Project description:IntroductionThere remains uncertainty regarding the differences in patient outcomes between monopolar transurethral resection of the prostate (MTURP) and bipolar TURP (BTURP) in the management of lower urinary tract symptoms (LUTS) secondary to benign prostatic obstruction (BPO).MethodsA systematic literature search was carried out up to March 19, 2019. Methods in the Cochrane Handbook were followed. Certainty of evidence (CoE) was assessed using the GRADE approach.ResultsA total of 59 randomized controlled trials (RCTs) with 8924 participants were included. BTURP probably results in little to no difference in International Prostate Symptom Score (IPSS) at 12 months (mean difference -0.24, 95% confidence internal [CI] -0.39--0.09; participants=2531; RCTs=16; moderate CoE) or health-related quality of life (HRQOL) at 12 months (mean difference -0.12, 95% CI -0.25-0.02; participants=2004, RCTs=11; moderate CoE), compared to MTURP. BTURP probably reduces TUR syndrome (relative risk [RR] 0.17, 95% CI 0.09-0.30; participants= 6,745, RCTs=44; moderate CoE) and blood transfusions (RR 0.42, 95% CI 0.30-0.59; participants=5727, RCTs=38; moderate CoE), compared to MTURP. BTURP may carry similar risk of urinary incontinence at 12 months (RR 0.20, 95% CI 0.01-4.06; participants=751; RCTs=4; low CoE), re-TURP (RR 1.02, 95% CI 0.44-2.40; participants=652, RCTs=6, I2=0%; low CoE) and erectile dysfunction (International Index of Erectile Function [IIEF-5]) at 12 months (mean difference 0.88, 95% CI -0.56-2.32; RCTs=3; moderate CoE), compared to MTURP.ConclusionsBTURP and MTURP probably improve urological symptoms to a similar degree. BTURP probably reduces TUR syndrome and blood transfusion slightly postoperatively. The moderate certainty of evidence available for primary outcomes suggests no need for further RCTs comparing BTURP and MTURP.
Project description:The International Prostate Symptom Score (IPSS), the quality of life (QoL) score, and the benign prostatic hyperplasia impact index (BII) are three different scales commonly used to assess the severity of lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH-LUTS). Based on a phase II clinical trial including 403 patients with moderate to severe BPH-LUTS, the objectives of this study were to (i) develop traditional pharmacometric and bounded integer (BI) models for the IPSS, QoL score, and BII endpoints, respectively; (ii) compare the power and type I error in detecting drug effects of BI modeling with traditional methods through simulation; and (iii) obtain quantitative translation between scores on the three abovementioned scales using a BI modeling framework. All developed models described the data adequately. Pharmacometric modeling using a continuous variable (CV) approach was overall found to be the most robust in terms of type I error and power to detect a drug effect. In most cases, BI modeling showed similar performance to the CV approach, yet severely inflated type I error was generally observed when inter-individual variability (IIV) was incorporated in the BI variance function (g()). BI modeling without IIV in g() showed greater type I error control compared to the ordered categorical approach. Lastly, a multiple-scale BI model was developed and estimated the relationship between scores on the three BPH-LUTS scales with overall low uncertainty. The current study yields greater understanding of the operating characteristics of the novel BI modeling approach and highlights areas potentially requiring further improvement.
Project description:BackgroundTo preliminary investigate the effects of silodosin 8 mg once daily on obstruction urodynamic parameters and subjective symptoms in Caucasian patients with lower urinary tract symptoms suggestive of benign prostatic enlargement.MethodsWe performed a single-center, open-label, single-arm, post-marketing interventional clinical trial. Inclusion criteria were: Caucasian subjects aged ≥50 years waiting to undergo surgery for lower urinary tract symptoms suggestive of benign prostatic enlargement, international prostate symptom total score ≥ 13, international prostate symptom-quality of life score ≥ 3, prostate volume ≥ 30 ml, maximum urine flow rate ≤ 15 mL/s, bladder outlet obstruction index > 40. Eligible subjects received one capsule of silodosin 8 mg once daily for 8 weeks. Invasive urodynamic evaluations were performed at baseline and at 8-weeks follow-up. International prostate symptom questionnaire was administered at baseline, after 4-weeks and 8-weeks of treatment.ResultsOverall, 34 subjects were included. Mean bladder outlet obstruction index significantly decreased from 70.6 to 39.2 and bladder outlet obstruction index class improved in 16 patients (53.3%). Statistically significant improvements of mean total international prostate symptom score, mean storage sub-score, mean voiding sub-score and mean quality of life sub-score were evident after 4-weeks of treatment with further improvements after 8-weeks. At the end of the treatment, all patients declared that their condition improved enough to spare or delay surgery.ConclusionsSilodosin 8 mg once daily significantly improves benign prostatic obstruction in Caucasian patients with lower urinary tract symptoms suggestive of benign prostatic enlargement waiting for surgery.Trial registrationEudraCT n. 2015-002277-38 Date of registration: 15th December 2017.
Project description:ContextRecently, prostatic urethral lift (PUL) is being used to treat lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). Although preliminary clinical studies on PUL are increasing, the long-term efficacy and safety of this procedure are still not well evaluated.ObjectiveThe objective of our study is to synthesize the existing literature evidence, and make a comprehensive and long-term systematic review for the PUL procedure.Evidence acquisitionA systematic search was performed from the electronic databases including PubMed, Embase, and OVID. The search period was up to January 1, 2020. Comprehensive retrospective and prospective studies on PUL were collected in accordance with specific inclusion and exclusion criteria. Pooled prostatic symptom scores, sexual health scores, and functional outcomes were calculated by using a fixed or random-effect model.Evidence synthesisNineteen articles meet our determined inclusion and exclusion criteria, and 11 independent patient series were included in the final analysis. Meta-analysis results indicated improvement after the PUL procedure, including International Prostate Symptom Score improvement of 9.73-12.16 points, BPH Impact Index improvement of 3.74-4.50 points, maximum flow rate improvement of 3.44-4.26 ml/s, and quality of life improvement of 2.20-2.55 points. Postvoid residual volume at most of the intervals was not significantly variable. Data regarding sexual function remained stable or improved slightly during the 24-mo follow-up period. Pooled estimates were largely heterogeneous except for sexual function.ConclusionsPUL can continue to relieve prostatic symptoms for 24 mo without causing serious complications. The extremely important advantage of the PUL procedure is that it can preserve or slightly improve sexual function. Longer-term and more comprehensive clinical trials are still needed to further clarify the functional outcomes and cost effectiveness of PUL.Patient summaryProstatic urethral lift is an attractive option for selected patients who seek rapid and durable relief of lower urinary tract symptoms with complete preservation of sexual function.
Project description:BackgroundWater vapor thermal therapy (WVTT) is a minimally invasive procedure for treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH). There are no known systematic reviews reporting the effectiveness and safety of this increasingly common BPH therapy.MethodsWe performed a systematic review and meta-analysis of studies utilizing WVTT for symptomatic BPH. The international prostate symptom score (IPSS), IPSS-quality of life (IPSS-QOL), BPH impact index (BPHII), and maximum flow rate (Qmax) were calculated as the weighted mean difference relative to baseline and reported in minimal clinically important difference (MCID) units. MCID thresholds were -3 for IPSS, -0.5 for IPSS-QOL, -0.5 for BPHII, and 2 mL/s for Qmax. The surgical retreatment rate was calculated using life-table methods.ResultsWe identified 5 cohorts treated with WVTT from 4 studies (514 patients; 40% with median lobe obstruction) with 2 years median follow-up (range: 6 months to 4 years). The IPSS, IPSS-QOL, BPHII, and Qmax significantly improved at all intervals between 3 months and 4 years; this benefit ranged from 3.3 to 3.8 MCID units for IPSS, 3.9 to 4.6 MCID units for IPSS-QOL, 6.8 to 8.2 MCID units for BPHII, and 1.5 to 3.0 MCID units for Qmax. The surgical retreatment rate was 7.0% at 4 years of follow-up data. Most adverse events were nonserious and transient; dysuria, urinary retention, and urinary tract infection were most common. No cases of de novo erectile dysfunction occurred.ConclusionsWVTT provided improvement in BPH symptoms that exceeded established MCID thresholds, preserved sexual function, and was associated with low surgical retreatment rates over 4 years.
Project description:The first clinical guidelines for male lower urinary tract symptoms (LUTS)/benign prostatic hyperplasia (BPH) were published in 2005. An update is urgently needed in view of BPH being recognised as one of ten chronic illnesses by the Ministry of Health, Singapore. This review summarises the definition of BPH and the epidemiology of male LUTS/BPH in Singapore. BPH can be phenotyped with noninvasive transabdominal ultrasonography, according to intravesical prostatic protrusion and prostate volume, and classified according to severity (staging) for individualised treatment. At the initial evaluation, the majority of patients (59%) can be managed with fluid adjustment, exercise and diet; 32% with medications, using alpha blockers and/or 5-alpha reductase inhibitors for prostates weighing more than 30 g; and 9% with surgical intervention for more advanced disease. The 2015 guidelines comprise updated evidence that will help family medicine practitioners and specialists manage this common ailment more cost-effectively.