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Purpose To evaluate the effectiveness of the symptom management after radiotherapy (SMaRT) group intervention to improve urinary symptoms in men with prostate cancer. Methods The randomised controlled trial (RCT) recruited men from one radiotherapy centre in the UK after curative radiotherapy or brachytherapy and with moderate to severe urinary symptoms defined as scores ≥ 8 on the International Prostate Symptom Score (IPSS) questionnaire. Sixty-three men were randomised either; to SMaRT, a 10-week symptom-management intervention including group support, education, pelvic floor muscle exercises, or a care-as-usual group. The primary outcome was the IPSS at 6 months from baseline assessment. Secondary outcomes were IPSS at 3 months, and International Continence Society Male Short Form (ICS), European Organisation for Research and Treatment of Cancer Quality of Life prostate scale (EORTC QLQ-PR25), EORTC QLQ-30 and Self-Efficacy for Symptom Control Inventory (SESCI) at 3 and 6 months from baseline. Analysis of covariance (ANCOVA) was used to analyse the effect of the intervention. Results SMaRT group intervention did not improve urinary symptoms as measured by IPSS at 6-months. The adjusted difference was − 2.5 [95%CI − 5.0 to 0.0], p = 0.054. Significant differences were detected at 3 months in ICS voiding symptoms (− 1.1 [− 2.0 to − 0.2], p = 0.017), ICS urinary incontinence (− 1.0 [− 1.8 to − 0.1], p = 0.029) and SESCI managing symptoms domain (13.5 [2.5 to 24.4], p = 0.017). No differences were observed at 6 months. Conclusions SMaRT group intervention provided short-term benefit in urinary voiding and continence and helped men manage symptoms but was not effective long term.

Background Lower urinary tract symptoms (LUTS) comprise storage symptoms, voiding symptoms and post-voiding symptoms. Prevalence and severity of LUTS increase with age and the progressive increase in the aged population group has emphasised the importance to our society of appropriate and effective management of male LUTS. Identification of causal mechanisms is needed to optimise treatment and uroflowmetry is the simplest non-invasive test of voiding function. Invasive urodynamics can evaluate storage function and voiding function; however, there is currently insufficient evidence to support urodynamics becoming part of routine practice in the clinical evaluation of male LUTS. Design A 2-arm trial, set in urology departments of at least 26 National Health Service (NHS) hospitals in the United Kingdom (UK), randomising men with bothersome LUTS for whom surgeons would consider offering surgery, between a care pathway based on urodynamic tests with invasive multichannel cystometry and a care pathway based on non-invasive routine tests. The aim of the trial is to determine whether a care pathway not including invasive urodynamics is no worse for men in terms of symptom outcome than one in which it is included, at 18 months after randomisation. This primary clinical outcome will be measured with the International Prostate Symptom Score (IPSS). We will also establish whether inclusion of invasive urodynamics reduces rates of bladder outlet surgery as a main secondary outcome. Discussion The general population has an increased life-expectancy and, as men get older, their prostates enlarge and potentially cause benign prostatic obstruction (BPO) which often requires surgery. Furthermore, voiding symptoms become increasingly prevalent, some of which may not be due to BPO. Therefore, as the population ages, more operations will be considered to relieve BPO, some of which may not actually be appropriate. Hence, there is sustained interest in the diagnostic pathway and this trial could improve the chances of an accurate diagnosis and reduce overall numbers of surgical interventions for BPO in the NHS. The morbidity, and therapy costs, of testing must be weighed against the cost saving of surgery reduction. Trial registration Controlled-trials.com - ISRCTN56164274 (confirmed registration: 8 April 2014).

Introduction and objectiveMultiple sclerosis (MS) is the most frequent autoimmune demyelinating disease of the central nervous system. MS patients usually present with lower urinary tract dysfunction (LUTD). Objective of this study is to evaluate and compare the efficacy and safety of treating MS patients with LUTD with either a b3 agonist (mirabegron) or anticholinergics. The study’s primary outcome is the LUTD symptom improvement. Material and MethodsThis is a multi-center, single-blinded, comparative study including 91 MS patients with LUTD. At baseline, patients underwent thorough clinical examination, urine cultivation and abdominal ultrasound and completed urination diaries and specific, validated questionnaires (NBSS, MusiQoL). At second visit, patients were administered either mirabegron or anticholinergics. Treatment was always carried out alongside with MS treatment. Reevaluation was performed 3 months after first visit. Patients underwent the same clinical and imaging tests that were carried out at first visit.ResultsWe compared several clinical and imaging parameters between the two groups at first visit and month 3 after treatment. Νo statistical difference was noted between the mirabegron group and the anticholinergic group in terms of LUTD improvement. In both groups, improvement from baseline regarding LUTD was recorded. Statistical analysis was performed using the paired and unpaired t test method. No patient discontinued either medication due to side effects.ConclusionsMS patients receiving either mirabegron or anticholinergic therapy for LUTD showed improvement. Nevertheless, no statistical difference was noted between the two cohorts at 3 months in terms of drug efficacy in all the statistically significant parameters.

PurposeDespite superiority of tamsulosin–dutasteride combination therapy versus monotherapy for lower urinary tract symptoms due to benign prostatic hyperplasia (LUTS/BPH), patients at risk of disease progression are often initiated on α-blockers. This study evaluated the impact of initiating tamsulosin monotherapy prior to switching to tamsulosin–dutasteride combination therapy versus immediate combination therapy using a longitudinal model describing International Prostate Symptom Score (IPSS) trajectories in moderate/severe LUTS/BPH patients at risk of disease progression.MethodsClinical trial simulations (CTS) were performed using data from 10,238 patients from Phase III/IV dutasteride trials. The effect of varying disease progression rates was explored by comparing profiles on- and off-treatment. CTS scenarios were investigated, including a reference (immediate combination therapy) and six alternative virtual treatment arms (delayed combination therapy of 1–24 months). Clinical response (≥ 25% IPSS reduction relative to baseline) was analysed using log-rank test. Differences in IPSS relative to baseline at various on-treatment time points were assessed by t tests.ResultsDelayed combination therapy initiation led to significant (p < 0.01) decreases in clinical response. At month 48, clinical response rate was 79.7% versus 74.1%, 70.3% and 71.0% and IPSS was 6.3 versus 7.6, 8.1 and 8.0 (switchers from tamsulosin monotherapy after 6, 12 and 24 months, respectively) with immediate combination therapy. More patients transitioned from severe/moderate to mild severity scores by month 48.ConclusionsCTS allows systematic evaluation of immediate versus delayed combination therapy. Immediate response to α-blockers is not predictive of long-term symptom improvement. Observed IPSS differences between immediate and delayed combination therapy (6–24 months) are statistically significant.

Background One-fourth of men older than 70 years have lower urinary tract symptoms (LUTS) that impair their quality of life. Transurethral resection of the prostate (TURP) is considered the gold standard for surgical treatment of LUTS caused by benign prostatic hyperplasia (BPH) that cannot be managed conservatively or pharmacologically. However, TURP is only an option for patients fit for surgery and can result in complications. Transurethral microwave thermotherapy (TUMT) and prostatic artery embolisation (PAE) are alternative minimally invasive surgical therapies (MISTs) performed in an outpatient setting. Both treatments have shown to reduce LUTS with a similar post-procedure outcome in mean International Prostate Symptom Score (IPSS). It is however still unknown if TUMT and PAE perform equally well as they have never been directly compared in a randomised clinical trial. The objective of this clinical trial is to assess if PAE is non-inferior to TUMT in reducing LUTS secondary to BPH. Methods This study is designed as a multicentre, non-inferiority, open-label randomised clinical trial. Patients will be randomised with a 1:1 allocation ratio between treatments. The primary outcome is the IPSS of the two arms after 6 months. The primary outcome will be evaluated using a 95% confidence interval against the predefined non-inferiority margin of + 3 points in IPSS. Secondary objectives include the comparison of patient-reported and functional outcomes at short- and long-term follow-up. We will follow the patients for 5 years to track long-term effect. Assuming a difference in mean IPSS after treatment of 1 point with an SD of 5 and a non-inferiority margin set at the threshold for a clinically non-meaningful difference of + 3 points, the calculated sample size was 100 patients per arm. To compensate for 10% dropout, the study will include 223 patients. Discussion In this first randomised clinical trial to compare two MISTs, we expect non-inferiority of PAE to TUMT. The most prominent problems with MIST BPH treatments are the unknown long-term effect and the lack of proper selection of candidates for a specific procedure. With analysis of the secondary outcomes, we aspire to contribute to a better understanding of durability and provide knowledge to guide treatment decisions. Trial registration ClinicalTrials.gov NCT05686525. Registered on January 17, 2023, https://clinicaltrials.gov/study/NCT05686525 .

Background Acute uncomplicated lower urinary tract infection (UTI) is one of the most common bacterial infections. Patients usually present with dysuria, urinary urgency, urinary frequency, and suprapubic pain or tenderness. Approximately 150 million people are diagnosed with UTI each year worldwide. The high recurrence rate of lower UTI is a common problem of clinical treatment. The misuse of antibiotics has led to the emergence of a number of resistant bacterial strains. Thus, traditional Chinese medicine is considered as an alternative option for treating acute uncomplicated lower UTI. Thus, this study aims to evaluate the efficacy and safety of Sanjin tablets (SJT) for the treatment of acute uncomplicated lower UTI, explore whether SJT can reduce or substitute the use of antibiotics, and reduce the recurrence rate in the treatment of acute uncomplicated lower UTI. Methods/design In this study, a randomized, double-blind, double-dummy, parallel control of positive drug, multicenter clinical study will be established. A total of 252 patients with acute uncomplicated lower UTI (syndrome of dampness-heat in the lower jiao) will be randomly allocated in the ratio of 1:1:1 to three groups: experimental group; control group 1; and control group 2. The experimental group receives Sanjin tablets plus levofloxacin tablets (LT) placebo; the control group 1 receives LT plus SJT placebo; and the control group 2 receives SJT plus LT on the first five days, SJT plus LT placebo on the last two days. Each group will be treated for seven days and followed-up 1–2 times. The primary outcome measures of effective rate and recurrence rate are symptoms. Secondary outcome measures of effective rate and recurrence rate are the urine leukocytes, bacteriology examination, and safety assessment. Outcomes will be assessed at baseline and after treatment. Discussion This study protocol will provide the research data of efficacy and safety of SJT for the treatment of acute uncomplicated lower UTI. The first aim is to determine whether Sanjin tablets can reduce the use of antibiotics; the second aim is to determine whether Sanjin tablets can substitute the use of antibiotics. The recurrence rate will be assessed after cured to determine whether SJT can reduce the recurrence rate. The results of this study will improve the rational use of drugs, especially the rational application of antibiotics. It will also enable safety evaluation from laboratory indices and adverse events, which will provide reliable evidence for clinical treatment. Trial registration ClinicalTrials.gov, NCT03658291 . Registered on 4 September 2018.

Objectives Monopolar transurethral resection of the prostate (TURP) is the gold standard surgical treatment for bothersome moderate to severe lower urinary tract symptoms (LUTS) secondary to benign prostate obstruction. The aim of the study is to compare monopolar versus bipolar TURP focusing on operative and functional outcomes, and evaluating complications with a long-term follow-up. Methods From January 2007 to July 2014, a total of 497 patients were randomized and prospectively scheduled to undergo bipolar (251) or monopolar (246) TURP. International prostate symptom score (IPSS), IPSS-Quality of life (QoL), post-void residual and maximum flow rate were assessed preoperatively and postoperatively at 3, 12, 24 and 36 months. Operative time, length of catheterization and hospitalization were all recorded. Complications were classified and reported. Results All patients completed the 36-month follow-up visit. Perioperative results showed no statistical significance between the two groups in terms of catheterization days, post-void residual, IPSS, IPSS-QoL score. The hospitalization length was found statistically significant in favor of the bipolar group. The 3-, 12-, 24- and 36-month follow-up showed significant and equal improvements in LUTS related to BPO in the two treatment groups. Regarding TURP complications, significant differences were observed in relation to urethral strictures, blood transfusion and TUR syndrome in favor of the bipolar group. Conclusions Monopolar and bipolar TURP are safe and effective techniques for BPH management. Bipolar TURP in our prospective study reported the same efficacy of monopolar prostate resection, with a significant reduction of related complications.

Background Current management for men with lower urinary tract symptoms (LUTS) is a pathway that results in prostate surgery in a significant proportion. While helpful in relieving benign prostatic obstruction (BPO), surgery may be ineffective for men suffering from difficulties not relating to BPO. The UPSTREAM trial started recruitment in October 2014 with the aim of establishing whether a care pathway including urodynamics (a diagnostic tool for BPO and thus an indication of whether surgery is needed) is no worse for men, in terms of symptomatic outcome, than one without (routine care). Methods/design This analysis plan outlines the main outcomes of the study and specific design choices, such as non-inferiority margins. The trial is currently recruiting in 26 hospitals across the UK, randomising men to either urodynamics or routine care, with recruitment set to end on the 31 December 2016. All outcomes will be measured 18 months after randomisation to allow sufficient time for surgical procedures and recovery. The primary outcome is based on a non-inferiority design with a margin of 1 point on the International Prostate Symptom Score (IPSS) scale. The key secondary outcome for this trial is surgery rate per arm, which is estimated to be at least 18% lower in the urodynamics arm. Surgery rates, adverse events, flow rate, urinary symptoms and sexual symptoms are secondary outcomes to be assessed for superiority. This is an update to the UPSTREAM protocol, which has already been published in this journal. Discussion This a priori statistical analysis plan aims to reduce reporting bias by allowing access to the trial’s objectives and plans in advance of recruitment end. The results of the trial are expected to be published soon after the trial end date of 30 September 2018. Trial registration ISRCTN registry, ISRCTN56164274 . Registered on 8 April 2014.

Summary Introduction Benign prostatic hyperplasia (BPH) resulting in lower urinary tract symptoms (LUTS) is a widespread disease that strongly interferes with the quality of life (QoL) of elderly males. It represents a real clinical and socio‐economic problem may be due to the lack of a diagnostic, therapeutic and care pathway (DTCP) tool for LUTS/BPH that considers elderly people population in its whole complexity. The aim of this study was to evaluate the clinical effectiveness of the proposed DTCP LUTS/BPH tool. Methods This prospective study was conducted on 278 patients over 75 years old with non‐neurogenic LUTS recruited from February to July 2014 by 10 general practitioners (GP) and two assisted sanitary residences (ASR). Only five GPs and one ASR were provided with the complete DTCP LUTS/BPH tool to create two different groups of patients: group A (138 patients) was treated without the aid of the DTCP; group B (140 patients) was treated according to the DTCP. Results At 1 year of follow‐up, the patients of Group B compared with Group A achieved a greater and significant mean reduction in the questionnaires score (International Prostate Symptom Score, Quick prostate test and QoL) linked to a higher increase in the flowmetry parameters (Qmax) and a lower postvoid residual. Furthermore, in Group B compared to Group A, a greater improvement of hydronephrosis, creatinine values and erectile dysfunction (ED) were obtained at 1 year of follow‐up. Conclusion The encouraging results obtained from this study are significant and support the use of this diagnostic, therapeutic and care tool (DTCP) as the ideal pathway management for elderly men with LUTS associated to BPH and ED. Further studies with greater number of elderly subjects and long‐term follow‐up are needed to confirm DTCP utility in the clinical management of LUTS/BPH and ED.

The sound of running water (SRW) has been effectively used for toilet training during toddlerhood. However, the effect of SRW on voiding functions in adult males with lower urinary tract symptoms (LUTS) has not been evaluated. To determine the effect of SRW on urination in male patients with LUTS, multiple voiding parameters of uroflowmetry with postvoid residual urine (PVR) were assessed according to the presence of SRW played by a mobile application. Eighteen consecutive male patients with LUTS were prospectively enrolled between March and April 2014. Uroflowmetry with PVR measured by a bladder scan was randomly performed once weekly for two consecutive weeks with and without SRW in a completely sealed room after pre-checked bladder volume was scanned to be more than 150 cc. SRW was played with river water sounds amongst relaxed melodies from a smartphone mobile application. The mean age of enrolled patients and their mean International Prostate Symptom Score (IPSS) were 58.9 ± 7.7 years (range: 46-70) and 13.1 ± 5.9, respectively. All patients had not been prescribed any medications, including alpha-blockers or anti-muscarinic agents, in the last 3 months. There was a significant increase in mean peak flow rate (PFR) with SRW in comparison to without SRW (15.7 mL/s vs. 12.3 mL/s, respectively, p = 0.0125). However, there were no differences in other uroflowmetric parameters, including PVR. The study showed that SRW from a mobile phone application may be helpful in facilitating voiding functions by increasing PFR in male LUTS patients.