Prostatism

  • 文章类型: Clinical Trial
    有证据表明,前列腺尿道抬高(PUL)在低发病率的症状性BPH中显着改善,仅基于侧叶(LL)增大的受试者。MedLift是L.I.F.T.的FDAIDE扩展。随机研究旨在检查PUL治疗梗阻性中叶(OML)的安全性和有效性。此非随机队列的纳入标准与L.I.F.T.随机研究,除了要求OML:≥50岁,IPSS≥13,Qmax≤12ml/s。主要终点分析量化IPSS相对于基线的改善和术后严重并发症的发生率。量化症状缓解,生活质量,流量,性功能持续12个月。将结果与历史L.I.F.TLL结果进行比较,并结合起来证明了PUL的全部有效性。在71名筛选的受试者中,45人报名参加。在1、3、6和12个月时,平均IPSS比基线改善至少13.5个百分点(p<0.0001)。生活质量和BPHII也得到了类似的改善(>60%和>70%,分别在3、6和12个月时,p<0.0001)。平均Qmax改善范围为90%至129%(p<0.0001)。在1个月,86%(CI73-94%)在回收质量量表上报告≥70,80%(CI66-89%)报告“好多了”或“好多了”,89%(CI76-95%)会推荐该程序。与LL科目相比,OML受试者的症状在每个时间点改善至少一样多(OML范围13.5-15.9,LL范围9.9-11.1,p≤0.01)。在结合OML和LL数据时,>70%(范围CI63-81%)的受试者在12个月内表现出IPSS改善≥8点。对组合数据集的分析表明,≥40%(CI30-51%)的性活跃男性在12个月内改善了勃起功能的最小临床重要差异。前列腺,包括患有中叶梗阻的人,可以安全有效地使用PUL程序进行治疗。
    Evidence indicating Prostatic Urethral Lift (PUL) delivers significant improvement in symptomatic BPH with low morbidity is based on subjects with lateral lobe (LL) enlargement only. MedLift was an FDA IDE extension of the L.I.F.T. randomized study designed to examine safety and efficacy of PUL for treatment of obstructive middle lobes (OML). Inclusion criteria for this non-randomized cohort were identical to the L.I.F.T. randomized study, except for requiring an OML: ≥ 50 years of age, IPSS ≥ 13, and Qmax ≤ 12 ml/s. Primary endpoint analysis quantified improvement in IPSS over baseline and rate of post-procedure serious complications. Quantification of symptom relief, quality of life, flow rate, and sexual function occurred through 12 months. Outcomes were compared to historical L.I.F.T LL results and were combined to demonstrate the full effectiveness of PUL. Of the 71 screened subjects, 45 were enrolled. At 1, 3, 6, and 12 months, mean IPSS improved from baseline at least 13.5 points (p < 0.0001). Quality of life and BPHII were similarly improved (>60% and >70%, respectively at 3, 6, and 12 months, p < 0.0001). Mean Qmax improvement ranged from 90 to 129% (p < 0.0001). At 1 month, 86% (CI 73-94%) reported ≥70 on the Quality of Recovery scale, 80% (CI 66-89%) reported being \"much\" or \"very much better,\" and 89% (CI 76-95%) would recommend the procedure. Compared to LL subjects, OML subjects\' symptoms improved at least as much at every time point (OML range 13.5-15.9, LL range 9.9-11.1, p ≤ 0.01). On combining OML with LL data, >70% (range CI 63-81%) of subjects demonstrated ≥ 8 point improvement in IPSS through 12 months. Analysis of the combined dataset indicates ≥ 40% (CI 30-51%) of sexually active men improved the minimal clinically important difference in erectile function through 12 months. Prostates, including those with middle lobe obstruction, can be treated with the PUL procedure safely and effectively.
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  • 文章类型: Comparative Study
    目的:本研究的目的是研究他达拉非添加α1-肾上腺素受体拮抗剂治疗的疗效和安全性。
    方法:对α1-肾上腺素受体拮抗剂治疗良性前列腺增生有持续性储存症状的患者纳入研究。患者被随机分配到5mg他达拉非或5mg索利那新治疗组,治疗12周。国际前列腺症状评分,膀胱过度活动症症状评分,尿流率,残余尿量,在治疗前以及治疗4周和12周后,前瞻性地测量血压。组间比较基线的变化。评估由于不良反应而停止治疗的比率。
    结果:在招募的75名患者中,38和37被分配到他达拉非和索利那新组,分别。两组之间的基线特征没有显着差异。与他达拉非治疗组相比,索利得草素治疗组的残余尿量变化明显更大;其他参数,包括下尿路症状和尿流测量,两组间无显著差异。他达拉非和索利那新组的7例(18%)和12例(32%)患者,分别,因不良事件中断治疗。他达拉非组停药的主要原因为胃部不适或恶心、头晕或眩晕;索利那新组停药的主要原因为排尿困难和便秘。两组之间的血压波动与基线相比没有显着差异。
    结论:他达拉非附加疗法在疗效和安全性方面均不逊于索利那新附加疗法。因此,他达拉非可能是一种替代的附加药物,用于患有对α1-肾上腺素受体拮抗剂无效的持续下尿路症状的患者。
    OBJECTIVE: The aim of this study was to investigate the efficacy and safety of tadalafil add-on therapy with α1 -adrenoceptor antagonists.
    METHODS: Patients with persistent storage symptoms refractory to α1 -adrenoceptor antagonists for benign prostatic hyperplasia were enrolled in the study. Patients were randomly assigned to either a 5 mg tadalafil or 5 mg solifenacin treatment group for 12 weeks. International Prostate Symptom Score, Overactive Bladder Symptom Score, urinary flow rates, residual urine volume, and blood pressure were measured prospectively before treatment and after 4 and 12 weeks of treatment. Changes from baseline were compared between groups. The rate of treatment discontinuation due to adverse effects was evaluated.
    RESULTS: Of the 75 patients recruited to the study, 38 and 37 were assigned to the tadalafil and solifenacin groups, respectively. There were no significant difference in baseline characteristics between the two groups. The change in the amount of residual urine volume was significantly larger in the solifenacin- than tadalafil-treated group; other parameters, including lower urinary tract symptoms and uroflowmetry measures, did not differ significantly between the two groups. Seven (18%) and 12 (32%) patients in the tadalafil and solifenacin groups, respectively, discontinued treatment because of adverse events. The main reasons for discontinuation in the tadalafil group were stomach discomfort or nausea and dizziness or vertigo; voiding difficulty and constipation were the main reasons for discontinuation in the solifenacin group. There was no significant difference in blood pressure fluctuations from baseline between the two groups.
    CONCLUSIONS: Tadalafil add-on therapy was not inferior to solifenacin add-on therapy in terms of effect and safety. Therefore, tadalafil could be an alternative add-on drug for patients with persistent lower urinary tract symptoms refractory to α1 -adrenoceptor antagonists.
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  • 文章类型: Journal Article
    OBJECTIVE: To compare the perioperative outcomes of thulium vapoenucleation of the prostate (ThuVEP) with holmium laser enucleation of the prostate (HoLEP) for patients with symptomatic benign prostatic obstruction (BPO).
    METHODS: Forty-eight and 46 patients were prospectively randomized to ThuVEP and HoLEP. All patients were assessed preoperatively and 4-week postoperatively. The complications were noted and classified according to the modified Clavien classification system. Patient data were expressed as median (interquartile range) or numbers (%).
    RESULTS: Median age at surgery was 73 (67-76) years and median prostate volume was 80 (46.75-100) cc and not different between the groups (p = 0.207). The median operative time was 60 (41-79) minutes without significant differences between both groups (p = 0.275). There were no significant differences between the groups regarding catheterization time [2 (2-2) days, p = 0.966] and postoperative stay [2 (2-3) days, p = 0.80]). Clavien 1 (13.8%), Clavien 2 (3.2%), Clavien 3a (2.1%), and Clavien 3b (4.3%) complications occurred without significant differences between the groups. However, the occurrence of acute postoperative urinary retention was higher after HoLEP compared to ThuVEP (15.2 vs. 2.1%, p ≤ 0.022). At 1-month follow-up, peak urinary flow rates (10.7 vs. 22 ml/s), post-void residual volumes (100 vs. 20 ml), International Prostate Symptom Score (20 vs. 10) and Quality of Life (4 vs. 3) had improved significantly (p ≤ 0.005) without significant differences between the groups.
    CONCLUSIONS: ThuVEP and HoLEP are safe and effective procedures for the treatment of symptomatic BPO. Both procedures give equivalent and satisfactory immediate micturition improvement with low perioperative morbidity.
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  • DOI:
    文章类型: Journal Article
    BACKGROUND: To report the five year results of a prospective, multi-center, randomized, blinded sham control trial of the Prostatic Urethral Lift (PUL) in men with bothersome lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).
    METHODS: At 19 centers in North America and Australia, 206 subjects ≥ 50 years old with International Prostate Symptom Score (IPSS ) > 12, peak flow rate (Qmax) ≤ 12 mL/s, and prostate volume 30 cc-80 cc were randomized 2:1 to the PUL procedure or blinded sham control. In PUL permanent UroLift implants are placed to hold open the lateral lobes of the prostate to reduce urinary obstruction. After randomized comparison at 3 months and the only opportunity to add more PUL implants, PUL patients were followed to 5 years. LUTS severity (IPSS), quality of life (QOL), BPH Impact Index (BPHII), Qmax, sexual function, and adverse events were assessed throughout follow up.
    RESULTS: IPSS improvement after PUL was 88% greater than that of sham at 3 months. LUTS and QOL were significantly improved by 2 weeks with return to preoperative physical activity within 8.6 days. Improvement in IPSS, QOL, BPHII, and Qmax were durable through 5 years with improvements of 36%, 50%, 52%, and 44% respectively. No difference was seen between Intent to Treat and Per Protocol populations. Surgical retreatment was 13.6% over 5 years. Adverse events were mild to moderate and transient. Sexual function was stable over 5 years with no de novo, sustained erectile or ejaculatory dysfunction.
    CONCLUSIONS: PUL offers rapid improvement in symptoms, QOL and flow rate that is durable to 5 years. These improvements were achieved with minimal use of a postoperative urinary catheter, rapid return to normal, and preservation of both erectile and ejaculatory function. Symptom improvement was commensurate with patient satisfaction. PUL offers a minimally invasive option in the treatment of LUTS due to BPH.
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  • 文章类型: Journal Article
    Depression and lower urinary tract symptoms (LUTSs) have been found to co-occur among aging men. The present study attempted to clarify the nature of this relationship, considering adverse life events as potential moderators and the inflammation as an underlying biological mechanism.
    The relationship between depression and LUTS was evaluated using data from the European Male Ageing Study, the largest multicenter population-based study of aging in European men. The sample included 3369 men who were assessed by means of several self-reported questionnaires, including the Beck Depression Inventory-II, the International Prostate Symptom Score, and the Adverse Life Events Scale. Participants were asked to provide information regarding general health and life-style, and medical comorbidities. Biological measures including prostate-specific antigen, testosterone, and C-reactive protein were measured.
    LUTS and depressive symptoms were correlated (R = 0.32, β = .10, p < .001), even after adjusting for life-style, psychological, and medical variables. A history of adverse life events was associated with both higher LUTS and Beck Depression Inventory scores. Furthermore, adverse life events moderated the LUTS-depression association (F = 22.62, b = 0.061, p < .001), which increased as a function of the number of life events. C-reactive protein was found to mediate the LUTS-depression association. This mediation effect was moderated by number of adverse life events.
    Participants with a history of adverse life events represent a vulnerable population in whom the association between somatic and depressive symptoms is stronger. One of the biological mechanisms underlying this association could be an activation of the central inflammatory signaling pathways.
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  • 文章类型: Journal Article
    OBJECTIVE: To evaluate change in quality of life (QoL) and symptoms in patients with lower urinary tract symptoms/benign prostatic hyperplasia (LUTS/BPH) in conditions of current clinical practice.
    METHODS: Prospective, longitudinal, multicenter open-label study was carried out in urology outpatient clinics. Patients were ≥40 years of age with an International Prostate Symptom Score (IPSS) score ≥ 8. QoL and symptoms were measured at baseline and 6 months using the Benign Prostatic Hyperplasia Impact Index (BII) and the IPSS.
    RESULTS: 1713 patients were included for analysis. Mean (SD) IPSS and BII scores at baseline were 16.8 (5.4) and 6.8 (2.6), respectively. 8.9 % (n = 153) of study participants did not receive treatment (watchful waiting, WW), 70.3 % (n = 1204) were prescribed monotherapy (alpha-adrenergic blockers [AB]; phytotherapy [PT, of which 95.2 % was the hexanic extract of Serenoa repens, HESr]; or 5-alpha-reductase inhibitors [5ARI]), and 20.8 % (n = 356) received combined treatment (AB + 5ARI; AB + HESr; others). At 6 months, improvements in QoL were similar across the different medical treatment (MT) groups, both for monotherapy (AB: mean improvement [SD] of 2.4 points [2.4]; PT: 1.9 [2.4]; 5ARI: 2.5 [2.3]) and combined therapy (AB + 5ARI: 3.1 [2.9]; AB + PT: 3.1 [2.5]). There were no clinically significant differences between MT groups and all showed significant improvement over WW (p < 0.05). HESr showed similar efficacy to AB and 5ARI both as monotherapy and in combination with AB. Results on the IPSS were similar.
    CONCLUSIONS: Improvements in QoL and symptoms were equivalent across the medical treatments most widely used in real-life practice to manage patients with moderate or severe LUTS. HESr showed an equivalent efficacy to AB and 5ARI with fewer side effects.
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  • DOI:
    文章类型: Comparative Study
    OBJECTIVE: Transurethral resection of the prostate (TURP) is considered gold standard for surgical treatment of benign prostatic hyperplasia (BPH). In this study, we aimed to compare post-operative clinical outcomes and adverse effects between monopolar and bipolar TURPs.
    METHODS: The study included 590 patients who underwent TURP by a single urologist (E.H.) between June 2006 and June 2014 with a diagnosis of BPH. Patients were divided into two groups as monopolar TURP (group 1, n = 300) and bipolar TURP (group 2, n = 290). Patients receiving oral anticoagulants or aspirin and those with prostate cancer diagnosis were not included in the study. Data regarding pre-operative age, International Prostate Symptom Score (IPSS), maximum urinary flow rate (Qmax), post voiding residual urine volume (PVR), serum prostate specific antigen (PSA) levels and prostate volume (Vp) of the patients were gathered from medical records. Groups were compared in terms of catheterization, operation time, hemoglobin (Hb) decrease, and IPSS, Qmax, and PVR values at post-operative 12th month follow-up visit.
    RESULTS: From pre-operative to post-operative period, IPSS, Qmax and PVR showed significant improvements within both groups (P < .001). When groups were compared with each other, bipolar TURP group had significantly lesser catheterization time and hemoglobin decrease than monopolar TURP group, while no significant differences were detected regarding all other variables.
    CONCLUSIONS: Bipolar and monopolar TURPs are both effective and safe treatment modality for BPH. Bipolar TURP is superior to conventional monopolar TURP in terms of catheterization time and Hb decrease.
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  • 文章类型: Journal Article
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  • DOI:
    文章类型: Comparative Study
    OBJECTIVE: We compared the effectiveness and complications of 980-nm diode laser vaporization and transurethral resection of the prostate (TURP) in patients with benign prostatic hyperplasia (BPH).
    METHODS: In total, 72 consecutive patients with BPH entered the study. All patients underwent general and urological evaluations. The primary outcome was improvement in the International Prostate Symptom Score (IPSS). The secondary outcomes were IPSS quality of life (QoL), maximum urinary flow rate (Qmax), residual volume, and complications. Patients were allocated randomly to the TURP and laser groups. The Ceralas HPD120, a diode laser system emitting at a wavelength of 980 nm, was used for photoselective vaporization of the prostate (PVP). TURP was performed with a monopolar 26 French resectoscope. Preoperative and operative parameters and surgical outcomes were compared.
    RESULTS: In total, 36 patients in each group underwent PVP and TURP. The mean age ± standard deviation was 63.1 ± 9.1 years and 64.7 ± 10.2 years in the PVP and TURP groups, respectively. There were no statistically significant differences in age, prostate size, prostate-specific antigen concentration, Qmax, preoperative IPSS, or preoperative Qmax between the two groups. The operation duration was also similar between the groups (P = .36). The catheterization time was 1.45 ± 0.75 and 2.63 ± 0.49 days in the PVP and TURP groups, respectively (P < .01). The PVP group had a shorter hospital stay than the TURP group. The 3-month postoperative Qmax increased to 9.90 ± 3.61 and 6.59 ± 6.06 mL/s from baseline in the TURP and PVP groups, respectively; there was no difference in the increases between the groups (P = .08). The IPSS and IPSS-QoL were significantly improved with the operation (P < .01), and this improvement was similar in both groups P = .3 and P = .8, respectively . The complication rate was also similar between the two groups.
    CONCLUSIONS: PVP with a diode laser is as safe and effective as TURP in the treatment of BPH, and the techniques have similar complication rates and functional results. PVP has the advantage of shorter hospitalization and catheter indwelling times and no need for discontinuation of anticoagulant therapy.
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  • 文章类型: Journal Article
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