Immediate and Long-term Outcomes of Lateral Retroperitoneal Pressure Regulating Balloon Placement During Artificial Urinary Sphincter Implantation.

OBJECTIVE: To describe immediate and long-term outcomes of pressure regulating balloon (PRB) placement, exchange, and extraction from the lateral retroperitoneum (LR) in male patients receiving an artificial urinary sphincter (AUS). METHODS: A retrospective chart review was performed on all patients that underwent primary AUS placement between 2006 and 2021. All patients had the PRB placed in the LR during the study period. Intraoperative complications during PRB placement, exchange, or removal, and indications for PRB revision, such as infection, erosion, or mechanical failures were analyzed. RESULTS: Five hundred forty-one patients were included in the study. All patients underwent primary implantation with no intraoperative complications including no incidents of bowel or vascular injury during PRB placement. In addition, there were no instances of intraoperative injury during PRB removal (with or without PRB replacement). After mean follow-up of 54.8months (range: 1-181months), 9 patients (1.7%) developed a reservoir-specific complication with infection (5 patients, 0.9%) being the most common issue found. The second most common type or reservoir issue was a palpable or herniated reservoir. There were 2 patients (0.4%) who herniated their reservoirs and one patient with a nonbothersome, but palpable reservoir. Lastly, there were 2 incidents (0.4%) of mechanical failure caused by a leak in the PRB. CONCLUSION: Due to the ease and safety of placing and removing PRBs from this location and exceedingly low rates of PRB-related complications in long-term follow-up, the LR should be considered as an ideal location for PRB placement in male patients receiving an AUS.

The 51-60 cm H2O Artificial Urinary Sphincter Pressure Regulating Balloon: Indications and Outcomes.

OBJECTIVE: To describe the role and long-term outcomes of using the 51-60cm H2O pressure regulating balloon (PRB) in male patients with an artificial urinary sphincter (AUS). METHODS: From 2005-2021, 90 patients with a variety of urethral risk factors underwent AUS placement with use of the low-pressure 51-60 cm H2O PRB to treat stress incontinence. Patient demographics, indication for use of the 51-60 cm H2O PRB, perioperative data, and postoperative outcomes were examined and Pearson's chi squared test and Wilcoxon rank sum test were used to identify associations with future revisions, erosion, and mechanical failure. RESULTS: Ninety patients were included in the study. After median follow-up of 46.6months (range: 6-146months), 4 (4.44%) patients developed an erosion-related complication that required device removal, 4 developed an infection, and 3 underwent surgery for pump relocation. One patient had a reported mechanical failure of unknown source. Thirty patients underwent revision surgery to reduce incontinence. Of the 4 patients with erosion, 1 was due to iatrogenic catheterization. The remaining 3 had numerous urethral risk factors. Univariate analysis was performed to identify predictors of cuff erosion, infection, and revision in patients with a 51-60 cm H2O PRB. No significant associations were found including prior pelvic radiation, age at AUS placement, presence of inflatable penile prosthesis (IPP), prior AUS erosion, or previous urethroplasty. CONCLUSION: The low-pressure 51-60 cm H2O PRB can be used in high-risk male patients with urinary incontinence with low rates of complications including erosion, infection, and mechanical failure. While patients may choose to undergo future revisional surgery to improve continence, the 51-60 cm H2O PRB should be considered as the initial PRB in patients with urethral risk factors.

Outcomes of Alternative Reservoir Placement in the Lateral Retroperitoneum During Inflatable Penile Prosthesis Placement.

OBJECTIVES: To describe outcomes of reservoir placement, exchange, and extraction from the lateral retroperitoneum (LR) in complex patients with a three-piece inflatable penile prosthesis (IPP). METHODS: A retrospective chart review was performed on all patients that underwent placement of an IPP from 2009 to 2019. Patients with placement of the reservoir in the LR were identified. Intraoperative complications during reservoir placement, exchange, or removal, reservoir-related outcomes, and secondary device-related outcomes were collated and compared to patients who underwent traditional Space of Retzius reservoir placement. RESULTS: A total of 587 men underwent primary IPP placement with 321 patients undergoing reservoir placement in the SOR and 266 in the LR. No significant differences were found in intra-operative reservoir-related outcomes (P=.272) between the 2 groups during placement, replacement, or extraction. Bowel injury occurred in 1 patient in the LR group during placement. No significant differences were found in postoperative reservoir complications (P= .534). Both groups each had one instance of patient reported bulge and pain at reservoir site (P= .6777). Two (0.6%) patients in the SOR group and 3 (1.1%) patients in the LR group had a reservoir failure or leak. There was a trend towards a lower rate of device infections in the LR group (1.9%) compared to the SOR group (4.7%) (P= .063). There were no significant differences in overall device mechanical failure rates between both groups (P= .919). CONCLUSIONS: Reservoir placement in the LR is safe in patients with complex pelvic anatomy with equivalent device durability and no difference in surgical outcomes compared to standard retropubic reservoir placement.

Predictors of Device-related Complications After Exchange of the Pressure-regulating Balloon in Men With an Artificial Urinary Sphincter.

OBJECTIVE: To identify patient and component specific factors that predispose patients to device-related complications when undergoing pressure-regulating balloon (PRB) exchange in men with an artificial urinary sphincter (AUS). METHOD: From 2009 to 2018, 55 patients underwent AUS revision with placement of a higher pressure 71-80 cm H2O PRB to treat recurrent stress incontinence. Patient demographics, perioperative data, and postoperative outcomes were examined and multivariable logistic regression analyses performed to identify predictors of erosion and mechanical failure. RESULT: After a median follow-up of 26.4 months (range: 6-103.7 months), 21 of 55 (38.1%) patients developed a device-related complication that required operative repair or removal of the AUS. Four (7.3%) patients developed erosion after the PRB pressure increase and 5 patients showed evidence of impending erosion on follow-up and underwent successful revision surgery. Twelve patients developed mechanical failure (cuff leak, n = 7; pump malfunction, n =4; unidentified fluid loss, n = 1). Multivariable logistic regression analysis found that increasing body mass index was a predictor of mechanical failure. Hypertension and lower body mass index were found to increase the risk of cuff erosion whereas radiotherapy was not. CONCLUSION: In the carefully selected patient, PRB exchange can be performed to treat recurrent incontinence in patients with an AUS, including those treated with pelvic radiotherapy. Our data suggest that this technique is susceptible to a high rate of revision surgery. As such, when revising a functional AUS system, meticulous preoperative screening, comprehensive informed consent, and follow-up protocols are essential in minimizing adverse events.

Dual Prosthetic Implantation After Radical Cystoprostatectomy and Neobladder: Outcomes of the Inflatable Penile Prosthesis and Artificial Urinary Sphincter in Bladder Cancer Survivors.

OBJECTIVES: To determine the impact of radical cystectomy and orthotopic neobladder (NB) diversion on device-related outcomes in patients who undergo subsequent placement of both, an artificial urinary sphincter (AUS) and 3-piece inflatable penile prosthesis. MATERIALS AND METHODS: Using an institutional prosthetic database, we identified 39 patients who underwent radical cystectomy and NB and subsequent implantation of both prosthetic devices from 2003 to 2017. Patient demographics, perioperative data, and postoperative outcomes including prosthetic infection, mechanical failure, revision surgery, and functional outcomes were examined and compared to an appropriate matched group of patients (n = 48, non-neobladder group). RESULTS: No intraoperative complications were observed. After median follow-up of 94 months (12-177 months), 1 patient developed an infection of their penile prosthesis and 4 patients developed an erosion of their AUS. In each case, the infection did not involve the other device. Two patients required revision surgery of their penile prosthesis due to mechanical failure (reservoir leak, n = 1; cylinder aneurysm, n = 1). Twenty-one patients underwent elective revision surgery to improve continence (cuff downsizing, n = 18; pressure-regulating balloon exchange, n = 3). There were 6 cases of AUS mechanical failure. No reservoir-related complications such as herniation or erosion were observed. Compared to the control group of non-neobladder patients, there were no significant differences in prosthetic infection, mechanical failure, and revision surgery. CONCLUSION: The AUS and 3-piece inflatable penile prosthesis can coexist safely in patients with NB without an increased risk of device-related complications.

Mechanical failure rates of artificial urinary sphincter components: Is the 3.5-cm urethral cuff at higher risk?

AIM: We report the rates of artificial urinary sphincter (AUS) mechanical failure in a contemporary cohort of patients stratified by component type and size to determine if the 3.5-cm cuff is at higher risk of failure. METHODS: From 2005-2016, a total of 486 male patients with stress incontinence underwent implantation or revision of an AUS. 993 individual cases were retrospectively reviewed (465 primary placements and 528 revisions). Components were separately tallied and cases of mechanical failure were identified. Multiple variables including duration until failure and follow-up interval were collected and analyzed for each malfunction. RESULTS: After median follow-up of 31.5 months, there were 48 distinct cases of mechanical failure. The urethral cuff was the most common component to fail (n = 27, 56.3%), followed by the pressure regulating balloon (PRB) (n = 6, 12.5%), tubing (n = 6, 12.5%), and the control pump, (n = 5, 10.4%). Four (8.3%) cases did not have the source of malfunction identifiable in available records though fluid loss was evident at the time of device interrogation. Sub-analyses of cuff failure events showed that the 3.5-cm cuff had a statistically significant higher risk of failure (HR: 7.313, (P < .0001) compared to larger cuff sizes. CONCLUSIONS: While each component is prone to malfunction, our study suggests that the 3.5-cm urethral cuff is more susceptible to failure and failure events occur earlier after placement than larger cuff sizes.

Three-Piece Inflatable Penile Prosthesis Placement Following Pelvic Radiation: Technical Considerations and Contemporary Outcomes.

BACKGROUND: Pelvic radiation is a known risk factor for the development and progression of erectile dysfunction. When medical therapy fails, the 3-piece inflatable penile prosthesis (IPP) can offer patients a definitive treatment option. Because of radiation-induced vascular changes and tissue fibrosis, a careful surgical approach is necessary to avoid intraoperative complications and attain successful outcomes. Despite its widespread use in prostate cancer treatment, there are no contemporary studies examining the effects that pelvic radiation can have on 3-piece IPP placement and device survival. AIM: To present technical considerations and contemporary outcomes of placing a 3-piece IPP for refractory erectile dysfunction in patients with a history of pelvic radiation. METHODS: We retrospectively reviewed 78 patients who underwent placement of a 3-piece IPP (AMS 700; Boston Scientific, Marlborough, MA, USA) after being treated with pelvic radiotherapy from 2003 through 2016. All patients had been treated with external beam and/or brachytherapy for treatment of prostate malignancy. An infrapubic approach was used in all patients, with reservoir placement in the space of Retzius or in the lateral retroperitoneal space. Patient demographics, perioperative data, and postoperative outcomes including prosthetic infection and mechanical failure were examined and statistical analysis was performed. OUTCOMES: Rates of device infection, revision surgery, and reservoir complications. RESULTS: No intraoperative complications were observed. After a mean follow-up of 49.0 months (6.6-116.8), 2 patients developed an infection of their prosthesis that required explantation. These patients underwent successful IPP removal and immediate reimplantation. 11 patients (14.1%) required revision surgery (pump replacement, n = 4; pump relocation, n = 2; cylinder replacement, n = 4; reservoir replacement owing to leak, n = 1). No reservoir-related complications such as herniation or erosion into adjacent structures were observed. CLINICAL IMPLICATIONS: The 3-piece IPP can be placed safely in a broad range of patients treated with pelvic radiotherapy. STRENGTHS AND LIMITATIONS: This study describes contemporary long-term outcomes of the IPP in patients treated with pelvic radiation and includes patients with prior pelvic surgery and artificial urinary sphincter, which are commonly encountered in practice. It is limited by its single-center experience and lacks a comparison group of patients. Objective patient satisfaction data were not available for inclusion. CONCLUSIONS: The 3-piece IPP can be placed successfully in patients with a history of pelvic radiation without a significant increase in infectious complications, reservoir erosion, or mechanical failure compared with the global literature. Loh-Doyle J, Patil MB, Nakhoda Z, et al. Three-Piece Inflatable Penile Prosthesis Placement Following Pelvic Radiation: Technical Considerations and Contemporary Outcomes. J Sex Med 2018;15:1049-1054.

Paratesticular Serous Papillary Carcinoma of High Grade and Malignant Potential: A Rare Case with a Role for Adjuvant Therapy.

Paratesticular serous papillary carcinomas are very rare, with less than 40 cases reported in the literature. These neoplasms are Müllerian in origin, and more commonly seen as epithelial-type ovarian cancer. Given the rarity of this tumor in men, staging and recommended treatment options do not exist. Herein, we present the case of a 35-year-old male with high-grade invasive serous papillary carcinoma. He was diagnosed after left radical orchiectomy for paratesticular mass and subsequently treated with adjuvant chemotherapy according to existing recommendations for its ovarian counterpart. Chemotherapy was well tolerated and surveillance imaging has shown no evidence of disease. This case suggests a potential role for adjuvant therapy in patients with high-grade paratesticular serous papillary carcinoma.

3-Piece Inflatable Penile Prosthesis Placement Following Radical Cystoprostatectomy and Urinary Diversion: Technique and Outcomes.

BACKGROUND: After radical cystoprostatectomy (RC), postoperative erectile dysfunction (ED) is a common consequence with multiple contributing etiologies. The inflatable penile prosthesis (IPP) offers patients a definitive treatment option when ED is refractory to medical therapies. Because of the hostile postoperative anatomy of these patients, a careful surgical approach is necessary for successful outcomes and to avoid adjacent organ injury. To date, there is no series describing the outcomes of 3-piece IPP placement in patients with urinary diversions. AIM: To present contemporary outcomes and a description of our technique in placing a 3-piece IPP for postoperative ED in patients with a history of RC with orthotopic neobladder, ileal conduit, or continent cutaneous diversion. METHODS: We retrospectively reviewed 80 patients who underwent primary placement of a 3-piece IPP (AMS 700; American Medical Systems Inc, Minnetonka, MN, USA) after RC and urinary diversion from 2003 through 2016. 79 patients underwent RC in their treatment of urologic malignancy (71 for bladder cancer, 8 for prostate cancer) and 1 underwent RC for refractory interstitial cystitis. An infrapubic approach was used in most patients, with reservoir placement in the lateral retroperitoneal space through a counterincision medial to the anterior superior iliac spine. Patient demographics, perioperative data, and postoperative outcomes including prosthetic infection and mechanical failure were examined and statistical analysis was performed. OUTCOMES: Rates of device infection, revision surgery, and reservoir complications. RESULTS: After mean follow-up of 53.9 months (6.5-150.7 months), 4 patients developed infection of the prosthesis that required explantation. 3 of those patients underwent successful IPP reimplantation. 5 patients required revision surgery (pump replacement, n = 3; pump relocation, n = 1; cylinder replacement for cylinder aneurysm, n = 1) for mechanical failure. No statistically significant associations were found between infection and comorbidities, urinary diversion, exposure to chemotherapy, radiation, or presence of an artificial urinary sphincter. CLINICAL IMPLICATIONS: The 3-piece IPP is an effective treatment option for medication-refractory ED that can be placed safely in patients with all forms of urinary diversion. STRENGTHS AND LIMITATIONS: This study represents the 1st series that describes a successful technique and long-term outcomes of patients with urinary diversion. It is limited by its single-surgeon, single-center experience and lacks validated patient satisfaction data in follow-up. CONCLUSIONS: The 3-piece IPP, with reservoir placement in the lateral retroperitoneum, can be implanted successfully in patients with all forms of urinary diversion without a significant increase in infectious complications, reservoir erosion, or mechanical failure. Loh-Doyle J, Patil MB, Sawkar H, et al. 3-Piece Inflatable Penile Prosthesis Placement Following Radical Cystoprostatectomy and Urinary Diversion: Technique and Outcomes. J Sex Med 2018;15:907-913.

Total bladder and posterior urethral reconstruction: salvage technique for defunctionalized bladder with recalcitrant posterior urethral stenosis.

PURPOSE: Recalcitrant posterior urethral stenosis is a challenging disease. When combined with a defunctionalized bladder, cutaneous urinary diversion is the most common surgical option. We present a novel technique of total lower urinary tract reconstruction, combining salvage cystectomy, ileal neobladder formation and urethral pull-through, as an orthotopic alternative in patients with a defunctionalized bladder and recalcitrant posterior urethral stenosis. MATERIALS AND METHODS: We completed a retrospective review of 8 patients who underwent salvage cystectomy, orthotopic ileal neobladder formation and urethral pull-through. Artificial urinary sphincter placement was performed in a staged fashion. Six patients received prostate cancer treatment including radiation therapy, 1 had urethral disruption after robotic radical prostatectomy, and 1 experienced bladder rupture and urethral distraction injury during a motorcycle accident. Patient demographics, operative variables and postoperative outcomes were examined. RESULTS: No high grade complications were observed after salvage cystectomy, orthotopic neobladder formation and urethral pull-through. After staged artificial urinary sphincter placement, a median of 2 revision surgeries (range 0 to 4) was required to establish social continence. All patients maintained functional urinary storage, urethral patency and social continence at a median followup of 58 months. No patient had complications related to orthotopic neobladder formation, including ureteroileal anastomotic stricture or pyelonephritis, and no patient required cutaneous diversion. CONCLUSIONS: Total lower urinary tract reconstruction with cystectomy, ileal neobladder formation and urethral pull-through offers an orthotopic alternative for patients with recalcitrant posterior urethral stenosis and defunctionalized bladders. Although it requires staged placement of an artificial urinary sphincter, this approach can offer functional urinary storage, durable urethral patency and avoidance of cutaneous urinary diversion.

Potential risk factors and outcomes of artificial urinary sphincter placement after radical cystectomy and orthotopic neobladder urinary diversion.

AIMS: Stress urinary incontinence (SUI) is a known possibility after radical cystectomy (RC) and orthotopic neobladder (ONB) urinary diversion. We retrospectively reviewed the outcomes and complications of patients who underwent artificial urinary sphincter (AUS) placement for treatment of SUI and evaluated potential risk factors (PRFs) for AUS failure. METHODS: Patients who underwent AUS placement after RC/ONB from 1994 to 2009 were identified. Variables evaluated included: demographics, cancer type, AUS characteristics, urinary incontinence (UI), revision procedures data, and PRFs for AUS failure. RESULTS: Demographic data was reviewed on 36 patients. Mean age at AUS placement was 72 (58-79) years. Mean time to AUS after RC/ONB was 28 (2-120) months. Mean follow up after AUS was 40 (2-132) months. TCC was the indication for RC in 94% of patients. The most commonly placed AUS cuff and reservoir size was 4.5 cm and 61-70 H2 O, respectively. Incontinence data was available in 29 patients. Pre-AUS placement 22, 3, and 4 patients were totally, daytime and nighttime only incontinent, respectively. Post-AUS placement, incontinence persisted in 5, 1, and 2 patients with total, daytime and nighttime incontinence, respectively. Prior to AUS placement 11/36 patients received chemotherapy and 10/36 had radiation. Mean time to the first revision/explantation due to UI/erosion/infection/malfunction was an average of 28 (3-96) months after AUS placement and occurred in 21/35 (60%) patients. There was no significant correlation noted between PRFs and UI pre-/post-AUS or between PRFs and the need for AUS revision. CONCLUSIONS: AUS is a safe, effective treatment with an acceptable complication rate for patients after RC/ONB with SUI.

A model for managing erectile dysfunction following prostate cancer treatment.

PURPOSE OF REVIEW: Radical prostatectomy, regardless of the technology used intraoperatively, induces erectile dysfunction for most men who undergo the procedure. For many men, this proves to be transient. Penile rehabilitation strategies have been developed with the goal of increasing the probability and speed of return of sexual function. The purpose of this work is to review the fundamentals of erectile dysfunction relevant to the postprostatectomy patient as well as the components that are often included in penile rehabilitation strategies. RECENT FINDINGS: Preservation of smooth muscle tissue is the key to preserving erectile function. This can be accomplished by providing the penis with regular exposure to oxygenated blood through intracaversonal injection therapy or vacuum erection device therapy. Dietary supplementation aimed to increase the nitric oxide production can also be beneficial. As well, chronic administration of PDE5 inhibitors may also help maintain the smooth muscle/collagen ratio in the corporal tissue. SUMMARY: These findings have led to the development of our management model that includes daily vacuum erection device therapy, dietary supplementation and PDE5 inhibitors which is described in detail. The success of any rehabilitation strategy is dependent on the patient compliance which needs to be facilitated by care-giver encouragement and the setting of realistic expectations.

Outcomes of artificial urinary sphincter placement in men after radical cystectomy and orthotopic urinary diversions for the treatment of stress urinary incontinence: the University of Southern California experience.

OBJECTIVE: To examine the outcomes of male patients who have undergone artificial urinary sphincter (AUS), AMS-800 (American Medical Systems Minnetonka, MN) placement for iatrogenic stress urinary incontinence after radical cystectomy (RC) and orthotopic neobladder (ONB) diversion in a single institution. MATERIALS AND METHODS: From 2002-2009, patients were prospectively randomized to undergo RC and Studer vs T-pouch neobladder reconstruction. We received IRB- approval to retrospectively review the charts of patients who underwent AUS placement for symptoms of SUI. Patients were mailed 2 validated questionnaires, International Continence Society Male-Short Form, the Incontinence Symptom Severity Index, and a pad questionnaire. RESULTS: Twelve male patients were identified. Average age at time of AUS placement was 73.8 years (range 52-82). Mean time between RC/ONB and AUS placement was 1.53 years (range 1-4). Mean follow-up time after initial AUS placement was 21.7 months (range 12-72). Ten patients (10/12; 83.3%) returned the validated questionnaires. In comparing pre-AUS to post-AUS continence, 90% of patients reported improvement in continence. Three patients deactivated their AUS during the day and activated it at night. There were no erosions (0%) or any mechanical malfunctions of the device (0%) in our cohort. There were no complications or injuries to the ONB during placement of the AUS components. CONCLUSION: AUS is a safe, effective continence procedure for patients with ONB and SUI. Complication rate, urinary symptoms, and quality of life these patients have as determined by validated questionnaires is acceptable.

Radical cystectomy with orthotopic neobladder reconstruction following prior radical prostatectomy.

PURPOSE: To review the perioperative and follow-up outcomes of patients undergoing radical cystectomy with orthotopic neobladder reconstruction for bladder cancer after prior radical prostatectomy (RP) for prostate cancer. METHODS: A retrospective review of more than 1,900 patients treated with radical cystectomy at USC between 1990 and 2011 was conducted. Fifty-six patients were identified who were previously treated with RP for prostate cancer. Twenty-four of these patients (43 %) underwent orthotopic neobladder reconstruction. Perioperative data and follow-up including postoperative continence were analyzed. RESULTS: The median age at cystectomy for these 24 patients was 68 years (range 55-89). The types of neobladder reconstruction were Kock neobladder in 3, Sigmoid reservoir in 1, Studer neobladder in 12, and T-pouch ileal neobladder in 8 patients. There were no major intraoperative complications. Of 19 patients eligible for evaluation of post-cystectomy urinary control, 11 patients (57.9 %) with good continence (0-1 pad/day) after RP regained preoperative level of urinary control after cystectomy within 1 year. The continence rate of 13 post-RP patients with good continence was 84.6 %. Among the 4 patients who received adjuvant radiotherapy after RP, 1 regained good continence. One with poor continence after prostatectomy had an artificial urethral sphincter (AUS) placed 2 months after cystectomy, and 2 with fair and poor continence after prostatectomy had an AUS placed at the time of cystectomy. CONCLUSIONS: Patients undergoing radical cystectomy after prior RP pose a challenge to urologists. Those who are continent post-RP have a fair chance of regaining good urinary control with neobladder reconstruction. Adjuvant radiotherapy for prostate cancer may have a negative impact on continence with neobladder reconstruction.