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.

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.

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.

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.

Implant of ATOMS® system for the treatment of postoperative male stress urinary incontinence: an Italian multicentric study.

BACKGROUND: The aim of this study was to evaluate efficacy and safety of the ATOMS system for the treatment of postoperative stress urinary incontinence (SUI). METHODS: We included all consecutive male patients referring for postoperative SUI and treated with ATOMS system from June 2013 to July 2017. Patients received anamnesis, 24 h Pad Test, Pad count, physical examination, urodynamic evaluation, ICIQ-UI SF questionnaire. We excluded patients with low bladder capacity and compliance, uncontrolled detrusor overactivity. RESULTS: We treated 98 patients with median age of 70.21±10.02 years. The most common cause of SUI was open radical prostatectomy in 79 patients. Ten patients had undergone urethrotomy, 7 bladder neck incision, 14 adjuvant radiotherapy. Thirty-nine patients suffered of mild incontinence (24 h Pad Test <200 g), 49 moderate incontinence (200-400 g), 10 severe incontinence (≥400 g). Thirty-one patients underwent previous incontinence surgery: 29 ProACT, 3 artificial urinary sphincters (in 2 cases both devices), 1 bulking agents and subsequent male sling. Median follow-up was 21.5 months. We had a significant reduction of mean 24 h Pads Test, pad count and ICIQ-UI SF questionnaire (P<0.01). At last follow-up 47.96% of patients were dry and 79.59% reached social continence. A high incontinence grade, adjuvant radiotherapy, previous urethral surgery and incontinence surgery have been associated with lower continence results. We had complications in 33 patients (33.7%). The device was removed in 4 cases due to scrotal port erosion and in one case due to persistent pain. CONCLUSIONS: The ATOMS system seems to be an effective and safe surgical treatment for postoperative male SUI.

Neuromodulation in urology, state of the art.

Sacral neuromodulation is an approved and validated treatment for overactive bladder syndrome, chronic non-obstructive retention, and chronic pelvic pain. Percutaneous tibial nerve stimulation is a less invasive approach of neuromodulation. We performed a literature research to assess the current evidence available about neuromodulation. Both techniques appear to be effective and safe third-line treatments. The overall success rate ranges from 43% to 85% for sacral neuromodulation and from 40% to 79.5% for percutaneous tibial nerve stimulation. Sacral neuromodulation has a higher incidence of complications in comparison to percutaneous tibial nerve stimulation, due to the more invasive surgical technique and the presence of a permanent implant. The incidence of surgical revision ranges between 9% and 33%. The most frequent complication with sacral neuromodulation is pain at implant site (15%-42%), followed by lead migration (4%-21%), pain at lead site (5.4%-19.1%), leg pain (18%), and infection (5.7%-6.1%). The quality of the studies on sacral neuromodulation and percutaneous tibial nerve stimulation in literature is quite modest, because of the shortage of good randomized clinical trial; most of the studies are prospective observational studies with mid-term follow-up.

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

ABSTRACT 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.

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.

A Multidisciplinary Approach on the Perioperative Antithrombotic Management of Patients With Coronary Stents Undergoing Surgery: Surgery After Stenting 2.

Perioperative management of antithrombotic therapy in patients treated with coronary stents undergoing surgery remains poorly defined. Importantly, surgery represents a common reason for premature treatment discontinuation, which is associated with an increased risk in mortality and major adverse cardiac events. However, maintaining antithrombotic therapy to minimize the incidence of perioperative ischemic complications may increase the risk of bleeding complications. Although guidelines provide some recommendations with respect to the perioperative management of antithrombotic therapy, these have been largely developed according to the thrombotic risk of the patient and a definition of the hemorrhagic risk specific to each surgical procedure, key to defining the trade-off between ischemia and bleeding, is not provided. These observations underscore the need for a multidisciplinary collaboration among cardiologists, anesthesiologists, hematologists and surgeons to reach this goal. The present document is an update on practical recommendations for standardizing management of antithrombotic therapy management in patients treated with coronary stents (Surgery After Stenting 2) in various types of surgery according to the predicted individual risk of thrombotic complications against the anticipated risk of surgical bleeding complications. Cardiologists defined the thrombotic risk using a "combined ischemic risk" approach, while surgeons classified surgeries according to their inherent hemorrhagic risk. Finally, a multidisciplinary agreement on the most appropriate antithrombotic treatment regimen in the perioperative phase was reached for each surgical procedure.

Headache, low back pain, other nociceptive and mixed pain conditions in neurorehabilitation. Evidence and recommendations from the Italian Consensus Conference on Pain in Neurorehabilitation.

Pain is a disabling symptom and is often the foremost symptom of conditions for which patients undergo neurorehabilitation. We systematically searched the PubMed and Embase electronic databases for current evidence on the frequency, evolution, predictors, assessment, and pharmacological and non-pharmacological treatment of pain in patients with headache, craniofacial pain, low back pain, failed back surgery syndrome, osteoarticular pain, myofascial pain syndrome, fibromyalgia, and chronic pelvic pain. Despite the heterogeneity of published data, consensus was reached on pain assessment and management of patients with these conditions and on the utility of a multidisciplinary approach to pain therapy that combines the benefits of pharmacological therapy, physiotherapy, neurorehabilitation, and psychotherapy. We of the Italian Consensus Conference on Pain in Neurorehabilitation (ICCPN) suggest a need to conduct randomized controlled trials on the efficacy of pain treatments and their risk-benefit profile for the conditions we have reviewed.

Myogenic potential of whole bone marrow mesenchymal stem cells in vitro and in vivo for usage in urinary incontinence.

Urinary incontinence, defined as the complaint of any involuntary loss of urine, is a pathological condition, which affects 30% females and 15% males over 60, often following a progressive decrease of rhabdosphincter cells due to increasing age or secondary to damage to the pelvic floor musculature, connective tissue and/or nerves. Recently, stem cell therapy has been proposed as a source for cell replacement and for trophic support to the sphincter. To develop new therapeutic strategies for urinary incontinence, we studied the interaction between mesenchymal stem cells (MSCs) and muscle cells in vitro; thereafter, aiming at a clinical usage, we analyzed the supporting role of MSCs for muscle cells in vitro and in in vivo xenotransplantation. MSCs can express markers of the myogenic cell lineages and give rise, under specific cell culture conditions, to myotube-like structures. Nevertheless, we failed to obtain mixed myotubes both in vitro and in vivo. For in vivo transplantation, we tested a new protocol to collect human MSCs from whole bone marrow, to get larger numbers of cells. MSCs, when transplanted into the pelvic muscles close to the external urethral sphincter, survived for a long time in absence of immunosuppression, and migrated into the muscle among fibers, and towards neuromuscular endplates. Moreover, they showed low levels of cycling cells, and did not infiltrate blood vessels. We never observed formation of cell masses suggestive of tumorigenesis. Those which remained close to the injection site showed an immature phenotype, whereas those in the muscle had more elongated morphologies. Therefore, MSCs are safe and can be easily transplanted without risk of side effects in the pelvic muscles. Further studies are needed to elucidate their integration into muscle fibers, and to promote their muscular transdifferentiation either before or after transplantation.