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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.

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 3yr 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-yr follow-up, all women were available for the evaluation. At 3 yr after surgery, 38 of 47 patients (81%) declared themselves cured. Similarly, at 3-yr evaluation, 39 of 47 patients (83%) were objectively cured. Only 5 patients (10.6 %) required reoperation 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-yr 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.

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.

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.

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

Aims OnabotulinumtoxinA (onaBNTa) for treating neurogenic detrusor overactivity (NDO) is widely used after its regulatory approval in adults. Although the administration of onaBNTa is still considered off-label in children, data have already been reported on its efficacy and safety. Nowadays, there is a lack of standardized protocols for treatment of NDO with onaBNTa in adolescent patients in their transition from the childhood to the adult age. With the aim to address this issue a consensus panel was obtained. Methods A panel of leading urologists and urogynaecologists skilled in functional urology, neuro-urology, urogynaecology, and pediatric urology participated in a consensus-forming project using a Delphi method to reach national consensus on NDO—onaBNTa treatment in adolescence transitional care. Results In total, 11 experts participated. All panelists participated in the four phases of the consensus process. Consensus was reached if ≥70% of the experts agreed on recommendations. To facilitate a common understanding among all experts, a face-to-face consensus meeting was held in Rome in march 2015 and then with a follow-up teleconference in march 2017. By the end of the Delphi process, formal consensus was achieved for 100% of the items and an algorithm was then developed. Conclusions This manuscript represents the first report on the onaBNTa in adolescents. Young adults should be treated as a distinct sub-population in policy, planning, programming, and research, as strongly sustained by national public health care. This consensus and the algorithm could support multidisciplinary communication, reduce the extent of variations in clinical practice and optimize clinical decision making.

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.

The aim was to validate the Italian version of the Incontinence-Quality of Life questionnaire (I-QoL) in women with clinical and urodynamic urinary incontinence (UI). A secondary end point was to compare the results of women with reported UI, but negative urodynamic findings. The Italian translation of the I-QoL was administered to 267 Italian women with pelvic organ prolapse

Objective: Prevention may improve the quality of life and sexual and reproductive health. To improve prevention require a comprehensive research approach that examines the frequency and risk factors for urologic conditions. In June 2016 the Italian Urologic Society coordinated a preventive initiative : the 1st Week of Male Urologic Prevention ”#Controllati”. Material and methods: During the 1st Week of Male Urologic Prevention “#Controllati”, men aged 18 years or more were invited to attend participating urologic centers for a free of charge visit for counseling about urologic or andrologic conditions. Each participating man underwent a physical examination. Further he was asked about his a medical history and about his urologic symptoms, sexual activity and possible related problems. Results: Data were collected in 81 centers: 2380 men answered the questionnaire. A total of 1226 subjects participating in the study reported one or more urinary symptom [51.5% (IC 95% 48.9%-54.5%)]. The risk of any urinary symptoms increased with age: in comparison with men aged < = 30 years or less the risk of any urinary symptoms was 2.31, 2.92, 5.12, 7.82 and 17.02 respectively in the class age 31-40, 41-50, 51-60, 61-70 and > = 71. Overweight/obese men were at increased risk of any urinary symptoms [OR1.35 (95% CI 1.12-1.64)]. 27.2% (IC 95% overall 25.2% -29.3%) of the subjects had at least a sexual disorder (erectile dysfunction, premature ejaculation, hypoactive sexual desire). The erectile dysfunction and hypoactive sexual desire increased with age, but premature ejaculation tended to be higher among younger aged men aged 40 years or more. Current any urinary symptoms [OR 1.85 (CI 1.40-2.43)], hypertension [OR 1.66 (95% CI 1.21-2.26) and diabetes (OR 2.37 (95% CI 1.45-3.88)] increased the risk of erectile dysfunction. Conclusions: This large survey gives a picture of the burden of the more frequent urologic conditions offering useful information in order to focus preventive campaign.

Objective: To assess the efficacy of transobturator tape (TOT) in the management of stress urinary incontinence at a medium term follow-up. Methods: TOT is a polypropylene tape positioned through the obturator foramen. 70 patients with type II urinary stress incontinence were treated with TOT between June 2003 and May 2006. Patients were prospectively studied by physical examination, quality of life questionnaire (I-QOL), visual analog scale, global impression (dry, improved, same, worse), preoperative urodynamic study, and pre- and postoperative flowmetry. Statistical analysis (t test) of the difference in I-QOL scores and flowmetry was made by StatSoft V. 5.1. Results: The average follow-up was 32 (range 12–48) months. The I-QOL score increased statistically significantly by 40 points. The average percent improvement was 80%. 90% (63/70) of the patients were dry and 5% (4/70) were improved. The pre- and postoperative uroflowmetry studies were not statistically different. Vaginal erosion occurred in 4 patients. Conclusion: TOT is a safe procedure with a good efficacy at 32-month follow-up.

To assess the impact of duloxetine dose escalation on tolerability and efficacy, 516 women with stress urinary incontinence were randomized to receive placebo or duloxetine in one of three regimens: 40 mg BID for 8 weeks, 40 mg QD for 2 weeks escalating to 40 mg BID for 6 weeks or 20 mg BID for 2 weeks escalating to 40 mg BID for 6 weeks. A non-inferiority analysis confirmed that the 20 mg BID starting dose was significantly better than the other two duloxetine regimens for nausea reduction (16.5% vs 25.2% and 29.4%). There were also significant differences in the discontinuation rates (7.5% vs 11.8% and 16.2%). The efficacy after 4 weeks was significantly better with duloxetine than with placebo. Starting duloxetine at 20 mg BID for 2 weeks before increasing to 40 mg BID significantly improved tolerability but did not impact duloxetine efficacy after all the subjects had been on 40 mg BID for at least 2 weeks.

Since December 1999 a new adjustable device for female stress urinary incontinence called the ACT (Adjustable Continence Therapy) has been used in a multicentre study. The two year follow-up of the Italian multicentre study is presented. Material & Methods A group of 37 female patients, affected by SUI was evaluated before and after the positioning of the ACT with physical examination, urodynamic study and quality of life questionnaires (I-QOL) Mean age was 58,5 (range 21.9 – 84.6). 59% (22/37) had type II SUI while 42% (15/37) had type III SUI. 57% (21/37) had had prior urogenital surgery. The ACT device consists of an adjustable silicon balloon, a subcutaneously positioned titanium port and a two lumen tube in between. The devices are positioned via a percutaneous perineal approach, using either local or regional anaesthesia. A 2 cm skin incision is made on each labia majora and through these incisions a delivery trocar is directed toward the bladder neck. The trocar is manoeuvred into the desired position using tactile guidance and an image intensifier (III). Each ACT device is then inserted via the delivery tool. Each balloon is positioned lateral to the bladder neck, proximal to the vesico-vaginal space, below the endopelvic fascia. Each balloon is then filled with one to two millilitres of the isotonic contrast/sterile water mixture with X rays confirmation of the correct location. The injection ports attached to each balloon are then positioned subcutaneously in each labia majora; the balloons are subsequently adjusted, if this is required. Results 15 patients reached 24 months of follow-up. 46% of them were dry at physical examination and wear no pads. Additional 26% were significantly improved. This group of patients had to wear 1 pad/daily. 56% of the patients required one adjustment to achieve continence, 10% two adjustments, 10% three adjustments 24% need no adjustments. No cases of urinary retention were reported out of 37 cases. One patient had a transient dyspareunia. Conclusions 70 % of our patients where dry or substantially improved and the patients quality of life increases significantly, this results includes mainly the patient with sever intrinsic sphincter deficiency and failed previous incontinence surgery. The ability to post-operatively adjust the ACT permits to reach the appropriate volume to each patient. However a longer follow up and a bigger number of procedures are required for definitive conclusions.

Female dysuria comprises a broad range of urinary symptoms that can be categorized into 2 groups: (1) burning, pain, or other discomfort during micturition and (2) voiding urinary symptoms (hesitancy, slow strain, intermittency, splitting, straining to void, terminal dribble).

Objectives: To provide an overview on the efficacy, tolerability, safety and health-related quality of life (HRQoL) of drugs with a mixed action used in the treatment of overactive bladder (OAB). Evidence Acquisition: MEDLINE database and abstract books of the major conferences were searched for relevant publications from 1966 to 2011 and using the key words ‘overactive bladder’, ‘detrusor overactivity’, ‘oxybutynin’, ‘propiverine’, and ‘flavoxate’. Two independent reviewers considered publications for inclusion and extracted relevant data, without performing a meta-analysis. Evidence Synthesis: Old and conflicting data do not support the use of flavoxate, while both propiverine and oxybutynin were found to be more effective than placebo in the treatment of OAB. Propiverine was at least as effective as oxybutynin but with a better tolerability profile even in the pediatric setting. Overall, no serious adverse event for any product was statistically significant compared to placebo. Improvements were seen in HRQoL with treatment by the oxybutynin transdermal delivery system and propiverine extended release. Conclusions: While there is no evidence to suggest the use of flavoxate in the treatment of OAB, both oxybutynin and propiverine appear efficacious and safe. Propiverine shows a better tolerability profile than oxybutynin. Both drugs improve HRQoL of patients affected by OAB. Profiles of each drug and dosage differ and should be considered in making treatment choices.

Although overactive bladder (OAB) and detrusor overactivity (DO) are not synonyms, they share therapeutic options and partially underlying physiopathological mechanisms. The aim of this overview is to give insight into new potential targets for the treatment of OAB and DO. A narrative review was done in order to reach this goal. Ageing, pelvic floor disorders, hypersensitivity disorders, morphologic bladder changes, neurological diseases, local inflammations, infections, tumors and bladder outlet obstruction may alter the normal voluntary control of micturition, leading to OAB and DO. The main aim of pharmacotherapy is to restore normal control of micturition, inhibiting the emerging pathological involuntary reflex mechanism. Therapeutic targets can be found at the levels of the urothelium, detrusor muscles, autonomic and afferent pathways, spinal cord and brain. Increased expression and/or sensitivity of urothelial-sensory molecules that lead to afferent sensitization have been documented as a possible pathogenesis of OAB. Targeting afferent pathways and/or bladder smooth muscles by modulating activity of ligand receptors and ion channels could be effective to suppress OAB.

Objective/background: A newly designed Spinal Cord Unit (SCU) was set up at the Orthopedic Traumatology Center (OTC), Turin, Italy, in July 2007. With the relocation of the SCU came the need to reorganize and improve the delivery of its services. The study reported here is a preliminary part of a project entitled ‘Experimentation and evaluation of personalized healthcare for patients with spinal cord injury’, which is a component of an overarching program of targeted research into healthcare funded by the Piedmont Region in 2006. The aim of this study was to assess the perception of care by patients with spinal cord injury (SCI) by collecting important data in order to determine whether an integrated and personalized care pathway could be effective both in hospital and in a rehabilitation setting. Design: Qualitative research study. The interview format was based on a narrative approach. Methods: Qualitative in-depth semi-structured interviews were conducted with 21 patients with SCI. Qualitative content analysis was used to identify categories and themes arising from the data. Results: Six main categories emerged from the perspectives of patients: expectations of rehabilitation care, impact and welcome, relationship with nurses and their involvement in treatment, relationship with physical therapists and participation in rehabilitation programs, relationship with physicians and their availability and attendance, and imparting of information on injury and rehabilitation outcomes. Care was the aspect new patients admitted to the SCU found most important. When closer relationships with staff formed, the healthcare professionals became an essential support. Patients with SCI commonly stated that receiving explicit information was necessary for accepting their condition. Conclusions: Analysis of the patients’ perceptions revealed a wealth of details on their experience in the SCU and the need for flexible planning of care time in particular. Incorporating the patients’ perceptions into a new care model could increase professionals’ awareness of patients’ needs and provide a useful basis for constructing a personalized care plan.

We developed a consensus on best practice in the real-life management of patients with overactive bladder (OAB) with onabotulinumtoxin A (Onabot/A).In March 2015, an interdisciplinary conference was convened. Eleven panelists were invited to review the literature, to present their personal experience and to respond to a number of questions from: "when do we propose Onabot/A treatment" to "when do you decide to re-inject a patient?" A summary of findings of the meeting was provided to all panelists for review and approval.The following statements were agreed. Refractory OAB can be defined based on lack of adherence to first- and second-line treatments for OAB regardless of the underlying cause. Onabot/A treatment can be proposed to refractory OAB patients provided they are willing to perform intermittent catheterization if needed. Before treatment, uroflowmetry with post-void residual evaluation is needed to rule out voiding dysfunction, while urodynamics should be done in cases of complicated OAB wet. Urinary tract infection should be ruled out or treated before the injection. The injection can be performed in the endoscopy room, in an out-patient basis, with local anesthesia. Antibiotic prophylaxis should be initiated with oral drugs. A first follow-up visit should be planned 10-15 days after treatment and residual urine checked. Retreatment can be decided on patients' request, when symptoms worsen.This consensus document provides a guide for the management of refractory OAB patients with Onabot/A in real life. A number of questions about the effectiveness of Onabot/A in real life remain open.