The International Female Coital Incontinence Questionnaire (IFCI-Q): Development, Validation and Reliability Study.

INTRODUCTION: Coital urinary incontinence is an underestimated urinary symptom characterized by urine leakage during intercourse with a serious impact on female sexual function, which often may lead to the abandon of sexual activity. To date, there are no specific validated questionnaires for coital incontinence (CI). AIM: Aim of the study was to develop and validate a questionnaire "International Female Coital Incontinence- Questionnaire" (IFCI-Q) to evaluate the presence, severity and type of CI and its impact on quality of sexual intercourse. METHODS: The IFCI-Q validation process included the following stages: (i) Questionnaire development and expert focus group (urologists and gynecologists experts in the field of functional urology); (ii) Administration of IFCI-Q to sexually active women complained for CI, by cognitive interview; (iii) Expert focus group to assess for content validity; (iv) Psychometric assessment of internal consistency by Cronbach's alpha calculation; (v) Test-retest reliability. MAIN OUTCOME MEASURE: Aim of the questionnaire was to evaluate the presence, severity and type of CI, its impact on quality of sexual intercourse and psychological status and to identify concomitant urinary symptoms. Psychometric properties outcomes: internal consistency and reliability are considered acceptable for Cronbach's α coefficient >0.7 and Cohen's k-test >0.6, respectively. Test-retest reliability was detected by administering the questionnaire twice to the all included women with a time interval of 2 weeks. The content validity was evaluated by a panel of clinical experts. RESULTS: Thirty women (mean ± SD age: 43.4 ± 17.1 years) complained of CI completed the IFCI-Q. A total of 43.4% of patients had OAB symptoms, 23.3% had mixed urinary incontinence (UI) and 6.6% complained of stress UI. Patients with CI during penetration had a higher prevalence of predominant SUI (7/10), and all women suffering from CI during orgasm had OAB symptoms (11/11). A total of 80% women feel depressed and 56.6% patients reported that CI restricts their sexual activity. Internal consistency and replicability of data were in the adequate range (Cronbach α = 0.737). The test-retest procedure revealed that the k-values of each item are very good. CONCLUSION: IFCI-Q is a reliable questionnaire on CI and demonstrated a high level of internal consistency and reliability. Gubbiotti M, Giannantoni A, Rubilotta E, et al. The International Female Coital Incontinence Questionnaire (IFCI-Q): Development, Validation and Reliability Study. J Sex Med 2022;19:158-163.

Increased risk of transurethral and suprapubic catheter self-extraction in COVID-19 patients: real-life experience.

INTRODUCTION: This study evaluated the prevalence of transurethral catheter self-removal in critically-ill COVID-19 non-sedated adult patients compared with non-COVID-19 controls. METHODS: COVID-19 patients who self-extracted transurethral or suprapubic catheters needing a urological intervention were prospectively included (group A). Demographic data, medical and nursing records, comorbidities and nervous system symptoms were evaluated. Agitation, anxiety and delirium were assessed by the Richmond Agitation and Sedation Scale (RASS). The control group B were non-COVID-19 patients who self-extracted transurethral/suprapubic catheter in a urology unit (subgroup B1) and geriatric unit (subgroup B2), requiring a urological intervention in the same period. RESULTS: 37 men and 11 women were enrolled in group A. Mean RASS score was 3.1 ± 1.8. There were 5 patients in subgroup B1 and 11 in subgroup B2. Chronic comorbidities were more frequent in group B than the COVID-19 group (P<0.01). COVID-19 patients had a significant difference in RASS score (P<0.006) and catheter self-extraction events (P<0.001). Complications caused by traumatic catheter extractions (severe urethrorrhagia, longer hospital stay) were greater in COVID-19 patients. CONCLUSION: This is the first study focusing on the prevalence and complications of catheter self-removal in COVID-19 patients. An increased prevalence of urological complications due to agitation and delirium related to COVID-19 has been demonstrated-the neurological sequelae of COVID-19 must be considered during hospitalisation.

Resilience in the face of pelvic pain: A pilot study in males and females affected by urologic chronic pelvic pain.

AIMS: Resilience represents a fundamental element in the experience of pain, as it allows adaptation to suffering and increases psychological social well-being and quality of life (QoL). We investigated resilience in patients affected by urologic chronic pelvic pain (UCPP) and the relationships with pain severity and distribution, catastrophizing and psychological distress. METHODS: Forty-eight consecutive UCPP patients were classified on a pain body map as being affected by pelvic pain only or widespread pain (WP), and underwent the evaluation of resilience with the 14-item Resilience Scale (RS-14), with higher scores indicating high resilience levels; scores < 56 denote very poor resilience. Pelvic and nonpelvic pain intensity and the bother of urinary symptoms on QoL were measured by means of Pain Numerical Rating Scale (PNRS) and Visual Analog Scale (VAS). Pain Catastrophizing Scale (PCS) and Depression Anxiety Stress Scales (DASS-21) investigated catastrophizing and psychological conditions. RESULTS: Overall, RS-14 mean ± SD total score was 50.2 ± 12.5 in patients with pelvic pain only and 40.2 ± 10.2 in those with WP. Significant relationships were observed between low resilience levels and high scores of pelvic and nonpelvic PNRS, VAS, pain catastrophizing scale and depression and anxiety, stress scale (for all: p < 0.001). Significantly lower RS-14 scores were detected in females and in patients with WP. CONCLUSIONS: A very poor resilience has been identified in UCPP patients, particularly in those with greater catastrophizing and mood alterations. WP and female gender were mostly affected. In UCPP patients, low resilience appears as a crucial factor in pain experience.

Continuing care for patients affected by urologic chronic pelvic pain in the era of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) pandemic.

AIMS: Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) pandemic poses a challenge to treatment of patients with urologic chronic pelvic pain (UCPP), who are at risk to be postponed in the priority of care. We investigated pain, catastrophizing, and psychological status in UCPP patients during SARS-CoV-2 by means of Skype telephone calls. METHODS: A total of 28 UCPP patients underwent Skype video consultations. Pain intensity was assessed with Pain Numerical Rating Scale (PNRS). Pain Catastrophizing Scale (PCS) and Depression Anxiety Stress Scales (DASS-21) were used to assess catastrophizing and psychological status. RESULTS: During SARS-CoV-2, UCPP patients showed higher intensity of pain than before (mean ± SD PNRS score: 7.25 ± 0.9 vs. 5.4 ± 0.7; p < .0001), with pain exacerbation in 75%; they showed higher PCS and DASS-21 scores as compared to before the pandemic (mean ± SD PCS total score: 32.4 ± 1.2 vs. 23.7 ± 3.5; mean ± SD DASS-21 total score: 42.03 ± 4.5 vs. 34.4 ± 2.2; p < .001 and p < .001, respectively). CONCLUSION: During SARS-CoV-2 pandemic UCPP patients presented with high intensity of pain, marked catastrophizing thoughts and severe alteration of the psychological status. These observations impose the need not to postpone assessment and treatment of these patients during the pandemic. Remote visits with video telephone calls are a simple way of continuing care in UCPP patients.

Urodynamics criteria of detrusor underactivity in women underwent middle urethral sling for stress urinary incontinence: What is the clinical role?

AIMS: To assess the role of detrusor underactivity (DUA), diagnosed by different urodynamic criteria, on outcomes of women underwent middle urethral sling (MUS) for stress urinary incontinence (SUI). METHODS: In this prospective study, DUA criteria of women with SUI, naïve for SUI surgery, candidates to MUS were: I Pdet@Qmax ≤10 cm H2O and Qmax ≤12 mL/s (Jeong et al.) ii Pdet@Qmax<30 cm H2O and Qmax<10 mL/s (Abarbanel and Marcus) iii Pdet@Qmax<20 cm H2O and Qmax<15 mL/s and BVE < 90% (BVE criteria) iv Pdet@Qmax<20 cm H2O + Qmax (PIP1 Griffiths) Control group (CG) comprised non-DUA patients. Preoperative and at 2-years follow-up evaluation included physical examination, uroflowmetry, post void residual urine (PVR), ICIQ-FLUTS. RESULTS: 102 patients fulfilled 2-years controls. DUA rate range was 16.7% (BVE) - 53.9% (PIP1-Griffith). The POUR rate varied: 20% (PIP1-Griffith) - 35.3% (BVE), 10% in CG. Tape incision rate for POUR was 3.4% in DUA, 4.5% in CG. No patients had urinary retention at 2-years follow-up. In DUA groups, Qmax did not change significantly after surgery and PVR was low. SUI recurrence rate was 2.8% in DUA, 4.5% in CG. Preoperatively, urgency and post-micturition dribble were the most (82.4%) and the less (26.7%) reported symptoms, respectively. At follow-up, frequency was the most prevalent (56.1%), reduced sensation/bladder pain the less usual (23.1%). ICIQ-FLUTS scores were higher in DUA groups. CONCLUSIONS: DUA did not have a negative impact on MUS outcomes in a mid-term follow-up. Early postoperative voiding complication rates changed according to the type of DUA urodynamic criteria.

Bladder and bowel dysfunction, adaptive behaviour and psychiatric profiles in adults affected by autism spectrum disorders.

AIMS: Bladder and bowel dysfunction (BBD) have been recognized in children affected by autism spectrum disorder (ASD), but no consistent information exist in adults with the condition. We evaluated the prevalence of BBD and the impact of psychiatric and behavioural profiles in adults affected by ASD. METHODS: Twenty-two adults and 13 children/teens with ASD and a matched group of typically developing subjects (TD) were prospectively studied. Patients and TD subjects underwent the evaluation of urinary incontinence (UI: diurnal, continuous or intermittent), nocturnal enuresis (NE), and bowel disturbances with the 3-day voiding and bowel diary. In addition, assessment of intellectual disability (ID) and psychiatric and adaptive behaviours with the Neuropsychiatric Inventory Scale (NPI) and the Vineland Adaptive Behaviour Scale 2nd Edition (Vineland-II), was performed. RESULTS: In adults, any type of incontinence was observed in 81.8% of cases, and NE and intermittent UI in 59.0% and 36.3% of patients, respectively. Faecal incontinence and constipation were detected 36.3% and in 68.1% of cases, respectively. ID was severe in 2 cases and profound in 18; NPI and Vineland-II items most affected were "Irritability/Lability," "Motor Activity," and "Agitation," and IQ-Socialization and IQ-Communication. Significant relationships were identified between intermittent UI and greater ID (P < .02) and high "anxiety" (P < .05), and between NE and high "euphoria/elevated mood" (P < .05). These results were similar to those observed in children/teens. CONCLUSIONS: Adults with ASD, and greater ID and mood disorders, present with a high prevalence of BBD. A shared pathogenetic mechanism could underlie the co-occurrence of ASD, mood disorders, and BBD.

Urodynamic findings and functional outcomes after laparoscopic sacrocolpopexy for symptomatic pelvic organ prolapse.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to evaluate the functional outcomes and urodynamic findings after laparoscopic sacrocolpopexy (LSC) in patients with stages II-IV pelvic organ prolapse (POP). METHODS: In this single-center prospective study, we evaluated 63 women (mean age 62.5 ± 7.5 years) women with symptomatic and advanced POP (stage II-IV) who underwent LSC without concomitant anti-incontinence surgery. The preoperative evaluation incuded history, clinical examination, and urodynamic testing. Women were followed up at 1, 3, 6, and 12 months after surgery and then annually using history, examination, and uroflowmetry. At 6 months, we performed urodynamic testing. To evaluate urinary symptoms, we used the Urogenital Distress Inventory (UDI)-6 questionnaire before and 6 months after surgery. RESULTS: Median follow- up was 22 months (range 8-48). After surgery, maximum flow (Qmax) significantly improved compared with baseline (14.17 ± 2.3 vs 27 ± 8.4 ml/s; p = 0.02), and the percentage of patients with elevated postvoid residual (PVR) significantly decreased (33.3% vs 11.1%; p = 0.001). Detrusor overactivity and bladder outlet obstruction disappeared in 73.6% and 85.7% of patients, respectively, while detrusor underactivity persisted in 66.6% of women. Twenty women (31.7%) reported stress urinary incontinence (SUI) before surgery (14 clinically evident and 6 as occult form), which persisted in only 7/20 (11%) patients following LSC, with no de novo cases. The most common preoperative symptoms were voiding symptoms, present in 42/63 (66.6%) patients, which resolved in 36 (85.7%). The overactive bladder syndrome disappeared in 60% of women, with no de novo cases. Results were reflected by a significant decrease in UDI-6 score from a median of 16 (0-45) at baseline to 5.5 (0-17) at the final follow-up (p = 0.001). The domain on storage symptoms (median 3 vs 1) and voiding symptoms (median 3 vs 1) of UDI-6 showed an improvement after surgery (p = 0.001). CONCLUSIONS: The urodynamic finding showed that LSC in women with advanced POP provides good functional outcomes.

The impact of Mirabegron on sexual function in women with idiopathic overactive bladder.

BACKGROUND: Overactive bladder (OAB) can frequently exert a negative effect on female sexual function. Mirabegron, a ß3 receptor agonist, improves OAB symptoms, but there are very few information about its role on female sexual dysfunction (FSD). Aim of the study was to assess the impact of Mirabegron on FSD in women affected by OAB. METHODS: Fifty sexually active women suffering from idiopathic OAB were included in the study. Patients were assessed by means of a urogynecologic physical examination and were asked to complete the 3-day voiding diary, the International Consultation on Incontinence Questionnaire- Short Form (ICIQ-SF), the Female Sexual Function Index (FSFI) questionnaire and VAS, before and 12 weeks after treatment with Mirabegron. In addition, at the same time points, patients underwent uroflowmetry with the measurement of post- void residual volume (PVR). RESULTS: At baseline all patients were affected by OAB symptoms, with 49/50 patients (98%) presenting with FSD. At 12- weeks follow- up, OAB symptoms improved significantly in all patients, with 59.5% of subjects achieving a complete urinary continence. FSFI Total Score significantly improved in 42/50 patients (84%) from 18.9 ± 4.3 to 21.8 ± 4.5 (p < 0.0001). Sixteen cases (32%) presented with no FSD. Also mean ± SD scores of ICIQ-SF and VAS significantly improved (from 17.1 ± 5 to 7.9 ± 4.8 and from 3.9 ± 1.2 to 6.9 ± 1.2 respectively, p < 0.000). CONCLUSIONS: Mirabegron not only is able to control urinary symptoms in women with OAB, but also induces a significant improvement in their sexual life.

Urinary and bowel disfunction in autism spectrum disorder: a prospective, observational study.

BACKGROUND: Vesico- sphincter and bowel dysfunction have been frequently detected in Autism spectrum disorder (ASD) patients, but to date no consistent information exist on adults affected by the disease. We evaluated the prevalence and types of bladder and bowel disfunction (BBD) in young and adult patients affected by ASD. SUBJECTS AND METHODS: Twenty- seven adults and 20 children/teens with ASD and a matched group of typically developing subjects were enrolled. Daily pads use and episodes of urinary incontinence (UI) were recorded in a 3- day voiding diary. Patients underwent also the measurement of post-void urinary residual volume and 3- day bowel diary. In addition, type and duration of the pharmacological agents assumed by the patients were accurately recorded. RESULTS: Any type of UI was observed in 85.1% of adults and in 90% of children/teens. In adults, nocturnal enuresis (NE, 62.9%) and diurnal intermittent UI (37%) were the most frequently observed bladder dysfunction while in children/ teens were NE (75%) and diurnal continuous UI (40%). In all patients was demonstrated a significant relationship between urinary symptoms and pharmacological agents, particularly NE and clotiapine (p<0.004) and periciazine (p<0.008). CONCLUSIONS: Young and adult patients with ASD present with a high prevalence of BBD and concomitant antipsychotic medications could to play a contribution in induction and/or maintaining of BBD.

Serenoa repens + selenium + lycopene vs tadalafil 5 mg for the treatment of lower urinary tract symptoms secondary to benign prostatic obstruction: a Phase IV, non-inferiority, open-label, clinical study (SPRITE study).

OBJECTIVE: To compare in a randomised, open-label, non-inferiority clinical study, the efficacy and tolerability of Serenoa repens (SeR) + selenium (Se) + lycopene (Ly) (SeR-Se-Ly) therapy vs tadalafil 5 mg in men with lower urinary tract symptoms (LUTS). PATIENTS AND METHODS: From May 2015 to January 2017, 427 patients were enrolled in 21 different centres (International Standard Randomised Controlled Trial Number Register [ISRCTN] 73316039). Inclusion criteria included: age between 50 and 80 years, International Prostate Symptom Score (IPSS) ≥12, maximum urinary flow rate (Qmax ) ≤ 15 mL/s, and post-void residual (PVR) <100 mL. Patients were randomised into two groups in a 2:1 ratio: Group A (SeR-Se-Ly, 1 tablet daily for 6 months) and Group B (tadalafil 5 mg, 1 tablet daily for 6 months). The primary endpoint of the study was the non-inferior variation in the IPSS and Qmax in Group A vs Group B after 6 months of treatment. RESULTS: In all, 404 patients completed the full protocol. When comparing both therapies, Group A was statistically not inferior to Group B considering the median change in IPSS (-3.0 vs -3.0; P < 0.01), IPSS quality of life (-2.0 vs -2.0; P < 0.05), and Qmax (2.0 vs 2.0 mL/s; P < 0.01). We found statistically significant differences in the increase of at least 3 points in Qmax (38.2% vs 28.1%; P = 0.04) and of at least 30% of Qmax (39.2% vs 27.3%; P < 0.01) in Group A compared to Group B. The percentage of patients with an increase of at least 3 points in the IPSS and a decrease of at least 25% of the IPSS was not statistically different between the two groups. For adverse events, four patients in Group A (1.44%) and 10 in Group B (7.81%) (P < 0.05) reported side-effects. CONCLUSION: We have shown that treatment with SeR-Se-Ly was not inferior to tadalafil 5 mg for improving IPSS and Qmax in men with LUTS.

Adolescence transitional care in neurogenic detrusor overactivity and the use of OnabotulinumtoxinA: A clinical algorithm from an Italian consensus statement.

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.

Real-life clinical practice of onabotulinum toxin A intravesical injections for overactive bladder wet: an Italian consensus statement.

PURPOSE: We developed a consensus on best practice in the real-life management of patients with overactive bladder (OAB) with onabotulinumtoxin A (Onabot/A). METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

A practical approach to the management of nocturia.

AIM: To raise awareness on nocturia disease burden and to provide simplified aetiologic evaluation and related treatment pathways. METHODS: A multidisciplinary group of nocturia experts developed practical advice and recommendations based on the best available evidence supplemented by their own experiences. RESULTS: Nocturia is defined as the need to void ≥1 time during the sleeping period of the night. Clinically relevant nocturia (≥2 voids per night) affects 2%-18% of those aged 20-40 years, rising to 28%-62% for those aged 70-80 years. Consequences include the following: lowered quality of life; falls and fractures; reduced work productivity; depression; and increased mortality. Nocturia-related hip fractures alone cost approximately €1 billion in the EU and $1.5 billion in the USA in 2014. The pathophysiology of nocturia is multifactorial and typically related to polyuria (either global or nocturnal), reduced bladder capacity or increased fluid intake. Accurate assessment is predicated on frequency-volume charts combined with a detailed patient history, medicine review and physical examination. Optimal treatment should focus on the underlying cause(s), with lifestyle modifications (eg, reducing evening fluid intake) being the first intervention. For patients with sustained bother, medical therapies should be introduced; low-dose, gender-specific desmopressin has proven effective in nocturia due to idiopathic nocturnal polyuria. The timing of diuretics is an important consideration, and they should be taken mid-late afternoon, dependent on the specific serum half-life. Patients not responding to these basic treatments should be referred for specialist management. CONCLUSIONS: The cause(s) of nocturia should be first evaluated in all patients. Afterwards, the underlying pathophysiology should be treated specifically, alone with lifestyle interventions or in combination with drugs or (prostate) surgery.

Long-term efficacy of the trans-obturator and retropubic mid-urethral slings for stress urinary incontinence: update from a randomized clinical trial.

PURPOSE: To report the extended long-term results of the use of tension-free vaginal tape(TVT) and trans-obturator tape (TOT) for the treatment of female stress urinary incontinence (SUI). METHODS: A prospective, multicentre randomized clinical trial comparing the use of TVT and TOT was used to evaluate 87 patients. The inclusion criteria were stress or mixed UI associated with urethral hyper mobility (the stress component was clinically predominant), while the exclusion criteria were previous anti-incontinence surgery and/or pelvic organ prolapse. The objective cure criteria were a negative provocative stress test and a negative 1-h pad test, with no further treatment for SUI. The subjective cure criteria were a 3-day voiding diary, quality-of-life questionnaires (UDI6-IIQ7), and patient satisfaction on a scale from 0 to 10. RESULTS: Eighty-seven patients were evaluated (47 TOT and 40 TVT) at a median follow-up of 100 months. Subjective and objective cure rates were 59.6 and 70.2 % in the TOT group and 75 and 87.5 % in the TVT group. The mid-to-long-term trend was a decreasing continence rate in patients who underwent TOT, compared with a stable rate for TVT. The Kaplan-Meier survival curve showed that continence rate decreased for up to 25 months after surgery, with stabilization thereafter for the TVT group while continuing to drop in the TOT group, with no inter-group difference. CONCLUSION: The patients in both groups were highly satisfied at long-term follow-up. The overall continence rate worsened for both groups within 25 months. While the results tend to stabilize in the TVT group, a further decline in the TOT was observed.

OnabotulinumtoxinA intradetrusorial injections improve sexual function in female patients affected by multiple sclerosis: preliminary results.

PURPOSE: To investigate the effects of onabotulinum toxin type A (Onabot/A) intravesical injections on urinary and sexual function in a group of patients affected by multiple sclerosis (MS). METHODS: We enrolled 31 MS female patients with symptoms of overactive bladder and detrusor overactivity. All patients underwent urodynamics and were administered 3-day voiding diary, Incontinence Quality of Life (I-QoL) questionnaire, Female Sexual Function Index (FSFI) questionnaire, Hamilton Anxiety Rating Scale (HAM-A) and Hamilton Depression Rating Scale (HAM-D) before and 3 months after Onabot/A intravesical injection. RESULTS: Onabot/A injection significantly improved urinary symptoms as shown by the 3-day voiding diary, I-QoL questionnaire and the urodynamic variables. In addition, it also significantly improved sexual functioning in continent patients and psychological status as demonstrated by the increase in FSFI, HAM-A and HAM-D scores. CONCLUSIONS: The Onabot/A-induced positive effect on sexual dysfunction in our MS patients is likely due to an indirect effect exerted by the overall urological clinical improvement on sexual function at both the psychological and emotional levels. The positive effect exerted by Onabot/A on the anxiety and depression scale also suggests that urinary symptoms have a negative impact on the psychological status of the patients.

Sacral neuromodulation and Botulinum toxin A for refractory idiopathic overactive bladder: a cost-utility analysis in the perspective of Italian Healthcare System.

OBJECTIVES: To assess the relative cost-effectiveness of two therapeutic strategies: one starting with sacral neuromodulation (SNM) versus one starting with Botulinum toxin A (BTX-A) for the management of refractory incontinent idiopathic overactive bladder (OAB) patients, from the perspective of the Italian National Health Service (INHS). METHODS: Direct medical costs (2011) and benefits (quality-adjusted life years-QALYs) were assessed over a ten-year time frame adapting to the Italian practice a published Markov model. Clinical inputs were based on the published literature and on the expert opinion. Resource consumption rates were provided by clinical experts; unit costs were collected from a single hospital accounting and from standard tariff lists and public prices. Interventional procedures and management of adverse events were costed through a micro-costing approach. The primary outcome was incremental costs per QALYs gained (i.e. differential costs divided by differential benefits). Deterministic (DSA) and probabilistic (PSA) sensitivity analyses were conducted to assess the robustness of the model. RESULTS: Starting with SNM appears to be cost effective (i.e. under 40.000/QALY) from year three (21,259/QALY) onwards and becomes dominant (i.e. more effective and less costly) at year ten: cumulative costs were 32,975 for early SNM and 33,309 for early BTX-A, while cumulative QALYs were 7.52 and 6.93, respectively. At year ten, DSA suggests the results robustness and 99.8 % of the PSA iterations fell within the cost-effectiveness threshold. CONCLUSIONS: A therapeutic strategy starting with SNM may be considered cost effective in the midterm and cost saving in the long-term treatment of idiopathic OAB from the INHS perspective.

Serenoa repens, lycopene and selenium versus tamsulosin for the treatment of LUTS/BPH. An Italian multicenter double-blinded randomized study between single or combination therapy (PROCOMB trial).

BACKGROUND: Phytotherapy has been used to treat patients with lower urinary tract symptoms (LUTS). We evaluated the efficacy and tolerability of combination therapy between Serenoa Repens (SeR), Lycopene (Ly), and Selenium (Se) + tamsulosin versus single therapies. METHODS: PROCOMB trial (ISRCTN78639965) was a randomized double-blinded, double-dummy multicenter study of 225 patients between 55 and 80 years old, PSA ≤ 4 ng/ml, IPSS ≥12, prostate volume ≤60 cc, Qmax ≤15 ml/sec, postvoid residual urine (PVR) <150 ml. Participants were randomized group A (SeR-Se-Ly), group B (tamsulosin 0.4 mg), group C (SeR-Se-Ly + tamsulosin 0.4 mg). The primary endpoints of the study were the reduction of IPSS, PVR, and increase of Qmax in group C versus monotherapy groups. RESULTS: The decrease for combination therapy was significantly greater versus group A (P < 0.05) and group B (P < 0.01) for IPSS and versus group A (P < 0.01) for PVR from baseline to 6 months. A greater decrease in IPSS was observed for Group C versus group A (P < 0.01) and increase in Qmax versus group B (P < 0.01), from 6 months to 12 months. At one year, the changes of IPSS and Qmax were greater for Group C versus monotherapies (each comparison <0.05). The proportions of men with a decrease of at least three points (each comparison P < 0.05) and decrease of 25% for IPSS (each comparison P < 0.01) were greater for Group C. CONCLUSION: SeR-Se-Ly + tamsulosin therapy is more effective than single therapies in improving IPSS and increasing Qmax in patients with LUTS.

Is retrograde intrarenal surgery for the treatment of renal stones with diameters exceeding 2 cm still a hazard?

INTRODUCTION: Major kidney stones have traditionally been treated with percutaneous nephrolithotomy. However, retrograde intrarenal surgery (RIRS), which until a few years ago was considered inappropriate for this purpose, is becoming a viable, attractive alternative. The aim of the current study was to assess the efficacy and safety of RIRS combined with holmium laser lithotripsy for the treatment of stones > 2 cm in diameter in a large series of patients, reporting complications according to the Clavien-Dindo classification. MATERIALS AND METHODS: By retrospective analysis, we identified a total of 162 patients who were affected by stones greater than 2 cm in diameter and who had undergone RIRS. We reviewed demographic and stone characteristics, intraoperative and postoperative outcomes, and complications. RESULTS: The mean stone size was 2.7 cm +/- 0.6 cm. The primary, secondary, and tertiary stone-free rates were 66%, 80.9%, and 87.7%, respectively. The mean number of procedures per patient was 1.48. The complication rates according to the Clavien-Dindo classification were Clavien I in 20.4% of patients, Clavien II in 0%, Clavien III in 4.9%, Clavien IV in 0.6%, and Clavien V in 0%. CONCLUSIONS: As an alternative to standard procedures for the treatment of renal calculi greater than 2 cm in diameter, RIRS is safe and effective, with a low complication rate.

Onabotulinumtoxin-A intradetrusorial injections modulate bladder expression of NGF, TrkA, p75 and TRPV1 in patients with detrusor overactivity.

How onabotulinumtoxinA (onab/A) injected in the detrusor muscle improves detrusor overactivity (DO) is still a matter of debate. Nerve growth factor (NGF) seems to play a role in determining urgency and DO. Recent studies showed that NGF decreases in patients with DO who respond to onab/A treatment. We investigated onab/A-induced changes on gene expression of NGF, TRPV1, TrkA and p75 in bladder wall tissue of patients affected by neurogenic and idiopathic DO. Twenty-five patients (18 with neurogenic DO and 7 with idiopathic DO) received onab/A injections into the detrusor muscle. Urodynamic studies and cystoscopies with sampling of the bladder wall were performed before and 1 month after onab/A injections. Onab/A-induced changes in urodynamic variables (first volume and maximum pressure of uninhibited detrusor contractions and maximum cystometric capacity) and NGF, TRPV1, TRKA, p75 gene expression by means of quantitative Real Time-Polymerase Chain Reaction. NGF protein levels were assessed in tissue homogenates by enzyme-linked immunosorbent assay. Onab/A significantly improved urodynamic findings (as shown by the increase in maximum cystometric capacity), decreased the bladder tissue levels of NGF protein and significantly increased NGF, TrkA, p75 and TRPV1 gene expression independently from the etiology of DO. No significant correlation has been found between NGF down-regulation and the increase in MCC. Correlations between NGF gene expression and NGF receptors' gene expression were influenced by onab/A dosages. In the short time follow-up, onab/A decreases NGF protein levels and increases NGF and associated receptors' gene expression possibly by inhibiting NGF release. Further studies with longer follow-up will clarify time course of onab/A-induced modifications in NGF expression.