Antibiotic prophylaxis in invasive urodynamics, a Delphi consensus of the Italian Society of Urodynamics (SIUD).

INTRODUCTION: Although antibiotic prophylaxis (AB) demonstrated a statistically significant reduction in bacteriuria after invasive urodynamics (UDS), no significant decrease in the incidence of urinary tract infections (UTI) has been confirmed. No absolute recommendations on the use of AB in case of relevant potential risk of UTI have been reported, though some categories of patients at increased infective probability after UDS have been recognized. The aim of this study is to report the experts' consensus on the best practice for the use of AB before UDS in the main categories of patients at potential risk of developing UTI. MATERIALS AND METHODS: A systematic literature review was performed on AB before UDS in males and females. A panel of experts from the Italian Society of Urodynamics, Continence, Neuro-Urology, and Pelvic Floor (SIUD) assessed the review data and decided by a modified Delphi method on 16 statements proposed and discussed by the panel. The cut-off percentage for the consensus was a ≥70% of positive responses to the survey. The study was a Delphi consensus with experts' opinions, not a clinical trial involving directly patients. RESULTS: The panel group was composed of 57 experts in functional urology and UDS, mainly urologists, likewise gynaecologists, physiatrists, infectivologists, pediatric urologists, and nurses. A positive consensus was achieved on 9/16 (56.25%) of the statements, especially on the need for performing AB before UD in patients with neurogenic bladder and immunosuppression. Urine analysis and urine culture before UDS are mandatory, and in the event of their positivity, UDS should be postponed. A consensus was reached on avoiding AB in menopausal status, diabetes, age, gender, bladder outlet obstruction, high postvoid residual, chronic catheterization, previous urological surgery, lack of urological abnormalities, pelvic organ prolapse, and negative urine analysis. CONCLUSIONS: Antibiotic prophylaxis is not recommended for patients without notable risk factors and with a negative urine test due to the potential morbidities that may result from antibiotic administration. However, AB can be used for risk categories such as neurogenic bladder and immunosuppression. The evaluation of urine analysis and urine culture and postponing UDS in cases of positive tests were considered good practices, as well as performing AB in the neurogenic bladder and immunosuppression.

Evaluation of the effect of 100U of Onabotulinum toxin A on detrusor contractility in women with idiopathic OAB: A multicentre prospective study.

AIMS: Intradetrusor injection of Onabotulinum Toxin A (BTX-A) is a third-line treatment for overactive bladder (OAB). Voiding dysfunction and the need for intermittent catheterization are potential complications, consequent to bladder contractility (BC) decrement. Primary aim: to evaluate BC variation after BTX-A detrusor injection in women with idiopathic OAB. METHODS: A prospective multi-institutional observational study was conducted. Medical history, bladder diary, 24-h pad test, and invasive urodynamic parameters were recorded before and 4-6 weeks after BTX-A 100U administration. BC was measured as Modified Projected Isovolumetric Pressure (PIP1), that is, maximum flow rate (Qmax) + detrusor pressure at Qmax (PdetQmax). Continuous variables were expressed as median and interquartile range. We compared continuous variables using Wilcoxon test and proportions between two times with Fisher exact test. RESULTS: No changes in PIP1 were observed (p > 0.05) in 45 women enrolled between January 2018 and September 2019. Median age was 54.6 years. At baseline, 91.1% had urge urinary incontinence, with 4.9 ± 2.6 daily pads used and a 24-h pad test of 205.4 ± 70.8 g. Baseline detrusor contractility was normal in all the patients. Postoperatively, an improvement in the 24-h pad test (p < 0.01), daily voids (p < 0.01), and nocturia (p < 0.01) occurred. Urodynamics pointed out a significant reduction of detrusor overactivity rate (p < 0.01) and an increase of median maximum cystometric capacity (p < 0.01). No difference was observed in median Qmax (p > 0.05), PdetQmax (p > 0.05), and PVR (p > 0.05). No patient needed postoperative catheterization. CONCLUSIONS: The current series provides evidence that detrusor injection of botulinum toxin is an effective option for treating OAB, without causing voiding dysfunction and BC impairment.

Artificial urinary sphincter or a second adjustable transobturator male system offer equivalent outcomes in patients whom required revision on the initial ATOMS device: An international multi-institutional experience.

AIM: To evaluate treatment options after surgical revision of adjustable transobturator male system (ATOMS) and the results of further incontinence implantation. MATERIALS AND METHODS: A retrospective multicenter study evaluating patients with surgical revision of ATOMS in academic institutions. Causes and factors affecting revision-free interval were studied and also the frequency of device explant and placement of second ATOMS or artificial urinary sphincter (AUS) at surgeon discretion. Operative results, complications (Clavien-Dindo), and efficacy (postoperative pad-test, pad-count, patient satisfaction, and patient global impression of improvement [PGI-I scale]) of each treatment option were compared. RESULTS: Seventy-eight out of 902 patients (8.65%) with ATOMS underwent surgical revision at 4.1 ± 2.4 years mean follow-up and 75 (8.3%) were explanted. The main causes for revision included persistence of incontinence (35.9%) and scrotal port erosion (34.6%). Independent risk factors of the shortened revision-free interval were previous anti-incontinence surgery (HR, 1.83; 95% CI, 1.06-3.16; p = 0.007) and port erosion (HR, 1.83; 95% CI, 1.06-3.16; p = 0.0027). Fifty-eight (6.4%) received a second implant: 31 repeated ATOMS and 27 AUS. Operative time was longer for AUS (p = .003). The visual analog scale of pain at hospital discharge (p = 0.837) and postoperative complications (p = 0.154) were equivalent. The predominant cuff size for AUS was 4.5 cm (59.3%). Mean follow-up after the second implant was 29.1 ± 25.8 months. Postoperative efficacy of secondary treatment results favored ATOMS based on pad-test (p = 0.016), pad-count (p = 0.029), patient satisfaction (p = 0.04), and PGI-I (p = 0.025). CONCLUSIONS: ATOMS surgical revision due to different reasons generally leads to device explant. Rescue treatment is possible with ATOMS or AUS. No difference in postoperative complications was detected between secondary devices, but efficacy favors repeating ATOMS implantation.

A Novel Artificial Urinary Sphincter (VICTO®) for the Management of Postprostatectomy Urinary Incontinence: Description of the Surgical Technique and Preliminary Results from a Multicenter Series.

AIMS: The objective of the study was to analyze short-term outcomes and safety profile of the newly designed artificial urinary sphincters (AUSs) VICTO® and VICTOplus®. METHODS: Data from the implant of VICTO® or VICTOplus® AUSs on a series of consecutive male patients with stress urinary incontinence (SUI) following radical prostatectomy (RP) were retrospectively collected in 3 tertiary referral centers between May 2017 and December 2019. Patients were affected by moderate-severe genuine SUI (200-400 or >400 g urine leakage in 24-h pad test) refractory to conservative treatment. Outcomes were evaluated through the 24-h pad test and the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF). Follow-up was scheduled after 3, 6, and 12 months and then when clinically needed. Nonparametric tests were applied in subgroup analyses. RESULTS: Seventeen patients were enrolled: 8 were implanted with the VICTO® device and 9 with VICTOplus®. The median age at surgery was 69 (interquartile range (IQR) 60-75) years. The median follow-up was 15 (IQR 12-18) months. At 12 months, the dry rate was 76.4% and the social continence rate was 94%. The postoperative complication rate was 17.6%. All complications were classified as Clavien-Dindo I. No difference in terms of outcomes was observed between the VICTO® and the VICTOplus® subgroups. CONCLUSIONS: Preliminary outcomes of the VICTO® and VICTOplus® implantation are satisfactory. These devices may represent a safe and realistic solution for patients with moderate-severe SUI following RP.

First experience with ATOMS system implant in neurogenic stress urinary incontinence.

AIM: To evaluate efficacy and safety of ATOMS implant in neurogenic patients with stress incontinence performing clean intermittent catheterization (CIC). METHODS: We included all patients with neurogenic sacral/subsacral lesion and stress urinary incontinence, treated with ATOMS implant between January 2018 and March 2019. All patients received anamnesis, 24-hour pad test and pad count, physical examination, video urodynamic evaluation, Qualiveen questionnaire. All patients were followed up at 12 months after implantation. Patients were considered "continent" when dry or when wearing a security pad (social continence). RESULTS: We treated eight male patients with a median age of 25 years, four affected by myelomeningocele, and four by cauda equine syndrome. The median preoperative 24-hour pad test was 225 g (interquartile range [IQR]: 180-275). During the surgical procedure, we did not fill the cushion to prevent postoperative urethral injuries when performing CIC in the early postoperative time. At a 12-month follow-up, we had a significant reduction in postoperative 24-hour pad test (median value: 7.5 g; IQR: 0-16.25; P < .05). All patients reached continence. We had a significant reduction in the Qualiveen scores (P < .05). Patients demonstrated to be satisfied with the results of the intervention at the PGI-I questionnaire. The only complications were four cases of temporary scrotal edema (Clavien-Dindo 1) treated with conservative therapy. All patients resumed CIC without urethral traumatism nor catheter insertion difficulties. We had no cases of device infection nor device removal. CONCLUSIONS: Implantation of ATOMS device seems to be an effective and safe minimally invasive procedure also in neurological patients with a low rate of postoperative complications.

Urethral bulking with Bulkamid: An analysis of efficacy, safety profile, and predictors of functional outcomes in a single-center cohort.

AIMS: The aim of the present work is to analyze the safety profile, effectiveness, and favorable and unfavorable predictors of clinical outcome in urethral bulking with Bulkamid, and to better identify the ideal candidate for the procedure. METHODS: We included all consecutive female patients treated with urethral bulking with Bulkamid at our institution within 2 years. Patients were affected by stress urinary incontinence (SUI) or mixed incontinence. Incontinence severity was classified as "mild" (urinary leakage <50 g/die), "moderate" (50-200 g/die), or "severe" (>200 g/die) at 24-hours pad test. Clinical success was defined as "dry" (no pads); clinical failure included "partial improvement" (>50% 24-hours pad test reduction) and "no benefit" (<50% 24-hours pad test reduction). The χ2 and Mann-Whitney tests were performed to assess the predictors of clinical outcome. RESULTS: The success rate was 36.1% (n = 35). Forty-three patients (44.3%) reported continence improvement. Complications included eight urinary retention cases (8.2%). Statistically significant correlation was observed between incontinence severity and clinical outcome in thee χ2 test (P = .008). No significant correlation was found between functional outcome and urodynamic incontinence features, postoperative urinary retention, previous pelvic surgery, age, and other physiological, pathological, and urodynamics characteristics. Urinary retention following the surgical procedure appeared to be related to clinical success with nonsignificant P value (P = .10). CONCLUSIONS: Bulkamid procedure could be proposed with good results in elderly patients or in patients requiring a low-invasive procedure with low risk of complications, affected either by SUI or mixed incontinence and with mild to moderate incontinence. Previous training to clean intermittent self-catheterization maneuver should be performed.

Efficacy and safety of adjustable balloons (Proact™) to treat male stress urinary incontinence after prostate surgery: Medium and long-term follow-up data of a national multicentric retrospective study.

AIMS: Male stress urinary incontinence (SUI) represents a complication after radical prostatectomy or benign prostatic obstruction surgery. The artificial urinary sphincter is considered the standard treatment but interest on minimally invasive devices, such as adjustable balloons, has recently increased. Aim of this study is to evaluate the efficacy and safety of the ProACT system. METHODS: In this multicentric retrospective study, we reported the data from nine centers. Patients with SUI who underwent a ProACT device implantation for postoperative SUI and had a minimum follow-up of 24 months were included. Efficacy was evaluated at the maximum available follow-up and was assessed utilizing a 24-hour pad test. Patients were considered: "Dry" if presenting a urine leak weight lower than 8 g at the 24-hour pad test; "Improved" if presenting a reduction of urine leak higher than 50% (but >8 g/24 hours); "Failure" if presenting a reduction in urine leak lower than 50%. The evaluation included a record of intraoperative and long-term complications. RESULTS: Safety and efficacy results are reported on 240 patients. 29.6% of patients were dry at 24 months, 37.5% were improved and 32.9% of patients were considered failures. The baseline mean pad weight of 367 g was reduced to 123 g at 24 months. Five-year follow-up on 152 patients showed similar efficacy. The complication rate was 22.5%, with the top complication being long-term balloon failure. CONCLUSIONS: ProACT implantation represents a safe and efficacious treatment for male postoperative SUI at both medium and long-term follow up. 67.1% of patients were dry or improved at 24 months. The majority of complications are low grade.

Implant of ATOMS® system for the treatment of postoperative male stress urinary incontinence: results of a single centre.

PURPOSE: The aim of our study is to evaluate the efficacy and safety of ATOMS® system for the treatment of postoperative male stress urinary incontinence (SUI). MATERIALS AND METHODS: We retrospectively evaluated all patients treated at our institution for postoperative male SUI with ATOMS® implant. We excluded patients with low bladder compliance (< 20 mL / cmH2O), uncontrolled detrusor overactivity, detrusor underactivity (BCI < 100), urethral or bladder neck stricture and low cystometric capacity (< 200 mL). RESULTS: From October 2014 to July 2017 we treated 52 patients, mean age 73.6 years. Most of them (92.3%) had undergone radical prostatectomy, 3.85% simple open prostatectomy, 3.85% TURP; 28.8% of patients had undergone urethral surgery, 11.5% adjuvant radiotherapy; 57.7% had already undergone surgical treatment for urinary incontinence. The average24 hours pad test was 411.6 g (180 - 1100). The mean follow-up was 20.1 months (8.1 - 41.5) 30.8% of patients were dry, 59.6% improved ≥ 50%, 7.7% improved < 50% and 1.9% unchanged. In total 73.1% reached social continence. There was a significant reduction of the 24 hours pad test and ICIQ - UI SF scores (p < 0.01). In the postoperative follow-up we detected complications in 8 patients (19%): 5 cases of displacement of the scrotal port, in 2 cases catheterization difficulties, one case of epididimitis and concomitant superficial wound infection; no prosthesis infection, nor explants. Radiotherapy, previous urethral surgery,previous incontinence surgery were not statistically related to social continence rates (p 0.65;p 0.11;p 0.11). CONCLUSIONS: The ATOMS® system is an effective and safe surgical treatment of mild and moderate male postoperative SUI with durable results in the short term.

Long-term outcome of the adjustable transobturator male system (ATOMS): results of a European multicentre study.

OBJECTIVE: To evaluate the long-term effectiveness and safety of the adjustable transobturator male system (ATOMS® , Agency for Medical Innovations A.M.I., Feldkirch, Austria) in a European-wide multicentre setting. PATIENTS AND METHODS: In all, 287 men with stress urinary incontinence (SUI) were treated with the ATOMS device between June 2009 and March 2016. Continence parameters (daily pad test/pad use), urodynamics (maximum urinary flow rate, voiding volume, residual urine), and pain/quality of life (QoL) ratings (visual analogue scale/Leeds Assessment of Neuropathic Symptoms and Signs, International Consultation on Incontinence Questionnaire-Short Form [ICIQ-SF]/Patient Global Impression of Improvement [PGI-I]) were compared preoperatively and after intermediate (12 months) as well as after individual maximum follow-up. Overall success rate, dry rate (<10 mL/day and 0-1 pad/day), device durability, treatment failure, and device complications were recorded. Nonparametric tests were used for statistical analyses. RESULTS: After a median (interquartile range [IQR]) follow-up of 31 (10-54) months and a median (IQR) of 3 (2-4) adjustments, the overall success rate was 90% (258 men) and the dry rate was 64% (184). Daily pad test and pad use decreased from a median of 400 mL/day and 4 pads/day to a median of 18 mL/day and 1 pad/day (both P < 0.001), concomitantly QoL ratings significantly improved and changed to a high level of satisfaction (PGI-I 4 to 2, ICIQ-SF 17 to 5; both P < 0.001). The UI results at 12 months were comparable to those at final follow-up. Chronic pain and intraoperative complications did not occur. Most of the postoperative complications were Clavien-Dindo grade I-III (no grade IV or V). At present, 231 (80%) of all the ATOMS devices are still functioning; 56 (20%) were removed, the most common reason being local titanium intolerance (41%) and leak/dysfunction (30%). The operating time and continence outcome varied between port generations. In this regard the latest port generation (silicone-covered scrotal port) was superior to its predecessors. Primary implantation (P = 0.002), good physical health (P = 0.001), and no history of radiotherapy (P < 0.001) were prognostic factors for beneficial treatment outcome. CONCLUSION: The ATOMS device is safe and shows high treatment efficacy and patient satisfaction in the largest cohort study to date. The latest generation, with its pre-attached silicone-covered scrotal port, is superior to its predecessors. Significantly better results were achieved with primary implantation and in those without a history of radiotherapy.

A randomized, open-label, multicenter study of the efficacy and safety of intravesical hyaluronic acid and chondroitin sulfate versus dimethyl sulfoxide in women with bladder pain syndrome/interstitial cystitis.

AIMS: Intravesical instillation of hyaluronic acid (HA) plus chondroitin sulfate (CS) in women with bladder pain syndrome/interstitial cystitis (BPS/IC) has shown promising results. This study compared the efficacy, safety, and costs of intravesical HA/CS (Ialuril® , IBSA) to dimethyl sulfoxide (DMSO). METHODS: Randomized, open-label, multicenter study involving 110 women with BPS/IC. The allocation ratio (HA/CS:DMSO) was 2:1. Thirteen weekly instillations of HA (1.6%)/CS (2.0%) or 50% DMSO were given. Patients were evaluated at 3 (end-of-treatment) and 6 months. Primary endpoint was reduction in pain intensity at 6 months by visual analogue scale (VAS) versus baseline. Secondary efficacy measurements were quality of life and economic analyses. RESULTS: A significant reduction in pain intensity was observed at 6 months in both treatment groups versus baseline (P < 0.0001) in the intention-to-treat population. Treatment with HA/CS resulted in a greater reduction in pain intensity at 6 months compared with DMSO for the per-protocol population (mean VAS reduction 44.77 ± 25.07 vs. 28.89 ± 31.14, respectively; P = 0.0186). There were no significant differences between treatment groups in secondary outcomes. At least one adverse event was reported in 14.86% and 30.56% of patients in the HA/CS and DMSO groups, respectively. There were significantly fewer treatment-related adverse events for HA/CS versus DMSO (1.35% vs. 22.22%; P = 0.001). Considering direct healthcare costs, the incremental cost-effectiveness ratio of HA/CS versus DMSO fell between 3735€/quality-adjusted life years (QALY) and 8003€/QALY. CONCLUSIONS: Treatment with HA/CS appears to be as effective as DMSO with a potentially more favorable safety profile. Both treatments increased health-related quality of life, while HA/CS showed a more acceptable cost-effectiveness profile.

The effectiveness of adjustable trans-obturator male system (ATOMS) in radiated patients is reduced: A propensity score-matched analysis.

Objectives: This study aimed to compare the effectiveness and safety of the adjustable trans-obturator male system (ATOMS®) to treat post-prostatectomy incontinence (PPI) in radiated patients compared with non-radiated patients, using propensity score-matching analysis to enhance the validity of the comparison. Patients and methods: Consecutive men with PPI treated with silicone-covered scrotal port ATOMS (A.M.I., Feldkirch, Austria) in nine different institutions between 2016 and 2022 were included. Preoperative assessment evaluated 24-h pad usage, urethroscopy and urodynamics, if indicated. Propensity score-matching analysis was based on age, length of follow-up, previous PPI treatment, previous bladder neck stricture, androgen deprivation and pad usage. The primary endpoint was dry rate, defined as no pads post-operatively with a security pad allowed. The secondary endpoints were complications, device removal and self-perceived satisfaction with the Patient Global Impression of Improvement (PGI-I) scale. Results: Of the 710 included patients, 342 were matched, and the study groups were balanced for the baseline matched variables. The mean baseline 24-h pad was 4.8 in both groups (p = 0.48). The mean follow-up was 27.5 ± 18.6 months, which was also equivalent between groups (p = 0.36). The primary outcome was achieved in 73 (42.7%) radiated patients and in 115 (67.3%) non-radiated patients (p < 0.0001). The mean pad count at the last follow-up was 1.5 and 0.8, respectively (p < 0.0001). There was no significant difference in complications (p = 0.94), but surgical revision and device explant rates were higher (p = 0.03 and p = 0.01, respectively), and the proportion of patients highly satisfied (PGI-I = 1) was lower in the radiated group (p = 0.01). At sensitivity analysis, the study was found to be reasonably robust to hidden bias. Conclusion: ATOMS implantation significantly outperformed in patients without adjuvant radiation over radiated patients.

Long-Term Survival Rate of ATOMS Implant for Male Stress Urinary Incontinence and Management of Late Complications.

BACKGROUND: stress urinary incontinence (SUI) still represents a major drawback of prostate surgery. The aim of this study is to evaluate long term efficacy, safety and survival of ATOMS system implant in a single center. METHODS: we retrospectively included al consecutive patients treated with ATOMS implant for SUI from October 2014 to July 2019. Patients received anamnesis, urodynamic evaluation, pre- and postoperative 24 h pad test and count. Patients were considered "continent" when dry or when wearing a security pad (social continence). RESULTS: we treated99 patientswith median age 77.98 years (IQR 72.7-82.52). Most of the patients had undergone radical prostatectomy. Median follow-up was 62.9 months (IQR 47.5-75.9). At last follow-up 74 (74.7%) patients reported continence. We had 21 early (<30 days) postoperative complications, all Clavien-Dindo (CD) grade 1 [11 temporary perineal pain, 4 urinary retention, 3 scrotal edema, 2 superficial wound dehiscence, 1 dysuria]. We had late postoperative complications in 28 patients [7 port dislocations requiring surgical repositioning (CD 3a), 6 device removals (CD 3a) due to port erosion (2), inefficacy (2), cushion leakage (1), mesh detachment (1), perineal pain (5), 2 cases of port extrusion solved with port removal leaving the device in place (CD 3a), 2 superficial wound dehiscence (CD 1), 2 UTI (CD 1), 1 scrotal edema (CD 1), 1 cushion deflate (CD 1), 1 dysuria (CD 1), 1 perineal pain (CD 1)]. The survival of the device was 97% at 12 months, 93% at 24 months, 91% at 36 months, 90% at 48 months and 87.9% at 60 months. CONCLUSIONS: This study demonstrates the good safety and efficacy of ATOMS implant for the treatment of SUI.

Management of complex ischial-urethral fistula in neurogenic patients performing clean intermittent self-catheterization.

INTRODUCTION: Neurogenic patients performing clean-intermittent self-catheterization (CIC) may develop an urethral erosion, resulting in ischial-urethral fistulas (I-UF). In this work we present our single-center experience in dealing with this peculiar complication. METHODS: In this work we included all neurogenic patients performing CIC treated at out Institution for I-UF. All patients had a spinal cord injury or myelomeningocele. We extracted from the patients' medical records the surgical management and postoperative clinical data. We defined failure the persistence of the fistula at X-ray contrast fistulography, retrograde urethrography, or uretrocystoscopy. RESULTS: We treated 11 patients (8 spinal cord injury, 3 myelomeningocele). Four patients have been treated with the placement of a new generation urethral stent (Uventa) after surgical toilette of the skin ulcer and placement of a temporary suprapubic catheter. All patients demonstrated a complete healing of the urethral lesion at stent removal and continued CIC without any difficulty. Four patients have been treated with perineal urethroplasty, requiring a buccal mucosal graft in two cases. In two patients a suprapubic permanent catheter was placed for a simpler bladder management due to the patients' comorbidities. In one case the incidental finding of an high grade muscle invasive urothelial bladder cancer, made it mandatory to perform an uretheroileocutaneostomy. CONCLUSIONS: This work represent a unique series of I-UF in neurogenic patients performing CIC. Surgical urethral reconstruction, often with the use of buccal mucosa in large lesions, may be a difficult solution in neurogenic patients, new generation stents (Uventa) represent a minimally invasive, effective, and safe alternative.

Comparison Study between Artificial Urinary Sphincter and Adjustable Male Sling: A Propensity-Score-Matched Analysis.

AIMS: This study aimed to compare the outcomes of the AUS and an adjustable male sling (ATOMSTM). METHODS: It was a retrospective observational cohort study with two arms. Propensity score matching (PSM) was performed in order to limit selection bias and, consequently, a comparison between groups in terms of functional outcomes (24 h pad test and perception of improvement questionnaires), complications (overall complications, high-grade complications, reinterventions and explantations) and device survival was performed. RESULTS: 49 patients in both arms were included. The baseline characteristics were similar between the groups. The mean follow up was 43 ± 35 months. Dryness was achieved in 22 patients (44.9%) in the AUS group and 11 (22.5%) in the sling group (p = 0.03). A total of 40 patients declared themselves well improved in the sling group (81%), while 35 (71%) declared the same in the AUS group (p = 0.78). The AUS was associated with more high-grade complications, reinterventions and explantations than the ATOMSTM. Survival at 60 months was 82 ± 9% in the sling group and 67 ± 7% in the AUS group (p = 0.03). CONCLUSIONS: While the AUS may be characterized by a higher dry rate, it has an increased risk of high-grade complications and reinterventions. It is proposed that the ATOMS prosthesis can be successfully used for patients who require a less invasive procedure that maintains good functional outcomes.

Results of Adjustable Trans-Obturator Male System in Patients with Prostate Cancer Treated with Prostatectomy and Radiotherapy: A Multicenter Study.

(1) Background: Treatment of male stress incontinence in patients with prostate cancer treated with radical prostatectomy and adjuvant pelvic radiation is a therapeutic challenge. The efficacy and safety of the adjustable trans-obturator male system (ATOMS) in these patients is not well established, despite the general belief that outcomes are worse than in patients without radiation. (2) Methods: Retrospective multicenter study evaluating patients treated with silicone-covered scrotal port (SSP) ATOMS implant after radical prostatectomy and radiotherapy in nine different institutions between 2016 and 2022. The primary endpoint was dry patient rate, defined as pad-test ≤ 20 mL/day. The secondary endpoints were complication rate (defined using Clavien-Dindo classification), device removal and self-perceived satisfaction using the Patient Global Impression of Improvement (PGI-I) scale. Wilcoxon rank-sum test, Fisher's exact test and logistic regression were performed using stepwise method with a 0.15 entry and 0.1 stay criteria. (3) Results: 223 patients fulfilled the criteria for inclusion and 12 (5.4%) received salvage prostatectomy after radiation and 27 (12.1%) previous devices for stress incontinence. After ATOMS adjustment, 95 patients (42.6%) were dry and 36 (16.1%) had complications of any grade (grade I, n = 20; grade II, n = 11; grade III, n = 5) during the first 3 months postoperatively. At a mean of 36 ± 21 months follow-up, the device was explanted in 26 (11.7%) patients. Regarding self-perceived satisfaction with the implant, 105 of 125 patients (84%) considered themselves satisfied (PGI-I 1 to 3). In the univariate analysis, dryness was associated to younger age (p = 0.06), primary prostatectomy (p = 0.08), no previous incontinence surgery (p = 0.02), absence of overactive bladder symptoms (p = 0.04), absence of bladder neck stricture (p = 0.001), no need of surgical revision (p = 0.008) and lower baseline incontinence severity (p = 0.0003). Multivariate analysis identified absence of surgical revision (p = 0.018), absence of bladder neck stricture (p = 0.05), primary prostatectomy (p = 0.07) and lower baseline incontinence severity (p < 0.0001) were independent predictors of dryness. A logistic regression model was proposed and internally validated. (4) Conclusions: ATOMS is an efficacious and safe alternative to treat male incontinence after radical prostatectomy and adjuvant radiotherapy. Factors predictive of dryness are identified in this complex scenario to allow for better patient selection.

How to Prevent Catheter-Associated Urinary Tract Infections: A Reappraisal of Vico's Theory-Is History Repeating Itself?

New, contextualized modern solutions must be found to solve the dilemma of catheter-associated urinary infection (CAUTI) in long-term care settings. In this paper, we describe the etiology, risk factors, and complications of CAUTI, explore different preventive strategies proposed in literature from the past to the present, and offer new insights on therapeutic opportunities. A care bundle to prevent CAUTI mainly consists of multiple interventions to improve clinical indications, identifying a timeline for catheter removal, or whether any alternatives may be offered in elderly and frail patients suffering from chronic urinary retention and/or untreatable urinary incontinence. Among the various approaches used to prevent CAUTI, specific urinary catheter coatings according to their antifouling and/or biocidal properties have been widely investigated. Nonetheless, an ideal catheter offering holistic antimicrobial effectiveness is still far from being available. After pioneering research in favor of bladder irrigations or endovesical instillations was initially published more than 50 years ago, only recently has it been made clear that evidence supporting their use to treat symptomatic CAUTI and prevent complications is needed.

Bulking agents for the treatment of recurrent stress urinary incontinence: a suitable option?

BACKGROUND: The management of recurrent female stress urinary incontinence (SUI) still needs worldwide standardization. Few data on the role of urethral bulking agents (UBA) for the treatment of recurrent stress urinary incontinence exist. The aim of this study is to assess the efficacy and safety of urethral bulking agents for the treatment of recurrent SUI. METHODS: A multicenter, prospective study was conducted in four tertiary referral centers in two countries. All consecutive women with urodynamically-proven recurrent SUI, and with a history of previous failed anti-incontinence surgical procedure (mid-urethral sling or single incision sling), treated by UBAs were included. We evaluated only patients who completed at least a 3-year follow-up. Data regarding subjective outcomes (International Consultation on Incontinence Questionnaire-Short Form, Patient Global Impression of Improvement, Urogenital Distress Inventory score and patient satisfaction score), objective cure (stress test) rates, and adverse events were collected during follow-up. Univariable and multivariable analyses was performed to investigate outcomes. RESULTS: Forty-seven consecutive patients were enrolled. At 3-year follow-up, all women were available for the evaluation. At 3 years after surgery, 38 of 47 patients (81%) declared themselves cured. Similarly, at 3-year evaluation, 39 of 47 patients (83%) were objectively cured. Only five patients (10.6%) required re-operation for UBA failure. The urodynamic diagnosis of preoperative detrusor overactivity and the PDet Max filling phase ≥15 cmH2O (hazard ratio: 2.74; 95% CI, 1.64-10.7; P=0.009 and 1.62; 95% CI, 1.11-3.42; P=0.04, respectively) were the only predictors of failure. Only four complications were reported (8.5%). CONCLUSIONS: The 3-year results of this study showed that bulking agents is an appropriately effective and safe option for the treatment of recurrent SUI. The presence of preoperative concomitant detrusor overactivity is associated with a significant decrease of the efficacy of this procedure.

Urethral Bulking in the Treatment of Stress and Mixed Female Urinary Incontinence: Results from a Multicenter Cohort and Predictors of Clinical Outcomes.

The aim of the present study is to analyze the outcomes of urethral bulking in the treatment of non-neurogenic female stress and mixed urinary incontinence and to assess predictors of clinical outcomes. We retrospectively included all consecutive patients affected by stress or mixed urinary incontinence and treated with urethral bulking. Outcomes were evaluated via the PGI-I questionnaire and the 24-h pad test. Between January 2010 and January 2020, we treated 216 patients (Bulkamid n = 206; Macro-plastique n = 10). The median age at surgery was 66 years (IQR 55−73.75). The median follow-up was 12 months (IQR 12−24). In total, 23.8% of patients were subjected to prior incontinence surgery, 63.8% of patients were affected by genuine stress urinary incontinence, 36.2% reported mixed urinary incontinence, whereas detrusor overactivity was confirmed in only 24.9%. The dry rate was 32.9%; nevertheless, 69.9% of patients declared themselves "very improved" or "improved" (PGI-I1-2). Low complications were observed, mostly classified as Clavien I. After univariate and multivariate analyses, the only statistically significant independent predictor of "dry" outcome was the 24 h pad test, p < 0.001. Urethral bulking could be proposed with more expectations of success in patients with mild urinary incontinence. Patients affected by moderate−severe incontinence are less likely to obtain clinical success; therefore, they should be carefully counselled about clinical expectations before the procedure.

Can urethral re-bulking improve the outcomes of a prior urethral bulking?

AIMS: To analyze the outcomes of urethral re-bulking in the treatment of female stress urinary incontinence. MATERIALS AND METHODS: We performed a multicenter observational retrospective study, which included all consecutive patients treated with urethral re-bulking for the treatment of persistent stress or mixed urinary incontinence after a previous urethral bulking. Objective outcomes were evaluated with the 24 h pad-test, while PGI-I questionnaires were administered to evaluate subjective outcomes. Clinical outcomes were assessed before re-bulking procedure and at last follow-up. Mann-Whitney's U test was used for subgroup analysis. Shapiro-Wilk's tests were used as normality tests. RESULTS: In total, 62 patients who underwent urethral re-bulking between 2013 and 2020 in a multicenter setting were included. Most patients did not reach complete continence after the first procedure (n = 56) while the remainder reported recurrence of urinary incontinence after initial benefit. Median age at surgery was 66 (IQR: 55-73). Median overall follow-up was 30 months (IQR: 24-41). Median time occurred between the first procedure and reintervention was 12 months (IQR: 7-27). Bulking agents for the re-bulking procedures were bulkamid(n = 56), macroplastique(n = 4), and Prolastic(n = 2). A statistically significant reduction of median 24 h pad test from 100 g(IQR: 40-200) to 35 g(IQR: 0-120) was observed (p = 0.003). Dry rate after rebulking was 36.6%, while 85.4% patients declared themselves 'very much improved' or 'much improved' (PGI-I 1-2). Very few low-grade complications were observed (n = 4). A single case of major complication occurred. CONCLUSIONS: Urethral re-bulking can be an effective technique for the treatment of stress urinary incontinence refractory to a previous urethral bulking and can determine a cumulative benefit after the first procedure.

Adjustable Transobturator Male System (ATOMS) Infection: Causative Organisms and Clinical Profile.

OBJECTIVE: To evaluate the clinical profile and the organisms producing adjustable transobturator male system (ATOMS) infection in a contemporary series. METHODS: Multicenter retrospective study evaluating patients undergoing ATOMS explant for clinical signs of infection from a series of 902 patients treated in 9 academic institutions. Clinical and microbiological data were evaluated. RESULTS: Infection presented in 24 patients (2.7%). The median age was 73 ± 7yrs and the median interval from ATOMS implantation to explant 11 ± 26.5mo. Infection was diagnosed within 3-months after surgery in 7(29.2%). Scrotal port erosion was present in 6 cases (25%) and systemic symptoms of parenchymatous testicular infection in 2(8.3%). The culture of the periprosthetic fluid was positive in 20(83.3%): 12(50%) Gram-negative bacteria, 9(37.5%) Gram-positive cocci and 1(4.2%) yeast. The most frequent isolates were Enterococcus and Proteus sp. (16.7% each), followed by Pseudomona sp. and S. epidermidis (12.5% each). Methicillin resistant S. aureus was detected only in 1 case (4.2%). Despite the infection 17 patients (70.8%) were satisfied with the implant and 18(75%) received a second device (11 repeated ATOMS and 7 AUS) at a median 9.7 ± 12.6mo after explant. Limitations include retrospective design and lack of microbiological cultures in ATOMS explanted for non-infective cause. CONCLUSION: Infection of a prosthetic device is a disturbing complication. A proportion of patients with ATOMS infection is associated to scrotal port erosion and/or parenchymatous urinary tract infection. Enterococcus and Proteus sp. are the most common organisms producing ATOMS infection and this could have implications for the selection of the most appropriate surgical prophylaxis.