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Prostate Cancer, Adolescent, Medicine, Comorbidity, Multivariate Analysis, and 15 moreHumans, Child, Male, Prostate, Clinical Sciences, Prevalence, Middle Aged, Adult, Biological markers, Prostate Specific Antigen, Benign Prostate Hyperplasia, Age of Onset, Case Control Studies, Cohort Studies, and Prostatic diseases
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Endocrinology, Andrology, Medicine, Cortisol, Humans, and 15 moreInternal Medicine, Female, Menstrual Cycle, Female Sexual Dysfunction, Clinical Sciences, Adult, Hormone, Female Sexual Function Index, Luteinizing Hormone, Follicle stimulating hormone, health status indicators, Gonadal Hormones, hydrocortisone, Medical and Health Sciences, and free testosterone
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Multiple sclerosis, Quality of life, Treatment Outcome, Medicine, Erectile dysfunction, and 12 moreHumans, Sexual Medicine, Female, Male, Phosphodiesterase Inhibitors, Middle Aged, Adult, Sildenafil, Combination drug therapy, Tadalafil, Psychology and Cognitive Sciences, and Medical and Health Sciences
Literature holds no information on a correlation between blood hormonal levels, in particular sex hormones and the sexual response of women with multiple sclerosis (MS). To investigate a possible correlation between hormonal status and... more
Literature holds no information on a correlation between blood hormonal levels, in particular sex hormones and the sexual response of women with multiple sclerosis (MS). To investigate a possible correlation between hormonal status and the sexual response of females with MS. The Female Sexual Function Index (FSFI) questionnaire was used to determine sexual dysfunctions (SDs). Methods for measuring blood hormones were chemiluminescence immunoassay, electrochemiluminescence immunoassay, enzyme immunoassay, and radioimmunoassay. During the screening phase, 55 women of reproductive age were recruited and completed the FSFI. In the first phase of the study females underwent a hematic hormonal evaluation on the third day of their menstrual cycle. Serum follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL), thyroid stimulating hormone (TSH), cortisol, dehydroepiandrosterone sulphate (DHEA-S), androstenedione, 17[alpha]-hydroxyprogesterone, total and free testosterone, 17 beta estradiol, inhibin and sex hormone binding globulin (SHBG), and thyroid hormones (fT3 and fT4) were checked. On the day 20-21 into their menstrual cycle the progesterone hematic value was noted. Patients with amenorrhea had all hormones tested once with a random blood drawing. After a 3-month period patients began phase 2, completing the FSFI again. The same blood hormones were investigated. Fifty-four females completed the study. Thirty-one continued to manifest at least one SD: desire (57.4%) was the most common. Overall, 36.4% showed abnormal hormonal alterations. The most frequent was 40% for 17 beta-estradiol. None of the FSFI domains, including the total score, revealed any statistically significant correlation to the hormones investigated. No statistically significant clinical predictive factors for blood hormone abnormalities were detected; comparing females with and without SD, P = 0.250 using chi-squared test was reached. Notable percentages of blood hormonal alterations and SD were documented, but no significant statistical correlations were detected between hormonal status and sexual function.
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Endocrinology, Multiple sclerosis, Medicine, Humans, Prolactin, and 15 moreInternal Medicine, Sexual Medicine, Female, Sexual Behavior, Menstrual Cycle, Questionnaires, Adult, Hormone, Chi Square Distribution, Luteinizing Hormone, Estradiol, Follicle stimulating hormone, health status indicators, Psychology and Cognitive Sciences, and Medical and Health Sciences
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Intermittent self catheterization questionnaire (ISC-Q) is a questionnaire exploring four issues related to self-intermittent catheterization (ISC): ease of use, convenience, discreteness and psychological well-being. Aim of the study is... more
Intermittent self catheterization questionnaire (ISC-Q) is a questionnaire exploring four issues related to self-intermittent catheterization (ISC): ease of use, convenience, discreteness and psychological well-being. Aim of the study is to develop and validate the Italian version of the ISC-Q. Two independent translations of the ISC-Q were performed and compared by an expert committee. A back translation to English was made by a linguistic expert, blinded to the original version. Patients using ISC to void their bladder were from 19 different spinal cord units; questionnaires were examined anonymously in a single center. A subgroup of 47 patients repeated the test at 2 weeks distance and completed the Qualiveen questionnaire to assess the convergent validity of ISC-Q. The internal consistency was determined from Cronbach's α coefficient. Criterion validity was determined through the concurrent use of Qualiveen. Reliability was performed by Intraclass Correlation Coefficient and test-retest. The sensitivity was determined by the effect size based estimate for small change (ES) and Minimal Detectable Change 95 (MDC95). 217 subjects (65.6% males, 34.4% females) were enrolled. Mean age: 43±10.1 years. Mean duration of ISC: 3.3±6.9 years. Cronbach's α ranged from 0.79 to 0.81. Pearson correlation between the different parts of ISC-Q and total score ranged from 0.24 to 0.78. ICC values were higher than 0.9. Convergent validity was faint to null. ES ranged from 3.8 to 6 points. MDC95 ranged from 4.1 to 12.1. The Italian ISC-Q has the same psychometric characteristics of the original questionnaire. ISC-Q is a valid, reliable and sensitive patient related outcome, specifically focused on ISC. our work provides a new validated measure for Italian patients to explore in future studies the role and impact of ISC.
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ObjectiveTo present the protocol for a randomized controlled trial (RCT) evaluating the efficacy and safety of transcutaneous tibial nerve stimulation (TTNS) for refractory neurogenic lower urinary tract dysfunction (NLUTD).Study Design... more
ObjectiveTo present the protocol for a randomized controlled trial (RCT) evaluating the efficacy and safety of transcutaneous tibial nerve stimulation (TTNS) for refractory neurogenic lower urinary tract dysfunction (NLUTD).Study Design and ResultsbTUNED (bladder and TranscUtaneous tibial Nerve stimulation for nEurogenic lower urinary tract Dysfunction) is an international multicentre, sham‐controlled, double‐blind RCT investigating the efficacy and safety of TTNS. The primary outcome is success of TTNS, defined as improvements in key bladder diary variables at study end compared to baseline values. The focus of the treatment is defined by the Self‐Assessment Goal Achievement (SAGA) questionnaire. Secondary outcomes are the effect of TTNS on urodynamic, neurophysiological, and bowel function outcome measures, as well as the safety of TTNS.ConclusionsA total of 240 patients with refractory NLUTD will be included and randomized 1:1 into the verum or sham TTNS group from March 2020 until August 2026. TTNS will be performed twice a week for 30 min during 6 weeks. The patients will attend baseline assessments, 12 treatment visits and follow‐up assessments at the study end.
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Sexual difficulties are common in patients with neurological disorders, and different domains of sexual function-desire, arousal, orgasm, and ejaculation-can be affected. Advances in the past 7 years in structural and functional... more
Sexual difficulties are common in patients with neurological disorders, and different domains of sexual function-desire, arousal, orgasm, and ejaculation-can be affected. Advances in the past 7 years in structural and functional neuroimaging have contributed to a greater understanding of the neural pathways involved in the regulation of sexual functions in health and disease, and this increased knowledge might help with development of future therapeutic strategies. A comprehensive assessment of patients includes history taking-covering the different domains of dysfunction, and primary, secondary, and tertiary contributory factors-as well as clinical examination in select patients (ie, patients for whom an associated non-neurological cause for sexual dysfunction is suspected). Investigations, such as assessment of associated cardiovascular risk factors, might also be indicated in specific situations. PDE5A inhibitors and intracavernosal injections of the prostaglandin alprostadil are effective for treating erectile dysfunction; however, options for managing other domains of sexual dysfunction in men and women remain poor. Research into different domains of sexual dysfunction is likely to lead to additional therapeutic strategies in the future.
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Hypothesis / aims of study For 15 years, SNM has become the standardized treatment for voiding dysfunction of the low urinary tract with both motor and sensory aetiology and for bowel dysfunctions. The literature confirms the long term... more
Hypothesis / aims of study For 15 years, SNM has become the standardized treatment for voiding dysfunction of the low urinary tract with both motor and sensory aetiology and for bowel dysfunctions. The literature confirms the long term efficacy for treatment of overactive bladder dry or wet, non obstructive urinary retention, painful bladder and chronic pelvic pain syndromes. ICI guidelines indicate NMS as specialist treatment urge incontinence due to detrusor overactivity with grade A recommendation in women and B in men (1). Up to now, there are 57 urological sites in Italy doing SNM with around 3500 implants performed. This study describes the present Italian clinical practice and is focused on the certitudes and issues in patient selection, in implant procedure and in follow up.
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Psychology and Medicine
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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... more
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. Media...
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Study design, materials and methods The study followed the declaration of Helsinki and was designed as a randomised, double-blind, parallel-group, multi centre study including 195 subjects from 6 countries and 13 centres. Ethical approval... more
Study design, materials and methods The study followed the declaration of Helsinki and was designed as a randomised, double-blind, parallel-group, multi centre study including 195 subjects from 6 countries and 13 centres. Ethical approval was obtained from all investigating centres and informed consent was obtained from all patients before study enrolment. Eligibility criteria were fulfilled before inclusion in the study; all subjects were experienced users of CIC with the reference catheter (LoFric Primo-PVC) for a minimum of one month before randomisation. After the initial month, randomisation was performed with patients allocated to receive the reference catheter or the study catheter (LoFric Primo PVC-free) for 4 weeks. For the duration of the study unlabelled catheters were supplied to the subject by their Treating Centre; both reference and study catheters were packed identically. Adverse events at any stage of the study were documented and followed up. The study was designed...
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treatment. METHODS: Patients (pts) who completed a 52-week phase 3 study of intradetrusor onabotA for treatment of UI due to NDO were eligible to enter a 3-year extension study in which they could receive multiple onabotA treatments (some... more
treatment. METHODS: Patients (pts) who completed a 52-week phase 3 study of intradetrusor onabotA for treatment of UI due to NDO were eligible to enter a 3-year extension study in which they could receive multiple onabotA treatments (some pts received 200U for all treatments, while others received 300U and switched to 200U following FDA approval). A total of 227 pts completed the entire 4-year study; this analysis includes data from pts who only received onabotA 200U (n¼122). Efficacy/safety assessments included mean change from baseline (at week 6) in number of daily UI episodes and IncontinenceQuality of Life (I-QOL) total summary score, proportions of pts with � 50% and 100% reduction in daily UI episodes, overall median duration of effect, adverse events (AEs), and initiation of de novo clean intermittent catheterization (CIC). Outcomes were assessed by year of treatment. For each patient, the mean value for each 6 week outcome measure was calculated from all treatments received...
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AimTools for remote clinical assessment have become increasingly important. Patient‐reported outcome questionnaires are increasingly being considered as the keystones of pelvic floor disorder assessment. An innovative English language... more
AimTools for remote clinical assessment have become increasingly important. Patient‐reported outcome questionnaires are increasingly being considered as the keystones of pelvic floor disorder assessment. An innovative English language multidisciplinary electronic Personal Assessment Questionnaire (ePAQ‐PF) was psychometrically validated in 2006. A certified Italian version (I.ePAQ‐PF) has been recently made available by the Italian Society of Urodynamics. In this study, we aimed to test the psychometric properties to validate the urinary dimension of the I.ePAQ‐PF.MethodsWomen complaining of lower urinary tract symptoms were enrolled. After providing informed consent, women filled in the I.ePAQ‐PF via a dedicated touch‐screen display (T0), together with concurrent questionnaires: International Consultation on Incontinence Questionnaire—Short form, Urgency Severity Scale, Urogenital Distress Inventory, and Patient Global Impression of Improvement. Cronbach's α and Spearman's ...
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Introduction: Electronic questionnaires offer invaluable advantages over paper-based ones. The aims of this study were to make available to Italian clinicians a culturally adapted version of the multidimensional electronic Personal... more
Introduction: Electronic questionnaires offer invaluable advantages over paper-based ones. The aims of this study were to make available to Italian clinicians a culturally adapted version of the multidimensional electronic Personal Assessment Questionnaire–Pelvic Floor and to test face validity and factorial analysis for the Urinary section. Methods: The original English-language version of electronic Personal Assessment Questionnaire–Pelvic Floor was cross-culturally adapted to the Italian language. At the Urogynaecology Unit of Buzzi Hospital in Milan, the Urinary section of the Italian version was completed by women symptomatic for pelvic floor dysfunction. Time to questionnaire completion was recorded, and a nine-item paper questionnaire about the questionnaire was completed. Descriptive analysis to define patient population characteristics and nine-item paper questionnaire analysis were performed. Factorial analyses on the Urinary section of the questionnaire and on the nine-it...
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To investigate the effect on urodynamics of 4 weeks treatment with solifenacin succinate in patients with neurogenic detrusor overactivity (NDO) due to multiple sclerosis (MS) or spinal cord injury (SCI). SONIC was a prospective,... more
To investigate the effect on urodynamics of 4 weeks treatment with solifenacin succinate in patients with neurogenic detrusor overactivity (NDO) due to multiple sclerosis (MS) or spinal cord injury (SCI). SONIC was a prospective, multicenter, double-blind, phase 3b/4 study investigating the efficacy and safety of solifenacin 10 mg in patients with NDO due to MS or SCI. Patients (n = 189) were randomized to placebo or active treatment (solifenacin 5 mg, 10 mg or oxybutynin hydrochloride 15 mg) for 4 weeks, after a 2-week, single-blind, placebo run-in period. The primary endpoint was change in maximum cystometric capacity (MCC) from baseline to end of treatment. The primary analysis compared solifenacin 10 mg versus placebo; all other comparisons were considered secondary. Secondary endpoints included changes in urodynamic parameters, patient-reported outcomes, and safety assessments. In the primary analysis, solifenacin 10 mg significantly improved mean change from baseline MCC versu...