Artificial Urinary Sphincter Implants in Men: A National Health Care Data System-Based Study to Assess Reinterventions in France.

PURPOSE: Significant concerns remain regarding the long-term outcomes of AMS 800 artificial urinary sphincter (AUS) implants in men. The objective was to assess the long-term AUS reintervention (replacement or removal) rates after a first-ever AUS implantation. MATERIALS AND METHODS: This population-based retrospective cohort study included all men age ≥ 18 years in France who underwent a first-ever AUS implantation (identified using a unique device identifier) for male stress urinary incontinence (SUI) after prostate cancer (PCa) or benign prostatic hyperplasia (BPH) treatment, between January 1, 2006, and December 31, 2018. The primary outcome was reintervention-free survival rates (replacements and removals), estimated using the Kaplan-Meier method. Secondary outcomes were replacement and removal. A multivariable Cox proportional hazards model was used to assess associations between patient and hospital factors and the hazard of reintervention. RESULTS: The study included 8475 men with a median age of 69 years (IQR, 65-74) and a median follow-up time of 6 years (IQR, 3-9). Reintervention-free survival was 71% (95% CI, 70-72) at 2 years, 57% (95% CI, 55-58) at 5 years, and 40% (95% CI, 38-41) at 10 years. Reintervention-free survival was lower after BPH surgery, after radiotherapy combined with RP, and in centers performing fewer implantations. Removal-free survival was 83% (95% CI, 83%-84%) at 2 years, 75% (95% CI, 74%-76%) at 5 years, and 66% (95% CI, 65%-68%) at 10 years. CONCLUSIONS: Among men undergoing AUS implantation for SUI because of PCa or BPH treatment, the probability of reintervention was 29% within 2 years after implantation. The median time to reintervention was 6.6 years (IQR, 6.4-7.1), and the reintervention-free survival rate at 10 years was 40%. These insights can inform therapeutic decision making for patients and surgeons during the management of male SUI.

Perioperative and functionnal outcomes of robot-assisted laparoscopic versus open ureterovesical reimplantation for benign lower ureteral pathologies: a single-center comparative study.

PURPOSE: The robot-assisted laparoscopic (RALUVR) and open (OUVR) approaches have both been described for ureterovesical reimplantation to treat benign lower ureteral pathologies. Thus, we aimed to compare the perioperative and functional outcomes of RALUVR vs. OUVR. METHODS: We performed a retrospective comparative study including all consecutive patients treated with RALUVR or OUVR for benign lower ureteral pathologies between January 2013 and December 2022 at our center. Logistic regression analyses were used to assess the predictors of complication ≥ Clavien-Dindo (CD) III within 90 days, prolonged length of stay (LOS), and 90-day overall success. The Kaplan-Meier method and Cox regression analyses were used to assess vesicoureteral reflux-free (VU-RFS) and stenosis-free (SFS) survivals. RESULTS: Overall, 44 patients underwent RALUVR (n = 19; 43%) and OUVR (n = 25; 57%). In univariable logistic regression analyses, the use of RALUVR vs. OUVR was not significantly associated with postoperative complications ≥ CDIII (OR = 0.98; 95% CI=[0.17-5.09]; p = 0.98), and 90-day overall success (OR = 1.43; 95% CI=[0.24-11.28]; p = 0.7). Despite a shorter median LOS after RALUVR vs. OUVR (4 vs. 10 days, respectively; p < 0.001), multivariable logistic regression analysis showed no impact of the surgical approach on prolonged LOS (OR = 0.51, 95% CI=[0.03-13.86]; p = 0.65). No significant difference was observed in 2-year VU-RFS (72.9% vs. 100%, respectively; p = 0.2) and 2-year SFS between the RALUVR and OUVR groups (85.7% vs. 87.7%, respectively; p = 0.8). In Cox regression analysis, the use of RALUVR vs. OUVR was not significantly associated with VU-RFS (HR = 4.26; 95% CI=[0.38-47.84]; p = 0.24) or SFS (HR = 1.32; 95% CI=[0.22-8.01]; p = 0.76). CONCLUSION: We observed that RALUVR provides similar perioperative and functional outcomes as compared to OUVR, except for potentially shorter LOS.

Artificial urinary sphincter: recent developments and the way forward.

PURPOSE OF REVIEW: The AMS 800 has dominated the treatment of postprostatectomy urinary incontinence (PPUI) due to intrinsic sphincter deficiency (ISD) for five decades. A narrative review from June 2022 to June 2024 was conducted using 'artificial urinary sphincter' (AUS) MeSH terms in Embase. We extracted information on innovative AUS, randomized controlled trials (RCTs) or prospective studies, and systematic reviews. We evaluated the latest guidelines and consensus and analyzed current trends to discuss options for advancing AUS practices. RECENT FINDINGS: Of 465 papers identified, 320 were excluded (irrelevant, duplicates, non-AUS devices, non-English, veterinary), and 145 were reviewed, with 24 selected: seven on novel AUS in development, 7 with higher-level evidence (1 RCT, 1 prospective, 4 systematic reviews, 1 nonsystematic review), and 9 retrospective relevant studies [pressure regulating balloon (PRB), revision strategies, radiotherapy history, manual dexterity/cognition, transscrotal vs. transperineal approach]. The final paper summarized current guidelines from Asia & Pacific on AUS. SUMMARY: In the past 2 years, six novel AUS have emerged, two female RCTs are ongoing, the SATURN study published its 1-year outcomes, and four systematic reviews on female AUS were conducted. These findings enhance evidence levels and position novel AUS to challenge the Gold Standard.

Long-term device survival after a first implantation of AMS800™ for stress urinary incontinence: Comparison between men and women.

PURPOSE: The artificial urinary sphincter is the reference treatment for stress urinary incontinence in men, but it remains rarely used in women. This study aimed to compare long-term device survival between women and men, after the first implantation of an AMS800™ artificial urinary sphincter (Boston Scientific) for the treatment of a non-neurogenic stress urinary incontinence. MATERIALS AND METHODS: This retrospective cohort study included all patients with nonneurogenic stress urinary incontinence who underwent surgery in a large-volume university hospital between 2000 and 2013. The primary outcome was the overall survival of the device, defined as the absence of any repeated surgery (revision or explantation) during follow-up. Men and women were matched 3:1 according to age and year of implantation. Differences were analyzed using a Cox model accounting for matching and applying time intervals because hazards were not proportional over time. Sensitivity analyzes were performed, excluding firstly a population with a history of radiotherapy and secondly a population with more than one previous surgery for urinary incontinence. RESULTS: A total of 107 women were matched to 316 men. Median follow-up was 6.0 years (Q1-Q3 1.8-9.4): 7.0 years (Q1-Q3 3.1-10.3) for women and 5.1 years (Q1-Q3 1.3-9.1) for men. During the follow-up, 56 patients had an explantation of the device: 44 men (13.9%) and 12 women (11.2%), and 113 had a revision: 85 men (26.9%) and 28 women (26.1%). Men have a significantly higher risk of explantation or revision than women between 6 months and 8 years after implantation (hazard ratio 2.12 [1.29-3.48]). Before 6 months and after 8 years, there were no significant differences. Both sensitivity analyses found consistent results. CONCLUSIONS: This study suggests that device survival seems better in women after the first 6 months.

Dynamic evaluation of MRI-targeted, systematic and combined biopsy for prostate cancer diagnosis through 10 years of practice in a single institution.

PURPOSE: To perform a dynamic evaluation of the prostate cancer (PCa) detection rate according to the biopsy strategy over 10 years of practice in a single institution that pioneered MRI-targeted fusion biopsy (MRI-TB). METHODS: This stage 4 IDEAL study prospectively included all consecutive patients who underwent transrectal prostate biopsy for clinically suspected PCa between January 2010 and November 2020. Patients with positive MRI (PIRADS score ≥ 3) underwent both MRI-TB and systematic biopsy (SB) while those with negative MRI (PIRADS score < 3) underwent SB only. The main outcome was the evolution of the detection rate of clinically relevant PCa (csPCa; grade ≥ 2). The secondary outcome was the change in PCa detection rate according to the biopsy method. RESULTS: A total of 2942 men underwent prostate MRI and a prostate biopsy: 2322 underwent MRI-TB and 620 had SB only. The detection rate of csPCa increased 2.5-fold from 23 to 58%. The detection rate of PCa and csPCa was significantly higher in patients who underwent MRI-TB compared to those who underwent SB only (67% vs. 52% and 40% vs. 32%, respectively (P < 0.001 for both comparisons)). The number of csPCa diagnosed by MRI-TB increased linearly over the study period and represented the majority of PCa diagnoses after 2016. CONCLUSION: Implementation of MRI-TB in patients with positive MRI led to improved detection of csPCa.

Predicting the risk of harboring high-grade disease for patients diagnosed with prostate cancer scored as Gleason ≤ 6 on biopsy cores.

PURPOSE: Biopsy and final pathological Gleason score (GS) are inconstantly correlated with each other. The aim of the current study was to develop and validate a predictive score to screen patients diagnosed with a biopsy GS ≤ 6 prostate cancer (PCa) at risk of GS upgrading. METHODS: Clinical and pathological data of 1,179 patients managed with radical prostatectomy for a biopsy GS ≤ 6, clinical stage ≤ T2b and preoperative PSA ≤ 20 ng/ml PCa were collected. The population study was randomly split into a development (n = 822) and a validation (n = 357) cohort. A prognostic score was established using the independent factors related to GS upgrading identified in multivariate analysis. The cutoff value derived from the area under the receiver operating characteristic curve of the score. RESULTS: After RP, the rate of GS upgrading was 56.7%. In multivariate analysis, length of cancer per core > 5 mm (OR 2.938; p < 0.001), PSA level > 15 ng/ml (OR 2.365; p = 0.01), age > 70 (OR 1.746; p = 0.016), number of biopsy cores > 12 (OR 0.696; p = 0.041) and prostate weight > 50 g (OR 0.656; CI; p < 0.007) were independent predictive factors of GS upgrading. A score ranged between -4 and 12 with a cutoff value of 2 was established. In the development cohort, the accuracy of predictive score was 63.7% and the positive predictive value was 71.2%. Results were confirmed in the validation cohort. CONCLUSION: This predictive tool might be used to screen patients initially diagnosed with low-grade PCa but harboring occult high-grade disease.

Artificial urinary sphincter AMS 800™ in males--can we explain residual leaks when sitting?

PURPOSE: Some patients fitted with an AMS 800™ type artificial urinary sphincter report urinary leaks in the sitting position whose mechanism remains unclear. In this experimental study we explain these residual leaks by characterizing fluid transfer and pressure variations in the device during cuff compression. MATERIALS AND METHODS: Two complete sets of AMS 800 devices were tested on an original test bench. A qualitative study using methylene blue dye was performed to assess fluid transfer within the device during manual cuff compression. After estimating the pressures exerted on the perineal floor in the sitting position, pressure variations in the AMS 800 components were measured in real time using the pressure sensors of a urodynamic workstation. RESULTS: When the AMS 800 cuff was compressed between 2 fingers, reflux of the blue dye into the balloon through the pump resistor was observed. After the cuff was compressed for 5, 10, 15 and 20 seconds at a pressure of 150 cm H2O, the minimal pressure measurements in the cuff were 37, 25, 14 and 12 cm H2O, respectively. Furthermore, the time required for cuff re-pressurization was 68, 87, 101 and 117 seconds, respectively. CONCLUSIONS: Urinary leaks reported in sitting position by patients fitted with an AMS 800 may be explained by compression of the urethral cuff between the pelvic floor and the chair, which causes emptying of the cuff into the balloon. Patients should be reassured that there is no implant dysfunction and may adopt simple lifestyle strategies to circumvent these leaks.

Robot-assisted Periprostatic Artificial Urinary Sphincter Implantation in Men with Neurogenic Stress Urinary Incontinence: Description of the Surgical Technique and Comparison of Long-term Functional Outcomes with the Open Approach.

BACKGROUND: Periprostatic artificial urinary sphincter implantation (pAUSi) is a rare yet relevant indication for male neurogenic stress urinary incontinence (SUI). OBJECTIVE: To describe the surgical technique of robot-assisted pAUSi (RApAUSi) and compare the long-term functional results with the open pAUSi (OpAUSi). DESIGN, SETTING, AND PARTICIPANTS: Data of 65 consecutive men with neurogenic SUI undergoing pAUSi between 2000 and 2022 in a tertiary centre were collected retrospectively. SURGICAL PROCEDURE: Thirty-three patients underwent OpAUSi and 32 underwent RApAUSi. OpAUSi cases were performed by a single surgeon, experienced in functional urology and prosthetic surgery. RApAUSi cases were performed by the same surgeon together with a second surgeon, experienced in robotic surgery. MEASUREMENTS: Outcome measures were achievement of complete urinary continence, intra- and postoperative complications, and surgical revision-free survival (SRFS). RESULTS AND LIMITATIONS: RApAUSi showed superior results to OpAUSi in terms of median (interquartile range) operative time (RApAUSi: 170 [150-210] min vs OpAUSi: 245 [228-300] min; p < 0.001), estimated blood loss (RApAUSi: 20 [0-50] ml vs OpAUSi: 500 [350-700] ml; p < 0.001), and median length of hospital stay (LOS; RApAUSi: 5 [4-6] d vs OpAUSi: 11 [10-14] d; p < 0.001). Clavien-Dindo grade ≥3a complications occurred more frequently after OpAUSi (RApAUSi: 1/32 [3%] vs OpAUSi: 10/33 [30%]; p = 0.014). Achievement of complete urinary continence (zero pads) was comparable between the groups (RApAUSi: 24/32 [75%] vs OpAUSi: 24/33 [73%]; p = 0.500). The median follow-up periods were 118 (50-183) and 56 (25-84) mo for OpAUSi and RApAUSi, respectively (p < 0.001). A tendency towards longer SRFS was observed in the RApAUSi group (p = 0.076). The main study limitation was its retrospective nature. CONCLUSIONS: RApAUSi is an efficient alternative to OpAUSi, resulting in shorter operative times, less blood loss, fewer severe complications, and a shorter LOS with similar functional results and need for revision surgery. PATIENT SUMMARY: Compared with open periprostatic artificial urinary sphincter implantation (pAUSi), robot-assisted pAUSi leads to faster recovery and similar functional results, with fewer postoperative complications.

Impact of Relative Volume Difference Between Magnetic Resonance Imaging and Three-dimensional Transrectal Ultrasound Segmentation on Clinically Significant Prostate Cancer Detection in Fusion Magnetic Resonance Imaging-targeted Biopsy.

BACKGROUND: Segmentation of three-dimensional (3D) transrectal ultrasound (TRUS) images is known to be challenging, and the clinician often lacks a reliable and easy-to-use indicator to assess its accuracy during the fusion magnetic resonance imaging (MRI)-targeted prostate biopsy procedure. OBJECTIVE: To assess the effect of the relative volume difference between 3D-TRUS and MRI segmentation on the outcome of a targeted biopsy. DESIGN, SETTING, AND PARTICIPANTS: All adult males who underwent an MRI-targeted prostate biopsy for clinically suspected prostate cancer between February 2012 and July 2021 were consecutively included. INTERVENTION: All patients underwent a fusion MRI-targeted prostate biopsy with a Koelis device. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Three-dimensional TRUS and MRI prostate volumes were calculated using 3D prostate models issued from the segmentations. The primary outcome was the relative segmentation volume difference (SVD) between transrectal ultrasound and MRI divided by the MRI volume (SVD = MRI volume - TRUS volume/MRI volume) and its correlation with clinically significant prostate cancer (eg, International Society of Urological Pathology [ISUP] ≥2) positiveness on targeted biopsy cores. RESULTS AND LIMITATIONS: Overall, 1721 patients underwent a targeted biopsy resulting in a total of 5593 targeted cores. The median relative SVD was significantly lower in patients diagnosed with clinically significant prostate cancer than in those with ISUP 0-1: (6.7% [interquartile range {IQR} -2.7, 13.6] vs 8.0% [IQR 3.3, 16.4], p < 0.01). A multivariate regression analysis showed that a relative SVD of >10% of the MRI volume was associated with a lower detection rate of clinically significant prostate cancer (odds ratio = 0.74 [95% confidence interval: 0.55-0.98]; p = 0.038). CONCLUSIONS: A relative SVD of >10% of the MRI segmented volume was associated with a lower detection rate of clinically significant prostate cancer on targeted biopsy cores. The relative SVD can be used as a per-procedure quality indicator of 3D-TRUS segmentation. PATIENT SUMMARY: A discrepancy of ≥10% between segmented magnetic resonance imaging and transrectal ultrasound volume is associated with a reduced ability to detect significant prostate cancer on targeted biopsy cores.

Pathological heterogeneity in sporadic synchronous renal tumors: Is the histological concordance predictable?

OBJECTIVE: To evaluate the pathological concordance rate of multiple synchronous renal masses (MSRM) presumed to be sporadic and to analyze predictive factors of concordance. MATERIAL AND METHODS: We identified from our institutional database patients with sporadic MSRM treated at our center between January 2000 and December 2015. All tumors were reviewed by a dedicated uropathologist. Pathological concordance rate was analyzed regarding clinical characteristics and preoperative imaging. RESULTS: We included 112 patients: 50 had unilateral synchronous renal masses and 62 bilateral synchronous renal masses. A total of 291 tumors were analyzed, with an average of 2.6 tumors per patient. Overall, the malignant concordance rate was 91.6%, the pathological concordance rate was 67.3% and the grade concordance rate was 62.5%. In univariate analysis, predictive factors of histological concordance were bilateral synchronous renal masses (odds ratio [OR] = 3.39; 95% CI: 1.06-10.8; P = 0.04), age<60 years (OR = 3.04; 95% CI: 1.2-7.7; P = 0.02) and ≥3 lesions (OR = 2.41; 95% CI: 1.03-5.68; P = 0.04). In multivariate analysis, age<60 remained significantly associated with histological concordance (OR = 3.84; 95% CI: 1.24-11.9; P = 0.02). CONCLUSIONS: The histological concordance rate of MSRM is low. Age at diagnosis <60 years, bilateral lesions and ≥3 tumors are predictive factors of histological concordance, but the pathological diagnosis remains difficult to predict. This heterogeneity is important to take into account, particularly when choosing the treatment upon the renal biopsy results from a single lesion.

Prospective assessment and histological analysis of adherent perinephric fat in partial nephrectomies.

OBJECTIVES: The complexity of partial nephrectomy (PN) is partly anticipated by morphometric tumor-based scores that do not consider patient-related issues such as adherent perinephric fat (APF). Also, the objective is to prospectively assess the predictive factors of APF during PN, its effect on complications, and to correlate it to the histological reality. METHODS: A total of 125 consecutive patients undergoing robotic or open PN were prospectively included. The Mayo adhesive probability score (MAP score) was compared to the peroperative presence of APF defined by a score≥2. Adipose tissue was analyzed histologically for fibrosis and inflammatory infiltrate of CD68+macrophages. Univariate and multivariate logistic regression analyses were performed to evaluate predictive factors of APF, and outcomes were compared using chi-square and Kruskal-Wallis tests. RESULTS: APF was present in 51 patients (40.8%) and associated with slight longer operating time and increased blood loss. Warm ischemia time, margins, transfusion, and the Clavien-Dindo score were not different. In multivariate analysis, only male sex, age, waist circumference, fat density on computed tomography, and MAP score were significant predictors of APF. A radioclinical score was more predictive of APF than MAP score alone. Histologically, there was no macrophage infiltration but larger adipocytes in APF without significant differences in fibrosis. CONCLUSIONS: APF can be accurately predicted using radioclinical data as the MAP score, combined with sex, age, and waist circumference. APF is associated with increased operative time and blood loss without postoperative complications. Histological analysis finds larger adipocytes in APF without inflammatory infiltrate, and no difference in fibrosis.