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Urinary tract infections (UTIs) are among the most prevalent microbial diseases and their financial burden on society is substantial. In the context of increasing antibiotic resistance, finding alternative treatments for UTIs is a top priority. We aimed to determine whether intravesical bacteriophage therapy with a commercial bacteriophage cocktail is effective in treating UTI. We did a randomised, placebo-controlled, clinical trial, at the Alexander Tsulukidze National Centre of Urology, Tbilisi, Georgia. Men older than 18 years of age, who were scheduled for transurethral resection of the prostate (TURP), with complicated UTI or recurrent uncomplicated UTI but no signs of systemic infection, were allocated by block randomisation in a 1:1:1 ratio to receive intravesical Pyo bacteriophage (Pyophage; 20 mL) or intravesical placebo solution (20 mL) in a double-blind manner twice daily for 7 days, or systemically applied antibiotics (according to sensitivities) as an open-label standard-of-care comparator. Urine culture was taken via urinary catheter at the end of treatment (ie, day 7) or at withdrawal from the trial. The primary outcome was microbiological treatment response after 7 days of treatment, measured by urine culture; secondary outcomes included clinical and safety parameters during the treatment period. Analyses were done in a modified intention-to-treat population of patients having received at least one dose of the allocated treatment regimen. This trial is registered with ClinicalTrials.gov, NCT03140085. Between June 2, 2017, and Dec 14, 2018, 474 patients were screened for eligibility and 113 (24%) patients were randomly assigned to treatment (37 to Pyophage, 38 to placebo, and 38 to antibiotic treatment). 97 patients (28 Pyophage, 32 placebo, 37 antibiotics) received at least one dose of their allocated treatment and were included in the primary analysis. Treatment success rates did not differ between groups. Normalisation of urine culture was achieved in five (18%) of 28 patients in the Pyophage group compared with nine (28%) of 32 patients in the placebo group (odds ratio [OR] 1·60 [95% CI 0·45–5·71]; p=0·47) and 13 (35%) of 37 patients in the antibiotic group (2·66 [0·79–8·82]; p=0·11). Adverse events occurred in six (21%) of 28 patients in the Pyophage group compared with 13 (41%) of 32 patients in the placebo group (OR 0·36 [95% CI 0·11–1·17]; p=0·089) and 11 (30%) of 37 patients in the antibiotic group (0·66 [0·21–2·07]; p=0·47). Intravesical bacteriophage therapy was non-inferior to standard-of-care antibiotic treatment, but was not superior to placebo bladder irrigation, in terms of efficacy or safety in treating UTIs in patients undergoing TURP. Moreover, the bacteriophage safety profile seems to be favourable. Although bacteriophages are not yet a recognised or approved treatment option for UTIs, this trial provides new insight to optimise the design of further large-scale clinical studies to define the role of bacteriophages in UTI treatment. Swiss Continence Foundation, the Swiss National Science Foundation, and the Swiss Agency for Development and Cooperation. For the Georgian and German translations of the abstract see Supplementary Materials section.

Purpose To compare effectiveness and safety of transurethral diode laser vaporization of prostate (diode LVP) versus bipolar transurethral vaporization of prostate (B-TUVP) in symptomatic benign prostatic hyperplasia (BPH) patients receiving oral anticoagulants/anti-platelet drugs. Patients and methods All symptomatic prostate patients receiving oral anticoagulants/anti-platelet drugs are prospectively enrolled in the study between January 2023 to May 2024 in our institution. Of total 98 patients were randomized to B-TUVP (48 patients) or diode LVP (50 patients). The primary outcome is to compare B-TUVP with diode LVP regarding operative bleeding and postoperative hemoglobin drop. Secondary outcomes assess time of urinary irrigation, time of urethral catheter removal, length of hospital stays, and 6-month postoperative functional outcomes; IPSS, postoperative flow rate, and postvoid residual urine. Results Baseline characteristics were similar in both groups. Diode LVP group had a significantly higher postoperative hemoglobin with a lower drop compared to B-TUVP group (p = 0.032, p = 0.007; respectively). The diode LVP group had a significantly reduced urinary irrigation duration compared to the B-TUVP group (p = 0.031). Also, diode LVP patients had early catheter removal compared to those in the B-TUVP group (p = 0.014). Additionally, the diode group had a notably reduced hospital stay duration compared to the B-TUVP group (p = 0.024). There were no significant differences between both groups regarding 6-month postoperative IPSS, Q max and PVRU. Conclusion Diode LVP of the prostate is a safer alternative for treating BPH with fewer risks compared to B-TUVP especially in patients receiving anticoagulants. Nonetheless, both treatments yield similar 6-months functional outcomes.

The purpose of this study is to compare the safety and efficacy of 1470 nm diode laser enucleation of the prostate (DiLEP) with modified bipolar transurethral resection of the prostate (B-TURP) in the surgical management of benign prostatic hyperplasia (BPH). 81 patients presenting with symptomatic BPH were randomly assigned to undergo either DiLEP ( n  = 41) or B-TURP ( n  = 40). Baseline properties, perioperative characteristics, complication data, and 12-month follow-up outcomes between both groups were comparatively analyzed. As a result, no significant differences were observed in basic properties between two groups. The 1470 nm DiLEP demonstrated comparable efficacy to B-TURP in improving maximum flow rate (Q max ), International Prostate Symptom Score (IPSS), post-void residual urine (PVR), and quality of life (QoL) score. However, compared to B-TURP, 1470 nm DiLEP exhibited superior retrieval efficiency (0.7 g/min vs. 0.5 g/min, P  = 0.001), reduced blood loss (9.4 g/L vs. 13.7 g/L, P  = 0.011), shorter operative duration (69.8 min vs. 96.2 min, P  = 0.015), as well as decreased postoperative irrigation (17.8 h vs. 32.5 h, P  = 0.003) and catheterization time (3.9 days vs. 6.0 days, P  < 0.001). Surgical complications were somewhat less common in the DiLEP group than in the B-TURP group. Overall, one-year follow-up outcomes demonstrated that 1470 nm DiLEP exhibited comparable safety and efficacy in alleviating lower urinary tract symptoms (LUTS) and benign prostatic obstruction (BPO) to B-TURP. However, it showed superior surgical efficiency and enhanced hemostatic control in the resection of medium to large prostates compared to B-TURP.

Purpose To evaluate the safety and efficacy of transurethral holmium laser enucleation of the prostate (HoLEP) compared to bipolar transurethral resection of the prostate (bTUR-P) in the treatment of benign prostatic hyperplasia (BPH). Methods A total of 220 BPH patients hospitalized from January 2022 to September 2023 were included in this study. These patients were randomly assigned to HoLEP and bTUR-P groups, with 110 participants in each group. We collected preoperative general information, perioperative data, complications, and postoperative follow-up indicators from both groups of patients. Results The baseline characteristics of patients in both groups were similar, with no statistical significance ( P  > 0.05). Compared to the bTUR-P group, the HoLEP group exhibited significantly less intraoperative bleeding ( P  < 0.001), shorter bladder irrigation time ( P  = 0.002), shorter catheter retention time ( P  < 0.001), and reduced postoperative hospitalization ( P  = 0.002). Additionally, the pain score during urination after catheter removal was significantly lower in the HoLEP group ( P  < 0.001). Postoperative complications occurred in both groups; however, they were less frequent in the HoLEP group (4 cases), primarily consisting of urinary retention and postoperative bleeding. The bTUR-P group experienced more complications (9 cases). Significant reductions in postoperative residual urine volume (RUV) were observed in both groups ( P  < 0.001). Both groups also showed significant improvements in Quality of Life (QoL) scores and International Prostate Symptom Scores (IPSS), with the HoLEP group demonstrating a more significant decrease in IPSS ( P  < 0.001). Conclusion After comprehensive evaluation, HoLEP was superior to bTUR-P in terms of safety and efficacy. Therefore, HoLEP may be a preferable choice for the treatment of BPH.

Background Urinary tract infections (UTI) are among the most prevalent microbial diseases and their financial burden on society is substantial. The continuing increase of antibiotic resistance worldwide is alarming. Thus, well-tolerated, highly effective therapeutic alternatives are urgently needed. Although there is evidence indicating that bacteriophage therapy may be effective and safe for treating UTIs, the number of investigated patients is low and there is a lack of randomized controlled trials. Methods and design This study is the first randomized, placebo-controlled, double-blind trial investigating bacteriophages in UTI treatment. Patients planned for transurethral resection of the prostate are screened for UTIs and enrolled if in urine culture eligible microorganisms ≥10 4 colony forming units/mL are found. Patients are randomized in a double-blind fashion to the 3 study treatment arms in a 1:1:1 ratio to receive either: a) bacteriophage (i.e. commercially available Pyo bacteriophage) solution, b) placebo solution, or c) antibiotic treatment according to the antibiotic sensitivity pattern. All treatments are intended for 7 days. No antibiotic prophylaxes will be given to the double-blinded treatment arms a) and b). As common practice, the Pyo bacteriophage cocktail is subjected to periodic adaptation cycles during the study. Urinalysis, urine culture, bladder and pain diary, and IPSS questionnaire will be completed prior to and at the end of treatment (i.e. after 7 days) or at withdrawal/drop out from the study. Patients with persistent UTIs will undergo antibiotic treatment according to antibiotic sensitivity pattern. Discussion Based on the high lytic activity and the potential of resistance optimization by direct adaptation of bacteriophages, and considering the continuing increase of antibiotic resistance worldwide, bacteriophage therapy is a very promising treatment option for UTIs. Thus, our randomized controlled trial investigating bacteriophages for treating UTIs will provide essential insights into this potentially revolutionizing treatment option. Trial registration This study has been registered at clinicaltrials.gov ( www.clinicaltrials.gov/ct2/show/NCT03140085 ). April 27, 2017.

Urinary incontinence is common immediately after prostate surgery. Men are often advised to do pelvic-floor exercises, but evidence to support this is inconclusive. Our aim was to establish if formal one-to-one pelvic floor muscle training reduces incontinence. We undertook two randomised trials in men in the UK who were incontinent 6 weeks after radical prostatectomy (trial 1) or transurethral resection of the prostate (TURP; trial 2) to compare four sessions with a therapist over 3 months with standard care and lifestyle advice only. Randomisation was by remote computer allocation. Our primary endpoints, collected via postal questionnaires, were participants' reports of urinary incontinence and incremental cost per quality-adjusted life year (QALY) after 12 months. Group assignment was masked from outcome assessors, but this masking was not possible for participants or caregivers. We used intention-to-treat analyses to compare the primary outcome at 12 months. This study is registered, number ISRCTN87696430. In the intervention group in trial 1, the rate of urinary incontinence at 12 months (148 [76%] of 196) was not significantly different from the control group (151 [77%] of 195; absolute risk difference [RD] −1·9%, 95% CI −10 to 6). In trial 2, the difference in the rate of urinary incontinence at 12 months (126 [65%] of 194) from the control group was not significant (125 [62%] of 203; RD 3·4%, 95% CI −6 to 13). Adjusting for minimisation factors or doing treatment-received analyses did not change these results in either trial. No adverse effects were reported. In both trials, the intervention resulted in higher mean costs per patient (£180 and £209 respectively) but we did not identify evidence of an economically important difference in QALYs (0·002 [95% CI −0·027 to 0·023] and −0·00003 [−0·026 to 0·026]). In settings where information about pelvic-floor exercise is widely available, one-to-one conservative physical therapy for men who are incontinent after prostate surgery is unlikely to be effective or cost effective. The high rates of persisting incontinence after 12 months suggest a substantial unrecognised and unmet need for management in these men. National Institute of Health Research, Health Technology Assessment (NIHR HTA) Programme.

IntroductionTransurethral resection of the prostate (TURP) is the gold standard surgical treatment to lower urinary tract symptoms and benign prostatic obstruction (LUTS/BPO). Although it has been proven to have substantial efficacy in improving functional outcomes, it has shown a high incidence of complications, including transurethral resection syndrome, massive bleeding, urinary incontinence and sexual dysfunction. High-frequency irreversible electroporation (H-FIRE) is a novel non-thermal ablation technique that delivers pulsed high-voltage but low-energy electric current to the cell membrane, thereby leading to cell death. H-FIRE has been reported to be tissue-selective, which leads to fewer side effects. However, no data are available on whether H-FIRE is non-inferior compared with TURP in treating patients with LUTS/BPO regarding safety and efficacy.Methods and analysisThis trial is a prospective, single-centre, randomised controlled, double-blinded and non-inferiority study in which all men with LUTS/BPO are included. This study aims to determine whether the HI-FIRE is non-inferior to TURP for achieving better functional outcomes as measured by the co-primary outcome of the change from baseline in maximal flow rate (Qmax) and the urinary symptoms by questionnaire of International Prostate Symptom Score (IPSS) scoring at 3 months after surgical treatment. The main inclusion criteria are men with prostatic volume range 30 to 100 mL, Qmax<15 mL/s and IPSS>8. A sample size of 118 participants is required, accounting for a 20% loss. All participants will be randomly allocated at a ratio of 1:1 to the H-FIRE arm (n=59) and the TURP arm (n=59). The primary outcome is to assess the change from baseline in Qmax and IPSS scoring at 3 months after surgical treatment.Ethics and disseminationEthical approval was obtained from the ethics committee of Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China. The results of the study will be disseminated and published in international peer-reviewed journals.Trial registration numberClinicalTrials.gov: NCT05306145.

Purpose In the present study, the impact of penile nerve block (PNB) on postoperative pain and Catheter‐Related Bladder Discomfort (CRBD) in the transurethral resection of prostate(TURP) patients were evaluated. Methods Participants of the present study were selected from patients who performed TURP under spinal anaesthesia for benign prostatic hyperplasia (BPH) between January 2018 and July 2020. The present study was planned as a single‐centre, randomised‐controlled prospective study in which the patients were divided into two groups. Group 1 was administered Control (n:40), and Group 2 ultrasonography(USG) guided PNB (n:40). The patients were included in the Groups, respectively. Visual analogue scale (VAS) scores were questioned and recorded in order to evaluate the postoperative pain complaints of the patients after the operation. In addition, in order to evaluate the CRBD, VAS scores were questioned and recorded as 0th, 0‐1th hour, 1st‐2nd hour, 2nd‐4th hour, 4th‐8th hour, 8th‐12th hour, and 12th‐24th hour. In addition, postoperative pain and need for analgesic drug were recorded. Tramadol was given to patients with moderate to severe CRBD. The findings were compared between the Groups. Results There was no statistical difference demographic and per‐operative data between Group 1 and Group 2. The CRBD and pain‐related VAS scores were significantly higher in Group 1 between the 0 and 8th hours. There was no difference between VAS scores in the postoperative 8‐24th hours. In total 24 hours, Group 2's need for tramadol was significantly less than Group 1. On examining the factors affecting CRBD in the multivariate analysis, age, body mass index(BMI), prostate volume, operation time do not affect CRBD statistically, and only PNB reduces CRBD (P: .029). While less drug‐related complications were observed in Group 2, no serious complications related to PNB were observed. Conclusion Penile nerve block is an effective method for the decrease pain and CRBD after urological surgery. It will also reduce the need for analgesics, and provide painless patients in the postoperative period.

Background Low-intensity shockwave therapy (Li-SWT) can improve bladder function through enhancement of angiogenesis and nerve regeneration and suppression of inflammation and overactivity. In this trial, we aimed to evaluate the efficacy of Li-SWT on persistent storage symptoms after transurethral surgery (TUS) for benign prostatic obstruction (BPO). Methods Between July 2020 and July 2022, 137 patients with persistent storage symptoms; urgency episodes/24 h ≥ 1 and daytime frequency ≥8, for at least three months after TUS for BPO were randomly allocated to Li-SWT versus sham versus solifenacin 10 mg/day in 3:1:1 ratio. The primary end point was the percent reduction from baseline in overactive bladder symptom score (OABSS) at 3-month follow-up. The changes in 3-day voiding diary parameters, quality of life (QoL) score, peak flow rate and residual urine at 3 and 6-month follow-up were compared. Treatment-related adverse effects were also evaluated. Results Baseline data were comparable between groups. The percent reduction from baseline in OABSS at 3-month follow-up was significantly higher in Li-SWT compared to sham (−55% versus −11%), and it was comparable between Li-SWT and solifenacin-10 (−55% versus −60%). Li-SWT achieved significant improvement like solifenacin-10 in 3-day voiding diary parameters and QoL score at 3-month follow-up. This improvement remained comparable between Li-SWT and solifenacin-10 at 6-month follow-up. No adverse effects related to Li-SWT were noted apart from tolerable pain during the procedure. Solifenacin-10 was associated with bothersome adverse effects in 73% of the patients with 11.5% discontinuation rate. Conclusions Li-SWT ameliorates persistent storage symptoms and promotes QoL after TUS for BPO, with comparable efficacy and better tolerance compared to solifenacin.

Transurethral resection of the prostate (TURP) is the gold standard surgical treatment for benign prostatic hyperplasia (BPH). Despite its widespread use, monopolar TURP carries a risk of significant complications, particularly transurethral resection (TUR) syndrome leading to hyponatremia and fluid overload. The study evaluates whether prophylactic furosemide prevents hyponatremia and TUR syndrome in monopolar TURP. This study was a triple-blind randomized clinical trial conducted in Al-Zahra and Khorshid educational hospitals of Isfahan, Iran, in 2022-2023. Patients undergoing monopolar TURP, were divided into two groups: those receiving preoperative furosemide and a control group. The primary outcomes were changes in serum sodium levels and the incidence of hyponatremia. Secondary outcomes included fluid balance, complication rates, and recovery times. Continuous data were analyzed using test/Mann-Whitney U, categorical data with Fisher's exact test, and time-based changes with repeated measures ANOVA. Normality was checked via Kolmogorov-Smirnov, and power analysis determined sample size. The furosemide group demonstrated a significantly lower incidence of hyponatremia than the control group (P=0.008). Additionally, serum sodium levels were significantly higher in the furosemide group after surgery (P=0.011), while potassium levels were lower (P=0.003). Mild hypokalemia was observed as a manageable side effect, primarily in patients with baseline potassium levels below 4.1 mmol/L. Preoperative administration of furosemide effectively reduces the risk of TUR syndrome during monopolar TURP. Furosemide effectively reduces hyponatremia but may increase hypokalemia in some cases, limiting its clinical utility during monopolar TURP. Patient-specific assessment and further research are needed to ensure its safe and effective use. IRCT20211208053328N2.