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Background: This prospective single-arm study is designed to compare in parallel 68Ga-PSMA PET/TRUS (transrectal or transperineal) fusion biopsy ("experimental test") with multiparametric MRI (mpMRI)/TRUS fusion prostate biopsy ("standard test") in men with a high suspicion of prostate cancer (PCa) after at least one negative biopsy. The primary objective was to evaluate the diagnostic performance of 68Ga-PSMA PET/TRUS fusion prostate biopsy in comparison to mpMRI/TRUS fusion prostate biopsy analyzed in parallel. Secondarily, we aimed to determine the relationship between the "experimental test" and the histopathological characteristics of the specimen, along with the clinical utility of the "experimental test" compared to the "standard test.", Summary: To test the superiority of 68Ga-PSMA PET/CT compared to mpMRI, we will enroll a minimum cohort of 128 patients. Inclusion criteria comprise: age >18 years; blood PSA level >4.0 ng/mL; free-to-total PSA ratio <20%; progressive rise of PSA levels in two consecutive blood samples despite antibiotics; serum blood tests suspicious for PCa; at least one previous negative biopsy; ASAP and/or high-grade PIN; negative digital rectal examination. All eligible patients will undergo 68Ga-PSMA PET/CT and mpMRI scans within 1 month's distance from each other, followed by biopsy session to be completed within 1 month's distance. Targeted TRUS fusion needle biopsy will be performed for all lesions detected with PET and mpMRI. The total duration of the study is 36 months., Key Messages: By comparing the "experimental test" and the "standard test" in parallel, we will be able to determine the superior diagnostic performance of 68Ga-PSMA PET/CT over mpMRI in detecting PCa, and in particular clinically significant PCa, in the specific cohort of patients with a high suspicion of PCa who are candidates to re-biopsy. The clinical impact of the "experimental test" will be subsequently analyzed in terms of the number of prostate biopsies that could be spared, time-consuming, patient friendliness, and cost-effectiveness., (© 2023 S. Karger AG, Basel.)

Purpose: To investigate the etiology and management of male iatrogenic urethral stricture in China., Methods: The data of 172 patients with iatrogenic urethral stricture who underwent treatment at a high volume reference center in China from January 2008 to February 2014 were analyzed retrospectively. Databases were analyzed to understand the impact of different types of iatrogenic injury on stricture location, length and treatment of urethral strictures, as well as success rates., Results: The most common type of iatrogenic stricture was urethral instrumentations in 80 patients (46.51%). Mean stricture length was 3.3 ± 2.54 cm and the longest strictures were those caused by intravesical instillation. Substitution urethroplasty was the most common intervention and was performed in 60.47% (104/172) of patients. The overall success rate was 85.00% (136/160). Univariable analyses revealed that the type of iatrogenic injury was significantly related to restenosis (p = 0.036), and it is more apt to postoperative restenosis in the type of intravesical instillation than others., Conclusion: Our results showed that urethral instrumentation is the most common etiology of iatrogenic urethral stricture, and most iatrogenic urethral strictures involve the anterior urethra. The different etiologies are closely associated with stricture location, length and the overall prognosis of urethral strictures., (© 2016 S. Karger AG, Basel.)

Objective: To confirm the accuracy of serum proPSA (p2PSA) and its derivatives, percentage of p2PSA to free PSA (%p2PSA) and Prostate Health Index (PHI) and to test the value of prostate dimension-adjusted related index p2PSA density (p2PSAD), %p2PSA density (%p2PSAD) and PHI density (PHID) in discriminating between patients with and without prostate cancer (PCa)., Patients and Methods: This is a prospective cohort study of 275 patients with a total PSA (tPSA) of 2-10 ng/ml who underwent initial prostate biopsy. Multivariate logistic regression models were complemented by predictive accuracy analysis., Results: PCa was diagnosed in 31.2% of subjects. Median tPSA did not differ between groups, while PSA density (PSAD), percent free PSA (%fPSA), p2PSA, %p2PSA, PHI, p2PSAD, %p2PSAD and PHID (all p < 0.05) were different between men with and without PCa. Univariate accuracy analysis showed p2PSAD (area under the receiver-operating characteristic curve [AUC]: 0.71), %p2PSAD (AUC: 0.76) and PHID (AUC: 0.77) to be the most accurate predictors of PCa at biopsy, significantly outperforming tPSA (AUC: 0.54), PSAD (AUC: 0.68) and %fPSA (AUC: 0.59) (p ≤ 0.001). At multivariate logistic regression models, p2PSAD and PHID significantly increased the accuracy of the basal multivariate model (all p < 0.01). At 90% specificity, sensitivity for p2PSAD, %p2PSAD and PHID were 33.7, 43 and 40.7%, respectively. Spearman's rho coefficient analysis demonstrated a significant relationship between Gleason score, %p2PSA (r = 0.216, p = 0.046), PHI (r = 0.223, p = 0.039) and %p2PSAD (r = 0.205, p = 0.05)., Conclusions: Considering patients suited for initial prostate biopsy by a tPSA range of 2-10 ng/ml, PSA isoforms were confirmed to be strong predictors of PCa. The prostate dimension-adjusted PSA isoforms have been shown to differentiate between patients with or without PCa, with an AUC of 0.71-0.77, p2PSAD offering a gain in accuracy with respect to tPSA, %fPSA and PSAD., (2014 S. Karger AG, Basel.)

Introduction: We investigated the relationship between posterior vault prolapse and overactive bladder (OAB) symptoms or detrusor overactivity (DO) and their changes after surgical repair., Methods: Forty-three patients with vault prolapse and prevalent posterior compartment prolapse underwent pelvic organ prolapse repair surgery: 28 received colposacropexy and 15 were treated by the vaginal approach. Subjective success was lack of prolapse-related symptoms or urgency. OAB symptoms, voiding symptoms and constipation were evaluated. Patient satisfaction was defined by a visual analog scale score (range 0-10). Objective anatomical success was defined as no vaginal prolapse of stage ≥2 at any vaginal site., Results: The median follow-up was 75 months (range 24-143). Preoperatively, 33/43 patients (76.74%) reported urgency. DO was found in 11/43 patients (25.6%), and 22/43 patients reported constipation. The anatomical outcome showed 2 persistent stage II rectoceles (6.9%). After surgery, OAB symptoms disappeared in 25/33 (75.88%) and persisted in 8 patients (24.2%); there was no de novo urgency. DO disappeared in 8/11 subjects (72.7%). Preoperative constipation was present in 17/33 patients with OAB symptoms (51.5%) and disappeared postoperatively in 13/17 patients (76.4%) (p < 0.013). De novo constipation appeared in 3 patients (associated with OAB in 2 patients)., Conclusions: Prevalent posterior compartment pelvic organ prolapse and OAB/DO were often associated. After surgery, OAB symptoms and DO were significantly reduced., (Copyright © 2013 S. Karger AG, Basel.)

Objective: To report conservative and surgical strategies for treatment of mesh erosion after pelvic organ prolapse (POP) repair., Methods: Between 1998 and 2008, 179 patients underwent integral pelvic floor reconstruction for advanced POP in our tertiary urogynecological unit. Patients' charts and follow-up data were entered into a computerized database and data analysis performed to search for mesh erosion/complications/surgery., Results: 12 patients were diagnosed and treated for mesh erosion: in 10 of 179, surgery was performed in our department and the mesh used was polypropylene (PP): 3 after colposacropexy (CSP) (5.5%), 5 after CSP + hysterectomy (Hys) (6.5%), and 2 after hysterosacropexy (HSP) (3.9%); in 1 case, Gore-tex mesh was used, and another case had undergone CSP in another hospital using PP mesh. Time to mesh erosion ranged from 2 to 66 months (mean 22.9), with 4 erosions (33%) within 6 months of POP repair. In 4 asymptomatic patients (33%) erosion was incidentally discovered during clinical check-ups at 4, 31, 36 and 66 months. Five cases (41%) presented with occasional vaginal bleeding, associated with dyspareunia in 2. Treatments were individualized but in all cases conservative treatment was unable to resolve the complications and surgery was needed. At a mean follow-up of 57 months (range 18-120) after surgical treatment all patients were asymptomatic and free from erosions., Conclusions: The surgeon who approaches management of complications after abdominal/laparoscopic sacropexy should possess a comprehensive understanding of pelvic floor anatomy and surgical skills in order to individualize the management of such complications., (Copyright © 2011 S. Karger AG, Basel.)

Objective: To evaluate the safety, tolerability and efficacy of adjuvant intravesical gemcitabine versus bacillus Calmette-Guérin (BCG) in the treatment of high-risk superficial bladder cancer., Method: 64 patients with high-risk superficial bladder cancer (pT1 and/or G3 and/or CIS) were assigned to interventions (gemcitabine or BCG) in a randomised controlled trial. All the patients were evaluated for recurrence and progression rates (primary endpoint) and safety and tolerability (secondary endpoint)., Results: The two groups were comparable in terms of baseline characteristics. Tolerability was better for gemcitabine, whereas the BCG group experienced the need for delayed treatment or withdrawal in 12.5% of cases. At a mean follow-up of 44 months, the recurrence rate in patients treated with BCG was 28.1%; the recurrence rate in patients who received gemcitabine was 53.1% (p = 0.037). Time to recurrence was shorter in patients treated with BCG (25.6 vs. 39.4 months, p = 0.042). No patients developed disease progression., Conclusions: Gemcitabine is significantly inferior to BCG, but given its favourable toxicity profile, it may be useful for patients intolerant to or otherwise unable to receive BCG., (Copyright 2010 S. Karger AG, Basel.)

Objective: Maximum urethral closure pressure (MUCP) and Valsalva leak point pressure (VLPP) have been considered objective parameters for studying the urethral integrity and predicting outcome after surgery for stress urinary incontinence (SUI). We test the hypothesis that preoperative MUCP and/or VLPP may predict long-term outcome after out-in transobturator tape (TOT) surgery for female SUI., Methods: 65 patients affected by stress or mixed urinary incontinence were enrolled in a prospective observational descriptive study conducted from May 2002 to November 2005 at a single tertiary urban teaching university urogynecological department. Preoperative MUCP and VLPP, stratified as < or = or >40 cm H(2)O and < or = or >60 cm H(2)O, respectively, were separately or in combination correlated with primary (continence status: dry or wet) and secondary outcome variables (quality of life questionnaires) after surgery., Results: Out of 65 patients, 6 (9.2%) did not attend the follow-up. The median follow-up was 46 months (mean 52 +/- 18; range 36-82). The overall objective cure rates (dry) were 74.4% for patients with VLPP >60 cm H(2)O and 65% for VLPP < or =60 cm H(2)O (p < 0.654). The overall objective cure rates (dry) were 75% for patients with MUCP >40 cm H(2)O and 68.6% for MUCP < or =40 cm H(2)O (p < 0.808). The overall objective cure rates (dry) were 82.4% for patients with MUCP >40 cm H(2)O and VLPP >60 cm H(2)O and 69.2% for MUCP < or =40 cm H(2)O and VLPP < or =60 cm H(2)O (p < 0.956)., Conclusions: These data seem to cast doubts on the predictive value of MUCP and VLPP in patients who underwent TOT., (Copyright 2009 S. Karger AG, Basel.)

Objective: To determine the response rate to the self-administered Incontinence Impact Questionnaire (IIQ) in an Italian female population., Patients and Methods: 172 consecutive patients referred to the urogynecological department of an urban university teaching hospital were invited to answer the self-administered IIQ. Correlations were investigated between answer rate, age, educational status and urogenital pathology., Results: Only 41.6% of patients with low educational status answered all questions compared with 47.6 and 58% of medium and high educational status (p = 0.038 and p = 0.011 respectively). Mean patient age correlated inversely with educational status (rho = -0.443; p < 0.0001) and directly with non-response rate (rho = 0.207; p = 0.007). The non-response rate was correlated significantly and inversely with educational status only in continent patients (rho = -0.254; p = 0.037) and in patients with pelvic organ prolapse (rho = -0.256; p = 0.017)., Conclusions: The IIQ answer rate correlated directly with educational status in an Italian female population., (Copyright (c) 2009 S. Karger AG, Basel.)

Objectives: To investigate the clinical effect of tamsulosin for the treatment of functional bladder outlet obstruction (BOO) in adult women., Methods: In a prospective, longitudinal open-label study, 63 women affected by functional BOO were treated with tamsulosin. Inclusion criteria were: age >18 years, reporting voiding symptoms (intermittent stream, hesitancy, straining and/or a feeling of incomplete emptying), uroflowmetry maximum flow rate (Q(max)) under 12 ml and/or presence of postvoid residual greater than 50% of the voiding volume. Exclusion criteria were: patients suffering from any other anatomical or functional disorder such as urethral stenosis, pelvic organ prolapse, neurological disturbances, or systemic diseases that could impact upon bladder voiding. Tamsulosin was administered in a single daily dose of 0.4 mg for at least 30 days. Primary outcomes were clinical efficacy and Q(max) improvement; secondary outcomes were tolerability and safety. Voiding and storage symptoms and uroflowmetry results were assessed before and at the end of the alpha-blocker therapy., Results: Tamsulosin therapy was well tolerated. After therapy voiding symptoms improved in 71.4% of patients (45/63; p < 0.0001), and if associated with storage symptoms in 66.67% (26/39; p < 0.00001). Recurrent infections were reduced by 50% in 81% (21/26) of patients. Uroflowmetry parameters improved in 36/63 patients (57.1%). Postvoiding residue improved in 62.5% (10/16) and disappeared in 25% (4/16) with no significant changes in voided volume. An improvement was observed in 66% (16/24) of patients with isolated voiding symptoms, in 51.2% (20/39) with associated storage symptoms and in 65% (17/26) of women with associated recurrent urinary infections., Conclusions: These results suggest that alpha-blocker may be an effective treatment option in women with voiding dysfunction due to functional BOO.

Aim: To analyze the sensitivity and specificity of the 1-hour pad test, as suggested by the International Continence Society, in the diagnosis of female urinary incontinence., Methods: 158 female patients, with or without urinary incontinence, underwent a 1-hour pad test. The pad test was assessed as positive or negative and pad weight was recorded. Uni- and multivariate analysis investigated correlation with age, body mass index (BMI), symptoms, prolapse grade, urinary incontinence grade and type, number of pads daily, urodynamic variables and Urogenital Distress Inventory and Incontinence Impact Quality of Life questionnaires., Results: A positive 1-hour pad test was significantly associated with urinary incontinence grade, with a positive stress test, with detrusor overactivity (DO), urine leakage and a positive Valsalva leak point pressure at urodynamics. The association between presence/absence of incontinence and DO, stress test, urine leakage and pad weight had 83% sensitivity and 89% specificity in predicting urinary incontinence. When the 1-hour pad test result was added to stress test and urine leakage versus presence/absence of incontinence, the sensitivity was 90%, and specificity 65%., Conclusions: Our data seem to confirm the 1-hour pad test has poor predictive value in the diagnosis of female urinary incontinence when associated to stress test and urine leakage., ((c) 2008 S. Karger AG, Basel.)

The urothelium, the epithelium lining the surface of the urinary bladder, is a unique cell type with high plasticity and a variety of cellular functions. The urothelium represents the first line of bladder defense and an interface between pathogens and defense mechanisms. Functions of the urothelium include control of permeability, immune responses and cell-cell communication, which seems to play a pivotal role in responding to injuries and infections. The urothelium responds to stretch, during the filling phase of micturition reflex, by increasing the size of apical umbrella cells and by releasing mediators which activate the sensory fibers. For this reason the concept of 'neuron-like properties' was suggested. Finally, despite the fact that the urothelium is a frequent site of cancer formation, few experimental model systems are currently available or well characterized for studying urothelial cancer in the era of genomics and proteomics. The purpose of this review is to give emphasis to urothelial physiology and pathophysiology in different bladder disorders and to offer an up-to-date contribution to the field of urothelial research., (2006 S. Karger AG, Basel.)

Introduction: In this study we critically review our '10-year' experience with intravesical vanilloids (capsaicin and resiniferatoxin) in the treatment of neurogenic incontinence, addressing the issue of their introduction into daily clinical practice., Materials and Methods: From July 1992 to June 2001, 54 patients suffering from detrusor hyperreflexia, due to spinal cord injuries, received intravesical instillation of capsaicin, and from January 1995 to June 2001, 47 patients received intravesical instillation of resiniferatoxin (RTX) in order to treat bladder dysfunction and symptoms. All patients presented detrusor hyperreflexia refractory to oral and/or intravesical oxibutynin and they displayed high-voiding pressure associated with frequent urine leakage. Capsaicin was used at a concentration of 10 mM; RTX was tested in two different concentrations: 10 nM and 10 microM. The outcome was considered according to simple parameters: (i) the number of patients who reported an improvement in clinical status (patient dry between clean intermittent catheterization) and urodynamic status (a bladder capacity 50% higher than pretreatment capacity, lasting more than 3 months after the instillation); (ii) the number of patients who continued intravesical therapy; (iii) the number of instillations they received; (iv) the length of the interval between 2 consecutive instillations, and (v) alternative therapies when vanilloids failed., Results: The topical intravesical instillation of capsaicin produced an improvement in symptoms and urodynamic parameters, in 29 patients (53.7%) after 3 months. In these 29 patients only 7 (24.13%) continued to received capsaicin in June 2001. The mean follow-up was 32.28 +/- 14.20 (range 8-52) months, the mean number of instillations was 6.14 +/- 2.54 (range 2-10) and the mean interval between the 2 consecutive instillations was 7.14 +/- 2.60 (range 4-12) months. The topical intravesical instillation of RTX produced an improvement in symptoms and urodynamic parameters in 73.33% of patients (a total of 45 patients) who received 10 microM. 18 of them (54.54%) continued to received RTX in June 2001. The mean follow-up was 27.88 +/- 10.95 (range 11-49) months, the mean number of instillations was 4.33 +/- 1.60 (range 2-8). The mean interval between 2 consecutive instillations was 9.61 +/- 2.99 (ranged 4-16) months., Conclusion: The results obtained using RTX seem to be very promising with regard to efficacy and tolerance, particularly in comparison with capsaicin. Even if the number of patients who received capsaicin and RTX remains small, the intravesical vanilloid receptor agonist RTX could offer an attractive alternative to oral medications in the treatment of neurogenic incontinence., (Copyright 2004 S. Karger AG, Basel)