Characterizing and Quantifying Material Fatigue of the Artificial Urinary Sphincter Pressure Regulating Balloon.

OBJECTIVE: To characterize and quantify changes in elastic properties and in vivo pressure characteristics of pressure regulating balloons (PRB) over time, we conducted an analysis of the mechanical characteristics of the PRB after removal from patients for revision surgery. METHODS: Pressure and elasticity characteristics of new and used 61-70 cm H2O PRBs were analyzed. Pressure-volume curves were generated using commercially available urodynamics equipment. PRB pressures were measured at a standard fill volume (23 cc). Elastance was calculated by the slope of the tangent line at the inflection point of the pressure-volume curve. Tests were repeated 5 times per PRB and intraclass correlations were used to gauge test-retest reliability. Regression models were used for continuous variables based on data distribution. RESULTS: Twenty-seven used PRBs were analyzed after excluding 3 for alternative pressure ratings and 2 for occult pinpoint leaks. Time from artificial urinary sphincter placement to removal ranged from 0.02-17.6 years (median 8.4, interquartile range (IQR) 5.7-10.0). The mean pressure of all extracted PRBs: 58.8 cm H=O (± 7.4), 17 (62.9%) below the standard operating range. Each year of use in-vivo was associated with 1.09 cm H2O pressure loss on linear regression (P <.01 CI -1.52 to -0.65). PRB pressures were not significantly different according to indication for removal (1-way analysis of variance (ANOVA) P = .11). Loss of elastance was non-linear, decreasing by 1.9% per year on Poisson regression (P <.01, CI -0.03 to -0.01). When accounting for PRB age, PRB pressure was independently associated with detrusor overactivity. CONCLUSION: In PRBs tested for pressure-volume characteristics, increasing PRB age was associated with decreased pressure and elasticity.

Synchronous Bladder Neck Contracture Dilation at the Time of Artificial Urinary Sphincter Placement Is Safe and Effective.

OBJECTIVE: To treat men with bladder neck contracture (BNC) and stress urinary incontinence, neither long-term nor comparative data exist to support the superiority of simultaneous BNC intervention at the time of artificial urinary sphincter placement (synchronous) or staged BNC intervention followed by artificial urinary sphincter placement (asynchronous). This study aimed to compare the outcomes of patients treated with synchronous and asynchronous protocols. METHODS: Using a prospectively maintained quality improvement database, we identified all men between the years of 2001-2021 with a history of BNC and artificial urinary sphincter placement. Baseline patient characteristics and outcome measures were collected. Categorical data were assessed with Pearson's Chi-square, and continuous data were assessed using independent sample t tests or the Wilcoxon Rank-Sum test. RESULTS: In total, 112 men met the inclusion criteria. Thirty-two patients were treated synchronously, and 80 were treated asynchronously. There were no significant differences between groups across 15 relevant variables. Overall follow-up duration was 7.1 (2.8, 13.1) years. Three (9.3%) in the synchronous group and 13 (16.2%) in the asynchronous group experienced an erosion. There were no significant differences in frequency of erosion, time to erosion, artificial sphincter revision, time to revision, or BNC recurrence. BNC recurrences after artificial sphincter placement were treated with serial dilation with no early device failure or erosion. CONCLUSION: Similar outcomes are achieved following synchronous and asynchronous treatment of BNC and stress urinary incontinence. Synchronous approaches should be considered safe and effective for men with stress urinary incontinence and BNC.

Urethral Stricture Formation After Artificial Urinary Sphincter Cuff Erosion Is Uncommon in the Absence of Pelvic Radiation.

PURPOSE: Reported rates of urethral stricture development after artificial urinary sphincter erosion are highly variable. We hypothesized that the risk of stricture is commensurate with the degree of erosion. MATERIALS AND METHODS: We reviewed our prospectively maintained quality improvement database for all patients with artificial urinary sphincter erosion from 2011 to 2022. The incidence of postoperative stricture development was compared to the severity of erosion using a graded scale: 1, <25% circumference; 2, 25%-50% circumference; 3, >50% and <100% circumference; and 4, 100% circumference. From 862 artificial urinary sphincter surgeries, 102 erosion cases were identified, and 63 with documented erosion severity were included for analysis. Additional analysis was performed on 28 cases without documented erosion severity for validation. RESULTS: Within the main cohort, urethral stricture developed in 22 (34.9%) patients. The incidence of stricture did not vary by grade of erosion (P = .73) and was not significantly higher in men with grade 4 erosion vs lower-grade erosions (32.7% vs 50.0%, P = .34). Radiation exposure was associated with a 41.1% higher incidence of stricture (P < .01) and nearly every stricture occurred in the setting of prior radiation (21 of 22; 95.5%). In the validation group, 10 (35.7%) developed stricture, mostly in the setting of radiation (8 of 10; 80%). Overall, 29 of 32 (90.6%) cases of stricture involved a history of radiation. CONCLUSIONS: Artificial urinary sphincter erosion does not lead to urethral stricture formation in most cases and is not associated with degree of erosion. Those who develop strictures nearly always have a history of pelvic radiation.

Clinical and Urodynamic Determinants of Earlier Time to Failure for the Artificial Urinary Sphincter.

OBJECTIVE: To determine clinical, surgical and urodynamic attributes associated with earlier AUS reintervention. The artificial urinary sphincter (AUS) is the gold standard treatment for postprostatectomy stress urinary incontinence. Factors impacting long-term device survival have not been investigated. MATERIALS AND METHODS: We identified men with post-prostatectomy incontinence who underwent AUS reintervention from 2011 to 2021 at a single center. Urodynamic study, pad weights and voiding diaries are routinely assessed prior to AUS placement. Relationships between clinical, urodynamic and surgical variables and AUS reintervention were assessed using cox regression. Multiple imputation of chained equations was used to handle missing data elements, with truncated linear regression for continuous variables and logistic regression for binary variables. RESULTS: A total of 524 records were reviewed and 92 met inclusion. Median time to AUS reintervention was 5.7 years (2.3, 9.4). Indications were mechanical failure (38; 41.3%), sub-cuff atrophy (37; 40.2%), erosion/infection (11; 11.9%) and other (6; 6.5%). On univariable testing, earlier intervention was associated with pad weight (P < .01), nocturnal voids (P = .01), bladder capacity (P = .01), bladder volume at strong sensation (P = .03), detrusor overactivity (P < .01) and maximum voiding pressure (P = .02). On multivariable analysis, earlier surgical intervention was associated with detrusor overactivity (HR 1.95, P < .01 CI 1.22-3.1) and pad weight (HR 1.0006, P = .02, CI 1.000-1.001). CONCLUSIONS: Detrusor overactivity is associated with significantly shorter time to AUS failure. This information may allow for more individualized counseling.

Bladder Neck Contractures Stabilize After Placement of the Artificial Urinary Sphincter.

PURPOSE: For male cancer survivors, the combination of stress urinary incontinence and recurrent bladder neck contracture presents a management dilemma with poor consensus. Our objective was to assess the impact of artificial urinary sphincter placement on bladder neck contracture recurrence among prostate cancer survivors with stress urinary incontinence and bladder neck contracture. MATERIALS AND METHODS: Men electing artificial urinary sphincter placement at our institution undergo synchronous bladder neck contracture treatment if indicated. An institutional database was queried for men with stress urinary incontinence and ≥1 intervention for bladder neck contracture. Records were divided according to whether an artificial urinary sphincter was ever placed. The impact of artificial urinary sphincter placement on bladder neck contracture recurrence was assessed using a multivariable conditional survival analysis, with survival defined as the recurrence-free interval following bladder neck contracture intervention. The proportional hazards assumption was assessed on the basis of Schoenfeld residuals. RESULTS: The analytic cohort consisted of 118 in the artificial urinary sphincter group and 88 in the non-artificial urinary sphincter group. Patients in both groups underwent a median of 2 (range 1-8) bladder neck contracture interventions over the entire course of their care, encompassing 445 total bladder neck contracture interventions. The artificial urinary sphincter group was on average 2.6 years younger (P = .02) and had a higher pack-year smoking history (P < .01). The presence of an artificial urinary sphincter was associated with a 61% lower bladder neck contracture re-intervention rate (HR 0.39, P < .01, CI 0.30-0.50) at any time when accounting for number of prior bladder neck contracture interventions and bladder neck contracture risk factors. CONCLUSIONS: Artificial urinary sphincter placement is associated with a lower rate of bladder neck contracture re-intervention. Artificial urinary sphincter placement should not be delayed or avoided due to the presence of bladder neck contracture.

Artificial Urinary Sphincter Cuff Downsizing Improves Continence and Patient Satisfaction in Cases of Sub-cuff Atrophy.

PURPOSE: The management of artificial urinary sphincter sub-cuff atrophy remains controversial, and clinical outcomes are underreported. We intend to examine the impact of cuff downsizing in cases of isolated sub-cuff atrophy. MATERIALS AND METHODS: We reviewed our prospectively collected, institutionally approved quality improvement database for this study from 2011 to 2022. Institutional Review Board approval was obtained for the analysis. Sub-cuff atrophy in patients with post-prostatectomy incontinence was diagnosed with a clinical presentation of recurrent urinary leakage, serial pelvic films, cystoscopy, and patient evaluation. Outcomes were assessed with pad use, subjective measures, and American Urological Association Symptom Score scores. RESULTS: During the study interval, 871 encounters for artificial urinary sphincter placement were identified, 229 for revision or replacement, of which cuff downsizing for isolated cases of sub-cuff atrophy occurred in 34. Downsizing took place after a median of 6.5 years after initial artificial urinary sphincter placement. Of the patients, 97% reported subjective improvement and 93% experienced a decrease in daily incontinence pad use, with a mean±SD decrease of 2.2±1.45 pads (P < .01). American Urological Association Symptom Score bother scores decreased from pre-downsizing values by a mean±SD of 1.5±1.4 (P = .01). After a median follow-up of 1.8 years after downsizing, 24 (70.6%) of downsized cuffs remained in place, 2 (5.9%) were further downsized, 2 (5.9%) required replacement for mechanical failure, 4 (11.8%) underwent removal for erosion, and 2 (5.9%) underwent replacement for a herniated pressure regulating balloon. CONCLUSIONS: When diagnosed using objective criteria, cuff downsizing improves continence and patient satisfaction in cases of sub-cuff atrophy.

Indications and Outcomes for Intermittent Catheterization following Bulbar AUS Cuff Placement.

OBJECTIVE: To evaluate the functional and surgical impact of CIC protocols in men with a bulbar AUS in place. Stress urinary incontinence (SUI) and poor bladder emptying are both sequelae of prostate cancer treatment, though there is sparse data to guide concomitant management. The safety of intermittent catheterization (CIC) in men with an artificial urinary sphincter (AUS) at the bulbar urethra remains unclear. METHODS: We performed a retrospective review of all bulbar urethral AUS procedures at our institution. Inclusion criteria were patients with a history of prostate cancer treatment, AUS placement for SUI, and a history of CIC before and/or after AUS placement. All eligible cases were retrospectively reviewed. Surgical and continence outcomes were analyzed. RESULTS: A total of 57 patients were identified with a history of CIC and AUS placement under the care of two surgeons. Eighteen continued to perform CIC or first initiated CIC after AUS placement and 39 discontinued CIC prior to AUS placement. The incidence of erosion was no different amongst patients who continued or discontinued CIC after AUS placement (17.9% vs 22.2%, P = .79). There was no difference in future AUS removal or replacement (56.4% vs 44.4%, P = .41). Both groups experienced improvement in urinary incontinence after placement of an AUS. CONCLUSION: Bulbar AUS placement in the setting of continuous intermittent catheterization can be considered in patients who are not surgical candidates for definitive treatment of their outlet obstruction.

Pelvic Fracture Urethral Distraction Defect.

Posterior pelvic fracture urethral distraction defects (PFUDD) can present formidable challenges in genitourinary reconstruction. Once the acuity of trauma subsides, the patient is often faced with chronic, debilitating genitourinary injuries. Treatment requires an astute diagnostic and technical approach, with definitive repair best accomplished in the hands of experts. A delayed, stepwise approach to repair following the resolution of acute injuries remains a time-tested platform for optimal outcomes. The evaluation, relevant anatomy, and approach to surgical repair are described herein.

Resection of Pubic Symphysis and Cystectomy Significantly Improves Short-Term Patient-Reported Physical Functioning Among Patients With Pubovesical Fistula and Pubic Bone Osteomyelitis.

OBJECTIVE: To investigate the impact of extirpative surgery for pubic bone osteomyelitis with pubovesical fistula on prostate cancer survivors' physical and mental health. MATERIALS AND METHODS: The Short Form 12 (SF-12) is a validated instrument for assessing health-related quality of life (HRQOL). We reviewed a prospectively maintained database of patients treated with extirpative surgery for pubovesical fistula from 2017-2021 who completed the SF-12. Wilcoxon signed-rank and McNemar's tests were used to analyze changes in SF-12 following surgery. Narcotic prescriptions in the year before and after surgery were assessed as an additional measure of pain burden. RESULTS: Eighteen patients were included. Four had pre-operative SF-12s, 3 had post-operative SF-12s, and 11 had both. Median age was 76.5 years (IQR 71.75-80.00). All patients had previous radiation for prostate cancer. Compared to global pre-operative scores, post-operative physical composite scores (PCS) significantly increased (29.95 ± 8.59 vs 42.48 ± 7.18; P <.001), but mental composite scores (MCS) were similar (45.35 ± 9.98 vs 52.21 ± 8.23). When comparing individual, paired pre-operative and post-operative scores there was a significant improvement in PCS (30.56 ± 9.87 vs 45.45 ± 8.56; P = .005), but not MCS (47.49 ± 6.92 vs 51.60 ± 8.88). Median morphine milligram equivalent significantly decreased in the year post-surgery compared to the year prior (103.1, 33.0-250.9 vs 34.25, 0.0-105.9; P = .0008). CONCLUSION: For prostate cancer survivors with pubovesical fistula and pubic bone osteomyelitis, urinary diversion with pubic bone resection improves physical functioning and decreases narcotic prescriptions without untoward effects on mental health.

Patient-Reported and Physiologic Outcomes Following Pelvic Exenteration for Non-Repairable Radiated Rectourethral Fistula.

OBJECTIVE: To investigate the impact of pelvic exenteration (PelvEX) on patient-reported pain, distress, and quality of life along with physiologic indicators of health in cancer survivors with radiated, non-repairable rectourethral fistula (RUF). MATERIALS AND METHODS: We reviewed a prospectively maintained quality improvement database of RUF patients at our institution from 2012 to 2020. Patients with radiated, non-repairable RUF who underwent PelvEX and had follow up to 1 year were included. Pain and distress scores were collected preoperatively and at 1-year follow up. Number of narcotic prescriptions in the 3 months before surgery and the year after surgery were abstracted. Short Form 12 surveys were administered in the postoperative period. Serum albumin, creatinine, carbon dioxide, hematocrit, and glucose were abstracted from electronic health records. Statistical analysis was performed using Wilcoxon signed-rank and Mann-Whitney tests. RESULTS: Eleven patients met inclusion criteria. Patient-reported pain significantly decreased at 1 year follow-up compared to preoperative scores (median pre: 4 vs 1 year post: 0, P = .0312). Patient-reported distress significantly decreased pre- versus post-PelvEX (median pre: 5 vs post: 0, P = .0156). At the time of postoperative pain and distress surveys, 9 (82.8%) patients did not have narcotic prescriptions. Postoperative Short Form 12 scores were similar to an age-matched United States population (mental: P = .3125; physical: P = .1484). Serum-based indicators of health were not different in the pre- versus postoperative period (all P >.05). CONCLUSION: PelvEX may be a valuable treatment option to decrease patient-reported pain and distress without compromising quality of life or physiologic health in patients with radiated, non-repairable RUF.

Buccal Reharvest for Urethroplasty After Graft Site Closure is Safe and Does Not Affect Long-Term Oral Health.

OBJECTIVE: To understand the effects of reharvest on safety and long-term oral health in patients requiring buccal mucosa reharvest from a previously harvested and closed site for management of recurrent urethral stricture disease. METHODS: We conducted an IRB approved retrospective chart review from 2014 to 2019 of all patients who underwent buccal graft urethroplasty at our referral based academic medical center. Surgical data was collected, and the validated Oral Health Impact Profile (OHIP-14) survey was administered to each patient. Descriptive statistics were performed and compared between patients who underwent a buccal graft reharvest and patients who underwent standard first time buccal harvest. Buccal graft beds were closed on both initial and reharvest. RESULTS: Four patients underwent a total of 5 ipsilateral buccal graft reharvests and 6 patients underwent first time buccal harvest. Median length of follow-up for all patients was 6 months (1-35 mo) and the median length of all grafts was 6 cm (5-6 cm) with no difference in the reharvest and first-time cohorts. For patients that underwent buccal reharvest, their median post-operative OHIP-14 score was 0 (0-9 pts) out of a possible 56 points. This compared to a median postoperative OHIP-14 score of 0 (0-10 pts) for patients who underwent first time buccal harvests with oral complications limited to one post-operative hematoma in the first-time cohort. CONCLUSION: Buccal grafts can safely be reharvested from a previous site with minimal concern for long-term oral health outcomes.

Do commonly used prostate medications alter prostate MRI and fusion biopsy performance?

AIMS: To determine whether phosphodiesterase inhibitors (PDEi) or α-antagonists (AA) were associated with differences in region of interest (ROI) characteristics or prostate cancer detection on fusion biopsy (FB). MATERIALS AND METHODS: Records from 847 consecutive patients undergoing FB at three separate institutions over a period of 2 years were retrospectively reviewed. Associations between medication use, Prostate Imaging Reporting & Data System (PIRADS) scores, and ROI locations were assessed with ordinal logistic regression. Associations with lesion size and International Society of Urologic Pathology (ISUP) grade group (GG) on biopsy were tested using multivariate regression. RESULTS: Medication use included PDEi in 14.2% and AA in 23.0%. PDEi use was associated with 19.3% smaller lesion diameter (-2.8 mm; CI from -4.8 to -0.7; p < 0.01) and lower PIRADS scores on MRI (OR 0.60; CI 0.40 - 1.00; p = 0.05). AA use was associated with higher PIRADS scores (OR 1.43; CI 0.97 - 2.11; p = 0.06), fewer positive fusion-directed biopsy cores (-28.6%, CI from -57.9 to 0.01%, p = 0.05), and downgrading on final pathology (-19%; CI from -40 to 2%; p = 0.06). CONCLUSION: For PIRADS scores ≥ 3, PDEi use is associated with smaller ROI and lower PIRADS scores, while AA use is associated with higher PIRADS scores. Neither medication was associated with differences in biopsy GG. Prospective studies are needed to investigate the discordance between multi-parametric magnetic resonance imaging (mpMRI) results and oncologic outcomes associated with PDEi and AA use.

Multicenter surgical outcomes of penile prosthesis placement in patients with corporal fibrosis and review of the literature.

Penile prosthesis (PP) insertion in the setting of corporal fibrosis can be challenging and a variety of techniques have been described to accomplish this, however the necessity of these maneuvers is debatable. Our objective was to investigate techniques and outcomes of PP placement in patients with corporal fibrosis at tertiary referral centers. Multicenter outcomes of 42 patients (mean age 53.4 ± 1.9 years) with corporal fibrosis who underwent placement of PP over a 10-year period were reviewed. The most common etiology of corporal fibrosis was prior PP explant due to either infection (40.5%) and/or erosion (16.7%). Fourteen patients (33.3%) had a history of priapism, 5 (11.9%) of which had one or more distal surgical penile shunts. Techniques used for PP placement included: sequential dilation (8-12 mm) with standard dilators in 15 (35.7%), dilation with cavernotomes in 25 (59.5%) and limited sharp corporal excision and dilation with cavernotomes in 1 (2.4%). Narrow cylinders were employed in ten patients (23.8%). Major complications occurred in one patient (2.4%) who underwent explant for infection and distal erosion. Most patients with corporal fibrosis can undergo successful placement of a PP using standard dilators or cavernotomes. Sharp corporal excision and other measures are rarely required.

Complaint of Testicular Discomfort in Patient with Esophageal Adenocarcinoma.

We report a case of esophageal cancer with solitary metastasis to the testicle in a 71-year-old man. The tumor was picked up on physical exam following new onset complaints of pain and swelling. While most testicular masses in older men are due to lymphoma, this case highlights the need to consider metastatic disease as a source of new symptoms in patients with a recent cancer diagnosis.

An assessment of current penile prosthesis reimbursement guidelines for insurance plans nationwide.

A lack of uniformity exists for insurance payer coverage for all categories of penile prostheses (PP). We sought to determine common insurance coverage criteria and barriers to implantation across common insurance plans from healthcare referral regions (HRR) nationwide. Coverage criteria and stipulations were reviewed regarding erectile dysfunction (ED) etiology, ED duration, contributing comorbid conditions, medications, drug use, diagnostic tests, use of procedures and prior interventions. Seventy of 100 plans included coverage criteria. 36.1% provided coverage only in cases of gender dysphoria. 27.7% required documentation of trial, contraindication or intolerance to pharmacologic therapy, with varying descriptors of what this entailed. 13.8% required at least consideration of prior pharmacologic therapy. 4.2% required trial or contraindication to classic second-line therapies. 25.0% stated that ED must be organic. Psychogenic ED was covered by 12.5% of plans. Eleven plans required at least 6 or 12 months of symptoms. Laboratory evaluation to rule out hypogonadism or hyperprolactinemia was required by five plans. Insurance coverage criteria for PP placement were highly variable by state and plan. Coverage is provided for PP implantation in most cases for ED of organic etiology following failure of pharmacologic therapy when contributing comorbidities are optimally managed.

Initial Experience of Magnetic Resonance Imaging Fusion Biopsy in the Community Setting.

INTRODUCTION: Magnetic resonance imaging fusion biopsy is diagnostically superior to transrectal ultrasound guided biopsy for detecting clinically significant prostate cancer. Fusion biopsy has an expanding role at major academic centers. However, the reproducibility of outcomes in the community setting is unknown. Our goal was to determine if there are significant differences in the yield of clinically significant prostate cancer upon implementation of fusion biopsy in the community setting. METHODS: We compared biopsy results from the first consecutive 175 patients undergoing fusion biopsy at an academic setting to the first 175 patients undergoing fusion biopsy at a community practice. Patients treated at an academic setting were matched to nonacademic setting treated patients using Mahalonobis distance matching. A treatment effects model was used to evaluate the effect of practice setting on the rate of clinically significant prostate cancer detection. RESULTS: The matching model resulted in 160 community based patients matched to 150 academic based patients. Balance was verified by reduction in standardized differences and variances ratios between samples. Standard errors and the 95% CI were calculated from 3,000 bootstrap samples. Practice setting had no significant effect on clinically significant prostate cancer detection, clinically significant prostate cancer detection by fusion biopsy, upgrading by fusion cores, upgrading by template cores, clinically significant prostate cancer missed by template cores or clinically significant prostate cancer missed by fusion cores. CONCLUSIONS: A sample-matched analysis of the first consecutive patients enrolled in fusion biopsy at an academic versus a community setting indicates that practice setting did not have a significant effect on the overall detection of clinically significant prostate cancer. This lends support to the use of fusion biopsy outside of academic centers.

The effect of botulinum toxin on ureteral inflammation.

PURPOSE: The impact of onabotulinum toxin type A (BoNT-A) on bladder afferent nerve pathways and chemosensory functions is an active area of investigation. There may be a role for BoNT-A in disorders of the ureter; however, no histologic studies have assessed the effects of BoNT-A on ureteral tissue. Our objective was to develop an animal model of ureteral inflammation and determine the impact of ureteral BoNT-A instillation on known mechanisms of inflammation. METHODS: The safety and feasibility of a novel animal model of ureteral inflammation was assessed. Through open cystotomy, the effect of ureteral BoNT-A instillation on inflammation was determined through H&E, masson's trichrome, Ki-67 stain, and prostaglandin E (PGE) synthase expression, a known marker of pain and inflammation in ureteral tissue. Urothelial microstructure was assessed using electron microscopy and standard histologic techniques. RESULTS: All experiments were carried to completion, and no systemic signs of botulinum toxicity were seen. BoNT-A exposure was associated with a decrease in PGE synthase expression in a dose-dependent fashion. BoNT-A exposure was not found to impact collagen deposition or cell proliferation. Disruption of tight junctions between urothelial cells was observed under conditions of inflammation. CONCLUSION: We describe the feasibility of a novel in vivo model of ureteral inflammation and report the first histologic study of the effects of BoNT-A on the ureter. Preliminary findings show that BoNT-A attenuates ureteral PGE synthase expression under conditions of inflammation. The application of BoNT-A may provide anti-inflammatory and analgesic effects in the context of ureteral disorders.