy and safety of the ProACT (Uromedica, Inc., MN, USA) balloon device, an alternative for the surgical management of incontinence after prostatectomy. PATIENTS AND METHODS: The initial patients who received this device at our institution were evaluated, using urodynamics at baseline and at 6 months. Perioperative variables were recorded and pad usage, volume adjustments, an estimate of Incontinence Quality of Life (I-QoL) and adverse events were recorded at baseline, and 1, 3, 6, 12 and 24 months after surgery. RESULTS: In all, 37 patients were treated on this protocol between November 2001 and March 2005. Of these, 30 had had radical prostatectomy and seven holmium laser enucleation of the prostate. The mean (range) pad usage decreased from 2.81 (1-12) at baseline to 0.7 (0-4) pads at 24 months, and the I-QOL increased from 49.7 (4.5-77) to 81.3 (13.6-100) over the same period. At 24 months, 62% of 34 men were pad-free and 81% required one pad or less. Bilateral explantation was required in three patients (11%) for infection (one) and balloon migration (two). All other adverse events were mild and transient. CONCLUSIONS: The ProACT balloon device is an acceptable therapy for the surgical management of incontinence after prostatectomy.

Does the Kaufman prosthesis still have a place? Review of thirteen years' experience.

The cases of 57 patients who underwent implantation of a Kaufman prosthesis for urinary incontinence at this center are reviewed. All except one of the patients were incontinent following prostatic surgery. Although many of the patients required revision or adjustments after the initial implantation, 55 percent of the cases eventually had a satisfactory outcome. Patients rendered incontinent after retropubic prostatectomy had a higher success rate with the Kaufman prosthesis than patients after other types of prostatectomy. This simple and relatively inexpensive device can still play a useful role in the treatment of patients with mild and moderate stress incontinence following prostatectomy.