Analysis of evidence on nutraceutical interventions for Peyronie's disease: a guideline-based critical review.

INTRODUCTION: The management of Peyronie's disease (PD) is a challenge for the clinician. Despite the lack of etiologic therapy, different nonsurgical approaches have often been empirically proposed. The most used treatment is based on nutraceutical drugs with antioxidant activity, although such an intervention remains controversial. OBJECTIVES: We reviewed the evidence from the randomized controlled trials included in the recommendations of the American Urological Association (AUA), Canadian Urological Association (CUA), European Association of Urology, and International Society for Sexual Medicine. METHODS: We searched PubMed, Scopus, Web of Science, and Cochrane Library for randomized controlled trials, reviews, and guidelines on nutraceutical interventions for PD. RESULTS: Our analysis provides detailed information on potential interventions, underlying the inconsistent evidence. Acetyl esters of carnitine, although not recommended by any of the available guidelines, showed potential benefit in some selected studies. Omega-3 fatty acids are not recommended due to withdrawn study evidence. The CUA and AUA were the only societies to consider the use of coenzyme Q10. While the CUA suggested that it might be offered as a treatment option, the AUA refrained from taking a definitive stance due to insufficient evidence. Similarly, conflicting recommendations have been produced on potassium para-aminobenzoate. While the CUA considers potassium para-aminobenzoate potentially useful in slowing PD progression, the AUA deems the evidence insufficient. Conversely, both the International Society for Sexual Medicine and European Association of Urology do not recommend its use. CONCLUSION: This critical comparative analysis of the most recent guidelines produced by the leading scientific societies highlights some inconsistencies in the recommendations on nutraceutical intervention for PD, even within a background of overall ineffectiveness of this treatment approach.

Effects of gender affirming hormone therapy with testosterone on coagulation and hematological parameters in transgender people assigned female at birth: A systematic review and meta-analysis.

BACKGROUND: Hormone replacement therapy is associated with an increased thromboembolic risk. The effects of testosterone (T) on coagulation markers in people assigned female at birth (AFAB) under gender affirming hormone therapy (GAHT) are not well described. METHODS: Systematic review and meta-analysis on English-language articles retrieved from PubMed, Scopus and Cochrane Library up to April 2023 investigating T therapy in AFAB people. Coagulation parameters included international normalized ratio (INR), fibrinogen, activated partial thromboplastin clotting time (aPTT), plasminogen activator inhibitor-1 (PAI-1); hematological variables included hemoglobin (Hb) and hematocrit (HCT). We also reported the rate of thromboembolic events. Data were combined as mean differences (MD) with a 95 % confidence interval (CI) of pre- vs post-follow-up values, using random-effects models. RESULTS: We included 7 studies (6 prospective and 1 retrospective) providing information on 312 subjects (mean age: 23 to 30 years) who underwent GAHT with variable T preparation. T therapy was associated with a significant increase in INR values [MD: 0.02, 95 % confidence interval (CI): 0.01-0.03; p = 0.0001], with negligible heterogeneity (I2 = 4 %). T therapy was associated with increased Hb (MD: 1.48 g/dL, 95%CI: 1.17 to 1.78; I2 = 9 %) and HCT (4.39 %, 95%CI: 3.52 to 5.26; I2 = 23 %) values. No effect on fibrinogen, aPTT and PAI-1 was found. None of the study reported thromboembolic events during the follow-up. CONCLUSION: Therapy with T increased blood viscosity in AFAB men. A slight increase in INR values was also found, but the clinical relevance and mechanism(s) of this finding needs to be clarified.

Relationship between male aging and semen quality: a retrospective study on over 2500 men.

PURPOSE: We aimed to evaluate whether and to what extent an association exists between male aging and worsening of semen parameters and to determine whether a threshold age can be identified above which the decline in semen quality becomes statistically significant. METHODS: 2612 men (age: 16-56 years) attending an andrology outpatient clinic for semen analysis and clinical evaluation were studied. Semen analyses were performed according to the ongoing WHO-recommended procedures. Total motile count (TMC) and total progressive motile count (TPMC) were calculated by multiplying total sperm number by total motility and progressive motility, respectively. RESULTS: Significant negative correlations were found between age and total motility (r = - 0.131, p < 0.0001), progressive motility (r = - 0.112, p < 0.0001), TPMC (r = - 0.042, p = 0.037), and normal sperm morphology (r = - 0.053, p = 0.007). All these associations persisted in multivariate regression models adjusted for abstinence time, smoking, history of male accessory gland infections, varicocele and the year in which semen analysis was performed. When comparisons were performed among quartiles of increasing age, the fourth quartile, corresponding to the age group > 40 years, was associated with a significant decrease in total and progressive motility. An earlier decline in the TPMC and percentage of normal forms was also observed. CONCLUSION: Advancing male age exhibits an independent association with a decrease in the percentage of motile and morphologically normal spermatozoa, with greater evidence from the age of > 40 years. Further studies are warranted to elucidate the mechanisms and clinical reflections of these associations.

Which PDE5 inhibitor is the most effective in the treatment of erectile dysfunction in men with spinal cord injury? A systematic review and network meta-analysis.

BACKGROUND: Phosphodiesterase 5 inhibitors (PDE5i) are the first-line drugs for erectile dysfunction (ED) but differences among available molecules should drive therapy personalization. Choosing one PDE5i over another is a challenge in men with spinal cord injury (SCI), as the evidence of efficacy for each molecule is derived from few studies and comparative "head-to-head" trials are lacking. OBJECTIVE: To assess the efficacy of the different PDE5i for SCI-related ED with a network meta-analysis (NMA) approach. MATERIALS AND METHODS: Databases from PubMed, Web of Science, Scopus, and Cochrane Library were checked for randomized controlled trials (RCTs) comparing any PDE5i to each other or placebo in men with traumatic SCI lasting ≥6 months. Data were incorporated in a random-effect NMA, where treatments' efficacy was ranked using the surface under the cumulative ranking curve (SUCRA). RESULTS: The 10 RCTs included provided information about 1,492 men with ED due to traumatic SCI. Intervention arms included sildenafil, tadalafil, and/or vardenafil. Overall, at the pairwise meta-analysis, PDE5i were four times more effective than placebo in improving erectile function (risk ratio: 4.13, 95% CI: 2.76, 6.19). The comparative analysis from NMA revealed that tadalafil was associated with the highest SUCRA value (81%), followed by vardenafil (68%) and sildenafil (49%). DISCUSSION AND CONCLUSION: Within the grading of comparison network, tadalafil appeared to be the best PDE5i in the treatment of SCI-related ED. Further focused studies are warranted to confirm these findings and define optimal doses and duration of therapy.

Effect of antioxidants on semen parameters in men with oligo-astheno-teratozoospermia: a network meta-analysis.

BACKGROUND: Although antioxidants are largely used in subfertile men with oligo-astheno-teratozoospermia (OAT), the choice among different molecules is challenged by the lack of comparative head-to-head studies. The network meta-analysis (NMA) can overcome limitations of pairwise meta-analyses, since it incorporates direct and indirect evidence into a single model generating an effectiveness hierarchy. OBJECTIVE: To assess with a NMA the effects of antioxidants in improving seminal parameters in idiopathic OAT. MATERIALS AND METHODS: PubMed, Scopus, Cinahl, and Cochrane Library databases were searched for randomized controlled trials (RCTs) comparing any antioxidant treatment to each other or placebo in men with at least one idiopathic seminal abnormality. Data were included in a random-effects NMA, where efficacy of treatments was ranked by surface under the cumulative ranking curve (SUCRA). RESULTS: 29 RCTs provided information on 2045 men (mean age: 33.5 years) with idiopathic OAT and 19 antioxidant preparations. Compared to placebo, l-carnitine, especially in combination with l-acetyl-carnitine (LAC), had the highest SUCRA for sperm concentration, progressive motility, and morphology. Folate was the only other compound effective on sperm concentration. Vitamin E+selenium or zinc had the highest SUCRA for total motility. A contribution on progressive motility was revealed for pentoxifylline and vitamin E+CoQ10.

Iodine Intake and Testosterone.

This cross-sectional study evaluates whether urinary iodine concentration is associated with testosterone among men who participated in the National Health and Nutrition Examination Survey.

Selective modulation of estrogen receptor in obese men with androgen deficiency: A systematic review and meta-analysis.

BACKGROUND: Although selective estrogen receptor modulators have been proposed as a treatment for men with central functional hypogonadism, only a few data have been produced in men with obesity-related functional androgen deficiency. OBJECTIVE: To determine whether and to what extent selective estrogen receptor modulators are an effective and safe therapy in men with obesity-related functional androgen deficiency. MATERIALS AND METHODS: A thorough search of PubMed, Web of Science, Scopus, and Cochrane Library databases was performed to identify studies comparing testosterone levels before and after treatment. Mean differences with 95% coefficient intervals were combined using random effects models. Funnel plot, Egger's test, and trim-and-fill analysis were used to assess publication bias. RESULTS: Seven studies met the inclusion criteria providing information on 292 men with obesity-related functional androgen deficiency treated with clomiphene citrate (12.5-50 mg daily) or enclomiphene citrate (12.5-25 mg daily) for 1.5-4 months. The pooled estimates indicated a significant increase in testosterone levels both with clomiphene (mean difference: 11.56 nmol/L; 95% coefficient interval: 9.68, 13.43; I2  = 69%, pfor heterogeneity  = 0.01) and enclomiphene citrate (mean difference: 7.50 nmol/L; 95% coefficient interval: 6.52, 8.48; I2  = 4%, pfor heterogeneity  = 0.37). After the exclusion of one study on severely obese men, who exhibited the highest response rate to clomiphene citrate, the heterogeneity disappeared (mean difference: 10.27 nmol/L; 95% coefficient interval: 9.39, 11.16; I2  = 0%, pfor heterogeneity  = 0.66). No publication bias was revealed by Egger's test and trim-and-fill analysis. No treatment-related unexpected findings regarding safety profile were registered. DISCUSSION AND CONCLUSION: Treatment with clomiphene citrate and enclomiphene citrate may be an effective and safe alternative to testosterone replacement therapy in men with obesity-related functional androgen deficiency. Further long-term studies are warranted to define clinical reflections of the selective estrogen receptor modulators-induced increase in testosterone levels and to better clarify the safety profile.

Infection rate of penile prosthesis implants in men with spinal cord injury: a meta-analysis of available evidence.

The risk of penile prosthesis implants (PPIs) infection in men with spinal cord injury (SCI), empirically theorized to be high, is widely variable among the studies. We performed a meta-analysis to define the pooled PPI infection rate and its possible risk factors in men with SCI. A thorough search of PubMed, Scopus and Web of Science was performed. The eighteen included studies provided information on 1079 implantation procedures, determining a pooled PPI infection rate of 8.0% (95% CI: 5.0-11.0%), with significant heterogeneity (I² = 67.0%). Trim-and-fill adjustment for publication bias had a small effect on the pooled estimate (adjusted odds ratio: 6.3%, 95% CI: 2.5-10.0%) with a substantial reduction in heterogeneity (I2 = 32.4%). The PPI infection rate was higher for inflatable PPIs than for malleable PPIs (16.4% vs 8.9%, p = 0.027). No differences were found between the different levels of SCI. In conclusion, the risk of PPI infection in SCI would be higher than that reported in the general population. However, the results were produced from dated and low/moderate quality studies that may not fully reflect the outcomes of modern PPIs and implantation protocols. There is an urgent need to gather more information on this topic through studies relevant to contemporary practice.

Association between urinary bisphenol A concentrations and semen quality: A meta-analytic study.

Although preclinical research has revealed disrupting effects on male reproductive functions of bisphenol A (BPA), as yet clinical studies have led to inconsistent results. The present meta­analysis aims to establish the existence and the extent of the association between BPA exposure and semen quality. A thorough search of PubMed, Scopus and Web of Science databases was carried out. Only studies reporting data from multivariable linear regression analyses (ß-coefficients with 95% CI), assessing the association between urinary levels of BPA and standard semen parameters were included. Nine studies provided information about an overall sample of 2,399 men. Only the negative association between urinary BPA levels and sperm motility reached statistical significance (pooled ß-coefficient = -0.82; 95% CI: -1.51 to -0.12, p = 0.02; Pfor heterogeneity = 0.1, I2 = 42.9%). Yet, such a significance was lost after data adjustment for publication bias, as well as at the sensitivity analysis, when each of the two studies that contributed most to the overall estimate was excluded. In conclusion, the overall estimates of data produced by clinical studies point to a clinically negligible, if any, association between urinary BPA concentrations and semen quality. Further studies in workers at high risk of occupational exposure are warranted to corroborate the herein revealed weak correlation with a worse sperm motility.

Erectile dysfunction in hyperuricemia: A prevalence meta-analysis and meta-regression study.

BACKGROUND: Whether and to what extent an association exists between hyperuricemia and erectile dysfunction (ED) has not yet been fully determined. OBJECTIVE: To define pooled prevalence estimates and correlates of erectile dysfunction in men with hyperuricemic disorders. MATERIALS AND METHODS: A thorough search of Medline, Scopus, and Cochrane Library databases was performed. Data were combined using random-effects models and the between-study heterogeneity was assessed by Cochrane's Q and I2 tests. A funnel plot was used to assess publication bias. RESULTS: Overall, 8 studies included gave information about 85,406 hyperuricemic men, of whom 5023 complained of erectile dysfunction, resulting in a pooled erectile dysfunction prevalence estimate of 33% (95% Confidence Interval: 13-52%; I² = 99.9%). The funnel plot suggested the presence of a publication bias. At the meta-regression analyses, among the available covariates that could affect estimates, only type 2 diabetes mellitus was significantly associated with a higher prevalence of erectile dysfunction (ß = 0.08; 95% Confidence Interval: 0.01, 0.15, p = 0.025). At the sub-group analysis, the pooled erectile dysfunction prevalence decreased to 4% (95% Confidence Interval: 0%-8%) when only the largest studies with the lowest prevalence of type 2 diabetes mellitus were included and increased up to 50% (95% Confidence Interval: 17%-84%) when the analysis was restricted to studies enrolling smaller series with higher prevalence of type 2 diabetes mellitus. CONCLUSIONS: A not negligible proportion of men with hyperuricemia can complain of erectile dysfunction. While a pathogenetic contribution of circulating uric acid in endothelial dysfunction cannot be ruled out, the evidence of a stronger association between hyperuricemia and erectile dysfunction in type 2 diabetes mellitus points to hyperuricemia as a marker of systemic dysmetabolic disorders adversely affecting erectile function.

Risk of Venous Thromboembolism in Transgender People Undergoing Hormone Feminizing Therapy: A Prevalence Meta-Analysis and Meta-Regression Study.

Background: Although venous thromboembolism (VTE) is a recognized side effect of some formulations of estrogen therapy, its impact in transgender people remains uncertain. The aim of this study was to define pooled prevalence estimate and correlates of VTE in Assigned Males at Birth (AMAB) trans people undergoing gender affirming hormone therapy. Methods: A thorough search of MEDLINE, COCHRANE LIBRARY, SCOPUS and WEB OF SCIENCE databases was carried out to identify suitable studies. Quality of the articles was scored using the Assessment Tool for Prevalence Studies. Data were combined using random effects models and the between-study heterogeneity was assessed by the Cochrane's Q and I2. Results: The eighteen studies included gave information about 11,542 AMAB undergoing gender affirming hormone therapy. The pooled prevalence of VTE was 2% (95%CI:1-3%), with a large heterogeneity (I2 = 89.18%, P<0.0001). Trim-and-fill adjustment for publication bias produced a negligible effect on the pooled estimate. At the meta-regression analysis, a higher prevalence of VTE was significantly associated with an older age (S=0.0063; 95%CI:0.0022,0.0104, P=0.0027) and a longer length of estrogen therapy (S=0.0011; 95%CI:0.0006,0.0016, P<0.0001). When, according to the meta-regression results, the analysis was restricted to series with a mean age ≥37.5 years, the prevalence estimate for VTE increased up to 3% (95%CI:0-5%), but with persistence of a large heterogeneity (I2 = 88,2%, P<0.0001); studies on younger participants (<37.5 years) collectively produced a pooled VTE prevalence estimate of 0% (95%CI:0-2%) with no heterogeneity (I2 = 0%, P=0.97). Prevalence estimate for VTE in series with a mean length of estrogen therapy ≥53 months was 1% (95%CI:0-3%), with persistent significant heterogeneity (I2 = 84,8%, P=0.0006); studies on participants subjected to a shorter length of estrogen therapy (<53 months), collectively produced a pooled VTE prevalence estimate of 0% (95%CI:0-3%) with no heterogeneity (I2 = 0%, P=0.76). Conclusions: The overall rate of VTE in AMAB trans people undergoing gender affirming hormone therapy was 2%. In AMAB population with <37.5 years undergoing estrogen therapy for less than 53 months, the risk of VTE appears to be negligible. Further studies are warranted to assess whether different types and administration routes of estrogen therapy could decrease the VTE risk in AMAB trans people over 37.5 years subjected to long-term therapy. Systematic Review Registration: [https://www.crd.york.ac.uk/PROSPERO/], identifier [CRD42021229916].

Men with spinal cord injury have a smaller prostate volume than age-matched able-bodied men: a meta-analysis of case-control studies.

STUDY DESIGN: Meta-analysis OBJECTIVES: Denervation and androgen deficiency, peculiar to individuals with chronic spinal cord injury (SCI), could hinder, to some extent, both prostate growth and activity. To comprehensively assess the relationship between SCI and prostate volume, we carried out a meta-analysis of the available case-control studies. METHODS: A thorough search of MEDLINE, Scopus and Web of Science was carried out to identify studies comparing prostate volume in men with and without SCI. Quality of the studies was assessed using the Newcastle-Ottawa Scale (NOS). Mean differences (MDs) in prostate volume were combined using a random effect model. Funnel plot was used to assess publication bias. RESULTS: Four studies met the inclusion criteria and provided information on 278 men with SCI and 1385 able-bodied controls. The overall difference in prostate volume between the two groups reached the statistical significance (pooled MD: -14.85 ml, 95% CI: -27.10 to -2.61, p = 0.02). In a subgroup analysis including only the studies with the highest NOS score, the pooled MD remained significant (pooled MD: -18.56, 95% CI: -33.14 to -3.99, p = 0.01). The shape of funnel plot did not allow to rule out a possible publication bias. CONCLUSIONS: This meta-analysis suggests that in men with SCI, prostate volume tends to be smaller than in age-matched able-bodied men. Longitudinal studies of men with long-lasting SCI in advanced age are warranted to clarify whether this condition is associated with a lower risk of age-related prostate proliferative diseases.

Discovery history and clinical development of mirabegron for the treatment of overactive bladder and urinary incontinence.

INTRODUCTION: Overactive bladder (OAB) and urinary incontinence, although not life-threatening, are very bothersome chronic health conditions. The limitations of current pharmacological treatment urge the need for novel drugs with alternative mechanisms of action. Huge efforts in this area of research led to the synthesis of several selective and potent ß3-adrenoceptor agonists that gained relevance through research during the late 80s and 90s. Mirabegron was the first compound of this new class of drugs that showed preclinical efficacy in several models of storage bladder dysfunction, together with a favorable human pharmacological profile. Having passed the proof-of-concept stage, an extensive clinical development and pharmacology program was performed during the last 10 years, involving >10,000 individuals, before mirabegron was granted marketing approval. AREAS COVERED: In this case history, the authors review the milestones in mirabegron's discovery based on a systematic literature review. EXPERT OPINION: Thanks to its tolerability and safety/efficacy balance, mirabegron has potential to fill a need for new treatment options for OAB, and paves the way for further development of a completely new class of drugs aimed to treat this condition. However, the exact role of mirabegron in clinical practice has yet to be defined. Further studies are needed in order to clarify, together with post-launch information, critical safety issues and cost-effectiveness in head-to-head comparison with current standard treatments.

OnabotulinumtoxinA injection therapy in men with LUTS due to primary bladder-neck dysfunction: objective and patient-reported outcomes.

OBJECTIVE: To determine efficacy and safety of OnabotulinumtoxinA (BoNT-A) injection therapy in medically refractory patients with lower urinary tract symptoms (LUTS) due to primary bladder-neck dysfunction (PBND). MATERIALS AND METHODS: Thirty-five consecutive ambulatory males diagnosed with PBND and refractory to medical therapy, with IPSS > 15, Qmax < 15 ml/sec, and total prostate volume < 30 cm(3), were screened from January 2010 to December 2011. Eligible patients underwent transurethral bladder-neck injection of BoNT-A (200 U, 50 U/ml × 4 sites) and were assessed at baseline, 2-, 6-, 9-, and 12-month postprocedure and until duration of clinical response. The primary outcome was the change from baseline in total IPSS, and secondary outcome were storage- and voiding-IPSS, QoL score, Qmax, and postvoiding residual volume (PVR), patient-reported outcomes. Adverse effects were also recorded, including ejaculatory dysfunctions. RESULTS: Of 30 enrolled patients (mean age 33.8 years), 29 (96.7%) completed the study. A statistically significant improvement of total IPSS was observed from 21.9 at baseline, to 7.8, 10.3, and 16.6 at 2, 6, and 9 months, respectively (P < 0.000). Statistically significant improvements from baseline of storage- and voiding-IPSS, QoL score, Qmax, and PVR were also observed until 9-month postprocedure. The proportion of patients with overall satisfaction was favorable although decreasing from 80% at 2 months, to 44.8% at 12 months. No significant adverse effects or ejaculatory dysfunctions were noted. CONCLUSIONS: BoNT-A injection therapy appears effective and safe in medically refractory men with PBND, although repeated procedures are required for long-term sustained benefit. Randomized controlled trials are warranted in order to corroborate these results.

Urological complications following inguinal hernioplasty.

Aim of this paper is to report a systematic review of the literature about the incidence and putative mechanisms of genital tract injuries following open and laparoscopic herniorraphy and their effects on sexual function and fertility and to point out the measures of prevention and of treatment. The most frequently described events have been intraoperative complications as bladder or spermatic cord structure damage, immediate postoperative complications as ischaemic orchitis, urinary retention, urinary tract infection, hydrocele or scrotal haematoma and bacterial orchitis, or long-term complications as chronic orchialgia, testis atrophy, sexual dysfunction and infertility. The evidence of literature shows that urological complication after hernioplasty are under-reported. Only a small number of studies to date have essentially dealt with sexual quality of life after inguinal hernia surgical repair. The sexual needs of patients with groin hernias are rarely discussed. Extensive laparoscopic procedures, due to the need of learning curve, have increased the risk of vas damage and infertility in young patients candidate to hernioplasty. Early diagnosis prevents urological complication as well as possible legal claims after hernia repair: it should be include careful history, objective and subjective symptoms and signs of uro-genital pathologies, lab data when necessary, immediate eco-color-Doppler imaging and urgent urological consultation. Despite the lack of prospective randomized trials, there is a growing evidence in literature about positive impact of hernioplasty on sexual function, encouraging future studies on this issue.

Efficacy of an assisted low-intensity programme of perioperative pelvic floor muscle training in improving the recovery of continence after radical prostatectomy: a randomized controlled trial.

UNLABELLED: Study Type - Therapy (RCT) Level of Evidence 1b. What's known on the subject? and What does the study add? Peri-operative pelvic floor muscle training reduces urinary incontinence for men undergoing radical prostatectomy (RP). A preoperative biofeedback session, combined with postoperative pelvic floor muscle training, and assisted sessions on a monthly basis only, is an effective low-intensity programme to improve recovery of continence in patients undergoing RP. OBJECTIVE: To evaluate the efficacy of preoperative biofeedback (BFB) combined with an assisted low-intensity programme of postoperative perineal physiokinesitherapy in reducing the incidence, duration and severity of urinary incontinence (UI) in patients undergoing radical prostatectomy (RP). PATIENTS AND METHODS: A prospective, single-centre, randomized controlled clinical study was designed. • The intervention group received a training session with BFB, supervised oral and written instructions on Kegel exercises and a structured programme of postoperative exercises on the day before open RP. After RP, patients received control visits, including a session of BFB, at monthly intervals only. • The control group received, after catheter removal, only oral and written instructions on Kegel exercises to be performed at home. Patients received control visits at 1, 3 and 6 months after catheter removal. • At each visit the number of incontinence episodes, the number of pads used and patient-reported outcome measures (International Consultation on Incontinence Questionnaire on Urinary Incontinence [ICIQ-UI], [ICIQ]-Overactive Bladder [OAB], University of California, Los Angeles-Prostate Cancer Index [UCLA-PCI], International Prostate Symptom Score-Quality of Life [IPSS-QoL]) were assessed in both groups. All patients were followed-up for a period of at least 6 months after catheter removal. • The primary outcome was the recovery of continence, strictly defined as a ICIQ-UI score of zero. RESULTS: Overall, 34 consecutive patients were eligible and 32 were available for the final analysis: 16 patients for each study group. The two groups were homogeneous for all pre- and intraoperative features examined. • In the intervention group, continence had been achieved by six, eight and 10 patients at 1-, 3- and 6-month follow-ups, respectively, vs no patients (P= 0.02), one patient (P= 0.01) and one patient (P= 0.002) in the control group at each follow-up, respectively. • The analysis of the UCLA-PCI and ICIQ-OAB scores, the number of incontinence episodes per week and the number of pads per week showed significant differences in favour of patients in the intervention group at 3 and 6 months. • Patients in the intervention group reported better IPSS-QoL scores at all follow-up times but the difference did not reach statistical significance. CONCLUSIONS: Preoperative BFB combined with a postoperative programme of perineal physiokinesitherapy and assisted sessions on a monthly basis only, is a treatment strategy significantly more effective than the standard care in improving recovery of continence in patients undergoing RP. • The impact on QoL appeared less evident, although a trend for a better QoL was observed in the intervention group.

Social, economic, and health utility considerations in the treatment of overactive bladder.

Overactive bladder (OAB) is a highly prevalent urinary syndrome with a profound impact on quality of life (QoL) of affected patients and their family because of its adverse effects on social, sexual, interpersonal, and professional function. Cost-of-illness analyses showed the huge economic burden related to OAB for patients, public healthcare systems, and society, secondary to both direct and indirect costs; however, intangible costs related to QoL impact are usually omitted from these analyses. Recently many novel treatment modalities have been introduced and the need to apply the modern methodology of health technology assessment to these treatment strategies was immediately clear in order to evaluate objectively their value in term of both improvement in length/quality of life and costs. Health utilities are instruments that allow a measurement of QoL and its integration in the economic evaluation using the quality-adjusted life-years model and cost-utility analysis. The development of suitable instruments for quantifying utility in the specific group of OAB patients is vitally important to extend the application of cost-utility analysis in OAB and to guide healthcare resources allocation for this disorder. Studies are required to define the cost-effectiveness of available pharmacological and nonpharmacological therapy options for this disorder.

Effect of metformin on the growth hormone response to growth hormone-releasing hormone in obese women with polycystic ovary syndrome.

OBJECTIVE: Obese women with polycystic ovary syndrome (PCOS) show a marked growth hormone (GH) hyporesponsiveness to several stimuli. We aimed to evaluate the impact of insulin metabolism on the GH secretion impairment in these subjects in relation to food ingestion. DESIGN: Prospective clinical study. SETTING: Academic research center. PATIENT(S): Nine obese women with PCOS. INTERVENTION(S): Metformin (1,500 mg/daily) was administered for three months. The study protocol, which was performed before and after therapy, included hormonal and lipid assays, oral glucose tolerance test (75 g), euglycemic hyperinsulinemic clamp, and growth hormone-releasing hormone (GHRH) test (50 microg/ev), both on fasting and after a standard meal. MAIN OUTCOME MEASURE(S): Growth hormone response to GHRH (expressed as the area under the curve) in different experimental conditions. RESULT(S): The preprandial GH response to GHRH was not modified by the therapy, whereas a significant increase (P<.05) occurred in the postprandial GH secretion, thus resembling the response of obese normal persons. This change was accompanied by a trend towards improvement, though not statistically significant, of all the evaluated glycoinsulinemic parameters. A significant reduction in cholesterol (P<.01) and androstenedione (P<.05) and an increase in sex hormone-binding globulin (P<.05) were also achieved. CONCLUSION(S): These data suggest that metformin is able to affect GH secretion in obese women with PCOS, even with minimal metabolic modifications.