Objective:To assess the factors associated with the use of active surveillance (AS) in NCCN favourable intermediate-risk (FIR) prostate cancer (PCa) patients who received the 17-gene Genomic Prostate Score (GPS) assay. Material and Methods:Contemporary data were collected from academic and large community group practices across the United States. Eligible patients had localized PCa classified as FIR per NCCN guidelines and received a GPS report between May 2017 and April 2019. Higher GPS results (scale: 0-100) were associated with a higher risk of adverse outcomes. The proportion of patients selecting AS was calculated with 95% confidence intervals. Uni-and multivariable logistic regression analyses were performed to determine the association between AS selection and relevant covariates. Results:There were 324 eligible patients (Gleason Score 3 + 4, 79%; PSA 10-20 ng/ml, 19%; clinical stage T2b-T2c, 2%; median percent positive cores, 16.7%; median GPS result, 26). The distribution of GPS results was 0-19 (23%), 20-40 (60%), and 41-100 (16%). Overall, 31% (95% CI 26%, 36%) selected AS: 58% (46%, 69%) with GPS 0-19, 27% (21%, 33%) with GPS 20-40, and 6% (1%, 16%) with GPS 41-100. In univariable models, the Gleason score, percent positive cores, PSA, and GPS results were significantly associated with AS selection. In a multivariable model, the percent positive cores and the GPS result remained significantly associated with AS selection. AS persistence was 91% (82%, 95%) at 12 months. Conclusions:The GPS result and percent positive cores appear associated with AS use after controlling for relevant clinical variables in NCCN FIR prostate cancer patients.

Aims The basic evaluation or percutaneous nerve evaluation (PNE) is a method to assess pre-implantation therapeutic response in patients considering sacral neuromodulation for the treatment of refractory overactive bladder. A new PNE lead with a more robust design and greater distensibility designed to reduce the possibility of lead migration has recently been introduced to the market. The aim of this prospective, multicenter, global, postmarket study was to evaluate the clinical performance and safety of the new InterStim PNE lead with the foramen needle. Methods Patients with overactive bladder were enrolled in this study. The primary objective of this study was to determine the proportion of subjects who demonstrated motor or sensory response(s) during lead placement using the InterStim PNE lead. Additional measures included the Patient Global Impression of Improvement (PGI-I), patient satisfaction at the end of therapy evaluation, and change in bladder symptoms from baseline to the end of therapy evaluation (1-week follow-up visit). Results One-hundred and ten subjects met the inclusion and exclusion criteria and underwent a lead implant procedure. Of those, 108 had a successful procedure and 107 completed the 1-week follow-up visit. Ninety-nine percent of subjects (109/110) had a motor or sensory response during needle placement (95% confidence interval [CI]: 95%-100%) and 97% of subjects (107/110) had a motor or sensory response during lead placement (95% CI: 92%-99%). The majority of subjects (88%, 95/108) reported their bladder condition was better at the follow-up visit compared to before the PNE implant procedure, as reported in PGI-I. Subjects reported being satisfied with how the therapy impacted their voiding symptoms (82%, 88/108) and that they would recommend this therapy (87%, 94/108) to other patients. Symptom improvement was demonstrated with urinary urge incontinence subjects having an average of 4.2 +/- 3.4 urinary incontinence episodes/day at baseline and 2.2 +/- 2.5 at follow-up, and urinary frequency subjects having an average of 12.5 +/- 4.4 voids/day at baseline and 10.5 +/- 4.3 voids/day at follow-up. Lead removal was deemed to be easy and safe by the implanting physician, with a total of three adverse device effects in 3/110 subjects. No event was categorized as serious and all were resolved without sequelae. Conclusions The updated InterStim PNE lead with a more robust design and greater distensibility designed to reduce migration was shown to have a high rate of motor or sensory response during lead placement. Furthermore, subjects reported high rates of global improvements and amelioration of symptoms, and the lead was easy to remove with minimal morbidity.

Aims The aim of this study is to evaluate the effect of sub-sensory amplitude settings of sacral neuromodulation therapy on overactive bladder symptoms in subjects with urinary urge incontinence. Methods Subjects who qualified for a neurostimulator device implant were randomized to one of three amplitude settings (50% of sensory threshold [ST], 80% of ST, and ST). Subjects completed urinary voiding diaries (3-day), International consultation on incontinence modular questionnaire-overactive bladder symptoms quality of life questionnaire, and patient global impression of improvement (PGI-I) to assess change in voiding symptoms and quality of life (QoL) from baseline through 12 weeks. Results Forty-eight subjects had a successful test stimulation, 46 were implanted with a neurostimulator device and 43 completed the 12-week follow-up visit. The change from baseline to 12 weeks is -3.0 urinary incontinence (UI) episodes/day (95% confidence interval [CI]: -4.4 to -1.7) for the 50% of sensory threshold group, -2.9 UI episodes/day (95% CI: -4.7 to -1.2) for 80% of sensory threshold group, and -3.6 UI episodes/day (95% CI: -5.2 to -1.9) for the sensory threshold group. In each randomized group, improvements were observed in health-related QoL, its subscales, and symptom interference. Subjects across all three randomization groups reported on the PGI-I that their bladder condition was better at 12 weeks compared to before they were treated with InterStim therapy. Conclusion These findings provide insights into possible advancements in the postimplantation phase of therapy with potential for improved patient comfort and increased device longevity.

218 Background: Molecular assays are used to improve risk stratification in prostate cancer. This study determined how the 17-gene Genomic Prostate Score (GPS) assay guides treatment decisions in patients with NCCN favorable intermediate-risk prostate cancer. Methods: This retrospective study included 324 patients from 7 urology practices in the United States. All patients had NCCN favorable intermediate-risk prostate cancer, defined as <50% positive biopsy cores and only one of the following risk factors: grade group 2 (Gleason Score 3+4), clinical stage T2b-T2c, or PSA 10-20 ng/mL. All patients also had a GPS assay report dated May 2017 to April 2019. The GPS assay allows risk stratification into post-GPS very low-, low-, favorable intermediate-, unfavorable intermediate-, and high-risk groups, with higher GPS scores representing increased risk. Data were collected from patients' charts/electronic health records. The proportion of patients who selected active surveillance (AS) over immediate definitive treatment and AS, monotherapy, or multimodal therapy was calculated with 95% confidence intervals (CI) using the Clopper-Pearson method. Results: Patients comprised 79% with Gleason Score 3+4, 19% with PSA 10-20 ng/mL, and 2% with clinical stage T2b; median GPS result was 26. Post-GPS risk groups were 0%, 16%, 11%, 57%, and 16% very low-, low-, favorable intermediate-, unfavorable intermediate-, and high-risk groups respectively. Overall, 31% (95% CI 26%, 36%) of patients selected active surveillance (AS), with rate declining as post-GPS risk increased: 57% (95% CI 42%, 71%) selected AS in the post-GPS low-risk, 51% (95% CI 34%, 69%) in the post-GPS favorable intermediate-risk, 26% (95% CI 20%, 33%) in the post-GPS unfavorable intermediate-risk, and 6% (95% CI 1%, 16%) in the post-GPS high-risk group. Post-GPS unfavorable intermediate/high risk-patients were more likely to receive monotherapy than low/favorable intermediate-risk patients (high, 72%; unfavorable intermediate, 64%; favorable intermediate, 37%; and low, 37%); high-risk patients were more likely to receive multimodal therapy (high, 23%; unfavorable intermediate, 10%; favorable intermediate, 11%; and low, 6%). Median follow-up time was 18 months, and one prostate cancer-related metastasis and 2 deaths (neither prostate cancer-related) were reported. Complications (erectile dysfunction, urinary/bowel incontinence) were more common in treated than AS patients. AS persistence was 91% (95% CI 82%, 95%) at 12 months; patients discontinued AS due to disease progression (61%) or patient preference/unknown reasons (39%). Conclusions: The GPS result is associated with selection of AS and treatment intensity in this first examination of genomic classifiers in a cohort of prostate cancer patients with NCCN favorable intermediate-risk.

OBJECTIVE To evaluate changes from baseline in urgency urinary incontinence episodes, urinary frequency and quality of life through 12 weeks of percutaneous tibial neuromodulation (PTNM) therapy using NURO in drug-naive overactive bladder syndrome (OAB) subjects. METHODS Eligible subjects underwent 12 weekly PTNM sessions with the NURO system. Changes in voiding symptoms were evaluated with bladder diaries from baseline through 12 weeks. Analyses were conducted for subjects with data at baseline and follow-up visits (sessions 1, 4, 8, and 12). Safety was evaluated through adverse events (AE) related to the device, procedure, and therapy. RESULTS Of 154 subjects enrolled in the study, 120 subjects met study criteria and received PTNM. The mean age was 64.8 years, mean duration of OAB diagnosis was 3.4 years and 86% female subjects. No subjects tried OAB medication prior to enrollment. At baseline, patients had 3.5 +/- 2.5 (mean +/- SD) UUI episodes/day. Statistically significant improvement in urgency urinary incontinence episodes from baseline was observed at each follow-up visit (P<.0001), with a reduction of 2.4 +/- 2.1 episodes after session 12 from baseline. Subjects with urinary frequency at baseline had 11.5 +/- 2.9 voids/day. After session 12, a statistically significant reduction of 1.7 +/- 2.5 voids/day was observed (P<.0001). Ninety-six percent (116/120) of subjects completed the study with diary data for the primary objective with an average of 11.6 sessions. There were no serious or unanticipated AEs. The most common AEs were medical device site pain (3.3%, 4/121) and extremity pain (3.3%, 4/121). CONCLUSION PTNM using NURO is an effective and safe treatment for drug-naive patients with OAB. (C) 2019 Elsevier Inc.