One treatment with onabotulinumtoxinA relieves symptoms of overactive bladder in patients refractory to one or more oral medications.

INTRODUCTION AND HYPOTHESIS: Patients with overactive bladder (OAB) often undergo prolonged treatment with one or more oral OAB medications. OnabotulinumtoxinA (onabotA), a type A botulinum toxin, may provide an appropriate alternative to oral treatments in patients intolerant of or refractory to one or more oral OAB medications. The GRACE study demonstrated real-world benefits of onabotA treatment for OAB in patients refractory to oral medications. This exploratory post hoc analysis of data from the GRACE study aims to determine if treatment history impacts benefit from treatment with onabotA. METHODS: This is a subanalysis of the GRACE study, a prospective observational study (NCT02161159) that enrolled patients with symptomatic OAB inadequately managed by at least one oral OAB medication. Patients had a treatment history of one or more anticholinergics (AC) and/or ß-3 adrenoreceptor agonists (ß-3) for relief of OAB; results were stratified according to treatment history. Patients in this analysis elected to discontinue oral medications upon treatment with onabotA. Safety was followed for 12 months in all patients that received at least 1 dose of onabotA; efficacy was determined over a 12-week period. RESULTS: Compared to baseline levels, significant reductions in urinary incontinence (UI), urgency, micturition, and nocturia were noted as early as 1 week and were sustained at 12 weeks, regardless of the type and number of oral medications taken before treatment with onabotA. At 12 weeks post-onabotA, the mean change from baseline UI episodes/day for those with a treatment history of only one AC was -2.4 (n = 43, p ≤ 0.001); more than one AC, -2.4 (n = 52, p ≤ 0.001); one ß-3, -3.3 (n = 12, p < 0.05); at least one AC and at least one ß-3, -3.2 (n = 56, p ≤ 0.001). Pad and liner use was significantly decreased at 12 weeks post-onabotA across all treatment history groups. Reductions in diaper pant use varied, with less of a reduction in patients with a treatment history of more than one AC compared to patients with a history of at least one AC and one ß-3 (p < 0.05) or those with a history of only one AC (p < 0.05). Overall, a total of 253/288 of patients (88%) reported improvements on the treatment benefit scale 12 weeks after treatment with onabotA, regardless of type and number of prior oral medications. In the population of patients that received at least one dose of onabotA (N = 504), 57 adverse events were reported in 38 patients (7.5%); 9 were serious (1.8%). Urinary retention was reported in 5 patients (1.0%); 1 was severe (0.2%). Symptomatic urinary tract infection was reported in 2 patients (0.4%). CONCLUSIONS: In this exploratory post hoc analysis of real-world data from the GRACE study, there were few significant differences in outcomes based on the type and number of prior oral medications. Thus, patients who are refractory to one or more oral OAB medications may benefit from earlier treatment with onabotA.

A Double-Blind, Placebo-Controlled Parallel Group Study to Evaluate the Effect of a Single Oral Dose of 5-HT1A Antagonist GSK958108 on Ejaculation Latency Time in Male Patients Suffering From Premature Ejaculation.

BACKGROUND: Premature ejaculation (PE) is a common male neurobiological sexual disorder, related to a disturbance in central serotonin (5-hydroxytryptamine or 5-HT) neurotransmission. AIM: To assess the efficacy of a single oral dose of 5HT1A receptor antagonist GSK958108 on ejaculation latency time (ELT) in male subjects suffering from PE. METHODS: A total of 35 male subjects were enrolled in a Phase 1 double-blind, placebo-controlled, parallel group masturbation-model study. All subjects completed the study. No subject was withdrawn from the study. There were no major protocol deviations reported during the study. OUTCOMES: The primary outcome of the study was to evaluate the effect of a single oral dose of 5HT1A receptor antagonist GSK958108 on ELT as measured in the masturbation model; additionally, we investigated drug's safety and tolerability. RESULTS: In the 3 mg GSK958108 treatment group, the ELT was estimated to be 16% longer (1.542 vs 1.328, 95% CI: -16% to +61%) than if the subjects had taken placebo. In the 7 mg GSK958108 treatment group, the ELT was estimated to be 77% longer (2.346 vs 1.328, 95% CI: +28% to +144%) than in the placebo group. The systemic exposure to GSK958108 increased with dosage between 3 mg and 7 mg. A significant trend toward an increase of ELT was observed with increasing plasma concentrations of GSK958108. A total of 4 patients all treated with 7 mg dose experienced minor drug related adverse events (5 adverse events in 4 patients): somnolence (n = 3), headache (n = 1), tinnitus (n = 1). CLINICAL IMPLICATIONS: In the current double-blind, placebo-controlled parallel group study the 5HT1A receptor antagonist GSK958108 was tested in 3 mg and 7 mg doses for PE treatment in humans. It was shown that GSK958108 significantly delayed ejaculation showing a new and safe alternative in PE treatment. STRENGTHS & LIMITATIONS: The present study showed innovative results suggesting an important role of 5HT1A receptor antagonist in the PE treatment. However, the use of masturbation model and the small population are the main limitations of this investigation. CONCLUSION: 5HT1A receptor antagonist GSK958108 3 mg per day and 7 mg per day was found to be well-tolerated, safe and effective for the treatment of PE subjects and demonstrated a strong association between 5HT1A receptors and ejaculation control in humans (NCT00861484). Migliorini F, Tafuri A, Bettica P, et al. A Double-Blind, Placebo-Controlled Parallel Group Study to Evaluate the Effect of a Single Oral Dose of 5-HT1A Antagonist GSK958108 on Ejaculation Latency Time in Male Patients Suffering From Premature Ejaculation. J Sex Med 2021;18:63-71.

OnabotulinumtoxinA is a well tolerated and effective treatment for refractory overactive bladder in real-world practice.

INTRODUCTION AND HYPOTHESIS: In randomized clinical trials onabotulinumtoxinA was demonstrated to be an effective and well-tolerated treatment for overactive bladder (OAB) with urinary incontinence (UI). However, data reporting onabotulinumtoxinA use in everyday clinical practice are limited. Here, we present the results from a large, first-of-its-kind real-world study in patients with OAB. METHODS: This was a prospective, observational, multinational study (GRACE; ClinicalTrials.gov , NCT02161159) performed in four European countries. Patients (N = 504) aged ≥ 18 years with OAB inadequately managed with ≥ 1 anticholinergic received onabotulinumtoxinA per their physician's normal clinical practice. RESULTS: Physicians primarily used rigid cystoscopes for onabotulinumtoxinA injection; anesthesia/analgesia was utilized during most treatment procedures. Significant reductions in UI episodes/day from baseline to weeks 1 and 12 were observed as well as in micturition, urgency, and nocturia episodes/day. These improvements in urinary symptoms corresponded to higher scores on the treatment benefit scale at week 12. The use of other OAB medications dropped from baseline to weeks 1 and 12 and was sustained to week 52, which paralleled a reduction in the number of incontinence products used during that time frame. Adverse reactions were reported in 2.6% of patients throughout the study. CONCLUSIONS: In this real-world study, significant improvements in urinary symptoms were seen following onabotulinumtoxinA treatment as early as week 1 and sustained to at least week 12. This was accompanied by a reduced reliance upon incontinence products and reduction in concomitant OAB medication use. OnabotulinumtoxinA was well tolerated with no new safety signals.

Influence of secondary diagnoses in the development of urinary incontinence after radical prostatectomy.

OBJECTIVE: To study whether there are factors related to secondary diagnoses (SDg) present in patients with prostate cancer that influence the development of urinary incontinence after radical prostatectomy (RP). MATERIALS AND METHODS: A retrospective multicenter observational study was performed reviewing the medical records of 430 men who underwent RP due to organ-confined prostate cancer in 9 different hospitals. Two study groups were distinguished: Group A (GA): Patients without urinary incontinence after RP; Group B (GB): patients with any degree of post-surgical urinary incontinence. RESULTS: Average age at surgery was 63.42 years (range 45-73). 258 patients were continent after surgery and 172 patients complaint of any degree of incontinence after RP. A higher percentage of healthy patients was found in group A (continent after surgery) than in group B (p = 0.001). The most common SDg prior to surgery were hypertension, lower urinary tract symptoms, dyslipidemia, diabetes mellitus and erectile dysfunction, but none did show a greater trend towards post-surgical incontinence. CONCLUSIONS: A better health status prior to surgery is associated to a lower incidence of new-onset urinary incontinence after radical prostatectomy. However, no correlation was found between the most common medical disorders and the development of post-surgical urinary incontinence.

Comparative study of bacterial translocation control with nitric oxide donors and COX2 inhibitor.

OBJECTIVE AND DESIGN: To evaluate the beneficial effects of exogenous NO and an inhibitor of the COX2, and their action levels in a model of SIRS/bacterial translocation (BT) induced by Zymosan A(®). MATERIAL AND METHODS: Ninety Wistar rats were submitted to different treatments, and after 12h and 24h they were anaesthetized in order to collect blood, mesenteric lymph nodes, and kidney for subsequent biochemical analyses and microbiological examinations. TREATMENTS: A nitric oxide donor, Molsidomine(®), was compared with a COX2 inhibitor, Celecoxib(®). METHODS: Zymosan A(®) was administered to Wistar rats. The animals were divided into 6 groups: one group for survival study, Group (1) No manipulation (BASAL); Group (2) vehicle of Zymosan A(®) given intraperitoneally (SHAM); Group I (control), with Zymosan A(®) (0.6g/kg) intraperitoneally; Group II (Molsidomine), with Molsidomine(®) (4mg/kg) through the penis dorsal vein, 30min prior to administration of the Zy(®) (0.6g/kg); Group III (Celecoxib), with Celecoxib(®) (400mg/kg) orally through a stomach tube, 6h prior to administration of the Zy (0.6g/kg). DETERMINATIONS: The parameters survival, bacterial translocation, renal function, neutrophil accumulation, oxygen free radicals (OFR), detoxifying enzymes, and cytokines were measured at different times after Zymosan administration. RESULTS: The model established induced a mortality rate of 100% and generated BT and systemic inflammatory response syndrome (SIRS) in all samples. It also significantly increased all variables, with p<.001 for MPO and all pro-inflammatory cytokines, and p<.01 for all OFR. Treatment with Molsidomine reduced mortality to 0%, decreased BT, MPO, pro-inflammatory cytokines and OFR (p<.001) significantly and increased IL-10 and IL-6 production. Moreover, the Celecoxib(®) showed a lower capacity for SIRS regulation. CONCLUSIONS: The exogenous administration of NO prevented BT and controlled SIRS. Therefore these results suggest that Molsidomine could be used as a therapeutic strategy to protect against BT.

PDE-5 inhibitors in monotherapy versus combination therapy in a sample of 1200 patients with erectile dysfunction.

OBJECTIVES: To compare the effectiveness in the treatment of erectile dysfunction when using PDE-5 inhibitors (PDE5i), alprostadil (PG-E1) and testosterone (TES) in monotherapy or combination therapy. MATERIAL AND METHODS: Observational multicentre retrospective study of men diagnosed and treated for ED between January 2008 and January 2014. Age, social and employment situation, pathological medical history, risk factors, usual treatments, IIEF-5 at the first consultation and at first and each 6 months follow-ups, physical examination, calculated total and free testosterone and received treatment were analysed. Descriptive statistics, one-way ANOVA analysis, Chi2 for qualitative data, t-test, Fisher's exact test and Pearson's correlation coefficient were used; p < 0.05 is considered significant. RESULTS: Average age was 58.61 years, SD5.02, average follow- up time 48.21 months, SD 6.21, range 6-174 months. Out of the patients 76.12% were married, 9.81% divorced/separated, 10.04% single, 4.03% widowed; 85.14% of the total in stable partnership but 66.16% were not accompanied by their partners. In total 844 patients received monotherapy (597 PDE5i; 62 PG-E1; 36 TES; 27 penile prosthesis; 121 psychotherapy/alternative therapies) and 357 combination therapy (167 PDE5i+TES; 124 PDE5i+PGE1; 66 PG-E1+TES). There was a homogeneous distribution between risk factors and medical history groups. Satisfactory response according to IIEF-5 was achieved for 72.33% of patients on PDE5i monotherapy, 46.65% of patients on PDE5i+PG-E1 combination therapy and 83.41% of patients on PDE5i+TES. CONCLUSIONS: The best therapeutic success for ED in this series was achieved through a combination of testosterone+PDE-5 inhibitors without increasing morbidity and maintaining the response over time. Larger studies with longer follow-up will corroborate these findings.

Influence of antiplatelet-anticoagulant drugs on the need of blood components transfusion after vesical transurethral resection.

AIMS: The effect of the antithrombotic preventive therapy on haemorrhage keeps uncertain. We investigate the influence of the antiplatelet and anticoagulant drugs (AP/AC drugs) on the transfusion requirement after vesical transurethral resection (VTUR). We also describe the epidemiology of the blood components transfusion in our department. MATERIALS AND METHODS: Retrospective observational study of a series of patients needing blood transfusion at the Urology Department between June 2010 and June 2013. Selection of 100 consecutive patients who were transfused after VTUR due to bladder transitional cell carcinoma (BTCC) (group A = GA). CONTROL GROUP: 100 consecutive patients who underwent VTUR due to BTCC and were not transfused (group B = GB). Transfusion criteria: Haemoglobin < 8 g/dl + anaemia symptoms. Age, gender, associated AP/AC treatment, secondary diagnoses, toxics, tumour stage and grade were analysed. RESULTS: 212 patients required transfusion of a blood component. 169 were men (79%) and 43 women (21%). Median age 77.59 years (SD 9.42, range 50-92). Secondary diagnoses: Diabetes Mellitus 64%, high blood pressure 77%, dyslipidemia 52%. 60% of patients were previously treated with AP/AC drugs. Average Haemoglobin pre-transfusion values: 7.4 g/dl (DE ± 0.7). Average Haemoglobin post-transfusion values: 8.9 g/Dl (DE ± 0.72). Most frequent transfusion indications were bladder cancer (37%), kidney cancer (11%), prostate cancer (8%), benign prostatic hyperplasia (BHP) (8%), other urological diagnoses (36%). Intraoperative transfusions indicated by the anaesthesiologist: kidney cancer (33%), BPH (28%). Patients who underwent VTUR due to BTCC were older in GA (77.59 years SD 9.42) than in GB (68.98 years SD 11.78) (p = 0.0001). Similar gender distribution (15 women in GA and 24 in GB). Less patients were asked to keep their treatment with ASA 100mg (AcetylSalicylicAcid) in GA (25.64%) than in GB (50%) (p = 0.0330). More aggressive tumour grade in GA (p = 0.0003) and higher stage in GA (p = 0.0018) regardless of concomitant treatment with AP/AC drugs. CONCLUSIONS: The pathologies which most needed blood components' transfusions in the Urology Department were (in order of frequency): bladder cancer, kidney cancer, prostate cancer, prostate adenoma. ASA100mg did not influence the transfusion's requirements in VTUR due to BTCC. Tumour stage and higher grade have a greater influence in transfusion's requirements than concomitant AP/AC treatment. The heterogeneity of AP/AC protocols does not allow to establish the benefit of stopping those drugs before surgery in terms of avoiding blood transfusions when performing a VTUR.

Reducing Recurrent Urinary Tract Infections in Women with MV140 Impacts Personal Burden of Disease: Secondary Analyses of a Randomized Placebo-controlled Efficacy Study.

Background: Recurrent urinary tract infection (rUTI) remains a major health burden for women. A randomized, double-blind, placebo-controlled trial (RCT; NCT02543827) reported that female patients with rUTI receiving a sublingual vaccine, MV140, had a reduction in rUTI and increase in UTI-free rate compared with placebo. Objective: To determine the impact of MV140 on the personal burden of disease in women with rUTI using secondary endpoint data from the pivotal RCT evaluating MV140. Design setting and participants: In the primary RCT, female patients with rUTI enrolled in Spain and UK (from October 2015 to April 2019) were randomized to placebo (6 mo) or MV140 (3 or 6 mo), and followed for 12 mo. Individuals analyzed in this secondary analysis included those in the placebo and 3-mo (recommended dose) groups. Intervention: A polybacterial sublingual vaccine, MV140 (four inactivated whole-cell bacteria-Escherichia coli, Klebsiella pneumoniae, Proteus vulgaris, and Enterococcus faecalis), or placebo. Outcome measurements and statistical analysis: Symptom severity scoring, antibiotic use, safety, and multiple aspects of quality of life (QoL; Short-Form Questionnaire [SF-36]) were assessed. Results and limitations: Compared with the placebo group (n = 76), the 3-mo vaccinated group (n = 74) experienced fewer overall UTI symptoms (mean symptom score 102.2 ± 222.9 vs 194.2 ± 178.8; p = 0.0002), fewer days on antibiotics (12.4 ± 17.7 vs 28.7 ± 25.2; p = 0.0001), and improved total, general, and physical SF-36 QoL improvement (differences in means for total SF-36 score 15.7; 95% confidence interval [CI] 8.80, 22.64; p < 0.0001), with only social function QoL showing no impact (4.07; 95% CI -4.93, 13.08; p = 0.3744). Conclusions: Three months of MV140 is associated with a reduction of the personal burden of UTI by reducing overall UTI symptoms and antibiotic use, improving QoL in women with rUTI. Patient summary: Three months of MV140 vaccine, which has previously been shown to reduce the risk of urinary tract infection safely, is associated with a reduction in the personal burden of disease.

Relationship between Mental Disorders, Smoking or Alcoholism and Benign Prostate Disease.

INTRODUCTION: Mental disorders, smoking, or alcoholism and benign prostate disease are highly prevalent in men. AIMS: To identify the relationship between mental disorders, smoking, or alcoholism and benign prostate disease. METHODOLOGY: A prospective multicenter study that evaluated prostate health status in 558 men from the community. Groups: GP-men who request a prostate health examination and whose medical history includes a mental disorder, smoking, or alcoholism prior to a diagnosis of benign prostate disease; GU-men who request a prostate health examination and whose medical history includes a benign prostate disease prior to a diagnosis of mental disorder, smoking, or alcoholism. VARIABLES: age, body mass index (BMI), prostate specific antigen (PSA), follow-up of the mental disorder, smoking or alcoholism, time elapsed between urological diagnosis and the mental disorder, smoking or alcoholism diagnosis, status of the urological disease (cured or not cured), concomitant diseases, surgical history, and concomitant treatments. Descriptive statistics, Student's t-test, Chi2, multivariate analysis. RESULTS: There were no mental disorders, smoking, or alcoholism in 51.97% of men. Anxiety, smoking, major depressive disorder, pathological insomnia, psychosis, and alcoholism were identified in 19.71%, 13.26%, 5.73%, 4.30%, 2.87%, and 2.15% of individuals, respectively. Nonbacterial prostatitis (31.54%), urinary tract infection (other than prostatitis, 24.37%), prostatic intraepithelial neoplasia (13.98%), and prostatodynia (1.43%) were prostate diseases. Unresolved symptomatic benign prostate disease was associated with anxiety, depression, and psychosis (p = 0.002). Smoking was the disorder that men managed to eliminate most frequently. The dominant disorder in patients with symptomatic benign prostatic disease was alcoholism (p = 0.006). CONCLUSIONS: Unresolved symptomatic benign prostatic disease is associated with anxiety, depression, and psychosis. Alcoholism is associated with a worse prognosis in the follow-up of symptomatic benign prostatic disease.

Enhancing Kidney Transplant Outcomes: The Impact of Living Donor Programs.

INTRODUCTION: The protocol for deceased donor kidney transplants has been standardised. The procedure for a living donor has peculiarities derived from the differences in the graft. When a living kidney donor program is implemented, changes occur in both the profile of the kidney transplant candidate and in the postoperative treatments. AIMS: To discover whether a living donor program influences the functional outcomes of kidney grafts in a longstanding classical deceased donor kidney transplant program and to identify the factors associated with transplant outcomes. METHODS: Retrospective observational multicentre study. SAMPLE: Kidney transplant patients in two urology referral centres for renal transplant in Spain between 1994 and 2019. Groups: TV (living transplant): patients given kidney transplants from living donors (n = 150); TCpre11 (deceased transplant previous to 2011): patients given kidney transplants from deceased donors before the living donor program was implemented (n = 650); and TCpost11 (deceased transplant after 2011): patients given kidney transplants from deceased donors after the living donor program was implemented (n = 500). RESULTS: Mean age was 55.75 years (18-80 years), higher in TCpre11. There were 493 female patients (37.92%) and 1007 male patients (62.08%). Mean body mass index (BMI) was 26.69 kg/m2 (17.50-42.78 kg/m2), higher in TCpre11. Mean ischemia time was 17.97 h (6-29 h), higher in TCpost11. Median duration of urethral catheter: 8 days (6-98 days), higher in TCpost11. Median duration of double-J ureteral stent: 58 days (24-180 days), higher in TCpost11. Pretransplant UTIs: 17.77%, higher in TCpre11 (25.69%) than in TV (12%), higher in TV (12%) than TCpost11 (9.2%), and higher in TCpre11 (25.69%) than TCpost11 (9.2%). Acute renal rejection in 9.33% of TV, 14.77% of TCpre11, and 9.8% of TCpost11. Multivariate analysis: TCpost11 featured higher BMI, more smoking, and chronic renal failure progression time. Lower use of nonantibiotic prophylaxis to prevent recurrent urinary tract infections, increased duration of urethral catheters due to obstructive problems, and favoured deterioration of kidney function was observed in the deceased donor program. The living donor (LD) program had a strong influence on deceased donor transplants in the prelysis phase. Implementation of a LD program was associated with a decrease in the likelihood of acute rejection in TCpost11 and an increase in the tendency towards normal kidney function. CONCLUSIONS: Implementing living donor transplant programs affects functional outcomes in deceased donor transplants, reducing the probability of acute rejection and increasing the tendency towards normal kidney function. Preventing recurrent urinary tract infections with measures other than antibiotics, smoking cessation, delaying the removal of the double-J stent from the graft, and pre-emptive transplant (transplant prior to dialysis) are associated with improved renal function of the graft.

Results of the surgical correction of urinary stress incontinence according to the type of transobturator tape utilized.

OBJECTIVES: To analyze the short and long term results of tapes of different materials used to treat stress urinary incontinence (SUI). A secondary objective was to evaluate the ability to adjust the tape after implantation. MATERIALS AND METHODS: Retrospective chart review of 355 patients with SUI operated between March 2003 and October 2011. Eight different types of transobturator tapes were used: Gynecare TVT-O®, Monarc®, SAFYRE®, Contasure KIM®, I-Stop®, DynaMesh®, Aris® Bandellete and Swing-band®. Results and complications were recorded. RESULTS: The mean age at operation was 61 years. Correction of SUI was achieved in 87.88% of cases. The best results were obtained with Contasure KIM® (98.26 % continence). The tape was well tolerated and was elastic enough to be able to be adjusted 48-72 hours after implantation without deformation. Slings with macropores and over lock stitches on the superior and inferior borders presented the lower rates of postoperative urinary retention, pain, perior postoperative bleeding and urinary tract infections. CONCLUSIONS: Transobturator tension free tapes require a short operation time and have a low complication rate. The possibility of adjustment in the early postoperative period increases the success rate and reduces complications. Knotless meshes with macropores and over lock stitches appear to be better balanced, are quite resistant to stretching and deformation when readjusted after implantation and present a low infection rate.

Late diagnosis of ureteral injury from anterior lumbar spine interbody fusion surgery: Case report and literature review.

BACKGROUND: Anterior Lumbosacral Interbody Fusion (ALIF) is a type of back surgery with the advantages of direct access to the spinal interbody space and the potential lessening morbidity related to posterior approaches. PURPOSE: To describe a rare case of left ureteral lesion from ALIF surgery diagnosed 4 months after the procedure. CASE DESCRIPTION: A 37-year-old Caucasian man with a long history of painful post-traumatic spondylolisthesis and degenerative L5-S1 disc disease underwent a retroperitoneal anterior L5-S1 discectomy, insertion of an interbody tantallium cage, and placement of a pyramid titanium plate fixed with screws. Four months later, due to recurrent left lumbar pain and mild renal failure, a CT scan was performed showing left hydronephrosis with a homolateral urinoma of 17 cm in diameter. A left nephrostomy was placed and the nephrostography detected a filiform leakage at L5-S1 level in communication with the urinoma. The patient underwent laparoscopic urinoma drainage, distal left ureterectomy, and Casati-Boari flap ureterocystoneostomy with ureteral double J stent placement. The stent was held for six weeks and, 1 month later, the control ultrasound scan was negative for hydronephrosis, the creatinine level had normalized and the patient was asymptomatic. CONCLUSION: Ureteral lesion from ALIF surgery is a very rare event. Spinal surgeons should be more awareness regarding the susceptibility of ureteral injuries along with the clinical presentation, diagnostic work-up, and management options for this kind of complication.

Relationship between Prostate Inflammation and Periodontal Disease-A Systematic Review and Meta-Analysis.

The aim of this systematic review and meta-analysis was to analyze the association between periodontal disease and prostate inflammation with a null hypothesis stating that periodontal disease does not increase the incidence of prostate inflammation. MATERIALS AND METHODS: A systematic literature review and meta-analysis of longitudinal observational cohort and case-control studies that evaluated the odds ratio or hazard ratio and confidence interval was undertaken based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) recommendations (2020). A total of four databases were consulted in the literature search: PubMed-Medline, Scopus, Embase, and Web of Science. After eliminating duplicated articles and applying the inclusion criteria, seven articles were selected for the qualitative and quantitative analyses. RESULTS: Four observational cohort studies and three observational cohort case-control studies were included in the meta-analysis. The four observational cohort studies were combined using the random effects model to estimate a hazard ratio of 1.32 with a confidence interval of 95% between 0.87 and 1.77. The meta-analysis presented high heterogeneity (Q test = 56.1; p value < 0.001; I2 = 94.9%). Moreover, the three observational case-control studies were combined using the random effects model to estimate an odds ratio of 1.62 with a confidence interval of 95% between 1.41 and 1.84. The meta-analysis presented high heterogeneity (Q test = 1.07; p value = 0.782; I2 = 0%). CONCLUSIONS: The incidence of periodontal disease does not increase the risk of the incidence of prostate inflammation.

Four vertex technique for correcting urethral prolapse: technique description and cohort study.

Introduction/Objectives: This study aims to describe the procedure and effectiveness of the four-vertex technique for correcting urethral prolapse in women. Methods and Materials: includes a retrospective case series of 17 patients who underwent surgery for urethral prolapse. Two study groups were distinguished based on the presence or absence of pelvic heaviness symptoms. The variables were analyzed, including age, BMI, concomitant diseases, obstetric and gynecological history, time from diagnosis to surgery, and outcomes of treatment. Results: All patients were postmenopausal, with a mean age at the time of the intervention of 70.41 years, with no differences between groups. Mean BMI was 23.67 kg/m2, higher in the group with a sensation of vaginal heaviness (p = 0.027). Mean time elapsed between diagnosis and operation was 231.58 days, with no differences between groups. Mean childbirth count was 2.29. The most frequent causes for consultation were urethrorrhagia (33.33%) and a bulging sensation (33.33%). After the intervention, 14 patients (82.35%) were asymptomatic, two (11.76%) had dysuria, and one (5.88%) had urinary urgency. Ten patients had pre-surgical urinary incontinence, which was resolved in nine patients. 17.46% subsequently presented pelvic organ prolapse. In three women there was secondary impairment of sexual activity. Conclusion: The four-vertex technique was effective in resolving symptoms in most patients. However, some patients experienced dysuria, urinary urgency, and pelvic organ prolapse after surgery. Urinary incontinence improved in most patients, but a few required additional treatments with suburethral tape. The study also identified associations between variables and the presence of cystocele, consultation for a bulging sensation, and bleeding from urethral prolapse. Overall, this study sheds light on the challenges and outcomes of surgical treatment for urethral prolapse and provides valuable insights for future research in this area.

Adverse Effects in Patients with Intellectual and Developmental Disabilities Hospitalized at the University Clinical Hospital.

(1) Background: Providing the patient with the health care they need in a personalized and appropriate manner and without adverse effects (AEs) is a part of quality of care and patient safety. The aim of this applied research project was the assessment of AEs as a clinical risk in patients with high social vulnerability such as persons with intellectual and developmental disabilities (PwIDD). (2) Methods: A retrospective epidemiological cohort study was performed on exposed and unexposed groups (the control group) in order to estimate the incidence of AEs in PwIDDs and assess their importance for this category of patients. (3) Results: AEs were observed with a frequency of 30.4% (95% CI) in the PwIDD exposed group, with significant differences to the unexposed group (p = 0.009). No differences were observed with regards to gender. Age was as a marker of care risk, with the highest incidence of AEs in the group of 60-69 years. (4) Conclusions: PwIDDs have a high risk of suffering AEs while receiving health care assistance due to their high social and clinical vulnerability. Health care practitioners must therefore be aware of these results and keep these observations in mind in order to carry out personalized, preventive, competent, effective, and safe medical care.

Sublingual MV140 for Prevention of Recurrent Urinary Tract Infections.

BACKGROUND: Recurrent urinary tract infections (UTIs), which consist of three or more episodes in 1 year or two or more infections in 6 months, affect 5% to 10% of women. MV140, a sublingual preparation of whole-cell inactivated bacteria, has shown clinical benefit in observational studies. This trial examined treatment with MV140 to prevent recurrent UTI. METHODS: In this multicenter, randomized, double-blind, placebo-controlled, parallel-group 1-year trial, 240 women 18 to 75 years of age from Spain and the United Kingdom with recurrent UTI were allocated to receive MV140 for 3 or 6 months or placebo for 6 months in a 1:1:1 ratio. The primary end point was the number of UTIs in the 9-month study period after 3 months of intervention. Key secondary end points were the percentage of women who were UTI free over the above period, time to UTI onset, and health-related quality of life. RESULTS: The median (interquartile range) of UTI episodes was 3.0 (0.5 to 6.0) for placebo compared with 0.0 (0.0 to 1.0) in both groups receiving MV140 (P<0.001). Among women treated with placebo, 25% (95% confidence interval [CI], 15% to 35%) were free of UTIs compared with 56% (95% CI, 44% to 67%) and 58% (95% CI, 44% to 67%) of women who received 3 and 6 months of MV140 treatment, respectively. A total of 205 AEs in 101 participants were registered (81, 76, and 48 in the placebo, 3-month MV140, and 6-month MV140 groups, respectively). CONCLUSIONS: In this controlled trial of modest size and duration, MV140 showed promising clinical efficacy in reducing recurrent UTI in women suffering from this condition. Adverse effects were not clinically limiting. (Funded by Inmunotek S.L. and Syner-Med [Pharmaceutical Products] Ltd.; ClinicalTrials.gov number, NCT02543827.)

Improvement in Quality of Life with Pelvic Floor Muscle Training and Biofeedback in Patients with Painful Bladder Syndrome/Interstitial Cystitis.

OBJECTIVE: To prove the benefits of pelvic floor muscle training with biofeedback (BFB) as a complementary treatment in women with bladder pain syndrome/interstitial cystitis (BPS/IC). METHODS: Prospective, randomized study in 123 women with BPS/IC. Groups: BFB+ (n = 48): women with oral drug treatment (perphenazine and amitriptyline) plus intravesical instillations (sodium hyaluronate) plus pelvic floor muscle training with BFB; BFB-: (n = 75): women with oral drug treatment plus intravesical instillations. VARIABLES: age, body mass index (BMI), time of follow-up, length of disease, time free of disease, diseases and health conditions concomitant, and responses to the SF-36 health-related quality of life questionnaire at the first consultation (SF-36 pre-treatment), and at the end of the study (SF-36 post-treatment). The treatment was considered successful when the SF-36 score reached values equal to or greater than 80 points or when the initial value increased by 30 or more points. RESULTS: Mean age was 51.62 years old (23-82). BMI was higher in BFB-. The mean length of BPS/IC condition was 4.92 years (1-20), shorter in BFB+ than in BFB-. Mean SF-36 score pre-treatment was 45.92 points (40-58), lower in BFB+ than in BFB-. Post-treatment SF-36 score was higher than pre-treatment SF-36 score both in BFB+ and BFB-. SF-36 values were higher in BFB+ compared to BFB- over the follow-up. CONCLUSIONS: BFB improves quality of life in women with BPS/IC as adjunct therapy to combined oral and intravesical treatment.

Remeex® System Effectiveness in Male Patients with Stress Urinary Incontinence.

BACKGROUND: When conservative management fails, patients with stress urinary incontinence (SUI) are considered for surgical treatment. Simpler, more economical and less invasive surgical techniques, such as the Remeex® system, have been developed. OBJECTIVES: To analyze the objective effectiveness of the Remeex® system in the treatment of male stress urinary incontinence. To study survival and complication rates of the Remeex® system in male SUI patients. MATERIALS AND METHODS: Prospective observational study between July 2015 and May 2020. Group A (n = 7; GA) patients with mild SUI. Group B (n = 22; GB) patients with moderate SUI. Group C (n = 18; GC) patients with severe SUI. Effectiveness was assessed by the number of patients achieving complete and partial dryness. Complete dryness was defined as patients using 0-1 safety pads per day; partial dryness as a >50% reduction in the number of pads used. Results were analyzed using descriptive statistics, Student's t-test. Chi2, Fisher's exact test, ANOVA, and multivariate analysis. Significance was set at p < 0.05. RESULTS: Mean age 69.76 years, mean follow-up 33.52 months. Objective effectiveness was observed in 89.36% of patients with incontinence. The effectiveness was 85.71% in GA, 90.91% in GB and 88.89% in GC. There were no significant differences among groups (p = 1.0000). 34.04% of patients with an implant required at least one readjustment, while 66.00% did not require any. There were no significant differences among groups (p = 0.113) Chi2 = 4.352. 95.74% of implants remained in place by the end of follow-up. We observed complications in 17.02% of patients. CONCLUSIONS: Remeex® system is an effective and safe method for male stress urinary incontinence treatment, regardless of the severity of the incontinence, with high survival and low complication and removal rates. System readjustments are required in one-third of the cases.

Relationship between obstetric history and recurrent urinary infections.

Urinary tract infections affect more than 50% of women. 25% derive from recurrent UTI (RUTI). It is not known the relationship between obstetric history and RUTI occurrence. Investigate the relationship between obstetric events and RUTI. Multicenter observational retrospective study. Groups: G.RUTI (n = 294): women with RUTI; G.NON.RUTI (n = 126): women without RUTI (treated and cured of renal cancer). Descriptive statistics, ANOVA analysis of variance (with Scheffe's test for normal samples and Kruskal-Wallis for other distributions), Fisher's exact test, Pearson and Spearman correlation studies, and multivariate analysis multiple regression were used. Mean age 61.04 years (19-92), G.RUTI: 56.77 years SD 4.46 (19-85). G.NON.RUTI: 71 years SD 6.73 (25-92) (p = 0.0001). Obstetric history: Nulliparous G.RUTI: 20 (3.4%) G.NON.RUTI: 90 (71.42%) p 0.0001; Eutocic G.RUTI: 416 (70.74%) G.NON.RUTI: 30 (23.8%) p 0.0001. Dystocic G.RUTI: 58 (9.86%) G.NON.RUTI: 56 (44.44%) p 0.0001. G.RUTI abortion: 102 (17.34%) G.NON.RUTI: 30 (23.8%) p 0.1381. Hysterectomy without adnexectomy G.RUTI: 100 (17%) G.NON.RUTI: 18 (14.28%) p 0.5640. Hysterectomy with adnexectomy G.RUTI: 100 (17%) G.NON.RUTI: 66 (52.28%) p 0.0001. Nulliparity, dystocic delivery, and hysterectomy with adnexectomy are more frequent in women without RUTI, while eutocic births are more associated with RUTI. The most prevalent gynaecological-obstetric history in women with RUTI is eutocic delivery associated with a good health state.

Impact of whole-cell bacterial immunoprophylaxis in the management of recurrent urinary tract infections in the frail elderly.

PURPOSE: This study aimed to determine the effectiveness of whole-cell bacterial immunotherapy, i.e. MV140 and autovaccines, in reducing the number ofurinary tract infections (UTIs)in frail elderly patients with recurrent UTI (RUTI). METHOD: A prospective cohort observational study was performed including 200 frail elderly subjects suffering RUTI, both females and males, between 2016 and 2018. The effectiveness of autovaccines and the polybacterial formulation MV140 (Uromune®), consisting ofwhole-cell heat-inactivated Escherichia coli25%, Klebsiella pneumoniae25%, Proteus vulgaris25% andEnterococcus faecalis25% were evaluated. Subjects initiated a 3-month sublingually daily course with MV140 or autovaccine, either first treatment or a new course if they had been previously vaccinated prior to inclusion in the study. Number of UTIs and quality of life (QoL, SF-36 score) were measured in the different study groups. RESULTS: The mean age for participants was 82.67 (SD, 7.12) for female and 80.23 (SD, 11.12) for male subjects. In all groups, 12 months following bacterial immunotherapy, the number of UTIs significantly decreased compared to before the treatment with autovaccine or MV140: the rate of reduction ranged between 7- and 40-fold. An increase in QoL scoring was also observed in any study group. When comparing medical interventions, MV140 conferred significantly higher benefit than autovaccines. For previously vaccinated individuals, a new 3-month course with MV140 or autovaccines provided further clinical improvement. CONCLUSIONS: MV140 and autovaccines emerge as valuable immunoprophylaxis for the management of RUTI in the frail elderly, contributing to an improvement in patient's quality of life. Herein, MV140 has shown to confer a higher effectiveness compared to autovaccines, regardless sex or course of treatment.