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Introduction: To report the long-term outcomes of robot-assisted radical cystectomy (RARC) for the treatment of muscle invasive and high-risk non-muscle invasive bladder cancer., Methods: We reviewed a single tertiary center database of RARC from 2004 to 2020. Concomitant extended pelvic lymph node dissection and extracorporeal urinary diversion were performed. Cox regression analysis and the Kaplan-Meier method were used to identify factors associated with and report time-to-event estimations of recurrence-free survival and overall survival. Clavien-Dindo complications were identified, categorized, and substratified by time from surgery within 90-days and between 90-days and >5-years postoperatively., Results: A total of 510 patients with median follow-up of 57.1 months (IQR 21.8-103.6) were included. Continent diversion was performed in 259 (51%) patients. Of the 340 (67%) ≥cT2 patients, 153 (45%) received cisplatin-based neoadjuvant chemotherapy. Recurrence was identified in 157 (31%) patients, and 118 (23%) died from bladder cancer. The overall complication rate was 52% with 267 (41%) major grade ≥ III events. Infectious (25%) and genitourinary (22%) complications were the most common irrespective of the time interval beyond 90-days. The risk of recurrence or death were increased by extravesical disease (HR 1.91 and 1.97, respectively) and lymph node positivity (HR 4.58 and 2.42, respectively) in multivariable analysis (all, P < 0.001). The estimated 5-, and 10-year recurrence-free and overall survival rates were 69% and 64% and 61% and 44%, respectively., Conclusions: RARC is a durable treatment that optimizes the probability of cure for patients requiring extirpation for bladder cancer. Targeting the modifiable complications of radical surgery may further improve the risk/benefit ratio of RARC., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Introduction: Focal therapy (FT) is a form of ablative treatment offered to men with localized, organ-confined prostate cancer (CaP). Pelvic multiparametric magnetic resonance imaging (mpMRI) and mpMRI/transrectal ultrasound fusion (MRI-US) guidance enable the precise delivery of FT with limited ablation of adjacent benign tissue or vital genitourinary structures. This article presents our findings on using MRI-US to perform FT as a primary treatment for men with intermediate-risk CaP., Methods: Thirty-six men underwent MRI-US fusion-guided FT cryoablation at a single center from 2018 to 2023 as a primary treatment for intermediate-risk CaP. Following FT, quarterly prostate-specific antigen (PSA) testing and a 6 to 9 month mpMRI and combined MRI-US targeted and systematic biopsy were performed. Oncological outcomes were determined using several endpoints containing biochemical recurrence, imaging failure, and pathological failure. Functional outcomes were measured using reported erectile dysfunction/potency rates, urinary incontinence rates, and the American Urologic Association Symptom Score (AUA-SS) and Sexual Health Inventory for Men (SHIM) indices., Results: Median follow-up was 29.1 months, most (75%) of whom had grade group 2 CaP. Out of the 36 men, 32 (88.9%) completed the combined MRI-targeted and systematic biopsy follow-up after treatment. The study had no major complications, but 12 (33.3%) patients experienced Clavien-Dindo grade II or lower complications. For oncological outcomes, 6 (16.7%) men had biochemical recurrence, 9 (25%) showed imaging failure, and 8 (22.2%) met the criteria for positive biopsy- out-of-field vs. in-field. 88.2% of previously potent patients remained potent postoperatively at 12 months. All patients were continent at 12 months. There were no statistically significant changes in the AUA-SS and SHIM scores postoperatively., Conclusion: MRI-US-guided cryoablation to target lesions in intermediate-risk CaP appears to be a safe treatment option, with functional outcomes indicating minimal short and intermediate-term morbidity and acceptable oncological outcomes. However, despite close monitoring and follow-up, there is still a limitation in accurately predicting/detecting pathological failure after FT. The long-term durability of FT for intermediate-risk, organ-confined CaP remains uncertain., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Consolidative resection or cytoreductive radical prostatectomy (CRP) may benefit men with non-organ confined prostate cancer. We report the safety, feasibility, and outcomes of robot-assisted laparoscopic CRP using a single-port (SP) or multi-port (MP) platform., Methods: We reviewed consecutive men with clinical node positive or metastatic castrate-sensitive prostate cancer who underwent IRB-approved CRP and extended pelvic lymph node dissection using the da Vinci SP or MP Surgical Systems (Intuitive Surgical, Sunnyvale, CA) from 2015-2022. Perioperative data and Clavien-Dindo 90-day complications were recorded., Results: Twenty-four men with a median age of 61 (IQR 56-69) years and prostate-specific antigen of 32.1 (IQR 21.9-62.3) ng/mL were included. Clinical N1, M1, or N1 + M1 disease were detected in 8 (33%), 9 (38%), 7 (29%) patients, respectively. There was no difference in positive margins, 41% vs. 29% (P = 0.67), lymph node yield, 21 (IQR 14-28) vs. 20 (IQR 13.5-21) nodes (P = 0.31), or estimated blood loss, 150 mL (IQR 100-200) vs. 50 mL (IQR 50-125) (P = 0.06), between the MP and SP cohorts, respectively. Hospital length of stay was significantly shorter for the SP group, same-day discharge (IQR 0-0), compared to MP, 1-day (IQR 1-1), P < 0.001. One grade III bowel obstruction and lymphocele occurred in the MP cohort. No major complications occurred in the SP cohort., Conclusion: Robot-assisted laparoscopic CRP is safe and feasible for select men with advanced castrate-sensitive prostate cancer., (© 2024. The Author(s).)

Background and Objective: Approximately two-thirds of men who undergo primary treatment for prostate cancer (PC) will experience biochemical recurrence (BCR). Salvage robot-assisted radical prostatectomy (sRARP) offers curative treatment in this disease setting and men who choose this option may avoid palliative androgen deprivation therapy (ADT). The purpose of this study was to describe long-term outcomes and patient feedback following sRARP., Methods: We reviewed data for consecutive men with biopsy-proven localized BCR who underwent sRARP and pelvic lymph node dissection at a single tertiary referral center between 2004 and 2021. Perioperative data, Clavien-Dindo complications, and functional outcomes were recorded . The Kaplan-Meier method was used to estimate prostate-specific antigen-free (≥0.2 ng/ml) survival (PSAFS) and metastasis-free survival (MFS). Three Likert-type items (score 1-5) from the validated Surgical Satisfaction Questionnaire-8 were distributed to patients postoperatively., Key Findings and Limitations: We included 78 men, of whom 72 (92%) had undergone primary radiotherapy and six (8%) had received primary prostate ablation. Median follow-up was 10.1 yr (interquartile range 5.8-12.4). Final pathology identified ≥pT3N0M0 in 35 patients (45%) and positive margins in 23 (29%). The overall complication rate was 50%. Of the 26 (33%) major (grade ≥III) complications, anastomotic stricture (32%) was most common. The estimated 3-, 5-, and 10-yr survival rates were 85.6% and 80.2%, 83.5% for PSAFS ( n  = 11), and 74.1%, 83.5%, and 70.5% for MFS ( n  = 23), respectively. At last follow-up, postoperative ADT had been administered to 17 patients (22%), and 39 men (50%) remained alive a decade after sRARP. Continence and potency were maintained in 33/62 (53%) and 1/16 (6%) patients, respectively. Thirty-five respondents (45%) reported median questionnaire scores (≥4) in favor of sRARP. Limitations include the small single-center series and a single query point for patient feedback., Conclusions and Clinical Implications: Long-term outcomes of sRARP suggest that the technical challenges and morbidity of the procedure are qualified by patient feedback and the opportunity to evade the morbidity and mortality of biochemically recurrent PC., Patient Summary: We reviewed the cancer outcomes and side effects of robot-assisted surgical removal of the prostate after treatment failure with radiation or ablation for prostate cancer. We found that this type of treatment has substantial risks and long-term side effects, but the surgery provides an opportunity to cure prostate cancer and/or avoid the consequences of indefinite hormonal treatment. Overall, most men who underwent this surgery were not disappointed with their decision despite the higher risks and consequences., (© 2023 The Author(s).)

Purpose: Multiparametric magnetic resonance imaging (mpMRI) targeted biopsy has emerged as an augmentation to systematic prostate biopsy (SBx) with improved diagnostic accuracy. The purpose of this study was to determine whether biopsy modality impacted management of prostate cancer (PCa)., Methods: We performed a retrospective review of patients with newly diagnosed non-metastatic PCa at our institution (2014-2020). Either ultrasound-guided 12-core SBx or SBx plus ≥1targeted biopsy cores from identifiable lesions on mpMRI were performed. Patients were managed with active surveillance (AS), radiation therapy (RT), or radical prostatectomy (RP). Multivariate logistic and multinomial regression analyses were performed., Results: Of 578 patients, 221(38%) proceeded with AS, 121(21%) received RT, and 236(41%) underwent RP. Median age and prostate-specific antigen (PSA) were 65.4 years and 7.2 ng/mL, respectively. On multivariate analysis, biopsy type did not predict decision to pursue treatment ( p =.951). On multinomial regression analysis, biopsy type did not predict selection of AS over RP ( p =.973) or RT over RP ( p =.813). Alternatively, age, grade group, and PSA were significant predictors of management selection., Conclusions: Biopsy technique did not impact management for patients with new PCa diagnosis. Despite paradigm shifts in obtaining tissue diagnosis, age, PSA, and grade group remain valuable indices for shared decision-making and counseling patients with PCa.

Purpose: Computerized tomographic urography is the diagnostic tool of choice for evaluating hematuria. In keeping with the ALARA (As Low As Reasonably Achievable) principle, we evaluated a triple bolus computerized tomography protocol designed to reduce radiation exposure., Materials and Methods: Patients with macroscopic or microscopic hematuria were prospectively randomized to conventional computerized tomography (100) or triple bolus computerized tomography (100). The triple bolus computerized tomography protocol entails 2 scans: pre-contrast scan followed by 3 contrast injections at 40 seconds, 60 seconds and 20 minutes prior to the second scan to capture all 3 phases. The conventional computerized tomography protocol requires 4 scans: pre-contrast scan, and 3 post-contrast scans at the corticomedullary, nephrographic and excretory phases. Radiation exposure and the detection of urological pathology were recorded based on radiology reports., Results: There were no differences in patient demographics or body mass index between the 2 groups. Triple bolus computerized tomography exposed patients to 33% less radiation (1,715 vs 1,145 mGy*cm for conventional vs triple bolus computerized tomography; p <0.001). For macroscopic hematuria, the pathology detection rates were 70% for triple bolus and 73% for conventional computerized tomography (p=0.72). For microscopic hematuria, the detection rates were 59% for triple bolus and 50% for conventional computerized tomography (p=0.68). In both groups, the rates of detection of urolithiasis, renal cysts, urological masses, bladder pathology and prostate pathology were no different between triple bolus and conventional computerized tomography., Conclusions: In both the settings of macroscopic and microscopic hematuria evaluation, triple bolus computerized tomography significantly reduces radiation exposure while providing equivalent detection of genitourinary pathology compared to conventional computerized tomography. The ability to detect upper tract filling defects was not specifically tested.

Objectives: Multidisciplinary cancer clinic (MDC) is an evaluation option for the management of prostate cancer (PCa). The purpose of MDC is to provide the patient with a comprehensive assessment and risk/benefit discussion of all pertinent treatment options. Our objective was to obtain a contemporary measure and analysis of urologists' opinion regarding PCa MDC., Material and Methods: We created a 14-item questionnaire for respondent baseline characteristics, subjective and objective inquiries regarding MDC for PCa management. The survey was distributed through email to members of the Society of Urologic Oncology and the Endourological Society. Data were analyzed using R (R Core team, 2017)., Results: One hundred and seven (51%) respondents reported participation in MDC; the majority of which were male (97.6%), academic (61.4%) urologists with urologic oncology fellowship training (50%), and >20 years in practice (40.3%). MDC patients were most commonly referrals (78.5%) and with high-risk disease (Gleason sum 8-10) (83.2%). A majority of the respondents felt that MDC was very or extremely beneficial for PCa research (45% and 19%, respectively) and treatment (35% and 20%, respectively). Responses dissuading the use of MDC included lack of infrastructure (41%) and time commitment (21%). On multivariate analysis, urologists with >10 years in practice were less likely to find MDC beneficial in the management of PCa (11-20 years, P = 0.028 and >20 years P = 0.009)., Conclusion: A contemporary sampling of urologists' opinion and practice patterns alludes to the benefits that advocate for and the resource demand that hinders routine use of MDC for PCa evaluation. Urologist training and practice environment can affect participation in PCa MDC., Competing Interests: There are no conflicts of interest., (© 2021 Published by Scientific Scholar on behalf of Journal of Clinical Imaging Science.)

Background: Black men have significantly higher incidence and are up to three times more likely to die of prostate cancer (PCa) than White men. Multiparametric magnetic resonance imaging-ultrasound fusion biopsy (FBx) has emerged as a promising modality for the detection of PCa. The goal of our study is to identify differences in utilization of FBx between Black and White men presenting with suspicion of PCa., Methods: We performed a retrospective review of Black and White men who presented with suspicion of PCa and required biopsy from January 2014 to December 2018. Multivariate logistic regression analysis was done to study the influence of race on the utilization of FBx., Results: Six hundred nineteen (Black: 182, White: 437) men were included in the study. Forty-one out of 182 (22.5%) Black men underwent FBx compared with 225/437 (51.5%) of White men (P < 0.001). After adjusting for age, race, prostate-specific antigen level, digital rectal exam, family history of PCa and health insurance provider, Black race was found to be a significant negative predictor of obtaining FBx (OR:0.32, 95% CI: 0.21-0.51, P < 0.001). Black race stayed an independent negative predictor (OR: 0.36, 95% CI: 0.20-0.64, P < 0.001) in the cohort of patients who were biopsy naïve; however, although reduced, there was no significant difference in the cohort with a prior negative biopsy (OR: 0.51, 95% CI: 0.19-1.36, P = 0.179)., Conclusions: Although FBx is a superior modality for early detection of PCa, we found that Black men were less likely to undergo FBx when presenting with PCa suspicion. Further investigation is needed to evaluate if this difference is patient preference or if there are underlying socioeconomic, cultural or provider biases influencing this disparity.

Introduction and Objectives: Ureteral injuries can occur during ureteral access sheath (UAS) deployment. The force exerted during deployment and the amount of force that results in ureteral injury is yet to be accurately quantitated. In this feasibility study, we developed and then tested a novel force-sensing device in our animal laboratory to identify the threshold force that results in a porcine ureteral injury. Methods: With Institutional Animal Care and Use Committee approval, we measured ureteral dilator and UAS deployment force using our proprietary University of California, Irvine Ureteral Access Sheath Force Sensor (UAS-FS). The exerted force was measured during deployment from the moment that the tip of the UAS was passed into the urethral meatus until it reached the renal pelvis; progression of the UAS along the ureter was monitored with fluoroscopy. Ureteroscopic evaluation was performed after deployment of each catheter/sheath ≥8F to assess for ureteral injury using the Postureteroscopic Lesion Scale (PULS). Results: Six juvenile Yorkshire female pigs (12 ureters) were studied. No injuries were detected when the deployment force was <4 Newtons (N), which was the case when the catheter/access sheath was ≤13F. Increasing UAS size >13F resulted in greater peak forces. In five of the pigs, ureters selected for 14F UAS deployment without previous sequential dilation were injured (PULS ≥3) at a mean threshold force of 4.84 N. Serial dilation had a higher threshold for PULS ≥3 at 5.56 N. Overall, injury of PULS ≥3 was routinely noted when the force applied exceeded 8.1 N. Conclusions: The UAS-FS reliably measured forces while deploying a UAS. Significant ureteral injury can routinely be avoided if the applied force is <4.84 N; PULS ≥3 routinely occurred when forces exceeded 8.1 N. Serial dilation may allow safe passage at higher deployment forces, as much as 5.56 N.

Introduction and Objectives: Medical expulsive therapy is based on pharmacologic ureteral relaxation. We hypothesized this concept may facilitate the deployment of the large 16 French (F) ureteral access sheath (UAS) when patients are intentionally pre-treated with oral tamsulosin, i.e., medical impulsive therapy., Methods: We retrospectively analyzed our experience with UAS deployment during endoscopic-guided percutaneous nephrolithotomy in prone position in patients pre-treated for 1 week with oral tamsulosin with a contemporary untreated cohort. Between January 2015 and September 2016, seventy-seven patients without a pre-existing ureteral stent met inclusion criteria. Demographic data, tamsulosin usage, UAS size, deployment failure, ureteral injuries, stone-free rates, and complications were recorded. Univariate and multivariate analysis was conducted to assess the impact of tamsulosin on deployment of the 16F UAS., Results: There was no statistical difference between the tamsulosin (n = 40) group and non-tamsulosin (n = 37) group in regard to demographic data. The tamsulosin group had a significantly higher percentage of 16F UAS deployment, 87 vs. 43% (p < 0.001), and no significant difference in ureteral injuries (p = 0.228). Univariate and multivariate analysis revealed that tamsulosin significantly increased the odds ratio (9.3 and 19.4, respectively) for successful passage of a 16F UAS. Despite a larger stone volume, there was no significant difference in computed tomography scan complete stone-free rates (29 vs. 42%; p = 0.277) at median post-operative time of only 3 days., Conclusions: In this retrospective study, 1 week of preoperative tamsulosin was associated with an increase in the deployment of a 16F UAS in patients without preoperative ureteral stent placement.

The concept of adipose tissue as an organ unto itself represents a new medical construct; already differences in the volume of perirenal fat around a tumor-bearing kidney have been described. We hypothesized that renal calculi may have similar impact on perirenal fat or alternatively abnormalities in urinary metabolites may be the result of perirenal fat affecting renal metabolism and subsequent stone formation. Accordingly, we conducted a study utilizing three-dimensional imaging software to evaluate perirenal fat volume (PFV) in patients with nephrolithiasis. Among 40 patients with a history of unilateral nephrolithiasis who underwent percutaneous nephrolithotomy between 2010 and 2016, the following data were acquired: body mass index, past medical history, stone characteristics and composition (i.e., calcium oxalate, calcium phosphate, uric acid, and struvite calculi). In addition, patients were stratified by dominant stone composition (≥ 50% fraction). Bilateral PFV measurements were obtained using the preoperative computed tomography scan and specialized three-dimensional imaging software. The PFV of stone-bearing kidneys was significantly greater than non-stone-bearing kidneys (397.3 and 323 cc, respectively; p = 0.004), with the PFV difference in patients with CO-dominant stone-bearing kidneys reaching statistical significance (p = 0.003). Subgroup analysis showed greater PFV surrounding the stone-bearing kidney irrespective of gender (p = 0.03), with male patients possessing significantly greater stone-bearing (p = 0.01) and bilateral PFV (p = 0.01) compared to females. No significant correlations were found between PFV and stone volume or stone density. The PFV of calcium oxalate stone-bearing kidneys is significantly greater than non-stone-bearing kidneys for both male and female patients with nephrolithiasis.

Objective: To compare the performance of 3 contemporary ureteroscopic biopsy devices for the histopathologic diagnosis of upper tract urothelial carcinoma (UTUC)., Methods: We retrospectively reviewed 145 patients who underwent 182 urothelial biopsies using 2.4F backloaded cup biopsy forceps, a nitinol basket, or 3F standard cup biopsy forceps at 3 tertiary academic centers between 2011 and 2016. Experienced genitourinary pathologists provided an assessment of each specimen without knowledge of the device used for biopsy. For patients who underwent nephroureterectomy without neoadjuvant chemotherapy within 3 months of biopsy-proven UTUC diagnosis, the biopsy grade was compared with both the grade and stage of the surgical specimen., Results: Biopsy utilization varied among the 3 institutions (P <.0001). Significant variabilities in specimen size (P = .001), the presence of intact urothelium (P = .008), and crush artifact (P = .028) were found among the biopsy devices. The quality of specimens from backloaded cup forceps was rated similarly to the nitinol basket (P >.05) and was favored over standard cup forceps specimens. Grade concordance was not affected by specimen size (P >.05), morphology (P >.1), or location (P >.5). No difference existed among the devices in the rate of acquiring a grade concordant biopsy; however, the backloaded cup forceps provided concordant biopsies that could be distinguished as low- and high-grade (P = .02)., Conclusion: The backloaded cup forceps and nitinol basket obtained a higher quality urothelial specimen compared with standard cup forceps. Ureteroscopic biopsy device selection did not significantly impact the accuracy of the histologic diagnosis of UTUC., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Introduction: Cystoscopy is a basic urologic skill necessary for the endoscopic evaluation of the urethra and bladder. Presented is a step-by-step guide for flexible cystoscopy of the male and female patient., Materials/methods: Routine flexible cystoscopy was performed on a male patient with a history of upper tract urothelial carcinoma and a female patient as part of a hematuria evaluation. The male patient was positioned supine, and the female patient frog-leg supine. Preoperative equipment included a flexible cystoscope (Storz 11272 VP; Karl Storz, Inc., Germany), irrigant, lubricating gel, sterile gloves, and towels/drapes. A typical cystoscopy room layout is shown., Results: This guide outlines the indications, preoperative preparation, and procedural steps for each gender, postoperative care, and troubleshooting recommendations. The video depicts the author's (R.V.C.) typical office cystoscopy procedure. In both cases, the cystoscopies were within normal limits., Conclusion: A simple, standardized manner for performing office-based flexible cystoscopy is essential to the practice of all urologists. By following the outlined steps, the urethra and the entire bladder, including the bladder neck area, can be thoroughly evaluated.

Introduction: To evaluate the flow characteristics produced by a manual and automated-pump irrigation system connected to a flexible ureteroscope., Materials and Methods: An in vitro analysis of a manual hand-pump infuser (HP) and the UROMAT Endoscopic Automatic System for Irrigation ® (E.A.S.I.) pump was performed. Standard irrigation tubing was used to connect a three-way valve to a flexible ureteroscope, the irrigation system, and a digital manometer. Flow rate and irrigation pressure measurements were recorded over a 15-minute period using pressure settings of 150 and 200 mm Hg for both irrigation pump systems. Once the HP was inflated to the initial pressure, it was not reinflated over the course of the trial. Data were collected with the working channel unoccupied and with placement of a 200 μm (0.6F) holmium laser fiber, 1.7F nitinol stone retrieval basket, or 2.67F guidewire., Results: The difference in pressure measured at the site of inflow of irrigation to the ureteroscope was significantly greater using the HP compared to the E.A.S.I. pump at pressure settings of 150 mm Hg with and without the use of ureteroscopic instrumentation (p < 0.001), and at 200 mm Hg with instrumentation in the working channel (p < 0.01). There was no significant difference in the flow rate of irrigation through the open-channel ureteroscope over the course of 5 minutes between the two pump systems., Conclusion: The flow rates of irrigation produced by the HP and the E.A.S.I. pump are similar at pressures of 150 and 200 mm Hg irrespective of the occupancy of a ureteroscope's working channel during the first 5-minutes of irrigation. Irrigation pressure at the entry site of the ureteroscope is subject to significant variability with use of the HP compared to the E.A.S.I. pump irrigation system.

Objective: This study was undertaken to compare the central nervous system (CNS) tolerability profiles of the extended-release formulations of oxybutynin chloride and tolterodine tartrate in the treatment of women with overactive bladder (OAB), as observed in the OPERA (Overactive bladder: Performance of Extended Release Agents) trial., Study Design: The OPERA trial was a randomized, double-blind, active-control comparison of the efficacy and safety of extended-release oxybutynin (10 mg/d) and extended-release tolterodine (4 mg/d) given to 790 women with OAB for 12 weeks. The incidence of reported CNS events was compared between the treatment groups by using the Fisher exact test., Results: The incidence of CNS adverse events was 9% and 8% for the oxybutynin and tolterodine treatment groups, respectively. The difference between groups was not statistically significant. All reported CNS adverse events were rated as mild or moderate in severity. There were no serious treatment-related adverse events in either group, and discontinuation because of a CNS adverse event was infrequent., Conclusion: The extended-release formulations of oxybutynin and tolterodine were observed to be associated with a similar low incidence of CNS adverse events, which were mostly mild or moderate in severity.

Purpose: We evaluated the efficacy and tolerability of pentosan polysulfate sodium (PPS) for the treatment of men with chronic pelvic pain syndrome (CPPS), National Institutes of Health (NIH) category III., Materials and Methods: In a 16-week double-blind study 100 men with a clinical diagnosis of CPPS were randomized to receive 300 mg PPS or placebo 3 times daily. Clinical Global Improvement (CGI) was the primary outcome measure. Additional outcome measures were the NIH-Chronic Prostatitis Symptom Index (CPSI), Subjective Global Assessment and Symptom Severity Index assessment tools., Results: Significantly more patients receiving PPS experienced moderate to marked improvement based on CGI assessment (18 or 37% vs 8 or 18%, p = 0.04). However, mean CGI scores were not significantly different between the PPS group (1.0) and placebo groups (1.0 vs 0.6, p = 0.107). All NIH-CPSI domains suggested a positive effect for PPS and for total NIH-CPSI the difference approached statistical significance (-5.9 or 22% vs -3.2 or 12%, p = 0.068). The PPS group showed significantly greater improvement in NIH-CPSI quality of life domain scores than the placebo group (-2.0 or 22% vs -1.0 or 12%, p = 0.031). Of patients receiving PPS 67% and 80% of those receiving placebo completed the 16-week study. Diarrhea, nausea and headache were the most common adverse events., Conclusions: Pentosan polysulfate (900 mg daily) was more likely than placebo to provide relief for CPPS symptoms.